The S-Wire Guidewire System is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used in trans-catheter aortic valve implantation (TAVI) procedures.

Device Description

The S-Wire Guidewire System is a sterile, single-use guidewire used for the placement of interventional devices within the aorta and the chambers of the heart. The S-Wire has a 0.035" diameter, and an overall length of 260 cm. The S-Wire construction consists of a nickel-titanium alloy core wire that is PTFE coated, ground and thermally formed. The S-Wire distal coil is made of 304V stainless steel: the distal and proximal ends of the stainless steel coil is bonded to the core wire. The distal portion of the S-Wire has silicone coating. The distal end of the S-Wire has a pre-formed double curve shape consisting of an approximately 360° bend with an outer diameter of approximately 3 cm, and a small S-curve at the distal tip of the wire that is fully contained within the 3 cm curved area. The S-Wire Guidewire System includes a disposable plastic 9 Fr introducer (6 inches long) that is used as an aid in loading the S-Wire into an intravascular catheter.

AI/ML Overview

The provided text describes a medical device, the S-Wire Guidewire System, and its substantial equivalence determination by the FDA. However, the document does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML algorithm or similar diagnostic tool where performance metrics like sensitivity, specificity, or accuracy would be relevant.

Instead, this document focuses on the regulatory clearance of a physical medical device (a guidewire) based on its comparability to a predicate device. The "performance testing" described refers to engineering and biocompatibility tests for the guidewire itself, not the performance of a diagnostic algorithm.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance for an AI/ML study, nor details about sample sizes for test/training sets, expert qualifications, or adjudication methods related to diagnostic performance.

The "Performance Testing" section on page 5 details the types of tests conducted:

Performance Testing for the S-Wire Guidewire System (Physical Device):

Measurement of physical characteristics and device integrity in accordance with FDA's Coronary and Cerebrovascular Guidewire Guidance and ISO 11070.
Specific tests included:
- Dimensional inspection
- Tensile strength (guidewire and introducer)
- Distal loop compression force
- Distal tip shape retention
- Tip stiffness
- Coating integrity
- Particulate evaluation
- Catheter compatibility
- Guidewire flex testing
- Guidewire fracture testing
- Corrosion resistance
Additional testing included:
- ISO 10993 biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, and pyrogen)
- Sterile package integrity testing (pouch seal tensile strength and dye penetration)

Acceptance Criteria and Reported Device Performance (as described for this physical device):

The document states: "The Concert Medical S-Wire Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device." However, the specific numerical acceptance criteria (e.g., "tensile strength must be > X N") and the actual measured results for these tests are not provided in this summary. The comparison is made against a predicate device, but again, the detailed comparative results are not present in this document beyond the general statement of "compared favorably."

In summary, assuming the request pertains to the kind of "device" described in the input and not an AI/ML diagnostic algorithm, the answer would be:

Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the document. The document states that "The Concert Medical S-Wire Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device," but does not list the specific numerical criteria or results for each test (e.g., tensile strength values, corrosion resistance levels).
Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML test set. For physical device testing, the sample size for each specific engineering test would be determined by the testing protocol, but this is not disclosed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not a diagnostic device or a study involving human interpretation.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a physical guidewire would be defined by engineering standards and material properties, against which the manufactured guidewire's performance is measured.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/13 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 a stylized symbol that resembles a caduceus, with three figures in profile facing right.

Public Health Service

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

August 18, 2016

Concert Medical, LLC % Pamela Papineau President Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave Ayer, Massachusetts 01432

Re: K153397

Trade/Device Name: S-Wire Guidewire System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: November 17, 2015 Received: November 24, 2015

Dear Ms. Papineau:

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 device

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related 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.

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 vours.

