(29 days)
The Ocu-Film Tip Cover is intended to be used to protect the Tono-Pen transducer from dust and fluids, and helps protect patients from risk of cross-contamination.
Ocu-Film Tip Cover
The provided document is a 510(k) clearance letter from the FDA for a device called "Ocu-Film Tip Cover." This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the Ocu-Film Tip Cover is substantially equivalent to legally marketed predicate devices and is intended to protect Tono-Pen transducers from dust and fluids, and to help protect patients from the risk of cross-contamination.
Therefore, I cannot provide the requested information because it is not present in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing growth and protection. The bird is positioned within a circle, and the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
Food and Drug Administration
Public Health Service
9200 Corporate Boulevard Rockville MD 20850
Reichert Inc. c/o Sandra Brown Quality Regulatory Affairs Manager 3362 Walden Ave. Depew, NY 14043
Re: K070534
Trade/Device Name: Ocu-Film Tip Cover Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Codes: HKY Dated: February 22, 2007 Received: February 26, 2007
Dear Ms. Brown:
This letter corrects our substantially equivalent letter of March 27, 2007.
We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 5 ro(x) promatice is substantially eqtivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in-interstate for use stated in the encrosure) to legally manage profithe Meciical Device Amendments on to commerce prior to May 26, 1970, the charter with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance with of a provisions of the Act. The and Cosment Act (Act) that do not require approvise of the general controls of the Act. The You may, merelore, market the device, subject to integration, listing of the may and general Controls provisions of the Fiel morals capalititions against misbranding and adulteration.
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APR - 5 2007
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) this extremations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional Controls: Existing miger segment on addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 do Roger be found in the Code of Federal Regarning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised inal FDA s issualles of a successfiles with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a determinations administered by other Federal agencies. You must light or any Federal statutes and regulations administers bet not limited to: registration mantas as set comply with all the Act s requirements, melants, watched requiremes, as setting CFR Part 607), rabening (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) roganient (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Sandra Brown
This letter will allow you to begin marketing your device as described in your Section 510(lt I his lener will anow you to begin manoling your as read of your device to a legally premance notheadon. The PDF maing of casion 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 Prices artitled If you desire specific acree for your as (240) 276-0115. Also, please note the regulation entitled, contact the Office of Compliance at (210) 216-still Part 807.97). You may obtain "Misoranomy by reference to pecification in the Act from the Division of Small other general information on your responsion.ess and its toll-free number (800) 638-2041 or Manufacturers, Internet and Outschury: http://www.fda.gov/cdrivindustry_support/index.html.
Sincerely yours,
M.B. Evertshon Si MusD
Malvina B. Eydelman, 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
510(k) Number (if known):
Device Name: Ocu-Film Tip Cover
Indications for Use:
The Ocu-Film Tip Cover is intended to be used to protect the Tono-Pen transducer from dust and fluids, and helps protect patients from risk of cross-contamination.
X 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deauisfei
3/23/2007
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devlses
510(k) Number K070534
Page ( of of
§ 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.