(149 days)
No
The summary does not mention AI, ML, or related concepts, and the description focuses on ultrasound localization without suggesting advanced image analysis or learning algorithms.
No
The device is described as an "accessory" and an "adjunct ultrasound localization system" for use prior to extracorporeal shock wave lithotripsy, not as a device that delivers therapy itself. Its function is to locate a stone, which is a diagnostic/localization step before therapy is applied by another device (LithoDiamond LTFS230).
No
The device description explicitly states, "The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications."
No
The device is described as an "accessory" and an "adjunct ultrasound localization system," implying it is a hardware component that works with an existing lithotripsy system. The description does not mention software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ULS0142 accessory is an ultrasound system used for localization of a target stone within the body prior to a medical procedure (lithotripsy). It uses ultrasound waves to visualize structures inside the body.
- Intended Use: The intended use clearly states it's for "ultrasound localization of a target stone" and "should only be used for lithotripsy-related applications." This is an in-vivo (within the living body) application, not an in-vitro (outside the living body) test on a sample.
Therefore, the ULS0142 falls under the category of a medical device used for imaging and localization within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ULS0142 accessory is indicated for ultrasound localization of a target stone prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230. The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.
Product codes
LNS
Device Description
The ULSUL42 accessory is an adjunct ultrasound localization system for use prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230. The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
AUG 1 9 2004
PREMARKET NOTIFICATION 510(K) SUMMARY
| Sponsor: | HMT High Medical Technologies AG
Kreuzlingerstrasse 5
CH-8574 Lengwil
Switzerland
Telephone: 011.41.71,686.6200
Fax: 011.41.71,686.6209
Contact: Karl Ensslen, PhD |
| ---------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
HMT High Medical Technologies AG Manufacturer: Kreuzlingerstrasse 5 CH-8574 Lengwil Switzerland Telephone: 011 41 71.686.6200 Fax: 011.41.71.686.6209 Contact: Karl Ensslen, PhD
Establishment Registration Number: 9614425
| Contact Person: | Patricia Landry
M Squared Associates, Inc.
719 A Street, NE
Washington DC 20002
Telephone: 202-546-1262
Fax: 202-546-3848
E-mail: tlandry@msquaredassociates.com |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name of Device: | Ultrasound Localization System ULS 0142 |
| Common Name: | Accessory to Extracorporeal Shock Wave Lithotripter |
| Classification name: | Lithotripter, Extracorporeal Shock-Wave, Urological |
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Product Code:
Regulation Class: Class II (Special Controls)
Caye K2
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Page 2 of 2
Regulation Number : 8876,5990
The ULSUL42 accessory is an adjunct ultrasound localization system for Device Description: use prior to extracorporcal shock wave lithotripsy with the LithoDiamond LTFS230.
The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.
The ULS 0142 accessory is indicated for ultrasound localization of a Indications for Use: target stone prior to extracorporeal shock wave lithotripsy with the LithoDiamond LTFS230.
The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.
The LithoDiamond ULS 0142 is substantially equivalent Basis for Substantial Equivalence to the LithoTron ULS 0132.
2
Image /page/2/Picture/1 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 circle is an abstract symbol resembling an eagle or bird with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 9 2004
HMT High Medical Technologies AG c/o Ms. Trish Landry Senior Consultant M Squared Associates, Inc. 719 A Street, N.E. WASHINGTON DC 20002
Re: K040741
Trade/Device Name: HMT Ultrasound Localization System ULS 0142 Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: August 6, 2004 Received: August 6, 2004
Dear Ms. Landry:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are card in 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 (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 docs not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a dolly regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing Comply with an the 110 110 110 Part 801); good manufacturing practice requirements as sct (2) CFR Part 801), advening (21 cegulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 100(k) This letter will allow you to begin marcemi, your outstance of your device to a legally premarket nothication. The PDA midn't in actassification 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 CIFR Part 801), please
rs the see latest of the many and in the comment of the seculation If you desire specific advice for your decles on of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion of the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general by reference to prematics notification (DTCPA) in the Act may be obtained from the Division of Strail information on your responsionities ander are Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free with Manufacturers, International and Octoballion of Seasonner of Seathern of Separamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
040741
Device Name: Ultrasound Localization System ULS 0142
Device Name. Gtt 250276
Indications For Use: The ULS0142 accessory is indicated for localization of a target stone prior to Indications I or 'Use. "The "See" "The "LithoDiamond LTFS230.
extracorporeal shock wave litthotripsy with the LithoDiamond LTFS230.
The ULS0142 is not indicated for use as a stand-alone diagnostic ultrasound system, and should only be used for lithotripsy-related applications.
Prescription Use X Presempelour Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Fivaluation (ODE)
Nancy Enogdor
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
Page 1 of
March 22, 2004
CONFIDENTIAL
Appendices