Description
The information collection provisions in this guidance have been approved under OMB control number 0910-0120. This approval expires 5/31/07 . An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
Scope & Applicability
Product Classes
5Biological indicators are regulated as class II medical devices
Guidance for devices to treat spinal insufficiency fractures
AC powered device with a fragmenting needle intended for use in cataract surgery; specific device subject to these labeling and sterilization requirements
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
3The appropriate panel is the Ophthalmic Devices Panel
Includes patients, healthcare providers, specialized professionals, and consumers.; Includes patients, healthcare providers, specialized professionals, lay users, consumers
Allowed value for reporter qualification
Regulatory Context
Attributes
5oscillated longitudinally at an ultrasonic frequency of about 40,000 hertz
Comparability factor against predicate device
Evidence of a new intended use based on communications
support the use of the proposed cycle and the desired sterility assurance level
The standard for clearing a 510(k) device relative to a predicate.
Identified Hazards
Hazards
3preclude adverse thermal tissue effects from heat generated by oscillation
Risks that must be delineated in labeling
preclude excessive vacuum build up which could cause collapse of the eye 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)
- Third Party Review Guidance for Phacofragmentation System Device Premarket Notification (510(k)) (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)