The Reichert Tono-Vera® Tonometer is a hand-held, battery powered instrument that utilizes rebound methodology to measure the intraocular pressure (IOP) of the eye. The tonometer propels a small, plastic-tipped measurement probe in a controlled manner against a patient's unanesthetized eye in order to calculate IOP. The device has a simple, four-button control system and an LCD that provides information to the operator and displays measurement results.

There are two Tono-Vera Tonometer models:
· Tono-Vera Tonometer Starter Kit, AA Battery, Model 16305; and
• Tono-Vera Tonometer Starter Kit, Rechargeable, Model 16306.

Both models of the Tono-Vera Tonometer have a required accessory, the Ocu-Dot® Tonometer Probe, model 16318. The Ocu-Dot Tonometer Probe is a sterile, single-use, disposable accessory.

The Tono-Vera Tonometer utilizes a camera-based alignment system, called ActiView™ to improve alignment with the apex of the cornea and reduce measurement variability caused by operator technique. The measuring process starts automatically once alignment conditions are fulfilled.

The device has two measurement options: 3+ (Quick) Measurement Option and 6 Measurement Option. Both the 3+ (Quick) Measurement Option and 6 Measurement Option use the same calculation for the IOP result. The 3+ (Quick) Option can calculate a final IOP result with as few as three measurements. The 6 Measurement Option always uses six measurements to calculate the final IOP result.

The Tono-Vera Tonometer can be connected to a computer with ReichertSync® installed on it. Data from ReichertSync can be imported by an EMR system.

The Tono-Vera Tonometer determines IOP by detecting and analyzing the motion of the measurement probe as it briefly contacts the cornea.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets it, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text primarily focuses on demonstrating substantial equivalence to a predicate device (Icare Ic100) and meeting an industry standard (ANSI Z80.10-2014) for tonometry. Specific numerical acceptance criteria for a direct comparison study between the Tono-Vera Tonometer and the Goldmann Applanation Tonometer are not explicitly stated as a table within the document. However, the performance metrics reported against the predicate device give us an indication of the performance expected and validated.

Metric (Against Predicate Device: Icare Ic100)	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (Tono-Vera)
Pressure Range 5 to <20 mmHg
Accuracy (±2 SD)	<0.95 (Predicate's performance)	0.49
Repeatability (CV%)	<6.30% (Predicate's performance)	2.30%
Pressure Range >20 to 60 mmHg
Accuracy (±2 SD)	<2.57 (Predicate's performance)	1.82
Repeatability (CV%)	<3.00% (Predicate's performance)	2.00%
Overall Equivalence	Safe and effective at IOP tonometry measurements without anesthesia per ANSI Z80.10-2014 standard	Met this standard

Study Details Proving Acceptance Criteria

The text describes two main evaluations:

Bench Test Comparison against Predicate Device (Icare Ic100): This study focused on demonstrating similar or improved performance characteristics compared to a legally marketed device.
Clinical Study against Goldmann Applanation Tonometer (referencing ANSI Z80.10-2014 standard): This study aimed to demonstrate the device's fundamental safety and effectiveness for IOP measurements.

Here's the breakdown of details for the latter, more comprehensive study:

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The text only mentions "Reichert conducted a clinical study."
Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The study compared the device against the Goldmann Applanation Tonometer, which is the "gold standard" for IOP measurement. The implication is that the measurements from this standard device served as the reference for ground truth.

4. Adjudication Method for the Test Set

The text does not mention any adjudication method. The comparison was against the Goldmann Applanation Tonometer, implying that its measurements were considered definitive.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly described in the provided text. The clinical study was focused on the Reichert Tono-Vera Tonometer's equivalence to the Goldmann Applanation Tonometer based on the ANSI Z80.10-2014 standard. There is no mention of comparing human readers with AI assistance versus without AI assistance. The Tono-Vera Tonometer itself uses a camera-based alignment system (ActiView™) which aids the operator, but this isn't presented as a human-AI comparison study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not explicitly described. The device is a tonometer operated by "properly trained eye care professionals," implying human interaction is integral to its use. While the "ActiView™" system has an auto-measure mode, the context suggests it's still part of a human-operated workflow, not a standalone AI device.

