(187 days)
Not Found
No
The summary describes a purely mechanical device (catheter with balloons) and contains no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes.
The device is intended for "removing arterial emboli," which is a direct treatment for a medical condition.
No
The device is described as an embolectomy catheter used for removing arterial emboli, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "Single Lumen Embolectomy catheter with three 100% silicone balloons," which are physical hardware components.
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, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The description clearly states the device is a "Single Lumen Embolectomy catheter with three 100% silicone balloons" intended for "Removing arterial emboli." This is a device used within the body (in vivo) to physically remove blockages.
The information provided describes a surgical or interventional device, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Removing arterial emboli.
Product codes
DXE
Device Description
Single Lumen Embolectomy catheter with three 100% silicone balloons. Catheter intended for use in removing arterial emboli. Sizes 2 to 7 French.
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
The conclusion drawn from the above is that the modified American BioMed Single lumen Embolectomy Catheters are equivalent in safety and efficacy to their predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
1972572
JAN 1 3 1998
Section 2
510(k) Summary
Single Lumen Embolectorny Catheter American BioMed, Inc. The Woodlands, Texas 77380
1
Section 2 510(k) Premarket Notification Summary
July 1997
Steven Rash President and CEO American BioMed, Inc P. O. Box 8429 The Woodlands, Texas 77387-8429 (281) 367-3895 (281) 367-3212 Fax
| CLASSIFICATION NAME: | Catheter, Embolectomy |
|---|---|
| COMMON/USUAL NAME: | Single Lumen Embolectomy Catheter |
| PROPRIETARY NAME: | Single Lumen Embolectomy Catheter |
| CLASSIFICATION: | 21 CFR Part 870.5150 Catheter, Embolectomy |
| PERFORMANCE STANDARDS: | No Performance Standards for the Catheter, |
| Embolectomy are effective as of this date. | |
| PREDICATED DEVICE | Catheter Embolectomy K881455 and K905139, |
| American BioMed, (CathLab Corp.) and Baxter | |
| Fogarty® Arterial Embolectomy Catheter. | |
| DEVICE DESCRIPTION | Single Lumen Embolectomy catheter with three |
| 100% silicone balloons. Catheter intended for use | |
| in removing arterial emboli. Sizes 2 to 7 French. | |
| INDICATIONS | Removing arterial emboli. |
| TECHNOLOGICAL CHARACTERISTICS | This modification of K881455 and K905139, |
| changes the number of balloons, two balloons are | |
| located at the distal end for embolus removal | |
| purpose, the third balloon is located at the proximal | |
| end as a safety balloon to prevent over injection of | |
| fluid. | |
| SUBSTANTIAL EQUIVALENCE | The Single Lumen Embolectomy Catheter is |
| equivalent to K881455, K905139, and Baxter |
Section 2 page 1
2
Fogarty Arterial Embolectomy Catheter, same intended use, with change in number of balloons.
| Parameter | American
BioMed Single
Lumen
Embolectomy
Catheter | American
BioMed Single
Lumen
Catheter
K881455 &
K905139 | Baxter Fogarty
Arterial
Embolectomy
Catheter
K No. Not Found
in FDA 510(k)
Data Base |
|------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Body Material | Silicone
Compound | Silicone
Compound | Polyvinylchloride |
| Balloon Material | Silicone
Compound | Silicone
Compound | Latex |
| Balloon to Body Bonding | No. All Silicone.
Formed through
dipping process | No. All Silicone.
Formed through
dipping process | Yes |
| Number of Balloons | Three. Two at
distal end and
one at proximal
end. | One. At distal
end. | One. At distal
end. |
| Catheter French Sizes | 2, 3, 4, 5, 6,
and 7 | 2, 3, 4, 5, 6,
and 7 | 2, 3, 4, 5, 6, and
7 |
| Catheter Length | 40, 60, 80, 100
cm. | 40, 60, 80, 100
cm. | 40, 60, 80, 100
cm. |
| Inflated Balloon
Diameter | 2 Fr. - 4 mm
3 Fr. - 5 mm
4 Fr. - 9 mm
5 Fr. - 11 mm
6 Fr. - 13 mm
7 Fr. - 14 mm | 2 Fr. - 4 mm
3 Fr. - 5 mm
4 Fr. - 9 mm
5 Fr. - 11 mm
6 Fr. - 13 mm
7 Fr. - 14 mm | 2 Fr. - 4 mm
3 Fr. - 5 mm
4 Fr. - 9 mm
5 Fr. - 11 mm
6 Fr. - 13 mm
7 Fr. - 14 mm |
| Maximum Liquid Volume | 2 Fr. - 0.05 ml
3 Fr. - 0.10 ml
4 Fr. - 0.50 ml
5 Fr. - 0.75 ml
6 Fr. - 1.25 ml
7 Fr. - 2.00 ml | 2 Fr. - 0.05 ml
3 Fr. - 0.10 ml
4 Fr. - 0.50 ml
5 Fr. - 0.75 ml
6 Fr. - 1.25 ml
7 Fr. - 2.00 ml | 2 Fr. - N/A
3 Fr. - 0.20 ml
4 Fr. - 0.75 ml
5 Fr. - 1.50 ml
6 Fr. - 2.00 ml
7 Fr. - 2.50 ml |
| Intended Use | Removing
arterial emboli | Removing
arterial emboli | Removing
arterial emboli |
Statement of Similarities and Differences
CONCLUSIONS
The conclusion drawn from the above is that the modified American BioMed Single lumen Embolectomy Catheters are equivalent in safety and efficacy to their predicate device.
3
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 1998
American Biomed, Inc c/o J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071
Re: K972572 Single Lumen Embolectomy Catheter Requlatory Class: II (two) Product Code: DXE Dated: October 17, 1997 Received: October 21, 1997
Dear Mr. Knauss:
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 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 Reqister. 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.
4
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) 594-4648. 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 requlation 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. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if Known)
Device Name: Single Lumen Embolectomy Catheter
Indications for use: Removing arterial emboli.
(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)
1
OR
Over-The-Counter Use
.
R-h
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K972572