The Duet 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. The Shock Wave Generator can be operated in 4 modes: a) Bottom Reflector only. b) Top reflector only. c) Alternate mode (asynchronous). d) Simultaneous mode (synchronous).

AI/ML Overview

Here's an analysis of the provided text regarding the device's acceptance criteria and study, structured to answer your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantifiable acceptance criteria such as "fragmentation rate of X% for stones of Y size" or "success rate of Z%". Instead, it relies on regulatory compliance and the device being a "minor modification" with "same fundamental scientific technology and intended use" as predicate devices.

Acceptance Criterion	Reported Device Performance
Safety	Meets IEC and UL standards (e.g., IEC 60601-1, UL 2601-1, etc.)
Effectiveness	"does not reduce safety and effectiveness" compared to predicate device
Technological Equivalence	"same fundamental scientific technology and intended use as predicate devices"
Intended Use	Indicated for "Fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones)."

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

Sample Size: The document explicitly states: "No clinical tests were performed." Therefore, there is no test set in the traditional sense of a clinical study involving human subjects or patient data.
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, as no clinical tests were performed and thus no ground truth derived from expert review of patient data.

4. Adjudication Method for the Test Set

Not applicable, as no clinical tests were performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

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

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done

This question is not applicable to this device. The "Duet" is an Extracorporeal Shock Wave Lithotripter (ESWL), which is a physical medical device, not an AI algorithm or software. Its performance is related to mechanical and acoustic properties, not software-based analysis.

7. The Type of Ground Truth Used

Not applicable in the context of clinical or AI-based performance. The "ground truth" for this submission appears to be compliance with engineering and electrical safety standards (as listed in Section 7 - Performance Testing) and the established safety and effectiveness profile of its predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device and not an AI algorithm that requires a training set.

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

Not applicable. This device is a physical medical device and not an AI algorithm.

Summary of the Device Submission's Approach:

This 510(k) submission for the Direx Systems Corporation Tripter X-1 Compact Duet is a "special 510(k)" submission. This type of submission is used for modifications to a manufacturer's own legally marketed device (the predicate device) where the modification does not affect the intended use or fundamental scientific technology, and does not raise new questions of safety or effectiveness.

Because it was deemed a "minor modification," the submission relied heavily on:

Substantial equivalence to predicate devices: The core argument is that the Duet shares the "same fundamental scientific technology and intended use" as its own prior device (Tripter X-1 Compact) and other legally marketed ESWL devices.
Compliance with recognized electrical and safety standards: Extensive testing against IEC and UL standards confirmed its safety from an engineering perspective.
Lack of requirement for new clinical data: The FDA agreed that "No clinical tests were performed" were necessary because the modification ("enables the use of 2 reflectors instead of one") was not considered to introduce new risks or alter the fundamental mechanism of action that would necessitate new human trials.

Summary

{0}------------------------------------------------

SECTION 6 - 510(k) SUMMARY

Kc23535

PG. I OF 3

[Submitted pursuant to 21 CFR 807.87(h)]

1. Submitter Information

Submitter:	Direx Systems Corporation11 Mercer RoadNatick Business ParkNatick, MA 01760
Telephone:Fax:Contact Person	(508) 651-0900(508) 651-8125Larisa GershteinQA Manager

Contact Person e-mail address:

lgershtein@direxusa.com

2. Device

Trade/Proprietary Name:	Tripter X-1 Compact Duet (to bemarketed as "Tripter Duet" or "Duet")
Common/Usual Name:	Extracorporeal Shock Wave Lithotripter(ESWL)
Classification Name/ Product code:	78 LNS
Regulatory Class:	Class II
Regulation Number:	21 CFR 876.5990

3. Predicate Devices

Tripter X-1 Compact: P920034 Storz Modulith SL-20/ (SLX): P920051 Storz SLK: K010340 PCK Stonelith V5: K011106

{1}------------------------------------------------

4. Intended Use:

Fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).

5. Technological Characteristics:

The Duet is a modification of an existing device that enables the use of 2 reflectors instead of one. The modified device has the same fundamental scientific technology and intended use as predicate devices.

6. Description

a) Bottom Reflector only.
b) Top reflector only.
c) Alternate mode (asynchronous).
d) Simultaneous mode (synchronous).

7. Performance Testing

The Duet Lithotripter was tested according to the following standards:

IEC 60601-1(1988) +A1 (1991) +A2 (1995)
IEC 60601-1-1 (2000)
IEC 60601-2-36 (1997)
IEC 60601-2-38 (1996) +A1 (1999)
UL 2601-1-1997, CSA-C22.2 No. 601.1
IEC 60601-1-2 (2001)
CISPR 11(1997) + A1 (1999) class B
IEC 606001-2-36 (1997), clause 36
IEC 61846 (1998-04) A
IEC EN 1441 A
IEC 60601-1-4 (2000) A

{2}------------------------------------------------

8. Clinical Tests

No clinical tests were performed.

9. Conclusion

The Duet 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.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2003

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

Re: K023535

Trade/Device Name: Tripter X-1 Compact Duet Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: December 19, 2002 Received: December 20, 2002

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 (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.

{4}------------------------------------------------

Page 2

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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 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

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for "Direx Systems Corp.". The word "Direx" is in a bold, sans-serif font, with a textured effect on the right side of the "X". Below the word "Direx" is a horizontal line, and below that is the text "Systems Corp.", also in a sans-serif font.

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Ko23535

Device Name:

4-1

Tripter-X1 Compact Duet

Indications for Use:

The Tripter-X1 Compact Duet Extracorporeal Shock Wave Lithotripter is indicated for use in 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 K023535

Prescription Use (Per 21 CFR § 801.109)

Over the Counter Use

David A. Ingram

(Division Sign-Off) Division of Reproducti and Radiological Devic 510(k) Number

11 Mercer Road ♦ Natick, Ma 01760 Phone: 1-888-TRIPTER ♦ Fax: 508-651-8125 A saa millean as a see a last die a mara a n

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.”)