Integra SL is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of a Shock Wave Generator (SWAG), a Urological Table (UT) and the remote controls. Integra SL also contains the necessary interfaces for fluoroscopic and (or) ultrasonic imaging devices. The device has no Software control.

Integra SL includes the following features:

EM Shockwave generator with parabolic reflector for focusing mechanism
Swinging reflector (i.e. shockwaves are produced by angularly moving the shockwave while keeping the Therapeutic focus (F2) at the stone such that the shockwaves converge on the stone from multiple orientations).
A stand alone UT unit
Modular construction

AI/ML Overview

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Set by which standard/guidance)	Reported Device Performance
No explicitly stated quantitative acceptance criteria beyond compliance with the listed standards and guidance documents.	Device was tested and found compliant with the following standards and guidance:
IEC 60601-1 (1988) +A1 (1991) +A2 (1995)	Met
IEC 60601-1-1 (2000)	Met
IEC 60601-1-2 (2001)	Met
IEC 606001-2-36 (1997)	Met
IEC 61846 (1998)	Met
IEC 60601-2-46 (1998)	Met
ANSI/ AAMI/ ISO 10993– 1 (1998)	Met
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	Met

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The document states "No clinical tests were performed." Performance testing was based on compliance with engineering and safety standards.
Data Provenance: Not applicable, as no clinical tests were performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No clinical tests were performed, and thus no expert-established ground truth for a test set was required.

4. Adjudication Method for the Test Set

Not applicable. No clinical tests were performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document explicitly states "No clinical tests were performed."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is an Extracorporeal Shock Wave Lithotripter (ESWL), a physical medical device, not an algorithm or software requiring standalone performance evaluation in the context of AI. The device has "no Software control."

7. Type of Ground Truth Used

Not applicable. No clinical tests were performed. The "ground truth" for this submission refers to compliance with safety and performance standards for a physical device.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The Direx Systems Corporation Integra SL device's acceptance criteria are primarily based on its compliance with a series of recognized international and national standards for medical devices, specifically those pertaining to Extracorporeal Shock Wave Lithotripters (ESWLs). The document lists several IEC, ANSI/AAMI/ISO standards, and FDA guidance documents.

The study proving the device meets these criteria is described as "Performance Testing" within the 510(k) submission. This does not involve clinical trials or studies with human subjects. Instead, it refers to in-house engineering and laboratory testing to ensure the device's design and functionality align with the safety, electrical, mechanical, and performance specifications outlined in the referenced standards. The submission asserts that the Integra SL "was tested according to the following standards:" and implicitly states that by meeting these standards, it fulfills the performance requirements.

The submission also leverages a "special 510(k)" pathway, stating that the Integra SL "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, Integra." This implies that the safety and effectiveness are largely established through the predicate device's prior clearance and the current device's adherence to the same core technology and performance standards, without new clinical data being necessary for this specific modification.

Summary

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SECTION 5 - 510(k) SUMMARY KC62147

[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

OCT 2 0 2006

Submitter:		Direx Systems Corporation437 Turnpike StreetCantonMA 02021
Telephone:		(339) 502-6013
Fax:		(339) 502-6018
Contact Person		Larisa GershteinQA Manager
Contact Person e-mail address:		lgershtein@direxusa.com
2. Device
Trade/Proprietary Name:		Integra SL
Common/Usual Name:		Extracorporeal Shock Wave Lithotripter
Regulation Number:		21 CFR 876.5990

Trade/Proprietary Name:	Integra SL
Common/Usual Name:	Extracorporeal Shock Wave Lithotripter (ESWL
Regulation Number:	21 CFR 876.5990
Regulatory Class:	Class II (special controls)
Product code:	78 LNS
Panel:	Gastroenterology and Urology

3. Predicate Devices

Direx Integra (K053640) Direx Tripter X - 1 Compact Duet (K041582)

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4. Intended Use:

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

5. Description

Integra SL includes the following features:

EM Shockwave generator with parabolic reflector for focusing mechanism
Swinging reflector (i.e. shockwaves are produced by angularly moving the shockwave while keeping the Therapeutic focus (F2) at the stone such that the shockwaves converge on the stone from multiple orientations).
▷ A stand alone UT unit
Modular construction

6. Clinical Tests

No clinical tests were performed

7. Performance Testing

Integra SL 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 606001-2-36 (1997)
. IEC 61846 (1998)
IEC 60601-2-46 (1998) .
ANSI/ AAMI/ ISO 10993– 1 (1998) .

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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. Substantial Equivalence

Integra SL is 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, Integra.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Larisa Gershtein QA Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021

OCT 2 0 2006

Re: K062147

Trade/Device Name: Integra SL Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: September 21, 2006 Received: September 22, 2006

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.

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Protecting and Promoting Public Health

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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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your 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:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours.

Nancy C. Hogdon

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

Enclosure

Page 2 -

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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 and features 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 "X" in "DiREX" is stylized with two intersecting lines.

Section 4: Indications for Use Statem

Indications for Use STATEMENT

510(k) Number (if known): K6Ce 2147

Device Name:

Integra SL

Indications for Use:

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

Prescription Use
(Per 21 CFR § 801.109)

Over the Counter Use

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

David A. Syverson
Division Sign Off

Division Sign-Off Division of Reproductive, Abdomin and Radiological Device 510(k) Number

437 Turnpike Street ◆ Canton, MA 02021 Phone: (339) 502-6013 ♦ Fax: (339) 502-6018 e - m a i l p r o m o @ d i r e x u s a . c o m

Regulation Number and Section

§ 876.5990 Extracorporeal shock wave lithotripter.

(a)
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.(b)
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.”)