DynaGraft® II Dental is derived from selected donated human borne tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a gel or putty-like consistency.

AI/ML Overview

The provided text is a 510(k) summary for the DynaGraft® II Dental device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or study data demonstrating performance against specific metrics.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the document. The document notes "Pre-clinical animal data and clinical data demonstrate that DynaGraft® II support bone ingrowth and stimulates active bone formation in a variety of bony defects," but it does not provide specific performance metrics or acceptance criteria for these outcomes.
Sample size used for the test set and the data provenance: This information is not explicitly stated. The document mentions "clinical case studies" but does not specify their size or origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
Adjudication method for the test set: This information is not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: The device is a "human bone graft material," not an AI algorithm, so this question is not applicable.
The type of ground truth used: The document refers to "bone ingrowth and stimulates active bone formation" and "bone repair," which would likely be assessed through histological examination or imaging in pre-clinical and clinical studies. However, the specific methodology for establishing
"ground truth" (e.g., pathology, expert consensus) is not detailed.
The sample size for the training set: This information is not applicable as the device is not an AI algorithm requiring a training set.
How the ground truth for the training set was established: This information is not applicable.

Summary of what is available from the document:

Device Name: DynaGraft® II Dental
Intended Use: Bone filling material for augmentation or reconstructive treatment of the alveolar ridge, including filling defects after root resection, apicoectomy, and cystectomy; filling extraction sockets; elevation of the maxillary sinus floor; and treatment of periodontal defects.
Predicating Device: Tissue Bone Matrix Sponge (K960267) and autograft.
Basis for Substantial Equivalence: Similar design, construction, and function to predicate devices, with the main human component (donor DBM) being the same. Both are osteoconductive and have osteoinductive potential, providing a scaffold for bone ingrowth and stimulating bone growth. Differences in carriers (collagen for TBM vs. reverse phase carrier for DynaGraft II) were deemed not to affect safety or effectiveness as they are all resorbable and perform the same function.
Testing Mentioned: Pre-clinical animal data and clinical data, biocompatibility, extensive bench and animal testing, and clinical case studies to confirm device resorption and bone healing. It also states that "Demineralized bone has been used in clinical practice for more than 25 years with no remarkable safety issues."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2005

Isotis Orthobiologics, Incorporated c/o Mr. Paul Doner 2 Goodyear, Suite B Irvine, California 92618

Re: K043573

Trade/Device Name: DynaGraft II Dental Regulation Number: 21 CFR 872.3930 Regulation Name: Human Bone Graft Material Regulatory Class: II Product Code: NUN Dated: July 25,2005 Received: July 26,2005

Dear Mr Doner:

This letter corrects our substantially equivalent letter of July 29,2005, regarding the product code.

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 (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 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 furtherannouncements concerning your device in the Federal Register.

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Page 2 - Mr. Doner

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 (OS) 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 continue 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Quann

Chiu Lin, Director 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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K043573

JUL 2 9 2005

510(k) Summary for IsoTis OrthoBiologic DynaGraft® II Dental

1. SPONSOR

IsoTis OrthoBiologics, Inc. 2 Goodyear, Suite B Irvine, CA 92618 U.S.A

Paul Doner Director of Quality Assurance and Regulatory Affairs 949-855-7168 Telephone: 949-595-8711 Fax:

E. Schutte +31-(0) 30-2295125 Telephone: +31-(0) 30-2280255 Facsimile: December, 2004 Date Prepared:

DEVICE NAME 2.

DynaGraft® II Dental Proprietary Name: Common/Usual Name: Human Bone Graft Material Bone void filler (Unclassified) Classification Name:

PREDICATE DEVICES 3.

Tissue Bone Matrix Sponge (K960267), autograft.

DEVICE DESCRIPTION 4.

5. INTENDED USE

DynaGraft II Dental is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

Filling of defects after root resection, apicoectomy and cystectomy -
Filling of extraction sockets to enhance preservation of the alveolar ridge -
Elevation of maxillary sinus floor -
Treatment of periodontal defects -

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

DynaGraft® II Dental and TBM sponge (K960267) are similar in design, construction and function. The main human component of donor DBM is the same. The

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KO43573

DynaGraft II products contain the same organic elements as natural bone (autologous bone graft). The proposed and predicate devices are osteoconductive and have been evaluated for osteoinductive potential. The DynaGraft II product, the TBM sponge and the autologous bone graft provide an interconnected, porous scaffold and an environment for new bone ingrowth and stimulate bone growth. All products are provided sterile and for single patient use. The only difference between the proposed device and autograft is that proposed device is that it is donor bone which doesn't contain the mineral components, but a gel like reverse phase carrier. The main difference between TBM sponge and DynaGraft II is the different carrier. For TBM, collagen is used, for DynaGraft II a reverse phase carrier. These differences do not affect safety or effectiveness since they are all resorbable and carry out the same function. The safety and biocompatibility testing performed for DynaGraft® II and the long history of safe clinical use for allograft and poloxamer based products support the safe use of DynaGraft II. The donor bone in the DynaGraft II product meets the requirements of the AATB. The polymer meets the essential requirements of the USP.

TESTING 7.

Pre-clinical animal data and clinical data demonstrate that DynaGraft® II support bone ingrowth and stimulates active bone formation in a variety of bony defects. Biocompatibility, extensive bench and animal testing as well as the clinical case studies using DynaGraft II have successfully been performed to confirm that the device is resorbed over time and allows bone repair.

Demineralized bone has been used in clinical practice for more than 25 years with no remarkable safety issues. The product to which DynaGraft II claims substantial equivalence; autograft, has been used safely for many years in the clinical environment.

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Indications for Use

510(k) Number (if known): K043573

Device Name:

DynaGraft II Dental

Indications for Use:

DynaGraft II Dental is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:

Filling of defects after root resection, apicoectomy and cystectomy -
Filling of extraction sockets to enhance preservation of the alveolar ridge ・
Elevation of maxillary sinus floor -
Treatment of periodontal defects -

AND/OR Prescription Use _ X (Part 21 CFR 801 Subpart D)

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 Burns

(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital, Division Control, Dental Devices 510(k) Number:

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Regulation Number and Section

§ 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.