A tonometer and acsessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye 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. We intend the device for use in the diagnosis of glaucoma.

Device Description

A tonometer and accessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye 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. We intend the device for use in the diagnosis of glaucoma.

AI/ML Overview

The Blood Flow Analyzer, manufactured by Paradigm Medical Industries, Inc., is a tonometer and accessories intended to measure intraocular pressure by applying a known force on the globe of the eye to measure intraocular tension by applanation (applying a small flat disk to the cornea). This device is intended for use in the diagnosis of glaucoma.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Degree of Accuracy (< 3mmHg)	< 3mmHg when compared with Goldmann tonometry

2. Sample Size and Data Provenance

The provided document does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts and their Qualifications

The provided document does not contain information regarding the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method

The provided document does not contain information regarding the adjudication method used for the test set.

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

There is no indication in the provided document that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, or any effect size related to human reader improvement with AI assistance. The device described appears to be a standalone instrument for physical measurement, not an AI-assisted diagnostic tool for image interpretation by readers.

6. Standalone Performance

The document describes the "Degree of Accuracy" of the Blood Flow Analyzer as "<3mmHg when compared with Goldmann tonometry." This indicates a standalone performance evaluation of the device's accuracy in measuring intraocular pressure.

7. Type of Ground Truth Used

The ground truth used for establishing the accuracy of the Blood Flow Analyzer was Goldmann tonometry. The device's accuracy is reported as being "<3mmHg" in comparison to this established method.

8. Sample Size for the Training Set

The provided document does not contain information regarding the sample size for the training set.

9. How Ground Truth for Training Set was Established

The provided document does not contain information regarding how the ground truth for the training set was established.

Summary

{0}------------------------------------------------

JUN 17 1997

K970887

June 2, 1997 510(K) Notification 510(18) Notification
Paradigm Medical Industries, Inc., Blood Flow Analyzer

Enclosure 1.

510(K) Summary

Submitted by:	Paradigm Medical Industries, Inc.1772 West 2300 SouthSalt Lake City, Utah 84119(801) 977-8970
Contact Person:	Richard Dirkson, Director of Regulatory Affairs
Prepared:	June 2, 1997
	Trade Name - Blood Flow Analyzer Common Name - Tonometer and Accessories Classification Name - Tonometer and Accessories
Predicate Device:	Ocular Blood Flow Laboratories (OBF) Model 115Computer Tonometer System (K873422, SE date 11/02/87)
	The OBF Labs' device was found equivalent to the Digilab OCVM-Ocular Cerebral Vascular Monitor manufactured by Digilab andthe Alcon Applanation Pneumatograph manufactured by Alconlaboratories, Inc.
Device Description:	A tonometer and accessories are devices intended to measureintraocular pressure by applying a known force on the globe of theeye to measure intraocular tension by applanation (applying asmall flat disk to the cornea). Accessories for the device mayinclude a tonometer calibrator or a tonograph recording system.We intend the device for use in the diagnosis of glaucoma.
Intended Use:	We intend the device for use in the diagnosis of glaucoma.
Degree of Accuracy:	When compared with Goldmann tonometry, the OBF Tonometerdegree of accuracy is <3mmHg.
Power Supply	110-250 VAC, 50-60 Hz, maximum power consumption40 W. Power supply is auto sensing. No voltageadjustments are required.
Sensor tips	25µ sensing film. Disposable to eliminate the risk ofcross infection, designed to be used only once. Suppliedin boxes of 50. Ultrasonically cleaned, then gammairradiated.
Slit lamp adapters	A range of adapters is available to suit most leadingmakes including Haag Streitt, Zeiss, Nikon, etc.
Printers	Can be connected to a Seiko label plus printing system,any printer which supports Hewlett Packard PCL level3+, or printers that are Cannon BJ10 compatible.
Database	A database system which runs under MicrosoftWindows™ 3.1 or higher is supplied. It allows analysis oftest results from the tonometer and monitoring of patientchanges over time, advanced group analysis and searchfacilities making it a powerful tool for both day-to-dayclinical use and research.
Keyboard	An 86-key keyboard, similar to laptop computers, isavailable which can be connected to the OBF system toallow entry of names and other patient information.
Carry case	an optional black ABS case is available to protect theTonometer and its accessories while in transit.
Probe dynamic frequencyresponse to intraocularpressure change	10 kHz
sampling frequency	200 Hz
Tonometer dimensions	280 x 240 x 100 mm, weight 4.5 kgs.(11 x 9.5 x 4 inches, 10 pounds)

{1}------------------------------------------------

March 7, 1997
510(k) Notification
Paradigm Medical Industries, Inc., Blood Flow Analyzer

Device Specifications:

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows a curved line. The line is thick and black. The curve is a shallow arc, with the ends pointing upwards.

SUBSTANTIAL EQUIVALENCE COMPARISON

Specification	OBF Model 115	Blood Flow Analyzer
Diagnostic Procedure	Non-invasive measurement of intraocular pressureand pulse amplitude with patient in position of sitting,standing, or supine.	Non-invasive measurement of intraocularpressure and pulse amplitude with patient inposition of sitting, standing, or supine.
Sensor	Remote sensor probe with gas powered sensingelement.	Remote sensor probe with gas powered sensingelement.
Sensor tip material	Silicone rubber membrane	Polyurethane membrane
Data Display	Computer monitor provides numerical readout andgraphical display	Console monitor provides numerical readout andgraphical display.
Data Recording	Dot Matrix Printer or laser printer or plotter with outputfor chart recorder (vertical axis=pressure [mmHg],horizontal axis=time [seconds])	Thermal Dot Matrix Printer or laser printer orplotter with output for chart recorder (verticalaxis=pressure [mmHg], horizontal axis=time[seconds]).
Data Storage	Computer memory system	Computer memory system, serialcommunications to a PC, floppy disk.
Gas	Physiologically inert dichlorodifluormethane	Filtered room air
Low gas indicator	red indicator lamp	N/A
Calibration	external calibration verifier standard (air gauge withplunger/silicone diaphragm system)	Calibration is performed once a month by theuser inserting the probe into a tube and thenpressing the calibration accept option - this thenchecks the pneumatics, etc. The user cannotalter the calibration.

