The device is a transportable Electromagnetic Extracorporeal Shock Wave Lithotripter incorporating a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and a Control subsystem. Also incorporated are interfaces for ECG synchronization, fluoroscopic imaging devices and sonographic imaging devices. The SWAG incorporates two stationary reflector-based electromagnetic transducers (Bottom and Top). Software control enables separate operation of the transducers in any one of three operating modes: "B" (Bottom only), "T" (Top only), "A" (B and T operate alternatively in a cyclic fashion, such that the time difference between the B and T pulses equals the time difference between the T and B pulses.

AI/ML Overview

The provided text is a 510(k) summary for the DUET MAGNA Extracorporeal Shock Wave Lithotripter. It focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against those criteria as would be expected for an AI/ML device.

Therefore, many of the requested items related to AI/ML device performance studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment methods) are not applicable or available in this document.

However, I can extract the information relevant to the performance testing and substantial equivalence described, which serves as the basis for device acceptance in this context.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for devices like the DUET MAGNA in a 510(k) process are primarily based on demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective. This typically involves meeting recognized standards for safety, performance, and functionality.

Acceptance Criterion (Implicit from 510(k) process)	Reported Device Performance (from document)
Intended Use Equivalence	"The intended use of Duet Magna is respectively similar to those of the predicate devices." (Fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter).
Functional Equivalence	"The device is a modification of Tripter Compact Duet and is functionally similar to Tripter Compact Duet, except for shockwave generation that is similar to that of Integra." (Incorporates SWAG, MFT, Control subsystem, interfaces for ECG, fluoroscopic, and sonographic imaging. Software control for separate operation of bottom/top transducers in "B", "T", or "A" modes.)
Safety and Performance Standards Compliance	"Furthermore, the Duet Magna has been tested and been found to conform, as do the predicate devices, to FDA recognized standards, including electrical safety testing per IEC 60601-1, EMC testing per IEC 60601-1-2, localization accuracy testing and road testing per the lithotripter special control guidance document." Also lists compliance with: IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 606001-2-36, IEC 61846, IEC 60601-2-38, ANSI/AAMI/ISO 10993-1, CISPR 11, IEC 60601-1-4, and the "Guidance for the Content of Premarket Notifications (...) for Extracorporeal Shock Wave Lithotripters".
No New Safety/Efficacy Issues	"Based on an analysis of similarities and differences, we believe that Duet Magna is substantially equivalent to its predicate devices without raising new safety and/or efficacy issues."

Study Information (as applicable for a non-AI/ML device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This device is a physical medical device (Extracorporeal Shock Wave Lithotripter), not an AI/ML software. The document describes compliance with performance and safety standards, but it does not involve a "test set" in the context of AI/ML performance evaluation. The testing would have involved engineering and functional tests on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: Ground truth and expert review are concepts relevant to AI/ML model validation, not typically for a physical medical device like a lithotripter being evaluated for substantial equivalence in this manner.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided: This is not an AI-assisted diagnostic or interpretation device that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable / Not Provided: This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable: For this device, "ground truth" would relate to the physical properties and functional performance measured against established engineering and medical device standards (e.g., shockwave pressure, localization accuracy, electrical safety, biocompatibility, etc.). These are assessed through physical testing, not expert consensus on diagnostic images or pathology.
The sample size for the training set
- Not Applicable / Not Provided: No "training set" is mentioned as this is not an AI/ML device.
How the ground truth for the training set was established
- Not Applicable / Not Provided: No "training set" or corresponding ground truth establishment is described.

Summary

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K111947 MAR - 1 2012 PG. I OF 3

510(k) SUMMARY

[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 Corporation960 Turnpike StreetCanton, MA 02021
Telephone:Fax:Contact Person		(339) 502-6013(339) 502-6018Larisa GershteinQA Manager
Contact Person e-mail address:		lgershtein@direxusa.com
2. Device
Trade/Proprietary Name:		Duet Magna
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

Tripter X - 1 Compact Duet (Direx Systems Corp) (K023535)
Tripter X - 1 Compact Duet (Direx Systems Corp) (K041582)
Integra (Direx Systems Corp) K053640)

4. Intended Use:

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

5. Description

The device is a transportable Electromagnetic Extracorporeal Shock Wave

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K111947
PG. 2 OF 3

Lithotripter incorporating a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and a Control subsystem.

Also incorporated are interfaces for ECG synchronization, fluoroscopic imaging devices and sonographic imaging devices.

The SWAG incorporates two stationary reflector-based electromagnetic transducers (Bottom and Top). Software control enables separate operation of the transducers in any one of three operating modes: "B" (Bottom only), "T" (Top only), "A" (B and T operate alternatively in a cyclic fashion, such that the time difference between the B and T pulses equals the time difference between the T and B pulses.

6. Performance Testing

The DUET MAGNA 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) .
IEC 606001-2-36 (1997) .
IEC 61846 (1998) .
. IEC 60601-2-38 (1996)
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

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K111947
PG. 3 of 3

6. Substantial Equivalence

The intended use of Duet Magna is respectively similar to those of the predicate devices. The device is a modification of Tripter Compact Duet and is functionally similar to Tripter Compact Duet, except for shockwave generation that is similar to that of Integra. Furthermore, the Duet Magna has been tested and been found to conform, as do the predicate devices, to FDA recognized standards, including electrical safety testing per IEC 60601-1, EMC testing per IEC 60601-1-2, localization accuracy testing and road testing per the lithotripter special control guidance document. Based on an analysis of similarities and differences, we believe that Duet Magna is substantially equivalent to its predicate devices without raising new safety and/or efficacy issues.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The logo is simple, using a black and white color scheme.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAR - 1 2012_

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

Re: K111947

Trade/Device Name: DUET MAGNA Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal shock wave Lithotripter Regulatory Class: II Product Code: LNS Dated: January 30, 2012 Received: February 3, 2012

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical

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Page 2-

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerély yours,

Sincerely yours,

Benjamin K. Ticho

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 2 Indications For Use Statement

Indications for Use Statement

K111947 510(k) Number (if known):

Device Name: DUET MAGNA

Indications for Use:

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

Prescription Use - Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices
510(k) Number	K111947

2-1

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.”)