(69 days)
Not Found
Not Found
No
The 510(k) summary describes a bone void filler material and a packaging modification. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The focus is on the material properties and delivery method.
Yes
This device is a bone void filler that resorbs and is replaced by new bone growth during healing, which directly contributes to the repair and restoration of bodily function in osseous defects.
No
Explanation: The device is a bone void filler intended to promote bone growth in skeletal defects, not to diagnose a condition.
No
The device description clearly states it is a resorbable bone void filler consisting of calcium phosphate and porcine gelatin, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description of NanOss BVF-E clearly states it is a resorbable bone void filler intended to be packed into bony voids or gaps in the skeletal system. It is a material implanted directly into the body to aid in bone healing.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples from the body or provide diagnostic information. Its function is purely therapeutic/reconstructive.
Therefore, NanOss BVF-E falls under the category of a medical device used for surgical implantation and bone repair, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Pioneer Surgical NanOss™ BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
Product codes
MOV
Device Description
NanOss BVF-E is a resorbable bone void filler consisting of calcium phosphate in a porcine gelatin carrier provided in granular form. This submission introduces a packaging modification intended to facilitate reconstitution of the device by mixing with saline or blood at the time of implantation.
NanOss BVF-E is radiopaque, provided sterile and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
skeletal system (extremities, pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
NanOss™ BVF-E
K1000361
APR 2 2 2010
510(k) Summary
Pioneer Surgical Technology Special 510(k): Device Modification
NanOss™ BVF-E
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Pioneer Surgical Technology 375 River Park Circle Marquette, MI 49855 Telephone: +1 (906) 226-4812 +1 (906) 226-4459 Fax:
Official Contact:
Representative/Consultant:
Jonathan Gilbert
David J. Collette or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: dcollette@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name: Classification Regulations:
Product Code: Classification Panel: Reviewing Branch:
NanOss™ BVF-E Bone Void Filler Filler, Bone Void, Calcium Compound 21 CFR 880.3045. Class II MOV Orthopaedic and Rehabilitation Devices Restorative Devices Branch
1
INTENDED USE
Pioneer Surgical NanOss™ BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
DEVICE DESCRIPTION
NanOss BVF-E is a resorbable bone void filler consisting of calcium phosphate in a porcine gelatin carrier provided in granular form. This submission introduces a packaging modification intended to facilitate reconstitution of the device by mixing with saline or blood at the time of implantation.
NanOss BVF-E is radiopaque, provided sterile and is intended for single use only.
EQUIVALENCE TO MARKETED PRODUCT
The modified NanOss BVF-E has the following similarities to the unmodified NanOss BVF-E: has the same intended use,
uses the same operating principle, incorporates the same basic design, incorporates the same materials, and is provided sterile.
In summary, the NanOss BVF-E, described in this submission is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology % Paxmed International, LLC David J. Collette, M.D. 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K100361
APR 2 2 2010
Trade/Device Name: NanOss™ BVF-E Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: March 30, 2010 Received: March 31, 2010
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 udications 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, Dr te 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contractly and warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 devire 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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Page 2 - David J. Collette, M.D.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/Aboutf DA/CentersOffices/CDRH/CDRHOffices/ucm1158091jy priou the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Buelum
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K100361
NanOss™ BVF-E
Indications for Use
Device Name:
NanOss™ BVF-E is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities, pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
Prescription Use XX Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Barry
Page 1 of
510(k) Number K100361
Page 15 of 68
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices