(62 days)
Not Found
No
The device description and intended use focus on mechanical suction and aspiration, with no mention of AI or ML capabilities.
No
The device is designed for the suction and aspiration of urinary tract calculi fragments, which is a mechanical removal process rather than a therapeutic treatment itself for disease or injury.
No
The device is designed for the suction and aspiration of urinary tract calculi fragments, and it works in conjunction with a lithotripter for stone fragmentation. Its purpose is to physically remove fragments and debris, not to provide diagnostic information about a disease or condition.
No
The device description clearly outlines physical components made of stainless steel (suction tube) and accessories for connecting hardware (handpiece and probe). It also describes different sizes and reusability, indicating a physical medical device, not software.
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 EMS SA LITHOVAC Suction/Aspiration Probe is a surgical instrument designed to physically remove urinary tract calculi fragments and debris from the body using suction. It is used during or after a medical procedure (lithotripsy) performed directly on the patient.
- No Sample Analysis: The device does not analyze any biological samples in vitro (outside the body) to provide diagnostic information. Its function is purely mechanical removal of material from within the body.
Therefore, the device falls under the category of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Electro Medical Systems SA LITHOVAC Suction/Aspiration Probe is designed for the suction and aspiration of urinary tract calculi fragments through rigid or semi-rigid endoscopes. It can be used alone, or it can be used during and after fragmentation of urinary tract calculi with the EMS Swiss LITHOCLAST intracorporeal lithotripter. It is specifically designed so that an EMS LITHOCLAST lithotripsy probe can be inserted through the LITHOVAC suction tube so that stone fragments and debris can be aspirated through the LITHOVAC suction tube simultaneously with lithotripsy.
Product codes
Not Found
Device Description
The EMS SA LITHOVAC Suction/Aspiration Probe is intended to be used to aspirate out urinary calculi. fragments and debris using a standard vacuum source, i.e. a regulated wall vacuum, a standard suction pump, or a peristaltic pump which can supply up to -0.8 bar vacuum. Accessory adapters are provided to permit it to be used to aspirate urinary stone fragments or debris produce during fragmentation of urinary stones with the EMS Swiss LITHOCLAST lithotripter.
The LITHOVAC consists of a suction tube with a trumpet valve, and accessories for connecting the EMS Swiss LITHOCLAST handpiece and probe to the suction tube.
The LITHOVAC suction tube is made of type 304 stainless steel and is available in four diameter/length combinations as follows:
- 1.6 mm OD/445 mm length disposable sterile .
- 1.6 mm OD/555 mm length disposable sterile .
- 3.5 mm OD/460 mm length reusable non-sterile .
- 4 mm OD/430 mm length reusable non-sterile ●
The size of the suction tube is chosen according to the size of the endoscope to be used, e.g., the 4 mm LITHOVAC Probe is used through a 12 Fr or greater endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Animal studies were performed in the pig model to assess the effectiveness and the potential for injury of the EMS LITHOVAC Probe used with the EMS LITHOCLAST Lithotripter in fragmenting and aspirating stones in the pig bladder and ureter.
The LITHOVAC/LITHOCLAST Probes were used to fragment and aspirate four stones in the pig bladder using maximum LITHOVAC suction. Immediately after treatment, only mild ecchymosis was noted at the areas where the stones were treated.
The LITHOVAC was then applied directly to three separate areas of the bladder mucosa at maximum suction for 10 seconds each. Only, mild ecchymosis was observed. At one week post-treatment, the bladder was harvested and showed no macroscopic or microscopic perforation, or fibrosis. The urothelium was intact demonstrating that even with the minimal mucosal damage immediately posttreatment, complete regeneration of normal urothelium had taken place within one week.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Uromat Suction Pump/Calcuson Ultrasonic Lithotrite System, the Olympus Ureteromat Pump/LUS Lithotripsy device, and numerous other vacuum aspiration systems such as the Corson Disposable Suction Irrigation Probe, and the Nezhat-Dorsey Hydro-Dissection Reusable Suction Irrigation Probe.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4370 Gastroenterology-urology evacuator.
