(111 days)
The Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and subacute thrombus within dialysis fistulae.
The Amplatz Thrombectomy Device (ATD) is a percutaneous, thrombectomy device consisting of a catheter, a small diameter impeller encased in a distal housing, and a driveshaft. The driveshaft is the connection between the impeller and a disposable, high speed, air driven motor. An infusion line with luer connector, attached to the proximal motor housing, allows infusion of saline. A foot pedal/regulator assembly is required to operate the air motor.
Here's an analysis of the provided text regarding the Amplatz Thrombectomy Device's acceptance criteria and study information, specifically noting the absence of certain data as this is a 510(k) summary and approval letter, not a detailed clinical study report:
This 510(k) submission for the Amplatz Thrombectomy Device focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with acceptance criteria for device performance as one might see for a diagnostic AI device. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, etc., which are typical for AI/diagnostic device evaluations) is not present in this type of regulatory document.
However, based on the provided text, here's what can be extracted and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | "Substantially equivalent to the Predicate ATD." |
| Functional and Safety Testing of New Design Features (Joint strengths, flow rate, flexibility, material biocompatibility) | "successfully undergone functional and safety testing of new design features, including joint strengths, flow rate tests, flexibility tests, and material biocompatibility tests." |
| Intended Use: Mechanical dissolution of acute and subacute thrombus within dialysis fistulae | Device is intended for this use. (Performance to achieve this is implied by substantial equivalence) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document refers to "functional and safety testing" rather than a clinical human-subject test set as understood for AI performance.
- Data Provenance: Not specified. The testing likely occurred in a laboratory setting or on simulated models for functional and safety aspects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable to this type of submission. This document describes the acceptance of a medical device based on engineering and safety tests, and equivalence to a predicate, not performance against an established ground truth in a diagnostic context.
4. Adjudication method for the test set
- Not applicable. (See answer to point 3).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a thrombectomy device, not an algorithm or AI. The device operates mechanically.
7. The type of ground truth used
- For the functional and safety testing: Engineering specifications, material standards, and possibly performance benchmarks against the predicate device.
- For the overall regulatory decision: Substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. (See answer to point 8).
Summary of what the document IS:
This is a 510(k) premarket notification for the Amplatz Thrombectomy Device. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed "predicate device." This usually involves comparing the new device's technological characteristics, indications for use, safety, and effectiveness to the predicate. Clinical studies with detailed performance metrics and ground truth establishment (as described in your questions) are more common for novel devices or those seeking PMA approval, or for AI/diagnostic devices where performance metrics are critical for regulatory acceptance.
In this case, the "study" is the submission demonstrating substantial equivalence, supported by functional and safety testing, rather than a clinical trial directly measuring treatment efficacy against an outcome "ground truth" or diagnostic accuracy.
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NOV 1 8 1998
510(k) Summary
510(K) SUMMARY
| SUBMITTER: | MICROVENA Corporation |
|---|---|
| CONTACT PERSON: | Tonya WeigelMICROVENA Corporation1861 Buerkle RoadWhite Bear Lake, MN 55110 |
| DATE PREPARED: | July 29, 1998 |
| TRADE NAME: | Amplatz Thrombectomy Device |
| CLASSIFICATION NAMEand NUMBER: | Peripheral Atherectomy CatheterClass II, 21 CFR 870.4875 |
| PRODUCT CODE: | 74MCW |
| PREDICATE DEVICE(S): | MICROVENA Corporation's Amplatz Thrombectomy Device |
| DEVICE DESCRIPTION: | The Amplatz Thrombectomy Device (ATD) is a percutaneous,thrombectomy device consisting of a catheter, a small diameterimpeller encased in a distal housing, and a driveshaft. The driveshaft isthe connection between the impeller and a disposable, high speed, airdriven motor. An infusion line with luer connector, attached to theproximal motor housing, allows infusion of saline. A footpedal/regulator assembly is required to operate the air motor. |
| INTENDED USE: | The Amplatz Thrombectomy Device (ATD) is intended for use in themechanical dissolution of acute and subacute thrombus withindialysis fistulae. |
| FUNCTIONAL &SAFETY TESTING: | The Amplatz Thrombectomy Device (ATD) device has successfullyundergone functional and safety testing of new design features,including joint strengths, flow rate tests, flexibility tests, and materialbiocompatibility tests. |
| CONCLUSION: | The Modified Amplatz Thrombectomy Device (ATD) is substantiallyequivalent to the Predicate ATD. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is depicted in black and white, and the text is also in black.
Food and Drug Administration Rockville MD 20857
NOV 1 8 1998
Ms. Tonya L. Weigel Regulatory Affairs Associate MICROVENA Corporation 1861 Buerkle Road White Lake, MN 55110-5246
Re: K982657 Trade Name: Amplatz Thrombectomy Device Regulatory Class: II Product Code: MCW Dated: October 27, 1998 Received: October 28, 1998
Dear Ms. Weigel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Ms. Tonya Weigel
you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callehan
Thomas J. Callan Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K99 2657
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Amplatz Thrombectomy Device is intended for use in the mechanical dissolution of acute and subacute thrombus within dialysis fistulae.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cid Dale Gutt Jr. TJ Callahan
(Division Sigh Off)
Division of Cardiovascular, Respir. and Neurological Devices 510(k) Number
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).