(29 days)
Not Found
Not Found
No
The summary describes a simple protective cover for a medical device and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No.
The device is described as a tip cover to protect a transducer from dust and fluids and to help protect patients from cross-contamination, not to provide a therapeutic effect.
No
The Ocu-Film Tip Cover is described as a protective cover for a Tono-Pen transducer, used to prevent contamination and protect the transducer from dust and fluids. It does not perform any diagnostic function itself.
No
The device description clearly identifies it as a "Tip Cover," which is a physical accessory, not software.
Based on the provided information, the Ocu-Film Tip Cover is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect a medical device (Tono-Pen transducer) and prevent cross-contamination between patients. This is a physical barrier function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: It's a "Tip Cover," which aligns with its protective function.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Ocu-Film Tip Cover is a medical device, but it falls under a different classification than an IVD.
N/A
Intended Use / 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.
Product codes
HKY
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
§ 886.1930 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.
0
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.
1
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
2
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
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