(208 days)
HEALOS Dental Bone Graft Substitute is intended to fill, augment, or reconstruct periodontal and/or bony defects of the upper or lower jaw. HEALOS is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
HEALOS Dental Bone Graft Substitute is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of the HEALOS Dental Bone Graft Substitute are Type I bovine collagen and hydrox yapatite. HEALOS Dental Bone Graft Substitute is approximately 30% mineral by weight. The subject of this 510(k) is to add additional size configurations. The formulation is identical to the predicate device- HEALOS Dental Bone Graft Substitute. There are no changes to the material, chemical composition, physical structure, or indications for use of the product.
Here's the analysis of the provided information regarding the acceptance criteria and study for the HEALOS Dental Bone Graft Substitute:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No Pre-established Performance Standards | The submission explicitly states: "No performance standards have been established for this type of device." |
| Substantial Equivalence to Predicate Device | "Preclinical testing has been completed to verify the subject device has the same characteristics as the predicate device." "Based on the predicate comparison and testing, the subject device HEALOS Dental Bone Graft Substitute is substantially equivalent to the predicate device." The FDA's letter confirms: "We have determined the device is substantially equivalent... to legally marketed predicate devices." |
| Identical Formulation to Predicate | The device description states: "The formulation is identical to the predicate device- HEALOS Dental Bone Graft Substitute." |
| No Changes to Material, Chemical Composition, Physical Structure, or Indications for Use (compared to predicate) | The device description states: "There are no changes to the material, chemical composition, physical structure, or indications for use of the product." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission mentions "Preclinical testing," but no details on the sample size or the nature of the test set (e.g., animal studies, in-vitro tests) are given. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Given that the device is a bone graft substitute and the performance evaluation relies on preclinical testing for substantial equivalence, it's unlikely that "experts" in the sense of clinicians establishing ground truth for a diagnostic AI device would be applicable here. The ground truth would likely be based on material science, biological response, or other preclinical endpoints.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable to this device. This document is for a medical device (bone graft substitute), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not have been conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable to this device. As mentioned above, this is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for demonstrating substantial equivalence appears to be based on direct comparison of characteristics and performance to the predicate device. This would likely involve:
- Material composition analysis: Ensuring identical components (Type I bovine collagen and hydroxyapatite) and ratios.
- Physical and chemical property testing: Confirming that the subject device's physical (e.g., structure, porosity) and chemical characteristics match the predicate.
- Biocompatibility and resorption studies (preclinical): Demonstrating similar biological interactions and degradation profiles to the predicate in relevant models.
- Mechanical property testing: If applicable to the scaffold's function, ensuring similar structural integrity.
The document states: "Preclinical testing has been completed to verify the subject device has the same characteristics as the predicate device." The "truth" is established by showing that the new device is functionally and compositionally the 'same' as the already approved predicate.
8. The Sample Size for the Training Set
This information is not provided and is not applicable as this is not an AI/ML device that requires training data in the traditional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable as this is not an AI/ML device.
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MAY 2 5 2010
510(k) Summary
Submitter: DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767
- Contact Person: Sharon Starowicz Director of Regulatory Affairs Voice: (508) 828-2867 Fax: (508) 828-3797 E-Mail: sstarow 1 @ its. jnj.com
Date Prepared: April 27, 2010
Device Class: Class II
Classification Name: Bone grafting material $872.3930
Classification Panel: Dental
FDA Panel Number: 76
Product Code(s): LYC and NPM
Proprietary Name: HEALOS Dental Bone Graft Substitute
Predicate Devices: HEALOS Dental Bone Graft Substitute (K081432)
Device Description: HEALOS Dental Bone Graft Substitute is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of the HEALOS Dental Bone Graft Substitute are Type I bovine collagen and hydrox yapatite. HEALOS Dental Bone Graft Substitute is approximately 30% mineral by weight. The subject of this 510(k) is to add additional size configurations. The formulation is identical to the predicate device- HEALOS Dental Bone Graft Substitute. There are no changes to the material, chemical composition, physical structure, or indications for use of the product.
Intended Use: HEALOS Dental Bone Graft Substitute is intended to fill, augment, or reconstruct periodontal and/or bony defects of the upper or lower jaw. HEALOS is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
Materials: The principal components of HEALOS Dental Bone Graft Substitute are Type I bovine collagen and hydroxyapatite.
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Performance Data: No performance standards have been established for this type of device. Preclinical testing has been completed to verify the subject device has the same characteristics as the predicate device.
Conclusion: Based on the predicate comparison and testing, the subject device HEALOS Dental Bone Graft Substitute is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 2 & 2010
Ms. Sharon Starowicz Director of Regulatory Affairs DePuy Spine, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767
Re: K093390
Trade/Device Name: HEALOS Dental Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC, NPM Dated: April 27, 2010 Received: April 28, 2010
Dear Ms. Starowicz:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Starowicz
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Th for
Anthony D. Watson, B.S., M.S., M.B.A. 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
510(k) Number (if known):
Device Name: HEALOS Dental Bone Graft Substitute
Indications For Use:
HEALOS Dental Bone Graft Material ("HEALOS"), is intended to fill, augment, or reconstruct periodontal and/or bony defects of the upper or lower jaw. HEALOS is a bone graft substitute that is resorbed and remodeled into new bone as part of the natural healing process.
Reim Kelly for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _K 09339C
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
§ 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.