(29 days)
Not Found
No
The summary describes a traditional lithotripter with imaging capabilities and standard safety/performance testing, with no mention of AI or ML.
Yes
The device is indicated for the fragmentation of urinary tract stones, which is a therapeutic intervention, and the description explicitly states it is designed for "therapeutic procedures usual in urology."
Yes
The device description explicitly states that the Delta III Lithotripter is designed for "diagnostic and therapeutic procedures usual in urology," and it includes an "X-ray C-Arm" and a "high resolution imaging chain" to provide "imaging to perform the procedures," which are integral components for diagnostic imaging.
No
The device description clearly outlines multiple hardware components including a basic unit with integrated X-ray C-arm and Therapy Arm, a patient table, and a control desk. It also mentions power supplies, control units, power electronics, shockwave generation components, and an X-ray unit. While there is software involved (image processing system), the device is fundamentally a hardware system with integrated software.
Based on the provided information, the Delta III Lithotripter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the fragmentation of urinary tract stones within the body (in vivo). IVD devices are used to examine specimens taken from the body (in vitro).
- Device Description: The device is a urological workstation designed for extracorporeal shock wave lithotripsy (ESWL), which is a treatment performed on the patient. It also includes imaging components (X-ray and potentially Ultrasound) for guiding the treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device's function is to deliver shock waves to break up stones inside the patient.
Therefore, the Delta III Lithotripter is a therapeutic medical device with integrated imaging capabilities, not an IVD.
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
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;
- 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.
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)
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 Kidney 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dornier Delta III Lithotripter (K170122)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
1
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
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) 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
Page 1 of 1 FDA
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.
4
- 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 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
5
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
6
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.