(371 days)
GluStitch® Twist Tissue Adhesive is intended for the topical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch® Twist may be used in conjunction with, but not in place of, deep dermal stitches.
GluStitch Twist Tissue Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. GluStitch Twist Tissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissue adhesive.
This document describes the GluStitch® Twist Tissue Adhesive and its performance testing. Below is an analysis of the provided text to extract the requested information regarding acceptance criteria and the study proving the device meets them.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format for most of the performance tests. Instead, it focuses on demonstrating substantial equivalence to the predicate device, Indermil® Tissue Adhesive. The reported performance is primarily in terms of "substantially equivalent" for various characteristics.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (GluStitch® Twist Tissue Adhesive) |
|---|---|
| Biocompatibility: | All tests performed using Good Laboratory Practices (GLP). |
| - In vitro cytotoxicity (ISO 10993-5) | Met (implied by "All of the testing was performed using Good Laboratory Practices") |
| - Local effects after implantation (ISO 10993-6) | Met (implied by "All of the testing was performed using Good Laboratory Practices") |
| - Irritation and skin sensitization (ISO 10993-10) | Met (implied by "All of the testing was performed using Good Laboratory Practices") |
| Sterilization and Shelf Life: | |
| - Sterility Assurance Level (SAL) | 10⁻⁶ obtained when subjected to 17.5 kGy of radiation |
| - Shelf life | 24 months (supported by real time and accelerated aging) |
| Comparative Testing (Substantial Equivalence to Indermil® Tissue Adhesive): | |
| - Tensile strength (ASTM F2255-05, F2258-05, F2458-05) | Substantially equivalent performance |
| - Set (polymerization) time | Substantially equivalent performance |
| - Heat of polymerization | Substantially equivalent performance |
| - Viscosity | Substantially equivalent performance |
| - Hydrolytic degradation | Substantially equivalent performance |
| - Applicator expression force | Substantially equivalent performance |
| - Chemical analysis | Substantially equivalent performance |
| In vivo assessment of incision closure (Safety and Efficacy): | |
| - Incidence of chemical burn | Substantially equivalent to Indermil® Tissue Adhesive |
| - Incidence of infection | Substantially equivalent to Indermil® Tissue Adhesive |
| - Histopathologic evidence of adverse effects on incision healing | Substantially equivalent to Indermil® Tissue Adhesive |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions an "in vivo assessment of incision closure was conducted in swine," but it does not specify the sample size (number of swine or number of incisions) used for this study.
The provenance of this data is a GLP (Good Laboratory Practices) study, indicating a prospective study design conducted under controlled conditions. The country of origin for the study is not explicitly stated.
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)
This information is not provided in the document. The in vivo study evaluated "histopathologic evidence," implying pathological assessment, but details about the number and qualifications of the experts (e.g., pathologists) who interpreted these findings are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This is not applicable. The device is a tissue adhesive, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The device is a physical tissue adhesive, not a software algorithm. Its performance is evaluated through direct physical and biological testing, not through algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the in vivo assessment, the ground truth was established through histopathologic evidence in swine, which is a form of pathology. The study also evaluated the incidence of chemical burn and infection as safety outcomes.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
GluStitch Incorporated Mr. Tim Robinson Regulatory and Clinical Quality Project Director Regulatory and Clinical Research Institute Incorporated 5353 Wayzata Boulevard. Suite 505 Minneapolis, Minnesota 55416
Re: K150032
Trade/Device Name: GluStitch® Twist Tissue Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: January 8, 2015 Received: January 11, 2015
Dear Mr. Robinson:
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 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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150032
Device Name GluStitch® Twist Tissue Adhesive
Indications for Use (Describe)
GluStitch® Twist Tissue Adhesive is intended for the topical skin incisions and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. GluStitch® Twist may be used in conjunction with, but not in place of, deep dermal stitches.
| Type of Use (Select one or both, as applicable) |
|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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GluStitch Inc.
