DOPPLER GUIDED PROCTOSCOPE, MODEL 500H

{0}------------------------------------------------ Ko52067 12 # AUG 2 9 2005 500H 510k Submission 500H Doppler Guided Proctoscope Multigon Industries, Inc. #### SUMMARY This summary of 510k safety and effectiveness information is being submitted in accordance with 21CFR part 807.92 1. Submitters name, address, phone number, contact person and preparation date: Name: Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 ext. 27 914 376 6111 Fax: Email: wstern@multigon.com Responsible person: William Stern Official correspondent: William Stern Multigon Industries, Inc. 1 Odell Plaza Yonkers, N.Y. 10701 Phone: 914 376 5200 ext. 27 914 376 6111 Fax: Email: wstern@multigon.com Date of Preparation: 7/1/05 2. Proprietary Name: Model 500H Doppler Guided Proctoscope Common /Usual Name: Non Fetal Ultrasonic Monitor Diagnostic Ultrasound Transducer Classification Name: 21 CFR892.1540 Non Fetal Ultrasonic Monitor 21 CFR892.1570 Diagnostic Ultrasound Transducer {1}------------------------------------------------ 500H 510k Submission 500H Doppler Guided Proctoscope Multigon Industries,Inc. Classification Number: 90JAF 90ITX 3. Substantially Equivalent Devices Multigon Industries, Inc. believes that the Model 500H Doppler Guided Proctoscope and Light source and transducers is substantially equivalent to the following cleared devices: | Trade or Proprietary Name | Manufacturer | 510(k) Number | |---------------------------|--------------------------------|---------------| | Model KM-25 | Koven Technology Inc. | k951449 | | Hemo-Dop | DWL Elektronische Systeme,GmbH | k041915 | The 500H includes Cuda Products Corp/ Sun Optics Light Source Model I-150 510k # k893491 and Cuda Products Corp/ Sunoptics fiber optic cable 510k# k901035 repackaged for convenience in the 500H. The 500H includes a CW 8 mHz Doppler which is an updated version of the 8 mHz Doppler electronics module of the model Multigon Model 500A Vascular Spectrum Analyzer with CW Doppler 510k# k860435 which has been repackaged as the 8 mHz CW Doppler without the spectrum analyzer in the 500H for convenience. The 500H has the functionality only of producing the 8 mHz CW Doppler and insonating blood vessels. It enables the user to listen to the 8 mHz CW Doppler sound without any display, or calculation function. Comparison of Multigon Model 500H Doppler Guided Proctoscope and the two predicate devices cited above: Koven Technology, Inc. Model KM-25 and DWL Elektronische Systeme GmbH Hemo-Dop | 500H | KM-25 | Hemo-Dop | |----------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------| | Uses 8mHz CW Doppler<br>Sound to locate<br>Hemorrhoidal artery | Same | Uses 8 mHz Pulsed<br>Doppler to locate<br>Haemorrrhoidal artery | | 8 mHz Doppler probe<br>is removable | 8 mHz Doppler probe<br>is built into the proctoscope | 8 mHz probe is built<br>in to the proctoscope | | Proctoscope is disposable | Proctoscope is not disposable | Proctoscope is not disposable | 12 {2}------------------------------------------------ 500H 510k Submission 500H Doppler Guided Proctoscope Multigon Industries, Inc. | Proctoscope has fiber<br>Optic illumination | Has incandescent<br>bulb illumination<br>built in scope | Has bulb illumination<br>built in scope | |---------------------------------------------|---------------------------------------------------------|-----------------------------------------| | | | C | Proctoscope has a port Same for hemorrhoidal artery ligation Same ## 4. DEVICE DESCRIPTION The model 500H Doppler guided proctoscope consists of two parts . The first part is a Doppler probe in a proctoscope that are used integrally with each other and are not intended to be used separately. The Doppler guided proctoscope has a removable fiber optic light pipe, and a removable 8 mHz CW Doppler probe. The second part is a combination 8 mHz continuous wave (CW) Doppler detector with loudspeaker and a light source. The Doppler guided proctoscope is inserted in the rectum and rotated until one of the branches of the hemorrhoidal artery is located. The artery is located when the user hears the classical arterial blood flow sound. The Doppler guided proctoscope is rotated such that the arterial sound is maximized thus insuring that the hemorrhoidal artery is under the Doppler probe and in the Doppler guided proctoscope's rectangular slit. The physcician or surgeon can then ligate the artery . The Doppler guided proctoscope is then rotated until the next hemorrhoidal artery branch is detected. The process is repeated until all detected hemorrhoidal arteries are located and ligated. After ligation the Doppler guided proctoscope can be rotated 360 degrees to make sure that all of the hemorrhoidal arterial branches have been ligated. #### 5. PERFORMANCE STANDARDS No performance standards have been established for the 500H Doppler Guided Proctoscope under section 514 of the Federal Food and Drug Act. However the 500H Doppler Guided Proctoscope has been designed to meet the following standards: UL 2601-1 Safety Requirements for Medical Equipment AIUM/NEMA UD 2 Standard for Real Time Dsplay of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment AIUM/NEMA UD 3 Standard for Real Time Display of Thermal and Mechanical Output Indices on Diagnostic Ultrasound Equipment IEC 1157 Declaration of Acoustic Power IEC60601-1-2 IEC60601-2-37 {3}------------------------------------------------ ## 6. INDICATIONS FOR USE The 500H is a Doppler guided proctoscope which is used to detect blood vessels supplying hemorrhoids and for performing HAL (Hemorrhoid Arterial Ligation) for Class II and Class III hemorrhoids. It is to be used by physicians in hospitals, clinics, and physicians offices by prescriptions or doctors orders. ### 7. CONTRA-INDICATIONS None known at this time. ## 8. COMPARISON TO PREDICATE DEVICES The 500H Doppler guided proctoscope has the same device characteristics as the approved predicate devices listed in item 3 above with the commonality of 8 mHz Doppler , principles of operation, and a Doppler guided proctoscope. ### 9. TEST DATA The Model 500H Doppler guided proctoscope has been subjected to extensive safety, performance testing, and validation before release. Final testing of the 500H included various