The KOWA KT-800 is a non-contact tonometer with an auto alignment ability of back and forth direction in addition to the same ability as the predicate device.

AI/ML Overview

The KOWA KT-800 is a non-contact tonometer indicated for measuring intraocular pressure to aid in the screening and diagnosis of glaucoma. The study submitted to support its clearance was a substantial equivalence comparison to its predicate device, the Kowa Automated Tonometer KT-500.

Here's the breakdown of the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the KOWA KT-800 were implicitly defined by demonstrating equivalence to the predicate device, Kowa Automated Tonometer KT-500, across several technical and performance specifications. Since it's a substantial equivalence comparison, the "reported device performance" of the KOWA KT-800 is generally stated as being "same" or meeting the specified standards, implying it performs equivalently to the predicate.

Acceptance Criteria (Based on Predicate)	Reported Device Performance (KOWA KT-800)
Measuring Function
Measuring range: 0 to 60mmHg	Same
Measuring accuracy: +/-1mmHg for 0-30mmHg, +/-2mmHg for 30-60mmHg	Same
Measurement time: within 100 milliseconds	Same
Working distance: 11mm	Same
Automatic alignment function: Horizontal & vertical direction, manual alignment	2D auto alignment (H&V), 3D auto alignment (H&V, F&B), Manual alignment
Automatic measurement function: Automatic air blow, manual air blow	Same
Moving range for measurement head (Up/Down): +/- 3mm	Up/Down: +/- 3mm
Moving range for measurement head (Right/Left): +/- 3mm	Right/Left: +/- 3mm
Fixation light: Internal green LED	Same
Electrical Safety IEC60601-1:1988, Amend 1:1991, Amend 2:1995	Met all requirements
Electromagnetic Compatibility IEC60601-1-2:2001	Met all requirements
Risk Management ISO14971:2000	Met all requirements
Ophthalmic Instrument Requirements ISO15004:1997	Met all requirements
Optical Hazard IEC60825-1:1993, Amend 1:1997, Amend 2:2001	Class 1
Tonometer Requirements ISO8612:2001	Met all requirements

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

The provided document does not specify a patient-based test set or its sample size. The performance data primarily relies on bench testing and adherence to international standards rather than a clinical study with patient samples. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).

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

Since no clinical test set with patient data was used to establish ground truth in the traditional sense, this information is not applicable. The "ground truth" for the device's performance was established through its compliance with recognized industry standards and direct comparison of technical specifications to a previously cleared predicate device.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring expert interpretation or consensus, an adjudication method is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted, as the submission focused on substantial equivalence based on technical specifications and adherence to standards, not on human-in-the-loop performance improvement with AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

A standalone performance study, as typically understood in the context of an algorithm's diagnostic accuracy on images, was not performed. The assessment was of the device's functional and safety characteristics in a standalone capacity, specifically its ability to perform measurements and comply with safety standards, but not in terms of image interpretation or classification by an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance was established through:

Compliance with international standards for electrical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2), risk management (ISO14971), ophthalmic instruments (ISO15004), optical hazard (IEC60825-1), and tonometers (ISO8612).
Direct technical comparison to a legally marketed predicate device (Kowa Automated Tonometer KT-500), where the predicate device's established performance served as the benchmark.

8. Sample Size for the Training Set

Since this device is a hardware medical device with automated measurement functions and not an AI/ML-driven imaging or diagnostic algorithm, the concept of a "training set" for an algorithm does not apply. The device's internal mechanisms and algorithms would have been developed and refined during its engineering and manufacturing process, but this is not typically referred to as a "training set" in the context of an FDA submission for such a device.

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

As there is no training set in the AI/ML context, this information is not applicable. The functional integrity and performance of the device's components and automated processes would be validated through engineering tests and quality control during design and manufacturing.

Summary

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K053444

JUN = 9 2006

10. Certification 10.1 Summary for public disclosure

Submitter information:

Applicant:	Kowa Company, Ltd.4-14, Nihonbashi-honcho 3-ChomeChuo-ku, Tokyo, 103-8433 JapanPhone: +81-3-3279-7329Fax: +81-3-3279-7541
Contact:	Shigeru TakimotoResearch and development sectionPhone: +81-53-428-5712FAX: +81-53-428-5719
Date summary prepared:	December 5, 2005

Device identification:

Device trade name:	KOWA KT-800
Classification name:	TONOMETER, AC-POWERED
Product code:	HKX

Intended use:

The KOWA KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

Comparison:

As a substantial equivalent device, Kowa Automated Tonometer KT-500 is chosen. In Table 10.1, regulation information of Kowa Automated Tonometer KT-500 is shown and in Table 10.2, detail information of the device is shown. KOWA KT-800 and Kowa automated Tonometer KT-500 have the same intended used and the similar to technological characteristics.

