(176 days)
MICROVENA Amplatz Thrombectomy Device (ATD)
Not Found
No
The device description details a mechanical device with a motor and screw, and the summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is indicated for the removal of thrombus, which is a medical treatment designed to restore health.
No
The device is described as a 'Percutaneous Mechanical Thrombectomy Device' used for the 'removal of thrombus', indicating a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines physical components such as a catheter, stainless steel housing, helical screw, drive shaft, and a battery-operated motor, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is used inside the body (in vivo) to physically remove thrombus (blood clots) from synthetic dialysis access grafts. It's a mechanical device for intervention, not for analyzing biological samples.
The description clearly indicates a device used for a therapeutic procedure within the body, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is designed for percutaneous removal of thrombus using aspiration and an internal helical screw to fragment and remove thrombus. The Baxter PMT device is indicated for removal of thrombus in synthetic dialysis access grafts.
Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is indicated for removal of thrombus in synthetic dialysis access grafts.
Product codes
74 MCW
Device Description
The Baxter Percutaneous Mechanical Thrombectomy (PMT) Device consists of a 6-French catheter terminating at a stainless steel housing in which a small diameter helical screw is attached to a drive shaft. A battery-operated motor rotates a flexible drive shaft connected to the helical screw at approximately 3,100 rpm. A central lumen within the device is provided for guidewire placement or infusion of fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
It has been demonstrated (through clinical studies) that the Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is as safe and effective as the predicate device for the removal of thrombus within synthetic dialysis access grafts.
The Baxter Percutaneous Mechanical Thrombectomy (PMT) Device has successfully undergone design validation, as well as functional, animal and clinical testing.
Key Metrics
Not Found
Predicate Device(s)
MICROVENA Amplatz Thrombectomy Device (ATD)
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
Baxter Healthcare Corporation 17221 Red Hill Avenue (Irvine)
PO Box 11150
Santa Ana, CA USA 92711-1150
Santa Ana, CA USA 92711-1150
949.250.2500
: :
: : .
MAY = 4 2000
raxter
510(k) Summary
| Submitter: | Baxter Healthcare Corporation, CardioVascular Group |
|---|---|
| Contact Person: | Diane Peterson, Senior Regulatory Affairs Associāte |
| Date Prepared: | November 9, 1999 |
| Trade Name: | Baxter Percutaneous Mechanical Thrombectomy (PMT) |
| Device | |
| Classification Name: | Peripheral Atherectomy Catheter |
| Predicate Devices: | MICROVENA Amplatz Thrombectomy Device (ATD) |
| Device Description: | The Baxter Percutaneous Mechanical Thrombectomy |
| (PMT) Device consists of a 6-French catheter | |
| terminating at a stainless steel housing in which a small | |
| diameter helical screw is attached to a drive shaft. A | |
| battery-operated motor rotates a flexible drive shaft | |
| connected to the helical screw at approximately 3,100 | |
| rpm. A central lumen within the device is provided for | |
| guidewire placement or infusion of fluids. | |
| Intended Use: | The Baxter Percutaneous Mechanical Thrombectomy |
| (PMT) Device is designed for percutaneous removal of | |
| thrombus using aspiration and an internal helical screw | |
| to fragment and remove thrombus. The Baxter PMT | |
| device is indicated for removal of thrombus in synthetic | |
| dialysis access grafts. | |
| Comparative | |
| Analysis | It has been demonstrated (through clinical studies) that |
| the Baxter Percutaneous Mechanical Thrombectomy | |
| (PMT) Device is as safe and effective as the predicate | |
| device for the removal of thrombus within synthetic | |
| dialysis access grafts. | |
| Functional/Safety | |
| Testing: | The Baxter Percutaneous Mechanical Thrombectomy |
| (PMT) Device has successfully undergone design | |
| validation, as well as functional, animal and clinical | |
| testing. | |
| Conclusion: | The Baxter Percutaneous Mechanical Thrombectomy |
| (PMT) Device is substantially equivalent to the | |
| predicate device. |
1
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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 consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
MAY = 4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diane Peterson Senior Regulatory Affairs Associate Baxter Healthcare Corporation Cardio Vascular Group 17221 Red Hill Avenue (Irvine) P.O. Box 11150 Santa Ana, CA 92711-1150
Re: K993816 Baxter Percutaneous Mechanical Thrombectomy Device Requlatory Class: II (two) Product Code: 74 MCW Dated: February 22, 2000 Received: February 23, 2000
Dear Ms. Peterson:
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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with 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 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
2
Page 2 - Ms. Diane Peterson
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described This lected will afrow you co boying . The FDA finding of substantial In your 510(x) premained to a legally marketed predicate device equivalence of your device of a your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advanced additionally 809.10 for in vitro regulation (21 Crk fart over the addition of Compliance at (301)
diagnostic devices), please contact the Office promotion and diagnostic devisor), Iv, for questions on the promotion and 594-4640. Addicionariff 10- quise contact the Office of compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 394 1039. There to premarket notification" (21CR 807.97).
"Misbranding by reference to premarket notification the 7ct mi "Misbranding by reference to promation on your responsibilities under the Act may ocher general information of Small Manufacturers Assistance at its be obtained from the Brillers. I (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
sincerely yours,
Christopher
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page of
510(k) Number (if known):
Kggz816
Device Name:
Baxter Percutaneous Mechanical Thrombectomy (PMT) Device
Indications for Use:
Baxter Percutaneous Mechanical Thrombectomy (PMT) Device is indicated for removal of thrombus in synthetic dialysis access grafts.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Eva
Of Device Evaluation (QDE)
Chito M.V. Kinta
(Division Sign-Off) Division of Cardiovascular, Respira and Neurological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)