performance tests designed to ensure that the device met all of its functional specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards. The Model 500H Doppler guided proctoscope device labeling includes instructions for safe and effective use, warnings, cautions and guidance for use. It has therefore shown to be safe and effective. ### 10. ACOUSTIC OUTPUT This is a summary table of the acoustic output of the 500H. The 500H acoustic output is below preamendment levels for vascular applications and is a Track 1 device. {4}------------------------------------------------ 500H Doppler Guided Proctoscope Multigon Industries, Inc. | | Acoustic Output 500H | | |----------------|------------------------------------|-------------------------| | System: | 500H | | | Probes: | 8 mHz ( center frequency 7.98 mHz) | | | | Three probes were tested. | | | | MI | Ispta.3 (mW/cm squared) | | Mean value | .0075 | 13.5 | | Std. Dev. (Sx) | 0.0003 | 1.3 | | Limit(X) | 0.089 | 19.1 | ### 11. SOFTWARE The 500H has no software or firmware associated with it. ## 12. LITERATURE REVIEW A review of the literature pertaining to the safety of the 500H Doppler guided proctoscope has been conducted and appropriate safeguards have been incorporated in the design of the 500H Doppler guided proctoscope. # 13. CONCLUSIONS The conclusion drawn from these tests is that the 500H Doppler guided proctoscope with an 8 mHz CW Doppler transducer is substantially equivalent in safety and efficacy to the predicate devices listed in item 3 above. {5}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. AUG 2 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Public Health Service Mr. William Stern Official Correspondent Multigon Industries, Inc. 1 Odell Plaza YONKERS NY 10701 Re: K052067 Trade Name: Model 500H Doppler Guided Proctoscope Regulation Number: 21 CFR 892.1540 Regulation Name: Nonfetal ultrasound monitor Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: JAF and ITX Dated: July 28, 2005 Received: August 3, 2005 Dear Mr. Stern: We have reviewed your Section 510(k) premarket notification of intent to market the device we have revewed your Section 510(K) prothantee is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosury to regarly manated to of the Medical Device Americal Device commerce provision in May 20, 1770, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general controls provider for the reactice, labeling, and prohibitions against misbranding and adulteration. This determination of substantial equivalence applies to the following transducers intended for use I ins determination of Substantial equily and #### Transducer Model Number ## 8 MHz Transducer Model 5008 If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classince (see above) into existing major regulations affecting your device can be may be subject to such additional controllars, 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 Flease be advised that 1 DAY's issualled of aevice complies with other requirements of the Act or any FDA hia statutes and regulations administered by other Federal agencies. You must comply with all {6}------------------------------------------------ Page 2 -- Mr. Stern the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); the Act STEQuirements, mortainly, but not miner mine requirements as set forth in the quality labeling (21 CFR Part 601), good manufacturing praviles ble, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This determination of substantial equivalence is granted on the condition that prior to shipping the I his device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in information, including acousine output measurenter 30, 1997 "Information for Manufacturers Seeking Appendix G, (Cherosed) of the Contr & Bound Systems and Transducers." If the special report is Marketing Clearance of Diagnostic Onluss (e.g., acoustic output greater than approved levels), then Incomplete of contains maccopable variable (org, assubts which as a result may be considered adulterated or misbranded. The special report should reference the manufacturer's 510(k) number. It should be clearly and The special reports.com and should be submitted in duplicate to: > Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 This letter will allow you to begin marketing your device as described in your 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 market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific administrat (240) 276-0120. 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, general information on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html If you have any questions regarding the content of this letter, please contact Mr. Rodrigo C. Perez at (301) 594-1212. Sincerely vours, Nancy C Brogdon Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure(s) {7}------------------------------------------------ # Indications for Use 510(k) Number (if known): 1052067 Device Name: Guided Proctoscope Model 500H Dippler The Model 500H Doppler Guided Proctoscope Indications For Use: is used to detect blood vessels supplying hemorrhoids and for performing HAL ( Hemorrhoid Arterial Ligation) for Class II and Class III hemorrhoids. It is to be used by physicians in hospitals, clinics, and physician's offices by prescriptions or doctor's orders. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K022067 Page 1 of {8}------------------------------------------------ #### Diagnostic Ultrasound Indications for Use Form # Fill out one form for each ultrasound system and each transducer. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | | | Mode of Operation | | | | | | | | | | |----------------------------------------------------------------------------------------------------|---|-------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--| | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | | | | N | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | | | | | Additional Comments: 8 MHz Transducer Model 5008 for the<br>Model 1500H Doppler Guided Proctoscope | | | | | | | | | | | | (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nancy C Brogdon (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices Prescription Use (Per 21 CFR 801.109) 510(k) Number F-3 . . . .