(111 days)
The Keeler CryoMaster & Probes are for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP).
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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Keeler CryoMaster & Probes." This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and performance studies.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or their data provenance.
- Information on the number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Results of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Results of any standalone algorithm performance studies.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets.
- How ground truth for training sets was established.
This document merely states that the FDA has reviewed the 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. Substantial equivalence is a regulatory standard, not a performance metric defined by a specific study with acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1999
Mr. Eugene R. Van Arsdale Marketing Manager Keeler Instruments, Inc. 456 Parkway Broomall, PA 19008
Re: K992954 Trade Name: Keeler CryoMaster & Probes Regulatory Class: II Product Code: 21 CFR 886.4170/Procode 86 HRN Dated: November 22, 1999 Received: November 29, 1999
Dear Mr. Arsdale:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Eugene R. Van Arsdale
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K992954
Page 1 of 1
Device Name: Keeler CryoMaster & Probes
Indications For Use: The Keeler CryoMaster & Probes are for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP).
| Quynh Hoang, Scientific Reviewer | |
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IF NEEDED)
Division of Ophthalmic Devices K9929.54 510(k) Number.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter USE
(Per 21 CFR 801.109
(Optional Format 1-2-96)
§ 886.4170 Cryophthalmic unit.
(a)
Identification. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.(b)
Classification. Class II.