BLOOD FLOW ANALYZER

{0} JUN 17 1997 K970887 June 2, 1997 510(K) Notification Paradigm Medical Industries, Inc., Blood Flow Analyzer Enclosure 1. 510(K) Summary Submitted by: Paradigm Medical Industries, Inc. 1772 West 2300 South Salt 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 115 Computer 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 and the Alcon Applanation Pneumatograph manufactured by Alcon laboratories, Inc. 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. Intended Use: We intend the device for use in the diagnosis of glaucoma. Degree of Accuracy: When compared with Goldmann tonometry, the OBF Tonometer degree of accuracy is <3mmHg. {1} March 7, 1997 510(k) Notification Paradigm Medical Industries, Inc., Blood Flow Analyzer ## Device Specifications: | Power Supply | 110-250 VAC, 50-60 Hz, maximum power consumption 40 W. Power supply is auto sensing. No voltage adjustments are required. | | --- | --- | | Sensor tips | 25μ sensing film. Disposable to eliminate the risk of cross infection, designed to be used only once. Supplied in boxes of 50. Ultrasonically cleaned, then gamma irradiated. | | Slit lamp adapters | A range of adapters is available to suit most leading makes including Haag Streitt, Zeiss, Nikon, etc. | | Printers | Can be connected to a Seiko label plus printing system, any printer which supports Hewlett Packard PCL level 3+, or printers that are Cannon BJ10 compatible. | | Database | A database system which runs under Microsoft Windows™ 3.1 or higher is supplied. It allows analysis of test results from the tonometer and monitoring of patient changes over time, advanced group analysis and search facilities making it a powerful tool for both day-to-day clinical use and research. | | Keyboard | An 86-key keyboard, similar to laptop computers, is available which can be connected to the OBF system to allow entry of names and other patient information. | | Carry case | an optional black ABS case is available to protect the Tonometer and its accessories while in transit. | | Probe dynamic frequency response to intraocular pressure 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) | {2} SUBSTANTIAL EQUIVALENCE COMPARISON | Specification | OBF Model 115 | Blood Flow Analyzer | | --- | --- | --- | | Diagnostic Procedure | Non-invasive measurement of intraocular pressure and pulse amplitude with patient in position of sitting, standing, or supine. | Non-invasive measurement of intraocular pressure and pulse amplitude with patient in position of sitting, standing, or supine. | | Sensor | Remote sensor probe with gas powered sensing element. | Remote sensor probe with gas powered sensing element. | | Sensor tip material | Silicone rubber membrane | Polyurethane membrane | | Data Display | Computer monitor provides numerical readout and graphical display. | Console monitor provides numerical readout and graphical display. | | Data Recording | Dot Matrix Printer or laser printer or plotter with output for chart recorder (vertical axis=pressure [mmHg], horizontal axis=time [seconds] | Thermal Dot Matrix Printer or laser printer or plotter with output for chart recorder (vertical axis=pressure [mmHg], horizontal axis=time [seconds]. | | Data Storage | Computer memory system | Computer memory system, serial communications 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 with plunger/silicone diaphragm system) | Calibration is performed once a month by the user inserting the probe into a tube and then pressing the calibration accept option - this then checks the pneumatics, etc. The user cannot alter the calibration. | {3} March 7, 1997 510(k) Notification Paradigm Medical Industries, Inc., Blood Flow Analyzer # References 1. Ravalico G; Toffoli G; Pastori G; Croce M; Calderini S. Age-related ocular blood flow changes. Invest Ophthalmol Vis Sci 1996 Dec;37(13):2645-50. 2. James CB; Smith SE. Pulsatile ocular blood flow in patients with low tension glaucoma. Br J Ophthalmol 1991 Aug;75(8):466-70. 3. 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. 4. Quaranta L; Manni G; Donato F; Bucci MG. The effect of increased intraocular pressure on pulsatile ocular blood flow in low tension glaucoma. Surv Ophthalmol 1994 May;38. 5. Krakau CE. Calculation of the pulsatile ocular blood flow. Invest Ophthalmol Vis Sci 1992 Aug;33(9):2754-6. 6. Krakau CE. A model for pulsatile and steady ocular blood flow. Graefes Arch Clin Exp Ophthalmol 1995 Feb;233(2):112-8. 7. 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. 8. 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. 9. 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. 10. 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. 11. Claridge KG; Smith SE. Diurnal variation in pulsatile ocular blood flow in normal and glaucomatous eyes. Surv Ophthalmol 1994 May;38 Suppl:S198-205. 12. Claridge KG. The effect of topical pilocarpine on pulsatile ocular blood flow. Eye 1993;7 (Pt 4):507-10. 13. Hopkins SD, Ocular haemodynamics in cataractous eyes. A pilot study. Acta Ophthalmol Suppl 1989;191:43-8. 14. James CB. Effect of trabeculectomy on pulsatile ocular blood flow. Br J Ophthalmol 1994 Nov;78(11):818-22. 10 {4} March 7, 1997 510(k) Notification Paradigm Medical Industries, Inc., Blood Flow Analyzer 15. 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. 16. 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. 17. Langham ME. Ocular blood flow and vision in healthy and glaucomatous eyes. Surv Ophthalmol 1994 May;38 Suppl:S161-8. 18. McRae LP; Kartchner MM. Pressure and volume measurements from the eye for detecting possible arterial obstruction. Ann Biomed Eng 1984;12(1):63-78. 19. 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. 20. Silver DM; Farrell RA. Validity of pulsatile ocular blood flow measurements. Surv Ophthalmol 1994 May;38 Suppl:S72-80. 21. 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. 22. Williamson TH; Harris A. Ocular blood flow measurement. Br J Ophthalmol 1994 Dec;78(12):939-45. 11 {5} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service 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 Lake 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, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7} March 7, 1997 510(k) Notification Paradigm Medical Industries, Inc., Blood Flow Analyzer 000006 # Statement of Indications for Use 510(k) number: unknown Device name: Blood Flow Analyzer Indications for use: 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. (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number: K970887 Prescription Use ☑ (Per 21 CFR 801.109)