(221 days)
To fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
The LithoDiamond ULTRA consists of: (1) a Therapy Unit; and (2) a Control Interface Master.
The Therapy Unit consists of the following submodules: (a) shock wave generator with therapy head; (b) movement unit (patient table and X-ray Isocentric C-Arm; (c) X-ray Component; (d) optional Ultrasound Localization System ("ULS") and (e) accessories. The X-ray Component of the Therapy Unit consists of the following modules: (a) X-ray module (monoblock and collimator), where the X-rays are generated; (b) Imaging Module, where the X-ray Image is detected and processed; (c) Electronics Module, containing control modules and power supplies: and (d) one or two high resolution black and white monitors. The X-ray Module and Imaging Module are mounted on a turnable C-Arm. The Electronics Module is mounted within the LithoDiamond ULTRA's Housing.
The Control Interface Master contains: (1) one or two X-ray Monitors; (2) the Control Panel; (3) the Remote Monitoring Connector Box; (4) the Release Buttons for X-ray and Shock Wave Generator; (5) the Foot Switch for the X-ray; and (6) a server PC accommodating the Software.
The LithoDiamond ULTRA is a modification to PCK's cleared Stonelith V5 device (K011106). The principal design changes to the Stonelith V5 lithotripter to form the LithoDiamond ULTRA lithoptriper are as follows: (1) use of interchangeable shock heads to provide electromagnetic and electrohydraulic therapy (in contrast to the existing StoneLith V5 device which delivers only electrohydraulic therapy); (2) replacement of the fixed imaging arm ("U" arm) (used with the Stonelith V5) with an Isocentric C-Arm; (3) changes in the software (used with the Stonelith V5) to accommodate the use of both electrohydraulic and electromagnetic therapy as well as the C-arm; (4) the addition of a motorized shock head; and (5) certain minor changes in the dimensions of the support table.
The LithoDiamond® ULTRA Extracorporeal Shock Wave Lithotripter: Acceptance Criteria and Study Details
Executive Summary
The LithoDiamond ULTRA Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney and ureter. To demonstrate its safety and effectiveness, PCK Electronic Industry and Trade Company, LTD, Inc. conducted performance testing, including Shock Wave Characteristics, Localization Accuracy, Road Testing, and Clinical Performance Testing. The device met all its specifications and functioned as intended. The substantial equivalence claim is based on performance data showing the device is as safe and effective as predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not outline specific numerical acceptance criteria. Instead, it broadly states that the device "met its specifications and functioned as intended" across several performance categories. The performance categories and the reported outcome are as follows:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Shock Wave Characteristics | Met its specifications and functioned as intended. |
| Localization Accuracy | Met its specifications and functioned as intended. |
| Road Testing | Met its specifications and functioned as intended. |
| Clinical Performance Testing | Met its specifications and functioned as intended. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size for the test set used in the performance studies.
The data provenance is retrospective, as the studies were conducted by PCK Electronic Industry and Trade Company, LTD, Inc., based in Sincan, Ankara, Turkey. The submission was sent to the FDA in the United States for regulatory review.
3. Number of Experts and their Qualifications for Ground Truth
The 510(k) summary does not provide information regarding the number of experts used to establish ground truth or their specific qualifications.
4. Adjudication Method
The 510(k) summary does not provide information regarding the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed or any effect size for human readers with and without AI assistance. The device in question is a lithotripter, not an AI diagnostic tool, so such a study would not be expected.
6. Standalone (Algorithm Only) Performance
A standalone performance study for the algorithm was not explicitly performed or described in the context of an "algorithm only without human-in-the-loop performance." The device is a physical medical device (lithotripter) with integrated software, and its performance is assessed as a complete system rather than evaluating an isolated algorithm. The "Performance Data" section describes testing of the overall device's characteristics and clinical performance.
7. Type of Ground Truth Used
The type of ground truth used is implied to be clinical outcomes data from the "Clinical Performance Testing" and measurements against technical specifications for "Shock Wave Characteristics," "Localization Accuracy," and "Road Testing." The exact nature or source of this clinical data (e.g., patient outcomes, stone fragmentation success rates, absence of complications) is not detailed.
8. Sample Size for the Training Set
The 510(k) summary does not specify the sample size for any training set. Given that this is a physical medical device and not a machine learning model in the modern sense of requiring extensive training data, a distinct "training set" for an AI algorithm is not explicitly mentioned as being part of the submission criteria for this type of device in 2006. The software changes mentioned (to accommodate new hardware) imply software development and testing, but not necessarily a "training set" in the context of machine learning.
9. How Ground Truth for the Training Set Was Established
As no specific "training set" in the context of machine learning is mentioned, no information is provided on how ground truth for such a set was established. Ground truth for the underlying device's development (its "training") would typically come from engineering specifications, industry standards, and preclinical testing results.
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K06/350
Page 1 of 3
510(k) SUMMARY
PCK's LithoDiamond ULTRA
DEC 2 2 2006
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
PCK Electronic Industry And Trade Company, LTD, Inc. 1 Organize Sanayi Bolgesi Orhan Isik Cad. No:4 Sincan 06935 Ankara TURKEY
OR
Phone: (+90) (312) 2672046 Facsimile: (+90) (312) 2670609
Contact Person:
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P 555 13th Street, NW Washington, DC 20004
(202) 637-5794 Phone: Facsimile: (202) 637-5910
As Regulatory Counsel to PCK Electronic Industry and Trade Company, LTD, Inc.
