(135 days)
The Graftgun Universal 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 Graftgun Universal Graft Delivery System is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. The device system consists of: a graft tube for containing and delivering the desired graft material to the surgical site; a plunger to express the graft material from the graft tube; an actuating handle to advance the plunger down the length of the graft tube via a ratcheting mechanism; and an end cap to retain the graft material in the graft tube until ready for use. The system also contains a syringe style loading device for loading the graft tube with graft material. The system is designed such that the graft tube can be filled with the desired graft material, attached to the actuating handle and plunger for use, then removed and refilled or replaced with a new graft tube. The kit comprises two graft tubes. One graft tube is capable of containing 5.0 cc of graft material and the second can contain up to 7.5 cc. Both graft tubes are marked with a graduated scale to measure the volume of graft placed. The graft tube does not have a Luer lock mechanism; the device does not require a needle or similar attachment, the graft tube contents being expressed directly from the tip of the graft tube into the graft site. Components are made of one or more of the following materials: polycarbonate, polypropylene, self-lubricating silicone, stainless steel, acrylonitrile butadiene styrene, and silicone elastomer. The device is packaged in a thermoformed tray with a Tyvek lid. Each tray is then packaged individually in a Tyvek-PE film pouch and an outer paperboard carton. The packaged device system is sterilized via gamma irradiation.
The provided text is a 510(k) Premarket Notification Summary for the Graftgun Universal Graft Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed acceptance criteria table and a comprehensive study report with the requested specifications for a new medical device.
Therefore, much of the information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for AI/algorithm-based devices) is not applicable to this type of regulatory submission because the Graftgun is a physical medical device, not an AI or software-intensive device requiring such detailed performance study data.
However, I can extract the information relevant to this specific device based on the principles of substantial equivalence.
Here's the breakdown of what can be inferred or explicitly stated from the document:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal "acceptance criteria" table with numerical performance targets and reported results in the way a clinical study for a drug or an AI diagnostic device would. Instead, substantial equivalence is demonstrated by comparing the new device's technological characteristics and indications for use to those of legally marketed predicate devices. The "performance" being evaluated is whether these characteristics do not raise new questions of safety or effectiveness.
| Characteristic / Performance Metric | Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Graftgun Universal Graft Delivery System) |
|---|---|---|
| Intended Use | Delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. | "Intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site." (Matches predicates) |
| Mechanism of Operation | Graft material expressed from graft tube via a plunger (similar to predicates, but specific actuation mechanism can differ without raising new safety/effectiveness concerns). | Graft material expressed from graft tube via a plunger, operated by a ratchet-actuated handle. Material expressed from graft tube directly to graft site. (Differs from predicates in specific actuation but similar function) |
| Sterility | Sterile, single use only, SAL 10^-6 (similar to predicates). | Sterile, single use only; SAL 10^-6; sterilized via γ radiation. (Different sterilization method than predicates (EO gas) but determined not to raise new safety/effectiveness issues) |
| Patient-Contact Materials | Polypropylene, polycarbonate (similar to predicates). | Polypropylene, polycarbonate. (Matches predicates) |
| Volume Capacity | Comparable to predicate devices (range from 4.0ml to 14.0ml). | Up to 7.5ml in graft tube (within range of predicates) |
The "study" that proves the device meets the acceptance criteria (of substantial equivalence) is the 510(k) submission process itself, which involves a detailed comparison of the new device to existing legally marketed predicate devices. The conclusion statement explicitly states: "The Graftgun Universal Graft Delivery System is substantially equivalent in intended use, principal of operation, and materials to the Bone Solutions Mixing and Delivery System and Bi-Portal Bone Graft Delivery System predicate devices. The difference in plunger actuation and method of sterilization are minor and do not raise any new safety or effectiveness issues for the Graftgun Universal Graft Delivery System for its intended indications."
2. Sample sized used for the test set and the data provenance
- Not applicable / not provided. For a physical device like a syringe, this type of regulatory submission typically relies on bench testing, material testing, and design verification/validation (D/V) activities to ensure functionality, sterility, biocompatibility, and mechanical integrity, rather than large-scale clinical "test sets" of patient data. The document does not detail specific sample sizes for these engineering tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / not provided. Establishing "ground truth" using experts for a test set is relevant for diagnostic or AI-driven devices. For a bone graft delivery system, the "ground truth" is defined by its engineering specifications, material properties, and intended mechanical function.
4. Adjudication method for the test set
- Not applicable / not provided. Adjudication methods are typically for resolving discrepancies in expert interpretations, primarily in diagnostic imaging or clinical evaluations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, this was not done. MRMC studies are specific to evaluating diagnostic performance, often for AI-assisted systems, comparing human performance with and without AI. This device is a physical delivery system, not a diagnostic or AI-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an algorithm or AI component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's safety and effectiveness is established through engineering specifications, material biocompatibility standards, sterilization validation, and mechanical performance testing (e.g., force to express graft, integrity of components). This is not derived from expert consensus on patient outcomes or pathology, but rather from adherence to recognized standards for medical device design and manufacturing.
