(142 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is a diagnostic tool used to measure intraocular pressure, not to treat a condition.
Yes
The device is intended to measure intraocular pressure, which is a diagnostic measurement for conditions like glaucoma.
No
The device is described as a "hand held non contact tonometer," which implies a physical hardware device used to measure intraocular pressure. The summary does not mention any software-only components or functions.
Based on the provided information, the PT100 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "measure the intraocular pressure of the eye." This is a measurement taken directly from the living body (in vivo), not on a sample of human origin (in vitro).
- 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 within those samples
- Providing information about a physiological or pathological state based on sample analysis
The PT100 is a medical device, but it falls under the category of devices that interact directly with the patient's body for measurement or treatment, rather than analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The PT100 is a hand held non contact tonometer intended to measure the intraocular pressure of the eye.
Product codes
HKX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
eye
Indicated Patient Age Range
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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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2002
Mr. Frank J. Drexelius Regulatory Affairs Manager Leica Microsystems, Inc. 3374 Walden Ave. Dephew, NY 14043
Re: K013259
Trade/Device Name: Reichert PT100 Portable (Tonometer) Regulation Number: 21 CFR 886.1930 Regulation Name: Non-Contact Tonometer Regulatory Class: II Product Code: HKX Dated: January 15, 2002 Received: January 17, 2002
Dear Mr. Drexelius:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreaty to togally to the enactment date of the Medical Device Amendments, or to commerce proc to May 20, 1978, are cassordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). and Cosmetion (110. (110.) that be nevice, subject to the general controls provisions of the Act. The I ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls provision 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 If your device is exassince (too as controls. Existing major regulations affecting your device can may be subject to back access as 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 I loase of devices that I bromination that your device complies with other requirements of the Act that I Dr Horal statutes and regulations administered by other Federal agencies. You must or any is 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 Of It Fat 0077; accems (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.
1
Page 2 - Mr. Frank J. Drexelius
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 premaince nedicate 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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Section D
510(k) Number (if known):_K(0)3 259
Device Name:_PT100
Indications for use:
The PT100 is a hand held non contact tonometer intended to measure the intraocular pressure of the eye.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Iluska L. Biuke nicholas
ivision Sign-Off) Division of Ophthalmic Devices
510(k) Number_K0/3259
Prescription Use_ Y (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)