(107 days)
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No
The summary describes a pneumatic lithotripter probe, a mechanical device for breaking stones. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications.
Yes
The device is described as "An endoscopic intracorporeal pneumatic lithotripter probe for use in fragmenting urinary calculi...". Lithotripsy is a medical procedure used to break up stones, which makes this a therapeutic device.
No
Explanation: The device is described as an endoscopic intracorporeal pneumatic lithotripter probe used for fragmenting urinary calculi, which indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly states it is a "probe," which is a physical hardware component used in medical procedures. The intended use also describes a physical action ("fragmenting urinary calculi") performed by this probe.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states the device is an "endoscopic intracorporeal pneumatic lithotripter probe" used for "fragmenting urinary calculi... through rigid, semi-rigid and flexible endoscopes." This means the device is used inside the body (intracorporeal) to physically break up stones.
- Lack of IVD Characteristics: The description does not mention any testing of samples, analysis of biological markers, or any other activity typically associated with IVDs.
Therefore, this device is a therapeutic device used for a medical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
An endoscopic intracorporeal pneumatic lithotripter probe for use in fragmenting urinary calculi, including renal, ureteral and bladder stones through rigid, semi-rigid and flexible endoscopes.
Product codes
78FFK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
urinary calculi, including renal, ureteral and bladder stones
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
The proposed Microvasive® Lithotripsy Probes are Substantiaily Equivalent to the currently marketed Lithotripsy Probes in terms of performance characteristics tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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) Premarket Notification
Lithotripsy Probe October 1, 1997
Boston Scientific Corporation Doctor Scientific Place
Natick, MA 01760-1537
SECTION X 510(K) SUMMARY
.
| Sponsor: | Boston Scientific Corporation
One Scientific Place
Natick, MA 01760-1537 | K973788 |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| | | P171 |
| | | JAN 21 1998 |
| Contact Person: | Lorraine M. Hanley Manager,
Regulatory Affairs or
Carol J. Holloway
Regulatory Affairs Specialist | |
| Submission Date: | October 1, 1997 | |
| Common/Usual Names:
Trade/Proprietary Name: | Endoscopic Intracorporeal Pneumatic Lithotripter Probe
To Be Determined | |
| Device Classification
and Name: | Boston Scientific Corporation believes that while the proposed device is
classified as Class III, a Class II classification is appropriate for this device
proposed by the EMS 515(i) submission currently under review.
• CFR 876-4480; Lithotripter, Electro-hydraulic
Product Code: 78FFK | |
| Substantial Equivalence: | The proposed Microvasive® Lithotripsy Probes are Substantially
Equivalent to the currently marketed Lithoclast Lithotripsy Probes used
for fragmenting urinary calculi, including renal, ureteral and bladder
stones, through rigid, semi-rigid and flexible endoscopes. | |
| Product Testing: | The proposed Microvasive® Lithotripsy Probes are Substantiaily
Equivalent to the currently marketed Lithotripsy Probes in terms of
performance characteristics tested. | |
1
Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 | 1998
Ms. Carol J. Holloway Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place Natick, Massachusetts 01760-1537 Re: K973788
Endoscopic Intracorporeal Pneumatic Lithotripter Probe Dated: October 1, 1997 Received: October 6, 1997 Regulatory class: III 21 CFR §876.4480/Product code: 78 FFK
Dear Ms. Holloway:
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 interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbraning and adulteration.
If your device is classified (see above) into either 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 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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.Lilian Yin
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
2
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K973788
Device Name:
MLP
Indications For Use:
An endoscopic intracorporeal pneumatic lithotripter probe for use in fragmenting urinary calculi, including renal, ureteral and bladder stones through rigid, semi-rigid and flexible endoscopes.
Image /page/2/Picture/7 description: The image shows a thick, black line that runs diagonally from the upper left corner to the lower right corner. The line is slightly curved and has some jagged edges. The background is white, which provides a high contrast to the black line. The line appears to be hand-drawn, possibly with a marker or pen.
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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
イ
or
Over-The-Counter Use_
Robert R. Sothman
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 97 388 510(k) Number _