(221 days)
PCK Stonelith V5, Dornier Compact Delta, Siemens Lithostar Modularis, Storz MODULITH Model SLX-F2, United Medical Systems' Piezolith 300 Lithotripter
Not Found
No
The summary describes standard image processing for X-ray images and software changes to accommodate new hardware, but there is no mention of AI or ML algorithms for image analysis, treatment planning, or any other function.
Yes
This device is a therapeutic device because its intended use is to fragment urinary stones, which is a treatment for a medical condition.
No
The device's "Intended Use" clearly states its purpose is "To fragment urinary stones," which is a therapeutic, not a diagnostic, function. While it includes imaging components (X-ray and optional Ultrasound), these are described as being used for localization during the treatment process, rather than for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a therapy unit with a shock wave generator, movement unit, X-ray component, and optional ultrasound system, as well as a control interface master with monitors and control panels. While software is mentioned as being housed on a server PC, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fragment urinary stones within the body (in the kidney and ureter). This is a therapeutic procedure performed directly on the patient.
- Device Description: The device is a lithotripter, which uses shock waves to break up stones. It includes components for generating shock waves, positioning the patient, and imaging the stones in vivo (within the body) using X-ray and potentially ultrasound.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
The device is a therapeutic medical device used for a procedure performed directly on the patient, not for analyzing samples outside the body.
N/A
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).
Product codes (comma separated list FDA assigned to the subject device)
LNS
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Ultrasound
Anatomical Site
kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower 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)
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).
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.
PCK Stonelith V5, Dornier Compact Delta, Siemens Lithostar Modularis, Storz MODULITH Model SLX-F2, United Medical Systems' Piezolith 300 Lithotripter
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.
Not Found
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
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 Wave |
| Lithotripter | |
| Classification Name: | Lithotripter, extracorporeal shock-wave, urological |
1
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
2
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.
3
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 .
4
Page 2 -
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
5
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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