(100 days)
HEALOS Bone Graft Material ("HEALOS") is intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
HEALOS is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of the HEALOS Bone Graft Substitute are Type I bovine collagen and hydroxyapatite. HEALOS is approximately 30% mineral by weight.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HEALOS Bone Graft Substitute:
Based on the provided text for K081432, there is no specific performance data or a study described that establishes and meets acceptance criteria in the traditional sense of a clinical or analytical performance study with metrics like sensitivity, specificity, or accuracy. This submission falls under the category of a 510(k) "Substantial Equivalence" determination, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.
The key statement is found under "Performance Data": "No performance standards have been established for this type of device." This indicates that the regulatory review for this product did not require a formal study with quantified acceptance criteria and measured device performance against those criteria. Instead, the focus was on the material composition and intended use of the device being comparable to existing, legally marketed predicate devices.
Therefore, many of the requested details about acceptance criteria, sample sizes, experts, and ground truth are not applicable or extractable from this specific 510(k) summary.
Here's what can be inferred and explicitly stated from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined for this 510(k) submission. The focus is on substantial equivalence to predicate devices based on material composition and intended use. | No specific quantitative performance metrics (e.g., success rate, healing time, new bone formation percentage) are reported as part of a formal acceptance criteria study within this document. The device description states it "provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process," implying its expected biological function. |
Explanation: The lack of performance standards for this type of device means there weren't pre-defined, measurable acceptance criteria that the sponsor needed to meet through a dedicated performance study for this 510(k). The regulatory approval stemmed from its similarity to predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable/Not specified in this 510(k) summary. No specific "test set" for a performance study is mentioned.
- Data Provenance: Not applicable/Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No "test set" and associated ground truth establishment by experts are described for this 510(k) submission.
4. Adjudication method for the test set
- Not applicable. No "test set" and associated adjudication method are described for this 510(k) submission.
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
- Was an MRMC study done? No. This device is a bone graft substitute, not an AI software or imaging device that would involve human readers or AI assistance.
- Effect size of human readers with/without AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a bone graft substitute, not an algorithm or AI system.
7. The type of ground truth used
- Not applicable. No ground truth is described as having been established for a performance study within this 510(k) summary. The "ground truth" for marketing approval implicitly relies on the established safety and efficacy of the predicate devices and the biological understanding of the materials used (Type I bovine collagen and hydroxyapatite) in bone regeneration.
8. The sample size for the training set
- Not applicable. No "training set" for an algorithm is described.
9. How the ground truth for the training set was established
- Not applicable. No "training set" for an algorithm is described.
Summary of Device and Approval Basis:
The HEALOS Bone Graft Substitute (K081432) is approved based on its substantial equivalence to previously cleared predicate devices (e.g., HEALOS Bone Graft Substitute K012751, K043308, Novabone Putty K051617, etc.). The device's components (Type I bovine collagen and hydroxyapatite) are well-understood biomaterials for bone grafting. The 510(k) summary explicitly states that "No performance standards have been established for this type of device," meaning regulatory approval for this particular product did not rely on a novel performance study proving specific quantitative endpoints. Instead, it relied on the similarity of its materials and intended use to existing, approved devices.
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1. 510(K) SUMMARY
|| |
| Submitter: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767 | AUG 29 2008 | |
|---|---|---|---|
| Contact Person: | Hande TufanSr. Regulatory Affairs Associate | Voice: (508) 828-3797Fax: (508) 828-3797E-Mail: ftufanya@dpyus.jnj.com | |
| Date Prepared: | August 25, 2008 | ||
| Device Class: | Class II | ||
| Classification Name: Bone grafting material§872.3930 | |||
| Classification Panel: Dental | |||
| FDA Panel Number: 76 | |||
| Product Code(s): | LYC | ||
| Proprietary Name: | HEALOS Bone Graft Substitute | ||
| Predicate Devices: | HEALOS Bone Graft Substitute (K012751, K043308)Novabone Putty Resorbable Bone Void Filler (K051617)NovaBone Dental Putty (K063596)Bio-Oss Collagen Blocks (K033815)Orthoss Resorbable Bone Void Filler (K014289)Collagraft Strip Bone Graft Matrix (K000122) | ||
| Device Description: | HEALOS is a mineralized collagen matrix processedinto lyophilized strips or pads for surgical implantation.The principal components of the HEALOS Bone GraftSubstitute are Type I bovine collagen andhydroxyapatite. HEALOS is approximately 30%mineral by weight. | ||
| Intended Use: | HEALOS Bone Graft Material ("HEALOS") isintended to fill, augment, or reconstruct periodontaland or bony defects of the upper or lower jaw. Theproduct provides a bone void filler that is resorbed andremodeled into new bone as part of the natural process. |
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Materials : The principal components of HEALOS are Type I bovine collagen and hydroxyapatite.
Performance Data: No performance standards have been established for this type of device.
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Public Health Service
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 eagle with three overlapping lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2008
Ms. Hande Tufan Senior Regulatory Affairs Associate DePuy Spine, Incorporated 325 Paramount Drive Raynham, Massachusetts 02767
Re: K081432
Trade/Device Names: HEALOS Bone Graft Substitute Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC, NPM Dated: August 27, 2008 Received: August 28, 2008
Dear Mr. Tufan:
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. Tufan
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Swaunns
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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K081432
Device Name: HEALOS Bone Graft Substitute
Indications For Use:
HEALOS Bone Graft Material ("HEALOS") is intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural process.
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)
Susan Rumsey
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K061422
§ 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.