(297 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. It describes a device for stone fragmentation, which is typically a mechanical process.
Yes
The device is intended for the fragmentation of calculi (kidney stones) in renal, ureteral, and bladder areas, which is a therapeutic intervention.
No
Explanation: The device is intended for the fragmentation of calculi, which is a treatment (therapeutic) and not a diagnostic function.
No
The description clearly states the device is an "instrument" used by surgeons for fragmentation of calculi, implying a physical device with a mechanical function, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fragmentation of renal, ureteral, and bladder calculi within the body by qualified surgeons. This is a therapeutic procedure performed directly on the patient.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
The description clearly indicates a device used for a surgical procedure, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
These instruments are intended for use by qualified surgeons and provide for the fragmentation of renal, ureteral and bladder calculi.
Product codes
78 FFK, FEO
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal, ureteral and bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
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| Applicant: | Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive Culver City, CA 90230 (310) 558-1500 |
|---|---|
| Contact: | Kevin Kennan Regulatory Affairs Specialist |
| Device Identification: | |
| Common Name: | Ultrasonic Lithotriptor |
| Trade Name: (optional) |
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Regulatory Affairs Specialist
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1998
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Re: K973251
Calcuson Ultrasonic Lithotripter and Accessories Dated: August 29, 1997 Received: August 29, 1997 Regulatory class: III 21 CFR §876.4480/Product codes: 78 FFK and FEO
Dear Mr. Kennan:
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 Act. 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 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 (OS) 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. 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 (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.
hiliau Yu
Lillian Yin, Ph.D.
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
510(k) Number (if known): Not yet assigned (9 7 3 J T S 7 3 J 1
Device Name: Calcuson Ultrasonic Lithotriptor
Indications for Use: These instruments are intended for use by qualified surgeons and provide for the fragmentation of renal, ureteral and bladder calculi.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Robert R. Sathing/ (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
|---|---|
| 510(k) Number | K973251 |
| Prescription Use: | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR Over-The-Counter Use:
(Optional Format 1-2-96)000003