(123 days)
Not Found
No
The document describes a bone void filler and its packaging/delivery system. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to fill bony voids or gaps and provides a bone void filler that resorbs and is replaced with bone during the healing process, indicating a therapeutic purpose to aid in bone healing and regeneration.
No
Explanation: The device is a bone void filler intended for surgical repair of osseous defects or traumatic injury to the bone, not for diagnosing medical conditions.
No
The device description clearly states it is a resorbable bone void filler consisting of calcium phosphate and a porcine gelatin carrier, provided in granular form. This is a physical material, 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 states that NanOss™ is a bone void filler intended to be packed into bony voids or gaps in the skeletal system. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition and form of the bone void filler, which is a material used for physical repair and regeneration, not for testing biological samples.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies listed are related to packaging, shelf-life, sterilization, and instrument validation, which are typical for a medical device used in surgery, not for an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. NanOss™ does not fit this description.
N/A
Intended Use / Indications for Use
NanOssTM 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 (i.e., extremities, posterolateral spine, and pelvis). NanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. NanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. 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 with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MOV
Device Description
NanOss™ is a resorbable bone void filler (BVF) consisting of calcium phosphate and a porcine gelatin carrier provided in granular form. The BVF is radiopaque, provided sterile and is intended for single use only. The product is provided pre-filled in a mixing container as NanOss™ or in a mixing chamber/syringe as NanOss™ Loaded.
The purpose of this submission is to obtain clearance for a merged indications for use statement and new packaging configuration (NanOssTM Loaded Kit). In addition, instrument accessories previously cleared for MIS graft placement in the posterolateral spine through a small incision are now available for graft placement in the skeletal system (i.e., extremities, pelvis).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., extremities, posterolateral 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)
The following non-clinical tests were performed to support a determination of substantial equivalence:
Packaging and Shelf-Life Validations per ASTM D4169-09: DC 13 & 17 and ASTM F1980 Sterilization Validation per ISO 11137-1 Instrument Validation Testing
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.
FortrOss Bone Void Filler (K110561), NanOss™ BVF-E (K100361)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Pioneer Surgical Technology, Incorporated (dba RTI Surgical, Incorporated) Ms. Sarah McIntyre Regulatory Affairs Associate II 375 River Park Circle Marquette, Michigan 49855
Re: K141600
Trade/Device Name: NanOss™, NanOss™ Loaded, NanOss™ Loaded Kit Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: September 16, 2014 Received: September 18, 2014
Dear Ms. McIntyre:
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 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
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald和Nean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141600
Device Name
NanOssTM, NanOss™ Loaded, NanOss™ Loaded Kit
Indications for Use (Describe)
NanOss™ 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 (i.e., extremities, posterolateral spine, and pelvis). NanOss must be mixed with autogenous blood or sterile saline for use in the extremities or pelvis. NanOss must be mixed with bone marrow aspirate and autograft bone as a bone graft extender in the posterolateral spine. 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 with bone during the healing process.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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NanOss™ Bone Void Filler 510(k) Summary Pursuant to 21 CFR 807.92
| Sponsor: | Pioneer Surgical Technology, Inc.
(DBA RTI Surgical, Inc.)
375 River Park Circle
Marquette, MI 49855 USA
Contact: Sarah McIntyre
Ph: (906) 225-5861
Fx: (906) 226-4459 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Prepared: September 16, 2014 |
| Name: | NanOss™ Bone Void Filler |
| Common Name: | Bone Void Filler |
| Trade/Proprietary | NanOss™, NanOss™ Loaded, NanOss™ Loaded Kit |
| Classification
Regulations: | Filler, Bone Void, Calcium Compound (Product Code MQV)
21 CFR 888.3045, Class II |
| Classification Panel: | Orthopaedic and Rehabilitation Devices |
| Predicate: | FortrOss Bone Void Filler (K110561)
NanOss™ BVF-E (K100361) |
| Intended Use: | NanOss™ 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 (i.e., extremities, posterolateral
spine, and pelvis). NanOss must be mixed with autogenous blood or sterile
saline for use in the extremities or pelvis. NanOss must be mixed with bone
marrow aspirate and autograft bone as a bone graft extender in the
posterolateral spine . 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 with bone during the
healing process. |
| Description: | NanOss™ is a resorbable bone void filler (BVF) consisting of calcium
phosphate and a porcine gelatin carrier provided in granular form. The
BVF is radiopaque, provided sterile and is intended for single use only. The
product is provided pre-filled in a mixing container as NanOss™ or in a
mixing chamber/syringe as NanOss™ Loaded. |
| | The purpose of this submission is to obtain clearance for a merged
indications for use statement and new packaging configuration (NanOssTM
Loaded Kit). In addition, instrument accessories previously cleared for MIS
graft placement in the posterolateral spine through a small incision are now
available for graft placement in the skeletal system (i.e., extremities, pelvis). |
| Testing: | The following non-clinical tests were performed to support a determination
of substantial equivalence:
Packaging and Shelf-Life Validations per ASTM D4169-09: DC 13
& 17 and ASTM F1980 Sterilization Validation per ISO 11137-1 Instrument Validation Testing |
| Substantial
Equivalence: | The bone void filler has the following similarities to the previously
cleared bone void filler product (K110561/K100361): has the same intended uses, uses the same operating principles, incorporates the same basic design, incorporates the same materials, is provided sterile and for single-use. |
| Conclusion: | The comparisons and testing conducted demonstrate the subject bone
void filler product described in this submission is substantially equivalent
to the predicate devices. |
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