(161 days)
Periacryl™ is indicated for use as a dental cement for bonding dental materials such as crowns, caps, and pins.
Not Found
Here's an analysis of the provided text regarding the acceptance criteria and study for PERIACRYL™ dental cement:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary of Equivalence) |
|---|---|
| Material Composition: | N-Butyl 2 Cyanoacrylate |
| - Type of Cyanoacrylate | |
| Intended Use: | Dental cement for bonding dental materials (crowns, caps, pins) |
| - Bonding dental materials | |
| Technological Characteristics: | Similar to predicate device (Indermil™ Dental) |
| - General characteristics | |
| Safety and Effectiveness: | Comparable to Indermil™ Dental cement |
| - Overall safety | |
| - Overall effectiveness |
Explanation of "Acceptance Criteria (Implicit)":
The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable acceptance criteria for a new, de novo device. Therefore, the "acceptance criteria" are inferred from the comparison points used to establish substantial equivalence. The core acceptance criterion for a 510(k) is that the new device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness. The performance parameters of the predicate device (Indermil™ Dental) effectively serve as the target for the new device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission relies on a comparison to a predicate device and does not present data from a test set in the traditional sense of a clinical trial or performance study on the PERIACRYL™ device itself.
- Data Provenance: Not applicable. The information is a declaration of substantial equivalence based on a comparison to existing, legally marketed devices. It does not refer to new data generated from a study on PERIACRYL™.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no mention of a test set with ground truth established by experts. The determination of substantial equivalence is made by the FDA based on the information provided in the 510(k) submission.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring expert adjudication is described.
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-assisted device, and no MRMC study is described. The device is a dental cement, not an imaging or diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
- The "ground truth" here is the performance and characteristics of the legally marketed predicate device (Indermil™ Dental cement). Substantial equivalence is demonstrated by showing that PERIACRYL™ shares the same intended use, similar technological characteristics, and comparable safety and effectiveness to this established predicate. The FDA's existing knowledge and acceptance of the predicate device form the basis for evaluating PERIACRYL™.
8. The Sample Size for the Training Set
- Not applicable. There is no mention of a "training set" as this is not an machine learning or AI-based device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set" for this type of device submission.
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SUMMARY OF SAFETY AND EFFECTIVENES APR - 9 1998 PERIACRYLTM
The Summary of Safety and Effectiveness of PERIACRYL™ dental cement reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Intended Use
Periacryl™ is indicated for use as a dental cement for bonding dental materials such as crowns, caps and pins.
Caution
Federal law (U.S.A.) restricts this device to sale to and use by a qualified dental or medical practitioner.
Contraindications:
Periacry]™ must not come in contact with the conjunctival sac since conglutination may occur.
Identification of predicate devices:
IndermilTM Dental (Loctite, Rocky Hill, CT 06067)
Substantial Equivalency Information
The Blacklock Medical Product's Periacryl™ dental cement is similar to the Indermil™ Dental cement currently offered by Loctite. As a further note, Tissu-Glu is another cyanoacrylate that has been offered for sale in the United States by Ellman International, Hewlitt New York since prior to 1976. This product is sold non sterile as is Periacryl™
| Loctite | Blacklock | |
|---|---|---|
| Materials | N-Butyl 2 Cyanoacrylate | N-Butyl 2 Cyanoacrylate |
| Sterilization | Gamma RadiationSAL 10-6 | Sterility is not claimed |
The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Blacklock Medical Product's PeriacryI™ dental cement are comparable to that of the Loctite's Indermil™ Dental cement.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 9 1998
Mr. Don Blacklock ·President Blacklock Medical Products, Incorporated 6671 London Court V4K 4W7 Delta, British Columbia CANADA
Re : K974097 Trade Name: Periacryl Requlatory Class: II Product Code: EMA Dated: January 13, 1998 Received: January 16, 1998
Dear Mr. Blacklock:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Blacklock
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdalgov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Directd Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K974097/51
Page _/ of _/ ...
510(k) Number (if known): K9740 97 Device Name:
Indications For Use:
05/01/98
PeriacryI™ is indicated for use as a dental cement for bonding dental materials such as crowns, caps, and pins.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
SeRunner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number KG974097
Prescription User (Per 21 CFR 801.109)
ଠନ୍ନ
Over-The-Counter Use_
(Optional Format 1-2-96)
SK=65
§ 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.