8. The sample size for the training set
- Not applicable / not provided. "Training sets" are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable / not provided.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
SurGenTec. LLC Mr. Travis Greenhalgh CEO 7601 N Federal Highwav # 150B Boca Raton, Florida 33487
Re: K170675
Trade/Device Name: Graftgun Universal Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: March 3, 2017 Received: March 6, 2017
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. The general controls provisions of the Actinclude 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
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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/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,
Jennifer R. Stevenson -S
For 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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Indications for Use
510(k) Number (if known) K170675
Device Name
Graftgun Universal Graft Delivery System
Indications for Use (Describe)
The Graftgun Universal 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)
IX Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
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7601 N Federal Highway #150B Boca Raton, FL 33487 P:916-759-7999 E: Customerservice@SurGenTec.com www.SurGenTec.com
Premarket Notification 510(k) Summary Graftgun Universal Graft Delivery System
1. Submitter Information:
| Owner: | SurGenTec, LLC |
|---|---|
| Address: | 7601 N Federal Hwy # 150BBoca Raton, FL 33487 |
| Contact: | Travis Greenhalgh, CEO |
| Telephone: | (916) 759-7999 |
| Email: | travis@SurGenTec.com |
| Date Submitted: | March 3, 2017 |
2. Name of Device:
| Trade Name: | Graftgun Universal Graft Delivery System |
|---|---|
| Common Name: | Graft Delivery Device |
| Regulation Number: | 21 CFR 880.5860 |
| Regulation Name: | Syringe, Piston |
| Regulatory Class: | Class II |
| Product Code: | FMF |
| Proposed Panel: | General Hospital |
3. Legally Marketed Predicate Device:
| Predicate #1: | K161568 - Bone Solutions Mixing and Delivery System[Bone Solutions, Inc.; cleared 09/16/2016] |
|---|---|
| Predicate #2: | K142661 - Bi-Portal Bone Graft Delivery System[Spinal Surgeries Strategies, LLC; cleared 12/11/2014] |
4. Device Description
The Graftgun Universal Graft Delivery System is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
The device system consists of: a graft tube for containing and delivering the desired graft material to the surgical site; a plunger to express the graft material from the graft tube; an actuating handle to advance the plunger down the length of the graft tube via a ratcheting mechanism; and an end cap to retain the graft material in the graft tube until ready for use. The system also contains a syringe style loading device for loading the graft tube with graft material.
The system is designed such that the graft tube can be filled with the desired graft material, attached to the actuating handle and plunger for use, then removed and refilled or replaced with a new graft tube. The kit comprises two graft tubes. One
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graft tube is capable of containing 5.0 cc of graft material and the second can contain up to 7.5 cc. Both graft tubes are marked with a graduated scale to measure the volume of graft placed. The graft tube does not have a Luer lock mechanism; the device does not require a needle or similar attachment, the graft tube contents being expressed directly from the tip of the graft tube into the graft site.
Components are made of one or more of the following materials: polycarbonate, polypropylene, self-lubricating silicone, stainless steel, acrylonitrile butadiene styrene, and silicone elastomer.
The device is packaged in a thermoformed tray with a Tyvek lid. Each tray is then packaged individually in a Tyvek-PE film pouch and an outer paperboard carton. The packaged device system is sterilized via gamma irradiation.
5. Indications for Use
The Graftgun Universal 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.
6. Technological Characteristics and Substantial Equivalence
The Graftgun Universal Graft Delivery System is substantially equivalent to the predicates, the devices having the same intended use and basic method of operation. The table below compares the indications and key technological attributes of the subject device to the predicates.
| Comparator | New DeviceGraftgun System | Predicate #1Bone Solutions[K161568] | Predicate #2Bi-Portal [K142611] |
|---|---|---|---|
| Product Code;Common Name | FMF; Syringe, Piston (21 CFR 880.5860) | ||
| Indications forUse | Intended to be usedfor the delivery ofhydrated allograft,autograft, or syntheticbone graft material toan orthopedicsurgical site. | Intended to be used forthe delivery of hydratedallograft, autograft, orsynthetic bone graftmaterial to anorthopedic surgical site. | Intended for thedelivery of hydratedallograft or autograft toan orthopedic surgicalsite. |
| Intended Use | Bone graft application to an orthopedic surgical site in an operating roomenvironment | ||
| Mechanism ofOperation | Graft materialexpressed from grafttube via a plunger,operated by a ratchet-actuated handle.Material expressedfrom graft tubedirectly to graft site. | Graft materialexpressed from grafttube via a plunger,operated by eitherthumb pressure or arotary assist drive.Device requiresattachment to a Luercompatible device for | Graft materialexpressed from grafttube via a plunger,operated by thumb orpalm pressure. Materialexpressed from grafttube directly to graftsite. |
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Graftgun Universal Graft Delivery System SurGenTec, LLC
| Comparator | New DeviceGraftgun System | Predicate #1Bone Solutions[K161568] | Predicate #2Bi-Portal [K142611] |
|---|---|---|---|
| dispensing graftmaterial to the graftsite. | |||
| Sterility | Sterile, single useonly; SAL 10-6; γradiation | Sterile, single use only;SAL 10-6; EO gas | Sterile, single use only;SAL 10-6; EO gas |
| Patient-ContactMaterials | Polypropylene,polycarbonate | Polypropylene,polycarbonate | Polypropylene |
| Volume | Up to 7.5ml in grafttube | Up to 14.0 ml | Up to 4.0 ml in grafttube |
7. Conclusion
The Graftgun Universal Graft Delivery System is substantially equivalent in intended use, principal of operation, and materials to the Bone Solutions Mixing and Delivery System and Bi-Portal Bone Graft Delivery System predicate devices. The difference in plunger actuation and method of sterilization are minor and do not raise any new safety or effectiveness issues for the Graftgun Universal Graft Delivery System for its intended indications.
§ 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).