The Applanation Tonometer HT-5000 is indicated for measurement of intraocular pressure (IOP). Intraocular pressure (IOP) is a very important physiological parameter and has always been an indispensable part of the diagnosis and treatment of ophthalmology, especially for glaucoma.

Device Description

The Applanation Tonometer HT-5000 is an active medical device, powered by AAA batteries. The device can be used in conjunction with slit lamp microscopes which are commercially available. Components of the tonometer contains applanation tonometer main body, weight bars, connection arms and measuring prisms.

AI/ML Overview

The provided text describes the Huvitz Applanation Tonometer HT-5000, a manual device for measuring intraocular pressure (IOP). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing studies proving the device meets clinical acceptance criteria for an AI/ML algorithm.

Therefore, many of the requested items related to AI/ML study design (such as human reader improvement with AI assistance, MRMC studies, ground truth establishment for AI training, etc.) are not applicable to this specific device and the information provided. This document describes a traditional medical device (a tonometer) and its physical and electrical performance, not an AI/ML diagnostic or assistive tool.

However, I can extract information related to the acceptance criteria and performance testing conducted for this manual measurement device.

Here's the breakdown of the information available in the provided text:

Device: Huvitz Applanation Tonometer HT-5000

Type of Device: Manual Applanation Tonometer (non-AI/ML device)

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this manual tonometer are primarily defined by adherence to recognized standards and comparative performance with a predicate device, focusing on physical measurement accuracy and safety.

Acceptance Criteria Category	Specific Criteria (Standard/Tolerance)	Reported Device Performance (HT-5000)	Notes
Measurement Deviation/Accuracy	0.49mN or 1.5% of measurement value, whichever is greater (Same as predicate)	Met the specified tolerance; provided reliable and repeatable IOP measurements within the provided IOP range.	Bench testing involved two experimenters measuring six different weight values 10 times in three devices. One investigator also compared accuracy against predicate devices.
Measurement Range	Predicate: 5-65 mmHg	3-75 mmHg	HT-5000 has a wider measurement range. The manufacturer states this difference doesn't affect safety, effectiveness, or intended use.
Electrical Safety	IEC 60601-1, Edition 3.2	All necessary safety testing conducted; demonstrated substantial equivalence to predicate device.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2, Edition 4.1	All necessary safety testing conducted; demonstrated substantial equivalence to predicate device.
Ophthalmic Instruments General Requirements	ISO 15004-1:2020	All necessary safety testing conducted; demonstrated substantial equivalence to predicate device.
Disinfection/Cleaning Validation	FDA guidance 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'	Proposed disinfection/cleaning procedure and disinfectants do not affect damage of mechanical characteristics, degradation of performance characteristics, or degradation of biological characteristics during the defined period.
Biocompatibility	ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021	Considered non-cytotoxic, non-sensitizer, and doesn't cause ocular irritant based on Vitro-Cytotoxicity, Skin Sensitization, and Ocular Irritation tests.	Patient contact part is the front surface of measuring prisms. Contact time ≤ 30 seconds.
Software Verification	IEC 62304:2015	Software verified against design requirements.	The device contains software for numerical display.
Performance Testing Standard	ANSI Z80.10-2014, Ophthalmic Instruments Tonometer	All necessary verification testing conducted; demonstrated substantial equivalence to predicate device in terms of performance and effectiveness.
Tonometer Prism Shelf-Life	Predicate: Recommend not used when > 2 years old	Recommend using for 2 years after first use in normal conditions, or replaced after 600 cycles of disinfection with dilute bleach in 10 minutes.	Manufacturer states effectiveness and safety verified in reliability test despite slight difference.

