(165 days)
Not Found
No
The description focuses on the physical properties and intended use as an optical prism, with no mention of AI/ML algorithms or data processing beyond basic image formation.
No
Explanation: The device is a tonometer prism used for measuring intraocular pressure, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate a medical condition.
Yes
Explanation: The device is used for "measurement of intraocular pressure of the human eye," which is a diagnostic function.
No
The device description explicitly states it is a physical prism made of PMMA, indicating it is a hardware component, not software.
Based on the provided information, the CATS®-D Tonometer Prism is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to measure intraocular pressure of the human eye in vivo (within the living body). IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body).
- Device Description: The device is a prism used with a tonometer, which is a device that directly interacts with the eye to measure pressure.
- Anatomical Site: The anatomical site is the human eye, indicating direct interaction with the body.
The device is a medical device, but it falls under the category of devices used for direct measurement or treatment of the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The CATS®-D Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.
Product codes (comma separated list FDA assigned to the subject device)
HKY
Device Description
The CATS®-D Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. It is made of PMMA, the corneal contact diameter is 6.5 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
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Design verification and sterilization validation and shelf-life testing were performed. Cytotoxicity (MEM Elution), Sensitization (Kligman Maximization Test), and Irritation (Intracutaneous irritation test) were performed per ISO 10993-5 and ISO 10993-10. The device was reported to be non-cytotoxic, non-sensitizing and non-irritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
CATS Tonometer LLC Paul Kramsky Consultant 1517 N. Wilmot Suite 143 Tucson, Arizona 85712
Re: K203850
Trade/Device Name: CATS®-D Tonometer Prism Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer and accessories Regulatory Class: Class II Product Code: HKY Dated: May 4, 2021 Received: May 6, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elvin Ng Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203850
Device Name
CATS®-D Tonometer Prism
Indications for Use (Describe)
The CATS®-D Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
510(k) Summary for the CATS®-D Tonometer Prism
5.1 Submission Sponsor:
CATS Tonometer, LLC 1517 N. Wilmot, Suite 143 Tucson, Arizona 85712 Telephone: 520- 975-4550
5.2 Contact:
CATS Tonometer, LLC 1517 N. Wilmot, Suite 143 Tucson, Arizona 85712 Telephone: 520- 975-4550 Contact: Nannon Roosa, President Email: nannon(@catsiop.com
5.3 Date Prepared:
June 8, 2021
5.4 Device Name:
| Trade/Proprietary Name: | CATS®-D Tonometer Prism |
|---|---|
| Classification Name: | Tonometer and Accessories |
| Product Code: | HKY |
| Regulation Number: | 21 CFR 886.1930 |
ર્સ્ટ Predicate Devices:
The CATS®-D Tonometer Prism is substantially equivalent in terms of intended use and technological characteristics to the CATS® Reusable Tonometer prism (K173904).
ર્ડ.6 Device Description:
The CATS®-D Tonometer Prism is used as an optical image prism for Goldmann applanation style tonometers. It is made of PMMA, the corneal contact diameter is 6.5 mm and the total length of the prism is 30 mm.
5.7 Indications for Use:
The CATS® Tonometer Prism is intended to be used with Goldmann type tonometers for the measurement of intraocular pressure of the human eye.
5.8 Performance Data:
Design verification and sterilization validation and shelf-life testing were performed. Cytotoxicity (MEM Elution), Sensitization (Kligman Maximization Test), and Irritation (Intracutaneous irritation test) were performed per ISO 10993-5 and ISO 10993-10. The device was reported to be non-cytotoxic, non-sensitizing and non-irritating.
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5.9 Substantial Equivalence:
The CATS®-D Tonometer Prism is substantially equivalent to the 510(k) cleared CATS® reusable prism with the exception being that the disposable prism is supplied with a sterilized detachable, which snaps on to the prism housing, whereas the 510(k) cleared reusable prism was connected to the body with adhesive. This change resulted in a very slight decrease in overall length of the prism, which does not affect the safety and effectiveness of the device. In addition, the packaging was changed to a cardboard box consisting of a PETG tray with Tyvek lid, and sterilization by Ethylene Oxide. The claim of substantial equivalence to the previously cleared CATS® Reusable Tonometer Prism (K173904) is supported by the following comparison of characteristics in Table 1 and non-clinical performance data. Therefore, the CATS®-D Tonometer Prism is substantially equivalent to the predicate device.
| Characteristic | CATS®-D Tonometer
Prism | CATS® Reusable
Tonometer Prism
(Predicate) |
|-----------------------------|-----------------------------------------------|--------------------------------------------------|
| Overall length | 28.75 mm | 30.0 mm |
| Base diameter | 10.9 mm | 10.9 mm |
| Contact surface diameter | 6.5 mm | 7.0 mm |
| Bi-Prism diameter | 6.0 mm | 6.0 mm |
| Bi-Prism length | 10.67 mm | 10.67 mm |
| Applanation Diameter | 3.29 ± 0.02 | 3.29 ± 0.02 |
| Bi-prism angle | 30 degrees | 30 degrees |
| Index of refraction | 1.4906 | 1.4906 |
| Prism construction material | PMMA | PMMA |
| Prism component adhesive | Class 9 | Class 9 |
| Prism contact surface | Concave-convex
contoured | Concave-convex
contoured |
| Prism surface finish | Optical polish | Optical polish |
| Force to IOP conversion | 1.0g = 10mm Hg | 1.0g = 10mm Hg |
| Prism tip | Detachable | Connected to body |
| Packaging | 4 PETG trays w/Tyvek
lids in cardboard box | Cardboard box |
| Sterilization | Ethylene Oxide | Non-sterile |