(111 days)
Not Found
Not Found
No
The description focuses on mechanical components and operation, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is intended for the mechanical dissolution of thrombus within dialysis fistulae, which is a direct treatment for a medical condition.
No
The device is described as a "thrombectomy device" intended for the "mechanical dissolution of acute and subacute thrombus." Its function involves removing thrombus, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like a catheter, impeller, driveshaft, motor, infusion line, and foot pedal/regulator assembly, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "mechanical dissolution of acute and subacute thrombus within dialysis fistulae." This describes a therapeutic procedure performed directly on the patient's body to treat a condition.
- Device Description: The description details a mechanical device with a catheter, impeller, driveshaft, and motor. This is consistent with a device used for a physical intervention, not for analyzing samples outside the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) obtained from the human body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or the analysis of biological samples.
Therefore, the Amplatz Thrombectomy Device is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and subacute thrombus within dialysis fistulae.
Product codes
74MCW, MCW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dialysis fistulae
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Amplatz Thrombectomy Device (ATD) device has successfully undergone functional and safety testing of new design features, including joint strengths, flow rate tests, flexibility tests, and material biocompatibility tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MICROVENA Corporation's Amplatz Thrombectomy Device
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
NOV 1 8 1998
510(k) Summary
510(K) SUMMARY
| SUBMITTER: | MICROVENA Corporation |
|---|---|
| CONTACT PERSON: | Tonya Weigel |
| MICROVENA Corporation | |
| 1861 Buerkle Road | |
| White Bear Lake, MN 55110 | |
| DATE PREPARED: | July 29, 1998 |
| TRADE NAME: | Amplatz Thrombectomy Device |
| CLASSIFICATION NAME | |
| and NUMBER: | Peripheral Atherectomy Catheter |
| Class 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 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. | |
| INTENDED USE: | The Amplatz Thrombectomy Device (ATD) is intended for use in the |
| mechanical dissolution of acute and subacute thrombus within | |
| dialysis fistulae. | |
| FUNCTIONAL & | |
| SAFETY TESTING: | The Amplatz Thrombectomy Device (ATD) device has successfully |
| undergone functional and safety testing of new design features, | |
| including joint strengths, flow rate tests, flexibility tests, and material | |
| biocompatibility tests. | |
| CONCLUSION: | The Modified Amplatz Thrombectomy Device (ATD) is substantially |
| equivalent 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
2
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
3
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