Cengiz Kabakcı General Manager PCK Electronic Industry and Trade Company, LTD, Inc. 1 Organize Sanayi Bolgesi Orhan Isik Cad. No:4 Sincan 06935 Ankara TURKEY
Phone: 90 (312) 267-2046 Facsimile: 90 (312) 267-0609
Filing Date: May 15, 2006
Name of Device and Name/Address of Sponsor
| Proprietary Device Name: | LithoDiamond ULTRA |
|---|---|
| Common/Generic Device Name: | Extracorporeal Shock WaveLithotripter |
| Classification Name: | Lithotripter, extracorporeal shock-wave, urological |
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VC61350
Page 2 of =
rns Product Code: Class II Regulatory Class: 21 CFR 876.5990 Regulation Number: PCK Electronic Industry and Trade Sponsor Company, LTD, Inc. 1 Organize Sanayi Bolgesi Orhan Isik Cad. No:4 Sincan 06935
Predicate Devices
The LithoDiamond ULTRA Extracorporeal Shock Wave Lithotripter is substantially equivalent to the following currently marketed devices:
Ankara TURKEY
- PCK Stonelith V5 .
- Dornier Compact Delta .
- Siemens Lithostar Modularis .
- Storz MODULITH Model SLX-F2 .
- United Medical Systems' Piezolith 300 Lithotripter .
Intended Use / Indications for Use
The LithoDiamond ULTRA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Technological Characteristics
The LithoDiamond ULTRA consists of: (1) a Therapy Unit; and (2) a Control Interface Master.
The Therapy Unit consists of the following submodules: (a) shock wave generator with therapy head; (b) movement unit (patient table and X-ray Isocentric C-Arm; (c) X-ray Component; (d) optional Ultrasound Localization System ("ULS") and (e) accessories. The X-ray Component of the Therapy Unit consists of the following modules: (a) X-ray module (monoblock and collimator), where the X-rays are generated; (b) Imaging Module, where the X-ray Image is detected and processed; (c) Electronics Module, containing control modules and power supplies: and (d) one or two high resolution black and white monitors. The X-ray
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K061350
page 3 of 3.
Module and Imaging Module are mounted on a turnable C-Arm. The Electronics Module is mounted within the LithoDiamond ULTRA's Housing.
The Control Interface Master contains: (1) one or two X-ray Monitors; (2) the Control Panel; (3) the Remote Monitoring Connector Box; (4) the Release Buttons for X-ray and Shock Wave Generator; (5) the Foot Switch for the X-ray; and (6) a server PC accommodating the Software.
The LithoDiamond ULTRA is a modification to PCK's cleared Stonelith V5 device (K011106). The principal design changes to the Stonelith V5 lithotripter to form the LithoDiamond ULTRA lithoptriper are as follows: (1) use of interchangeable shock heads to provide electromagnetic and electrohydraulic therapy (in contrast to the existing StoneLith V5 device which delivers only electrohydraulic therapy); (2) replacement of the fixed imaging arm ("U" arm) (used with the Stonelith V5) with an Isocentric C-Arm; (3) changes in the software (used with the Stonelith V5) to accommodate the use of both electrohydraulic and electromagnetic therapy as well as the C-arm; (4) the addition of a motorized shock head; and (5) certain minor changes in the dimensions of the support table.
Performance Data
In accordance with FDA's Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Uretal Calculi (August 9, 2000), PCK conducted the following types of performance testing: Shock Wave Characteristics; Localization Accuracy; Road Testing; and Clinical Performance Testing. In all instances, the LithoDiamond ULTRA met its specifications and functioned as intended. The laboratory and clinical data provide reasonable assurance of the safety and effectiveness of the LithoDiamond ULTRA for the extracorporeal fragmentation of urinary stones in the kidney (renal pelvis and renal calvces) and ureter (upper, middle, and lower ureter).
Substantial Equivalence
The LithoDiamond ULTRA has the same or similar intended uses and indications for use; similar principles of operation; and similar technological characteristics as its predicate devices. The technological differences between the LithoDiamond ULTRA and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the LithoDiamond ULTRA is as safe and effective as the predicate devices. Thus, the LithoDiamond ULTRA is substantially equivalent to legally marketed extracorporeal shock wave lithotripters.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
PCK Electronic Industry and Trade Company, LTD c/o Jonathan S. Kahan Hogan & Hartson LLP Columbia Square 555 Thirteenth Street, NW WASHINGTON DC 20004
DEC 2 2 2006
Re: K063150
Trade/Device Name: LithoDiamond® ULTRA Extracorporeal Shock Wave Lithotripter Regulation Number: 21 CFR $876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: October 25, 2006 Received: October 25, 2006
Dear Mr. Kahan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. The text around the edge of the circle is difficult to read.
ing and Promoting Public .
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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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx. | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: (KOG)350 ____ )
Device Name: LithoDiamond ULTRA
Indications for Use:
To fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).
Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number .
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§ 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.”)