Kowa Automated Tonometer KT-500 is a non-contact tonometer with two direction automated alignment ability, up and down duration and left and right direction alignment. In addition, Kowa Automated Tonometer KT-500 can measure the intraocular pressure automatically by blowing the air to the subject eye.

KOWA KT-800 has an auto alignment ability of back and forth direction in addition to the same ability as the predicate device.

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KOWA KT-800 delivers safety equivalent to that of the predicate device. The comparison of the devices are provided in Table 10.2.

Performance data:

KOWA KT-800 was tested the following terms and conformed to all specific requirements based on standards. KOWA KT-800 is equivalent to the predicted device.

Electrical safety

KOWA KT-800 was tested in accordance with IEC60601-1: 1988, Amendment 1:1991 and Amendment 2: 1995, and met to all requirements of standard and amendments.

Electromagnetic compatibility

KOWA KT-800 was tested in accordance with IEC60601-1-2: 2001, and met to all requirements of standard.

Risk management

KOWA KT-800 was evaluated in accordance with ISO14971: 2000, and met to all requirements of standard. The risk management of the device were deemed satisfactory. Remaining risks will be noted in the user manual, so users will be able to avoid them.

Test requirements and test procedure for ophthalmic instruments

KOWA KT-800 was tested in accordance with ISO15004: 1997 and was found to meet all requirements of the standard. For optical hazard, KOWA KT-800 was evaluated in accordance with IEC60825-1: 1993 and amendments, A1: 1997 and A2: 2001.The results were Class 1.

Test requirements and test procedure for tonometer

KOWA KT-800 was evaluated in accordance with ISO8612: 2001 and was found to meet all requirements of the standard.

Conclusion:

KOWA KT-800 is equipped with the fundamental technology features equivalent to the predicate device, and also delivers the equivalent level of safety.

Thus it is concluded that there is no difference in the basic functions and safety between KOWA KT-800 and the predicate device.

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Table 10.1: Predicate device
Predicate Device	Manufacturer	510(k) No.	Date Cleared
Kowa Automated TonometerKT-500	Kowa Company, Ltd.	K013805	10/11/2002

Table 10 1· Predic -.. は

Table 10.2: Predicate device comparison

Table 10.2: Predicate device comparison
	Submitted device	Predicate device
Device name	KOWA KT-800	Kowa Automated Tonometer KT-500
Intended use	For measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.	For the measurements of intraocular pressure to aid in the diagnosis of glaucoma.
Measuring function
Measuring range	same	0 to 60mmHg
Measuring accuracy	same	+/-1mmHg for 0 to 30mmHg less+/- 2mmHg for 30mmHg to 60mmHg
Measurement time	same	within 100milisecond
Working distance	same	11mm
Automatic alignment function	2D auto alignment:Horizontal & vertical direction3D auto alignment:Horizontal & vertical direction, and forward & backwardManual alignment:Manual alignment	2D auto alignment:Horizontal & vertical directionManual alignment:Manual alignment
Automatic measurement function	same	Automatic air blowmanual air blow
Moving range for measurement head	Up/Down: +/- 3mmRight/Left: +/- 3mmForward/Backward +/- 3mm	Up/Down: +/- 3mmRight/Left: +/- 3mm
Fixation light	same	Internal green LED
Display and Printer
Display	5.6 inch color TFT monitor	5 inch B&W CRT monitor
Printer	same	58mm wide thermal line printer
Power specification and dimension
Dimension	274mm(W) x 457mm(L) x 458mm(H)	260mm(W) x 450mm(L) x 450mm(H)
Weight	18kg	17kg
Power supply	AC 100V to 230V, 50/60Hz	AC 100 to 240V, 50/60Hz
Power consumption	60VA	65VA

Кома Страну - Чи. КОИ ССР 800

球 - - - - - -

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kowa Co. Ltd. c/o Shinichi Yamanaka, Cosmos Corporation 319 Akeno Obata-Cho, Watarai-Gun Mie-Ken,

Japan 519-05

Re: K053444

Trade/Device Name: Kowa KT-800 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer Regulatory Class: Class II Product Code: HKX Dated: May 25, 2006 Received: May 30, 2006

Dear Mr. Yamanaka:

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 indictions 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 Fedral 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, Inting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

JUN - 9 2006

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 100-100.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eichelman SimWD

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

-K053444_ 510(k) Number (if know):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The KOWA KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device

Clay R. Buttemer

510(k) Number K053444

Kowa Cemograv, Ltd., KOWA KT SOF

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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.