GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord are for the temporary retraction of the gingival margin. The Retraction Cord is placed in the sulcus to displace gum tissue for a small period of time in dental procedures.

Device Description

GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are dental retraction materials used to aid accurate impressions of sub-gingival margins by temporary gingival displacement, control sulcular seepage and control hemorrhage. Non-impregnated retraction materials are to be used in combination with an astringent/hemostatic solution of choice. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The non-impregnated retraction materials consists only of braided or knitted cotton yarn soaked with an aqueous surfactant solution and then dried to facilitate absorption of medicament containing retraction solution of dentist's choice into the cotton cord. The braided and knitted cord configurations are available in different sizes to fit the sulcus.

AI/ML Overview

This document describes the premarket notification (510(k)) for GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document focuses on demonstrating substantial equivalence to a predicate device (Quicknit Cord, K131799) based on shared technological characteristics, intended use, and indications for use, rather than presenting a performance study against specific acceptance criteria for a new clinical claim or diagnostic capability.

Therefore, many of the requested elements for a study demonstrating acceptance criteria cannot be extracted from this document, as it is a 510(k) submission for a medical device regulatory clearance, not a clinical performance study with acceptance criteria.

However, I can extract information related to the non-clinical performance data provided, which serves as evidence for safety and substantial equivalence.

Here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics for a clinical study in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it presents non-clinical performance data and states that Biocompatibility meets requirements of ISO 10993.

Test/Characteristic	Acceptance Criteria (Implied by standard)	Reported Device Performance
Biocompatibility	Meets requirements of ISO 10993	Meets requirements of ISO 10993
Cutting Test	(Not explicitly stated)	(Not explicitly stated, but performed)
Water Contact Test	(Not explicitly stated)	(Not explicitly stated, but performed)
In Vitro Cytotoxicity	Meets requirements of ISO 10993-5:2009	(Implied by Biocompatibility statement)

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable. No clinical test set is described as this is a non-clinical evaluation for substantial equivalence.
Data Provenance: Not applicable for a clinical test set. The non-clinical tests (Cutting Test, Water Contact Test, Biocompatibility) would have been conducted in a laboratory setting, likely by the manufacturer or a contract research organization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set with ground truth established by experts is described.

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

Not applicable. No clinical test set is 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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a dental retraction cord, not an AI-powered diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

Not applicable for a clinical ground truth. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the referenced ISO standards.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

Summary of what the document does provide regarding "proof" of meeting criteria:

The document asserts that the device meets safety and effectiveness requirements by demonstrating substantial equivalence to a legally marketed predicate device (Quicknit Cord, K131799). This demonstration relies on:

Non-clinical performance data: "Cutting Test, Water Contact Test and Biocompatibility testing" were performed.
Compliance with standards: The non-clinical performance testing utilized ISO 10993-1:2009 (Biological evaluation of medical devices) and ISO 10993-5:2009 (Tests for in Vitro Cytotoxicity). The document explicitly states that the "Biocompatibility meets requirements of ISO 10993".
Comparison to Predicate: A comparison table (Table 8.1) highlights the similarities between the proposed device and the predicate in terms of intended use, indications for use, material composition (both primarily cotton, non-impregnated), product code, classification, and material compatibility. The key differences noted (e.g., configurations, presence of a surfactant in the proposed device) are argued to "not raise new questions of safety and effectiveness."
No Clinical Performance Data: The document explicitly states, "Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical data.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

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

January 13, 2017

Kerr Corporation % Mohammad Saad Ansari Regulatory Affairs Specialist II Sybron Dental Specialties 1717 W. Collins Ave Orange, California 92867

Re: K162164

Trade/Device Name: GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord Regulation Number: None Regulation Name: Retraction Cord Regulatory Class: Unclassified Product Code: MVL Dated: December 15, 2016 Received: December 19, 2016

Dear Mohammad Saad Ansari:

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

{1}------------------------------------------------

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 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,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K162164

Device Name

GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ 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."

{3}------------------------------------------------

K162164 510(k) SUMMARY

Submitter Information: 1.
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687

Contact Person:	Mohammad Saad Ansari
Telephone Number:	909-962-5644
Fax Number:	909-962-5694

Date Prepared: January 9, 2017

1. Device Name:
- Proprietary Name: .
- . Classification Name:
- . CFR Number:
- Device Class: Unclassified .
- . Product Code:

3. Predicate Device:

GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are substantially equivalent to the legally marketed device(s) Microscopy, Division of Neo-Flo, Inc.'s Quicknit Cord, K131799, product code MVL, cleared on January 16th, 2014.

