(113 days)
The modified Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and sub-acute thrombus within dialysis fistulae.
The Amplatz Thrombectomy Device (ATD) is a percutaneous, rotational thrombectomy device consisting of a polyurethane catheter. Inside the catheter, a distal rotor housing contains a small diameter, recessed impeller, attached to a drive shaft. The shaft is connected to a disposable, high speed, air driven motor. An infusion line with luer connector, attached to the proximal motor assembly, allows for infusion of saline through the catheter. A foot pedal/regulator assembly is required to operate the air motor.
The provided document is a 510(k) summary for the Amplatz Thrombectomy Device (ATD). It describes the device, its intended use, and states that it has undergone functional and safety testing to demonstrate substantial equivalence to a predicate device.
However, the document does not contain specific acceptance criteria for device performance or the details of a study proving those criteria were met in the way that would typically be described for clinical performance of a diagnostic device or a AI/ML-based system.
The document primarily focuses on functional and safety testing of modified design features, not clinical outcomes or performance against a specific metric. Therefore, I cannot extract the detailed information requested in your prompt regarding acceptance criteria and performance study specifics.
Here's a breakdown of what can be inferred or what is explicitly missing based on your requested points:
1. A table of acceptance criteria and the reported device performance
- Missing. The document states: "The modified Amplatz Thrombectomy Device (ATD) device has successfully undergone functional and safety testing of new design features, including joint strengths, flow rate tests, burst tests, flexibility tests, device life tests, maceration capability tests, and material biocompatibility tests." It does not provide specific acceptance criteria values (e.g., "joint strength must exceed X N") or the quantitative results achieved for these tests. It concludes that the device "successfully underwent" these tests, implying compliance without detailing the metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Missing. This refers to a clinical performance study, which is not detailed in this 510(k) summary. The testing mentioned (functional/safety) would involve engineering samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Missing. This would be relevant for a clinical or diagnostic performance study, which is not described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Missing. Same as above.
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
- Not applicable / Missing. This is for AI/ML-based systems, and the ATD is a mechanical thrombectomy device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Missing. This is for AI/ML-based systems.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable / Missing. For the functional and safety testing, the "ground truth" would be engineering specifications and standards (e.g., material properties, physical dimensions, burst pressure ratings), not clinical outcomes or expert consensus on medical images.
8. The sample size for the training set
- Not applicable / Missing. This is for AI/ML-based systems, and the ATD is a mechanical thrombectomy device.
9. How the ground truth for the training set was established
- Not applicable / Missing. This is for AI/ML-based systems.
In summary: The provided 510(k) summary is for a mechanical thrombectomy device and focuses on establishing substantial equivalence through functional and safety testing of its design features. It does not include the type of clinical performance study details, expert ground truth establishment, or AI/ML-specific information requested in your prompt.
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Image /page/0/Picture/0 description: The image shows the logo for Microvena Corporation. The logo consists of a stylized "M" made of two double-lined zig-zag shapes. To the right of the "M" is the word "MICROVENA" in a bold, sans-serif font, with the word "CORPORATION" in a smaller font below it.
971984
510(k) Summary
SEP 1 9 1997
| Contact/Submitter: | Janell Colley, Regulatory Affairs Associate |
|---|---|
| Date Prepared: | September 8, 1997 |
| Trade Name: | The Amplatz Thrombectomy Device |
| Common Name: | Thrombectomy Catheter |
| Classification Name: | Percutaneous Catheter (per 21 CFR 870.1250) |
| Predicate Devices: | MICROVENA Amplatz Thrombectomy Device |
| Device Description: | The Amplatz Thrombectomy Device (ATD) is a percutaneous, rotationalthrombectomy device consisting of a polyurethane catheter. Inside thecatheter, a distal rotor housing contains a small diameter, recessed impeller,attached to a drive shaft. The shaft is connected to a disposable, high speed,air driven motor. An infusion line with luer connector, attached to theproximal motor assembly, allows for infusion of saline through the catheter.A foot pedal/regulator assembly is required to operate the air motor. |
| Intended Use: | The modified Amplatz Thrombectomy Device (ATD) is intended for use inthe mechanical dissolution of acute and sub-acute thrombus within dialysisfistulae. |
| Functional/SafetyTesting: | The modified Amplatz Thrombectomy Device (ATD) device has successfullyundergone functional and safety testing of new design features, includingjoint strengths, flow rate tests, burst tests, flexibility tests, device life tests,maceration capability tests, and material biocompatibility tests. |
| Conclusion: | The modified Amplatz Thrombectomy Device (ATD) is substantiallyequivalent to the predicate device. |
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP | 9 ---
Ms. Janell Colley Microvena Corporation 1861 Buerkle Road 55110-5246 White Bear Lake, Minnesota
Re : K971984 Amplatz Thrombectomy Device Regulatory Class: II (two) Product Code: 74 MCW September 5, 1997 Dated: Received: September 9, 1997
Dear Ms. Colley:
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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation 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 regulations.
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Paqe 2 - Ms. Janell Colley
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) 594-4639. 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 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/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. 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):
Device Name:
Indications for Use:
The intended use for the device is the mechanical dissolution of acute and sub-acute thrombus within dialysis fistulae.
Ta A. R
(Division Sign-Off)
Amplatz Thrombectomy Device
. . . . . Of Cardiovascular, Respiratory, curological Device 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).