(83 days)
High Viscosity Dermabond Topical Skin Adhesive
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No
The device description and intended use are for a topical tissue adhesive, and there is no mention of AI or ML in the provided text.
Yes
The intended use explicitly states it is for topical application to hold closed easily approximated skin edges of wounds from surgical incisions and trauma-induced lacerations, which is a therapeutic purpose.
No
The document describes derma+flex® QS™ High Viscosity Tissue Adhesive as a tissue adhesive intended for topical application to close skin edges of wounds. It is a treatment device, not a diagnostic one which identifies a condition or analyzes data.
No
The device description clearly describes a physical product (tissue adhesive, tube, pouch, applicator tips) and does not mention any software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "topical application only to hold closed easily approximated skin edges of wounds." This is a direct application to the body for a physical purpose (holding skin together), not for examining specimens in vitro (outside the body) to obtain diagnostic information.
- Device Description: The description details a sterile liquid adhesive applied to the skin, which polymerizes. This aligns with a topical medical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health condition.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and topical.
N/A
Intended Use / Indications for Use
derma+flex® QS™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. derma+flex® QS™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
Product codes
MPN
Device Description
derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile. liquid topical skin adhesive containing a monomeric (2-octy) cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA180 applicator tips. The dauber applicator is comprised of a selfpuncturing cap and a foam surface, which allows spreading of the adhesive with uniformity. The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. derma+flex® QS™ High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity derma+flex® QS™ is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
derma+flex® QS™ High Viscosity Tissue Adhesive was evaluated in tests to establish a performance and safety profile in accordance with the Class II Specials Controls Guidance Document: Tissue Adhesive for Topical Approximation of Skin.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
High Viscosity Dermabond Topical Skin Adhesive
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4010 Tissue adhesive.
(a)
Tissue adhesive for the topical approximation of skin —(1)Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.(2)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b)
Tissue adhesive for non-topical use —(1)Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.
0
Image /page/0/Picture/0 description: The image shows the logo for Chemence Medical Products. The logo includes a medical symbol with a snake wrapped around a staff, followed by the company name in block letters. Above the logo, there is a handwritten code "K101276".
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Section 5. Abbreviated 510(k) Summary
Submitted By: Chemence Medical Products, Inc. 185 Bluegrass Valley Pkwy. Alpharetta, GA 30005-2222 Phone: 678-879-5446 678-879-0251 Fax:
JUL 2 8 2010
Contact Person: Patricia D. Lehman Director of Regulatory Affairs Phone: 678-879-5446 Ext. 201 Email: plehman@chemence-us.com
Date of Summary: April 30, 2010
Device Trade Name: derma+flex QS High Viscosity Tissue Adhesive
Product Code: MPN
Tissue Adhesive (21CFR 878.4010)
High Viscosity Dermabond Topical Skin Adhesive
Common Name: Topical Skin Adhesive
Classification Name:
Predicate Device:
Device Description:
derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile. liquid topical skin adhesive containing a monomeric (2-octy) cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA180 applicator tips. The dauber applicator is comprised of a selfpuncturing cap and a foam surface, which allows spreading of the adhesive with uniformity. The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. derma+flex® QS™ High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity derma+flex® QS™ is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site.
1
Image /page/1/Picture/0 description: The image shows the logo for Chemence Medical Products. The logo consists of a caduceus symbol on the left, followed by the word "CHEMENCE" in large, bold letters. Below that, the word "MEDICAL" is printed in a smaller font, and below that, the word "PRODUCTS" is printed in an even smaller font.
Page 2 of 2
Indications for Use:
derma+flex® QS™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. derma+flex® QS™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
Substantial Equivalence:
derma+flex® QS™ High Viscosity Tissue Adhesive is substantially equivalent to High Viscosity Dermabond Topical Skin Adhesive with regard to Indication for Use, formulation, technology, target population, intended application, mechanism of action and performance at achieving their intended use. Both devices present the same main chemical characteristics (2-Octyl Cyanoacrylate) and equivalent formulating materials with similar chemical characteristics. Devices shown to be equivalent in all performance and safety tests. derma+flex® QS™ High Viscosity Tissue Adhesive was evaluated in tests to establish a performance and safety profile in accordance with the Class II Specials Controls Guidance Document: Tissue Adhesive for Topical Approximation of Skin.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JUL 2 8 2010
: 1.110
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Chemence Medical Products, Inc. % Ms. Patricia D. Lehman Director of Regulatory Affairs 185 Bluegrass Valley Parkway, Suite 100 Alpharetta, Georgia 30005-2222
Re: K101276
Trade/Device Name: derma+flex® QS™ High Viscosity Tissue Adhesive Regulation Number: 21 CFR 878.4010(a) Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: May 04, 2010 Received: May 06, 2010
Dear Ms. Lehman:
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
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Page 2 - Ms. Patricia D. Lehman
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); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
cerely yours,
For Peter S. Rummel
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
້ັມັບLİ
510(k) Number:
Device Name:
derma+flex® QS™ High Viscosity Tissue Adhesive
Indications for Use:
derma+flex® QS™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.
derma+flex® QS™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kuore for MXM
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101276
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