(68 days)
Not Found
No
The device description and performance studies focus on the chemical properties and adhesive strength of the cyanoacrylate compound, with no mention of AI or ML.
No
The device is described as a liquid adhesive bandage intended to cover minor cuts, scrapes, burns, and minor irritations of the skin to help protect them from infection. This function aligns with providing a barrier or support, rather than actively treating an underlying medical condition or restoring function, which defines a therapeutic device.
No
The device is described as a liquid adhesive bandage intended to cover and protect minor skin irritations from infection. It does not mention diagnosing any condition.
No
The device description clearly states it is a "formulated compound of the cyanoacrylate series" which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cover and protect minor skin injuries. This is a topical application for wound care, not a diagnostic test performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details the chemical composition and how it polymerizes to form an adhesive bandage. This is consistent with a wound closure or protection device, not a diagnostic assay.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The GluSeal® 90 does not fit this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Hydrolytic Byproducts Analyses indicated that no other significant degradation products were produced in the GluSeal® 90 formulated cyanoacrylate. Additionally, the GluSeal® 90 samples produced similar levels of formaldehyde as found in the Indermil samples.
The Thermal Effects Study concluded that the GluSeal® 90 had very little exotherm of the adhesive. Furthermore, the GluSeal® 90 performed similarly to the control article Indermil during these tests.
The Adhesive Strength Properties Study concluded that the GluSeal® 90 appears to have similar properties to the Indermil commercial tissue adhesive
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
12 2017 11:51 人 > Section 5: 510k) Su imary
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. . . .
. . ..
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
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22 45 23 33 1 1 1 1 1
83752
| Applicant | Don Blacklock
GluStitch, Inc.
7188 Progress Way, #307
Delta, British Columbia
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
clearance date May 2, 2007; and
• K002338 Closure Medical Corporation's Liquidermtm Liquid
Adhesive 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 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. |
| 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 from
infection. |
| 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 an
ophthalmologist. No attempt should be made to open the eye(s). The
adhesive will lose its adhesion over time, between one and four days and
the 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. |
| Technological
Characteristics | When applied on a wound, the GluSeal® 90 product polymerizes to form a
thin, protective film, within less than a minute. The applied GluSeal® 90
has a high degree of adhesion strength. The GluSeal® 90 film remains
adhered to the tissue surface until the underlying tissue is sloughed through
natural re-epithelialization or until mechanically displaced. |
| Performance
Testing | The Hydrolytic Byproducts Analyses indicated that no other significant
degradation products were produced in the GluSeal® 90 formulated
cyanoacrylate. Additionally, the GluSeal® 90 samples produced similar
levels of formaldehyde as found in the Indermil samples.
The Thermal Effects Study concluded that the GluSeal® 90 had very little
exotherm of the adhesive. Furthermore, the GluSeal® 90 performed
similarly to the control article Indermil during these tests.
The Adhesive Strength Properties Study concluded that the GluSeal® 90
appears to have similar properties to the Indermil commercial tissue
adhesive |
| Substantial
Equivalency
Information | The GluSeal® 90 formulation has been subjected to the appropriate
biocompatibility testing in accordance with ANSI/AAMI/ISO 10993 and
the results have confirmed that the product is safe for its intended use.
GluSeal® 90 has also been subjected to mechanical and performance tests
demonstrating 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 to
legally marketed devices. |
.
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510k) Summary continue _ KO 83 752
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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.
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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 C
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|---------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | | |
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