Retraction Cord

872.3275

MVL

GingiKnit+, GingiBraid+, and GingiBraid+

ShortCut Non-Impregnated Retraction Cord

1. Description of Device:
  GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are dental retraction materials used to aid accurate impressions of sub-gingival margins by temporary gingival displacement, control sulcular seepage and control hemorrhage. Non-impregnated retraction materials are to be used in combination with an astringent/hemostatic solution of choice. The usage is inherently of transient nature. Typical exposure time is less than five minutes. The non-impregnated retraction materials consists only of braided or knitted cotton yarn soaked with an aqueous surfactant solution and then dried to facilitate absorption of medicament containing retraction solution of dentist's choice into the cotton cord. The braided and knitted cord configurations are available in different sizes to fit the sulcus.

Image /page/3/Picture/15 description: The image contains two figures. The figure on the left shows a black circle surrounded by six white circles. The figure on the right shows a three-dimensional view of a cylinder with a textured surface.

{4}------------------------------------------------

న. Intended Use:
Retraction Cords are for the temporary retraction of the gingival margins and hemostasis procedures.
1. Indications for Use:
  GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are for the temporary retraction of the gingival margin. The Retraction Cord is placed in the sulcus to displace gum tissue for a small period of time in dental procedures.
1. Description of Safety and Substantial Equivalence:
  Technological Characteristics

The designs of GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord are similar to the predicate Quicknit Cord (K131799). They are all Non-Impregnated Retraction Cord products. Neither product contains an additional hemostatic chemical agent. The proposed device includes a surfactant wetting agent.

Non-Clinical Performance Data 8.
Non-clinical performance data included Cutting Test, Water Contact Test and Biocompatibility testing.

The following standards were utilized for the non-clinical performance testing:

. ISO 10993-1: 2009 Biological evaluation of medical devices
ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in . Vitro Cytotoxicity

	Table 8.1: Predicate and Proposed Device Comparison Table

Element	PredicateQuicknit Cord	Proposed GingiKnit+,GingiBraid+, and ShortCutwith GingiBraid+ Non-impregnated Cord
510(k)	K131799	K162164
Target Users	Licensed dental professionals	Licensed dental professionals
Intended Use	Retraction Cords are for thetemporary retraction of thegingival margins and hemostasisprocedures.	Retraction Cords are for thetemporary retraction of thegingival margins and hemostasisprocedures.
Indications for Use	Quicknit Cord is unimpregnatedcord for the temporary retractionof the gingival margin. Thegingival retraction cord is placedin the sulcus (between the gumtissue and your tooth structure)to displace the gum tissue for asmall period of time in dentalprocedures.	GingiKnit+, GingiBraid+, andGingiBraid+ ShortCut Non-Impregnated Retraction Cord arefor the temporary retraction ofthe gingival margin. TheRetraction Cord is placed in thesulcus to displace gum tissue fora small period of time in dentalprocedures.

{5}------------------------------------------------

Element	PredicateQuicknit Cord	Proposed GingiKnit+,GingiBraid+, and ShortCutwith GingiBraid+ Non-impregnated Cord
Common Name	Retraction Material	Retraction Material
Classification Name	None	None
Class	Unclassified	Unclassified
Product Code	MVL	MVL
Astringent/HemostaticAgent	None	None
Contact Time	Unknown	Less than 5 minutes
Material Composition	100% Cotton	Cotton and surfactant
Material Compatibility	Biocompatibility meetsrequirements of ISO 10993	Biocompatibility meetsrequirements of ISO 10993
Configurations	Knitted	Knitted, Braided, Braided withShortCut

9. Clinical Performance Data

Clinical performance testing has not been performed for GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord.

10. Conclusion as to Substantial Equivalence

The proposed device and the predicate Quicknit Cord (K131799) differ in their configuration, packaging, and delivery method. Neither the predicate nor the proposed devices are impregnated with hemostatic solutions and are primarily composed of cotton material. The proposed device includes a surfactant wetting agent to aid in soaking. The proposed GingiKnit+, GingiBraid+, and GingiBraid+ ShortCut Non-Impregnated Retraction Cord have similarities in select performance characteristics as compared to the predicate. Results of nonclinical testing demonstrate that any noted differences in technological characteristics between the proposed and predicate products to not raise new questions of safety and effectiveness. The proposed product line is substantially equivalent to the predicate Quicknit Cord (K131799) based on design, performance, biocompatibility testing, indications for use and the intended use.