TRIPTER X-1 COMPACT DUET

{0}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ # SECTION 6 - 510(k) SUMMARY #### Kc23535 PG. I OF 3 [Submitted pursuant to 21 CFR 807.87(h)] ## 1. Submitter Information | Submitter: | Direx Systems Corporation<br>11 Mercer Road<br>Natick Business Park<br>Natick, MA 01760 | |--------------------------------------|-----------------------------------------------------------------------------------------| | Telephone:<br>Fax:<br>Contact Person | (508) 651-0900<br>(508) 651-8125<br>Larisa Gershtein<br>QA Manager | Contact Person e-mail address: lgershtein@direxusa.com #### 2. Device | Trade/Proprietary Name: | Tripter X-1 Compact Duet (to be<br>marketed as "Tripter Duet" or "Duet") | |------------------------------------|--------------------------------------------------------------------------| | Common/Usual Name: | Extracorporeal Shock Wave Lithotripter<br>(ESWL) | | Classification Name/ Product code: | 78 LNS | | Regulatory Class: | Class II | | Regulation Number: | 21 CFR 876.5990 | #### 3. Predicate Devices Tripter X-1 Compact: P920034 Storz Modulith SL-20/ (SLX): P920051 Storz SLK: K010340 PCK Stonelith V5: K011106 {1}------------------------------------------------ ## 4. Intended Use: Fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones). # 5. Technological Characteristics: The Duet is a modification of an existing device that enables the use of 2 reflectors instead of one. The modified device has the same fundamental scientific technology and intended use as predicate devices. ## 6. Description The Duet is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means. The Shock Wave Generator can be operated in 4 modes: - a) Bottom Reflector only. - b) Top reflector only. - c) Alternate mode (asynchronous). - d) Simultaneous mode (synchronous). #### 7. Performance Testing The Duet Lithotripter was tested according to the following standards: - > IEC 60601-1(1988) +A1 (1991) +A2 (1995) - > IEC 60601-1-1 (2000) - > IEC 60601-2-36 (1997) - > IEC 60601-2-38 (1996) +A1 (1999) - > UL 2601-1-1997, CSA-C22.2 No. 601.1 - > IEC 60601-1-2 (2001) - > CISPR 11(1997) + A1 (1999) class B - > IEC 606001-2-36 (1997), clause 36 - IEC 61846 (1998-04) A - IEC EN 1441 A - IEC 60601-1-4 (2000) A {2}------------------------------------------------ ## 8. Clinical Tests No clinical tests were performed. ## 9. Conclusion The Duet meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the fundamental technology or reduce safety and effectiveness, of the Company's predicate device, the Tripter X-1 Compact. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 #### JAN 1 7 2003 Ms. Larisa Gershtein QA Manager DiREX Systems Corp. 11 Mercer Road NATICK MA 01760 Re: K023535 Trade/Device Name: Tripter X-1 Compact Duet Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: December 19, 2002 Received: December 20, 2002 Dear Ms. Gershtein: 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 (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, 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 (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. 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 1000-1050. {4}------------------------------------------------ Page 2 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 one of the following numbers, based on the regulation number at the top of the letter: | 8xx. 1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for "Direx Systems Corp.". The word "Direx" is in a bold, sans-serif font, with a textured effect on the right side of the "X". Below the word "Direx" is a horizontal line, and below that is the text "Systems Corp.", also in a sans-serif font. # INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Ko23535 Device Name: 4-1 Tripter-X1 Compact Duet Indications for Use: The Tripter-X1 Compact Duet Extracorporeal Shock Wave Lithotripter is indicated for use in the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones). (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED) 510(k) Number K023535 Prescription Use (Per 21 CFR § 801.109) OR Over the Counter Use David A. Ingram (Division Sign-Off) Division of Reproducti and Radiological Devic 510(k) Number 11 Mercer Road ♦ Natick, Ma 01760 Phone: 1-888-TRIPTER ♦ Fax: 508-651-8125 A saa millean as a see a last die a mara a n