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) K153397

Device Name S-Wire Guidewire System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary - Revised (Clean Copy)

Date Prepared:	15 July 2016
General Information
Owner's Name:	Concert Medical, LLC
Address:	77 Accord Park DriveNorwell, MA 02061
Telephone:	781-871-7882
Fax:	781-724-4555
Contact Person:	Pamela Papineau, RAC (US, EU, CAN)Delphi Medical Device Consulting, Inc.5 Whitcomb AvenueAyer, MA 01432
Telephone:	(978) 772-3552
Fax:	(978) 796-5460
Subject Device:
Trade Name:	S-Wire Guidewire System
Common Name:	Catheter Guide Wire
Product Code:	DQX
FDA Regulation:	21 CFR 870.1330 - Catheter Guide Wire
Device Classification:	Class II
Predicate Device:
Product Name:	Lake Region Pre-Formed Guidewire (Boston Scientific SafariPre-Shaped TAVI Guidewire)
Common Name:	Catheter Guide Wire
Product Code:	DQX
FDA Regulation:	21 CFR 870.1330 - Catheter Guide Wire
Device Classification:	Class II
Premarket Notification:	K130798, K151244
Indications for Use

Device Description:

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made of 304V stainless steel: the distal and proximal ends of the stainless steel coil is bonded to the core wire. The distal portion of the S-Wire has silicone coating. The distal end of the S-Wire has a pre-formed double curve shape consisting of an approximately 360° bend with an outer diameter of approximately 3 cm, and a small S-curve at the distal tip of the wire that is fully contained within the 3 cm curved area. The S-Wire Guidewire System includes a disposable plastic 9 Fr introducer (6 inches long) that is used as an aid in loading the S-Wire into an intravascular catheter.

Substantial Equivalence

The Concert Medical S-Wire Guidewire System is substantially equivalent to the Lake Region Pre-Formed Guidewire (K151244 & K130798), which is marketed by Boston Scientific Corp. as the Safari Pre-Shaped TAVI guidewire. Substantial equivalence, which is summarized below, is based on indications for use, physical and technological characteristics, and comparative device testing.

	Concert Medical S-Wire GuidewireSystem (current submission)	Lake Region Pre-Formed Guidewire(K151244 & K130798)
Device Common/Usual Name	Catheter Guide Wire	Catheter Guide Wire
Device Class	Class II	Class II
Product Code / Regulation	DQX / 21 CFR 870.1300	DQX / 21 CFR 870.1300
Regulation Name	Catheter Guide Wire	Catheter Guide Wire
Prescription Use	Rx Only	Rx Only
Indications for Use	To facilitate the introduction andplacement of interventional deviceswithin the chambers of the heart,including those used in trans-catheteraortic valve implantation (TAVI)procedures	To facilitate the introduction andplacement of interventional deviceswithin the chambers of the heart,including those used within trans-catheter aortic valve procedures
Guidewire OD	0.035"	0.035"
Guidewire Length	260 cm	260 cm – 300 cm
Guidewire Materials	Nickel-titanium superelastic alloy,304V stainless steel, adhesive	A313 stainless steel
Guidewire Coating	PTFE (shaft); Silicone (distal coil)	PTFE
Tip Shape	Atraumatic double curve	Atraumatic double curve
Sterile Device?	Yes	Yes
Sterilization Type	Ethylene Oxide	Ethylene Oxide
EO Sterilization Residuals	Per ISO 10993-7	Per ISO 10993-7
Disposable / Reusable	Disposable	Disposable

Performance Testing:

Performance testing for the Concert Medical S-Wire Guidewire System consists of the measurement of physical characteristics and device integrity in accordance with FDA's Coronary and Cerebrovascular Guidewire Guidance and ISO 11070 (Sterile, single-use intravascular catheter introducers); testing included dimensional inspection, tensile strength (guidewire and introducer), distal loop compression force, distal tip shape retention, tip stiffness, coating integrity, particulate evaluation, catheter compatibility, guidewire flex testing, guidewire fracture testing and corrosion resistance. Where applicable, comparative test results are provided

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for the S-Wire and the predicate device. Additional testing included in this Premarket Notification includes ISO 10993 biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility and pyrogen) and sterile package integrity testing (pouch seal tensile strength and dye penetration). The Concert Medical S-Wire Guidewire System met all predetermined acceptance criteria and compared favorably with the predicate device.

Conclusion:

The Concert Medical S-Wire Guidewire System has been demonstrated to be substantially equivalent to the predicate device.

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.