(42 days)
For calcium hydroxide root canal therapy either prior to or after root career industration for emergency root canal there prior for treatment of root resorptions: and for early still and area root canar preparation; for emergency root canal treat. for treatment of root resorptions; and for early childhood trauma.
The Roeko Calcium Hydroxide Points are deposit preparations which release calcium hydroxide from a gutta percha matrix. The device consists of calcium hydroxide, gutta percha, barium sulfate, stearic acid, and colorants.
The provided text is a 510(k) summary for the Roeko Calcium Hydroxide Points. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to establish novel performance criteria. Therefore, the details requested in your prompt regarding acceptance criteria and a study proving device performance are largely not present in this document.
Here's an analysis of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or detailed performance metrics. The demonstration of safety and effectiveness relies on substantial equivalence to a predicate device, not on meeting predefined performance targets through a standalone study.
2. Sample size used for the test set and the data provenance
- Cannot be provided. No new efficacy study or test set is described. The device is deemed substantially equivalent based on its technical characteristics being similar to the predicate and its intended use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Cannot be provided. No test set requiring expert ground truth establishment is mentioned.
4. Adjudication method for the test set
- Cannot be provided. No test set requiring adjudication is mentioned.
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
- Cannot be provided. This document concerns a dental filling material, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study or AI assistance is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. Again, this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. Without a study, there's no ground truth data type. The safety and effectiveness are inferred from the predicate device.
8. The sample size for the training set
- Cannot be provided. No training set for an algorithm is mentioned or relevant to this device type.
9. How the ground truth for the training set was established
- Cannot be provided. No training set is involved.
Summary of available information related to performance/equivalence:
- Device Name: Roeko Calcium Hydroxide Points
- Intended Use: Temporary filling and disinfection of root canals between endodontic visits following pulp removal. Also indicated for calcium hydroxide root canal therapy, emergency root canal treatment, treatment of root resorptions, and early childhood trauma.
- Predicate Device: TempCanal™ manufactured by Pulpdent Corporation.
- Basis for Substantial Equivalence: "The technical characteristics are similar to those found with the predicate device where a root canal is temporarily filled with calcium hydroxide. In the Roeko device, calcium hydroxide powder is delivered from a gutta percha matrix inserted into the canal. In the predicate device, calcium hydroxide is delivered as an aqueous suspension by dispensing it into the canal through a syringe."
In essence, the "study" demonstrating the device meets "acceptance criteria" here is the assertion and FDA's agreement that the Roeko Calcium Hydroxide Points are substantially equivalent to the predicate device based on similar technical characteristics and intended use. This type of 510(k) submission does not typically involve new clinical performance studies or specific quantitative acceptance criteria beyond established product standards for the class of device.
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Section 9 510 (k) Summary
OCT 30 1997
510 (k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. S 807.92.
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The submitter of this premarket notification is: James Delaney, Associate EXPERTech Associates, Inc. 100 Main Street, Suite 120 Concord, MA 01742-5307 Tel.: (508) 371 - 0066 Fax : (508) 371 - 1676 This summary was prepared on August 29, 1997.
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The name of this device is Roeko Calcium Hydroxide Points. Its common name is Calcium Hydroxide Points, and its classification name is Calcium Hydroxide Cavity Liner.
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The Roeko Calcium Hydroxide Points are substantially equivalent to TempCanal™ manufactured by Pulpdent Corporation.
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The Roeko Calcium Hydroxide Points are deposit preparations which release calcium hydroxide from a gutta percha matrix. The device consists of calcium hydroxide, gutta percha, barium sulfate, stearic acid, and colorants.
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The device is intended for temporary filling, and disinfection of root canals between endodontic visits following pulp removal.
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The technical characteristics are similar to those found with the predicate device where a root canal is temporarily filled with calcium hydroxide. In the Roeko device, calcium hydroxide powder is delivered from a gutta percha matrix inserted into the canal. In the predicate device, calcium hydroxide is delivered as an aqueous suspension by dispensing it into the canal through a syringe.
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OCT 3 0 1997
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.
Mr. James Delaney ·Associate Roeko USA, Incorporated C/O Expertech Associate, Incorporated 100 Main Street, Suite 120 Concord, Massachusetts 01742
K973539 Re: Roeko Calcium Hydroxide Points Trade Name: Requlatory Class: II Product Code: EJK Dated: September 15, 1997 September 18, 1997 Received:
Dear Mr. Delaney:
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. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Delaney
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin 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 diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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.ffla.qov/cdrh/dsmamain.html".
Sincerely yours,
kf. Clatuck
Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
. Enclosure
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1973539 510(k) Number (if known):
Device Name:Roeko_Calcium_Hydroxide_Points_
Indications For Use: For calcium hydroxide root canal therapy ei ther prior to or after root career industration for emergency root canal there prior
for treatment of root resorptions: and for early still and area root canar preparation; for emergency root canal treat.
for treatment of root resorptions; and for early childhood trauma.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susen Runar
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Den 510(k) Number
Prescription Use (Per 21 CFR 801.109)
: : : : : :
OR
Over-The-Counter Use
(Optional Fornist 1-2-95)
004
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.