(297 days)
These instruments are intended for use by qualified surgeons and provide for the fragmentation of renal, ureteral and bladder calculi.
Not Found
The Karl Storz Calcuson Ultrasonic Lithotriptor is intended for the fragmentation of renal, ureteral, and bladder calculi.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria for the Calcuson Ultrasonic Lithotriptor in terms of specific performance metrics (e.g., fragmentation rate, stone clearance rate, or power output). The 510(k) submission process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device rather than defining new performance benchmarks for a novel device.
However, the "Indications for Use" section implicitly sets the functional acceptance criterion: The device must be capable of fragmenting renal, ureteral, and bladder calculi.
The reported device performance, based on the FDA's clearance, is that it is "substantially equivalent" to legally marketed devices for the stated indications. This implies that the device is expected to perform comparably to existing ultrasonic lithotriptors in terms of its ability to fragment the specified types of calculi. Without a detailed study report, specific numerical performance data for the Calcuson itself is not provided in this regulatory document.
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) clearance letter and associated documents do not include information about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission where, if a study was conducted, it would primarily focus on demonstrating substantial equivalence, often through bench testing, animal studies, or comparison to existing clinical data of the predicate device, rather than a full-scale clinical trial to establish novel performance metrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not specify the number of experts or their qualifications used to establish ground truth for any test set. As mentioned, a formal clinical study with ground truth established by experts is not detailed in this 510(k) summary.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as there is no specific test set or clinical study described within the provided regulatory information.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size related to human reader improvement with or without AI assistance. This device is an ultrasonic lithotriptor, a surgical tool, and not a diagnostic imaging device that would typically involve human "readers" or AI assistance in interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The Karl Storz Calcuson is a surgical instrument operated by a qualified surgeon, not an algorithm or AI system. Therefore, a standalone performance study in the context of AI is irrelevant.
7. Type of Ground Truth Used:
Given the nature of the device and the provided document, the "ground truth" for the 510(k) submission would likely be established through:
- Bench testing: Demonstrating the ability to fragment various types of calculi in a controlled environment.
- Performance specifications: Meeting engineering and design specifications for power output, frequency, and other physical characteristics suitable for lithotripsy.
- Comparison to predicate device: The fundamental "ground truth" for substantial equivalence is the established performance and safety profile of the legally marketed predicate device(s).
No direct clinical "ground truth" in the form of pathology, expert consensus on images, or outcomes data from a de novo clinical trial is described in this regulatory filing.
8. Sample Size for the Training Set:
Not applicable. This is a medical device, an ultrasonic lithotriptor, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
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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
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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
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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
§ 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.”