(21 days)
Not Found
No
The description focuses on the mechanical function of a rigid probe for stone fragmentation and does not mention any computational or learning capabilities.
Yes
The device is described as an accessory to a lithotripter for the fragmentation of ureteral calculi, which is a therapeutic intervention aimed at treating medical conditions (kidney stones).
No
The device is described as a surgical tool for fragmenting ureteral calculi, acting to couple shockwaves and fix stones. Its function is interventional (treatment), not diagnostic.
No
The device description explicitly states it is a rigid stainless steel rod, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This includes tests for diagnosis, monitoring, or screening.
- Device Function: The Swiss LITHOCLAST® Multipurpose Probe is a surgical instrument used within the body to fragment kidney stones. It is a mechanical device that physically interacts with the stone.
- Intended Use: The intended use clearly states it's for "fragmentation of ureteral calculi through rigid or semi-rigid endoscopes." This is a therapeutic procedure, not a diagnostic test performed on a specimen.
The device description and intended use clearly indicate it's a surgical accessory used for a therapeutic purpose, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
The Swiss LITHOCLAST® Multipurpose Probe is intended to be used as an accessory to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of ureteral calculi through rigid or semi-rigid endoscopes.
Product codes
78 FFK
Device Description
The Multipurpose Probe is a rigid, 3 Fr (1.0 mm) Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece of the target to the stone. A lateral notch in the distal end of the probe allows for fixation of mobile ureteral stones, thus reducing the risk of stone push back in the ureter. The probe can be reused five times and may be sterilized by steam sterilization according to standard hospital procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureteral
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
Probe longevity testing, probe tip velocity and displacement testing, and clinical use assessment were performed to support the substantial equivalence of the Multipurpose Probe to the 1.0 mm LITHOCLAST ® Probe.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
0
510(k) Summary for ELECTRO MEDICAL SYSTEMS SA SWISS LITHOCLAST® MULTIPURPOSE PROBE
-
- SPONSOR
ELECTRO MEDICAL SYSTEMS SA Chemin de la Vaurpilliere 31 CH-1260 Nyon Switzerland
- SPONSOR
Contact Person: Giani Campana Quality Manager
June 30, 1999 Date Prepared:
2. DEVICE NAME
| Trade/Proprietary Name: | Swiss LITHOCLAST® Multipurpose Probe |
|---|---|
| Common/Usual Name: | Accessory to endoscopic intracorporeal pneumatic |
| lithotripter | |
| Classification Name: | Accessory to electrohydraulic lithotripter (Class III) |
INTENDED USE 3.
The Swiss LITHOCLAST® Multipurpose Probe is intended to be used as an accessory to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of ureteral calculi through rigid or semi-rigid endoscopes.
4. DEVICE DESCRIPTION
Swiss LITHOCLAST® Multipurpose Probe
The Multipurpose Probe is a rigid, 3 Fr (1.0 mm) Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece of the target to the stone. A lateral notch in the distal end of the probe allows for fixation of mobile ureteral stones, thus reducing the risk of stone push back in the ureter. The probe can be reused five times and may be sterilized by steam sterilization according to standard hospital procedures.
1
5. BASIS FOR SUBSTANTIAL EQUIVALENCE
The Multipurpose Probe is substantially equivalent to the EMS 1.0 mm Probe. This predicate device was cleared for use in fragmenting ureteral and bladder stones under K951531 and renal stones under K963285. The main difference between these devices is the distal, lateral notch of the Multipurpose Probe which serves for tangential fixation of mobile stones. The Multipurpose Probe is specifically intended for use in fragmenting of stones in the ureter.
Probe longevity testing, probe tip velocity and displacement testing, and clinical use assessment were performed to support the substantial equivalence of the Multipurpose Probe to the 1.0 mm LITHOCLAST ® Probe.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three heads, each head facing a different direction. The eagle's body is represented by flowing lines, giving it a sense of movement and dynamism.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 1999
Electro Medical Systems SA c/o Ms. Sheila M. Hemeon-Heyer, Esq., RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K992251 Swiss LITHOCLAST® Multipurpose Probe Dated: July 2, 1999 Received: July 6, 1999 Requiatory Class: III 21 CFR §876.4480/Procode: 78 FFK
Dear Ms. Hemeon-Heyer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _K992251
SWISS LITHOCLAST® MULTIPURPOSE PROBE Device Name:
Indications For Use:
The Swiss LITHOCLAST® Multipurpose Probe is intended to be used as an accessory to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of ureteral calculi through rigid or semi-rigid endoscopes.
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| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use __________ |
|---|---|---|
| ------------------------------------------ | ---- | --------------------------------- |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K992251 |
|---|---|
| --------------- | --------- |
| Electro Medical Systems SA Special 510(k)
SWISS LITHOCLAST® MULTIPURPOSE PROBE | 7/2/99 | CONFIDENTIAL
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