7. The Type of Ground Truth Used

External Reference Standard: The ground truth for the clinical study was established by comparison to the Goldmann Applanation Tonometer (GAT), which is widely considered the gold standard for intraocular pressure (IOP) measurement. The study aimed to demonstrate equivalence "per the requirements of the ANSI Z80.10-2014 standard," which likely sets performance benchmarks relative to GAT.

8. The Sample Size for the Training Set

Not applicable/Not mentioned. The text describes performance testing and a clinical study, but does not refer to a "training set" in the context of machine learning. The device utilizes an "ActiView™" camera-based alignment system, which might involve internal algorithms, but no specific machine learning training data or training set size is provided.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned. As no machine learning training set is explicitly discussed, there's no information on how its ground truth might have been established.

Summary

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May 1, 2024

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Reichert, Inc. Elizabeth Schultz Manager, Regulatory Affairs 3362 Walden Avenue, Suite 100 Depew. New York 14043

Re: K233516

Trade/Device Name: Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer And Accessories Regulatory Class: Class II Product Code: HKY Dated: March 22, 2024 Received: March 25, 2024

Dear Elizabeth Schultz:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh-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 Y. Ng -S

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

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K233516 - Elizabeth Schultz

Enclosure

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Indications for Use

Submission Number (if known)

K233516

Device Name

Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)

Indications for Use (Describe)

The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes is intended to be used 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) #: K233516		510(k) Summary
Contact Details		21 CFR 807.92(a)(1)
Applicant Name		Reichert, Inc.
Applicant Address		3362 Walden AvenueSuite 100Depew NY 14043United States
Applicant Contact Telephone		716-686-4568
Applicant Contact		Ms. Elizabeth Schultz
Applicant Contact Email		Elizabeth.Schultz@ametek.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name		Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes(16305, 16306, 16318)
Common Name		Tonometer and accessories
Classification Name		Tonometer, Manual
Regulation Number		886.1930
Product Code		HKY
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K153694	Icare Ic100	HKY
Device Description Summary		21 CFR 807.92(a)(4)
Device Description [807.92(a)(4)]a. Physical Description:

There are two Tono-Vera Tonometer models:

· Tono-Vera Tonometer Starter Kit, AA Battery, Model 16305; and

• Tono-Vera Tonometer Starter Kit, Rechargeable, Model 16306.

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Both models of the Tono-Vera Tonometer have a required accessory, the Ocu-Dot® Tonometer Probe, model 16318. The Ocu-Dot Tonometer Probe is a sterile, single-use, disposable accessory.

b. Device Features:

The Tono-Vera Tonometer can be connected to a computer with ReichertSync® installed on it. Data from ReichertSync can be imported by an EMR system.

The Tono-Vera Tonometer determines IOP by detecting and analyzing the motion of the measurement probe as it briefly contacts the cornea.

c. Patient Contact: There are two direct patient contact points: the adjustable Flexi-Soft Forehead Rest which is used to stabilize the device during the measurement sequence and the Ocu-Dot Tonometer Probe which touches the patient's eye during the measurement sequence.

d. Use Environment: The Tono-Vera Tonometer is a prescription-only device. It is intended to be used by properly trained eve care professionals such as ophthalmologists, opticians, and eye-care technicians. The device will be used in doctors' offices, clinics, and hospitals.

Intended Use/Indications for Use

The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes is intended to be used for the measurement of intraocular pressure of the human eye.

Indications for Use Comparison

The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes have the same intended use and Indications for Use as the Icare Ic100 (K153694). Both devices are intended to be used for the measurement of intraocular pressure (IOP) of the human eye. The Indications for Use of the Tono-Vera Tonometer and Ocu-Dot® Tonometer Probes adopts the same language from the Indication for Use of the Icare Ic100 (K153694) in that both devices are intended to be used for the measurement of intraocular pressure of the human eye. Both devices have similar IOP measurement ranges and accuracy profiles. Both devices are similar in size, shape, and display function. The differences between the Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes and the Icare Ic100 (K153694), do not raise any different questions of safety and effectiveness as confirmed through the Performance Testing.

Technological Comparison

The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (proposed device) and the Icare Ic100 (K153694) (predicate device) are highly similar in key safety and technological characteristics. Both devices use rebound technology to measure intraocular pressure (IOP). Both devices are active, microprocessor controlled, handheld devices that use a sterile, disposable, single-use probe to contact a patient's unanesthetized eye during the IOP measurement.

