(441 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on the physical lithotripsy technology.
Yes
The "Intended Use / Indications for Use" section explicitly states "therapeutic use in the treatment of ureteric calculi".
No
Explanation: The device is indicated for therapeutic use (fragmentation of urinary calculi) and does not mention diagnosis.
No
The device description clearly states it is a lithotripter, which is a hardware device used in surgical procedures. It also mentions inline ultrasound imaging, indicating hardware components are involved.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves testing blood, urine, tissue, etc., outside of the body.
- Device Function: The Storz Modulith® Lithotripter is a therapeutic device used to fragment kidney and ureter stones within the body using shock waves. It's a surgical procedure, not a laboratory test on a specimen.
- Intended Use: The intended use clearly states "therapeutic use in the treatment of ureteric calculi" and "noninvasive fragmentation of urinary calculi." This is a treatment, not a diagnostic test.
- Device Description: The description mentions use by "qualified surgeons during a variety of lithotripsy surgical procedures," further reinforcing its role in a surgical setting.
The device uses imaging (Inline Ultrasound) to guide the therapeutic procedure, but the imaging itself is not the primary diagnostic component in the sense of an IVD. The diagnosis of the calculi would have been made prior to the lithotripsy procedure.
N/A
Intended Use / Indications for Use
The Storz Modulith® Lithotripter Models SLK is manufactured by Storz Indication: Medical AG are indicated for the therapeutic use in the treatment of ureteric calculi in lithotripsy procedures.
Storz Modulith® Lithotripter Model SLK is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
Product codes
78 LNS
Device Description
The lithotripter models described in this submission are intended for use by qualified surgeons during a variety of lithotripsy surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Inline Ultrasound Imaging
Anatomical Site
kidney and upper ureter (for urinary calculi)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
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
AUG 1 6 2002
KD11700
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 is accurate and complete to the best of Karl Storz Endoscopy - America's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc. on behalf of: Karl Storz Lithotripsy-America, Inc. 1765 The Exchange, Suite 100 Atlanta, GA 30339 (770) 303-0808 | ||||
|---|---|---|---|---|---|
| Contact: | Jennifer S. Portugal Clinical Affairs Specialist | ||||
| Device Identification: | |||||
| Common NameLithotriptersTrade NameModulith® Lithotripter Model SLK | Common Name | Lithotripters | Trade Name | Modulith® Lithotripter Model SLK | |
| Common Name | |||||
| Lithotripters | |||||
| Trade Name | |||||
| Modulith® Lithotripter Model SLK |
The Storz Modulith® Lithotripter Models SLK is manufactured by Storz Indication: Medical AG are indicated for the therapeutic use in the treatment of ureteric calculi in lithotripsy procedures.
Device Description: The lithotripter models described in this submission are intended for use by qualified surgeons during a variety of lithotripsy surgical procedures.
The proposed labeling changes to the Storz Modulith® Substantial Equivalence: Lithotripter Models SLK have no effect on the safety and effectiveness of the device's intended use.
Signed:
Jennifer Portugal
Clinical Affairs Specialist
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle head facing right, with three curved lines representing the eagle's feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle head. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2002
James A. Lee, Ph.D. Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe 5th Floor CULVER CITY CA 90230-7600
Re: K011700
Trade/Device Name: Storz Modulith® Lithotripter Model SLK with Inline Ultrasound Imaging Regulation Number: 21 CFR 876.5990 Regulation Name: Extracorporeal shock wave lithotripters, urological Regulatory Class: II Product Code: 78 LNS Dated: May 17, 2002 Received: May 20, 2002
Dear Dr. Lee:
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 contact the Office of 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 your responsibilities under the Act 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 Croydon
Nancy 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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510(k) Number (if known): K011700
Modulith® Lithotripter Model SLK Device Name:
Storz Modulith® Lithotripter Model SLK is indicated for use in the Indications for Use: noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ==============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | ✓ | OR Over-The-Counter Use: | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
David 4. Seiferman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K011700 |
|---|---|
| --------------- | ---------------------------------------------------------- |