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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "TechDevice Percutaneous Occlusion Balloon Catheter." This document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than performance against specific acceptance criteria for a diagnostic or AI-driven decision-making system.

Therefore, many of the requested fields are not applicable or cannot be extracted from this type of regulatory submission. The submission details physical and performance design characteristics and bench testing, but not clinical study data for AI or diagnostic performance.

Here's an attempt to address the request based on the provided text, highlighting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from text)	Reported Device Performance (from text)
Not explicitly stated as "acceptance criteria" for a study.	Tensile Strength (balloon-to-shaft and hub/lube-to-shaft): No specific values reported, but comparative testing was performed and deemed equivalent.
	Balloon Burst Testing: No specific values reported, but comparative testing was performed and deemed equivalent.
	Balloon Multiple Inflation Testing: No specific values reported, but comparative testing was performed and deemed equivalent.
Substantial equivalence to predicate device (K021721).	The device has been shown to be safe and effective for its intended use based on comparison to predicate and results of comparative bench testing.

2. Sample size used for the test set and data provenance

Sample Size for Test Set: Not applicable. The submission refers to "comparative bench testing" rather than a clinical trial with a test set of patient data. The sample sizes for the bench tests (e.g., number of catheters tested for burst strength) are not provided.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as this was bench testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts

Not applicable. Ground truth is not established by experts for bench testing of device physical properties. The "ground truth" here would be the physical properties of the predicate device.

4. Adjudication method for the test set

Not applicable. There is no adjudication method described for bench testing results against a "ground truth" in the context of expert consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/diagnostic device. An MRMC study was not performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This is not an AI/diagnostic device. A standalone algorithm performance was not done.

7. The type of ground truth used

For the bench testing, the "ground truth" would be the established performance characteristics of the predicate device (Equalizer Balloon Catheter K021721). The TechDevice catheter's performance was compared to these.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI or diagnostic device based on machine learning.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" and therefore no ground truth established for it.

Summary

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K051137

510(k) Summary

General Company Information

Name	TechDevice Corporation
Address	650 Pleasant StreetWatertown, 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 / 21CFR 870.1250
Predicate Devices	Equalizer Balloon Catheter (K021721)Boston Scientific CorporationNatick, MA 01760

Product Description:

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.

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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.

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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

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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

Regulation Number and Section

§ 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).