The bench test comparison for measurement accuracy and repeatability using proposed device and predicate device was performed to establish basis for substantial equivalence over the entire measurable

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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IOP range (5 to 60 mmHg) of the proposed device. The results for Pressure Range 5 to <20 mmHg showed the proposed device with Accuracy (±2 SD) of 0.49 and Repeatability (CV%) of 2.30% as compared to the predicate device with Accuracy (±2 SD) of 0.95 and Repeatability (CV%) of 6.30%. Whereas the results for Pressure Range >20 to 60 mmHg showed the proposed device with Accuracy (±2 SD) of 1.82 and Repeatability (CV%) of 2.00% as compared to the predicate device with Accuracy (±2 SD) of 2.57 and Repeatability (CV%) of 3.00%.

The Tono-Vera utilizes a camera-based alignment system, called ActiView, to improve alignment and reduce measurement variability associated with operator technique, whereas the predicate device is a manual device which does not have a comparable alignment system. However, the ActiView Auto Measure Mode can be disabled in the system menu and the operator can choose to take manual measurements instead.

The Tono-Vera has a Data Transfer feature where the IOP measurement results can be transferred via Bluetooth to an EMR system whereas the predicate has no Data Transfer capabilities.

Both the Tono-Vera Tonometer (Model 16305 (AA Battery)) and predicate device have the same power supply, 4 x 1.5V AA batteries. Whereas the second option of Tono-Vera Tonometer (Model 16306 (Rechargeable)) uses a 3.7V Li-ion rechargeable battery pack.

The Tono-Vera device has a measurement range of 5-60 mmHg (display range of 1-99 mmHg) and the predicate device has a measurement range of 7-50 mmHg (display range of 1-99 mmHg.). The predicate device uses six measurements to produce a single IOP result. Tono-Vera 6 Measurement Option also uses six measurements to produce a single IOP result. In addition, Tono-Vera has a second measurement option that can be selected by the operator. The Tono-Vera 3+ (Quick) Measurement option can produce an IOP result in as few as three measurements.

The devices are similar in Display, Weight, and Dimensions. The devices are similar in materials in that both use thermoplastic materials for the device housings and tonometer probe tip. There are minor differences in the Force applied to the eye during the rebound measurement and in the Device Orientation during use. The predicate has a wider range for force applied to the eve during measurement. The predicate device must be oriented roughly horizontally, whereas the Tono-Vera can be oriented horizontally within ± 15 degrees.

Overall, the Tono-Vera Tonometer and Ocu-Dot Tonometer Probes are substantially equivalent to the predicate device, Icare ic 100 Tonometer. They share technological characteristics with regard to physical and measurement attributes. Reichert has performed comprehensive performance testing to demonstrate that the device meets all required specifications. The testing demonstrated that the technological differences between Tono-Vera Tonometer and Ocu-Dot Tonometer Probes and the Icare Ic100 (K153694) do not raise any different questions of safety or effectiveness.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

All necessary bench testing were conducted on the Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes to support a determination of substantial equivalence to the predicate device.

Non-Clinical Testing included:

Performance Testing Bench
· Electrical Safety and Electromagnetic Compatibility
· Biocompatibility Testing
· Sterilization Validation Testing
· Shelf-Life and Packaging Validation Testing

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The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes does not raise different questions of safety or effectiveness when compared to the predicate Icare Ic100 (K153694) Tonometer.

Reichert conducted a clinical study between May 2022 and August 2022. (National Clinical Trial Number NCT05345262). The primary endpoint of the study was to determine if the Reichert Tono-Vera® Tonometer is equivalent to the Goldmann Applanation Tonometer per the requirements of the ANSI Z80.10-2014 standard. The study was a prospective, cross-sectional, single-center, nonsignificant risk study. The results demonstrate that Reichert Tono-Vera® Tonometer is safe and effective at IOP tonometry measurements without the need for anesthesia per the requirements of the ANSI Z80.10-2014 standard.

The Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes are substantially equivalent to the predicate Icare Ic100 (K153694) Tonometer. The devices have the same intended use, similar indications for use, and both devices use rebound technology to measure intraocular pressure. The devices have similar IOP measurement ranges and accuracy profiles. They are similar in size, shape. and display function. The Clinical study results demonstrate that Tono-Vera is safe and effective at IOP tonometry measurements without the need for anesthesia per the requirements of the ANSI Z80.10-2014 standard.

Regulation Number and Section

§ 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.