The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Device Description

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.

The Delta III is composed of the following modules:

. Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
Patient Table;
. Control Desk - Image Processing.

The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.

The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete Xray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.

The Delta III's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.

The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.

AI/ML Overview

This document describes a 510(k) submission for the Delta III Lithotripter, which is a modification to a previously cleared device. As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies to establish absolute performance against defined acceptance criteria for a novel device.

Therefore, the typical structure for reporting acceptance criteria and study details for a new device's performance may not be fully applicable here. However, I can extract the information provided regarding the changes and how their safety and effectiveness were addressed.

Here's an analysis based on the provided text, addressing the points you requested where relevant:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., stone free rate, re-treatment rate) for the modified device, as this is a modification to a predicate device. The primary performance demonstration is focused on showing that the changes do not negatively impact safety or effectiveness.

Acceptance Criteria (Implied for changes)	Reported Device Performance
Electrical safety compliance	Device is in compliance with IEC 60601-1:2005.
Electromagnetic compatibility compliance	Device is in compliance with IEC 60601-1-2:2007.
Radiation protection compliance	Device is in compliance with IEC 60601-1-3: 2008 and IEC 60601-2-54.
Safety of equipment for extracorporeally induced lithotripsy compliance	Device is in compliance with IEC 60601-2-36: 1997.
Ultrasonics characteristics of fields compliance	Device is in compliance with IEC 61846.
Usability compliance	Device is in compliance with IEC 62366:2007.
Software functionality (wheel performance, collision protection)	Appropriate software verification testing was performed.
Hand controller function	Verification of hand controller function testing was performed.
Ultrasound localization accuracy (with additional ultrasound units)	Engineering analysis concluded prior ultrasound localization accuracy testing supported compatibility.
No new unanticipated risks	No unanticipated new risks identified.
Maintains intended use, technological characteristics, and principles of operation of predicate	The modified Delta III has the same intended use, technological characteristics, and principles of operation as the predicate device. Minor differences do not alter intended use or affect safety/effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes tests for compliance with electrical, EMC, radiation, and usability standards, as well as software and hardware verification. These are typically engineering and bench tests, not clinical studies with human subjects in the traditional sense. Therefore, the concept of "sample size used for the test set" for patient data, country of origin, or retrospective/prospective does not apply to the provided performance data. The tests performed are on the device itself.

3. 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)

This section is not applicable. The performance data provided is based on compliance with international standards and internal engineering verification, not on expert adjudication of clinical outcomes or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable, as the tests are for engineering compliance and verification, not for clinical outcomes requiring expert adjudication.

5. 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

This section is not applicable. The device is a lithotripter, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical medical device (lithotripter), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the verification tests mentioned (e.g., electrical safety, software functionality), the "ground truth" is defined by the requirements of the applicable international standards (e.g., IEC 60601 series) and the design specifications of the device. For example, for electrical safety, the ground truth is compliance with the specified voltage limits or isolation requirements in the standard. For software, it's meeting the intended function and not introducing errors.

8. The sample size for the training set

This section is not applicable. The document describes a physical medical device and its modifications, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.

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

August 8, 2017

Dornier MedTech America, Inc. John Hoffer VP Ouality. Regulatory, Clinical 1155 Roberts Blvd Suite 100 Kennesaw, Georgia 30144

K172084 Re:

Trade/Device Name: Delta III Lithotripter Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal Shock Wave Lithotripter Regulatory Class: Class II Product Code: LNS Dated: July 10, 2017 Received: July 10, 2017

Dear John Hoffer:

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Charles Viviano -S

For

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known) K172084

R172084

Device Name

Delta III Lithotripter Indications for Use (Describe)

The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

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PSC Publishing Services (301) 443-6740 EP

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510(k) SUMMARY

Delta III Lithotripter

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

Dornier MedTech America, Inc. 1155 Roberts Blvd. Kennesaw, GA 30144

Date Prepared: July 10, 2017

Contact Person: John Hoffer

Phone: 770-514-6163

Name of Device and Name/Address of Sponsor

Delta III Lithotripter

Dornier MedTech America, Inc. 1155 Roberts Blvd. Kennesaw, GA 30144

Common or Usual Name

Shock Wave Lithotripter

Classification Name

According to 21 C.F.R. § 876.5990, FDA has classified extracorporeal shock wave lithotripters as Class II devices with special controls. The Product Code for these lithotripters is LNS.

