GluSeal® 90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.

Device Description

The GluSeal® 90 is a formulated compound of the cyanoacrylate series. The compound, which exists in monomeric form in the plastic containers, polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water]. It has the ability to adhere to moist living tissues. It demonstrates a favorable tissue response and reveals no toxic or foreign body reaction in humans.

AI/ML Overview

This document describes the GluSeal® 90 liquid adhesive bandage, a device intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection. The primary study presented is a performance testing comparison to predicate devices, focusing on demonstrating substantial equivalence rather than a detailed clinical trial with acceptance criteria for specific performance metrics.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the GluSeal® 90, as it primarily focuses on demonstrating substantial equivalence to predicate devices through performance testing. Instead, the "acceptance criteria" can be inferred as achieving similar performance or being comparable to the predicate devices in the described tests.

Performance Test Category	Acceptance Criteria (Inferred)	GluSeal® 90 Reported Performance
Hydrolytic Byproducts	Similar degradation products and formaldehyde levels to predicate Indermil samples.	"No other significant degradation products were produced." "Produced similar levels of formaldehyde as found in the Indermil samples."
Thermal Effects	Similar exotherm profile to predicate Indermil during polymerization.	"Had very little exotherm of the adhesive." "Performed similarly to the control article Indermil during these tests."
Adhesive Strength Properties	Similar properties to predicate Indermil commercial tissue adhesive.	"Appears to have similar properties to the Indermil commercial tissue adhesive."
Biocompatibility	Product is safe for its intended use per ANSI/AAMI/ISO 10993.	"Confirmed that the product is safe for its intended use."
Mechanical and Performance Tests	Equivalence to predicated devices.	"Demonstrating equivalence to the predicated devices."

2. Sample Size for Test Set and Data Provenance

The document does not specify the exact sample sizes used for the "Hydrolytic Byproducts Analyses," "Thermal Effects Study," and "Adhesive Strength Properties Study." It implicitly compares GluSeal® 90 to "Indermil samples" (for hydrolytic and thermal effects) and "Indermil commercial tissue adhesive" (for adhesive strength), but the number of samples for each is not given.

The data provenance is not explicitly stated regarding country of origin, but it is a regulatory submission to the US FDA from a Canadian applicant (GluStitch, Inc., Delta, British Columbia, Canada). The studies appear to be retrospective in the sense that they were conducted for this premarket notification rather than as part of a continuous, ongoing monitoring process.

3. Number of Experts and Qualifications

The document does not mention the number of experts used to establish ground truth or their qualifications for the performance tests described. These appear to be laboratory-based tests rather than expert-reviewed clinical outcomes.

4. Adjudication Method

No adjudication method is mentioned as the studies are laboratory-based performance tests rather than clinical evaluations requiring expert consensus.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. This is not applicable as the device is a liquid adhesive bandage, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

Yes, standalone performance studies were done. The "Performance Testing" section describes three distinct studies evaluating the GluSeal® 90 independently and in comparison to a control (Indermil):

Hydrolytic Byproducts Analyses: Evaluated degradation products and formaldehyde levels.
Thermal Effects Study: Assessed exotherm during polymerization.
Adhesive Strength Properties Study: Compared adhesive properties.

Additionally, biocompatibility testing was performed in accordance with ANSI/AAMI/ISO 10993, which is a standalone evaluation of the device's biological safety.

7. Type of Ground Truth Used

The ground truth for these performance tests is based on laboratory measurements and established scientific methods for analyzing chemical composition (degradation products, formaldehyde), thermal properties (exotherm), and physical properties (adhesive strength). For biocompatibility, the ground truth is adherence to the ANSI/AAMI/ISO 10993 standard, which relies on a battery of biological tests.

8. Sample Size for Training Set

No training set is mentioned. This device is a physical product (liquid bandage), not an AI algorithm that requires training data.

9. How Ground Truth for Training Set Was Established

Not applicable as there is no training set for an AI algorithm.

Summary

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

12 2017 11:51 人 > Section 5: 510k) Su imary

. "",

. . . .

. . ..

The Summary of Safety and Effectiveness on the GluSeal® 90 reflects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

and the state and the comments of

ાં છે.