www.glustitch.com ◎ Ph: (877) 940-2262 Fax: (877) 450-4000
510(K) SUMMARY
| Submitted by: | GluStitch, Inc. |
|---|---|
| Contact Person: | Don BlacklockPresidentGluStitch, Inc.307-7188 Progress WayDelta BC V4G 1M6CanadaTel: 800-667-2130Fax: 604-940-0552Email: blacklock@glustitch.com |
| Date of Summary: | January 8, 2016 |
| Device Trade Name:Common or Usual Name:Classification Name:Class:Product Code: | GluStitch® Twist Tissue AdhesiveTopical Tissue AdhesiveTissue Adhesive (21 CFR 878.4010)IIMPN |
| Predicate Device(s): | Indermil® Tissue Adhesive (P010002) |
| Device Description: | GluStitch Twist Tissue Adhesive is a sterile, topical tissueadhesive containing n-butyl-2-cyanoacrylate. GluStitch TwistTissue Adhesive is supplied in a single patient use, twist-and-use ampoule that contains at least 0.5g of liquid tissueadhesive. |
| Indication for Use: | GluStitch Twist Tissue Adhesive is intended for the topicalclosure of surgical skin incisions and trauma-inducedlacerations in areas of low skin tension that are simple,thoroughly-cleansed, and have easily approximated skin edges.GluStitch Twist may be used in conjunction with, but not in placeof, deep dermal stitches. |
| TechnologicalCharacteristics(compared to predicate): | The technological characteristics of the GluStitch Twist TissueAdhesive are equivalent in performance to the predicate deviceIndermil Tissue Adhesive (P010002). GluStitch Twist TissueAdhesive has been shown to be substantially equivalent andhas the same performance characteristic to the predicatedevices through comparison to the Indication for Use, |
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GluStitch Inc.
www.qlustitch.com @ Ph: (877) 940-2262 Fax: (877) 450-4000
formulation, technology, intended application, mechanism of action, and performance.
The GluStitch Twist Tissue Adhesive uses n-butyl-2cyanoacrylate technology to facilitate wound closure. It is supplied sterile, in single use applicators that are designed to deliver the adhesive to the wound, to bond to the skin edges to provide wound closure and to maintain wound approximation.
The main differences between GluStitch Twist Tissue Adhesive and Indermil Tissue Adhesive relate to a minor change to the formulation to allow stability after sterilization and addition of violet D & C Violet #2 for visibility purposes.
Substantial Equivalence Rationale:
GluStitch Twist Tissue Adhesive is substantially equivalent to Indermil Tissue Adhesive (P010002) with regard to Indication For Use, formulation, technology, intended application, mechanism of action and performance at achieving its intended use.
Performance Testing:
Biocompatibility
The biocompatibility tests conducted were for a "breached or compromised surface with prolonged contact duration of greater than 24 hours but less than 30 days". All of the testing was performed using Good Laboratory Practices (GLP).
| ISO 10993-5 | (2009) | Biological Evaluation of MedicalDevices, Part 5: Tests for in vitrocytotoxicity |
|---|---|---|
| ISO 10993-6 | (2007) | Biological Evaluation of MedicalDevices, Part 6: Tests for localeffects after implantation |
| ISO 10993-10 | (2010) | Biological Evaluation of MedicalDevices, Part 10: Tests forirritation and skin sensitization |
Sterilization and Shelf Life
Sterilization validation testing indicates a Sterility Assurance Level of 10-6 (SAL 10-6) is obtained when GluStitch Twist Tissue Adhesive is subjected to 17.5 kGy of radiation. Real time and accelerated aging shelf life testing has been
conducted. The data from these studies support a 24 month shelf life.
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GluStitch Inc.
www.glustitch.com ◎ Ph: (877) 940-2262 Fax: (877) 450-4000
Comparative Testing
The following comparative testing demonstrated substantially equivalent performance between GluStitch Twist Tissue Adhesive and Indermil Tissue Adhesive:
- Tensile strength (ASTM F2255-05, F2258-05, F2458-05) ■
- Set (polymerization) time ם
- ם Heat of polymerization
- ם Viscosity
- Hydrolytic degradation ■
- 트 Applicator expression force
- ם Chemical analysis
In vivo assessment of incision closure was conducted in swine, the objective of which was a 15 day GLP study to demonstrate substantial equivalence of the safety and equivalence of GluStitch Twist Tissue Adhesive to Indermil Tissue Adhesive in closing incisions. Primary safety objective evaluated the incidence of chemical burn, infection, and the histopathologic evidence of the tissue adhesive adversely affecting incision healing. Study parameters were evaluated at 4, 9 and 14 days post-closure, corresponding to Study Days 5, 10 and 15 respectively. The results demonstrate substantial equivalence of the safety and efficacy of GluStitch Twist Tissue Adhesive in relation to Indermil Tissue Adhesive for incision closure in an in vivo swine model.
Conclusion: Based on the non-clinical testing conducted, GluStitch Twist Tissue Adhesive is considered safe and effective when used as indicated. Performance testing has demonstrated GluStitch Twist is substantially equivalent to the legally marketed predicate device, Indermil Tissue Adhesive.
§ 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.