The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (nonresorbable) for use as a space-making barrier in the treatment of periodontal defects.

Device Description

The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is composed of microporous PTFE material. It has a nominal thickness of 250 microns and is supplied in two sizes (25mm x 30mm and 12mm x 24mm). The membranes are single use and are supplied in sterile sealed pouches.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called the Salvin CytoSurg™ Non-Resorbable PTFE Membrane. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a study proving performance against specific acceptance criteria in the context of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML device cannot be extracted from this document.

However, I can extract the performance data and the conclusion related to the device's substantial equivalence to its predicate, as presented in the document.

Acceptance Criteria and Reported Device Performance (as related to substantial equivalence):

Acceptance Criteria Category	Specific Tests Performed	Reported Device Performance
Physical Properties	Tensile Strength	Bench testing demonstrated substantial equivalence to the predicate device
	Tear Resistance	Bench testing demonstrated substantial equivalence to the predicate device
	Geometric Comparisons	Demonstrated substantial equivalence to the predicate device
Biocompatibility	ISO 10993-5 / Tests Cytotoxicity	Met their acceptance criteria
	ISO 10993-6 / Tests Local Effects After Implantation	Met their acceptance criteria
	ISO 10993-10 / Tests for irritation and skin sensitization	Met their acceptance criteria
	ISO 10993-11 / Tests for Systemic Toxicity	Met their acceptance criteria
Other Validations	Packaging Validation	Met their acceptance criteria
	Sterilization Validation	Met their acceptance criteria

Since this is not an AI/ML device, the following information is not applicable and cannot be extracted from the provided text:

Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

Summary

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

September 8, 2016

Salvin Dental Specialties c/o John Kapitan President Kapstone Medical 100 E. South Main St., PO Box 1458 Waxhaw, North Carolina 28173

Re: K160493

Trade/Device Name: Salvin CytoSurg110 Non-Resorbable PTFE Membrane Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPK Dated: August 8, 2016 Received: August 11, 2016

Dear John Kapitan:

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 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 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K160493

Device Name: Salvin CytoSurg™ Non-Resorbable PTFE Membrane

Indications for Use:

The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (nonresorbable) for use as a space-making barrier in the treatment of periodontal defects.

Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

K160493

1. Applicant

Salvin Dental Specialties, Inc. 3450 Latrobe Drive Charlotte, NC 28211

Date Prepared: September 7, 2016 Contact Person: John Kapitan Tel: (704) 516-5120 Email: jkapitan@kapstonemedical.com

2. Device Name

Proprietary Trade Name:	Salvin CytoSurg™ Non-Resorbable PTFE Membrane
Common/Usual Name:	PTFE Barrier Membrane
Classification Name:	Bone grafting material
Regulation Number:	21CFR872.3930
Product Code:	NPK
Classification:	II
Panel:	Dental

3. Predicate Devices

The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is substantially equivalent to the Cytoflex® Non-Resorbable Barrier Membrane, produced by Unicare Biomedical.

Applicant	Salvin Dental	Unicare Biomedical
Product Name	CytoSurg™ Non-ResorbablePTFE Membrane	Cytoflex® Non-ResorbableBarrier Membrane
510(k) Number	K160493	K012144
Product Code	NPK	NPK
Regulation #	21CFR872.3930	21CFR872.3930
Class	II	II
Prescription or O-T-C?	Prescription	Prescription
Provided Sterile or Non-sterile?	Sterile	Sterile
Indications for Use	The Salvin CytoSurg™ Non-Resorbable PTFE Membrane isa temporarily implantablematerial (non-resorbable) foruse as a space-making barrierin the treatment ofperiodontal defects.	Cytoflex® is a temporarilyimplantable material (non-resorbable) for use as a space-making barrier in thetreatment of periodontaldefects.
Components and Size(s)	250 micron thickness	250 micron thickness

Comparison Table

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Applicant	Salvin Dental	Unicare Biomedical
Product Name	CytoSurg™ Non-ResorbablePTFE Membrane	Cytoflex® Non-ResorbableBarrier Membrane
	25mm x 30mm
	12mm x 24mm	25mm x 30mm
Device/Implant Materials	ePTFE	ePTFE
Sterilization Methodology	ETO	ETO

4. Description of the Device

5. Indications for Use

The Salvin CytoSurg™ Non-Resorbable PTFE Membrane is a temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

6. Technology Characteristics

The technological characteristics of the Salvin CytoSurg™ Non-Resorbable PTFE Membrane are equivalent to the predicate device. The subject and predicate devices have the same design including the same material, fiber size, and membrane thickness.

7. Summary of Performance Data

Specific Tests Performed:	Tensile Strength
	Tear Resistance
	ISO 10993-5 / Tests Cytotoxicity
	ISO 10993-6 / Tests Local Effects After Implantation
	ISO 10993-10 / Tests for irritation and skin sensitization
	ISO 10993-11 / Tests for Systemic Toxicity
	Packaging Validation
	Sterilization Validation

Bench testing including tensile strength and tear resistance, as well as geometric comparisons of the Salvin Cytosurg™ device to the Unicare Biomedical Cytoflex® device demonstrated substantial equivalence. The results for Biocompatibility Testing, Packaging Validations and Sterile Validation met their acceptance criteria.

7. Conclusion

The Salvin CytoSurg™ Membrane is substantially equivalent to the Unicare Biomedical Cytoflex predicate device (K012144). In addition to conclusions from performance testing and geometric comparisons, the devices have "Indications for Use," are available by prescription only, utilize ePTFE material, and are provided sterile for single-use only. It can be concluded that the Salvin CytoSurg™ Membrane is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.3930 Bone grafting material.

(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.