(184 days)
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Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on standard lithotripsy components.
Yes
The device is indicated for noninvasive fragmentation of urinary calculi, which is a treatment for a medical condition.
No
Explanation: The device is indicated for "noninvasive fragmentation of urinary calculi," which describes a therapeutic fragmentation procedure rather than a diagnostic process. Although it includes an X-ray and ultrasound system, these are used for guidance during treatment, not for diagnosing a condition.
No
The device description explicitly states it is a lithotripsy system comprised of hardware components including a therapy source, X-ray system, ultrasound system, and patient table.
Based on the provided information, the Storz Medical MODULITH® Model SLX F2 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Storz Medical MODULITH® Model SLX F2 is a lithotripsy system. Its function is to noninvasively fragment urinary calculi (kidney stones) within the body using shock waves.
- Intended Use: The intended use clearly states "noninvasive fragmentation of urinary calculi in the kidney and upper ureter." This is a therapeutic procedure performed directly on the patient's body, not a diagnostic test performed on a sample outside the body.
Therefore, the Storz Medical MODULITH® Model SLX F2 is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Storz Modulith® Lithotripter Model SLX-12 is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
The Storz Medical MODULITH® Model SLX F2 is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
Product codes (comma separated list FDA assigned to the subject device)
78 LNS
Device Description
The Storz Modulth® Lithotripter Model SLX-F2 is lithotripsy system comprised of a therapy source, an X-ray system, an ultrasound system and a patient table.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray system, an ultrasound system
Anatomical Site
kidney and upper ureter
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Storz Modulith® Lithotripter Model SLX
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.”)
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Image /page/0/Picture/0 description: The image is a black and white photograph with a grainy texture. The left side of the image has a white circle with a black dot in the center. The rest of the image is a mix of black and white spots, with some vertical lines running through it. The overall impression is one of noise and distortion.
Image /page/0/Picture/1 description: The image shows the text "Karl Storz Endoscopy-America, Inc.". The text appears to be a company name. The text is black and the background is white.
600 Corporate Pointe 5th Floor Culver City, California 90230-7600 Phone 310 338 8100
Toll Free 800 421 0837 Fax 310 410 5527
AUG 2 6 2004
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: | Renate A. MacLaren, Ph.D.
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Extracorporeal Shockwave Lithotripter |
| Trade Name: | Storz Modulith® Lithotripter Model SLX-F2 |
The Storz Modulith® Lithotripter Model SLX-12 is indicated for use in the Indication: noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
Device Description: The Storz Modulth® Lithotripter Model SLX-F2 is lithotripsy system comprised of a therapy source, an X-ray system, an ultrasound system and a patient table.
Substantial Equivalence: The Storz Modulith® Lithotripter Model SLX-F2 is substantially equivalent to the Storz Modulith® Lithotripter Model SLX since the basic features, design and intended uses are the same or similar. The minor differences in design, dimensions and features between the Storz Modulith® Lithotripter Model SLX-F2 and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
Renate A. MacLaren, Ph.D. Senior Regulatory Affairs Specialist
00621
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2004
Renate A. MacLaren, Ph.D. Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe 5th Floor CULVER CITY CA 90230-7600
Re: K040476
Trade/Device Name: Storz MODULITH Model SLX-F2 Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: August 11, 2004 Received: August 12, 2004
Dear Dr. MacLaren:
We have reviewed your Scction 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 Section 510(k) This letter will allow you to ocgil marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalers and thus, premarket notification. The FDA miding of sabbanial equiveland 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 advice for your device on our last age of the regulation number at the top of the 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 Additionally, 101 questions on the promotion ...
Office of Compliance at (301) 594-4639. Also, please notes Othce of Compliance at (501) 594-057. Fass, presses 807.97) you may obtain. Other general by reference to prematics nombation (Dr of the Act may be obtained from the Division of Small information on your responsionities and consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its tour demansm Manufacturers, International and Collisanter Passering Passes of Collectives and mamain.html.
Sincerely yours,
Nancy C. Brogdon
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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Indications for Use
510(k) Number (if known): K040476
Device Name: Storz MODULITH® Extracorporeal Lithotripter, Model SLX-F2 Indications for Use: The Storz Medical MODULITH® Model SLX F2 is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter..
Prescription Use
(Part 21 CFR 801 Subpart D) the markdown representation should be as faithful to the original image as possible.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Page _ of _
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040476
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