GLUSEAL 90, MODEL GLU9010

K083752 · Glustitch, Inc. · KMF · Feb 23, 2009 · General Hospital

Device Facts

• Record ID: K083752
• Device Name: GLUSEAL 90, MODEL GLU9010
• Applicant: Glustitch, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Feb 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

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.

Device Story

GluSeal® 90 is a cyanoacrylate-based liquid adhesive bandage. Applied topically to minor skin wounds; polymerizes rapidly upon contact with moisture (hydroxyl ions) to form a protective film. Used in clinical or home settings to cover minor cuts, scrapes, burns, and irritations. Provides a physical barrier to protect wounds from infection. Film remains adhered until natural re-epithelialization occurs or mechanical displacement. Benefits include rapid application and wound protection.

Clinical Evidence

No clinical data. Bench testing only. Studies included hydrolytic byproduct analysis, thermal effects (exotherm) study, and adhesive strength properties. Results showed GluSeal® 90 performed similarly to the control article (Indermil) and met specifications.

Technological Characteristics

Formulated cyanoacrylate monomer. Polymerizes to a thin film in <1 minute. Biocompatibility tested per ANSI/AAMI/ISO 10993. No specific material standards or software components described.

Indications for Use

Indicated for covering minor skin cuts, scrapes, burns, and irritations to protect against infection. Contraindicated for eye application, infected areas, draining wounds, mucosal surfaces, and patients with cyanoacrylate hypersensitivity.

Regulatory Classification

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.

Predicate Devices

• ProDerma (K063202)
• Liquiderm Liquid Adhesive Bandage (K002338)

Reference Devices

• Indermil

Submission Summary (Full Text)

{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

Q

ાં છે.

22 45 23 33 1 1 1 1 1

83752

| Applicant | Don Blacklock<br>GluStitch, Inc.<br>7188 Progress Way, #307<br>Delta, British Columbia<br>Canada 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, market<br>clearance date May 2, 2007; and<br>• K002338 Closure Medical Corporation's Liquidermtm Liquid<br>Adhesive Bandage, market clearance date January 29, 2001. |
| Description: | The GluSeal® 90 is a formulated compound of the cyanoacrylate series.<br>The compound, which exists in monomeric form in the plastic containers,<br>polymerizes extremely rapidly in the presence of anions, especially of<br>hydroxyl ions [in the presence of water]. It has the ability to adhere to<br>moist living tissues. It demonstrates a favorable tissue response and<br>reveals no toxic or foreign body reaction in humans. |
| Intended Use | GluSeal® 90 liquid adhesive bandage is intended to cover minor cuts,<br>scrapes, burns, and minor irritations of the skin and help protect them from<br>infection. |
| Contraindication: | Do not apply GluSeal® 90 adhesive to the eye(s). If contact with the eye(s)<br>occurs, keep the eye(s) closed and covered, and immediately contact an<br>ophthalmologist. No attempt should be made to open the eye(s). The<br>adhesive will lose its adhesion over time, between one and four days and<br>the eye(s) will open spontaneously with no damage.<br>Do not use on infected areas, or wounds that are draining. |
| Warning | Do not use on mucosal surfaces (e.g., oral cavity, lips).<br>Do not use if hypersensitive to cyanoacrylate. |
| Technological<br>Characteristics | When applied on a wound, the GluSeal® 90 product polymerizes to form a<br>thin, protective film, within less than a minute. The applied GluSeal® 90<br>has a high degree of adhesion strength. The GluSeal® 90 film remains<br>adhered to the tissue surface until the underlying tissue is sloughed through<br>natural re-epithelialization or until mechanically displaced. |
| Performance<br>Testing | The Hydrolytic Byproducts Analyses indicated that no other significant<br>degradation products were produced in the GluSeal® 90 formulated<br>cyanoacrylate. Additionally, the GluSeal® 90 samples produced similar<br>levels of formaldehyde as found in the Indermil samples.<br><br>The Thermal Effects Study concluded that the GluSeal® 90 had very little<br>exotherm of the adhesive. Furthermore, the GluSeal® 90 performed<br>similarly to the control article Indermil during these tests.<br><br>The Adhesive Strength Properties Study concluded that the GluSeal® 90<br>appears to have similar properties to the Indermil commercial tissue<br>adhesive |
| Substantial<br>Equivalency<br>Information | The GluSeal® 90 formulation has been subjected to the appropriate<br>biocompatibility testing in accordance with ANSI/AAMI/ISO 10993 and<br>the results have confirmed that the product is safe for its intended use.<br><br>GluSeal® 90 has also been subjected to mechanical and performance tests<br>demonstrating equivalence to the predicated devices. |
| Conclusion | Testing as shown that the GluSeal® 90 performs to its specifications,<br>operates as intended, is safe and effective, and is substantially equivalent to<br>legally marketed devices. |

.

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

# 510k) Summary continue _ KO 83 752

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

ir

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

of

{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 [phone]. 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 [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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 C<br>ิโครที่ 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