(134 days)
No
The summary mentions image processing software (AGFA MUSICA) but does not contain any terms or descriptions indicative of AI/ML technology being used for image analysis, decision support, or any other function.
Yes
The device description explicitly states that it is designed for "extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology." Additionally, its intended use is for "fragmentation of urinary tract stones," which is a direct treatment of a medical condition.
Yes
The device description states that the Delta III Lithotripter is designed for "diagnostic and therapeutic procedures usual in urology." Additionally, it explicitly mentions "diagnostic" as part of its capability.
No
The device description clearly states it is a modular urological work station composed of hardware components like a Basic Unit with integrated X-ray C-arm and Therapy Arm, Patient Table, and Control Desk/Image Storage (UIMS). While it includes software (UIMS with AGFA MUSICA), it is an integral part of a larger hardware system.
Based on the provided information, the Delta III Lithotripter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is the fragmentation of urinary tract stones. This is a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a lithotripter, which uses shock waves to break up stones within the body. It also includes imaging components (X-ray and Ultrasound) for guidance and diagnosis in vivo.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological or pathological state. The Delta III Lithotripter does not perform this function.
While the device includes imaging capabilities and image processing (which can be part of an IVD workflow), its primary function and intended use are therapeutic and diagnostic in vivo, not in vitro.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
LNS
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray, ultrasound
Anatomical Site
urinary tract, renal calyces, renal pelvis, upper ureter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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.
4
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.
5
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.