(9 days)
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.
The modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannulated applicator tip and accessories for mixing bone graft materials and filling of the system. The modified InFill™ Graft Delivery System is provided sterile, for single use only.
The provided text describes a 510(k) premarket notification for a medical device called the InFill™ Graft Delivery System. This document focuses on demonstrating that the modified device is substantially equivalent to a previously cleared predicate device (K121476), rather than presenting a study to prove the device meets specific acceptance criteria in the traditional sense of a clinical trial or performance study against predefined metrics.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly answered from the provided text, as the submission relies on demonstrating equivalence through technical characteristics and a series of engineering tests.
Here's an attempt to extract relevant information and address the questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria with specific thresholds. Instead, it refers to "all specified criteria" being met for various engineering tests. The "reported device performance" is that the device "met all specified criteria and did not raise new safety or performance questions."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Simulated Use Performance | Met all specified criteria; performed as intended. |
| Volume Verification Accuracy | Met all specified criteria; performed as intended. |
| Maximum Force Verification (e.g., integrity) | Met all specified criteria; performed as intended. |
| Force to Dispense (e.g., ease of use) | Met all specified criteria; performed as intended. |
| Separation Force Testing (e.g., structural integrity) | Met all specified criteria; performed as intended. |
| Liquid Leak Testing (e.g., containment) | Met all specified criteria; performed as intended; no new safety concerns. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests.
The data provenance is from engineering tests conducted on the device itself, likely at the manufacturer's facility. It is not clinical data and therefore not retrospective or prospective in the human study sense, nor does it have a country of origin in that context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable. The "ground truth" here is determined by engineering specifications and objective measurements against those specifications. There are no human experts establishing ground truth in the context of diagnostic performance or clinical outcomes.
4. Adjudication Method for the Test Set
This question is not applicable as there is no human adjudication for these engineering tests. Test results would be compared directly against predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This question is not applicable. The device is a "Graft Delivery System" (a medical piston syringe with accessories) for delivering bone graft material. It is a mechanical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance data in this context is based on engineering specifications and measurable physical properties of the device established through standard testing methodologies (e.g., volume measurement, force measurement, leak detection). It is not expert consensus, pathology, or outcomes data, as those apply to clinical or diagnostic devices.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical product, not an algorithm that requires a training set. The "training" for such a device would refer to the developmental and design iterations leading to the final product which is not detailed here.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 17, 2014
Pinnacle Spine Group, LLC Ms. Rebecca K Pine Official Correspondent 1601 Elm Street, Suite 300 Dallas. Texas 75201
Re: K143488
Trade/Device Name: InFill™ Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Regulatory Class: Class II Product Code: FMF Dated: December 4, 2014 Received: December 8, 2014
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 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
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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 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/Resourcesfor You/Industry/default.htm. 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 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,
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5. Indications for Use Statement
| 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) | K143488 |
| Device Name | InFill™ Graft Delivery System |
| Indications for Use (Describe) | 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. |
| 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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FOR FDA USE ONLY
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FORM FDA 3881 (1/14)
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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: | December 4, 2014 |
| CONTACT PERSON: | Rebecca K Pine1601 Elm Street, Suite 300Dallas, TX 75201Phone: 760.809.5178Fax: 760.290.3216 |
| TRADE NAME: | InFill™ Graft Delivery System |
| COMMON NAME: | Piston Syringe |
| CLASSIFICATIONNAME: | Piston Syringe |
| DEVICECLASSIFICATION: | Class 2, per 21 CFR 880.5860 |
| PRODUCT CODE | FMF |
| PREDICATE DEVICES: | InFill™ graft Delivery System (K121476) |
Substantially Equivalent To:
The modified InFill™ Graft Delivery System is substantially equivalent in intended use, principal of operation and technological characteristics to the InFill™ Graft Delivery System cleared under premarket notification K121476
Description of the Device Subject to Premarket Notification:
The modified InFill™ Graft Delivery System is comprised of a disposable medical piston syringe, a cannulated applicator tip and accessories for mixing bone graft materials and filling of the system. The modified 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.
Technical Characteristics:
The modified InFill™ Graft Delivery System has the same technological characteristics and is similar in overall design, materials and configuration compared to the current InFill™ Graft Delivery System as shown in the table below.
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| Modified InFill™ Graft Delivery System | InFill™ Graft Delivery System (K121476) | |
|---|---|---|
| Materials | SAME | Medical grade polymers |
| Method of filling | SAME | Front-loaded via barrel |
| How supplied | SAME | Sterile, single use only |
| Syringe | ||
| Syringe type | SAME | Piston |
| Plunger Actuation | SAME | Screw |
| Principle of operation | SAME | Facilitates delivery of bone graft material. |
| Material use | SAME | Bone graft materials |
| Bone graft pre-loaded | SAME | No |
| Tip type | SAME | Luer lock |
| Syringe Volume | SAME | 12cc |
| Barrel markings | SAME | Milliliter, graduated |
| Barrel transparency | SAME | Clear |
| Cannula | ||
| Cannula length | 300mm275mm150mm | 275mm (10.8 in) |
| Cannula tip | SAME | Smooth, atraumatic |
| Marking | SAME | No |
| Cannula OD | 3.5mm4.8mm8.0mm | 4.8mm |
| Hub | SAME | Threaded screw |
| Accessories | ||
| Mixing accessories | SAME | Mixing plunger, closed syringe cap (optional) |
| Filling accessories | SAME | Funnel, stand (optional) |
| Graft removal accessory | SAME | Stylet (optional) |
Performance Data:
All necessary testing has been performed for the InFill™ Graft Delivery System to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.
The device design was qualified through the following tests:
- . Simulated Use Testing
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- Volume Verification
- . Maximum Force Verification
- Force to Dispense Verification ●
- Separation Force Testing .
- Liquid Leak Testing ●
The modified InFill™ Graft Delivery System met all specified criteria and did not raise new safety or performance questions.
Basis for Determination of Substantial Equivalence:
The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified InFill™ Graft Delivery System is found to have a safety and effectiveness profile that is similar to the predicate device and is determined by Pinnacle Spine Group LLC, to be substantially equivalent to the InFill™ Graft Delivery System (K121476).
§ 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).