(81 days)
The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures in refractory glaucoma, for retinal detachment, cryo destruction, cataract extraction, cryo destruction of lash follicles, extraction of fragments within the eye, and treatment of retinopathy of prematurity (ROP).
Cryomatic System and Probes comprising of: a) Cryomatic Console b) Cryomatic Probes
This looks like a 510(k) premarket notification for a medical device. Based on the provided text, there's no information about a study with acceptance criteria and device performance as typically understood for AI/ML or diagnostic devices.
The submission is for the Cryomatic System and Probes, which is an ophthalmic cryo system. This device is classified as a Class II cryogenic surgical device.
The core of this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices, which are identified as:
The substantial equivalence is based on "similarity of the subject device to the predicate devices in intended use, materials, design and principles of operation."
Therefore, there isn't a "study" in the sense of a clinical trial or performance evaluation with specific acceptance criteria as you've outlined for diagnostic or AI/ML devices. Instead, the "proof" the device meets acceptance criteria (i.e., being safe and effective for its indicated use) is established by its similarity to already approved devices.
To directly answer your questions based only on the provided text:
- Table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices, not performance against specific numerical acceptance criteria.
- Sample sized used for the test set and the data provenance: Not applicable. There's no test set described for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission for a surgical instrument (an ophthalmic cryo system) seeking clearance based on substantial equivalence to existing devices, not unique performance data from a new clinical study.
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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.
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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,
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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 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
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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
§ 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.