(75 days)
The Storz Modulith® Lithotripter Model SLK with Multiview option is intended for noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
The Storz Modulith® Lithotripter Model SLK with Multiview option is an extracorporeal pressure wave lithotripter. The Multiview option facilitates the additional display of up to two imaging systems on the Lithotrack® monitor.
This looks like a 510(k) summary and FDA clearance letter for a medical device called the "Storz Modulith® Lithotripter Model SLK with Multiview option." This document asserts substantial equivalence to a predicate device rather than providing a detailed study demonstrating that the device meets specific acceptance criteria through performance data.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not present in the provided text. This is typical for a 510(k) submission where the primary argument for clearance is substantial equivalence to an already legally marketed device, rather than novel clinical performance data.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Available. The document does not provide a table of acceptance criteria or reported device performance metrics tied to specific criteria. The clearance is based on substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable / Not Available. No specific test set data is provided for the "Storz Modulith® Lithotripter Model SLK with Multiview option" to demonstrate its performance against acceptance criteria. The clearance relies on the equivalence to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable / Not Available. No ground truth establishment for a test set of the new device is discussed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. No test set or adjudication method is mentioned for the new device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a lithotripter, which fragments urinary calculi. It is not an AI-assisted diagnostic imaging device, so an MRMC study with human readers improving with AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical lithotripter, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Available. As no new performance study for the device is presented, no ground truth type for such a study is mentioned. The clearance is based on the previously established performance and safety of the predicate device.
8. The sample size for the training set
- Not Applicable. This is a hardware device (lithotripter) and not a software algorithm that would require a training set.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set for this type of device.
Summary based on the provided text:
The provided documents (510(k) Summary and FDA Clearance Letter) for the "Storz Modulith® Lithotripter Model SLK with Multiview option" do not describe a study to prove the device meets specific acceptance criteria through performance data. Instead, the clearance is based on a demonstration of substantial equivalence to an existing predicate device. The statement explicitly says: "The Storz Modulith® Lithotripter Model SLK with Multiview option for lithotripsy is substantially equivalent to the predicate device since the basic features and intended use are identical, and the design is similar. The minor differences between the Storz Modulith® Lithotripter Model SLK with Multiview option and the predicate device raises no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."
Therefore, the requested information pertaining to studies, sample sizes, ground truth establishment, and expert involvement for a new performance study is not applicable and not present in this type of submission.
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OCT 1 6 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.
Applicant:
Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 338-8100
Contact:
Jennifer S. Portugal Clinical Affairs Specialist
Device Identification:
Common Name Lithotripter
Trade Name The Storz Modulith® Lithotripter Model SLK with Multiview option
Indication: The Storz Modulith® Lithotripter Model SLK with Multiview option is intended for noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
Device Description: The Storz Modulith® Lithotripter Model SLK with Multiview option is an extracorporeal pressure wave lithotripter. The Multiview option facilitates the additional display of up to two imaging systems on the Lithotrack® monitor.
Substantial Equivalence: The Storz Modulith® Lithotripter Model SLK with Multiview option for lithotripsy is substantially equivalent to the predicate device since the basic features and intended use are identical, and the design is similar. The minor differences between the Storz Modulith® Lithotripter Model SLK with Multiview option and the predicate device raises no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Jennifer S. Portugal
Clinical Affairs Specialist
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services-USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" written around it. Inside the circle is a symbol that resembles three stylized human figures or waves, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2001
Ms. Jennifer S. Portugal Clinical Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe, 5th Floor CULVER CITY CA 90230-7600
Re: K012482
Trade/Device Name: Storz Modulith® Lithotripter Model SLK with Multiview option Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II
Product Code: 78 LNS Dated: July 31, 2001 Received: August 2, 2001
Dear Ms. Portugal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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), please If you desire specific at compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on by received to premained than at may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K012482
Not yet assigned
510(k) Number (if known):
Storz Modulith® Lithotripter Model SLK with Multiview option Device Name:
The Storz Modulith® Lithotripter Model SLK with Multiview option is Indications for Use: indicated for use in the noninvasive fragmentation of kidney and upper ureteral calculi.
(PLEASE DO NOT WRITE BELQW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of ODRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012482
Prescription Use: / OR Over-The-Counter Use:
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)