(86 days)
Not Found
No
The summary describes a traditional lithotripter and does not mention any AI or ML components or capabilities.
Yes
The device is used for the noninvasive fragmentation of urinary calculi, which is a medical treatment.
No
The device is described as a lithotripter used for fragmenting urinary calculi, which is a therapeutic function, not a diagnostic one. It treats a condition rather than identifying or characterizing a disease or condition.
No
The device description clearly states it is an Extracorporeal Shock Wave Lithotripter Device, which is a hardware-based system that generates shock waves.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Storz MODULITH® Lithotripter SLX-F2 F180 is an Extracorporeal Shock Wave Lithotripter. It uses shock waves generated outside the body to break up kidney and ureteral stones inside the body. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "noninvasive fragmentation of urinary calculi in the kidney and upper ureter." This is a treatment, not a diagnostic test.
The device description and intended use clearly indicate that this is a therapeutic device used to treat a condition within the body, not a device used to perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
The Storz MODULITH® Lithotripter SLX-F2 F180 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)
LNS
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney and upper ureter
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 SLX-F2 (K040476), Medispec Econolith EM1000 (K063504)
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.
Not Found
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).
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
KD72188
pg 1 of 2
DEC 2 6 2007
510(k) SUMMARY
.
:
| Sponsor/Submitter: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230-7600
Phone: (310) 338-8100
Fax: (310) 410-5519 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Crystal Dizol
Regulatory Affairs Associate
Email: 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 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. |
| Indications for Use: | The Storz MODULITH® Lithotripter SLX-F2 F180 is indicated for use in
the noninvasive fragmentation of urinary calculi in the kidney and upper
ureter. |
| Technological
Characteristics: | The Storz MODULITH® Lithotripter SLX-F2 F180 and its predicate
devices generate shock waves using electromagnetically repelled
membranes. The shock waves are focused onto the stone by a
parabolic reflector dish, and are transferred to the patient's body via
contact with a water-filled rubber cushion. |
| Summary of
Substantial
Equivalence: | The Storz MODULITH® Lithotripter SLX-F2 F180 is substantially
equivalent to the predicate devices since the intended uses and
technological characteristics are similar. 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. |
Att: Substantial Equivalence Table for Storz MODULITH® Lithotripter SLX-F2 F180
:
:
1
RE STORZ ENDOSCOP 0
JBSTANTIAL EQUIVALENCE TABLE FOR STORZ MODULITH® SLX-F2 F1
| Manufacturer | Storz Medical AG
MODULITH® SLX-F2 F180 | Storz Medical AG
MODULITH® 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 mm
F2: 4.7 x 39 mm | F1: 2 x 20 mm
F2: 4.8 x 36 mm | 11 x 175 mm |
| Peak-positive pressure,
Min/Max (MPa) | F1: 18 - 107
F2: 15 - 36 | F1: 18 - 107
F2: 16 - 44 | 9.8 - 41.6 |
| Focal energy,
Min/Max (MPa) | F1: 1.9 - 2.1
F2: 3.8 - 4.0 | F1: 2.2 - 2.5
F2: 4.3 - 5.5 | Unavailable |
| Number of Energy Levels | 26 | 26 | Unavailable |
| Intended Use | For use in the noninvasive
fragmentation of urinary
calculi in the kidney and
upper ureter. | For use in the noninvasive
fragmentation of urinary
calculi in the kidney and
upper ureter. | For use in non-invasive
fragmentation of upper
urinary tract stones, to
include urinary stones
located in the kidney (renal
pelvis and renal calyces) and
upper ureter. |
: ೧೮೭೪
K072758
pg. 2 of 2
2
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.
3
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
4
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
Page 1 of 1
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _