(214 days)
No
The device description and performance studies focus on the material composition and biological properties of a bone graft, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated to fill bony voids or gaps of the skeletal system and is replaced with bone during the healing process, making it a therapeutic device.
No
This device is a bone graft material used to fill osseous defects, not to diagnose medical conditions.
No
The device description clearly states it is a "bone void filler" comprised of physical materials (calcium phosphate particulates, polymer binder) and is supplied as a physical product ("single-use device is supplied sterile in multiple package formats"). It is a physical medical device, 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 the device is used to "fill bony voids or gaps of the skeletal system." This is a therapeutic and structural application within the body.
- Device Description: The description details a "bone void filler" comprised of calcium phosphate particulates and a polymer binder. This is a material intended for implantation and interaction with bone tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, collect a sample for analysis, or provide information about a patient's health status through in vitro testing.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, packaging, shelf-life, material characterization, and in vivo bone formation. These are all relevant to an implantable or therapeutic device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
OsteoFlo® NanoPuty - Quadphasic Synthetic Bone Graft is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or the result of traumatic injury to the bone. The device resorbs and is replaced with bonedus ing the healing process.
Product codes
MQV
Device Description
The OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft is an osteoconductive, non-hardening bone void filler. The device is comprised of macroporous calcium phosphate particulates in a bioresorbable polymer binder. The quadphasic particles are composed of HA, a-TCP, B-TCP and bioactive glass. The device also contains micro-sized HA particles. On implantation, the binder is resorbed and bone forms on and between the porous particles as they are gradually resorbed. OsteoFlo® NanoPutty can be easily packed into osseous defects and adheres to bone surfaces. The device is ready to use, requiring no mixing before application. The single-use device is supplied sterile in multiple package formats.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. the extremities 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 performance data were provided to demonstrate substantial equivalence of the subject device to the predicate.
- Biocompatibility per ISO 10993-1:2018
- . Sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013
- Packaging validation per ISO 11607-1:2009 and ISO 11607-2:2006 ●
- Shelf-life testing per ASTM 1980-16 ●
- Material characterization, including x-ray diffraction, particle size, and ● particle porosity and surface area
- . In vivo evaluation in a critical-size rabbit femoral defect model
The in vivo evaluation compared the performance of the device to the NovaBone Putty predicate. Evaluation of local biological effects and bone formation demonstrated performance substantially equivalent to the predicate, with no evidence of adverse events or device related failures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
August 14, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SurGenTec, LLC Travis Greenhalgh CEO 911 Clint Moore Rd Boca Raton, Florida 33487
Re: K200064
Trade/Device Name: OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 23, 2020 Received: July 24, 2020
Dear Mr. Greenhalgh:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200064
Device Name
OsteoFlo® NanoPutty®- Quadphasic Synthetic Bone Graft
Indications for Use (Describe)
OsteoFlo® NanoPuty - Quadphasic Synthetic Bone Graft is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or the result of traumatic injury to the bone. The device resorbs and is replaced with bonedus ing 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)
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Premarket Notification 510(k) Summary OsteoFlo NanoPutty Bone Void Filler - K200064
Submitter Information: 1.
| Owner: | SurGenTec, LLC |
|---|---|
| Address: | 911 Clint Moore Rd |
| Boca Raton, FL 33487 | |
| Contact: | Travis Greenhalgh, CEO |
| Telephone: | (916) 759-7999 |
| Email: | travis@SurGenTec.com |
| Date Submitted: | December 9, 2019 |
2. Name of Device:
| Trade Name: | OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft |
|---|---|
| Common Name: | Bone Void Filler |
| Classification Name: | Resorbable Calcium Salt Bone Void Filler |
| Device Regulation: | 21 CFR 888.3045 |
| Regulatory Class: | Class II |
| Product Code: | MQV |
3. Legally Marketed Predicate Device:
Predicate: NovaBone Putty - Bioactive Synthetic Bone Graft NovaBone Products, LLC K110368, K101860, K082672
The following devices also are cited as reference devices within the submission:
- Bioactive Bone Graft Putty: K132071; Biostructures, LLC
- NovaBone MacroPor-Si+: K110925; NovaBone Products, LLC
- NanOss BVF-E: K081558; Pioneer Surgical Technology
Device Description 4.
The OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft is an osteoconductive, non-hardening bone void filler. The device is comprised of macroporous calcium phosphate particulates in a bioresorbable polymer binder. The quadphasic particles are composed of HA, a-TCP, B-TCP and bioactive glass. The device also contains micro-sized HA particles. On implantation, the binder is resorbed and bone forms on and between the porous particles as they are gradually resorbed.
