The PaxWire™ Occlusion Balloon System (PaxWire System) is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures. The PaxWire System consists of an occlusion catheter with a distal atraumatic stainless-steel J-tip, a compliant Chronoprene balloon, an 80 cm working length stainless steel shaft with a maximum 0.035" diameter proximal to the balloon, and an internal valve on the proximal end of the catheter. The effective length of the Pax Wire System is 99 cm with the inflation handle attached. The balloon can be inflated up to 12 mm for temporary flow occlusion in the iliofemoral artery. The balloon includes radiopaque markers located at each end of the balloon to aid positioning during fluoroscopy. The internal valve can be manually opened to control balloon inflation. The system also includes an inflation handle, a 10 cc Prep Syringe, and a 3 cc Inflation Syringe.

AI/ML Overview

The PaxWire Occlusion Balloon System is indicated for temporary flow occlusion in the iliofemoral artery. The provided text describes the 510(k) summary for this device, outlining its comparison to predicate devices and the performance data submitted to support its substantial equivalence. However, the document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or a detailed study description with sample sizes, ground truth provenance, expert qualifications, or adjudication methods.

The document primarily focuses on listing the types of tests conducted:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document lists the types of tests performed but does not state the predetermined acceptance criteria for each test or the specific quantitative results achieved by the device against these criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document mentions "bench testing" and "biocompatibility testing" but does not specify sample sizes for any of these tests or details about data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/provided. The testing reported is primarily bench and biocompatibility testing, not studies requiring expert interpretation or ground truth establishment in a clinical context.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/provided. As above, the nature of the testing described does not involve adjudication of clinical data.

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

This information is not applicable. The device described is a physical medical device (occlusion balloon system), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is not relevant.

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

This information is not applicable. See point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable/provided. For the bench and biocompatibility tests performed, compliance with technical specifications and safety standards would be the "ground truth," but the specifics of how these were defined or measured are not detailed in the document.

8. The sample size for the training set

This information is not applicable/provided. The device is not an AI algorithm that requires a training set.

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

This information is not applicable/provided. See point 8.

In summary, the provided FDA 510(k) summary details the device's indications for use, its description, and the types of non-clinical tests (biocompatibility and bench tests) conducted to demonstrate substantial equivalence to predicate devices. However, it lacks the specific quantitative results, acceptance criteria, study methodologies, and details about human-reader involvement or AI elements that would be required to answer most of the questions posed.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles facing to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 14, 2015

AccessClosure, Inc. Kelly Jabbal Manager, Regulatory Affairs 5452 Betsy Ross Drive Santa Clara, California 95054

Re: K143613

Trade/Device Name: PaxWire Occlusion Balloon System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: July 13, 2015 Received: July 14, 2015

Dear Kelly Jabbal,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

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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Indications for Use

510(k) Number (if known) K143613

Device Name PaxWire Occlusion Balloon System

Indications for Use (Describe)

The PaxWire Occlusion Balloon System is indicated for temporary flow occlusion in the iliofemoral artery.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a red graphic element above the company name. The graphic element is made up of several curved lines that converge at a point. The text "CardinalHealth" is written in a bold, sans-serif font.

510(k) Summary PaxWire™ Occlusion Balloon System

Submitter's Name and Address:

AccessClosure, Inc. A Cardinal Health Company 5452 Betsy Ross Drive Santa Clara, CA 95054 Tel: 408-610-6517 Fax: 408-610-6702

Contact Name and Information:

Kelly Jabbal Manager, Regulatory Affairs Tel: 408-610-6517 Fax: 408-610-6702

Date Prepared:

August 13, 2015

Proprietary Name:

PaxWire™ Occlusion Balloon System ("PaxWire System") Model No. ACX101

Common Name:

Vascular Clamp

Product Code:

MJN - Catheter, Intravascular Occluding, Temporary

Regulation Number:

21 CFR 870.4450

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Image /page/4/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a red abstract symbol above the company name. The symbol is made up of several curved lines that resemble a stylized bird in flight. The text "CardinalHealth" is written in a bold, sans-serif font.

