TRIPTER X-1 COMPACT

K040470 · Direx Systems Corp. · LNS · Apr 28, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040470
• Device Name: TRIPTER X-1 COMPACT
• Applicant: Direx Systems Corp.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Apr 28, 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 Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

Device Story

The Tripter-X1 Compact is a transportable electrohydraulic extracorporeal shock wave lithotripter (ESWL) used for fragmenting urinary tract stones. The system comprises a shock wave generator (SWAG), a motorized floating treatment table (MFT), and control means. It incorporates a sonographic localization option, allowing clinicians to use ultrasound imaging to position the device relative to the stone. The device is operated by healthcare professionals in a clinical setting. By focusing shock waves on the stone, the device facilitates fragmentation, which can assist in the treatment of renal and ureteral calculi. The output is controlled by the operator to ensure accurate targeting based on sonographic feedback.

Clinical Evidence

No clinical tests were performed.

Technological Characteristics

Transportable electrohydraulic extracorporeal shock wave lithotripter. Components include a shock wave generator (SWAG), motorized floating treatment table (MFT), and control unit. Features a sonographic localization option for ultrasound-guided positioning.

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 Series Lithotripters (Tripter-X1 and Tripter -X1 Compact) (P-920034)
• Tripter X1 Compact Duet (K023535)
• Ipu Rx-2 Image processing unit, Radiology (K964327)
• Dornier CompactS / Compact Delta (P840008/S56)
• Dornier Compact Alpha (K002929 and K011873)
• SONOLITH 3000 (P880011)

Submission Summary (Full Text)

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APR 2 8 2004

# SECTION 6 - 510(k) SUMMARY

K040470
Page 1 of 2

[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] |
| 2. Device | |
| Trade/Proprietary Name: | Tripter X-1 Compact (to be marketed as<br>"Compact") w. Sonographic Localization<br>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 Series Lithotripters (Tripter-X1 and Tripter -X1 Compact): P-920034 Tripter X1 Compact Duet: K023535 Ipu Rx-2 Image processing unit, Radiology K964327 Dornier CompactS / Compact Delta: P840008/S56 Dornier Compact Alpha: K002929 (and K011873) SONOLITH 3000 PMA: P880011

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K640470

Coyh. 242

## 4. Intended Use:

The intended use of the Tripter-X1 Compact 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 Compact 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 Compact 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 Compact 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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2004

Ms. Larisa Gershtein QA Manager DiREX Systems Corporation 11 Mercer Road NATICK MA 01760

Re: K040470

Trade/Device Name: Tripter-X1 Compact Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: April 1, 2004 Received: April 5, 2004

Dear Ms. Gershtein:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have a rowe a your 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally premarket notification. The PDA mailing or casonalism 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 for your dones on one of the following numbers, based 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, Tor questions on the promotion = ............................................................................................................................... Othice of Compliance at (301) 33 P 1.059 Part 807.97) you may obtain. Other general by reference to prematical (Dr. It is in the Act may be obtained from the Division of Strail information on your responsional and Consumer Assistance at its toll-free number [phone] or Manufacturers, International and Octablant Solusion of Schools of Schildsmaldsmamain.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

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# INTENDED USE STATEMENT

510(k) Number (if known): X04047 o

Device Name:

Tripter-X1 Compact

Intended Use:

The intended use of the Tripter-X1 Compact Extracorporeal Shock Wave Lithotripter is 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 K040470

Prescription Use (Per 21 CFR § 801. 109)

OR

Over the Counter Use

Daniel G. Seymann

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

11 Mercer Road ↓ Natick, Ma 01760 Phone: 1-888-TRIPTER + Fax: [phone] e - mail : p r o m o @ d i r e x u s a . c o m