The LexiPliant™ Dilator Sheath Set is intended for use in patients requiring the percutaneous dilatation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects.

Device Description

The LexiPliant Dilator Sheath Set family consists of an inner and outer polymer sheath that may be used individually or as a set in a telescoping fashion. The inner sheath terminates with beveled tips. The outer sheath terminates with one beveled tip and one blunt tip. The sheaths are designed to dilate tissue while facilitating the removal of cardiac leads, indwelling catheters and foreign objects. The device is introduced at a cardiac pacemaker or defibrillator pocket's implantation site and then advanced over the lead or object that is to be extracted. The rotation and progression of the inner and outer sheaths causes dilation of the tissue binding the lead or object within the vasculature. Upon dilation of the surrounding tissue, the lead or object can be removed by traction.

AI/ML Overview

The provided text is a 510(k) summary for the LexiPliant™ Dilator Sheath Set. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested sections about study design, sample sizes, expert involvement, and ground truth cannot be directly extracted from this document.

Here's an attempt to answer the questions based only on the provided text, with explicit notes about when information is not available:

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

The document does not explicitly state quantitative "acceptance criteria" for the device's performance in a clinical context (e.g., success rate of lead removal). Instead, it lists various engineering and biological tests conducted to demonstrate substantial equivalence to a predicate device.

Test Category	Test Name	Acceptance Criteria (Not explicitly stated as quantitative targets in the document)	Reported Device Performance (Implied to meet criteria for substantial equivalence)
Design Verification & Validation	Dimensional Verification	Assumed to meet design specifications, similar to predicate.	Subject device "met" requirements, similar to predicate.
	Tensile	Assumed to meet strength requirements, similar to predicate.	Subject device "met" requirements, similar to predicate.
	Cantilever Bend	Assumed to meet flexibility/rigidity requirements, similar to predicate.	Subject device "met" requirements, similar to predicate.
	Dilatation	Assumed to achieve effective tissue dilation, similar to predicate.	Subject device "met" requirements, similar to predicate.
	Tip Compression	Assumed to withstand compression, similar to predicate.	Subject device "met" requirements, similar to predicate.
	Torque Tip	Assumed to provide adequate torque transmission, similar to predicate.	Subject device "met" requirements, similar to predicate.
	Sheath Cycle	Assumed to withstand repeated use/stress, similar to predicate.	Subject device "met" requirements, similar to predicate.
	Kink Fatigue	Assumed to resist kinking under stress, similar to predicate.	Subject device "met" requirements, similar to predicate.
	Radiopacity	Assumed to be visible under fluoroscopy, similar to predicate.	Subject device "met" requirements, similar to predicate.
Sterilization	Product adoption equivalency per AAMI TIR:28-2009	Assumed to achieve sterility equivalent to recognized standards.	Subject device "met" requirements, similar to predicate.
Biocompatibility	Physiochemical	Assumed to be chemically stable and non-toxic.	Subject device "met" requirements, similar to predicate.
	Cytotoxicity	Assumed to be non-toxic to cells.	Subject device "met" requirements, similar to predicate.
	Sensitization	Assumed not to cause allergic reactions.	Subject device "met" requirements, similar to predicate.
	Irritation/Intracutaneous Reactivity	Assumed not to cause irritation.	Subject device "met" requirements, similar to predicate.
	Acute Systemic Toxicity	Assumed not to cause acute systemic toxic effects.	Subject device "met" requirements, similar to predicate.
	C3a and SC5b-9 Complement Activation	Assumed not to cause significant complement activation.	Subject device "met" requirements, similar to predicate.
	Indirect and direct Hemolysis	Assumed not to cause red blood cell lysis.	Subject device "met" requirements, similar to predicate.
	In Vivo Thromobogenicity-Dog Model	Assumed not to cause excessive clotting in vivo.	Subject device "met" requirements, similar to predicate.
	Material Mediated Pyrogenicity	Assumed not to cause fever.	Subject device "met" requirements, similar to predicate.
	Genotoxicity – Ames Test	Assumed not to cause genetic mutations.	Subject device "met" requirements, similar to predicate.

Note: The document states "The results of design verification and validation testing demonstrate that the subject device is as safe and clinically effective as the predicate device" and that the testing results "demonstrated that the subject device is as safe and clinically effective as the predicate device." This implies that the device met the internal acceptance criteria for each test to achieve substantial equivalence.

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

The document explicitly states: "Preclinical and clinical data was not required to demonstrate substantial equivalence."
Therefore, there were no clinical test sets or data provenance as typically understood for a clinical study. The "test set" consists of the physical devices themselves and materials used in the listed engineering and biocompatibility tests. The specific sample sizes for each of these engineering and lab tests are not provided in this summary.

