(208 days)
P970019
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML use.
Yes
The device is an Extracorporeal Shock Wave Lithotripter, which is used to fragment kidney and ureteral calculi, indicating a therapeutic function.
No
The device, LithoDiamond, is identified as an Extracorporeal Shock Wave Lithotripter, which is a therapeutic device used to fragment kidney and ureteral calculi. While it has an imaging system, its primary function is treatment, not diagnosis. The "Intended Use" states it's for patients with calculi, indicating a treatment purpose rather than a diagnostic one.
No
The device description explicitly states it is an "Extracorporeal Shock Wave Lithotripter," which is a hardware device that uses shock waves to break up kidney stones. While it has a new imaging system (x-ray component), the core function and description point to a physical device, not software only.
Based on the provided information, the LithoDiamond is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used in patients with renal and upper ureteral calculi. This indicates a direct interaction with the patient's body for treatment, not for testing samples outside the body.
- Device Description: It is described as an Extracorporeal Shock Wave Lithotripter, which is a therapeutic device used to break up kidney stones.
- Anatomical Site: The device targets the renal and upper ureteral areas within the patient's body.
- Input Imaging Modality: While it uses x-ray imaging, this is for guiding the treatment, not for analyzing biological samples.
- Performance Studies: The performance studies focus on shock wave characteristics and safety data related to the treatment of stones within the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The LithoDiamond's function is to treat a condition within the body, not to analyze samples from the body.
N/A
Intended Use / Indications for Use
The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4m and 20mm in size.
Product codes
78 LNS
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal and upper ureteral
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
The equivalence argument in the 510(k) was supported by bench data (as outlined in FDA's "Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi." (August 9, 2000)). Detailed shock wave characteristics as well as safety data were presented in the 510(k). An initial report on the imaging system (x-ray component) is also on file at FDA.
Key Metrics
Not Found
Predicate Device(s)
P970019
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
PREMARKET NOTIFICATION 510(K) SUMMARY
| Applicant: | HealthTronics Surgical Services, Inc.
1841 West Oak Parkway
Marietta, Georgia 30062
Telephone: 770-419-0691
Facsimile: 770-419-9490 | DEC 23 2002 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Manufacturer: | HMT High Medical Technologies, AG
Lengwil, Switzerland | |
| Official Contact: | Peter Weiman
Manager of Clinical Programs
HealthTronics Surgical Services, Inc. | |
The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4m and 20mm in size.
This device is substantially equivalent to the predicate device, the LithoTron (P970019), also manufactured by HMT. The primary difference in the devices is that the LithoDiamond has a new imaging system.
The equivalence argument in the 510(k) was supported by bench data (as outlined in FDA's "Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi." (August 9, 2000)). Detailed shock wave characteristics as well as safety data were presented in the 510(k). An initial report on the imaging system (x-ray component) is also on file at FDA.
1
DEPARTMENT OF HEALTH & HUMAN SERVICE
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Re: K021775
Mr. Peter Weiman Manager of Clinical Programs HealthTronics, Inc. 1841 West Oak Parkway MARIETTA GA 30062
Trade/Device Name: HealthTronics LithoDiamond (ESWI Lithotripter (LTF0230) Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: September 25, 2002 Received: September 27, 2002
Dear Mr. Weiman:
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 (OS) 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 i 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/dsmarnain.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 USI
510(k) Number (if known): K021775
Device Name: LithoDiamond
Indications for Use:
The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PrescriptionDevice/
David h. Wegman
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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