Description
Thisdocumentreflects the current review guidance for the Phacofragmentation System device. It is based on 1) current scientific knowledge, 2) clinical experience, 3) previous submissions by manufacturers to the Food and Drug Administration (FDA), and 4) the Food, Drug and Cosmetic Act, as amended, the Safe Medical Devices Act of 1990 as amended, and FDA regulations in the Code of Federal Regulations (CFR). Following advances in science and medicine, and any new amendments by the Congress to the device acts, these review criteria will be reevaluated and revised as necessary.
Scope & Applicability
Product Classes
5Third Party Review Guidance for Phacofragmentation System Device; The primary device subject to this 510(k) guidance.
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 may convert the system into a combination device.
The devices that are the subject of this guidance are Class II non-spinal metallic bone screws and washers
Stakeholders
3Entity responsible for submitting NDINs
Individual responsible for re-sterilization or following instructions
Allowed value for reporter qualification
Regulatory Context
Attributes
3Evidence of a new intended use based on communications
support the use of the proposed cycle and the desired sterility assurance level
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
Risk of febrile reaction
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)
- CPG Sec. 398.300 Registration of Assemblers of Diagnostic X-Ray Systems as Device Manufacturers (Status: Final)
- Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA Staff (Status: Final)
- 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)
- Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency Use (Status: Final)
- CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic System (Status: Final)
- CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) (Status: Final)
- CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by Ostomates (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)