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)

Not applicable. No experts were used to establish ground truth because there was no clinical study. The testing performed was largely engineering and lab-based, overseen by product developers and quality assurance personnel.

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

Not applicable. No clinical test set or adjudication process as described.

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

Not applicable. This device is a physical medical instrument (dilator sheath), not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

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

Not applicable. For the engineering and biocompatibility tests, the "ground truth" would be the established scientific and engineering principles, test standards (e.g., AAMI TIR:28-2009 for sterilization), and comparison to the predicate device's characteristics, as measured by laboratory equipment and procedures, rather than clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. As there was no AI/algorithm, there was no training set.

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

Not applicable. As there was no AI/algorithm, there was no training set or ground truth for it.

Summary

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MAR 2 7 2

510(k) Summary, K133631, page

Spectranetics
Always Reaching Farther

510(k) Summary

This 510(k) summary was prepared in accordance with 21 CFR 807.92(c)

Prepared on March 11. 2014

510(k) Submitter / Holder:	Spectranetics9965 Federal DriveColorado Springs, CO 80921.3617Establishment Registration No: 3007284006
Contact:	Ms. Pharoah GarmaRegulatory Affairs ManagerOffice: 719.447.2385Fax: 719.447.2040Email: Pharoah.Garma@SPNC.com

Subject Device

Device Trade Name:
Device Common Name:
Device Class:
Classification Regulation:
Regulation Description:
Product Code:
510(k) Type:
Model Numbers:

LexiPliant™ Dilator Sheath Set Dilator Sheath 21 CFR 870 1310 Vessel dilator for percutaneous catheterization DRE Traditional Standard: 550-008, 550-010, 550-011, 550-013 Long: 555-508, 555-510, 555-511, 555-513

Predicate Device

The LEXiPliant Dilator Sheath Sets were compared to the following legally marketed predicate device:

510(k) Number:	K0923
Manufacturer:	Spectra
Trade Name:	VisiShe
Device Common Name:	Dilator

78 (cleared on November 02, 2009) anetics Corp. eath™ Dilator Sheath Sheath

Device Description

Intended and Indications for Use

The LexiPliant Dilator Sheath Set is intended for use in patients requiring the percutaneous dilatation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects.

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Technological Characteristics

The LexiPliant Dilator Sheath Set features similar design and functional characteristics as the predicate device (K092378 - VisiSheath Dilator Sheath Set). The results of design verification and validation testing demonstrate that the subject device is as safe and clinically effective as the predicate device.

Performance Data

The following testing was conducted to validate and verify that the subject device met was substantially equivalent to the predicate device:

Design Verification and Validation Testing

. Dimensional Verification
Tensile .
Cantilever Bend .
. Dilatation
Tip Compression .
Torque Tip �
Sheath Cycle .
Kink Fatigue .
Radiopacity ●

Sterilization

. Product adoption equivalency per AAMI TIR:28-2009

Biocompatibility

Physiochemical .
Cytotoxicity ●
Sensitization .
Irritation/Intracutaneous Reactivity .
Acute Systemic Toxicity .
C3a and SC5b-9 Complement Activation .
Indirect and direct Hemolysis .
In Vivo Thromobogenicity-Dog Model .
Material Mediated Pyrogenicity .
. Genotoxicity – Ames Test

Preclinical and Clinical Data:

Preclinical and clinical data was not required to demonstrate substantial equivalence. The design characteristics of the subject device are similar to the predicate. The design verification test results demonstrated that the subject device is as safe and clinically effective as the predicate device.

Substantial Equivalence

Based on the similarities in design between the subject and predicate device, and the performance data, the LexiPliant Dilator Sheath Set is substantially equivalent to the VisiSheath Dilator Sheath Set (K092378).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

March 27, 2014

Specranetics Corporation % Pharoah Garma Regulatory Affairs Manager 9965 Federal Drive Colorado Springs, CO 80921-3617

Re: K133631

Trade/Device Name: LexiPliant™ Dilator Sheath Set Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: February 25, 2014 Received: February 26, 2014

Dear Ms. Garma,

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.

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Page 2 - Pharoah Garma

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Bram D. Zuckerman -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133617

Device Name LexiPliant™ Dilator Sheath Set

Indications for Use (Describe)

The LexiPlianTM Dilator Sheath Set is intended for use in patients requiring the perculaneous dilatation of tissue to facilitate the removal of cardiac leads, indwelling catheters, and foreign objects.

Bram D. Zuckerman -S 2014.03.27 16:38:50 -04'00'

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)

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)

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).