(59 days)
Not Found
No
The device description and intended use describe a mechanical system for delivering bone graft material, with no mention of AI or ML capabilities.
No
The device is a delivery system for bone graft material; it does not directly treat a disease or condition itself.
No
The device is a delivery system for bone graft material and is not described as analyzing or interpreting biological signals or images for diagnostic purposes.
No
The device description explicitly states it is comprised of a disposable medical piston syringe and a cannulated applicator tip, which are physical hardware components.
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 bone graft material to an orthopedic surgical site. This is a surgical procedure performed on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The device is a syringe and applicator tip used for delivering material. This aligns with a surgical delivery system, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information.
Therefore, the InFill™ Graft Delivery System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The InFill™ Graft Delivery System is comprised of a commercially available disposable medical piston syringe (syringe barrel w/female luer, plunger) and a cannulated applicator tip. The InFill™ Graft Delivery System is provided sterile, for single use only.
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)
Not Found
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.
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
§ 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).
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510(k) Summary
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6. 510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Pinnacle Spine Group, LLC |
|---|---|
| DATE PREPARED: | June 09, 2011 |
| CONTACT PERSON: | Rebecca K Pine |
| 1601 Elm Street, Suite 300 | |
| Dallas, TX 75201 | |
| Phone: 760.809.5178 | |
| Fax: 760.290.3216 | |
| TRADE NAME: | InFillTM Graft Delivery System |
| CLASSIFICATION | |
| NAME: | Piston Syringe |
| DEVICE | |
| CLASSIFICATION: | Class II |
| REGULATION | |
| NUMBER | 880.5860 |
| PRODUCT CODE | FMF |
| PREDICATE DEVICES: Wright Medical Bone Graft Syringe, K023088 | |
| FibirJet Graft Delivery System K100754 |
Substantially Equivalent To:
The InFill™ Graft Delivery System is substantially equivalent in intended use, principal of operation and technological characteristics to the Wright Medical Bone Graft Delivery System and the FibriJet Graft Delivery System.
Description of the Device Subject to Premarket Notification:
The InFill™ Graft Delivery System is comprised of a commercially available disposable medical piston syringe (syringe barrel w/female luer, plunger) and a cannulated applicator tip. The InFill™ Graft Delivery System is provided sterile, for single use only.
Indication for Use:
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.
Technological Characteristics:
The InFill™ Graft Delivery System has the same technological characteristics and is
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Section 6
similar in overall design, materials and configuration compared to the predicates.
Basis for Determination of Substantial Equivalence:
Upon reviewing and comparing intended use, design, materials, principle of operation and overall technological characteristics, the InFill™ Graft Delivery System is determined by Pinnacle Spine Group, LLC, to be substantially equivalent to existing legally marketed devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine 1601 Elm Street, Suite 300 Dallas, Texas 75201
Re: K111632
Trade/Device Name: InFill™ Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: June 09, 2011 Received: June 13, 2011
AUG 1 1 2011
Dear Ms. Pine:
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
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Page 2 - Ms. Rebecca K. Pine
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/Reportal?roblem/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 vours.
Mark N. Mel
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: InFill™ Graft Delivery System
Indications for Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
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Thilke Rabe for mkm
(Division Sign Off)
(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111632