{3}------------------------------------------------

References

Ravalico G: Toffoli G: Pastori G: Croce M: Calderini S. Aqe-related ocular blood flow 1. changes. Invest Ophthalmol Vis Sci 1996 Dec;37(13):2645-50.
1. James CB; Smith SE. Pulsatile ocular blood flow in patients with low tension glaucoma. Br J Ophthalmol 1991 Aug:75(8):466-70.
1. Silver DM; Farrell RA; Langham ME; O'Brien V; Schilder P. Estimation of pulsatile ocular blood flow from intraocular pressure. Acta Ophthalmol Suppl 1989;191:25-9.
1. Quaranta L; Manni G; Donato F; Bucci MG. The effect of increased intraocular pressure on pulsatile ocular blood flow in low tension claucoma. Surv Ophthalmol 1994 May:38.
1. Krakau CE. Calculation of the pulsatile ocular blood flow. Invest Ophthalmol Vis Sci 1992 Aug;33(9):2754-6.
1. Krakau CE. A model for pulsatile and steady ocular blood flow. Graefes Arch Clin Exp Ophthalmol 1995 Feb;233(2):112-8.
1. Bosem ME: Lusky M: Weinreb RN. Short-term effects of levobunolol on ocular pulsatile flow. Am J Ophthalmol 1992 Sep 15:114(3):280-6.
1. Bosley TM; Cohen MS; Gee W; Reed J 3d; Sergott RC; Savino PJ. Amplitude of the ocular pneumoplethysmography waveform is correlated with cardiac output. Stroke 1993 Jan;24(1):6-9.
1. Carenini AB; Sibour G; Boles Carenini B. Differences in the longterm effect of timolol and betaxolol on the pulsatile ocular blood flow. Surv Ophthalmol 1994 May;38 Suppl:S118-24.
1. Claridge KG; James CB. Ocular pulse measurements to assess pulsatile blood flow in carotid artery disease. Br J Ophthalmol 1994 Apr;78(4):321-3.
1. Claridge KG; Smith SE. Diurnal variation in pulsatile ocular blood flow in normal and glaucomatous eyes. Surv Ophthalmol 1994 May;38 Suppl:S198-205.
1. Claridge KG. The effect of topical pilocarpine on pulsatile ocular blood flow. Eye 1993;7 ( Pt 4):507-10.
1. Hopkins SD, Ocular haemodynamics in cataractous eyes. A pilot study.Acta Ophthalmol Suppl 1989;191:43-8.
1. James CB. Effect of trabeculectomy on pulsatile ocular blood flow. Br J Ophthalmol 1994 Nov:78(11):818-22.

{4}------------------------------------------------

March 7. 1997 510(k) Notification Paradigm Medical Industries, Inc., Blood Flow Analyzer

1. Kerty E; Horven I; Dahl A; Nyberg-Hansen R. Ocular and cerebral blood flow measurements in healthy subjects. A comparison of blood flow velocity and dynamic tonometry measurements before and after acetazolamide. Acta Ophthalmol (Copenh) 1994 Aug;72(4):401-8.
1. Kothe AC. The effect of posture on intraocular pressure and pulsatile ocular blood flow in normal and glaucomatous eyes. Surv Ophthalmol 1994 May:38 Suppl:S191-7.
1. Langham ME. Ocular blood flow and vision in healthy and glaucomatous eyes. Surv Ophthalmol 1994 May;38 Suppl:S161-8.
1. McRae LP; Kartchner MM. Pressure and volume measurements from the eye for detecting possible arterial obstruction. Ann Biomed Eng 1984:12(1):63-78.
1. Morsman CD; Bosem ME; Lusky M; Weinreb RN. The effect of topical beta-adrenoceptor blocking agents on pulsatile ocular blood flow. Eye 1995;9 ( Pt 3):344-7.
1. Silver DM; Farrell RA. Validity of pulsatile ocular blood flow measurements. Surv Ophthalmol 1994 May;38 Suppl:S72-80.
1. Sugiyama DT; Townsend JC; Bright DC: Ilsen PF. Support for the vasogenic theory of glaucoma: case reports and literature review. J Am Optom Assoc 1993 Aug;64(8):568-82.
1. Williamson TH; Harris A. Ocular blood flow measurement. Br J Ophthalmol 1994 Dec;78(12):939-45.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 17 1997

Mr. Richard Dirkson -Director of Regulatory/Quality Affairs Paradigm Medical Industries, Inc. 1772 West 2300 South Salt Bake City, UT 84119

Re: K970887 Trade Name: Blood Flow Analyzer Regulatory Class: II Product Code: 86 HKY Dated: June 2, 1997 Received: June 6, 1997

Dear Mr. Dirkson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{6}------------------------------------------------

Page 2 - Mr. Richard Dirkson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

0000006

March 7, 1997 510(k) Notification Paradigm Medical Industries, Inc., Blood Flow Analyzer

Statement of Indications for Use

510(k) number: unknown Device name: Blood Flow Analyzer

Indications for use: A tonometer and acsessories are devices intended to measure intraocular pressure by applying a known force on the globe of the eye 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. We * intend the device for use in the diagnosis of glaucoma.

Denis L. McCarthy
(Division Sign-Off)

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.