(134 days)
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.
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 Storage (UIMS).
This document is a 510(k) summary for the Delta III Lithotripter, detailing minor changes to an existing device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a human-in-the-loop performance evaluation. The information provided primarily consists of engineering and software validation.
Here's an analysis based on the provided text, addressing your questions to the extent possible:
1. Table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria for clinical performance in the way one might expect for a new diagnostic or AI device. Instead, the "acceptance criteria" are implied by compliance with standards and functional validation tests, with the reported performance being "does not impact the performance" and "equal to or better than the predicate."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Standards Compliance: | |
| IEC 60601-1 (Electrical safety) | Compliant |
| IEC 60601-1-2 (EMC) | Compliant |
| IEC 60601-1-3 (Radiation protection) | Compliant |
| IEC 60601-2-36 (Lithotripsy safety) | Compliant |
| IEC 60601-2-28 (X-ray tube assemblies) | Compliant |
| IEC 60601-2-54 (X-ray equipment safety) | Compliant |
| IEC 62366-1 (Usability engineering) | Compliant |
| IEC/TR 62366-2 (Usability guidance) | Compliant |
| Bench Testing (Functional Validation): | |
| New ultrasound device provides visual and accurate images for stone visualization | Performance assured; provides visual and accurate images |
| New camera image quality is equal to or better than the predicate | Image quality equal to or better than the predicate |
| UIMS software with AGFA package does not impact equipment functioning and processes X-ray images | Does not impact functioning; provides ability to further process X-ray images |
| Electrical safety, EMC, functional usability are fully addressed | Demonstrated compliance with standards and equivalent performance to predicate |
| No unanticipated new risks identified | No unanticipated new risks identified |
2. Sample size used for the test set and the data provenance
The document describes bench testing and standards compliance, not a clinical test set with patient data. Therefore, there is no mention of a "sample size for the test set" in the context of patient data, nor its provenance (country of origin, retrospective/prospective). The tests mentioned are engineering and software validation tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to the submission described. The described tests are about technical performance, safety, and functionality, not about expert interpretation of medical images or patient outcomes. Ground truth in this context would refer to engineering specifications or validated functional requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the submission describes engineering and software validation, not a clinical study requiring adjudication of diagnoses or findings.
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
No MRMC comparative effectiveness study was done or is mentioned. The submission is for minor changes to an existing lithotripter, focusing on hardware component replacements and software updates, not AI integration for improved human reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device (Delta III Lithotripter) is a medical device for shock wave lithotripsy. While it includes image processing software (UIMS with AGFA MUSICA), the evaluation described is for the functional performance of these components within the overall system, not a standalone algorithm being evaluated for diagnostic accuracy without human involvement. The AGFA MUSICA software enhances X-Ray image processing, but it's part of the lithotripter system for visual guidance during procedures, not a diagnostic AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the described tests, the "ground truth" would be established by:
- Engineering specifications and regulatory standards: For electrical safety, EMC, radiation protection, and usability.
- Predicate device performance: For the ultrasound image quality and camera image quality, the ground truth for comparison is the performance of the components being replaced.
- Functional requirements: For the UIMS software validation, the ground truth is that the software should perform its intended function (e.g., image processing, PACS connection) without negatively impacting other equipment functions.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific validation tests.
8. The sample size for the training set
Not applicable. This submission does not involve a machine learning or AI model that requires a training set in the conventional sense. The UIMS software update involves incorporating the AGFA MUSICA package, which is likely a pre-existing, validated image processing software, not a custom-trained model for this specific application.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set.
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September 3, 2020
Dornier MedTech America, Inc. John S. Hoffer VP Quality, Regulatory, Clinical 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144
Re: K201074
Trade/Device Name: Delta III Lithotripter Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal Shock Wave Lithotripter Regulatory Class: II Product Code: LNS Dated: August 4, 2020 Received: August 6, 2020
Dear John S. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino, M.S. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality 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)
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)
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FORM FDA 3881 (8/14)
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SECTION V
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: Auqust 3, 2020
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 (K172084)
Purpose of the 510(k) Notice
The Delta III Lithotripter that is the subject of this submission to the Dornier Delta III Lithotripter (K172084) to include the following minor changes:
- Replacement of Image Intensifier camera for X-Ray as a result of the current models obsolescence,
- o Replacement of operating system Windows 7 with Windows 10.
- Update the UIMS system to incorporate the AGFA MUSICA software package to enhance and improve the X-Ray image processing.
- . Offer the optional ultrasound unit (SonoScape X3 Pro with transducer 510(k) K163427).due to the obsolescence of the current BK Ultrasound Model.
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.
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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; o
- . Patient Table;
- Control Desk/Image Storage (UIMS). .
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 X- ray 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.
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 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.
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Performance Test Data
Standards Testing
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 + Cor. :2006 + Cor. :2007 + A1:2012,Electrical safety of ● medical devices;
- . IEC 60601-1-2: 2014, Electomagnetic compatibility;
- IEC 60601-1-3: 2008, Radiation protection in diagnostic X-rayequipment;
- IEC 60601-2-36:2014. Safety of equipment for extracorporeally induced ● lithotripsy:
- IEC 60601-2-28:2010 Medical electrical equipment Part 2-28: Particular . requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- IEC 60601-2-54:2009 + Cor.:2010 + Cor.:2011, Medical electrical equipment -● particular requirements for the basic safety and essential performance of x-ray equipment: and
- IEC 62366-1:2015 + COR1:2016, Medical Devices Part 1: Application of . usability engineering to medical devices.
- IEC/TR 62366-2:2016 Medical devices Part 2: Guidance on the application of . usability engineering to medical devices
Bench Testing
The company has performed functional validation testing to assure the modifications do not impact the performance of the equipment. These tests included:
-
- Evaluate the performance of the new ultrasound device to assure it provides visual and accurate images for stone visualization.
-
- Compare the images from the new camera to assure the image quality is equal to or better than the predicate
- Validate the UIMS software to demonstrate the inclusion of the AGFA software package 3. does not impact any functioning of the equipment and provides the ability to further process the x-ray images
In summary, during the verification testing, the electrical safety of the system, electromagnetic compatibility and functional usability issues were fully addressed by demonstrating compliance with the appropriate standards and equivalent performance to the predicate. 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 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.
§ 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.”)