Study Details (Performance Testing)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: "six different weight values for 10 times in three devices." This indicates 60 measurements per device (6 weights * 10 repetitions), across 3 devices, totaling 180 measurements for the primary bench testing. Additionally, "one investigator measured each weight values in 3 devices and predicate devices" for comparative accuracy.
- Data Provenance: Not explicitly stated, but implied to be laboratory bench testing conducted by the manufacturer, Huvitz Co., Ltd. (Republic of Korea). The data is retrospective in the context of the 510(k) submission, meaning it was collected prior to submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is a manual measurement device, not an AI/ML diagnostic tool requiring expert ground truth in the same way. The "ground truth" for the performance testing was established by applying "known pressures" via calibration bars, verified using the calibration procedure described in ISO 8612:2009, and comparing the device's readings against these known values.
- The bench testing was conducted by "two different experimenters" and "one investigator." Their specific qualifications are not detailed, beyond being capable of performing these technical measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of this device's performance testing. The "ground truth" is physical calibration weights/pressures, not human interpretation requiring adjudication. Performance was assessed by comparing measurements against these known values.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a manual medical device, not an AI-powered one. No human-in-the-loop AI assistance is described or claimed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm. The device itself is the "standalone" unit for measurement. Its performance was assessed independently against physical standards and compared to a predicate device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For performance testing, the ground truth was known physical forces/pressures applied using calibrated equipment (calibration bars), referencing "known pressures covering the measurement range." This is a metrological ground truth.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense.
- For the device's internal calibration during manufacturing, "known pressures covering the measurement range are applied to the measurement arm using a calibration arm using calibration bars." This is a factory calibration procedure, not an AI training process.
How the ground truth for the training set was established:
- Not applicable for the same reason as above. For factory calibration, "ground truth" is established by certified physical standards.

Summary

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October 23, 2023

Image /page/0/Picture/1 description: The image shows 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" in blue, with the word "ADMINISTRATION" underneath.

Huvitz Co., Ltd. % Dave Kim President Mtech Group 7505 Fannin St. Suite 610 Houston, Texas 77054

Re: K232143

Trade/Device Name: Applanation Tonometer HT-5000 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer And Accessories Regulatory Class: Class II Product Code: HKY Dated: September 21, 2023 Received: September 21, 2023

Dear Dave Kim:

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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Enclosure

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Indications for Use

510(k) Number (if known)

K232143

Device Name The Applanation Tonometer HT-5000

Indications for Use (Describe)

The Applanation Tonometer HT-5000 is a manual device intended to measure an intraocular pressure by applanation to aid in the diagnosis of glaucoma.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) Summary

The Summary of 510(k) safety and effectiveness is being summited to comply with 21 CFR Part 807. 92.

General Information

Manufacturer:

Huvitz Co., Ltd. 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, Republic of Korea Phone: 82-31-428-9100 Fax: 82-31-477-8617

Official Correspondent:

Dave Kim, MBA Mtech Group. 7505 Fannin St. Suite 610, Houston, TX 77054 Tel: +713-467-2607 E-mail: davekim(@mtechgroupllc.com

Device Information:

- Trade Name:	The Applanation Tonometer
- Proprietary Name:	HT-5000
- Device Classification Name:	Tonometer, Manual
- Regulation Number:	21 C.F.R. 886.1930,
- Classification:	Class II
- Product Code:	HKY
- Review Panel:	Ophthalmic

Predicate Device Information:

- 510(k) Number:	K133234
- Trade Name:	Digital Keeler Applanation Tonometer (D-KAT)
- Proprietary Name:	R-type KAT
- Device Classification Name:	Tonometer, Manual
- Regulation Number:	21 C.F.R. 886.1930
- Product Code:	HKY
- Review Panel:	Ophthalmic

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Description:

Indication for Use:

The Applanation Tonometer HT-5000 is a manual device intended to measure an intraocular pressure by applanation to aid in the diagnosis of glaucoma.

Intended Use:

The operation principle is based on Goldmann applanation method, which is considered as the gold standard for measuring intraocular pressure. The applanation tonometer plays an important role in the diagnosis and treatment of ophthalmic diseases.

