(23 days)
No
The device description focuses on mechanical and ultrasonic energy delivery for stone fragmentation and does not mention any AI or ML components.
Yes
The device is intended for the intracorporeal fragmentation of ureteral calculi, which directly treats a medical condition.
No
The device is described as being used for the fragmentation of urinary tract calculi, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines hardware components including operating units, handpieces, probes, a footswitch, and requires a compressed air supply. It is a physical medical device with different operational modes for lithotripsy.
Based on the provided text, the EMS Swiss LithoClast® Master is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "intracorporeal fragmentation of ureteral calculi in the kidney, ureter, and bladder" and "fragmentation of urinary tract calculi in the kidney, ureter, and bladder." This describes a therapeutic procedure performed within the body to break up stones.
- Device Description: The description details a system that uses pneumatic and/or ultrasound energy delivered through probes to physically break down stones. This is a mechanical/energy-based treatment, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Swiss LithoClast® Master's function is to treat a condition (kidney stones) by physically breaking them apart, which is a therapeutic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The EMS Swiss LithoClast® Master is intended for the intracorporeal fragmentation of ureteral calculi in the kidney, ureter, and bladder.
The EMS Swiss LithoClast® Master is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.
Product codes
78 FFK
Device Description
The Swiss LithoClast® Master is a modified version of the Swiss LithoClast® previously cleared under K951531 and K963285. Three possible modes of operation are available using the Swiss LithoClast® Master: (1) pneumatic lithotripsy alone; (2) ultrasound lithotripsy alone; (3) and combined pneumatic and ultrasound lithotripsy.
The system consists of two independent operating units in one housing, which allows for independent operation of the two modalities. Delivery of energy is controlled using a common two-pedal footswitch.
The pneumatic unit of the system is essentially the same as the Swiss LithoClast®. Operation of this unit requires a supply of medical quality compressed air from either a compressor or a central hospital supply. The compressed air provides the pressure a compresses ve a be projectile within the Swiss LithoClast® handpiece toward the proximal end of the probe. The pressure pulse propagates to the distal tip of the probe and is transferred to the stone, resulting in fragmentation. The pneumatic unit prood and in combination with the Swiss LithoVac® for suction of stone fragments. The LithoClast® probes can be inserted through the LithoVac® probes for simultaneous lithotripsy and suction.
The ultrasound handpiece consists of an ultrasound transducer containing the piezoelectric elements, which are driven by a generator operating at approximately 24 kHz. The resulting longitudinal waves are propagated along the ultrasound probe to the target stone. The ultrasound transducer and probes are hollow, permitting simultaneous suction. Two probe sizes are available: 3.3 mm and 3.8 mm.
Combined operation of the pneumatic and ultrasound units is desirable for certain hard kidney and bladder stones. In order to use the combined energy, the pneumatic and ultrasound handpieces must be mounted together to form a LithoClast® Master handpiece using an adjustment interface. The 1 mm pneumatic probe is inserted through the adjustment interface and through either the 3.3 mm or 3.8 mm ultrasound probe. The probes must be length-adjusted by turning the nut of the adjustment interface so that the tip of the pneumatic probe is flush with the tip of the ultrasound probe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, ureter, bladder (urinary tract)
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)
Substantial equivalence has been demonstrated by stone fragmentation testing. These tests confirmed that use of the Swiss LithoClast® Master results in equivalent or faster fragmentation of a variety of standard artificial stone materials (ranging from soft to hard) when tested against various predicate ultrasound lithotripters.
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
10/2445 PG-10-3
510(k) Summary for Electro Medical Systems SA SWISS LITHOCLAST® MASTER
1. SPONSOR
ELECTRO MEDICAL SYSTEMS SA Chemin de la Vaurpilliere 31 CH-1260 Nyon Switzerland
Giani Campana Contact Person: Quality Manager
July 31, 2001 Date Prepared:
2. DEVICE NAME
| Trade/Proprietary Name: | EMS Swiss LithoClast® Master (a.k.a. Swiss
LithoClast® Ultra | | | | | |
|-------------------------|-------------------------------------------------------------------|--|--|--|--|--|
| Common/Usual Name: | Endoscopic intracorporeal pneumatic and ultrasonic
lithotripsy | | | | | |
| Classification Name: | Electrohydraulic lithotripsy | | | | | |
INTENDED USE 3.
The EMS Swiss LithoClast® Master is intended for the intracorporeal fragmentation of ureteral calculi in the kidney, ureter, and bladder.
