The PW Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The PW Guidewires are not to be used in cerebral blood vessels.

Device Description

The Tatara Vascular, LLC PW Guidewires are steerable guidewires with a maximum diameter of 0.014" (0.36mm) and nominal length of 180cm. The wires are constructed from a stainless steel solid core wire with two grind profiles that distinguish the gram stiffness of the wire. The core wire transitions to an angled tip of either 0.30mm or 0.75 mm in length. The distal end of the guidewires have a radiopaque coil. A hydrophilic coating is applied to the distal portion of the guidewires. The proximal portion of the guidewires is coated with polytetrafluoroethylene (PTFE).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Tatara Vascular, LLC PW Guidewires. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with extensive human-in-the-loop or standalone AI studies.

Therefore, the information regarding acceptance criteria and performance is primarily focused on non-clinical laboratory testing to show that the new device performs as intended and is comparable to predicate devices. There is no mention of studies involving human readers, AI assistance, or complex diagnostic accuracy metrics as typically seen in AI/ML device submissions.

Here's a breakdown based on the provided text, addressing your questions to the extent possible:

Acceptance Criteria and Device Performance

Since this is a guidewire, the acceptance criteria are based on physical and mechanical properties and material safety, not diagnostic accuracy.

Table of Acceptance Criteria and Reported Device Performance:

The document lists the types of non-clinical laboratory tests performed. While it states "met the required acceptance criteria," it does not provide a specific table with numerical acceptance criteria values or the quantitative reported device performance for each test. It only lists the tests performed and a general statement of compliance.

Test Performed	Statement of Performance Against Acceptance Criteria
Tensile Strength	Met required acceptance criteria
Torque Strength	Met required acceptance criteria
Torqueability	Met required acceptance criteria
Tip Flexibility	Met required acceptance criteria
Tip Load	Met required acceptance criteria
Coating Adhesion	Met required acceptance criteria
Simulated Use	Met required acceptance criteria
Resistance to Wire Fracture	Met required acceptance criteria
Dimensional Verification	Met required acceptance criteria
Catheter Compatibility	Met required acceptance criteria
Radiopacity Testing	Met required acceptance criteria
Biocompatibility (ISO 10993-1)	Suitable for intended use

Study Details (Relevant to Device Substantial Equivalence, Not AI/ML)

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the document. The tests performed are non-clinical bench tests; thus, "sample size" would refer to the number of guidewires tested for each physical property. This information is typically detailed in the full test reports, not usually in the 510(k) summary.
- Data Provenance: The data originates from non-clinical laboratory testing (bench testing) of the Tatara Vascular, LLC PW Guidewires. It is not patient data, and therefore, concepts like "retrospective or prospective" or "country of origin of the data" are not applicable in this context.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This question is not applicable to this type of device submission. Ground truth for a guidewire's mechanical properties is established through standardized engineering and materials testing methods using calibrated equipment, not by human expert consensus on images or outcomes.
Adjudication Method for the Test Set:
- Not applicable. As described above, there's no human interpretation or adjudication involved in establishing the performance of a guidewire in bench tests.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for diagnostic devices, particularly those involving AI/ML for image interpretation. The PW Guidewires are a mechanical interventional device, and their substantial equivalence is demonstrated through engineering performance and material safety, not by comparative effectiveness studies with human readers.
Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:
- No. This question is specific to AI/ML algorithms. The device described is a physical guidewire, not an AI algorithm.
Type of Ground Truth Used:
- The "ground truth" for the performance of the guidewire in non-clinical testing is based on engineering specifications, material science principles, and established international standards (e.g., ISO 10993-1 for biocompatibility). Performance is measured objectively via test equipment.
Sample Size for the Training Set:
- Not applicable. There is no "training set" in the context of a physical medical device like a guidewire. Training sets are used for machine learning models.
How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, this question is irrelevant to this device submission.

In summary, the provided document details the regulatory pathway for a conventional medical device (a guidewire) seeking 510(k) clearance by demonstrating substantial equivalence. The focus is on showing the device meets established engineering, material, and safety standards through non-clinical testing, rather than complex clinical studies involving human interpretation or AI performance metrics.

