(210 days)
Not Found
No
The document describes a bone graft material and its composition, with no mention of AI or ML technology.
No
The device is described as an autograft extender and bone void filler for orthopedic use, which assists in bone regeneration but is not a standalone therapeutic device that treats a condition.
No
Explanation: The device is a bone void filler and autograft extender used for orthopedic applications, not for diagnosing conditions.
No
The device description clearly states it is derived from human bone tissue and processed into particles, indicating a physical, non-software component.
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 orthopedic use as an autograft extender and bone void filler. This involves direct application to bone tissue within the body.
- Device Description: The description details a material derived from human bone tissue for filling bone defects.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a therapeutic material used to aid in bone repair in vivo.
N/A
Intended Use / Indications for Use
For orthopedic use, OrthoBlast II Paste and Putty are intended for use as an autograft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The OrthoBlast II products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.
Product codes (comma separated list FDA assigned to the subject device)
MQV, MBP
Device Description
OrthoBlast® II DBM Putty and Paste 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 putty-like consistency.
OrthoBlast® II DBM Putty and Paste 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
extremities, spine and pelvis
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
IsoTis OrthoBiologics, Inc. OrthoBlast® II DBM Putty and Paste 510(k) Premarket Notification
Revised September 25, 2007
REVISED FROM MARCH 5, 2007
5. 510(K) SUMMARY
OCT I 5 2007
510(k) Summary for IsoTis OrthoBiologics, Inc. OrthoBlast II Putty and Paste
5.1 SPONSOR
IsoTis OrthoBiologics, Inc. 2 Goodyear, Suite B Irvine, CA 92618 U.S.A
Contact Person: Telephone: Main Tele: Facsimile: Date Prepared:
Karon Morell (949) - 855-7168 (949) - 595-8710 (949) — 595-8711 December 14, 2006
5.2. DEVICE NAME
Proprietary Name:
Regulation Name: Regulatory Class: Product Code: MQV
OrthoBlast® II Demineralized Bone Matrix Putty and Paste Human Bone Graft Material ll
5.3. Predicate Device
DynaGraft II (Demineralized Bone Matrix): K040419 OrthoBlast II Paste and Puttv K050642
5.4. DEVICE DESCRIPTION
OrthoBlast® II DBM Putty and Paste 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 putty-like consistency.
OrthoBlast® II DBM Putty and Paste are osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.
1
ર-ર INTENDED USE (EXPANDED INDICATION FOR SPINE APPLICATIONS)
For orthopedic use, OrthoBlast II Paste and Putty are intended for use as an autograft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The OrthoBlast II products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.
5.6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
OrthoBlast® II DBM Putty and Paste has obtained previous 510(k) clearance for orthopeadic (K050642) indications.
OrthoBlast II is substantially equivalent to DynaGraft II Putty previously cleared by FDA (K040419). OrthoBlast II is similar to DynGraft II as both products utilize ground, human donor, demineralized cortical bone to manufacture 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 and predicate devices have the identical 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 cancellous bone tissue in particulate form from the same donor while DynaGraft II does not.
5.7 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 2007
Isotis Orthobiologics, Inc. % Ms. Karon Morell Vice President Quality Assurance and Regulatory Affairs 2 Goodyear, Suite B Irvine. CA 9261
Re: K070751
Trade/Device Name: Orthoblast II DBM Demineralized bone matrix paste and putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MBP, MQV Dated: June 14, 2007 Received: June 18, 2007
Dear Ms. Morell:
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.
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.
3
Page 2 - Ms. Karon Morell
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 Office of Compliance at (240) 276-0120. 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Bneuk
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
IsoTis OrthoBiologics, Inc.
June 14, 2007 Response to Question OrthoBlast® II DBM Putty and Paste 510(k) Premarket Notification
INDICATIONS FOR USE STATEMENT 4)
510(k) Number (if Known): K070751
Device Name: OrthoBlast® II DBM Demineralized Bone Matrix Paste and Putty
Indications for Use:
Indications for Use
For orthopedic use, the OrthoBlast II Paste and Putty are intended for use as an autograft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The OrthoBlast II products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
barbara Buenda to mom
Division of General, Restorative. and Neurological Devices
510(k) Number K070751