DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)

K011873 · Dornier · LNS · Aug 31, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K011873
• Device Name: DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
• Applicant: Dornier
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Aug 31, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dornier Compact Alpha Lithotripter is indicated for fragmentation of 5-25 mm kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones > 4mm.

Device Story

The Dornier Compact Alpha Lithotripter (DoLi S and DoLi S-XP) is an extracorporeal shock wave lithotripter used for the fragmentation of urinary tract stones. The device utilizes electromagnetic shock wave generation (EMSE 220f/220F-P) to focus acoustic energy on stones within the patient's body. It is operated by trained medical professionals in a clinical setting. The system allows for non-invasive stone disintegration, potentially reducing the need for surgical intervention. The physician monitors the procedure and stone fragmentation progress, using the output to guide treatment delivery and assess stone clearance.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design comparisons to legally marketed predicate devices.

Technological Characteristics

Extracorporeal shock wave lithotripter using electromagnetic shock wave generation (EMSE 220f/220F-P). Class II device (21 CFR 876.5990, Product Code 78 LNS).

Indications for Use

Indicated for patients with 5-25 mm kidney stones (renal calyx or pelvic) and ureteral stones > 4 mm (upper, middle, or lower).

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

• Dornier MFL5000 (P840008 / S24/S40/S45)
• Dornier Lithotripter S (P840008 / S64)
• Siemens Lithostar C (P870018 / S11)

Submission Summary (Full Text)

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K011873

# AUG 3 1 2001

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Medical Systems, Inc.'s Compact Alpha Lithotripter

In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the Dornier Lithotripter S with the EMSE 220f as well as the Dornier Lithotripter S-XP with EMSE 220F-P is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices, which includes the following: Dornier MFL5000 (P840008 / S24/S40/S45), Dornier Lithotripter S (P840008 / S64) and Siemens Lithostar C (P870018 / S11).

### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

| Dornier Medical Systems, Inc. | Phone: | 770-426-1315 |
|----------------------------------|------------------------------|------------------------------|
| 1155 Roberts Boulevard | Facsimile: | 770-514-6288 |
| Kennesaw, GA 30144 | Date Prepared: June 14, 2001 | |
| Contact Person: Suzanne Courtney | Phone:<br>Fax: | 770-514-6204<br>770-514-6288 |

#### Name of Device and Name/Address of Sponsor

Dornier Lithotripter S & Dornier Lithotripter S-XP Dornier Medical Systems, Inc. 1155 Roberts Boulevard Kennesaw. GA 30144

#### Classification Name

According to 21 CFR § 876.5990, FDA has classified extracorporeal shock wave lithotripters as Class II device with special controls. The Product Code for these lithotripters is 78 LNS..

#### Predicate Devices

Dornier MFL5000 (P840008 / S24/S40/S45) Dornier Lithotripter S (P840008 / S64) Siemens Lithostar C (P870018 / S11)

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KO//873

#### Intended Use

The Dornier Compact Alpha Lithotripter is indicated for fragmentation of 5-25 mm kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones > 4mm.

## Technological Characteristics and Substantial Equivalence

From a clinical perspective and comparing design specifications, the Dornier I ron a cliniour porce EMSE 220f as well as the Dornier Lithotripter S-XP with EMSE 220F-P, and the predicate devices are substantially equivalent and have EMOE £20. ", and intended use. Based on the technological characteristics and overall performance of the devices, Dornier Medical Systems, Inc. believes that no significant differences exist between the Dornier Lithotripter S with the EMSE 220f as well as the Dornier Lithotripter S-XP with EMSE 220F-P and the predicate devices, Dornier MFL5000 (P840008 / S24/S40/S45), Dornier products - a (P840008 / S64) and Siemens Lithostar C (P870018 / S11).

Dornier Medical Systems, Inc. believes the minor differences of the Dornier Lithotripter S with the EMSE 220f as well as the Dornier Lithotripter S-XP and its predicate devices should not raise any concerns regarding the overall safety or effectiveness.

- This information was prepared for the sole purpose of compliance Advisory: with the Safe Medical Devices Act of 1990. It does not imply that the procedures described herein can be performed with the equipment described without substantial risk of personal injury or oqath to patients due to operator error or in procedures requiring a high degree of skill.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 2001

Ms. Suzanne Courtney Manager, Regulatory and Quality Affairs Dornier Medical Systems, Inc. 1155 Roberts Blvd. KENNESAW GA 30144

Re: K011873

Dornier Lithotripter Doli S and Doli S-XP Dated: August 7, 2001 Received: August 8, 2001 Regulatory Class: II 21 CFR §876.5990/Procode: 78 LNS

Dear Ms. Courtney:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have is We have revel your boured in the indications for use stated in the enclosure) to legally marketed in interstate subsantany of the May 28, 1976, the enatived to the Medical Device Amendments, or to devices that have been reclassified in onliner with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to accordance with the 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 If your device is elassined (soc ao voy more easier a your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, 800 to 07.1 A suosalitian) System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic as set for an and Drug Administration (Q) (CT Newill verify such assumptions. Failure to comply with the GMP regulation may Q in the regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please resur this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of This teating and to our 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 this letter:

| 8xx.1xxx | (301) 594-459 |
|----------------------------------|---------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-461 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-461 |
| 892.2xxx, 3xxx, 4,xxx, 5xxx | (301) 594-465 |
| Other | (301) 594-469 |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-663. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 [phone] or [phone] 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

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### PREMARKET NOTIFICATION

### INDICATIONS FOR USE STATEMENT

510(k) Number:

K011873

Dorner Lithotripter S ("DoLi S") & Dornier Lithotripter S-XP ("DoLi S-XP") Device Name:

Indications for Use:

Indicated for the fragmentation of 5-25 mm kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle and lower ureteral stones > 4mm.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">✓</span> |
|------------------|---------------------------------------------------|
|------------------|---------------------------------------------------|

or

| Over-the-Counter Use | <span style="text-decoration: overline;"></span> |
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Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,