(88 days)
The TwinTrode® ELC 134 Electrode, is intended for multiple patient use during lithotripsy procedures as a replacement electrode to be used with the LithoTron Lithotripsy System.
The TwinTrode® ELC 134 Electrode is a multiple patient use electrode for electrohydraulic extracorporeal shock wave lithotripter. It is substantially equivalent to the NewTrode® ELC 124 Both electrodes are components of the HealthTronics LithoTron Electrode (predicate device). Lithotripsy System. The TwinTrode and NewTrode devices are very similar and are utilized as part of the LithoTron The TwinTrode differs from the NewTrode in that the longevity of the system identically. TwinTrode is up to 2.5 times greater than the longevity of the NewTrode.
This submission pertains to the TwinTrode® ELC 134 Electrode, a device used in lithotripsy procedures.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Longevity (total usable shocks) to be substantially equivalent or improved over predicate. Longevity of TwinTrode® is "up to 2.5 times greater than the longevity of the NewTrode®." -
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "Performance testing verifying this increase in total useable shocks has been provided in the 510(k)," but does not detail the sample size (e.g., number of electrodes tested).
- Data Provenance: Not explicitly stated, but implies laboratory or bench testing ("Performance testing"). There is no mention of human subject data, and it's unlikely given the nature of the device and the statement "Clinical data were not required to demonstrate substantial equivalence."
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Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This device's performance evaluation focuses on physical longevity rather than diagnostic accuracy requiring expert image interpretation or clinical assessment.
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Adjudication Method for the Test Set:
- Not applicable. The "ground truth" for this device's performance is measured empirically (total usable shocks), not via expert human judgment.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This type of study is typically for evaluating diagnostic imaging or AI algorithms where human readers are involved. The TwinTrode® is a component of a lithotripsy system, and its evaluation did not involve human readers interpreting "cases."
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The study was standalone in the sense that it likely involved direct testing of the device's physical properties (longevity) without human intervention in the performance measurement itself. However, it's not an "algorithm only" study as it's a physical medical device, not a software algorithm. The performance testing was of the device itself.
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The Type of Ground Truth Used:
- Empirical Performance Data: The ground truth for the TwinTrode® seems to be based on direct measurement of the device's durability or "longevity" in terms of "total useable shocks." This is a quantifiable physical characteristic.
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The Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The performance data is from the device itself, not from an algorithm trained on a dataset.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set mentioned or implied.
Summary of the Study:
The study conducted for the TwinTrode® ELC 134 Electrode was a performance testing focused on demonstrating its longevity (total usable shocks) compared to its predicate device, the NewTrode® ELC 124. The only explicit performance criterion mentioned is that the TwinTrode®'s longevity is "up to 2.5 times greater" than the predicate.
The 510(k) submission explicitly states: "Clinical data were not required to demonstrate substantial equivalence." This indicates that the evaluation was primarily based on non-clinical performance data, likely bench or laboratory testing, rather than studies involving human patients or complex diagnostic assessments. The document does not provide details on the specific methodology, sample sizes of devices tested, or the exact test conditions, beyond stating that "Performance testing verifying this increase in total useable shocks has been provided in the 510(k)."
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PREMARKET NOTIFICATION 510(K) SUMMARY 8.0
| Applicant: | HealthTronics, Inc.1841 West Oak ParkwayMarietta, Georgia 30062Telephone: 770-419-0691Facsimile: 77-419-9490 |
|---|---|
| NOV 1 6 2001 | |
| Manufacturer: | HMT High Medical Technologies, AGLengwil, Switzerland |
| Official Correspondent: | Peter WeimanManager, Clinical ProgramsHealthTronics, Inc. |
The TwinTrode® ELC 134 Electrode is a multiple patient use electrode for electrohydraulic extracorporeal shock wave lithotripter. It is substantially equivalent to the NewTrode® ELC 124 Both electrodes are components of the HealthTronics LithoTron Electrode (predicate device). Lithotripsy System.
The TwinTrode and NewTrode devices are very similar and are utilized as part of the LithoTron The TwinTrode differs from the NewTrode in that the longevity of the system identically. TwinTrode is up to 2.5 times greater than the longevity of the NewTrode. Performance testing verifying this increase in total useable shocks has been provided in the 510(k). Clinical data were not required to demonstrate substantial equivalence.
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Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Mr. Peter Weiman Manager of Clinical Programs HealthTronics Surgical Services, Inc. 1841 West Oak Parkway, Suite A MARIETTA GA 30062-9923
Re: K012785
Trade/Device Name: Twin Trode® ELC 134 Electrode Regulatory Number: 21 CFR 876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: 78 LNS Dated: August 15, 2001 Received: August 20, 2001
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 (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 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 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/dsmamain.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
NOV 1 6 2001
Page 1 of 1
510(k) Number (if known): K012785
Device Name: TwinTrode® ELC 134 Electrode
Indications for Use:
The TwinTrode® ELC 134 Electrode, is intended for multiple patient use during lithotripsy procedures as a replacement electrode to be used with the LithoTron Lithotripsy System.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Navy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012785
Prescription Use
§ 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.”)