(a)
Identification. A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.(b)
Classification. (1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
0
Piq.3
510(k) Summary
EMS LITHOVAC SUCTION/ASPIRATION PROBE
Sponsor/Applicant 1.
DEC I 6 1996
Electro Medical Systems SA Chemin de la Vuarpilliere 31 CH-1260 Nyon Switzerland
Contact Person:
Mr. Wolfgang Merkle EMS Deutschland Steigstr. 14 D-88709 Meersburg Germany
Date Prepared: October 11, 1996
2. Device Name
| Trade or Proprietary Name: | LITHOVAC Suction/Aspiration Probe |
|---|---|
| Common/Usual Name: | Suction/aspirator, evacuator |
| Classification Name: | Gastroenterology-urology evacuators |
3. Identification of the Predicate or Legally Marketed Device(s) to Which Equivalence is Being Claimed
Uromat Suction Pump/Calcuson Ultrasonic Lithotrite System, the Olympus Ureteromat Pump/LUS Lithotripsy device, and numerous other vacuum aspiration systems such as the Corson Disposable Suction Irrigation Probe, and the Nezhat-Dorsey Hydro-Dissection Reusable Suction Irrigation Probe.
1
Device Description 4.
K964111
p2073
The EMS SA LITHOVAC Suction/Aspiration Probe is intended to be used to aspirate out urinary calculi. fragments and debris using a standard vacuum source, i.e. a regulated wall vacuum, a standard suction pump, or a peristaltic pump which can supply up to -0.8 bar vacuum. Accessory adapters are provided to permit it to be used to aspirate urinary stone fragments or debris produce during fragmentation of urinary stones with the EMS Swiss LITHOCLAST lithotripter.
The LITHOVAC consists of a suction tube with a trumpet valve, and accessories for connecting the EMS Swiss LITHOCLAST handpiece and probe to the suction tube.
The LITHOVAC suction tube is made of type 304 stainless steel and is available in four diameter/length combinations as follows:
- 1.6 mm OD/445 mm length disposable sterile .
- 1.6 mm OD/555 mm length disposable sterile .
- 3.5 mm OD/460 mm length reusable non-sterile .
- 4 mm OD/430 mm length reusable non-sterile ●
The size of the suction tube is chosen according to the size of the endoscope to be used, e.g., the 4 mm LITHOVAC Probe is used through a 12 Fr or greater endoscope.
ડ. Intended Use
The Electro Medical Systems SA LITHOVAC Suction/Aspiration Probe is designed for the suction and aspiration of urinary tract calculi fragments through rigid or semi-rigid endoscopes. It can be used alone, or it can be used during and after fragmentation of urinary tract calculi with the EMS Swiss LITHOCLAST intracorporeal lithotripter. It is specifically designed so that an EMS LITHOCLAST lithotripsy probe can be inserted through the LITHOVAC suction tube so that stone fragments and debris can be aspirated through the LITHOVAC suction tube simultaneously with lithotripsy.
2
6. Technological Characteristics
K964111 P3073
The EMS LITHOVAC Probe technological characteristics are the same as the predicate devices in that they are suction/aspiration devices that consist of probes or tubes for evacuating fluids and debris during or after lithotripsy treatment.
7. Performance Testing
Animal studies were performed in the pig model to assess the effectiveness and the potential for injury of the EMS LITHOVAC Probe used with the EMS LITHOCLAST Lithotripter in fragmenting and aspirating stones in the pig bladder and ureter.
The LITHOVAC/LITHOCLAST Probes were used to fragment and aspirate four stones in the pig bladder using maximum LITHOVAC suction. Immediately after treatment, only mild ecchymosis was noted at the areas where the stones were treated.
The LITHOVAC was then applied directly to three separate areas of the bladder mucosa at maximum suction for 10 seconds each. Only, mild ecchymosis was observed. At one week post-treatment, the bladder was harvested and showed no macroscopic or microscopic perforation, or fibrosis. The urothelium was intact demonstrating that even with the minimal mucosal damage immediately posttreatment, complete regeneration of normal urothelium had taken place within one week.