DORNIER LITHOTRIPTER 140(DOLI 140)

K011773 · Dornier · LNS · Jun 22, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K011773
• Device Name: DORNIER LITHOTRIPTER 140(DOLI 140)
• Applicant: Dornier
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Jun 22, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones and upper ureteral stones.

Device Story

Dornier Lithotripter 140 (Doli 140) is an extracorporeal shock wave lithotripter used for fragmenting urinary tract stones. It functions by generating shock waves focused on the stone to induce fragmentation. The device is operated by trained healthcare professionals in a clinical setting. The system design is based on established lithotripsy technology, similar to the predicate Dornier Compact Alpha and Compact Delta systems. The device provides a non-invasive treatment option for patients with renal or upper ureteral stones, potentially reducing the need for more invasive surgical interventions. Clinical decision-making is supported by the device's ability to target and fragment stones, with the provider monitoring the procedure and stone fragmentation progress.

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 (Class II, 21 CFR 876.5990, Product Code 78 LNS). Utilizes shock wave generation for stone fragmentation. Design and performance specifications are consistent with predicate Dornier Compact Alpha and Compact Delta systems.

Indications for Use

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

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 Compact Alpha Lithotripter (K002929)
• Dornier Compact Delta Lithotripter (P840008 / S65)

Submission Summary (Full Text)

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JUN 2 2 2001

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Dornier Medical Systems, Inc.'s Dornier Lithotripter 140

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 140 ("Doli 140")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 Compact Alpha Lithotripter (K002929) and Dornier Compact Delta Lithotripter (P840008 / S65.

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

| Dornier Medical Systems, Inc.<br>1155 Roberts Boulevard<br>Kennesaw, GA 30144 | Phone: | 770-426-1315 |
|-------------------------------------------------------------------------------|----------------|--------------|
| | Facsimile: | 770-514-6288 |
| | Date Prepared: | June 5, 2001 |
| Contact Person: Suzanne Courtney | Phone: | 770-514-6206 |
| | Fax: | 770-514-6288 |

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

Dornier Lithotripter 140 ("Doli 140") 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 Compact Alpha Lithotripter (K002929) Dornier Compact Delta Lithotripter (P840008 / S65)

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#### Intended Use

K011773
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The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract stones, i.e. renal calyceal stones, renal pelvic stones and upper ureteral stones.

#### Technological Characteristics and Substantial Equivalence

From a clinical perspective and comparing design specifications, the Dornier Lithotripter 140 ("Doli 140") and the predicate devices are substantially equivalent and have the same 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 140 ("Doli 140") and the predicate devices, Dornier Compact Alpha Lithotripter (K002929) and Dornier Compact Delta Lithotripter (P840008 / S65).

Dornier Medical Systems, Inc. believes the minor differences of the Dornier Lithotripter 140 ("Doli 140") 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 death to patients due to operator error or in procedures requiring a high degree of skill.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2001

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

Re: K011773 Dornier Lithotripter 140 ("Doli 140") Dated: June 5, 2001 Received: June 7, 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 determined the we have reviewed your Section 310(x) notherions of mich evelosure) to legally marketed predicate devices device is substantially equivality tot the mactions 16, 1976, the enactment date of the Medical Device Amendments, or to devices marketed in mierslate commeted provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been reclassified in accordance will and provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the general on pro research practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval) it may be subject If your device is classifica (so above nate viass affecting your device can be found in the Code of Federal Regulations, To Such additional controls. Existing major regulated determination assumes compliance with the Current Good Manufacturing ITIE ZT, Paris 800 0 693. A Subsianty of Trailent Georgianion (QS) for Medical Devices: General regulation (21 CFR Partic Practice requirements, as set four in the Quality Dread Nog Administration (FDA) will Verify such as anyances and 820) and that, timough periodic QS mspecions, the Programs, In addition, FDA may publish further announcements to comply will the Unit Togulation may road. In regencies to your premarket notification submission does not concerning your device in the rederal Register. I 1660 notes 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 I his letter will and would to begally marketed predicated 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 and additionally 809.10 for in vitro II you desire specific advice tor your de radition of [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your entified, "Misoraliung of telefice to premation "(Ereires of Small Manufacturers Assistance at its toll-free number (800) 1638-2041 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours

Nancy C Brogdon
Nancy C. Brogdon

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

Enclosure (s)

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## PREMARKET NOTIFICATION

# INDICATIONS FOR USE STATEMENT

510(k) Number:

Koi 1773

Device Name:

Dornier Lithotripter 140

Indications for Use:

The Dornier Lithotripter 140 ("Doli 140") is indicated for fragmentation of urinary tract The Domic Laronplor Tron ( S. ) ( ) = ) = s, renal pelvic stones, and upper ureteral stones.

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------------|
| Prescription Use | <span></span> |
| or | |
| Over-the-Counter Use | <span></span> |

Qirrd a. Lygom
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K011773