(35 days)
Intended Use: The Calset unit is used to warm dental composite materials and whitening bleach to130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).
The Calset is a warming device used to heat dental materials prior to their use in the mouth. It consists of a base unit that contains a heating element a temperature control circuit with LED indicators, a removable metal tray that is designed to hold different materials and a low voltage wall transformer that provides power to the unit.
Here's an analysis of the provided text regarding the Calset Composite Heater, focusing on the acceptance criteria and study information:
The provided text is a 510(k) summary for a medical device called the "Calset Composite Heater." This document is used to demonstrate substantial equivalence to a predicate device, not to provide detailed study results for performance acceptance criteria in the way one might find for a novel, high-risk device requiring extensive clinical trials.
Therefore, many of the typical questions about AI/ML algorithm studies (like training set size, ground truth for training, MRMC studies, specific performance metrics for algorithms) are not applicable to this type of submission. The focus here is on demonstrating the device functions as intended and is safe, primarily through comparison to an already-approved predicate device and basic performance testing.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the intended use and the comparison to the predicate device. The performance is reported directly in the description.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Temperature Settings: | |
| - Warm dental composite materials to 130°F (54°C) or 155°F (68°C) | The Calset has three temperature settings: 98°F (37°C), 130°F (54°C) or 155°F (68°C). |
| - Warm anesthetic carpules to 98°F (37°C) (body temperature) | The Calset has three temperature settings: 98°F (37°C), 130°F (54°C) or 155°F (68°C). The 98°F setting on the Calset is used together with a removable metal tray that holds anesthetic carpules. |
Study that Proves the Device Meets Acceptance Criteria:
The document describes the device and its intended uses, and implicitly relies on the technical specifications and comparison to the predicate device to prove it meets the criteria. It does not provide a detailed "study" in the sense of a clinical trial or a performance study with a separate test set, ground truth, or statistical analysis. This is typical for Class I or Class II devices undergoing 510(k) clearance, where substantial equivalence is the primary focus.
The "study" here is more of an engineering verification that the device achieves the stated temperatures.
Additional Requested Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document does not describe a "test set" in the context of clinical data or image data. The performance claims are based on the device's engineering specifications. There is no indication of clinical data provenance.
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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):
- N/A. Ground truth for a diagnostic or AI algorithm is not relevant here. The ground truth for device performance would be a calibrated thermometer measuring the actual temperature achieved by the heater.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable, as there is no test set in the context of diagnostic or AI-driven performance.
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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:
- N/A. This device is a composite heater, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a hardware device; there is no embedded algorithm in the sense of AI/ML that would have standalone performance. Its "performance" is its ability to heat to specified temperatures, which is a physical characteristic.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the temperature claims, the ground truth would be physical measurement with calibrated instruments (e.g., thermometers). This is not explicitly stated but is implicitly assumed for any device that makes temperature claims.
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The sample size for the training set:
- N/A. There is no training set mentioned or implied, as this is not an AI/ML device.
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How the ground truth for the training set was established:
- N/A. No training set exists.
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Image /page/0/Picture/0 description: The image shows the text "JUN 2 3 2006" on the top left and "K06 1395" on the top right. Below the date is the word "ADDENT" with the text "510(k) SUMMARY" below it. The text is black and the background is white.
Submitters Name: Joshua Friedman, D.D.S
Address: AdDent, Inc 43 Miry Brook Rd. Danbury, CT 06810
Phone: (203) 778-0200
Fax: (203) 792-2275
Device Name: Calset Composite Heater
Common Name: Composite Warmer
Classification Name: Not officially classified
Marketed Device of Equivalence: Aesthetic Warmer. Product code EFC, regulation number 872.6100 (exempt).
Description of the Device:
The Calset is a warming device used to heat dental materials prior to their use in the mouth. It consists of a base unit that contains a heating element a temperature control circuit with LED indicators, a removable metal tray that is designed to hold different materials and a low voltage wall transformer that provides power to the unit.
Intended Use: The Calset unit is used to warm dental composite materials to 130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).
Characteristics of the Calset Compared to Predicate Device: Both the Calset and the Anesthetic Warmer heat material that are in contact with the patient. The SE device heats anesthetic solution to body temperature (98°F). The Calset has three temperature settings 98°F (37°C), 130°F (54°C) or 155°F (68°C). The 98°F setting on the Calset is used together with a removable metal tray that holds anesthetic carpules.
1.00000000 C. L. Mira Ago tare a miller 2012 (1 2018 128 120 (18) 2019-19130000000
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2006
Joshua Friedman, DDS President AdDent, Incorporated 43 Miry Brook Road Danbury, Connecticut 06810
Re: K061395
Trade/Device Name: Calset Composite Heater Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ, EFC, and EEG Dated: May 17, 2006 Received: May 24, 2006
Dear Dr. Friedman:
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.
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Page 2 - Joshua Friedman, DDS
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.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 yours.
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
KO 61395
510(k) Number (if known):
Device Name: Calset Composite Heater
Indications for Use:
Intended Use: The Calset unit is used to warm dental composite materials and whitening bleach to130°F (54°C) or 155°F (68°C). It is also used to warm anesthetic carpules to 98°F (37°C) (body temperature).
Prescription Use
(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 OF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
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on of Anesthesiology, General Hospital,
dion Control, Dental Devices
2
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.