Predicate Device:

Primary: Berenstein Occlusion Balloon Catheter ("Berenstein Catheter") Boston Scientific Corp. K132990

Secondary: Amplatz Super Stiff Guidewire ("Amplatz Guidewire") Meadox Medicals, a Division of Boston Scientific Corp. K930622

Device Description:

The PaxWire System consists of the following:

An occlusion catheter (see Figure 1 below) with a distal atraumatic stainless-steel J-tip (23 cm in length), a compliant Chronoprene balloon, an 80 cm working length stainless steel shaft with a maximum 0.035" diameter proximal to the balloon, and an internal valve on the proximal end of the catheter. The effective length of the Pax Wire System is 99 cm with the inflation handle attached. The balloon can be inflated up to 12 mm for temporary flow occlusion in the iliofemoral artery (shown in un-inflated view in Figure 1 below). The balloon includes radiopaque markers located at each end of the balloon to aid positioning during fluoroscopy. The internal valve can be manually opened to control balloon inflation.
Image /page/4/Figure/8 description: The image shows a medical device with several labeled components. Starting from the left, there is a "Flexible J-tip", followed by a "Compliant Balloon". Next to the balloon is the "Shaft", and finally, on the right side, there is an "Internal Valve". The device appears to be designed for insertion into a body cavity or vessel.

Figure 1. PaxWire Occlusion Balloon System (Catheter)

. An inflation handle that is manually operated and is used to inflate and deflate the balloon. The inflation handle can be removed while the balloon is inflated so that a dilator can be advanced over the proximal end of the device.
A 10 cc Prep Syringe ●
A 3 cc Inflation Syringe

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Intended Use / Indications for Use:

The PaxWire System is indicated for temporary flow occlusion in the iliofemoral artery.

Comparison of Technological Characteristics:

The PaxWire System can be regarded as a "hybrid" of two predicate devices: the Berenstein Catheter and the Amplatz Guidewire. Both the PaxWire System and the Berenstein Catheter employ the same scientific concept of utilizing an internal lumen to inflate a distal compliant balloon to provide temporary occlusion. The Berenstein Catheter is placed over the guidewire, whereas the Paxwire System allows for placement independent of a guidewire. The Pax Wire System also utilizes the same scientific concept of a wire feature of the Amplatz Guidewire to allow a sheath dilator to be advanced over the proximal end of the PaxWire System shaft. It is in this configuration that the PaxWire System is appropriately compared to the predicate devices.

Performance Data:

Performance data to support a determination of substantial equivalence included biocompatibility and bench testing as follows:

Biocompatibility Testing:

Cytotoxicity
Sensitization ●
Intracutaneous Reactivity ●
Hemolysis, direct contact using pooled blood from 3 donors
Hemolysis, extract using pooled blood from 3 donors
Systemic Toxicity
. Materials Mediated Pyrogenicity
Partial Thromboplastin Time (PTT)
Complement Activation
Thromboresistance Test in Canine ●
Bacterial Endotoxin

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Bench Testing:

Package Integrity ●
. Balloon Integrity
Deflation Time ●
Leak Test
Weld Strength
Inflated Balloon Pull and Torque
Unconstrained Inflated Balloon Diameter and Burst
Valve Remains Closed
Force to Open/Close Valve and Maximum Force to Actuate the Valve
Valve Tensile Strength and Cycling
Extension Line to Stopcock and Inflation Handle Tensile Strength
Lateral (Shaft) Stiffness
. Tip Flexibility
Buckling
Kinking
Dimensional Verification of Crossing Profile, J-Tip Radius, Diameter and Effective Length
. Balloon Fatigue Cycling
Corrosion
Simulated Use

Conclusion:

The conclusions drawn from the testing outlined above demonstrate that the PaxWire System is substantially equivalent to the predicates.

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).