(73 days)
SurgiSeal ™Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. SurgiSeal ™Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
SURGISEALTM Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.
The provided text is a Premarket Notification Summary (510(k)) for the SurgiSeal Topical Skin Adhesive. This document focuses on demonstrating substantial equivalence to a predicate device (Dermabond) based on bench testing and biocompatibility. It is not a study that provides detailed acceptance criteria and reported performance for a device against a pre-defined set of metrics from a clinical or imaging study.
Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical or AI algorithm performance studies, which are not described here.
Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Dermabond in: | SurgiSeal uses the same active ingredient (2-Octyl Cyanoacrylate) as Dermabond. |
| - ASTM Standardized Tests for Adhesion | Results comparable to Dermabond. |
| - ISO10993 Biocompatibility Tests for Safety | Equivalent to Dermabond. |
| - Animal Test for effect on healing | Equivalent to Dermabond. |
| - Performance profile in accordance with Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin. (Bench Tests) | Results comparable to Dermabond. |
| Moisture Vapor Transmission Rate | Higher results than Dermabond, suggesting greater transmission of moisture and oxygen to the wound, with potential for faster healing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "bench tests" and "animal tests" but does not provide details on sample sizes or specific methodologies for these tests.
- Data Provenance: Not specified. The nature of the tests (bench, animal) implies laboratory conditions, but no geographic origin is mentioned, nor whether it was retrospective or prospective (these terms are more relevant to clinical studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The tests described are laboratory-based (adhesion, biocompatibility, animal healing) and do not involve human expert interpretation or ground truth establishment in the way an imaging diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human interpretation or adjudication of results.
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
- Not applicable. This is not an AI device or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (topical skin adhesive), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench tests (adhesion, biocompatibility, moisture vapor transmission): The "ground truth" would be established by the standardized test methodologies themselves and the physical/chemical properties measured according to those standards.
- For animal tests: Histological analysis, wound healing assessments, or other physiological markers would likely serve as the "ground truth," but details are not provided.
8. The sample size for the training set
- Not applicable. This document describes premarket notification for a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not a machine learning algorithm.
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DEC 1 9 2008
KO82993 Premarket Notification Summary
Submitted by: Adhezion Biomedical 506 Pine Mountain Road Hudson, NC 28638
Phone: 828-728-6116
Contact Person: Richard G. Jones Sr. Vice President Phone: 610-431-2398 Email: Rjones@Adhezion.com
Page 1 of 2
Date of Summary: October 3, 2008
Device Trade Name: SurgiSeal Topical Skin Adhesive
Common or Usual Name: Topical Skin Adhesive
Classification Name: Tissue Adhesive Product Code: MPN
Predicate Device: Dermabond High Viscosity Topical Skin Adhesive
Device Description: SURGISEALTM Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.
When SURGISEAL is applied to the skin, it polymerizes in minutes.
Indications for Use: SURGISEAL is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.
SURGISEAL may be sued in conjunction with, but not in place of, deep dermal sutures.
Substantial Equivalence: SurgiSeal is substantially equivalent to Dermabond. Both use the same active ingredient, 2-Octyl Cyanoacrylate, equivalent in the ASTM Standardized Tests for Adhesion, ISO10993 Biocompatibility Tests for Safety and Animal Test for effect on healing.
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082993
Other Testing: SurgiSeal was evaluated in tests to establish a performance profile in accordance with the Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin. The Bench Tests, with Dermabond as control, showed results comparable. One test, Moisture Vapor Transmission Rate, showed higher results which suggest greater transmission of moisture and oxygen to the wound that has the potential to provide a faster healing rate.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, clutching a caduceus in its talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Adhezion Biomedical % Mr. Richard G. Jones Senior Vice President 506 Pine Mountain Road Hudson, North Carolina 28638
DEC 1 9 2008
Re: K082993
Trade/Device Name: SurgiSeal™ Topical Skin Adhesive Regulation Number: 21 CFR 878,4010 (a) Regulation Name: Tissue adhesive for topical approximation of skin Regulatory Class: II Product Code: MPN Dated: October 3, 2007 Received: October 7, 2007
Dear Mr. Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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. Iisting 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 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.
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Page 2 - Mr. Richard G. Jones
This letter will allow you to begin marketing your device as described in your Section 510(k) promarket 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 Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting 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 vours.
Mark N. Mullens
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510{k} Number (if known); K082993
Device Name: SurgiSeal ™Topical Skin Adhesive
Indications For Use: SurgiSeal ™Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations.
SurgiSeal ™Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
ਮ Prescription Lise (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A Milkim
Page 1 of _
(Division Sign-Off) Division of General, Restor and Neu
510(k) Number
§ 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.