(64 days)
GluSite is indicated for use as dental cement for bonding dental materials such as crowns, caps, and pins, or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease.
GluSite (2-octyl cynoacrylate) is a clear colorless, free-flowing liquid monomer packaged in a glass multiple-use vials. Upon contact with weak bases, GluSite polymerizes to form a strong adhesive bond. Depending on the availability of moisture, this could take up to one minute.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GluSite device:
This document ([K013446](https://510k.innolitics.com/device/K013446)) is a 510(k) summary for a medical device seeking market premarket clearance. It is not a detailed study report, but rather a summary to establish substantial equivalence to a predicate device. Therefore, much of the requested information regarding detailed study design (sample sizes for training/test sets, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details) is not present in this document.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative "acceptance criteria" through a table of targets that the device had to meet. Instead, the core of the evaluation for a 510(k) is demonstrating substantial equivalence to a predicate device. The "performance" is reported as equivalent to the predicate.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Equivalent Intended Use | GluSite's intended use is equivalent to CLOSURE Medical Corporation's Octyldent®. |
| Equivalent Technological Characteristics | The chemical composition, octyl cyanoacrylate, is equivalent. |
| Equivalent Performance | Test results demonstrate that the two devices are equivalent in performance (presumably mechanical properties relevant to dental cement). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified. It's common for 510(k) submissions to include bench testing or in-vitro tests, but the document doesn't detail the type or origin of this data. It only states "test results."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. For a medical device like dental cement, "ground truth" would typically refer to objective measurements of physical properties (e.g., bond strength, setting time, solubility) rather than expert interpretation of images.
4. Adjudication method for the test set:
This information is not provided and is generally not applicable to the type of performance testing expected for a dental cement (which focuses on objective physical properties rather than subjective interpretations).
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:
- MRMC Study: No, an MRMC study was not conducted (and would not be relevant) for this device.
- Effect size of human readers with/without AI assistance: This is not applicable as GluSite is a dental cement, not an AI-powered diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Test: Not applicable in the context of an "algorithm only" device. However, the "test results" mentioned imply a standalone performance evaluation of the cement's physical properties. The document states "test results demonstrates that the two devices are equivalent in performance," which suggests direct comparison of the substance itself without a human-in-the-loop component.
7. The type of ground truth used:
The document implies that the ground truth for performance comparison was based on objective, measurable physical and chemical properties of the dental cement, such as those related to its claim of being equivalent to the predicate in "chemical composition" and "performance." For dental cements, these typically include properties like:
- Bond strength
- Setting time
- Solubility
- Film thickness
- Radiopacity
- Biocompatibility
8. The sample size for the training set:
Not applicable and not provided. As a physical dental cement, there is no "training set" in the machine learning sense. The device's performance is inherent to its material properties, not learned from data.
9. How the ground truth for the training set was established:
Not applicable and not provided. There is no training set for this type of device.
Summary of Key Takeaways from the document:
The provided 510(k) summary for GluSite focuses on establishing substantial equivalence to the predicate device, Octyldent®, based on:
- Equivalent intended use
- Equivalent chemical composition (both are 2-octyl cyanoacrylate)
- Undisclosed "test results" demonstrating equivalent performance.
The document does not delve into the detailed methodology of these "test results" regarding sample sizes, expert involvement, or adjudication methods, as its purpose is a high-level regulatory summary for equivalence.
{0}------------------------------------------------
K 013446.
510(k) SUMMARY
The Summary of Safety and Effectiveness on the GlaSite reflects data available and experiences in the time the submission was The Summary of Saley and Elfectivelies on the Glickle reliects data Prairies and or test may requires in the closes of the conclusions or recommendations set forth.
| Applicant | Don BlacklockGluStitch, Inc.7188 Progress Way, #307Delta, BC., V4G 1M6 | DEC 2 0 2001 |
|---|---|---|
| Telephone | (800) 667-2130 | |
| Facsimile | (877) 450-4000 | |
| Date | October 15, 2001 | |
| Name | GluSite | |
| Classification | Dental Cement, 21 CFR 872.3275 | |
| Predicate: | CLOSURE Medical Corporation's Octyldent®, K980159 – marketclearance date, April 9, 1998 | |
| Description | GluSite (2-octyl cynoacrylate) is a clear colorless, free-flowing liquidmonomer packaged in a glass multiple-use vials. Upon contact with weakbases, GluSite polymerizes to form a strong adhesive bond. Depending onthe availability of moisture, this could take up to one minute. | |
| Intended Use | GluSite is indicated for use as dental cement for bonding dental materialssuch as crowns, caps, and pins, or temporarily attaching a fiber to thesurface of the tooth in a procedure to treat periodontal disease. | |
| Contraindication: | • GluSite is contraindicated for use in patients with hypersensitivity tothe adhesive.• GluSite must not come in contact with the conjunctival sac sinceconglutination may occur. | |
| Caution: | • Federal law (U.S.A.) restricts this device to sale by or on the order of aphysician. | |
| TechnologicalCharacteristics | The intended use of the GluStitch, Inc.'s GluSite and CLOSURE MedicalCorporation's Octyldent® are equivalent. The chemical composition,octyl cyanoacrylate are equivalent, and test results demonstrates that thetwo devices are equivalent in performance. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2001
Mr. Donald Blacklock President GluStitch, Incorporated #307 7188 Process Way Delta, British Columbia, CANADA
Re: K013446
Trade/Device Name: GluSite Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: October 15, 2001 Received: October 15, 2001
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
{2}------------------------------------------------
Page 2 - Mr. Blacklock
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal buter and systements, including, but not limited to: registration You must comply with an the Free Progant CPT CFR Part 801); good manufacturing practice allu listing (21 OF R Pat 007), acclines (QS) regulation (21 CFR Part 820); and if requirences as set form in the qualify is a 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 I his letter will anow you to ocgin maneting your and equivalence of your device to 310(k) promance noticate 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 If you desire specific ac not 70. Jour for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and Office of Collightance at (e office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under nother (11 OF CF CF CF CF CF CF Cr of Small Manufacturers, International and the Act may of obtained install-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Page 1 / 008 of 1 / 008
| 510(k) Number (if known): | K013446 |
|---|---|
| Device Name: | GluSite |
Indications For Use:
GluSite is indicated for use as dental cement for bonding dental materials such as
the tooth Grusite is indicated for as as demail concerners a fiber to the surface of the tooth in a procedure to treat periodontal disease.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
510(k) Number _
and General Hospital Dev
user Ninger
Division Sign-only
Division of Dental, Infection Control,
OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
1 / 008
(Optional Format 1-2-96)
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.