Method of Operation:

Applanation Tonometer is an appliance which intends to measure intraocular pressure based on Goldmann method, also known as Goldmann Applanation Tonometer (GAT). The intraocular pressure, measured by applanation tonometer, is computed from the force required to flatten a constant area of the cornea.

Huvitz Applanation Tonometer HT-5000 is designed in accordance with the Goldmann method which measures intraocular pressure to maintain a uniform applanation of the surface of the eye.

A disinfected or sterile disposable measuring prism is mounted on the Tonometer head at the end of the measurement arm and placed against the cornea after the cornea has been anaesthetized. By moving the slit lamp, the measuring prism comes into contact with the center of the cornea over the pupillary area. The examiner uses a cobalt blue filter to view the semi-circle then adjust the measurement drum on applanation tonometer to apply force to the tonometer head till the inner edges of the semicircle appears in the view where the prism applanation surface becomes ø = 3.06 mm (area = 7.354 mm2). The value is presented on the digital display.

Calibration

During factory calibration procedure, known pressures covering the measurement range are applied to the measurement arm using a calibration arm using calibration bars verified using the calibration procedure described in the Tonometer Standard ISO 8612:2009. Calibration provides a relationship between pressure applied to the measurement arm and the position of the rotating measuring drum. Lineal interpolation is used between the calibration points.

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Substantial Equivalence

Huvitz Applanation Tonometer HT-5000 is considered to be substantially equivalent to the predicate deivce Digital Keeler Applanation Tonometer R-type KAT(K133234). HT-5000 has the same intended use, indications for use, technical features and principles of operation as R-type KAT which has been previously cleared by FDA.

Features	Predicate Device	Subject Device	Notes
	Digital Keeler ApplanationTonometer R-type D-KATK133234	The ApplanationTonometer HT-5000
Type	Manual ContactTonometer	Manual ContactTonometer	Same
Indication for Use	The Keeler ApplanationTonometer is indicatedfor measuring intraocularpressure to aid in thescreening and diagnosisof Glaucoma.	The ApplanationTonometer HT-5000 is amanual device intendedto measure anintraocular pressure byapplanation to aid in thediagnosis of glaucoma.	Same
Units of measure	mmHg-millimeter ofmercury	mmHg-millimeter ofmercury	Same
Design	Slit lamp mounted manualdial	Slit lamp mountedmanual dial	Same
Measurement Range	5-65 mmHg	3-75 mmHg	HT-5000 has awidermeasurementrange thanKeeler's.However, thedifferencedoesn't affectsafety,effectiveness orthe intended use.
Display	Numerical Display-Direct read-out of IOP inmmHg from display	Numerical Display-Direct read-out of IOPin mmHg from display	Same
MeasurementDeviation	0.49mN or 1.5% ofmeasurement valuewhichever is the greater	0.49mN or 1.5% ofmeasurement valuewhichever is the greater	Same
Power Requirement	Single AA battery topower digital display	4-AAA battery to powerdigital display	As voltage ishigh, the powerefficiencyincreases.However, thedifferencedoesn't affect
			safety andeffectiveness.
Software	Contains software	Contains software	Same
Measurement Method	Goldmann method- themeasuring of pressure tomaintain a uniformapplanation of the surfaceof the eye	Goldmann method- themeasuring of pressure tomaintain a uniformapplanation of thesurface of the eye	Same
Calibration	Maintenance andcalibration requiredFactory SetCalibration arm assemblyis supplied with eachdevice to checkcalibration	Maintenance andcalibration requiredFactory SetCalibration armassembly is suppliedwith each device tocheck calibration	Same
Biocompatibility	All materials are testedfor biocompatibility	All materials are testedfor biocompatibility	Same
Cleaning andDisinfectionInstruction forTonometer Prisms	Disinfectants,concentration and time ofimmersion-Pantasept- 3% aqueoussolution for 10 minutes,Hydrogen Peroxide 3%aqueous solution for 10minutesSodium Hypochlorite-10% aqueous solution for10 minutes	Disinfectants,concentration and timeof immersion-Hydrogen Peroxide 3%aqueous solution for 10minutesSodium Hypochlorite-500 ppm aqueoussolution for 10 minutes	Cleaning anddisinfectioninstruction fortonometer prismsare the same. Thedifference inconcentration ofdisinfectant suchas sodiumhypochlorite
Tonometer Prismsrecommended shelf-life	Recommend that theprism is not used when itbecomes more than twoyears of age	Recommend using oftwo years after first usein normal conditions orrecommends that thetonometer prism bereplaced after 600 cyclesof disinfection withdilute bleach in 10minutes	Therecommendedshelf-life oftonometer prismsis slightlydifferent fromeach other.Effectiveness andsafety wasverified in thereliability test.
Sterilization ofTonometer Prisms	Non-Sterile	Non-Sterile	Same

