(104 days)
P970019
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on traditional shock wave lithotripsy technology.
Yes
The device is described as an "extracorporeal shock wave lithotripsy device" intended to "fragment urinary stones," which is a direct therapeutic intervention.
No
Explanation: The device is described as an extracorporeal shock wave lithotripsy device intended to fragment urinary stones, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the LithoGold is an "extracorporeal shock wave therapy device" and details its components, including an electrohydraulic shock wave generator, ECG gating, and integration with other hardware like a table, C-arm, and ECG monitor. This clearly indicates it is a hardware-based medical device, not software-only.
No, this device 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 LithoGold is an extracorporeal shock wave lithotripsy device. It uses shock waves applied outside the body to fragment urinary stones inside the body.
- Intended Use: The intended use clearly states it's for fragmenting urinary stones in the kidney and ureter. This is a therapeutic procedure performed directly on the patient, not a diagnostic test on a sample.
The information provided describes a medical device used for treatment, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).
Product codes (comma separated list FDA assigned to the subject device)
LNS
Device Description
The LithoGold is an extracorporeal shock wave therapy device designed for the non-invasive fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle and lower ureter). The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities.
The LithoGold unit will be combined with the Modularis Uro Plus (table) and Arcadis Varic (C-arm) or Siremobil Compact L (C-arm), all products manufactured by Siemens Medical Solutions, Inc .; and the ECG Monitor Infinity Gamma (ECG) manufactured by Draeger Medical systems, Inc. These components have each been cleared for distribution in the U.S.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney (renal pelvis and calyces) and ureter (upper, middle and lower)
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)
The confirmatory clinical study showed that the LithoGold ESWL system is expected to treat patients with renal or ureteral calculi with safety and effectiveness outcomes substantially equivalent to those for predicate lithotripsy devices.
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.
HealthTronics LithoTron (P970019)
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
Section 5: 510(k) Summary
Tissue Regeneration Technologies Sponsor: 110 Arnold Mill Park. Suite 400 Woodstock, Georgia 30188
Manufacturer: MTS Europe GmbH Robert-Bosch-Str. 18 D-78467 Konstanz, Germany
- Contact: Cherita James M Squared Associates, Inc 719 A Street. NE Washington, DC 20002 Ph: 202-546-1262 Ext 257 Fax: 202-546-3848
Date of submission: July 21, 2006
Proprietary Name: LithoGold
Common name: Extracorporeal shock wave lithotriptor
Recommended classification regulation: 876.5990
Class: Il
Panel: Gastroenterology/Urology Devices
Product Code: LNS
Intended Use: The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).
Predicate device: HealthTronics LithoTron (P970019)
Device description: The LithoGold is an extracorporeal shock wave therapy device designed for the non-invasive fragmentation of urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle and lower ureter). The LithoGold employs an electrohydraulic method of shock wave generation with both ECG gating and fixed frequency capabilities.
The LithoGold unit will be combined with the Modularis Uro Plus (table) and Arcadis
NUW -- 2 2005
1
Varic (C-arm) or Siremobil Compact L (C-arm), all products manufactured by Siemens Medical Solutions, Inc .; and the ECG Monitor Infinity Gamma (ECG) manufactured by Draeger Medical systems, Inc. These components have each been cleared for distribution in the U.S.
Summary of non-clinical testing: Testing in accordance with "Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotribters Indicated for the Fragmentation of Kidney and Ureteral Calculi (2000)" has been successfully completed. The LithoGold acoustic qualities have been measured using the methodology described in the consensus standard IEC 61846 "Ultrasonics - Pressure pulse lithotripters - Characteristics of fields" (1998). Additionally, the device has been found to conform to recognized consensus standards for electrical and EMC testing.
Summary of clinical testing:
The confirmatory clinical study showed that the LithoGold ESWL system is expected to treat patients with renal or ureteral calculi with safety and effectiveness outcomes substantially equivalent to those for predicate lithotripsy devices.
Basis for Substantial Equivalence: Both the LithoGold and the predicate device have similar technical design features and indications for use. Bench testing and clinical testing confirm the substantial equivalence of the LithoGold to the LithoTron extracorporeal shock wave delivery system.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three swooping lines representing the human form. The symbol is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Tissue Regeneration Technologies, Inc. c/o Ms. Cherita James Regulatory Consultant M Squared Associates, Inc. 719 A Street, N.E. WASHINGTON DC 20002
NOV - 2 2006
Re: K062081
Trade/Device Name: LithoGold Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: September 12, 2006 Received: September 13, 2006
Dear Ms. James:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the encready to regary and of the Medical Device Amendments, or to devices that prov to May 20, 1770, the onecations and the provisions of the Federal Food, Drug, and Cosmetic tiale occh roolabilited in are approval of a premarket approval application (PMA). You may, Act (free) market the device, subject to the general controls provisions of the Act. The general therefore, mance the det include requirements for annual registration, listing of devices, good controls provisions or allabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is olashiba (500 acorry) and controls. Existing major regulations affecting your Apployal), it thay be sabject to Jack aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA ate roo bat of rither announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle. The word "Centennial" is below the letters. Three stars are below the word "Centennial".
moting Public J
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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 ($1 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C Hodgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Finclosure
4
Indications for Use
X062081
510(k) Number (if known): not yet assigned
Device Name: LithoGold
Indications For Use: The LithoGold is an extracorporeal shock wave lithotripsy device intended to fragment urinary stones in the kidney (renal pelvis and calyces) and ureter (upper, middle and lower).
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062081
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