(137 days)
Not Found
No
The summary describes a resorbable bone void filler material and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
Explanation: The device is intended to fill bony voids or gaps and aids in the growth of new bone, which directly treats an injury or condition, classifying it as a therapeutic device.
No
The device is described as a bone void filler intended to promote bone growth, not to diagnose medical conditions or analyze patient data.
No
The device description clearly states it is a "resorbable porous, calcium phosphate bone void filler," which is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a bone void filler for surgical implantation to aid in bone healing. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description focuses on the material properties and function as a scaffold for bone growth, which is consistent with a medical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, tissue) to provide diagnostic information about a patient's health status. IVDs are designed for this purpose.
Therefore, NB3D Bone Void Filler is a medical device used for surgical intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
NB3D Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is intended to be used in conjunction with bone marrow aspirate and autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. NB3D provides an open void/gap filler that resorbs and is replaced by the growth of new bone during the healing process.
Product codes
MQV
Device Description
NB3D is a resorbable porous, calcium phosphate bone void filler that provides a scaffold for the in-growth of new bone. NB3D is an osteoconductive implant with an interconnected porosity similar to human cancellous bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterolateral spine
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)
Characterization testing performed included methods described in ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ASTM F1185. Animal testing performed to demonstrate substantial equivalence included determination of radiographic, biomechanical, histological and other characteristics of the subject device and the predicate Vitoss Bioactive device in a rabbit posterolateral spine fusion model.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091031, K081439, K071046, K082166
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
510(k) Summary
Pioneer Surgical Technology NB3D Bone Void Filler
November 21, 2011
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Pioneer Surgical Technology |
|---|---|
| 375 River Park Circle | |
| Marquette, MI 49855 | |
| Telephone: | +1 (906) 226-4812 |
| Fax: | +1 (906) 226-4459 |
| Official Contact: | Jonathan Gilbert |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | NB3D Bone Void Filler |
|---|---|
| Common Name: | Bone Void Filler |
| Classification Regulations: | Filler, Bone Void, Calcium Compound |
| 21 CFR 888.3045 | |
| Class II | |
| Product Code: | MQV |
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
| Reviewing Branch: | Restorative Devices Branch |
INTENDED USE
NB3D Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is intended to be used in conjunction with bone marrow aspirate and autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. NB3D provides an open void/gap filler that resorbs and is replaced by the growth of new bone during the healing process.
Pioneer Surgical Technology, Inc. K111944 - N83D
Page 1 of 2
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DEVICE DESCRIPTION
NB3D is a resorbable porous, calcium phosphate bone void filler that provides a scaffold for the in-growth of new bone. NB3D is an osteoconductive implant with an interconnected porosity similar to human cancellous bone.
EQUIVALENCE TO MARKETED DEVICES
Pioneer Surgical Technology submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, NB3D Bone Void Filler (NB3D) is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:
Pioneer Surgical Technology FortrOss Bone Void Filler cleared under K091031;
Orthovita, Inc. Vitoss Bioactive Foam Bone Graft Substitute-STRIP and PACK, cleared under K081439;
Synthes (USA) chronOSTM Composite, cleared under K071046; and
Medtronic Sofamor Danek MASTERGRAFT® Strip, cleared under K082166.
The subject device and the predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrinsic to the stability of the bony structure.
Characterization testing performed included methods described in ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ASTM F1185. Animal testing performed to demonstrate substantial equivalence included determination of radiographic, biomechanical, histological and other characteristics of the subject device and the predicate Vitoss Bioactive device in a rabbit posterolateral spine fusion model.
Overall, NB3D has the following similarities to the remaining predicate devices:
- has the same intended use, .
- . uses the same operating principle,
- incorporates the same basic design, .
- incorporates the same or very similar materials, and •
- has similar packaging and is sterilized using the same materials and processes. .
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the symbol in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 222 2011
Pioneer Surgical Technology, Inc. % PaxMed International. LLC Mr. Floyd G. Larson 11234 El Camino Real. Suite 200 San Diego, California 92130
Re: K111944
Trade/Device Name: NB3D Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bond void filler device Regulatory Class: Class II Product Code: MOV Dated: November 10, 2011 Received: November 14, 2011
Dear Mr. Larson:
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. Please note: CDRH does not evaluate information related to contract liability 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 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
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Page 2 – Mr. Floyd G. Larson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for 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.
Sincerely yours,
Evil Keith
~ Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number: . K111944
NB3D Bone Void Filler: Device Name:
Indications for Use:
NB3D Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product is intended to be used in conjunction with bone marrow aspirate and autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. NB3D provides an open void/gap filler that resorbs and is replaced by the growth of new bone during the healing process.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
signature
(Division Division of Surgical, Orthopedic, sho Restorative Devices
510(k) Number K111944
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