(77 days)
Not Found
No
The device description and performance studies focus on the physical properties and measurement accuracy of a modified optical prism, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is used for the measurement of intraocular pressure, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended to be used for the "measurement of intraocular pressure," which is a diagnostic measurement. It measures a physiological parameter to aid in diagnosis.
No
The device description explicitly states it is a physical prism made of PMMA, which is a hardware component. The performance studies also involve physical testing on cadaver eyes and bench testing, further indicating it is not a software-only device.
Based on the provided information, the CATS Tonometer™ Prism is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "measurement of intraocular pressure" using a tonometer. This is a direct measurement of a physical parameter within the human body (the eye).
- Device Description: The device is described as an "optical image prism" used with a tonometer. It physically interacts with the eye's surface to facilitate the measurement.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. The CATS Tonometer™ Prism does not process or analyze such specimens. It is a component of a device that directly measures a physical property in vivo.
The device is clearly intended for direct clinical use on a patient's eye, which is characteristic of an in vivo diagnostic or measurement device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CATS Tonometer™ Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure.
Product codes (comma separated list FDA assigned to the subject device)
HKY
Device Description
The CATS Tonometer™ Prism is used as an optical image prism for Goldmann applanation style tonometers. It is a modification of the standard Goldmann Applanation Tonometer (GAT) prism, with the only alteration being the modification of the flat surface in the GAT to a curved surface and a compensatory lengthening in the CATS prism. The CATS prism is made of PMMA, the corneal contact diameter is 7 mm and the total length of the prism is 30 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human eye
Indicated Patient Age Range
adult population
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data
Design verification testing, which consisted of optical and mechanical tests, demonstrated that the CATS Tonometer™ Prism met the design requirements articulated in ANSI Z80.10-2014. Bench testing was also performed in accordance with both ANSI Z80.10, Ophthalmic Instruments - Tonometers and FDA Guidance (March 27, 2006): Tonometers - Premarket Notification [510(k)] Submissions using human cadaver eyes. The primary purpose of this study was to statistically demonstrate that the null hypothesis is valid as far as the difference in IOP measurements between the CATS Tonometer™ Prism and the Goldmann (GAT) tonometer prism in accuracy and repeatability. The study indicated that the accuracy and both inter-operator as well as intra-operator repeatability met or exceeded the performance requirements of the reference GAT tonometer.
Clinical Data
The CATS Tonometer™ Prism was clinically evaluated in accordance with both ANSI Z80.10-2014, Ophthalmic Instruments - Tonometers and FDA Guidance (March 27, 2006): Tonometers - Premarket Notification 510(k) Submissions. The primary performance endpoint was accuracy of IOP measurement readings, as measured by applanation tonometry. The success criteria for the primary endpoint was that the CATS tonometer prism measurements to be within ± 5 mmHg of the GAT tonometer prism measurements. No more than 5% of the paired differences between the reference tonometer (CATS prism) and the test tonometer (GAT prism) readings for each pressure range, would be greater than the tolerance levels:
| IOP range (mmHg) | Tolerance of paired
differences (mmHg) |
|------------------|-------------------------------------------|
| 7 to 16 | ±5 |
| >16 to
§ 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/0 description: The image contains two logos. The first logo on the left is the Department of Health & Human Services - USA logo. The second logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
March 9, 2018
CATS Tonometer, LLC % Paul Kramsky President, Rockin' Regulatory, Inc. 21831 Tumbleweed Circle Lake Forest, CA 92630
Re: K173904
Trade/Device Name: CATS Tonometer Prism Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and Accessories Regulatory Class: Class II Product Code: HKY Dated: December 22, 2017 Received: December 22, 2017
Dear Paul Kramsky:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley S. Cunningham -S
for 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) K173904
Device Name CATS Tonometer™ Prism
Indications for Use (Describe)
The CATS Tonometer™ Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K173904
510(k) Summary for the CATS Tonometer™ Prism
1. Submission Sponsor:
CATS Tonometer, LLC 1517 N. Wilmot Road, Suite 143 Tucson, Arizona 85712 Telephone: 520- 975-4550
2. Contact:
CATS Tonometer, LLC 1517 N. Wilmot Road, Suite 143 Tucson, Arizona 85712 Telephone: 520- 975-4550 Contact: Nannon Roosa, COO and CFO Email: nroosa@intuortech.com
3. Date Prepared:
March 6, 2018
4. Device Name:
| Trade/Proprietary Name: | CATS Tonometer™ Prism |
|---|---|
| Classification Name: | Tonometer and Accessories |
| Product Code: | HKY |
| Regulation Number: | 21 CFR 886.1930 |
ട്. Predicate Devices:
The CATS Tonometer prism is substantially equivalent in terms of intended use and technological characteristics to the GOLDEN VISION (Goldmann) Manual Tonometer (K981432).
6. Device Description:
The CATS Tonometer™ Prism is used as an optical image prism for Goldmann applanation style tonometers. It is a modification of the standard Goldmann Applanation Tonometer (GAT) prism, with the only alteration being the modification of the flat surface in the GAT to a curved surface and a compensatory lengthening in the CATS prism. The CATS prism is made of PMMA, the corneal contact diameter is 7 mm and the total length of the prism is 30 mm.
7. Indications for Use:
The CATS Tonometer™ Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure.
4
8. Performance Data:
Non-Clinical Data
Design verification testing, , which consisted of optical and mechanical tests, demonstrated that the CATS Tonometer™ Prism met the design requirements articulated in ANSI Z80.10-2014. Bench testing was also performed in accordance with both ANSI Z80.10, Ophthalmic Instruments - Tonometers and FDA Guidance (March 27, 2006): Tonometers - Premarket Notification [510(k)] Submissions using human cadaver eyes. The primary purpose of this study was to statistically demonstrate that the null hypothesis is valid as far as the difference in IOP measurements between the CATS Tonometer™ Prism and the Goldmann (GAT) tonometer prism in accuracy and repeatability. The study indicated that the accuracy and both inter-operator as well as intra-operator repeatability met or exceeded the performance requirements of the reference GAT tonometer.
Clinical Data
The CATS Tonometer™ Prism was clinically evaluated in accordance with both ANSI Z80.10-2014, Ophthalmic Instruments - Tonometers and FDA Guidance (March 27, 2006): Tonometers - Premarket Notification 510(k) Submissions. The primary performance endpoint was accuracy of IOP measurement readings, as measured by applanation tonometry. The success criteria for the primary endpoint was that the CATS tonometer prism measurements to be within ± 5 mmHg of the GAT tonometer prism measurements. No more than 5% of the paired differences between the reference tonometer (CATS prism) and the test tonometer (GAT prism) readings for each pressure range, would be greater than the tolerance levels:
| IOP range (mmHg) | Tolerance of paired
differences (mmHg) |
|------------------|-------------------------------------------|
| 7 to 16 | ±5 |
| >16 to