Description
Office of Product Evaluation and QualityOffice of Health Technology 1: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
Scope & Applicability
Product Classes
6Third Party Review Guidance for Phacofragmentation System Device; The primary device subject to this 510(k) guidance.
Devices subject to section 522 postmarket surveillance orders; devices subject to postmarket surveillance orders
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
1Entity providing guidance documents upon request
Regulatory Context
Attributes
4Oscillated longitudinally at an ultrasonic frequency of about 40,000 hertz
Classification of components or accessories
Classification of components or accessories
Standard for 510(k) clearance
Identified Hazards
Hazards
4to preclude adverse thermal tissue effects, these devices incorporate cooling mechanisms
Safety information required in the labeling
Claim that device is free of fever-inducing substances
preclude excessive vacuum build up, because it could cause collapse of the anterior chamber
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)
- Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (Status: Final)
- CPG Sec. 391.200 Warning Statement in Advertisements for High-Intensity Mercury Vapor Discharge Lamps that are not Self-Extinguishing (21 CFR 1040.30(e)(3)*) (Status: Final)
- Testing Guidance for Male Condoms Made From New Material (Non-Latex) (Status: Final)
- Third Party Review Guidance For Vitreous Aspiration and Cutting Device Premarket Notification (510(k)) (Status: Final)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Implanted Blood Access Devices for Hemodialysis: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Evidentiary Expectations for 510(k) Implant Devices: Draft Guidance for Industry and Food and Drug Administration Staff (Status: Draft)
- Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)