The NavajoTM PTA balloon dilatation catheter is intended to dilate stenoses in the peripheral arteries (iliofemoral, popliteal, infra popliteal, renal arteries); and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Navajo™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal adaptor, coaxial lumen shaft, and a distal dilatation balloon. The Navajo PTA Balloon Dilatation Catheter is compatible with guide wires with a maximum diameter of 0.035" and with 5F to 7F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating on the shaft and is available in useable catheter lengths of 80, 100, 120 and 130cm.

AI/ML Overview

The provided document describes the Navajo™ PTA Balloon Dilatation Catheter and its substantial equivalence to a predicate device, the AgilTrac .035 Peripheral Dilatation Catheter (K022738). The document summarizes performance testing but does not provide specific acceptance criteria or detailed study results with exact performance metrics in a way that directly translates to the requested table format for "reported device performance."

Therefore, the response below will reconstruct the information where possible and explicitly state what is not available based on the provided text.

Acceptance Criteria and Device Performance

The document states, "All tests confirmed the products met the pre-defined acceptance criteria." However, the specific quantitative acceptance criteria for each performance test are not explicitly provided, nor are the exact numerical "reported device performance" values. Instead, a list of performance tests is given. For some characteristics (e.g., Rated Burst Pressure), the comparison to the predicate device implies acceptable performance.

Note: The table below summarizes the types of performance characteristics tested. Actual numerical acceptance criteria and reported performance values are not detailed in this document.

Performance Characteristic	Acceptance Criteria (Implied/General)	Reported Device Performance (Implied/General)
Catheter Dimensions, Balloon & Tip Profile	Met predefined specifications for dimensions and profile.	Met predefined specifications.
Catheter Prep, In/deflation Time	Met predefined specifications for preparation and inflation/deflation.	Met predefined specifications.
Catheter Fatigue Integrity	Withstood anticipated fatigue cycles without failure.	Demonstrated integrity over fatigue cycles.
Balloon Compliance	Met predefined compliance specifications.	Met predefined specifications.
Balloon Rated Rupture Pressure (RBP)	Equal to or higher than predicate device's RBP.	Same or higher RBP than predicate, indicating better safety margin.
Catheter Shaft Pressure Integrity	Withstood specified internal pressures without leakage/failure.	Demonstrated integrity under specified pressures.
Catheter Interface Compatibility, GW Lumen Collapse Pressure	Compatible with specified guidewires (0.035"), resistant to lumen collapse.	Compatible with 0.035" guidewires, resistant to lumen collapse.
Catheter Luer - Shaft Tensile Strength	Met predefined tensile strength requirements.	Met predefined requirements.
Catheter Shaft - Balloon Bond Tensile Strength	Met predefined tensile strength requirements.	Met predefined requirements.
Catheter Soft Tip Tensile Strength	Met predefined tensile strength requirements.	Met predefined requirements.
Catheter Shaft Coating Integrity	Demonstrated integrity of the hydrophilic coating.	Maintained coating integrity.
Catheter Flexibility, Kink and Torque Strength	Met predefined requirements for flexibility, kink resistance, and torqueability.	Exhibited acceptable flexibility, kink resistance, and torque strength.

Detailed Study Information (Based on provided text):

The document describes pre-clinical (bench) testing rather than a clinical study involving patients or human readers. Therefore, several requested categories are not applicable.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific tests. The document refers to "Navajo™ PTA Balloon Dilatation Catheters" in plural, implying multiple units were tested.
- Data Provenance: Not specified, but generally refers to in-house laboratory testing (bench testing) as implied by the nature of the "Performance Testing" listed. It is retrospective in the sense that the tests were completed and then reported.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This was not a study requiring expert readers to establish ground truth for clinical outcomes or image interpretations. The "ground truth" was established by engineering specifications and objective measurements against defined standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No human adjudication process is mentioned or implied for these types of engineering performance tests.
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 was not an AI-assisted diagnostic or interpretative device, nor was it a human factors study. It was a physical medical device performance study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not involve an algorithm performed in a standalone manner.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests was based on engineering specifications, regulatory standards (ISO), and objective physical measurements. For example, a "Rated Burst Pressure" test would compare the actual burst pressure of the balloon against a predetermined, specified safe operating pressure.
The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI or machine learning model that undergoes "training."
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an algorithm was involved.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three intertwined snakes and a staff.

