OrthoBlast® It DBM Paste and Putty are bone filling materials 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 -

Device Description

OrthoBlast® II DBM Paste and Putty is derived from selected donated human bone 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, cancellous chips from the same donor, and then formulated to a paste or puttylike consistency.
OrthoBlast® II DBM Paste and Putty are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

AI/ML Overview

This document is a 510(k) summary for a medical device called OrthoBlast II DBM Paste and Putty, seeking clearance from the FDA. It is not a study report detailing acceptance criteria or device performance based on a study, but rather a regulatory submission for market clearance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available in the provided text.

Here's why and what information is available:

Nature of the Document: This is a 510(k) "Premarket Notification." The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. It's not a clinical trial report that establishes new performance metrics through a study against predefined acceptance criteria.
"Performance Data" Section (Section 7): This section states: "Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification."
- This indicates that "performance" in this context refers to demonstrating equivalence and safety through existing data, material characterization, and animal studies, not necessarily human clinical trials with statistical acceptance criteria.
- It also states "The osteoinductive potential is demonstrated in athymic mouse model." This is an animal study, not a human clinical study.

What can be extracted from the provided text is:

1. Device Name and Intended Use:

Proprietary Name: OrthoBlast® II Demineralized Bone Matrix Paste and Putty
Intended Use: Bone filling materials 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

2. Predicate Device:

DynaGraft II Dental (Demineralized Bone Matrix) [K043573]

3. Basis for Equivalence (Instead of Acceptance Criteria):

The device is considered "substantially equivalent" based on:

Utilizing ground, human donor cortical demineralized bone.
Utilizing an inactive poloxamer reverse phase carrier (RPM).
Having the same indications for use.
Being provided sterile.
Intended for single patient use.

Differences noted for context (though not acceptance criteria):

Predicate device (DynaGraft II) contains more demineralized bone by weight and volume and less synthetic carrier.
OrthoBlast II incorporates the same donor's cancellous tissue in particulate form, while DynaGraft II does not.

In summary, the provided text does not contain the information required to fill out the table and answer the specific questions about acceptance criteria and a study proving device meets acceptance criteria, as it is a regulatory submission for substantial equivalence rather than a detailed study report.

Summary

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5.0 510(K) SUMMARY MA: 2 9 200€

510(k) Summary for IsoTis OrthoBiologics, Inc. OrthoBlast II Putty and Paste

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

Contact Person:	Eliane Schutte
Telephone:	+31-(0) 30-2295253
Facsimile:	+31-(0) 30-2280255
Date Prepared:	February 03, 2006

1. DEVICE NAME

Proprietary Name:	OrthoBlast® II Demineralized Bone Matrix Paste andPutty
Regulation Name:	Human Bone Graft Material
Regulatory Class:	II
Product Code:	NUN

3. PREDICATE DEVICE

DynaGraft II Dental (Demineralized Bone Matrix) [K043573]

4. DEVICE DESCRIPTION

OrthoBlast® II DBM Paste and Putty are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.

5. INTENDED USE (EXPANDED INDICATION FOR DENTAL APPLICATIONS)

OrthoBlast® II DBM Paste and Putty are bone filling materials 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 -

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K060332

Elevation of maxillary sinus floor -

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

OrthoBlast® II DBM Paste and Putty is substantially equivalent to DynaGraft II Dental Putty previously cleared by FDA under 510(k) K043573. Both products utilize ground, human donor cortical demineralized bone for the product. Both products utilize an inactive poloxamer reverse phase carrier (RPM) as a containing agent to provide the product's putty-like consistency and handling characteristics. The proposed device and predicate device have the same indications for use, are provided sterile and are intended for single patient use. The main difference between the two products is that DynaGraft II Putty and Gel contains more demineralized bone by weight and volume and less synthetic carrier than OrthoBlast II pastes and putties. OrthoBlast II also incorporates the same donor's cancellous tissue in particulate form while DynaGraft II does not.

7. PERFORMANCE DATA

Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification.

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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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them, resembling a stylized flag or banner.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Isotis NV Ms. Elaine Schutte Director of Regulatory Affairs Isotis Orthobiologics, Incorporated 2 Goodyear, Suite B Irvine, California 92618

Re: K060332

Trade/Device Name: OrthoBlast® II DBM Demineralized Bone Matrix Paste and Putty Regulation Number: 872.3930 Regulation Name: Bone Graft Material Regulatory Class: II Product Code: NUN Dated: February 8, 2006 Received: February 9, 2006

MAK 2 9 2006

Dear Ms. Schutte:

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 further announcements concerning your device in the Federal Register.

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Page-2 Ms. Elaine Schutte

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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

CieR

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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KOW 382

INDICATIONS FOR USE STATEMENT 4.0

Indications for Use

510(k) Number (if Known):

Device Name: OrthoBlast® II DBM Demineralized Bone Matrix Paste and Putty

Indications for Use:

OrthoBlast® It DBM Paste and Putty are bone filling materials 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 -

Prescription Use _ X (Part 21 CFR 801 Subpart D) Subpart C)

AND/OR

Over-The-Counter Use (21 CFR 801

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Suare

Commony General Hos 1100 1101 Dental Davides

K060332

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.