(81 days)
Not Found
No
The summary describes a cryosurgery system and probes, with no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is used for cryopexy procedures in ophthalmic surgery to treat various medical conditions, which falls under the definition of a therapeutic device designed to treat disease or injury.
No
Explanation: The device is described for use in ophthalmic surgery for various cryopexy procedures and treatments, not for diagnosing conditions.
No
The device description explicitly lists hardware components: a Cryomatic Console and Cryomatic Probes.
Based on the provided information, the Keeler Cryomatic System and probes are not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in ophthalmic surgery for various procedures on the patient's eye. This is an in vivo application (within a living organism).
- Device Description: The description mentions a console and probes, which are typical components of a surgical device used directly on the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) outside the body, which is the defining characteristic of an IVD.
IVDs are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The Keeler Cryomatic System is a surgical tool used directly on the patient.
N/A
Intended Use / Indications for Use
The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures for retinal detachment, cyclocryo destruction in refractory glaucoma, extraction of magnetic and non-magnetic foreign bodies and lens fragments within the eye, cryo destruction of lash follicles and treatment of retinopathy of prematurity (ROP).
Product codes
HRN
Device Description
Cryomatic System and Probes comprising of: a) Cryomatic Console b) Cryomatic Probes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmic / eye
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K062412
510 (k) Summary Section 3
February 23rd 2006
NUW - 6 2006
1 Submitter
Keeler Instruments Inc 456 Parkway Broomall PA. 19008 USA.
Contact: Mr. Eugene r. Van Arsdale Marketing Manager Tel: 001 610 353 4350 Fax: 001 610 353 7814 E.Mail: erv@keelerusa.com
2 Name of Device
Proprietary Name: Cryomatic System and Probes comprising of:
- a) Cryomatic Console
- b) Cryomatic Probes
Common Name
- Ophthalmic Cryo. Systems and Probes
Device Classification: Cryogenic Surgical devices have been placed in Class II as per 21 CFR Regulation Number 886.4170 and assigned the Product Code 86HRN
3 Predicate Devices
The components of the Cryomatic System are substantially equivalent to the following legally marketed devices:
This statement is based on the similarity of the subject device to the predicate devices in intended use, materials, design and principles of operation.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is represented by three abstract, wave-like lines, and the text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 6 2006
Keeler Instruments Inc. c/o Mr. Eugene R. Van Arsdale 456 Parkway Broomall, PA 19008
Re: K062412
Tradc/Device Name: Cryomatic System & Probes Regulation Number: 21 CFR 886.4170 Regulation Name: Cryophthalmic unit Regulatory Class: II Product Code: HRN Dated: October 18, 2006 Received: October 20, 2006
Dear Mr. Van Arsdale:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in intestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Fiond, Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, ing and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, TDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as seg forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000,
2
Page 2 - Mr. Eugene R. Van Arsdale
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Egelston MD
Malvina B. Fydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Page 1 of 1
KO62412 510(k) Number (if known):
Device Name: Cryomatic System & Probes
Indications for Use:
The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy The Reeler Cryoniatic Bystem and procedures in refractory glaucoma, extraction of for remal detachinent, eyello destruction, cataract extraction, cryo destruction of lash follicles fragments within treatment of retinopathy of prematurity (ROP)
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Marsha L. Dimple Nicholas
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K062412