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

January 30, 2015

Curative Medical Inc. Bill Jacqmein Regulatory Affairs Consultant 1591 Deephaven Dr. Woodbury, Minnesota 55129

Re: K141354

Trade/Device Name: Navajo PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: PTA Balloon Dilatation Catheter Regulatory Class: Class II Product Code: LIT Dated: May 15, 2014 Received: December 24, 2014

Dear Bill Jacqmein,

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 809); 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 809), 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 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)

Device Name

Navajo PTA Balloon Dilatation Catheter

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

Submitter:	Curative Medical Inc.3227 Kifer RoadSanta Clara, CA 95051Establishment Number: 3008361782
Company Contact Person:	Jessica Chiu, VP of R&D
	Phone: (408) 414-2188Fax: (408) 413-3000Email: jchiu@curativemedical.com
Submission Correspondent:	Bill Jacqmein, Regulatory Affairs Consultant
	Address: 2320 Parkview Lane, Woodbury, MN 55125Phone: (404) 216-6190Email: bjacqmein@gmail.com
Date Prepared:	15 May 2014
Proprietary Name:	Navajo PTA Balloon Dilatation Catheter
Common Name:	Percutaneous catheter
Product Code:	LIT -Catheter, Angioplasty, Peripheral, Transluminal
Device Classification:	Class II, 21 CFR 870.1250 - Percutaneous Catheter
Predicate Devices:	AgilTrac .035 Peripheral Dilatation Catheter (K022738

Device Description:

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Intended Use:

The Navajo™ PTA balloon dilatation catheter is intended to dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Comparison of Technological Characteristics:

The Navajo™ PTA balloon dilatation catheter incorporates substantially equivalent device materials, configurations, packaging, technology, sterilization process and intended use as those featured in the AgilTrac .035 Peripheral Dilatation Catheter.

Characteristic	Proposed compared to Predicate
Components	Same components, similar configuration, design and function.
Materials	Same materials
Packaging	Same Packaging
Guidewire compatibility	Same compatibility
Balloon Lengths	Similar Lengths; Navajo™ Lengths are inside the minimumand maximum range of the predicate device.
Effective Length	Similar Lengths; Navajo™ Lengths are inside the minimumand maximum range of the predicate device
Rated Burst Pressure (RBP)	Same or higher RBP; better safety margin for Navajo™
Intended Use	Same intended use

Summary of Performance Data and Substantial Equivalence:

Navajo™ PTA Balloon Dilatation Catheters were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the pre-defined acceptance criteria. Curative Medical Inc. has determined that the Navajo™ PTA Balloon Dilatation Catheters are safe and effective. The Navajo™ PTA Balloon Dilatation Catheters have been tested and shown to be compliant with the following standards documents:

. ISO 10555-1:2009- Sterile, single-use intravascular catheters - Part 1: General requirements
ISO 10555-4:1996- Sterile, single-use intravascular catheters Part 4: Balloon dilatation . catheter
. ISO 10993-1:2009- Biological evaluation of medical devices – Part 1: Evaluation and testing

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. ISO 10993-4:2002+AMD1:2006-Biological testing of medical and dental materials and devices - Part 4: Selection of tests for interactions with blood
ISO 10993-5: 2009- Biological evaluation of medical devices Part 5: Tests for in vitro . cytotoxicity
. ISO 10993-10:2010 - Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2006- Biological testing of medical and dental materials and devices -Part 11: Tests for systemic toxicity
. EN ISO 11135-1: 2007 Sterilization of Medical Devices – Validation and routine control of ethylene oxide sterilization
EN ISO 11607-1: 2009- Packaging for terminally sterilized medical devices Part 1: . Requirements for materials, sterile barrier systems and packaging systems

Performance Testing:

The following performance tests were completed:

Catheter Dimension, Balloon & Tip Profile
Catheter Prep, In/deflation Time
Catheter Fatigue Integrity
Balloon Compliance
Balloon Rated Rupture Pressure
Catheter Shaft Pressure Integrity
Catheter Interface Compatibility, GW Lumen Collapse Pressure
Catheter Luer - Shaft Tensile Strength
Catheter Shaft - Balloon Bond Tensile Strength
Catheter Soft Tip Tensile Strength
Catheter Shaft Coating Integrity
Catheter Flexibility, Kink and Torque Strength

This 510(k) submission presents the results of the testing and detailed descriptions to demonstrate that Navajo PTA Balloon Dilatation Catheter is substantially equivalent to the AgilTrac .035 Peripheral Dilatation Catheter (K022738).

Conclusion:

Based on the indications for use, technological characteristics, safety and performance testing, the Navajo™ PTA Balloon Dilatation Catheter has been shown to be appropriate for its intended use and is considered substantially equivalent to the AgilTrac .035 Peripheral Dilatation Catheter (K022738).

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).