Description
This guidance document provides recommendations for 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use. These devices are designed to deliver irrigation fluid to the surgical site, such as knee, shoulder, hip, elbow, ankle, and wrist joint cavities, during arthroscopic procedures.
Scope & Applicability
Product Classes
2intended for multiple patient use; Subject of the guidance document regarding premarket notification submissions.; external-communicating devices in contact with tissue/bone/dentin; Intended for Multiple Patient Use; Subject of the labeling requirements and multi-patient use validation.
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
1Entity responsible for submitting NDINs
Regulatory Context
Attributes
5Intended use of the tubing sets
Validated use life for certain consumable components.
e.g., 24 Hour Use tubing
Status required for valve and connector components.
Requirement for devices provided sterile or non-sterile
Identified Hazards
Hazards
6automated liquid handling systems can pose a risk of contamination within or between test runs
Entry of microorganisms into the sterile fluid path
undesirable reversal of water flow causing contamination
Risk resulting from contaminated irrigation systems
biocompatibility endpoint and risk from chemicals leaching from device
risk of febrile reaction
Related CFR Sections (3)
- 21CFR888.1100§ 888.1100 Arthroscope.
(a) Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.Read full regulation →
- 21CFR801.109§ 801.109 Prescription devices.
A device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe except under the supervision of a practitioner licensed by law to direct the use of such device, and hence for which “adequate directions for use” canRead full regulation →
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information:Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
- 2025-08-26
CGMP/QSR/Medical Devices/Adulterated
Miach Orthopaedics
See Also (8)
- Presenting Risk Information in Prescription Drug and Medical Device Promotion (Status: Draft)
- Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (Status: Draft)
- Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers (Status: Draft)
- Surgical Staplers and Staples for Internal Use - Labeling Recommendations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- 510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments (Status: Final)
- CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases (Status: Final)