TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)

K050091 · Direx Systems Corp. · LNS · Mar 16, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050091
• Device Name: TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)
• Applicant: Direx Systems Corp.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Mar 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Duet SP Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

Device Story

Duet SP is a transportable electrohydraulic extracorporeal shock wave lithotripter (ESWL). System components include a shock wave generator (SWAG), motorized floating treatment table (MFT), and control unit. Device incorporates sonographic localization for stone positioning. Operated by clinical staff in a medical setting to fragment urinary tract stones (renal calyceal, renal pelvic, upper ureteral). Clinical benefit is non-invasive stone fragmentation, reducing need for surgical intervention.

Clinical Evidence

No clinical tests were performed.

Technological Characteristics

Transportable electrohydraulic lithotripter. Includes shock wave generator, motorized floating treatment table, and control system. Features sonographic localization for ultrasound-guided positioning. Fundamental technology is identical to predicate devices.

Indications for Use

Indicated for fragmentation of urinary tract stones, including renal calyceal, renal pelvic, and upper ureteral stones in adult patients.

Regulatory Classification

Identification

An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.

Special Controls

*Classification.* Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)

Predicate Devices

• Duet (K023535)
• Duet SLO (K041582)
• TWINHEADS TH-101 (K030346)

Submission Summary (Full Text)

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# SECTION 6 -- 510(k) SUMMARY

[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<br>Contact Person e-mail address: | [phone]<br>[phone]<br>Larisa Gershtein<br>QA Manager<br>[e-mail] |
| 2. Device | |
| Trade/Proprietary Name: | Duet SP |
| 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

Duet k023535, Duet SLO k041582, and TWINHEADS TH-101 k030346

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#### 4. Intended Use:

The intended use of the Duet SP Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

#### 5. Technological Characteristics:

This Duet includes a sonographic localization option that enables the use of ultrasound for positioning. The 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.

#### 7. Clinical Tests

No clinical tests were performed.

#### 8. Conclusion

The Duet with the Sonographic Localization Option 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 devices: Duet k023535 and Duet SLO k041582.

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Image /page/2/Picture/1 description: The image is a black and white emblem. The emblem is circular and contains a stylized bird in the center. The bird is flying towards the right. The text "DEPARTEMENT OF KULTUR & KESENIAN NEGARA" is written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 2005

Ms. Larisa Gershtein Quality Assurance Manager Direx Systems Corp. 11 Mercer Road NATICK MA 01760

Re: K050091

Koodor1
Trade/Device Name: Duet SP Extracorporeal Shock Wave Lithotripter Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: February 17, 2005 Received: February 22, 2005

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 (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 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
. I has begin and the subserved and coloralence of your device to a lexall This letter will allow you to begin market it your device of your device of your device to a legally
premarket notification. The FDA innding of substantial equir device and premarket notification. The FDA finding of Substantial equiralifor of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our labering regaration (1 - 1 - 1
contact the Office of Compliance at one of the following numbers, based on the regulation the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misorianaling of your responsibilities under the Act from the 807.97). You may obtain other general information on your respear.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K050091

Device Name: Duet SP Extracorporeal Shock Wave Lithotripter

Indications for Use: The intended use of the Duet SP Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

V Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Broadon

(Division Sig Division of Reproductive, Ab and Radiological Devices 510(k) Number