(348 days)
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is used for the noninvasive fragmentation of calculi (kidney stones), which directly treats a medical condition.
No
The device is a lithotripter used for fragmenting calculi (kidney stones) in the kidney and ureter, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is an "Extracorporeal Shock Wave Lithotripter Device" which generates shock waves, indicating it is a hardware device. The performance studies also mention electrical safety and EMC testing, further confirming it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the noninvasive fragmentation of calculi (stones) within the body (kidney and ureter). This is a therapeutic procedure performed directly on the patient.
- Device Description: The device generates shock waves to break up stones in vivo (within the living body).
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information.
IVD devices are used to examine specimens in vitro to provide information for the diagnosis, treatment, or prevention of disease. This device performs a therapeutic action directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
LNS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, in upper, middle and lower ureter
Indicated Patient Age Range
all adults and children 3 years or over.
Intended User / Care Setting
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Modulith SLX-F2 180 (K072788)
Reference Device(s)
LM-9300 ELMA (K142561)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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, Inc
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong
Regulatory Affairs Manager
424-218-8379 (phone) |
| Date of Preparation: | April 22nd, 2020 |
| Type of 510(k)
Submission: | Traditional |
| Device Identification: | Trade Name: MODULITH SLX-F2
Common Name: Lithotripter, Excorporeal Shock-Wave, Urological
Classification Name: Extracorporeal shock wave lithotripter |
| Product Code: | LNS |
| Regulation: | 21 CFR 876.5990 |
| Predicate Device(s): | Modulith SLX-F2 180 (K072788) – Primary
LM-9300 ELMA (K142561) - Secondary
The above reference device have not been subject to any recall |
| Device Description: | 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. |
| Intended Use and
Indications for use: | 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. |
| Technological
Characteristics: | The MODULITH SLX-F2 is a modification to the Modulith
SLX-F2 180. The inclusion of pediatric patients as well as
treatment of pancreatic, middle and lower ureter stones in its
indication does not raise new or different issues of safety and
effectiveness as supported by reviews of published literatures.
Thus, the subject devices are substantially equivalent to the
predicate device. |
| 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. |
| Substantial
Equivalence: | The intended use, operating principles, technological characteristics
and features are similar, if not identical, between that subject and
predicate devices. The minor differences between the subject and
predicate devices do not raise new or different questions or safety
and effectiveness.
As proven by the comparisons and rationale in this section, the
differences do not raise different questions of safety and
effectiveness because the intended use, operating principles,
technological characteristics, and features are significantly similar, if
not identical. Both systems also comply with identical standards
and safety testing, where applicable. |
| 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. |
| Conclusion: | The MODULITH SLX-F2 is substantially equivalent to its predicate
device. The non-clinical bench, literature review and comparative
testing demonstrate that the device is as safe and effective as the
legally marketed devices. |
4
5