(86 days)
The Storz MODULITH® Lithotripter SLX-F2 F180 is intended for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
The Storz MODULITH® Lithotripter SLX-F2 F180 is an Extracorporeal Shock Wave Lithotripter Device. It generates shock waves that are focused onto a kidney or ureteral stone so that the stone fragments can be passed with the patient's urine.
This document is a 510(k) summary for the Storz MODULITH® Lithotripter SLX-F2 F180. The content primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in terms of efficacy. Therefore, I cannot extract information regarding study design, sample sizes, ground truth establishment, or multi-reader studies as these are not present in the provided text.
Based on the provided information, the device's performance acceptance criteria are implicitly related to its technological characteristics and intended use being similar to legally marketed predicate devices, rather than explicit quantitative metrics of fragmentation success rate for urinary calculi.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (Storz MODULITH® SLX-F2 F180) |
|---|---|
| Shock wave generator: Electromagnetic | Shock wave generator: Electromagnetic |
| Treatment depth: Comparable to predicates (165 mm, 145-175 mm) | Treatment depth: 180 mm |
| Focal size: Comparable to predicates (e.g., F1: 2 x 20 mm, F2: 4.8 x 36 mm for SLX-F2; 11 x 175 mm for EM1000) | Focal size: F1: 2 x 24 mm, F2: 4.7 x 39 mm |
| Peak-positive pressure: Min/Max (MPa) comparable to predicates (e.g., F1: 18 - 107, F2: 16 - 44 for SLX-F2; 9.8 - 41.6 for EM1000) | Peak-positive pressure: F1: 18 - 107 MPa, F2: 15 - 36 MPa |
| Focal energy: Min/Max (MPa) comparable to predicates (e.g., F1: 2.2 - 2.5, F2: 4.3 - 5.5 for SLX-F2) | Focal energy: F1: 1.9 - 2.1 MPa, F2: 3.8 - 4.0 MPa |
| Number of Energy Levels: Comparable to predicates (e.g., 26 for SLX-F2) | Number of Energy Levels: 26 |
| Intended Use: Noninvasive fragmentation of urinary calculi in the kidney and upper ureter. | Intended Use: Noninvasive fragmentation of urinary calculi in the kidney and upper ureter. |
2. Sample size used for the test set and the data provenance:
- This information is not provided in the document. The submission is based on demonstrating substantial equivalence through comparison of technical specifications, not results from a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable/provided. No clinical test set with ground truth established by experts is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable/provided. No clinical test set is described.
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:
- This information is not applicable/provided. This is a lithotripter, a medical device for breaking stones, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable/provided. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not applicable/provided. No clinical trial data is presented for this 510(k) summary, as it relies on substantial equivalence.
8. The sample size for the training set:
- This information is not applicable/provided. This is not an AI/machine learning device that would require a training set.
9. How the ground truth for the training set was established:
- This information is not applicable/provided. As above, this is not an AI/machine learning device.
Summary of the Study Proving Acceptance Criteria:
The "study" proving the device meets acceptance criteria, in the context of this 510(k) submission, is a comparison of technological characteristics and intended use against legally marketed predicate devices (Storz MODULITH® Lithotripter SLX-F2 and Medispec Econolith EM1000). The submission argues that "The minor differences between the Storz MODULITH® Lithotripter SLX-F2 and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This demonstrates "substantial equivalence" as the primary "acceptance criterion" for regulatory approval in this context.
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KD72188
pg 1 of 2
DEC 2 6 2007
510(k) SUMMARY
.
