(348 days)
The STORZ MEDICAL Lithotripter Model MODULITH® SLX-F2 is indicated for the use in the noninvasive fragmentation of calculi in the kidney, in upper, middle and lower ureter for all adults and children 3 years or over.
The MODULITH® Lithotripter SLX-F2 is an Extracorporeal Shock Wave Lithotripter Device. It generates shock waves that are focused onto the urinary calculi so that the stone fragments can be passed with the patient's urine.
The provided text is a 510(k) summary for the KARL STORZ Endoscopy-America, Inc. Modulith SLX-F2, an Extracorporeal Shock Wave Lithotripter. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria for an AI/algorithm-driven device.
Therefore, the document does not contain the information requested regarding acceptance criteria related to AI/algorithm performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods for AI, or multi-reader multi-case (MRMC) studies.
The provided text only discusses the following in relation to performance data:
- Non-Clinical Performance Data: "The MODULITH SLX-F2 follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: Electrical Safety and EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-36, IEC 61849), Software Verification and Validation Testing (Guidance for the Content of Premarket Submissions for Software Contained in Medical Device Level of concern: Moderate). Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the MODULITH SLX-F2 has met all its design specification and is substantially equivalent to its predicate device."
- Clinical Performance Data: "Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. However, literature reviews on the effectiveness of the subject device or equivalent devices on pediatric population and an analysis of stone composition in patient between 1 to 18 years old to support the applicability of OUS data to US population was provided to establish substantial equivalence for use in pediatric populations."
In summary, the document does not provide the 9 specific pieces of information requested because it's a 510(k) summary for a physical medical device (lithotripter), not an AI/algorithm-driven device requiring performance metrics like sensitivity, specificity, or MRMC studies.
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March 30, 2021
KARL STORZ Endoscopy-America, Inc. Winkie Wong Manager, Regulatory Affairs 2151 E. Grand Avenue El Segundo, CA 90245
Re: K201001
Trade/Device Name: Modulith SLX-F2 Regulation Number: 21 CFR§ 876.5990 Regulation Name: Extracorporeal Shock Wave Lithotripter Regulatory Class: II Product Code: LNS Dated: February 26, 2021 Received: March 2, 2021
Dear Winkie Wong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Modulith SLX-F2
Indications for Use (Describe)
The STORZ MEDICAL Lithotripter Model MODULITH® SLX-F2 is indicated for the use in the noninvasive fragmentation of calculi in the kidney, in upper, middle and lower ureter for all adults and children 3 years or over.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
510(k) SUMMARY
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 is accurate and complete to the best of KSEA's knowledge.
| Applicant: | KARL STORZ Endoscopy-America, Inc2151 E. Grand AvenueEI Segundo, CA 90245 |
|---|---|
| Contact: | Winkie WongRegulatory Affairs Manager424-218-8379 (phone) |
| Date of Preparation: | April 22nd, 2020 |
| Type of 510(k)Submission: | Traditional |
| Device Identification: | Trade Name: MODULITH SLX-F2Common Name: Lithotripter, Excorporeal Shock-Wave, UrologicalClassification Name: Extracorporeal shock wave lithotripter |
| Product Code: | LNS |
| Regulation: | 21 CFR 876.5990 |
| Predicate Device(s): | Modulith SLX-F2 180 (K072788) – PrimaryLM-9300 ELMA (K142561) - SecondaryThe above reference device have not been subject to any recall |
| Device Description: | The MODULITH® Lithotripter SLX-F2 is an Extracorporeal ShockWave Lithotripter Device. It generates shock waves that are focusedonto the urinary calculi so that the stone fragments can be passedwith the patient's urine. |
| Intended Use andIndications for use: | The STORZ MEDICAL Lithotripter Model MODULITH® SLX-F2is indicated for the use in the noninvasive fragmentation of calculi in |
| the kidney, in upper, middle and lower ureter for all adults andchildren 3 years or over. | |
| TechnologicalCharacteristics: | The MODULITH SLX-F2 is a modification to the ModulithSLX-F2 180. The inclusion of pediatric patients as well astreatment of pancreatic, middle and lower ureter stones in itsindication does not raise new or different issues of safety andeffectiveness as supported by reviews of published literatures.Thus, the subject devices are substantially equivalent to thepredicate device. |
| Non-ClinicalPerformance Data: | The MODULITH SLX-F2 follows the FDA recognized consensusstandards and is tested according to the following standards andFDA Guidance:Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-36 IEC 61849 Software Verification and Validation Testing Guidance for the Content of Premarket Submissionsfor Software Contained in Medical Device Level of concern: Moderate Additional bench testing was performed to ensure the device met itsdesign specifications. The bench testing performed verified andvalidated that the MODULITH SLX-F2 has met all its designspecification and is substantially equivalent to its predicate device. |
| SubstantialEquivalence: | The intended use, operating principles, technological characteristicsand features are similar, if not identical, between that subject andpredicate devices. The minor differences between the subject andpredicate devices do not raise new or different questions or safetyand effectiveness.As proven by the comparisons and rationale in this section, thedifferences do not raise different questions of safety andeffectiveness because the intended use, operating principles,technological characteristics, and features are significantly similar, ifnot identical. Both systems also comply with identical standardsand safety testing, where applicable. |
| Clinical PerformanceData: | Clinical performance is not required to demonstrate substantialequivalence to the predicate devices. However, literature reviews onthe effectiveness of the subject device or equivalent devices onpediatric population and an analysis of stone composition in patientbetween 1 to 18 years old to support the applicability of OUS data toUS population was provided to establish substantial equivalence foruse in pediatric populations. |
| Conclusion: | The MODULITH SLX-F2 is substantially equivalent to its predicatedevice. The non-clinical bench, literature review and comparativetesting demonstrate that the device is as safe and effective as thelegally marketed devices. |
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§ 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.”)