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Electrical Safety and Electromagnetic Capability (EMC)

All necessary safety testing was conducted on the subject device and demonstrated that HT -5000 is substantially equivalent to the predicate device in terms of safety and effectiveness. The safety testing included the followings:

Electrical and Mechanical Safety Testing (according to IEC 60601-1, Edition 3.2)
Electromagnetic Compatibility (according to IEC 60601-1-2, Edition 4.1)
ISO 15004-1:2020 Ophthalmic instruments -- Fundamental requirements and test methods -Part 1:

General requirements applicable to all ophthalmic instruments.

Disinfection Validation

Disinfection/cleaning procedure was applied according to a FDA guidance 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'

A disinfection and cleaning validation was conducted to evaluate performance and safety after a tonometer prism is exposed to a cleaner or to a disinfectant and during defined period.

Proposed disinfection/cleaning procedure and disinfectants doesn't affect damage of mechanical characteristics, degradation of performance characteristics and degradation of biological characteristics during defined period.

Biocompatibility

The biocompatibility evaluation for patient contact material (Measuring prism) of Huvitz Applanation Tonometer was conducted in accordance with ISO 10993-5:2009, ISO 10993-10:2021 and ISO 10993-23:2021 as recognized by FDA. The patient-contact part of HT-5000 is the front surface of measuring prisms.

Contact time: t ≤ Max. 30 second

Patient's contact part: Patient's cornea.

The Applanation tonometer prism of testing included the following tests:

Vitro-Cytotoxicity
Skin Sensitization
Ocular Irritation

Based upon results obtained from studies and in line with ISO10993-5:2009, ISO 10993-10:2021 and ISO 10993-23:2021, Applanation Tonometer prism supplied by Huvitz Co., Ltd is considered as noncytotoxic, non-sensitizer and doesn't cause ocular irritant.

Performance Testing

Bench testing was conducted to verify the measuring force in accordance with ANSI Z80.10-2014, Ophthalmic Instruments Tonometer.

Bench testing was conducted by two different experimenters to measure six different weight values for 10 times in three devices. In addition, one investigator measured each weight values in 3 devices and predicate devices to compare accuracy. The results indicated that HT-5000 provided reliable and

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repeatable IOP measurements within provided IOP range and, HT-5000 met the specified tolerance as the predictive device.

All necessary verification testing was conducted on the subject device under ANSI Z80.10-2014, Ophthalmic Instruments Tonometer and demonstrated that HT-5000 is substantially equivalent to the predicate device in terms of performance and effectiveness

Software

The software used in HT-5000 has been verified against design requirements, as required by IEC 62304:2015 Medical device software - Software life cycle processes.

Conclusion:

HT-5000 has the similar intended use and technological features as the predicate device. Any differences between HT-5000 and the predicate device do not raise any questions regarding safety and effectiveness.

All bench testing and analysis demonstrated that the subject device is substantially equivalent with its predicate device and that the device is safe and effective as intended.

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.