22 45 23 33 1 1 1 1 1

83752

Applicant	Don BlacklockGluStitch, Inc.7188 Progress Way, #307Delta, British ColumbiaCanada V4G 1M6
	FEB 23 2009
Telephone	800-667-2130
Facsimile	877-450-4000
Date	December 18, 2008
Name	GluSeal® 90
Classification	Liquid Bandage, 21 CFR 880.5090
Predicate:	• K063202 Procurement Technology Systems, LLC, ProDerma, marketclearance date May 2, 2007; and• K002338 Closure Medical Corporation's Liquidermtm LiquidAdhesive Bandage, market clearance date January 29, 2001.
Description:	The GluSeal® 90 is a formulated compound of the cyanoacrylate series.The compound, which exists in monomeric form in the plastic containers,polymerizes extremely rapidly in the presence of anions, especially ofhydroxyl ions [in the presence of water]. It has the ability to adhere tomoist living tissues. It demonstrates a favorable tissue response andreveals no toxic or foreign body reaction in humans.
Intended Use	GluSeal® 90 liquid adhesive bandage is intended to cover minor cuts,scrapes, burns, and minor irritations of the skin and help protect them frominfection.
Contraindication:	Do not apply GluSeal® 90 adhesive to the eye(s). If contact with the eye(s)occurs, keep the eye(s) closed and covered, and immediately contact anophthalmologist. No attempt should be made to open the eye(s). Theadhesive will lose its adhesion over time, between one and four days andthe eye(s) will open spontaneously with no damage.Do not use on infected areas, or wounds that are draining.
Warning	Do not use on mucosal surfaces (e.g., oral cavity, lips).Do not use if hypersensitive to cyanoacrylate.
TechnologicalCharacteristics	When applied on a wound, the GluSeal® 90 product polymerizes to form athin, protective film, within less than a minute. The applied GluSeal® 90has a high degree of adhesion strength. The GluSeal® 90 film remainsadhered to the tissue surface until the underlying tissue is sloughed throughnatural re-epithelialization or until mechanically displaced.
PerformanceTesting	The Hydrolytic Byproducts Analyses indicated that no other significantdegradation products were produced in the GluSeal® 90 formulatedcyanoacrylate. Additionally, the GluSeal® 90 samples produced similarlevels of formaldehyde as found in the Indermil samples.The Thermal Effects Study concluded that the GluSeal® 90 had very littleexotherm of the adhesive. Furthermore, the GluSeal® 90 performedsimilarly to the control article Indermil during these tests.The Adhesive Strength Properties Study concluded that the GluSeal® 90appears to have similar properties to the Indermil commercial tissueadhesive
SubstantialEquivalencyInformation	The GluSeal® 90 formulation has been subjected to the appropriatebiocompatibility testing in accordance with ANSI/AAMI/ISO 10993 andthe results have confirmed that the product is safe for its intended use.GluSeal® 90 has also been subjected to mechanical and performance testsdemonstrating equivalence to the predicated devices.
Conclusion	Testing as shown that the GluSeal® 90 performs to its specifications,operates as intended, is safe and effective, and is substantially equivalent tolegally marketed devices.

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

510k) Summary continue _ KO 83 752

・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

The Summary of Safety and Effectiveness on the GluSeal® 90 rchects data available and represented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies and or tests may require alterations of the conclusions or recommendations set forth.

--- .

5 / 002

প

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 bars extending from its back, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2009

GluStitch, Inc. % Mr. Don Blacklock President 307-7188 Progress Way Delta, British Columbia V4G 1M6 Canada

Re: K083752 Trade/Device Name: GluSeal® 90 Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF

Dated: December 17, 2008

Received: December 17, 2008

Dear Mr. Blacklock:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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

Page 2 - Mr. Don Blacklock

forth in 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biomctric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely a

fp
Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

ection 4: Indication for Use Summary

510(k) Number (if known):		AQ2 7 Cิโครที่ 1988 - 1998 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999

GluSeal® 90 Device Name:

Indications For Use:

GluSeal® 90 liquid adhesive bandage is intended to cover minor cuts, scrapes, burns, and minor irritations of the skin and help protect them from infection.

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The-Counter-Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Rest . and Neurological General, Rest

510(k) Number 14053152

4 / 001

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.