(53 days)
Blugoo HD is used to reproduce the structure of a patient's teeth and gums.
Blugoo HD is a three part product (Part A, Part B, and Part C). Part A and B are a two part resin based impression mix. Blugoo HD Part C Yellow Wash is a two part resin based impression material. It can be used in conjunction with Blugoo HD for high definition impressions.
This 510(k) premarket notification describes a dental impression material named Blugoo HD. The submission focuses on demonstrating substantial equivalence to a predicate device, Extrude, rather than providing a performance study with specific acceptance criteria and reported device performance metrics in the way a diagnostic AI device would.
Therefore, many of the requested sections (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are not applicable to this type of submission for a dental impression material. The submission aims to show that the new material performs similarly to an already approved material for its intended use.
Here's an overview based on the provided document:
1. Table of acceptance criteria and the reported device performance
Not applicable. For a dental impression material, acceptance criteria would typically involve physical and chemical properties matching or performing equivalently to a predicate device, as opposed to diagnostic performance metrics like sensitivity or specificity. This document lists attributes for comparison but does not provide specific numerical acceptance criteria or reported performance values.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The submission does not describe a clinical performance study with a 'test set' in the context of diagnostic performance. The comparison is based on technological characteristics and material properties.
3. 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)
Not applicable. Ground truth as typically understood in AI/diagnostic studies is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method 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. Blugoo HD is a dental impression material, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. Blugoo HD is a physical material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Ground truth in the diagnostic sense is not relevant here. The "ground truth" for this type of submission is the performance of the legally marketed predicate device against which the new device is compared. This comparison is based on established industry standards and material science, not clinical diagnostic outcomes.
8. The sample size for the training set
Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set involved.
Summary of the Study / Equivalence Claim:
The study described is not a performance study in the diagnostic sense, but rather a substantial equivalence claim based on a comparison of technological characteristics between the new device (Blugoo HD) and a legally marketed predicate device (Extrude, manufactured by Sybron Dental Specialties, Inc., K012405).
The submission asserts that Blugoo HD has similar technological characteristics to the predicate device in the following areas:
- Anatomical sites
- Design
- Formulation
- Type
- Intended use
- Mixing time
- Working time
- Minimum removal time from start of mix
- Linear dimensional change
- Elastic recovery
- Strain in compression
- Impression longevity
- Storage conditions
- Detail reproduction
- Compatibility with gypsum
The evidence presented is this list of comparative characteristics. The regulatory body (FDA) reviewed this claim and determined that the device is substantially equivalent to the predicate device for its stated indications for use: "Blugoo HD is used to reproduce the structure of a patient's teeth and gums."
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Premarket Notifications [510(k)], Blugoo, Lancer Orthodontics
JUN 2 2 2007
Image /page/0/Picture/1 description: The image contains the text "5. 510(k) Summary" on the left side of the image. To the right of the text is the number K071192. Below the number is the logo for Lancer Orthodontics.
Submitter's name: Address:
Phone: Fax number: Name of contact person: Lancer Orthodontics 253 Pawnee Street San Marcos, CA 92078 760-744-5585 760-744-5842 Grace Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 fax: 949-552-2821
| Date the summary was prepared: | April 25, 2007 |
|---|---|
| Name of the device: | Blugoo HD |
| Trade or proprietary name: | Blugoo HD |
| Common or usual name: | Dental impression material |
| Classification name: | Material, Impression |
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
Extrude, manufactured by Sybron Dental Specialties, Inc. The reference number is K012405.
Description of the device:
Blugoo HD is a three part product (Part A, Part B, and Part C). Part A and B are a two part resin based impression mix.
Blugoo HD Part C Yellow Wash is a two part resin based impression material. It can be used in conjunction with Blugoo HD for high definition impressions.
Indications:
Blugoo HD is used to reproduce the structure of a patient's teeth and gums.
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Summary of the technological characteristics of our device compared to the predicate device:
Extrude, manufactured by Sybron Dental Specialties, Inc. and Blugoo HD were compared in the following areas and found to have similar technological characteristics and therefore to be equivalent.
Anatomical sites Design Formulation Type Intended use Mixing time Working time Min removal time from start of mix Linear dimensional change Elastic recovery Strain in compression Impression longevity Storage conditions Detail reproduction Compatibility with gypsum
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
JUN 2 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lancer Orthodontics, Incorporated C/O Ms. Grace Holland Regulatory Specialists. Incorporated 3722 Ave. Sausalito Irvine, California 92606
Re: K071192
Trade/Device Name: Blugoo HD Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: June 14, 2007 Received: June 18, 2007
Dear Ms. Holland:
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 - Ms. Grace Holland
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 (OS) 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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4. Indications for Use Statement Indications for Use
510(k) Number (if known): K671192
Device Name: Blugoo HD
Indications For Use:
Blugoo HD is used to reproduce the structure of a patient's teeth and gums.
Prescription Use AND/OR Over-The-Counter Use > (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suren Punne
Ton Sign-Off) sion of Anesthesiology, General Hospital, Jonon Control, Dental Devices
K Number: K071193
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REGULATORY SPECIALISTS, INC.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).