INTEGRA

K053640 · Direx Systems Corp. · LNS · Mar 1, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K053640
• Device Name: INTEGRA
• Applicant: Direx Systems Corp.
• Product Code: LNS · Gastroenterology, Urology
• Decision Date: Mar 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5990
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INTEGRA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.

Device Story

Integra is a transportable electromagnetic (EM) extracorporeal shock wave lithotripter (ESWL) for urinary stone treatment. It integrates an EM shockwave generator with a parabolic reflector for focusing, a fluoroscopic imaging system (based on 3Dscope), and interfaces for ultrasonic imaging. Unlike systems requiring patient table movement, the reflector moves in three directions for targeting. The device features an in-line X-ray localization system and an off-line movable ultrasound transducer. Operated by clinicians in a clinical setting, the device uses imaging to localize stones, then delivers focused shock waves to fragment them. This non-invasive procedure aims to facilitate stone passage, reducing the need for invasive surgery.

Clinical Evidence

Confirmatory clinical study conducted per FDA guidance 'Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi'.

Technological Characteristics

Transportable EM lithotripter; EM shockwave generator with parabolic reflector; in-line X-ray localization; off-line ultrasound transducer; 3-axis reflector movement. Complies with IEC 60601-1, 60601-1-1, 60601-1-2, 60601-1-3, 60601-2-7, 60601-2-36, 60601-2-38, IEC 61846, CISPR 11, and ISO 10993-1.

Indications for Use

Indicated for fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter 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

• Storz Modulith® SL-20/ (SLX) (P920051)
• Storz Modulith® Lithotripter Model SLK (K010340)
• Direx Tripter X - 1 Compact Duet (K041582)
• Direx 3Dscope (K041213)

Submission Summary (Full Text)

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# SECTION 5 - 510(k) SUMMARY ___________________________________________________________________________________________________________________________________________________

K053640

[Submitted pursuant to 21 CFR 807.92(a). All data included in this document are accurate and complete to the best of DSC's knowledge.]

#### 1. Submitter Information

| Submitter: | Direx Systems Corporation<br>437 Turnpike Street<br>Canton, MA 02021 |
|--------------------------------------|----------------------------------------------------------------------|
| 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: | Integra |
| Common/Usual Name: | Extracorporeal Shock Wave Lithotripter (ESWL) |
| Regulation Number: | 21 CFR 876.5990 |
| Requlatory Class: | Class II (special controls) |
| Product code: | 78 LNS |
| Panel: | Gastroenterology and Urology |

#### 3. Predicate Devices

Storz Modulith® SL-20/ (SLX) (P920051) Storz Modulith® Lithotripter Model SLK (K010340) Direx Tripter X - 1 Compact Duet (K041582) Direx 3Dscope (K041213)

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# 4. Intended Use:

The INTEGRA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.

### 5. Description

INTEGRA is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device is the result of integrating the cleared fluoroscopy imaging device - 3Dscope and lithotripter. INTEGRA also contains the necessary interfaces for ultrasonic imaging devices.

INTEGRA includes the following features:

- EM Shockwave generator with parabolic reflector for focusing mechanism A
- High Level of integration: the shock wave generator is fully integrated with A the fluoroscopic system and stationary patient table.
- In lieu of the patient table movement the reflector is moved in three A directions
- > In-line X-Ray localization system which is executed with lateral movement
- > Off-line movable Ultrasound transducer

#### 6. Performance Testing

The Integra Lithotripter was tested according to the following standards:

- IEC 60601-1 (1988) +A1 (1991) +A2 (1995) .
- IEC 60601-1-1 (2000) .
- IEC 60601-1-2 (2001) .
- IEC 60601-1-3 (1994) .
- IEC 60601-2-7 (1998) .
- . FDA CDRH 21CFR 1020.30
- FDA CDRH 21CFR 1020.32 .
- IEC 606001-2-36 (1997) .
- IEC 61846 (1998) .
- IEC 60601-2-38 (1996) .

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- ANSI/ AAMI/ ISO 10993– 1 (1998) .
- CISPR 11 (1997) + A1 (1999) class B �
- IEC 60601-1-4 (2000) .
- Guidance for the Content of Premarket Notifications (510(k)s) for . Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; August 9, 2000

#### 7. Clinical Tests

The Confirmatory study was conducted according to "Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi; August 9, 2000, Chapter 8 subchapter D: (Clinical Performance Testing, confirmatory clinical study ).

## 8. Substantial Equivalence

INTEGRA is substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same or similar.

Specifically, The devices have the same intended uses (the Storz devices and Compact Duet).

In terms of generation and focusing of pressure waves Integra is similar to the Storz predicates. (both use parabolic reflectors that converge pressure waves to a focal point). Both Integra and Storz SL-20/ (SLX) have also the same shockwave orientation (the angle of reflector is 90°).

Similarly to the Storz devices, Integra contains an in-line X-ray localization system.

The Ultrasound localization is similar to that of Compact Duet in the sense that the ultrasound probe of both devices is located outside the reflector.

Most of the X-ray parameters are the same as the ones of 3Dscope.

The minor differences in design, dimensions and features between Integra and its predicates raise no new issues of safety and effectiveness.

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Image /page/3/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge of the circle. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the left. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2006

Ms. Larisa Gershtein OA Manager DiREX Systems Corporation 437 Turnpike Street CANTON MA 02021

Re: K053640

Trade/Device Name: Integra Regulation Number: 21 CFR 8876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: December 27, 2005 Received: December 30, 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 ms lotter with and on. The FDA finding of substantial equivalence of your device to a legally prematics notification: "Thesults 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 11 you doors affect of Compliance at one of the following numbers, based on the regulation number at 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 Anot production other general information on your responsibilities under the Act 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/industry/support/index.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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Image /page/5/Picture/0 description: The image shows the logo for DiREX Systems Corp. The logo is in black and white, with the word "DiREX" in large, bold letters. Below the word "DiREX" is a horizontal line, and below that is the text "SYSTEMS CORP." in smaller letters. The logo is simple and professional-looking.

#### Section 4: Indications for Use Statement

# Indications for Use STATEMENT

510(k) Number (if known): K05 3690

Device Name:

Integra

Indications for Use:

The INTEGRA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter

Prescription Use X
(Per 21 CFR § 801.109)

OR

Over the Counter Use_

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

Daniel A. Segarra

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

437 Turnpike Street ♦ Canton. MA 02021 Phone [phone] + Fax [phone] e - mail promo (a), dire x u sa. com