(100 days)
No
The 510(k) summary describes a bone graft material composed of collagen and hydroxyapatite, with no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes
Explanation: The device is intended to fill, augment, or reconstruct periodontal and bony defects, indicating a therapeutic purpose in addressing medical conditions.
No
Explanation: The device, HEALOS Bone Graft Material, is described as a bone void filler intended to fill, augment, or reconstruct bony defects. Its function is to provide a matrix for new bone formation, not to diagnose a condition.
No
The device description clearly states that HEALOS is a "mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation," indicating it is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- HEALOS Description: The provided information clearly states that HEALOS is a "mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation." It is a material intended to be placed inside the body to fill bone defects.
- Intended Use: The intended use is to "fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw." This is a therapeutic and reconstructive purpose, not a diagnostic one.
Therefore, based on the description and intended use, HEALOS is a medical device used for surgical implantation and bone regeneration, not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes
LYC, NPM
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No performance standards have been established for this type of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
1. 510(K) SUMMARY
|| |
| Submitter: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 | | AUG 29 2008 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------|
| Contact Person: | Hande Tufan
Sr. Regulatory Affairs Associate | Voice: (508) 828-3797
Fax: (508) 828-3797
E-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 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. | | |
| Intended 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. | | |
1
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.
2
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.
3
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
4
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