(43 days)
No
The device description focuses on mechanical components and energy transmission for stone fragmentation. There is no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device is used for the fragmentation of urinary tract calculi (kidney stones), which is a treatment for a medical condition.
No
Explanation: The device is described as being used for the "fragmentation of urinary tract calculi," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly details physical hardware components (handpiece, probe, projectile, shock transmitter) made of materials like aluminum alloy and stainless steel. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "fragmentation of urinary tract calculi... through rigid or semirigid endoscopes." This describes a therapeutic procedure performed directly on the patient's body to break up stones.
- Device Description: The description details a handpiece and a probe that transmit mechanical energy to break up stones. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for a therapeutic intervention within the body.
N/A
Intended Use / Indications for Use
The LITHOCLAST® MASTER Handpiece and the 3.2 mm probe have the same intended use as their predicate accessories, that is, for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or semirigid endoscopes. The 3.2 mm probe is specifically indicated for use in fragmenting large stones in the bladder and kidney.
The Swiss LITHOCLAST® MASTER HANDPIECE and the 3.2 MM PROBE are intended to be used as accessories to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or semirigid endoscopes. The 3.2 mm Probe is specifically indicated for use in fragmenting large stones in the bladder and kidney.
Product codes
78 FFK
Device Description
MASTER Handpiece
The MASTER Handpiece is 18 mm in diameter, 228 mm long, and is constructed of aluminum alloy. The proximal end of the handpiece is connected to the LITHOCLAST pressure regulator. The chosen treatment probe is attached to the distal end of the handpiece using a screw cap. The metal projectile inside the handpiece is driven forward by the pressure from the pressure regulator. The energy from the projectile is transmitted to the probe by a shock transmitter at the distal end of the handpiece. The handpiece is sealed at both the distal and proximal ends, which: (1) prolongs the life time of the handpiece by preventing dirt, moisture and other particles from entering the handpiece; and (2) allows for the changing of probes during a treatment without the risk of breaking sterility.
3.2 mm Probe
The 3.2 mm probe is a rigid Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece to the target stone. The probe is reusable 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
urinary tract (including renal, ureteral and bladder)
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)
MASTER Handpiece
Life time and probe displacement tests were performed to support the substantial equivalence of the MASTER Handpiece.
3.2 mm Probe
Probe velocity and displacement tests, impact pressure, disintegration efficiency, and in-vitro tissue impact studies were performed to support the substantial equivalence of the 3.2 mm probe.
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
§ 876.4480 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
K 974164
Jor i ok
510(k) Summary
DEC 18 1997
ELECTRO MEDICAL SYSTEMS SA LITHOCLAST® MASTER Handpiece and
3.2 mm Probe
- Sponsor 1.
ELECTRO MEDICAL SYSTEMS SA Chemin de la Vaurpilliere 31 CH-1260 Nyon Switzerland
Manfred Schulz Contact Person: General Manager
Date Prepared: October 31, 1997
-
- Device Name
| Trade/Proprietary Name: | LITHOCLAST® MASTER Handpiece and 3.2 mm Probe |
|---|---|
| Common/Usual Name: | Accessories to endoscopic intracorporeal pneumatic lithotripter |
| Classification Name: | Accessories to electrohydraulic lithotripter (Class III) |
3. Intended Use
The LITHOCLAST® MASTER Handpiece and the 3.2 mm probe have the same intended use as their predicate accessories, that is, for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or The 3.2 mm probe is specifically indicated for use in semirigid endoscopes. fragmenting large stones in the bladder and kidney.
1
K974164
fg 2 of 3
Device Description 4.
MASTER Handpiece
The MASTER Handpiece is 18 mm in diameter, 228 mm long, and is constructed of aluminum alloy. The proximal end of the handpiece is connected to the LITHOCLAST pressure regulator. The chosen treatment probe is attached to the distal end of the handpiece using a screw cap. The metal projectile inside the handpiece is driven forward by the pressure from the pressure regulator. The energy from the projectile is transmitted to the probe by a shock transmitter at the distal end of the handpiece. The handpiece is sealed at both the distal and proximal ends, which: (1) prolongs the life time of the handpiece by preventing dirt, moisture and other particles from entering the handpiece; and (2) allows for the changing of probes during a treatment without the risk of breaking sterility.
3.2 mm Probe
The 3.2 mm probe is a rigid Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece to the target stone. The probe is reusable and may be sterilized by steam sterilization according to standard hospital procedures.
5. Basis For Substantial Equivalence
MASTER Handpiece
The MASTER Handpiece is substantially equivalent to the EMS Standard Handpiece that was cleared for marketing under K951531 and K963285. The main difference between the two devices is that the MASTER Handpiece is sealed at both the distal and proximal ends, while the Standard Handpiece is open and requires the use of a silicone sleeve to provide a watertight seal between the probe and the handpiece. Life time and probe displacement tests were performed to support the substantial equivalence of the MASTER Handpiece.
2
3.2 mm Probe
K 974/64
rg3 q3
The EMS 3.2 mm probe is substantially equivalent to the EMS probes with smaller diameters (0.8, 1.0, 1.6, 2.0 mm). These predicate devices were cleared for marketing under K951531 and K963285. The main difference between these devices is the probe diameter. The larger 3.2 mm probe is specifically intended for use in fragmenting large stones in the bladder and kidney. Probe velocity and displacement tests, impact pressure, disintegration efficiency, and in-vitro tissue impact studies were performed to support the substantial equivalence of the 3.2 mm probe.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES - ......
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 18 1997
Re: K974164
ELECTRO MEDICAL SYSTEMS SA c/o Ms. Rosina Robinson Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
EMS Swiss LITHOCLAST® MASTER Handpiece and 3.2mm Probe Dated: October 31, 1997 Received: November 5, 1997 Regulatory class: III 21 CFR §876.4480/Product code: 78 FFK
Dear Ms. Robinson:
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 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). You may, therefore, subject to the general controls provisions of 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 (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 requirement, as set forth in the Quality System Regulation (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 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 predication 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), please 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/dsmamain.html".
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Swiss LITHOCLAST® MASTER HANDPIECE and 3.2 MM Device Name: PROBE
Indications For Use:
The Swiss LITHOCLAST® MASTER HANDPIECE and the 3.2 MM PROBE are intended to be used as accessories to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or semirigid endoscopes. The 3.2 mm Probe is specifically indicated for use in fragmenting large stones in the bladder and kidney.
(Please do not write below this line - Continue on another page if necessary)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert P. Satting
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K974164 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use_
(Optional Format 1-2-96)