(111 days)
Not Found
Not Found
No
The summary describes a cryosurgical device for ophthalmic procedures and does not mention any AI or ML capabilities.
Yes
The device is used in ophthalmic surgery for procedures like cryopexy for retinal detachment, cyclo destructive procedures in glaucoma, and cataract extraction, all of which are therapeutic interventions.
No.
The device is used for surgical procedures such as cryopexy, destructive procedures, and extraction, which are therapeutic interventions rather than diagnostic processes.
No
The device description is not found, but the intended use clearly describes a physical device (CryoMaster & Probes) used in surgical procedures, which are hardware components.
Based on the provided information, the Keeler CryoMaster & Probes are not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within a living organism) for surgical procedures on the eye. IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor conditions.
- Anatomical Site: The device is used on the "ophthalmic" (eye) anatomical site, which is a part of the living body.
- Device Description, Image Processing, AI/ML, Input Imaging Modality, Training/Test Sets, Performance Studies, Key Metrics: The lack of information in these sections, which are common for IVD devices that often involve analyzing data from specimens, further supports that this is not an IVD.
Therefore, the Keeler CryoMaster & Probes are a surgical device used directly on the patient, not an IVD device used to analyze specimens.
N/A
Intended Use / 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).
Product codes
86 HRN
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a bird in flight, composed of three stylized lines.
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 .
1
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
2
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 | |
|---|---|
| (PLEASE DO NOT WRITE BELOW THE LINE-CONTINUE ON ANOTHER PAGE |
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)