:
| Sponsor/Submitter: | Karl Storz Endoscopy - America, Inc.600 Corporate PointeCulver City, CA 90230-7600Phone: (310) 338-8100Fax: (310) 410-5519 |
|---|---|
| Contact Person: | Crystal DizolRegulatory Affairs AssociateEmail: cdizol@ksea.com |
| Date of Submission: | September 24, 2007 |
| Device Trade Name: | Storz MODULITH® Lithotripter SLX-F2 F180 |
| Common Name: | Extracorporeal Shock Wave Lithotripter |
| Classification Name: | Lithotripter, Extracorporeal Shock-Wave, Urological |
| Regulation Number: | 21 CFR 876.5990 |
| Product Code: | LNS |
| Predicate Device(s): | Storz MODULITH Lithotripter SLX-F2 (K040476)Medispec Econolith EM1000 (K063504) |
| Device Description: | The Storz MODULITH® Lithotripter SLX-F2 F180 is an ExtracorporealShock Wave Lithotripter Device. It generates shock waves that arefocused onto a kidney or ureteral stone so that the stone fragments canbe passed with the patient's urine. |
| Indications for Use: | The Storz MODULITH® Lithotripter SLX-F2 F180 is indicated for use inthe noninvasive fragmentation of urinary calculi in the kidney and upperureter. |
| TechnologicalCharacteristics: | The Storz MODULITH® Lithotripter SLX-F2 F180 and its predicatedevices generate shock waves using electromagnetically repelledmembranes. The shock waves are focused onto the stone by aparabolic reflector dish, and are transferred to the patient's body viacontact with a water-filled rubber cushion. |
| Summary ofSubstantialEquivalence: | The Storz MODULITH® Lithotripter SLX-F2 F180 is substantiallyequivalent to the predicate devices since the intended uses andtechnological characteristics are similar. The minor differences betweenthe Storz MODULITH® Lithotripter SLX-F2 and the predicate devicesraise no new issues of safety and effectiveness, as these designdifferences have no affect on the performance, function or intended useof the devices. |
Att: Substantial Equivalence Table for Storz MODULITH® Lithotripter SLX-F2 F180
:
:
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RE STORZ ENDOSCOP 0
JBSTANTIAL EQUIVALENCE TABLE FOR STORZ MODULITH® SLX-F2 F1
| Manufacturer | Storz Medical AGMODULITH® SLX-F2 F180 | Storz Medical AGMODULITH® SLX-F2 | Medispec, Ltd.Econolith™ EM1000 |
|---|---|---|---|
| Trade/Proprietary Name | |||
| 510(k) Number | Not Yet Assigned | K040476 | K063504 |
| Shock wave generator | Electromagnetic | Electromagnetic | Electromagnetic |
| Diameter of source | 300 mm | 300 mm | Unavailable |
| Treatment depth | 180 mm | 165 mm | 145-175 mm |
| Focal size (typical) | F1: 2 x 24 mmF2: 4.7 x 39 mm | F1: 2 x 20 mmF2: 4.8 x 36 mm | 11 x 175 mm |
| Peak-positive pressure,Min/Max (MPa) | F1: 18 - 107F2: 15 - 36 | F1: 18 - 107F2: 16 - 44 | 9.8 - 41.6 |
| Focal energy,Min/Max (MPa) | F1: 1.9 - 2.1F2: 3.8 - 4.0 | F1: 2.2 - 2.5F2: 4.3 - 5.5 | Unavailable |
| Number of Energy Levels | 26 | 26 | Unavailable |
| Intended Use | For use in the noninvasivefragmentation of urinarycalculi in the kidney andupper ureter. | For use in the noninvasivefragmentation of urinarycalculi in the kidney andupper ureter. | For use in non-invasivefragmentation of upperurinary tract stones, toinclude urinary stoneslocated in the kidney (renalpelvis and renal calyces) andupper ureter. |
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K072758
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 6 2007
Crystal Dizol Regulatory Affairs Associate Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe 5th Floor Culver City, CA 90230-7600
K072788 Re:
Trade/Device Name: Storz MODULITH® Lithotripter SLX-F2 F180 Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: Class II Product Code: LNS Dated: September 24, 2007 Received: October 1, 2007
Dear Ms. Dizol:
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, 1796, 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 such 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.
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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.
This letter will allow you to begin marketing your device as described in your Section 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K072788
Storz MODULITH® Lithotripter SLX-F2 F180 Device Name:
Indications for Use: The Storz MODULITH® Lithotripter SLX-F2 F180 is intended for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
Prescription Use: (21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hubert Leuner
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _
§ 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.”)