4
OsteoFlo® NanoPutty can be easily packed into osseous defects and adheres to bone surfaces. The device is ready to use, requiring no mixing before application. The single-use device is supplied sterile in multiple package formats.
5. Indications for Use
The OsteoFlo® NanoPutty® - Quadphasic Synthetic Bone Graft is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or the result of traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.
Technological Characteristics and Substantial Equivalence 6.
OsteoFlo® NanoPutty - Ouadphasic Synthetic Bone Graft is substantially equivalent to the predicate NovaBone Putty Bioactive Synthetic Graft. The devices have the same intended use and basic method of operation. The table below compares the indications and key technological attributes of the OsteoFlo NanoPutty device to the predicate.
| Comparator | New Device | Predicate |
|---|---|---|
| OsteoFlo NanoPutty | NovaBone Putty [K110368] | |
| Product Code; | ||
| Common Name | Resorbable Calcium Salt Bone Void Filler Device | |
| (21 CFR 888.3045) | ||
| Indications for | ||
| Use | OsteoFlo® NanoPutty – | |
| Quadphasic Synthetic Bone | ||
| Graft is indicated to fill bony | ||
| voids or gaps of the skeletal | ||
| system (i.e. the extremities and | ||
| pelvis) that are not intrinsic to | ||
| the stability of the bony | ||
| structure. These osseous defects | ||
| may be surgically created or the | ||
| result of traumatic injury to the | ||
| bone. The device resorbs and is | ||
| replaced with bone during the | ||
| healing process. | NovaBone Putty is indicated for bony | |
| voids or gaps that are not intrinsic to | ||
| the stability of the bony structure. | ||
| NovaBone Putty is indicated to be | ||
| gently packed into bony voids or gaps | ||
| of the skeletal system (i.e. the | ||
| extremities, posterolateral spine, and | ||
| pelvis). These defects may be | ||
| surgically created osseous defects or | ||
| osseous 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. | ||
| Intended Use | Both devices are intended for use as bone void fillers for repair of defects | |
| in the skeletal system. The devices are intended to be resorbed during | ||
| defect healing and replaced with new bone tissue. | ||
| Mechanism of | ||
| Operation | The device is applied as a pre- | |
| mixed putty. The synthetic | ||
| binder is resorbed to expose | ||
| quadphasic particles. The | ||
| particles act as osteoconductive | ||
| scaffolds for new bone | ||
| formation as they are slowly | ||
| resorbed | The device is applied as a pre-mixed | |
| putty. The synthetic binder is resorbed | ||
| to expose bioactive glass particles. | ||
| The particles act as osteoconductive | ||
| scaffolds for new bone formation as | ||
| they are slowly resorbed | ||
| Material | ||
| Composition | Quadphasic macroporous | |
| calcium phosphate particulates | ||
| in a bioresorbable polymer | Bioactive glass particles, 90-710 μm, | |
| in a bioresorbable polymer binder |
5
| Comparator | New Device
OsteoFlo NanoPutty | Predicate
NovaBone Putty [K110368] |
|--------------|----------------------------------------------------|-----------------------------------------------|
| | binder | |
| Sterility | Sterile; SAL 10-6;
E-beam radiation; Single-Use | Sterile, SAL 10-6;
γ radiation; Single-Use |
| Product Size | 1.0 ml – 10 ml | 2.5 ml – 15 ml |
7. Performance Data
The following non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicate.
- Biocompatibility per ISO 10993-1:2018
- . Sterilization validation per ISO 11137-1:2006 and ISO 11137-2:2013
- Packaging validation per ISO 11607-1:2009 and ISO 11607-2:2006 ●
- Shelf-life testing per ASTM 1980-16 ●
- Material characterization, including x-ray diffraction, particle size, and ● particle porosity and surface area
- . In vivo evaluation in a critical-size rabbit femoral defect model
The in vivo evaluation compared the performance of the device to the NovaBone Putty predicate. Evaluation of local biological effects and bone formation demonstrated performance substantially equivalent to the predicate, with no evidence of adverse events or device related failures.
8. Conclusion
The design characteristics of the OsteoFlo NanoPutty device do not raise different questions of safety and effectiveness. Non-clinical study data supports that the device is safe and effective. These data support that the OsteoFlo NanoPutty device is substantially equivalent to the predicate device.