CATS Tonometer Prism

K173904 · Cats Tonometer, LLC · HKY · Mar 9, 2018 · Ophthalmic

Device Facts

• Record ID: K173904
• Device Name: CATS Tonometer Prism
• Applicant: Cats Tonometer, LLC
• Product Code: HKY · Ophthalmic
• Decision Date: Mar 9, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.1930
• Device Class: Class 2

Intended Use

The CATS Tonometer™ Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure.

Device Story

CATS Tonometer Prism is an optical accessory for Goldmann applanation tonometers; used by clinicians to measure intraocular pressure (IOP). Device modifies standard Goldmann prism by replacing flat contact surface with curved (concave-convex) surface and adjusting length. During clinical use, prism contacts cornea; applanation force is converted to IOP reading (1.0 g = 10 mmHg). Curved surface design aims to improve measurement accuracy compared to traditional flat prisms. Device is used in clinical settings; provides objective IOP data to assist physicians in diagnosing or monitoring ocular conditions like glaucoma.

Clinical Evidence

Clinical evaluation performed per ANSI Z80.10-2014 and FDA guidance. Study compared CATS Tonometer Prism to reference GAT prism in an adult population. Primary endpoint was accuracy of IOP measurement (success criteria: ±5 mmHg difference). Results showed no statistically significant difference in IOP measurements or inter/intra-operator repeatability between CATS and GAT prisms. All paired differences met tolerance levels across specified pressure ranges (7-16, >16-23, and ≥23 mmHg).

Technological Characteristics

Material: PMMA; Prism length: 30 mm; Contact diameter: 7 mm; Refractive index: 1.4906; Adhesive: USP Class VI; Sensing principle: Applanation tonometry; Connectivity: None (mechanical/optical accessory); Sterilization: Not specified; Standards: ANSI Z80.10-2014.

Indications for Use

Indicated for use with Goldmann type tonometers to measure intraocular pressure in adult patients.

Regulatory Classification

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.

Predicate Devices

• GOLDEN VISION (Goldmann) Manual Tonometer (K981432)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|-------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="text-decoration: overline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 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: [phone]

#### 2. Contact:

CATS Tonometer, LLC 1517 N. Wilmot Road, Suite 143 Tucson, Arizona 85712 Telephone: [phone] Contact: Nannon Roosa, COO and CFO Email: [e-mail]

#### 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.

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#### 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<br>differences (mmHg) |
|------------------|-------------------------------------------|
| 7 to 16 | ±5 |
| >16 to < 23 | ±5 |
| ≥23 | ±5 |

The study population included adult population with a balanced distribution in sex and age. No statistically significant difference in IOP measurement was observed between the CATS tonometer prism and the reference GAT tonometer prism. No statistically significant difference in IOP measurement repeatability was observed between the CATS tonometer prism and the reference GAT tonometer prism with respect to inter-operator, intra-operator, as well as lot repeatability.

## Conclusion

Based upon the non-clinical and clinical testing performed, the CATS Tonometer Prism is as safe, as effective, and performs as well as the predicate device. A comparison of the CATS Tonometer Prism and the predicate device is presented in Table 1.

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#### 9. Substantial Equivalence:

The claim of substantial equivalence to the previously cleared GOLDEN VISION (Goldmann) Manual Tonometer (K981432) is supported by the following comparison of characteristics in Table 1 and non-clinical and clinical performance data. Therefore, the CATS Tonometer Prism is substantially equivalent to the predicate device.

| Characteristic | CATS Tonometer™ | Goldmann Tonometer (GAT) |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Indications for use | To be used with<br>Goldmann type<br>tonometers for the<br>measurement of<br>intraocular pressure<br>of the human eye. | To be used for the<br>measurement of<br>intraocular pressure<br>of the human eye. |
| Overall prism length | 30.0 mm | Same |
| Base diameter | 10.96 mm | Same |
| Contact surface diameter | 7.0 mm | Same |
| Bi-prism diameter | 6.0 mm | Same |
| Bi-prism length to corneal<br>contact at full applanation<br>diameter | 10.67 mm @ 3.29 mm | 10.0 mm @ 3.06 mm |
| Bi-prism angle | 30° | Same |
| Index of refraction | 1.4906 | Same |
| Prism construction material | PMMA | Same |
| Prism component adhesive | USP Class VI | Same |
| Prism contact surface | Concave-convex<br>contoured | Flat |
| Prism surface finish | Optical polish | Same |
| Applanating area – diameter | 3.29 mm | 3.06 mm |
| Force to IOP conversion | 1.0 g = 10 mmHg | Same |

| Table 1 - Comparison of CATS Tonometer™ and GAT Prisms | | |
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| | | |