(176 days)
No
The document describes a lithotripter, a device for fragmenting stones using mechanical energy. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance study is a retrospective clinical study comparing the device's effectiveness to predicate devices, not an evaluation of an AI/ML algorithm's performance.
Yes
The device is intended for fragmenting urinary tract calculi, which is a medical procedure to treat a health condition.
No
The device is described as a lithotripter used for fragmenting urinary tract calculi, which is a therapeutic intervention, not a diagnostic one.
No
The device is described as a "LITHOTRIPTER," which is a medical device used to fragment stones. The description of its use with endoscopes and the clinical study involving treatment of renal stones strongly suggest a physical device that delivers energy (likely acoustic or mechanical) to break up stones, not a software-only device. The predicate devices also appear to be physical lithotripters.
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 tract calculi through rigid or semirigid endoscopes. This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: While not found, the intended use clearly points to a therapeutic device used in a surgical or interventional setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is used to physically break up stones within the body.
N/A
Intended Use / Indications for Use
The EMS SwISS LITHOCLAST LITHOTRIPTER is intended for use in fragmenting urinary tract calculi (renal, ureteral, and bladder) through rigid or semirigid endoscopes.
Product codes
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract (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
A retrospective clinical study of the results on 83 kidneys with renal stones treated by two investigational sites was provided to support the safety and effectiveness of the EMS SWISS LITHOCLAST for treatment of renal stones. The clinical data demonstrates that the EMS SWISS LITHOCLAST is substantially equivalent in safety and effectiveness to that of the predicate devices cited above as reported in the medical literature.
Key Metrics
Not Found
Predicate Device(s)
K951531, Wolf 2270 Ultrasound Generator and Sonatrodes, K923487, K863642/K885255
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 963285
FEB 1 3 1997
11 72
510(k) Summary for the Expansion of the Indications for Use of the Electro Medical Systems SA EMS SWISS LITHOCLAST LITHOIRIPTER (per 21 CFR 807.92)
| 1. | Date Prepared: | August 16, 1996 |
|---|---|---|
| 2. | Sponsor/Applicant: | Electro Medical Systems SA |
| Chemin de la Vaurpilliere 31 | ||
| CH-1260 Nyon | ||
| Switzerland | ||
| 3. | Contact Person: | Manfred Schulz |
| 4. | Device Name: | |
| Trade/Proprietary Name: | EMS SWISS LITHOCLAST LITHOTRIPTER | |
| Common/Usual Name: | Endoscopic intracorporeal pneumatic lithotripter | |
| Classification Name: | Electrohydraulic Lithotripter | |
| 5. | Device Classification: | Class III |
| 6. | Predicate Devices: | |
| EMS SWISS LITHOCLAST LITHOTRIPTER (for ureteral and bladder stones) K951531Wolf 2270 Ultrasound Generator and SonatrodesWolf 2280 Electrohydraulic Lithotripter (K923487)Candela LaserTripter (K863642/K885255) | ||
| 7. | Intended Use: |
The EMS SwISS LITHOCLAST LITHOTRIPTER is intended for use in fragmenting urinary tract calculi (renal, ureteral, and bladder) through rigid or semirigid endoscopes.
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1
K963285
p292
Operational and Technological Characteristics: 8.
The operational and technological characteristics of the LITHOCLAST are unchanged.
A retrospective clinical study of the results on 83 kidneys with renal stones treated by two investigational sites was provided to support the safety and effectiveness of the EMS SWISS LITHOCLAST for treatment of renal stones. The clinical data demonstrates that the EMS SWISS LITHOCLAST is substantially equivalent in safety and effectiveness to that of the predicate devices cited above as reported in the medical literature.