(145 days)
No
The summary describes a mechanical system for mixing and delivering bone graft material and does not mention any AI or ML components or functionalities.
No.
The device is a Mixing and Delivery System used for bone graft material; it delivers the material rather than actively providing therapy itself.
No.
The device is used for delivering bone graft material to a surgical site, not for diagnosing medical conditions.
No
The device description explicitly lists physical components like a syringe, spindle, nut, cap, pusher, and cannulae, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site." This describes a device used during a surgical procedure to deliver material to the body, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description details components for mixing and delivering graft material, which aligns with the surgical delivery function. There is no mention of components for analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes
- Using reagents
The device is clearly intended for direct use in a surgical setting for the physical delivery of bone graft material.
N/A
Intended Use / Indications for Use
The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Mixing and Delivery System is used to mix graft material such that it can be delivered to the patient. The system is comprised of the mixing/delivery syringe and auxiliary components including a threaded spindle with nut, open bore luer cap, pusher and cannulae which provide alternative methods of delivery for the mixed material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopedic surgical site
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 testing was performed to demonstrate the device performs as intended:
Liquid and Air Leak Testing
Separation from Axial Load Testing
Disconnection Torsional Testing
Sterility Validation Testing and Packaging Validation Testing
The Mixing and Delivery System met all specified criteria and did not raise new safety or performance questions.
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.
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 18, 2020
Bone Solutions, Inc. % Karen E. Warden, Ph.D. President BackRoads Consulting Incorporation Po Box 566 12520 Heath Road Chesterland, Ohio 44026
Re: K192674
Trade/Device Name: Mixing and Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 21, 2020 Received: January 23, 2020
Dear Dr. Warden:
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/cfpmn/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.
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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 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 mediation-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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192674
Device Name Mixing and Delivery System
Indications for Use (Describe)
The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.
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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510(k) Summary
| Date: | 11 February 2020 |
|---|---|
| Sponsor: | Bone Solutions, Inc. |
| 5712 Colleyville Blvd, STE 210 | |
| Colleyville, TX 76034 | |
| Sponsor Contact: | Drew Diaz, CEO |
| Office: 817.809.8850 | |
| customerservice@bonesolutions.net | |
| 510(k) Contact: | Karen E. Warden, PhD |
| President, BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| info@followbackroads.com | |
| Proposed Trade Name: | Mixing and Delivery System |
| Common Name: | Piston syringe |
| Device Classification: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Code: | Piston syringe, 880.5860, FMF |
| Submission Purpose: | To add auxiliary components to the cleared Bone Solutions Mixing and |
| Delivery System components. | |
| Device Description: | The Mixing and Delivery System is used to mix graft material such that it |
| can be delivered to the patient. The system is comprised of the | |
| mixing/delivery syringe and auxiliary components including a threaded | |
| spindle with nut, open bore luer cap, pusher and cannulae which provide | |
| alternative methods of delivery for the mixed material. | |
| Indications for Use: | The Mixing and Delivery System is intended to be used for the delivery of |
| hydrated allograft, autograft, or synthetic bone graft material to an | |
| orthopedic surgical site. | |
| Primary Predicate: | Bone Solutions Mixing and Delivery System (Bone Solutions, Inc. - |
| K161568) | |
| Reference Devices: | InFill™ Graft Delivery System (Pinnacle Spine Group - K143488), ETEX |
| Mixing and Delivery System (ETEX Corporation - K141245) | |
| Performance Data: | The following non-clinical performance testing was performed to |
| demonstrate the device performs as intended: | |
| Liquid and Air Leak Testing | |
| Separation from Axial Load Testing | |
| Disconnection Torsional Testing | |
| Sterility Validation Testing and Packaging Validation Testing | |
| The Mixing and Delivery System met all specified criteria and did not raise | |
| new safety or performance questions. | |
| Substantial | |
| Equivalence | |
| Comparison: | The subject Mixing and Delivery System components possess the same |
| indications for use and technological characteristics as the predicate | |
| devices and/or reference devices as shown below. |
4
| System →
Features↓ | Subject device: Bone
Solutions Mixing and
Delivery System
K192674 | Primary predicate: Bone
Solutions Mixing and
Delivery System
K161568 | Reference device: InFill™
Graft Delivery System
K143488 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use: | The Mixing and Delivery
System is intended to be
used for the delivery of
hydrated allograft,
autograft, or synthetic bone
graft material to an
orthopedic surgical site. | The Bone Solutions Mixing
and Delivery System is
intended to be used for the
delivery of hydrated
allograft, autograft, or
synthetic bone graft
material to an orthopedic
surgical site. | The InFill™ Graft Delivery
System is intended to be
used for the delivery of
hydrated allograft, autograft
or synthetic bone graft
material to an orthopedic
surgical site |
| Basic
design | Piston syringe with auxiliary
components | Piston syringe with auxiliary
components | Piston syringe with auxiliary
components |
| Material | Medical grade polymers | Medical grade polymers | Medical grade polymers |
| Principle of
operation | Mix and deliver graft
material | Mix and deliver graft
material | Mix and deliver graft
material |
| How
supplied | Sterile, single use only | Sterile, single use only | Sterile, single use only |
| Syringe | Piston | Piston | Piston |
| Plunger | Axial push or helical screw | Axial push | Helical screw |
| Tip | Luer | Luer | Luer |
| Volume | 14cc | 14cc | 14cc |
| Cannula | Luer & open bore threaded | Luer & open bore threaded | Luer & open bore threaded |
| Length | 100 & 150mm | -- NA -- | 150, 275 & 300mm |
| Diameter | 4.3 & 8.0mm | 4.3 & 8.0mm | 3.5, 4.8 & 8.0mm |
| Accessories | Mixing plunger, funnel | Mixing plunger, funnel | Mixing plunger, funnel |
Substantial Equivalence Conclusion:
Bone Solutions has demonstrated that the Mixing and Delivery System possesses the same intended use and technological characteristics as the predicate devices. Therefore the Mixing and Delivery System is substantially equivalent for its intended use.