(51 days)
ENA HFO is a composite system for direct and indirect aesthetic restorations in anterior and posterior sectors.
ENA HFO is a system for direct and indirect aesthetic restorations in anterior and posterior sectors, composed by a light curing radiopaque composite, available in different colors, with accessories for application and polishing. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the K062906 device:
It is important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria, performance studies with sample sizes, expert involvement, or statistical analyses typically found in a full study report or technical documentation. The summary primarily lists the device's properties and claims similarity to existing products.
Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list quantitative acceptance criteria for device performance. Instead, it states that the device has "similar technological characteristics" and "similar physical data" to predicate devices. The "Risk to Health" section implicitly defines areas where the device should not fail, which could be interpreted as a form of acceptance criteria in terms of safety.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: No allergies or hypersensitivities. | Cytotoxicity tests performed (appears in Appendix V) - implies acceptable |
| Adhesion: Complete adhesion on teeth. | Not explicitly stated as a performance metric, only as a potential adverse effect if not met. |
| Curing: Complete and correct curing. | Not explicitly stated as a performance metric, only as a potential adverse effect if not met. |
| Polymerization: No or minimal polymerization gap/shrinkage. | Not explicitly stated as a performance metric, only as a potential adverse effect if not met. |
| Filling: Complete filling of the cavity. | Not explicitly stated as a performance metric, only as a potential adverse effect if not met. |
| General Performance: Similar to predicate devices in composition and physical data. | "They have similar composition (bis-GMA resin and glass filler) and similar physical data." |
Study Information
Based on the provided 510(k) summary, the following study information is available:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary.
- Data Provenance: Not specified. The summary mentions "cytotoxicity tests" (in Appendix V, which is not provided), but no details on the data origin (e.g., country) or whether it was retrospective or prospective.
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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 510(k) summary. The summary does not describe a clinical study or a study involving expert assessment to establish ground truth for performance metrics.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided as there is no mention of a test set with human adjudication in the summary.
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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:
- No MRMC study was conducted or reported. This device is a dental composite material, not an AI-assisted diagnostic tool, so such a study would not be applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is a physical material, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The summary implies that performance (e.g., cytotoxicity, physical data) was assessed against standard laboratory tests and material specifications, likely comparing to predicate devices or industry standards like ISO 4049:2000. It does not refer to clinical outcomes, expert consensus, or pathology for establishing ground truth of inherent device performance.
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The sample size for the training set:
- Not applicable/Not provided. The summary refers to a manufactured product and its testing, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable/Not provided, as there is no training set for a machine learning model.
In summary, the provided K062906 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It highlights the device's intended use, composition, and similarity to existing products, along with general safety considerations (like cytotoxicity tests). It does not offer the detailed efficacy study data, expert involvement, or statistical results that would typically answer many of the questions asked.
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NOV 17 2006
510(k) Summary
Submitter: Mr. Eugenio Miceli, QA Manager, Micerium SpA, Via Marconi, 83, 16030 Avegno (GE), Italy. Phone: 39 0185 7885 880.
- Classification Name and Number: Material, Tooth Shade, resin (EBF 872.3690) I.
- Common/Usual Name: Dental Composite for direct and indirect restoration. II.
- III. Proprietary Name: ENA HFO, ENA Tender, ENA Flow,.
- Registration No .: Foreign, in process IV.
XI.
- "ISO 4049:2000 Dentistry Polymer Based Filling, Restorative and Luting V. materials".
- VI. Premarket Notification truthful and accurate statement
- Description of the Device: ENA HFO is a system for direct and indirect aesthetic VII. restorations in anterior and posterior sectors, composed by a light curing radiopaque composite, available in different colors, with accessories for application and polishing. The accessories contact tissue for less than 1 hour and therefore are exempt from 510(k) requirements and are described only generally.
- VIII. Labels and Labeling: Draft labels of the ENA HFO system and instructions for use are provided.
- IX. Substantial Equivalence: The the ENA HFO system is substantially equivalent to several other composite systems currently on the market used for direct and indirect restorations by dentist and dental technicians. A list of these is provided.
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These products have the same intended use as predicate devices, intended to be used as direct or indirect teeth restoration material.
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The technological characteristics for this product are similar to those of the predicate devices and those currently on the market. They have similar composition (bis-GMA resin and glass filler) and similar physical data.
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IX.1 Risk to Health
Potential adverse affects and complications common to composite materials include: -
Allergies or hypersensitivities
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No or not complete adhesion on teeth
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Wrong or not complete curing
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Polymerisation gap, shrinkage
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- Wrong or not complete filling of the cavity
cytotoxicity tests appears in appendix V. I
- Indications for Use. ENA HFO is a composite system for direct and indirect aesthetic X. restorations in anterior and posterior sectors.
(End of Summary)
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eugenio Miceli QA Manager Micerium, SpA Via Marconi 83 16030 Avegno (Ge) ITALY
NOV 1 7 2006
Re: K062906
Trade/Device Name: ENA HFO Composite System Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 19, 2006 Received: September 27, 2006
Dear Mr. Miccli:
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 mail. therefore, market the device, subject to the general controls provisions of the Act. Troundly, controls provisions of the Act include requirements for annual registration. I sting 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 - Mr. Eugenio Miceli
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/cdrl/industry/support/index.html
Sincerely yours.
Suitte Y. Mchale MD.
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
510(k) Number (if known): K062906
Device Name: ENA HFO Composite System
Indications for Use:
ENA HFO is a composite system for direct and indirect aesthetic restorations in anterior and posterior sectors.
Prescription Use × (21 CFR Part 801 Subpart D)
AND/OR
:
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Super Suave
1 . . an-Oif) of Anesthesiology, General Hospilli, on Control, Dental Devices
x0620106
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§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.