Biotex Non-Absorbable PTFE Suture is indicated for use in dental soft tissue approximation and/or ligation. The device is not indicated for use in cardiovascular, ophthalmic surgery, microsurgery or peripheral neural tissue. Biotex is provided sterile as a single use device and the duration of use or contact with the body is less than 30 days.

Device Description

Biotex Non-Absorbable PTFE Suture is comprised of a single-arm, non-absorbable monofilament suture and the stainless-steel surgical needle connected to the suture. It is composed of 100% high-density PTFE provided uncoated, undyed and sterile for one-time use only.

AI/ML Overview

The Biotex Non-Absorbable PTFE Suture was evaluated for substantial equivalence to a predicate device through mechanical, physical, and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Mechanical/Physical	Diameter	Conforms to USP monograph for non-absorbable sutures	Conformed to USP monograph
	Tensile Strength	Conforms to USP monograph for non-absorbable sutures	Conformed to USP monograph
	Needle Adhesion	Conforms to USP monograph for non-absorbable sutures	Conformed to USP monograph
Biocompatibility	Cytotoxicity (ISO 10993-5)	Met acceptance criteria	All acceptance criteria were met
	Sensitization (ISO 10993-10)	Met acceptance criteria	All acceptance criteria were met
	Intracutaneous Reactivity (ISO 10993-10)	Met acceptance criteria	All acceptance criteria were met
	Acute Systemic Toxicity (ISO 10993-11)	Met acceptance criteria	All acceptance criteria were met
	Genotoxicity (ISO 10993-3)	Met acceptance criteria	All acceptance criteria were met
	Implantation (ISO 10993-6)	Met acceptance criteria	All acceptance criteria were met
Sterilization	Pyrogen Testing	Met acceptance criteria	All acceptance criteria were met
	EO Sterilization Residuals	Met acceptance criteria	All acceptance criteria were met
Stability	Shelf-Life	Met acceptance criteria	All acceptance criteria were met

2. Sample Size and Data Provenance

The document does not specify the exact sample sizes used for each test. The studies were performed in accordance with FDA's Class II Special Controls Guidance Document for Surgical Sutures and ISO 10993-1. These are likely prospective evaluations conducted in a laboratory setting, with data provenance typically from the device manufacturer's testing facilities.

3. Number of Experts and Qualifications

Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe device. The ground truth for this device is based on standardized physical, mechanical, and biological testing, not expert interpretation of medical images.

4. Adjudication Method

Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe device. The assessment relies on objective measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a medical device for approximation and/or ligation of dental soft tissue, not an AI/CADe system.

6. Standalone Performance Study

Yes, standalone (algorithm only) performance was done. The performance of the Biotex Non-Absorbable PTFE Suture was assessed independently against established standards such as the USP monograph for non-absorbable sutures and ISO 10993-1 for biocompatibility.

7. Type of Ground Truth Used

The ground truth used for performance evaluation was based on:

Established Standards: USP monograph for non-absorbable surgical sutures (for mechanical and physical properties).
International Standards: ISO 10993-1 "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process" (for biocompatibility).
Internal Specifications: Derived from the above standards, for tests like pyrogenicity, EO residuals, and shelf-life.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/CADe system that requires a "training set." Performance is evaluated against pre-defined, objective criteria.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for physical medical devices of this nature. The ground truth for the performance evaluation relies on established scientific and regulatory standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

July 16, 2019

Purgo Biologics Inc. % Seonghwan Song, RA Staff E-607, 700, Pangyo-ro Bundang-gu Seongnam-si KR 13516 Gyeonggi-do

Re: K180992

Trade/Device Name: Biotex Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: June 11, 2019 Received: June 13, 2019

Dear Seonghwan Song:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nina Mezu-Nwaba, PharmD., MPH., MSc, CAPT USPHS Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality 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: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name Biotex

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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Image /page/3/Picture/0 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a circular icon to the left of the word "Purgo" in a bold, pink font. To the right of "Purgo" are the words "Dental Biologics Solution," stacked vertically, also in a pink font. The logo is simple and modern, with a focus on the company's name and its connection to dental biologics.

K180992, pg. 1 of 3

Section 5 - 510(k) Summary

SUBMITTER .