DEVICE DESCRIPTION 4.
The Swiss LithoClast® Master is a modified version of the Swiss LithoClast® previously cleared under K951531 and K963285. Three possible modes of operation are available using the Swiss LithoClast® Master: (1) pneumatic lithotripsy alone; (2) ultrasound lithotripsy alone; (3) and combined pneumatic and ultrasound lithotripsy.
1
The system consists of two independent operating units in one housing, which allows for independent operation of the two modalities. Delivery of energy is controlled using a common two-pedal footswitch.
The pneumatic unit of the system is essentially the same as the Swiss LithoClast® Operation of this unit requires a supply of medical quality compressed air from either a compressor or a central hospital supply. The compressed air provides the pressure a compresses ve a be projectile within the Swiss LithoClast® handpiece toward the proximal end of the probe. The pressure pulse propagates to the distal tip of the probe and is transferred to the stone, resulting in fragmentation. The pneumatic unit prood and in combination with the Swiss LithoVac® for suction of stone fragments. The LithoClast® probes can be inserted through the LithoVac® probes for simultaneous lithotripsy and suction.
The ultrasound handpiece consists of an ultrasound transducer containing the piezoelectric elements, which are driven by a generator operating at approximately 24 kHz. The resulting longitudinal waves are propagated along the ultrasound probe to the target stone. The ultrasound transducer and probes are hollow, permitting simultaneous suction. Two probe sizes are available: 3.3 mm and 3.8 mm.
Combined operation of the pneumatic and ultrasound units is desirable for certain hard kidney and bladder stones. In order to use the combined energy, the pneumatic and ultrasound handpieces must be mounted together to form a LithoClast® Master handpiece using an adjustment interface. The 1 mm pneumatic probe is inserted through the adjustment interface and through either the 3.3 mm or 3.8 mm ultrasound probe. The probes must be length-adjusted by turning the nut of the adjustment interface so that the tip of the pneumatic probe is flush with the tip of the ultrasound probe.
BASIS FOR SUBSTANTIAL EQUIVALENCE ડ.
The pneumatic module of the Swiss LithoClast® Master is substantially equivalent to the Swiss LithoClast®, which was previously cleared for intracorporeal fragmentation of ureteral and bladder stones under K951531 and for kidney stones under K963285. The ultrasound module of the Swiss LithoClast® Master is substantially equivalent to predicate ultrasonic lithotripters, including the Storz Ultrasound Lithotripters and the Richard Wolf Ultrasound Generator. The Swiss LithoClast® Master has the same intended use and similar technical specifications as compared with the predicate devices. Substantial equivalence has also been demonstrated by stone fragmentation testing. These tests confirmed that use of the Swiss LithoClast® Master results in
2
equivalent or faster fragmentation of a variety of standard artificial stone materials (ranging from soft to hard) when tested against various predicate ultrasound lithotripters. .
:
. .
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized symbol resembling three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.
Public Health Service
AUG 2 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Electro Medical Systems SA % Ms. Sheila Hemeon-Heyer, J.D., R.A.C. Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760
Re: K012445
EMS Swiss LithoClast® Master (a.k.a. Swiss LithoClast® Ultra) Lithotripter Dated: July 31, 2001 Received: August 1, 2001 Regulatory Class: II 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 We live 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 marketed in merslate onlinetee provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have bear to assimos in accordance marked provisions of the Act. The general controls provisions of the Act thelefore, market the device, subjor to the Edical of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject It your device is classince (so above) and tions affecting your device can be found in the Code of Federal Regulations, to such additional comrol. "Discusivally equivalent determination assumes compliance with the Current Good Manufacturing I I die 21, I all 800 to 02-71 11 de Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 1 rache requirements, to set tour in the Quant the Food and Drug Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to compy with the Unit Togulation ind Tecan in regerates to your premarket notification submission does not concenting your dorited in the Four 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 If you desire specific at ree to your confice of Compliance at (301) 594-4639. 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, advanting of your are to premarket notification" (21CFR 807.97). Other general information on your responsibilities under Intelligence of tecented to premained in Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely vours
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K012445 510(k) Number (if known):
Device Name: SWISS LITHOCLAST® MASTER
Indications For Use:
The EMS Swiss LithoClast® Master is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broxton
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Prescription Use _ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Electro Medical Systems SA Special 510(k) SWISS LITHOCLAST® MASTER
July 31, 2001
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