F 900 by C.S.O. S.R.L. | FDA 510(k) Summary

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the CSO Models A900 and F900 Applanation Tonometers. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain the detailed study information typically requested regarding acceptance criteria, device performance, and ground truth establishment.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's what can be inferred or stated based on the provided text:

Acceptance Criteria and Reported Device Performance: This information is not present in the document. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies with defined acceptance criteria for novel device performance claims.
Sample size for the test set and data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
Standalone (algorithm only without human-in-the-loop performance) study: Not mentioned. Since this is a manual tonometer, the concept of an "algorithm only" performance study is not applicable.
Type of ground truth used: Not mentioned.
Sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary based on the document:

This document is a regulatory clearance for a manual applanation tonometer. Its clearance is based on substantial equivalence to predicate devices marketed prior to May 28, 1976. This regulatory pathway means that no specific new clinical performance study, acceptance criteria, or ground truth establishment details are typically required to be submitted or are present in this type of 510(k) summary letter. The device's performance is implicitly considered acceptable because it is substantially equivalent to a device already deemed safe and effective.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 6 2002

C.S.O. s.r.l. c/o R. Brent Miner 197 Belvoir Road Williamsville, NY 14221

Re: K022054

Trade/Device Name: Applanation Tonometer (CSO Models A900 and F900) Regulation Number: 886.1930 Regulation Name: Manual Tonometer Regulatory Class: Class II Product Code: HKY Dated: June 14, 2002 Received: June 24, 2002

Dear Mr. Miner:

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 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) that do not require approval of a premarket approval application (PMA). 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 (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, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does 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 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - R. Brent Miner

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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510 (k) Number (if known) K022054
Device Name: Tonometer, Manual

Indications For Use: CSO F 900 and A 900

A manual device intended to measure intraocular pressure by applanation (applying a small flat disk to the cornea)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over –The-Counter Use (Optional Format 1-2-(6)

Daryl Kauton

(Division Sign-Off) Division of Ophthalmic Devices

02 510 (k) Number

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.