(113 days)
Not Found
Not Found
No
The device description focuses on mechanical components and operation, with no mention of AI or ML terms, image processing, or data-driven performance metrics.
Yes
The device is intended for the mechanical dissolution of thrombus, which directly treats a medical condition (thrombus formation) in dialysis fistulae.
No
The device is described as a thrombectomy device intended for the mechanical dissolution of thrombus, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines hardware components such as a catheter, rotor housing, impeller, drive shaft, air-driven motor, infusion line, luer connector, and foot pedal/regulator assembly. The performance studies also focus on testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "mechanical dissolution of acute and sub-acute thrombus within dialysis fistulae." This describes a therapeutic procedure performed directly on the patient's body to remove a blockage.
- Device Description: The description details a mechanical device with a catheter, rotor, impeller, drive shaft, motor, and infusion line. These are components used for a physical intervention within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The provided information does not mention any analysis of specimens or diagnostic purposes.
Therefore, the modified Amplatz Thrombectomy Device (ATD) is a therapeutic medical device used for a procedure within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The modified Amplatz Thrombectomy Device (ATD) is intended for use in the mechanical dissolution of acute and sub-acute thrombus within dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
74 MCW
Device Description
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MICROVENA Amplatz Thrombectomy Device
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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, 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. | |
| Intended Use: | The modified Amplatz Thrombectomy Device (ATD) is intended for use in |
| the mechanical dissolution of acute and sub-acute thrombus within dialysis | |
| fistulae. | |
| Functional/Safety | |
| Testing: | 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. | |
| Conclusion: | The modified Amplatz Thrombectomy Device (ATD) is substantially |
| equivalent to the predicate device. |
1
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.
2
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
3
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)