(296 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes
The device is intended for temporary vessel occlusion, which directly treats a physiological condition (blood flow) to achieve a desirable clinical outcome.
No
The device description clearly states its purpose as "temporary vessel occlusion, where the stoppage of blood flow is desirable." This is a therapeutic action, not a diagnostic one. No mention is made of detecting, monitoring, or analyzing any medical condition.
No
The device description clearly details physical components like a latex balloon, catheter shaft, and luer connectors, indicating it is a hardware 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 of the body (in vitro).
- Device Function: The TechDevice Percutaneous Occlusion Balloon Catheter is used inside the body (in vivo) to physically block blood flow in a vessel. It does not analyze or test any bodily fluids or tissues.
- Intended Use: The intended use clearly states "for temporary vessel occlusion, where the stoppage of blood flow is desirable." This is a therapeutic or interventional use, not a diagnostic one.
The information provided describes a device used for a medical procedure within the body, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The TechDevice Percutaneous Occlusion Balloon Catheter is for temporary vessel occlusion, where the stoppage of blood flow is desirable. This device is not indicated for neuro, or cardiac use.
Product codes
MJN
Device Description
The occlusion balloon catheter consists of a latex balloon (outside diameter 11mm, 15mm, 18mm or 27mm) mounted on the distal end of a 5 French catheter shaft ( 45cm -- 100cm in length). The dual-lumen catheter shaft terminates in a proximal molded bifurcation attached to luer connectors. The hub labeled "Distal" connects to the distal lumen which passes completely through the catheter and can be used for catheter placement over a guidewire, or fluid infusion into the vessel. The second hub, labeled "Balloon", terminates under the balloon via an opening skived into the extrusion. This is used for balloon inflation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel
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
Substantial equivalence for this device was based on a comparison of labeling, physical and performance design characteristics as compared to the predicate device, as well as on the results of comparative bench testing. Comparative performance testing included tensile strength (balloon-to-shaft and hub/lube-to-shaft), balloon burst testing and balloon multiple inflation testing.
Key Metrics
Not Found
Predicate Device(s)
Equalizer Balloon Catheter (K021721)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
510(k) Summary
General Company Information
| Name | TechDevice Corporation |
|---|---|
| Address | 650 Pleasant Street |
| Watertown, MA 02472 | |
| Contact Person: | Leigh Hayward |
| Telephone: | 617-972-5808 |
General Device Information
| Product Name: | TechDevice Percutaneous Occlusion Balloon Catheter |
|---|---|
| Common Name: | Vascular occlusion balloon catheter |
| Classification: | Catheter, Intravascular Occluding, Temporary (Class II); MJN / 21 |
| CFR 870.1250 | |
| Predicate Devices | Equalizer Balloon Catheter (K021721) |
| Boston Scientific Corporation | |
| Natick, MA 01760 |
Product Description:
The occlusion balloon catheter consists of a latex balloon (outside diameter 11mm, 15mm, 18mm or 27mm) mounted on the distal end of a 5 French catheter shaft ( 45cm -- 100cm in length). The dual-lumen catheter shaft terminates in a proximal molded bifurcation attached to luer connectors. The hub labeled "Distal" connects to the distal lumen which passes completely through the catheter and can be used for catheter placement over a guidewire, or fluid infusion into the vessel. The second hub, labeled "Balloon", terminates under the balloon via an opening skived into the extrusion. This is used for balloon inflation.
Indications for Use:
The TechDevice Percutaneous Occlusion Balloon Catheter is for temporary vessel occlusion, where the stoppage of blood flow is desirable. This device is not indicated for neuro, or cardiac use
Safety and Performance:
Substantial equivalence for this device was based on a comparison of labeling, physical and performance design characteristics as compared to the predicate device, as well as on the results of comparative bench testing. Comparative performance testing included tensile strength (balloon-to-shaft and hub/lube-to-shaft), balloon burst testing and balloon multiple inflation testing.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the TechDevice Percutaneous Occlusion Balloon Catheter has been shown to be safe and effective for its intended use.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2006
TechDevice Corporation c/o Mr. Leigh Hayward Director of Technical Operations 650 Pleasant St. Watertown, MA 02472
Re: K051137
TechDevice Percutaneous Occlusion Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II Product Code: MJN Dated: February 10, 2006 Received: February 13, 2006
Dear Mr. Hayward:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Leigh Hayward
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R D/E I MR
Bram D/Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: TechDevice Percutaneous Occlusion Balloon Catheter
Indications for Use:
The TechDevice Percutaneous Occlusion Balloon Catheter is for temporary vessel occlusion, where the stoppage of blood flow is desirable. This device is not indicated for neuro, or cardiac use.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-the -Counter Use (21 CFR 807 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K05 1137 |
000009