The Protek Venous Dilator Sets are comprised of vascular dilators with diameters of 14, 18, 22 and 26 Fr. outer diameter. There are two distinct kits, one intended for insertion of cannula smaller than 26 Fr. which includes the 14, 18, and 22 Fr. dilators and one intended for the insertion of cannula larger than 26 Fr. which also includes the 26 Fr. dilator. The Dilators are designed to accept a standard 0.038 inch guidewire. The Protek Venous Dilator Sets are intended as a single patient, single use, sterile device.

Each dilator consists of a tube with a hub. The dilators fit over a guidewire during insertion. The dilators are used to prepare the target vessel for the safe introduction of a large bore cannula. The dilator body is constructed from radiopaque material for visualization under nuoroscopy.

AI/ML Overview

The provided document is a 510(k) premarket notification letter and supporting documentation for the Protek Venous Dilator Sets. It focuses on demonstrating substantial equivalence to a predicate device for a medical dilator. This type of document does not include information related to acceptance criteria, study details, expert involvement, or statistical analysis typically found in an FDA submission for AI/ML-driven devices or diagnostic tools.

Therefore, I cannot provide the requested information for this specific document because it describes a physical medical device (dilator) and not a device that relies on AI/ML or requires a complex validation study with acceptance criteria related to diagnostic performance.

The document details non-clinical testing for the dilator, such as:

Tensile Strength: "Pull test with objective acceptance criteria." Conclusion: "All test articles met acceptance criteria. Mechanical integrity is more than adequate for the intended application."
Deflection Test: "Compliance measurement with side-by-side comparison to similar sized predicate devices." Conclusion: "The Protek Venous Dilators are all more compliant than similarly sized predicate devices, as designed."
Biocompatibility: "Testing per ISO-10993 for an external communicating device in contact with circulating blood for limited duration less than 24 hours." Conclusion: "All tests passed."

This is the extent of the "acceptance criteria" and "study" information available in this document. It does not fit the format of an AI/ML-driven diagnostic study.

Summary

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

January 06, 2017

CardiacAssist, Inc. Dr. Greg A. Johnson Vice President, Regulatory Affairs and Quality Assurance 240 Alpha Drive Pittsburgh, Pennsylvania 15238

Re: K162181

Trade/Device Name: Protek Venous Dilator Sets Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: December 6, 2016 Received: December 7, 2016

Dear Greg Johnson:

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 of medical devicerelated adverse events) (21 CFR 803); 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.

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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,

M.A. Hilleman

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) K162181

Device Name Protek Venous Dilator Sets

Indications for Use (Describe)

The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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് CardiacAssist, Inc.

Date: 8/3/2016

Applicant

CardiacAssist, Inc. 240 Alpha Drive Pittsburgh, PA 15238 Telephone: 412-963-7770 Fax: 412-963-0800

Contact person

Greg Johnson, PhD Title: Vice President of Regulatory Affairs and Quality Assurance Phone: 412-963-7770 x266 e-mail: gjohnson@tandemlife.com

Device

Trade/Proprietary Name:	Protek Venous Dilator Sets
Common Name:	Vessel dilator for percutaneous catheterization
Classification Name:	Vessel dilator for percutaneous catheterization (21 CFR 870.1310)
	Product Code DRE)

Predicate Devices

Avalon Elite Vascular Access Kit (K081940)

Device Description

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Intended Use

The Protek Venous Dilator Sets are intended for single use by a trained physician to assist in vessel cannulation.

Comparison of Technological Characteristics

Technological differences between the Protek Venous Dilators and the predicate Avalon Elite Vascular Access Kit dilators are limited to the following differences:

The Protek Venous dilators are approximately .35" (0.9 cm) longer than the predicate ● device.
The venous dilators are tapered on the distal 1.3" of the dilator body. The predicate ● dilator includes a taper of similar length at the distal end but also includes a 1" straight section leading into the taper.
The predicate device includes smaller and larger dilators than the Protek Venous ● Dilator Kits.
The predicate device includes a kit with additional components such as a guidewire, ● mini scalpel, 10 cc syringe, and introducer needle not present with the Protek Venous Dilators.
. The Protek Venous Dilators have a proximal hub which is not present on the predicate.
The Protek Venous Dilators are more compliant than the predicate dilators.

Summary of Non-clinical Testing

Testing of the Protek Venous Dilator Sets included tensile strength, deflection (compliance) measurement, and biocompatibility.

Test	Method	Conclusion
Tensile Strength	Pull test with objectiveacceptance criteria	All test articles met acceptancecriteria. Mechanical integrity ismore than adequate for the intendedapplication.
Deflection Test	Compliance measurement withside-by-side comparison tosimilar sized predicate devices	The Protek Venous Dilators are allmore compliant than similarly sizedpredicate devices, as designed.
Biocompatibility	Testing per ISO-10993 for anexternal communicating devicein contact with circulatingblood for limited duration lessthan 24 hours	All tests passed.

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Conclusion

Testing of the Protek Venous Dilators demonstrated that tensile strength is sufficient for the intended use, that each individual dilator is more compliant (as designed) than a similarly sized predicate dilator, and that the dilators meet biocompatibility requirements for the intended use. The Protek Venous Dilator Sets are determined to be substantially equivalent to the predicate Avalon Elite Vascular Access Kit (K081940)

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).