MODIFICATION TO TRIPTER X-1 COMPACT DUET

K041582 · Direx Systems Corp. · LNS · Jul 7, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041582
• Device Name: MODIFICATION TO TRIPTER X-1 COMPACT DUET
• Applicant: Direx Systems Corp.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Jul 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Tripter-X1 Compact Duet Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

Device Story

Transportable electrohydraulic extracorporeal shock wave lithotripter (ESWL); consists of shock wave generator (SWAG), motorized floating treatment table (MFT), and control system. Incorporates sonographic localization option for ultrasound-guided stone positioning. Used in clinical settings for fragmentation of urinary tract stones. Physician operates device to target stones; shock waves break stones into smaller fragments. Benefits patient by providing non-invasive treatment for urolithiasis.

Clinical Evidence

No clinical tests were performed.

Technological Characteristics

Electrohydraulic shock wave generator; motorized floating treatment table; sonographic localization system for ultrasound-based positioning. Transportable form factor. No specific material standards or software architecture details provided.

Indications for Use

Indicated for patients requiring fragmentation of urinary tract stones, specifically renal calyceal, renal pelvic, and upper ureteral stones.

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

• Tripter X1 Compact Duet (K023535)
• Tripter X1 Compact (K040470)

Submission Summary (Full Text)

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

JUL - 7 2004

K04/582

Page 1 of 2

# 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 | [phone]<br>[phone]<br>Larisa Gershtein<br>QA Manager |
| Contact Person e-mail address: | [e-mail] |
| <b>2. Device</b> | |
| Trade/Proprietary Name: | Tripter X-1 Compact Duet (to be<br>marketed as "Duet") w. Sonographic<br>Localization Option |
| 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 X1 Compact Duet: K023535 Tripter X1 Compact: K040470

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

K041582
Page 2 of 2

#### 4. Intended Use:

The intended use of the Tripter-X1 Duet 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 device, the Tripter X-1 Compact Duet.

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

Image /page/2/Picture/2 description: The image shows a black and white drawing of a circular shape with three curved lines inside. The lines appear to be flowing or cascading downwards. The circle is not fully complete, as it is made up of a series of dots or dashes.

f rod and Drug Administration 9200 Corporate Boulevard Reast ville 140 20450

JUL - 7 2004

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

Re: K041582

Trade/Device Name: Tripter –XI Compact Duct with Sonography Localization Option Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: May 9, 2004 Received: June 14, 2004

Dear Ms. Gershtein:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 ro(x) prematice 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 enclosure) to regary manological Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Days commerce prior to May 28, 1776, the exactiance with the provisions of the Federal Food, Drug, devices that have been recassince in accordance with a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvince controls provisions of the Act. The You may, therefore, market the devros, subject to me go
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rice meralies commitment against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), If your device is classified (SC above) and entines regulations affecting your device can be
it may be subject to additional controls. Existing major It may be subject to adultional controls. Bittle 31, Parts 800 to 898. In addition, FDA may found in the Code of rederal regarders.
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 Picase be advised that FDA 3 issuates of a secondics with other requirements of the Act that FDA has made a decemmation mac your intered by other Federal agencies. You must of any Pederal statues and regalations as themelers of the limited to: registration and listing comply with an the Act STEQuirements, metaling, no and manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing de collect (21 CFR Part 807), labeling (21 CFR Part 820); and 1f applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); 2009; 1950 forth in the quality Systems (Qo) registeriors (25-542 of the Act); 21 CFR 1000-1050.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) This lefter will allow you to begin marketing of substantial equivalence of your device to a legally premarket nothication. The FDA momg or bassification 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 If you desire specific advice tor your decided on be and against on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions of the promotion and the regulation entitled, "Misbranding Othios of Compliance at [phone]. Fab., production of Coltain. Other general by relerence to premarket notification (DFCF it in a may be obtained from the Division of Small information on your responsionities and consumer Assistance at its toll-free number [phone] or Manufacturers, International and Octoballity of/hearth.com/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

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

Image /page/4/Picture/0 description: The image shows the logo for "Direx Systems Corp.". The word "Direx" is in large, bold, black letters. Underneath "Direx" is a horizontal line, and below that is the text "Systems Corp." in smaller, black letters. The logo appears to be for a company in the systems or technology industry.

# INTENDED USE STATEMENT

510(k) Number (if known):

04/582

Device Name:

Tripter-X1 Compact Duet

Intended Use:

The intended use of the Tripter-X1 Compact Duet Extracorporeal The Intended use of the fripter is the fragmentation of urinary tract stones Shock Wave Exholipter frenal pelvic, and upper ureteral stones).

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

510(k) Number K041582

Prescription Use (Per 21 CFR § 801.109) OR

Over the Counter Use_

Nancy Brogdon

(Division Sign-Off) () (Division Sign on) of Reproductive, Abdominal, and Radiological Devices 510(k) Number.

11 Mercer Road ♦ Natick, Ma 01760 Phone: 1-888-TRIPTER ♦ Fax: [phone] ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4-1