(48 days)
Not Found
No
The summary describes a bone filling material derived from human bone tissue and processed. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML. The performance studies rely on material data and animal test results, not algorithmic performance metrics.
Yes
The device is described as a "bone filling material" used for "augmentation or reconstructive treatment," indicating its role in treating or restoring tissue, which aligns with the definition of a therapeutic device.
No
Explanation: The device, OrthoBlast® II DBM Paste and Putty, is described as a bone filling material intended for augmentation or reconstructive treatment of the alveolar ridge. Its function is to fill defects and promote bone growth, not to diagnose conditions.
No
The device description clearly states that the device is derived from human bone tissue and is a physical paste or putty, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that OrthoBlast® II DBM Paste and Putty are "bone filling materials indicated for augmentation or reconstructive treatment of alveolar ridge." This describes a material used in vivo (within the body) for a therapeutic purpose (bone regeneration).
- Device Description: The description details the composition of the material (demineralized bone matrix, carrier, cancellous chips) and its properties (osteoconductive and osteoinductive). This aligns with a medical device used for tissue repair or replacement, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information about a patient's health status.
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
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 -
- Elevation of maxillary sinus floor -
Product codes
NUN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge
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)
Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows a handwritten text that appears to be a code or identifier. The text reads 'K060332' and is written in a cursive style. A horizontal line is drawn beneath the text, possibly to emphasize or separate it from other content.
5.0 510(K) SUMMARY MA: 2 9 200€
510(k) Summary for IsoTis OrthoBiologics, Inc. OrthoBlast II Putty and Paste
-
- SPONSOR
IsoTis OrthoBiologics, Inc. 2 Goodyear, Suite B Irvine, CA 92618 U.S.A
- SPONSOR
| Contact Person: | Eliane Schutte |
|---|---|
| Telephone: | +31-(0) 30-2295253 |
| Facsimile: | +31-(0) 30-2280255 |
| Date Prepared: | February 03, 2006 |
-
- DEVICE NAME
| Proprietary Name: | OrthoBlast® II Demineralized Bone Matrix Paste and
Putty |
|-------------------|-------------------------------------------------------------|
| 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 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.
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 -
1
- 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.
2
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.
3
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
4
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