(80 days)
For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge
Unigraft is a synthetic bioactive glass material for use in the repair of oral defects, including periodontal defects, extraction sites and augmentation of the alveolar ridge. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.
The bioactive glass (45S5 Bioglass) used in Unigraft is one of the most extensively studied bioactive glass compositions, which has been shown to bond to bone as well as soft tissue. The same material is used in legally marketed devices, including BioGran® and PerioGlas®. When implanted in the living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone minerals. The biological apatite layer of the granules provides an osteo-conductive scaffold for the generation of new osseous tissue.
Here's an analysis of the provided 510(k) summary for the Unigraft device, addressing your specific questions.
Important Note: The provided document is a 510(k) summary for a medical device (synthetic bone graft material), not an AI/Software as a Medical Device (SaMD). Therefore, many of your questions related to AI/SaMD performance metrics, ground truth, expert adjudication, and training/test set details are not applicable to this type of submission. I will address them by stating "Not Applicable" or explaining why they don't fit.
Unigraft (K993784) - Device Acceptance Criteria and Study Details
The Unigraft device is a synthetic bioactive glass material intended for oral defect repair. Its approval is based on demonstrating substantial equivalence to existing, legally marketed predicate devices. The primary "acceptance criteria" in this context is the successful demonstration of this substantial equivalence through comparative testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|
| Material Composition Equivalence: Unigraft's material (45S5 Bioglass) should be the same as or comparable to predicate devices. | Unigraft utilizes "45S5 Bioglass," which is described as one of the "most extensively studied bioactive glass compositions" and the "same material is used in legally marketed devices, including BioGran® and PerioGlas®." |
| Intended Use Equivalence: Unigraft's indications for use should be substantially similar to predicate devices. | "For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge." This is consistent with devices classified as "endosseous implant for bone filling and augmentation." |
| Mechanism of Action Equivalence: Unigraft's biological interaction should be similar to predicate devices. | Describes "time dependent surface modification" resulting in a "calcium phosphate layer... equivalent... to hydroxyapatite found in bone minerals," providing an "osteo-conductive scaffold." This mechanism is characteristic of bioactive glasses in this category. |
| Performance Equivalence (Comparative Testing): Unigraft should perform comparably to predicate devices in relevant tests. | "The Unigraft device was evaluated comparatively against a predicate device using a variety of test methods. The results of these tests demonstrate that the Unigraft device is substantially equivalent to a predicate device." (Specific test types or detailed results are not provided in this summary.) |
| Safety Profile: Implied through equivalence to legally marketed devices. | Not explicitly detailed, but assumed to be acceptable given the substantial equivalence claim to devices already on the market. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided 510(k) summary. The summary only states that the device was "evaluated comparatively against a predicate device using a variety of test methods."
- Data Provenance: Not specified. It's likely pre-clinical (in vitro, in vivo animal studies) for material characterization and biocompatibility, but the origin (e.g., country, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a medical device (material) submission, not an AI/SaMD. "Ground truth" in the context of AI/SaMD for diagnostic accuracy is not relevant here. The evaluation would involve material science, biocompatibility, and potentially animal or limited human clinical studies (though not detailed here).
4. Adjudication Method for the Test Set
- Not Applicable. As above, this concept (common in AI/SaMD for resolving discrepancies among human readers) is not relevant for the type of testing described in this 510(k) summary.
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 is a medical device (material) submission, not an AI/SaMD. MRMC studies are specific to evaluating human reader performance with and without AI assistance for diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. As above, this is not an AI/SaMD submission, so there is no "algorithm" to evaluate in a standalone manner.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable (in the AI/SaMD sense). For this type of medical device, "ground truth" would relate to verifiable material properties (chemical composition, physical structure), biocompatibility test results (e.g., ISO 10993 standards), and potentially histological evidence from animal studies showing bone ingrowth or integration. The summary does not detail the specific methods or types of ground truth used in the comparative testing.
8. The Sample Size for the Training Set
- Not Applicable. This is a medical device (material) submission, not an AI/SaMD that requires training data.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or AI model is involved.
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510(k) summary (As Required by Section 807.92 (c))
1. Submitter
| Name: | Unicare Biomedical, Inc. |
|---|---|
| Address: | 25951 La Cuesta Avenue, Laguna Hills, CA 92653 |
| Contact: | Stan Yang, 949-362-1772 |
| Date: | November 5, 1999 |
2. Device Name
| Trade Name: | Unigraft |
|---|---|
| Common Name: | Synthetic bone graft material |
| Classification Name: | Endosseous implant for bone filling and augmentation |
| Device Classification: | Class III |
3. Predicate Devices
PerioGlas®, BioGran® and others
4. Device Description
Unigraft is a synthetic bioactive glass material for use in the repair of oral defects, including periodontal defects, extraction sites and augmentation of the alveolar ridge. It is manufactured as irregular shaped synthetic granules, sized at 200-420 microns.
The bioactive glass (45S5 Bioglass) used in Unigraft is one of the most extensively studied bioactive glass compositions, which has been shown to bond to bone as well as soft tissue. The same material is used in legally marketed devices, including BioGran® and PerioGlas®. When implanted in the living tissue, the material undergoes a time dependent surface modification. The surface reaction results in the formation of a calcium phosphate layer, which is equivalent in composition and structure to the hydroxyapatite found in bone minerals. The biological apatite layer of the granules provides an osteo-conductive scaffold for the generation of new osseous tissue.
5. Comparison with Predicate Devices
The Unigraft device is substantially equivalent to devices currently in US commercial distribution, which are classified as endosseous implant for bone filling and augmentation. Examples of such products include PerioGlas®. BioGran® and OsteoGraf. These products are made of bioactive ceramic materials with similar performance.
6. Device Testing
The Unigraft device was evaluated comparatively against a predicate device using a variety of test methods. The results of these tests demonstrate that the Unigraft device is substantially equivalent to a predicate device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 7 2000
Stan Yang, Ph.D. Unicare Biomedical, Incorporated 25951 La Cuesta Avenue Laquna Hills, CA 92653
Re : K993784 Trade Name: Unigraft Requlatory Class: Unclassified Product Code: LYC Dated: November 5, 1999 Received: November 8, 1999
Dear Dr. Yang:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labelinq, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Paqe 2 - Dr. Yang
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. 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.fda,gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
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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510(K) NUMBER: K99-3784 DEVICE NAME: UNIGRAFT INDICATIONS FOR USE:
For the repair of periodontal infrabony defects, extraction site and augmentation of the alveolar ridge
Concurrence of CDRH, Office of device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
610(k) Number 2993784
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.