Description
This guidance was written prior to the February 27, 1997 implementation of FDA's Good Guidance Practices, GGP's. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP's.
Scope & Applicability
Product Classes
7Third Party Review Guidance for Phacofragmentation System Device; The primary device subject to this 510(k) guidance.
Subject of the premarket notification 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
multifunctional handpieces would convert the device to a combination device
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
1a legally marketed device to which equivalence is drawn in a 510(k)
Regulatory Context
Attributes
3Standard for 510(k) clearance
Evidence of a new intended use based on communications
Quality parameter that must remain unchanged for the policy
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)
- 21CFR807.87§ 807.87 Information required in a premarket notification submission.
Each premarket notification submission shall contain the following information: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 →
- 21CFR807.92§ 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 →
- 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 →
See Also (8)
- Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (Status: Final)
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates (Status: Final)
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Clinical Electronic Thermometers (Status: Final)
- Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (Status: Final)
- Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters (Status: Final)
- CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers (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)