Summary

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

January 22, 2016

Tatara Vascular, LLC % Jill Munsinger Regulatory Consultant JMCS. LLC 11470 Kenyon Ct. NE Blaine, Minnesota 55449

Re: K152497

Trade/Device Name: PW Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 15, 2015 Received: December 18, 2015

Dear Jill Munsinger:

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

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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.

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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510(k) Number: K152497

Device Name: PW Guidewires

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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K152497

This 510(k) summary is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K152497

Applicant Information:

Date Prepared:	January 20, 2016
510(k) Owner:	Tatara Vascular, LLC
Address:	10000 Cedar Ave. GCIC-10Cleveland, OH 44106
Facsimile Number:	(216) 445-6514
Regulatory Correspondent:	Jill Munsinger
Phone Number:	651-270-0572
E-mail:	jill.munsinger@outlook.com

Device Information:

Classification:	Class II Percutaneous Guidewire
Trade Name:	PW Guidewires
Common Name:	Percutaneous Guidewire
Classification Name:	Percutaneous Guidewire

Predicate Devices:

The Tatara Vascular, LLC PW Guidewire is substantially equivalent in intended use, method of operation and technical aspects to the following predicate devices:

K041531 - Asahi Confianza Pro Guidewire K052339 - Asahi MiracleBros Guidewire

Device Description:

Intended Use:

The PW Guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The PW Guidewires are not to be used in cerebral blood vessels.

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Comparison to Predicate Device(s):

Comparison of the Tatara Vascular, LLC PW Guidewires and predicate devices show that the technological characteristics (indications, components, design, materials, sterilization method, and operating principles) of the PW Guidewires are identical or similar to the currently marketed predicate devices. The following table outlines the comparison of the PW Guidewires to the predicate devices.

Characteristic	PW Guidewires	Asahi Confianza Pro	Asahi MiracleBros
510(k) Number	TBD	K041531	K052339
Indications for Use	...to facilitateplacement of balloondilatation catheters orother intravasculardevices duringpercutaneoustransluminal coronaryangioplasty (PTCA)and percutaneoustransluminalangioplasty (PTA).The PW Guidewiresare not to be used incerebral bloodvessels.	Same	Same
Sterilization	Ethylene Oxide toSAL 10-6	Same	Same
Target Body Location	Coronary andperipheralvasculature. Notcerebral vasculature.	Same	Same
Core Wire Material	Stainless steel	Same	Same
Nominal OuterDiameter	0.014" (0.36mm)	Same	Same
Overall length	180 cm	180 cm and 300 cm	180 cm and 300 cm
Proximal Coating	PTFE	Same	Same
Distal Coating	Hydrophilic	Same	Hydrophobic
Tip Load	5g, 12g	9.3g, 12.4g	3.9g, 4.4g, 8.8g, 13g
Tip Radiopacity	2.5cm	20cm	11cm
Tip Outer Diameter	0.26mm	0.23mm	0.36mm

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Non-clinical laboratory testing was performed on the Tascular, LLC Pwditional S10(k)
Non-clinical laboratory testing was performed on the Tatara Vascular, LLC PW Guidewires t demonstrate the device would perform as intended. The following tests and assessments were performed:

Tensile Strength
Torque Strength
Torqueability
Tip Flexibility
Tip Load
Coating Adhesion
Simulated Use ●
Resistance to Wire Fracture
Dimensional Verification
Catheter Compatibility ●
Radiopacity Testing ●

The in vitro bench tests demonstrated that the Tatara Vascular, LLC PW Guidewires met the required acceptance criteria and performed in a similar manner to the predicate devices. Performance data demonstrate that the device will function as intended and has an equivalent performance profile as the predicate devices.

Biocompatibility tests were also conducted to demonstrate the materials of the Tatara Vascular, LLC PW Guidewires were suitable for human use. The materials necessary to construct the PW Guidewires are similar to the predicate devices and were evaluated in accordance with ISO 10993-1. The results of the biocompatibility evaluations demonstrated the materials of the PW Guidewires are suitable for their intended use.

Summary:

Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, the Tatara Vascular, LLC PW Guidewires have been shown to be substantially equivalent to currently marketed predicate devices.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.