(245 days)
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No
The 510(k) summary describes a collagen biomaterial for dental surgery, with no mention of software, algorithms, or any technology related to AI or ML.
No
The device aids in wound healing post dental surgery by providing a resorbable matrix, but it does not directly treat a disease or condition itself.
No
Explanation: The device is a resorbable material intended for placement in the area of dental implants, bone defects, or ridge reconstruction to aid in wound healing. It is a therapy/treatment device, not a diagnostic one.
No
The device description clearly states it is a "resorbable membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon," which is a physical biomaterial, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use in dental surgery procedures as a resorbable material to aid in wound healing. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details a physical biomaterial used for placement in the body. It doesn't describe any components or processes related to testing samples from the human body to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting analytes, or providing diagnostic results.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
OTA Collagen Biomaterial is intended for use in dental surgery procedures as a resorbable material for placement in the area of dental implants, bone defects or ridge reconstruction to aid in wound healing post dental surgery.
Product codes
NPL, NPM
Device Description
OTA Collagen Biomaterial is an off-white, biocompatible, non-friable, resorbable membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. When moistened with water, saline, serum or blood, the porous material is flexible and conforms to the contours of the defect site. The material is easily cut with scissors or scalpel to meet the needs of the surgeon. OTA Collagen Biomaterial is non-pyrogenic and is provided sterile for single use only.
OTA Collagen Biomaterial is available in four shapes and a number of sizes. It can be applied as an onlay to cover simple defects or can be used for bone graft containment.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
OTA Collagen Biomaterial
510(k) Summary
Osseous Technologies of America, Inc. AIG 29 2008 OTA Collagen Biomaterial
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Osseous Technologies of America, Inc.
4500 Campus Drive, Suite 662
Newport Beach, CA 92660
Telephone: +1 (949) 250-0184
Fax: +1 (949) 250-0197 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Janet May, Director of Operations |
| Representative/Consultant: | David J. Collette, MD or
Floyd G. Larson
PaxMed International, LLC
11234 El Camino Real, Suite 200
San Diego, CA USA 92130
Telephone: +1 (858) 792-1235
Fax: +1 (858) 792-1236 |
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations: Product Code: Classification Panel: Reviewing Branch:
OTA Collagen Biomaterial Collagen dental membrane Barrier, Animal Source, Intraoral, Class II, Unclassified NPL Dental Products Panel Dental Devices Branch
Email: dcollette@paxmed.com
INTENDED USE
OTA Collagen Biomaterial is intended for use in dental surgery procedures as a resorbable material for placement in the area of dental implants, bone defects or ridge reconstruction to aid in wound healing post dental surgery.
1
510(k) Summary
OTA Collagen Biomaterial
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DEVICE DESCRIPTION
OTA Collagen Biomaterial is an off-white, biocompatible, non-friable, resorbable membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. When moistened with water, saline, serum or blood, the porous material is flexible and conforms to the contours of the defect site. The material is easily cut with scissors or scalpel to meet the needs of the surgeon. OTA Collagen Biomaterial is non-pyrogenic and is provided sterile for single use only.
OTA Collagen Biomaterial is available in four shapes and a number of sizes. It can be applied as an onlay to cover simple defects or can be used for bone graft containment.
EQUIVALENCE TO MARKETED PRODUCT
Osseous Technologies of America, Inc. demonstrated that, for the purposes of FDA's regulation of medical devices, OTA Collagen Biomaterial is substantially equivalent in indications and design principles to predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
OTA Collagen Biomaterial has the following similarities to the predicate devices:
- has the same intended use. 트
- uses the same operating principle,
- 트 incorporates the same basic design,
- 트 incorporates the same materials, and
- 트 is sterilized using the same process.
In summary, OTA Collagen Biomaterial is, in our opinion, substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2008
Osseous Technologies of America C/O Dr. David J. Collette Regulatory Affairs PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K073685
Trade/Device Names: OTA Collagen Biomaterial Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: August 21, 2008 Received: August 22, 2008
Dear Dr. Collette:
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 - Dr. Collette
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,
Susan Rummo
Chiu Lin, Ph.D.
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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510(k) Premarket Notification
OTA Collagen Biomaterial
Indications for Use
510(k) Number (if known):
Device Name: OTA Collagen Biomaterial
Indications for Use:
OTA Collagen Biomaterial is intended for use in dental surgery procedures as a resorbable material for placement in the area of dental implants, bone defects or ridge reconstruction to aid in wound healing post dental surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| Page 1 of | |
| 510(k) Number: | RC73685 |