Description
Karaya gum powder and devices made from karaya gum powder intended for use by ostomates have been the subject of recalls because the devices contained opportunistic pathogens.
Scope & Applicability
Product Classes
6Third Party Review Guidance for Phacofragmentation System Device; The primary device subject to this 510(k) guidance.
If this device is to be marketed as a kit, all components must be described
Biological indicators are regulated as class II medical devices
The primary device type discussed in the guidance.; Device type subject to the review checklist
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
2Entity responsible for submitting NDINs
Allowed value for reporter qualification
Regulatory Context
Attributes
4The phaco tip is oscillated at about 40,000 hertz.
Specifications that are directly associated with the intended use of the device.
Quality parameter that must remain unchanged for the policy
The standard for clearing a 510(k) device relative to a predicate.
Identified Hazards
Hazards
3Risk from heat generated by ultrasonic oscillation
Safety information required in the labeling
Risk caused by excessive vacuum build up
Related CFR Sections (4)
- 21CFR807.92§ 807.92 Content and format of a 510(k) summary.
(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. All 510(k) summaries shall conRead 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 →
- 21CFR886.4670§ 886.4670 Phacofragmentation system.
(a) Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.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 →
See Also (8)
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- CPG Sec. 390.425 Records and Reports; Applicability - 21 CFR 1002.1 (Status: Final)
- Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer] (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)
- Guidance on the Content and Format of Premarket Notification [510(k)] Submissions for Sharps Containers (Status: Final)
- Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles (Status: Final)