Predicate Device

Dornier Delta III Lithotripter (K170122)

Purpose of the 510(k) Notice

The Delta III Lithotripter that is the subject of this submission is a modification to the Dornier Delta III Lithotripter (K170122) to include the following minor changes:

The UIMS cart wheels were required to be replaced as a result of their obsolescence, O
Several electronic components were required to be modified or upgraded as O a result of additional IEC electrical testing,
In order to affix the CE Mark, the power rating label of the Delta III X-ray device had o to be changed to reflect the effective power as measured instead of the actual power input level.

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A modification to the collision system was required due to instances when the o restoring force relating to the collision system is too low, the collision system output signal remains in "collision mode" even though the collision situation has been corrected.
O For user convenience and preference, a software change was made that allows the user to utilize fluoroscopy without significant delay directly after a snap shot is taken,
Additional Ultrasound base units are now being offered to use with the identical o ultrasound transducer, and
A easier applied inner coating lining of the hand controller has been implemented. o

The modified Delta III has the same intended use, technological characteristics, and principles of operation as the predicate device. The difference between the modified Delta III and the predicate device does not raise any new or different questions of performance, safety or effectiveness. Thus, Dornier believes that the modified Delta III is substantially equivalent.

Intended Use/Indications for Use

The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

Device Description

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.

The Delta III is composed of the following modules:

. Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
Patient Table;
. Control Desk - Image Processing.

The Delta III's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological

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procedures.

The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.

All of the characteristics described above of the Delta III subject to this submission are identical to the predicate device.

Technological Characteristics

As described in the section above, the Delta III device has the same technical characteristics as the predicate. This includes function and operation of the three main modules that comprise the system, the Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment, the Patient Table and the Control Desk and Image Processing ability. The minor changes that are associated with this submission do not change the essential function and use of the Delta III as compared to the predicate.

Performance Data

The company has complied with all of the requirements described in FDA's Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidnev and Ureteral Calculi.

The device is in compliance with the following standards:

IEC 60601-1:2005,Electrical safety of medical devices;
. IEC 60601-1-2:2007, Electomagnetic compatibility:
IEC 60601-1-3: 2008, Radiation protection in diagnostic X-ray equipment; ●
IEC 60601-2-36: 1997, Safety of equipment for extracorporeally induced lithotripsy; ●
. IEC 61846, Ultrasonics - pressure pulse lithotripters characteristics of fields;
IEC 60601-2-54, Medical electrical equipment particular requirements for the . basic safety and essential performance of x-ray equipment; and
. Usability: IEC 62366:2007, Application of usability engineering to medical devices.

In summary, during the verification testing, the electrical safety of the system and the electromagnetic compatibility were fully addressed by demonstrating compliance with the applicable standards. In addition, appropriate software verification testing to sections of IEC 60601-1 for wheel performance and collision protection, and verification of hand controller function testing were also performed to address the modifications made that are subject to this submission.

Also, an engineering analysis concluded that the prior ultrasound localization accuracy testing supported the compatibility of the additional ultrasound systems that were added.

There were no unanticipated new risks identified

Conclusions

The Delta III is as safe and effective as the cited predicate device. The Delta III has the same intended uses and indications, technological characteristics, and principles of

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operation as its predicate device. The minor differences do not alter the intended the use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the Delta III and its predicate devices raise no new or different questions of safety or effectiveness. Design controls demonstrate that the Delta III is as safe and effective as the predicate device. Thus, the Delta III is substantially equivalent.

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.”)