PURGO BIOLOGICS INC. E-607, 700, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do, Korea Postal Code 13516

Contact Person: Hana Jung Regulatory Affairs Manager Phone: +82 70 4827 4863 Fax: +82 2 549 4003 Email: junghn@purgo.co.kr

Date Prepared: 2018.04.05

II. DEVICE

Name of Device: Biotex Common or Usual Name: PTFE Nonabsorbable Surgical Sutures Classification Name: Nonabsorbable Expanded Polytetrafluoroethylene (ePTFE) Surgical Suture (21 CFR 878.5035) Regulatory Class: Class II (special controls) Product Code: NBY

III. PREDICATE DEVICE

Osteogenics Biomedical Inc. Cytoplast PTFE Suture, K072076 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. SPECIAL CONTROLS

FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" was followed during the preparation of this submission.

Section 5 - 510(k) Summary

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Image /page/4/Picture/1 description: The image shows a logo for a company called "Purgo Dental Biologics Solution". The logo features a stylized atom symbol to the left of the word "Purgo", which is written in a bold, pink font. To the right of "Purgo" are the words "Dental Biologics Solution", stacked vertically in a smaller, pink font.

V. DEVICE DESCRIPTION

VI. INDICATIONS FOR USE

Biotex Non-Absorbable PTFE Suture is indicated for use in dental soft tissue approximation and/or ligation. The device is not indicated for use in cardiovasular, ophthalmic surgery, microsurgery or peripheral neural tissue.

Biotex is provided sterile as a single use device and the duration of use or contact with the body is less than 30 days.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Biotex Non-Absorbable PTFE Suture is substantially equivalent to the predicate device; Cytoplast PTFE suture, in which the basic features, raw materials and intended uses are the same. Biotex Non-Absorbable PTFE Sutures have been designed to meet the requirements for diameter, tensile strength, and needle adhesion as specified per USP. Any differences between the Biotex Non-Ahsorbable PTFE Suture and the predicate device are considered minor or insignificant Therefore, it does not raise any questions concerning safety and effectiveness.

	Biotex Non-AbsorbablePTFE Suture	Cytoplast PTFE Suture(K072076)
Product Code	NBY	Identical
SutureCharacteristic	Non-absorbable expandedpolytetrafluoroethylene surgicalsuture	Identical
Intended Use	Approximation and/or ligationof dental soft tissue	Identical
TechnologicalCharacteristic	Monofilament, uncoated,synthetic non-absorbablesurgical suture	Identical
Material	polytetrafluoroethylene (PTFE)	Identical
Sizes	3-0, 4-0, 5-0 in 14" or 18"lengths	2-0, 3-0, 4-0 in 18" lengths
Sterilization	EO	Identical
Packaging	Device packaged in plasticcase of racetrack design andinserted in Tyvek / Poly pouch	Device wound onto innersupport card, within a Tyvek /Poly pouch
ContactDuration	Intended for use less than 30days	Intended for use for 2 to 4weeks

Section 5 - 510(k) Summary

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Image /page/5/Picture/1 description: The image shows the logo for Purgo Dental Biologics Solution. The logo features a gray circular icon with a smaller circle inside and a line extending upwards to another circle. To the right of the icon is the word "Purgo" in a pink sans-serif font, and to the right of that is the text "Dental Biologics Solution" in a smaller, also pink, sans-serif font.

VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Mechanical and Physical testing

Non-clinical laboratory performance testing was conducted to confirm that the Biotex Non-Absorbable PTFE Suture conforms to the USP monograph for non-absorbable is substantially is substantially equivalent to the predicate device. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, issued on June 3rd of 2003.

Biocompatibility testing

The biocompatibility evaluation for the Biotex Non-Absorbable PTFE Suture was conducted in accordance with the International Standard ISO 10993-1.2009 "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA to further ensure substantial equivalence with the predicate device.

Assessment of the candidate device included the following tests:

Cytotoxicity (ISO 10993-5)
Sensitization Test (ISO 10993-10)
Intracutaneous Reactivity (ISO 10993-10)
0 Acute Systemic Toxicity (ISO 10993-11)
. Genotoxicity (ISO 10993-3)
. Implantation Test (ISO 10993-6)
Pyrogen Testing
EO Sterilization Residuals
Shelf-Life

All of the acceptance criteria were met.

IX. CONCLUSIONS

Based on the information provided within this 510(k) submission, Purgo Biologics Inc. concludes that the Biotex Non-Absorbable PTFE Suthre is substantially equivalent in safety and performance to the legally marketed predicate device listed according to the requirements of the Federal Food, Drug, and Cosmotic Act.

Completed by / Title:

Raina

Hana Jung / RA manager Section 5 - 510(k) Summary

Regulation Number and Section

§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.

(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.