(208 days)
The LithoDiamond is indicated for use in patients with renal and upper ureteral calculi between 4mm and 20mm in size.
The LithoDiamond is an Extracorporeal Shock Wave Lithotripter. The primary difference in the devices is that the LithoDiamond has a new imaging system.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the context of device performance metrics like sensitivity, specificity, or human-AI comparative effectiveness.
The document is a 510(k) summary for the LithoDiamond, indicating its substantial equivalence to a predicate device (LithoTron). The primary difference noted is a "new imaging system" for the LithoDiamond. The equivalence argument 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." It also states that "An initial report on the imaging system (x-ray component) is also on file at FDA."
Therefore, based only on the provided text, I can infer the following about the study and acceptance criteria:
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Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy for the "new imaging system." Instead, the acceptance criteria are implicitly linked to demonstrating substantial equivalence to the predicate device (LithoTron) through bench data. The primary performance aspect mentioned is the device's ability to fragment renal and upper ureteral calculi between 4mm and 20mm, which is aligned with the predicate device's function.Acceptance Criteria (Inferred from context) Reported Device Performance (Inferred from context) Demonstrate substantial equivalence in shock wave characteristics, safety data, and imaging system performance to the predicate device (LithoTron). "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." The FDA found the device "substantially equivalent" for the stated indications. Indications for use: fragment renal and upper ureteral calculi between 4mm and 20mm. The device is indicated for this use, implying it meets the performance for this indication, likely demonstrated through bench data and comparison to the predicate. -
Sample Size and Data Provenance:
The text refers to "bench data" and an "initial report on the imaging system (x-ray component)." This implies in vitro or engineering tests rather than patient studies. The sample size for such bench tests is not specified, nor is the country of origin of the data. It's safe to assume these are not patient-derived data (retrospective or prospective imaging studies) but rather engineering/laboratory data. -
Number of Experts and Qualifications for Ground Truth:
Not applicable, as the equivalence was primarily based on bench data and comparison to a predicate device, not on expert-established ground truth for a diagnostic test. -
Adjudication Method:
Not applicable for the type of study described. This applies to studies involving human readers or expert review of medical images/data. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC study is not mentioned. The device is a lithotripter with an imaging system, and the submission focuses on its physical characteristics and equivalence to a predicate, not an AI-assisted diagnostic workflow. There's no mention of human readers or AI assistance in a diagnostic context that would warrant an MRMC study. -
Standalone (Algorithm Only) Performance Study:
No, a standalone algorithm performance study is not mentioned. While there's an "imaging system (x-ray component)," the documentation focuses on its substantial equivalence through bench data, not on its isolated diagnostic performance as an algorithm. -
Type of Ground Truth Used:
The ground truth for the equivalence argument was primarily derived from:- Predicate device characteristics: The LithoTron's established performance and characteristics served as the benchmark.
- Bench data: Measurements and engineering tests performed on the LithoDiamond to assess shock wave characteristics and safety.
- Imaging system report: Data from the x-ray component, likely technical specifications and performance metrics rather than ground truth derived from patient-specific diagnoses.
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Sample Size for the Training Set:
Not applicable. The description refers to a 510(k) submission based on substantial equivalence and bench data, not an AI/Machine Learning model that would require a training set. -
How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set for an AI/ML model.
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PREMARKET NOTIFICATION 510(K) SUMMARY
| Applicant: | HealthTronics Surgical Services, Inc.1841 West Oak ParkwayMarietta, Georgia 30062Telephone: 770-419-0691Facsimile: 770-419-9490 | DEC 23 2002 |
|---|---|---|
| Manufacturer: | HMT High Medical Technologies, AGLengwil, Switzerland | |
| Official Contact: | Peter WeimanManager of Clinical ProgramsHealthTronics 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.
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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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Page 2
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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§ 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.”)