(25 days)
The KaVo Everest® ZH-Blank is used in the manufacture of dental prosthetics.
The KaVo Everest® ZH-Blank is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the KaVo Everest® ZH-Blank:
Based on the provided 510(k) summary, the device is a material for dental prosthetics, and its clearance process differs significantly from a typical AI/software-as-a-medical-device (SaMD) study focusing on diagnostic or prognostic performance. Therefore, many of the requested categories (like MRMC studies, expert ground truth, sample sizes for training/test sets) are not applicable or not explicitly detailed in this type of submission.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance for KaVo Everest® ZH-Blank
The submission for the KaVo Everest® ZH-Blank is based on demonstrating substantial equivalence to predicate devices and adherence to the classification for porcelain powders, rather than on specific quantitative performance metrics typically seen for diagnostic devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Submission Type) | Reported Device Performance |
|---|---|
| Material Formulation Equivalence: - Comparable chemical composition and physical properties to legally marketed predicate devices (KaVo Everest Z-Blank, KaVo Everest G-Blank, Vita inCeram Zirconia). | The claim of substantial equivalence is based on comparisons of formulations of the KaVo device to legally marketed predicates. The submission concludes the material is substantially equivalent to cited legally marketed predicates. |
| Intended Use Equivalence: - Used in the manufacture of dental prosthetics, consistent with predicate devices. | The claim of substantial equivalence is based on comparisons of intended uses of the KaVo device to legally marketed predicates. The device is intended for use in the manufacture of dental prosthetics. |
| Regulatory Identification Compliance: - Conforms to the FDA's identification for porcelain powders for clinical use (21 CFR 872.6660). | The submission is based on the IDENTIFICATION of porcelain powders in 21 CFR 872.6660. The device is classified as a Class II medical device under this regulation with product code EIH. |
| Safety and Effectiveness: - No new questions of safety or effectiveness are raised compared to predicate devices. | The FDA letter implicitly confirms this by granting substantial equivalence, stating the device is subject to general controls and does not require PMA. |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable / Not specified. This device is a material, not a diagnostic algorithm. Therefore, there is no "test set" in the context of an AI/SaMD performance evaluation. The substantial equivalence argument relies on comparing material specifications and intended use.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no "ground truth" establishment in the traditional sense for this type of material submission, as it's not a diagnostic device.
4. Adjudication Method for the Test Set
- Not applicable. No test set or expert adjudication was performed as part of this submission type.
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 submission is for a dental material (a physical product), not an AI/SaMD system designed to assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This submission is for a dental material, not a standalone algorithm.
7. The Type of Ground Truth Used
- Implicitly "regulatory compliance" and "material property comparison." For this type of submission, the "ground truth" is that the material's formulation and intended use correspond to those of legally marketed predicate devices and the relevant FDA regulation for "Porcelain Powder for Clinical Use." There isn't an "expert consensus," "pathology," or "outcomes data" ground truth in the typical diagnostic sense.
8. The Sample Size for the Training Set
- Not applicable / Not specified. As this is a material submission based on substantial equivalence, there is no "training set" in the context of an AI/SaMD and no data used for machine learning model development.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no training set or associated "ground truth" for this type of device submission. The "truth" is established through documented material specifications and their comparison to established predicate devices and regulatory definitions.
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K03322
OCT 2 8 2003
EXHIBIT 2 510(k) SUMMARY: KaVo Everest® ZH-Blank
This 510(k) summary of safety and effectiveness for KaVo Everest® ZH-Blank material is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
KaVo America Corporation Applicant:
Address: 340 East Main Street . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Lake Zurich, IL 60045
Manufacturer: KaVo Elektrotechnisches Werk GmbH, D-88293, Leutkirch im Allgau Germany
Contact Person: Ms. Jennifer Pottala
Telephone: 847-550-6800 847-550-6825 (Fax) 800-323-8029
Preparation Date: June, 2003 (of the Summary)
Device Name: KaVo Everest® ZH-Blank Common Name: Dental Frame Material for Dental Prosthesis
Classification: Porcelain, powder for clinical use 21 CFR 872.6660 Class II medical device Product Code: EIH Panel: 76
| Predicate devices: | K032081 KaVo Everest Z-Blank KaVo Everest G-Blank K030607 and VitainCeram Zirconia, K022996, among others. |
|---|---|
| Device description: | The KaVo Everest® ZH-Blank is a pre-formed material for use by dentallaboratories in filling orders/prescriptions for dental prosthetics |
| Indications: | The KaVo Everest® ZH-Blank is used in the manufacture of dentalprosthetics.KaVo proposes that the materials distributed within the United States belabeled:"CAUTION: Federal (US) law restricts the sale of this device to, or on theorder of, licensed professionals." |
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510(k) SUMMARY KaVo Everest® ZH-Blank
| Performance Data: | None required. The claim of substantial equivalence is based on comparisonsof formulations and intended uses of the KaVo devices to legally marketedpredicates and to the IDENTIFICATION of porcelain powders in 21 CFR872.6660. |
|---|---|
| CONCLUSION: | Based on the information in the notification KaVo America believes that TheKaVo Everest® ZH-Blank is substantially equivalent to cited legally marketedpredicates and to the IDENTIFICATION in the classifying regulation (21 CFR872.6660). |
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: 上一篇: 上一篇:
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2003
KaVo America Corporation C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates PO Box 7007 Deerfield, Illinois 60015
Re: K033221
Trade/Device Name: KaVo Everest® ZH-Blank Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 29, 2003 Received: September 14, 2003
Dear Mr. Kamm:
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 - Mr. Kamm
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 (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Chiu Lin, Ph.D.
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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j) Indications for Use
510(k) Number
Device Name: KaVo Everest® ZH-Blank .
Indications for Use: The KaVo Everest® ZH-Blank is used in the manufacture of dental prosthetics.
"CAUTION: Federal (US) law restricts the sale of this device to, or on the order of, licensed professionals."
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR Over the Counter Use (Per 21 CFR 801.109)
Susan Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.