(30 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 piston type syringe intended for the delivery of prepared allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
This document describes the FDA's 510(k) premarket notification for the SurGenTec Graftgun Universal Graft Delivery System (K180937). The submission seeks to prove substantial equivalence to a previously cleared device (K170675), with the only modification being that the 5cc graft or syringe tubes can now be supplied preloaded with graft material by a registered graft facility, packaged, sterilized, and shipped to the surgical facility.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of acceptance criteria and the reported device performance:
The document details a series of potential failure modes and the corresponding tests performed to ensure the device's functionality and integrity are not compromised by the new pre-loading and sterilization process. While explicit numerical acceptance criteria are not presented in a table format, the "Action Taken" column describes the tests conducted and implies that the device passed these tests, thus meeting implicitly defined acceptance criteria. The document states that the "results of that analysis showed that after mitigation and characterization of each remaining risk's severity and probability, all remaining risks were ranked as Acceptable."
| Potential Effects of Failure | Potential Cause | Action Taken (Reported Device Performance) |
|---|---|---|
| The bone graft loaded by the Bone Graft Manufacturer cannot be pushed through the Graft tube | The bone graft loaded is too viscous to be pushed through the tube. | Functionality Test -Specific material (GGDVT15 Rev A) performed on tubes after they have gone through the Bone Graft manufacturer's entire process. - 12.5 (Implied: Passed, graft can be pushed through) |
| Device's physical properties are diminished by the Bone Graft company's manufacturing process (Ex: filling, freezing storage temperatures, etc.) | Tube was weakened from Bone Graft manufacturer's process and the user bending the tube to reach desired graft dispensing location. | Tube Bend Test (GGDVT05 Rev A) performed on tubes after they have gone through the Bone Graft manufacturer's entire process. - 12.3 (Implied: Passed, tube integrity maintained after bending) |
| Marking on tube are rubbed off from bone graft manufacturer's process. | Markings rubbed off during Bone Graft manufacturer's process. | Ink scratchoff test (GGDVT01 Rev A) performed after they have gone through the Bone Graft manufacturer's entire process. - 12.1 (Implied: Passed, markings remain visible) |
| Marking on tube are rubbed off during use | Markings were affected during the Bone Graft manufacturer's process so they can be rubbed off easier. | Ink scratchoff test (GGDVT01 Rev A) performed after they have gone through the Bone Graft manufacturer's entire process. - 12.1 (Implied: Passed, markings remain visible during use) |
| Device's physical properties are diminished by the Bone Graft company's manufacturing process (Ex: filling, freezing, storage temperatures, etc.). | Tube was weakened from Bone Graft manufacturer's process so when the user squeezes handle to dispense graft it breaks the tube. | Tube burst test (GGDVT11 Rev A) and Functionality -Specific Material test (GGDVT15 Rev A) performed on tubes after they have gone through the Bone Graft manufacturer's entire process. - 12.4 and 12.5 (Implied: Passed, tube does not break during dispensing) |
| Device's physical properties are diminished by the Bone Graft company's manufacturing process (Ex: filling, freezing, storage temperatures, etc.). | Connection with tube was weakened from Bone Graft manufacturer's process which allowed the ring to fall off. | Ring Pull Off Test (GGDVT02 Rev A) performed on tubes after they have gone through the Bone Graft manufacturer's entire process. - 12.2 (Implied: Passed, ring remains attached) |
| Cracks. Breaks. Handles on syringe break. | The assembly was weakened from Bone Graft manufacturer's process so the device breaks before it can load the Graft Tube | Functionality Test-Specific material test (GGDVT16 Rev A) performed on prototype and production validation. - 12.6 (Implied: Passed, handles and assembly maintain integrity) |
| Reduction of components in the kit causes a reduction of sterility | Less components in the tray affects the way the componentsare sterilized | The gamma sterilizer (Sterigenics) advised that removing components at this scale is no issue for gamma sterilization. Because the density was decreased and packaging configuration did not change significantly, the validated gamma sterilization process should not have affect on sterility. (Implied: Sterility is maintained) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document provides test identification numbers (e.g., GGDVT15 Rev A, GGDVT05 Rev A) but does not specify the sample size used for each test. The number "12.5" which appears after some tests codes is not clearly defined but could potentially be a sample size (e.g., 12.5 units or batches). This is not explicitly stated.
- Data Provenance: The tests were performed on "tubes after they have gone through the Bone Graft manufacturer's entire process." This indicates the tests were conducted prospectively on devices subjected to the new pre-loading and sterilization conditions. The document does not specify the country of origin of the data, but the context implies it relates to the US FDA submission process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
The provided text does not mention the use of experts to establish ground truth for the device's functional and physical property tests. These are engineering and performance validation tests, not diagnostic or clinical interpretation tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As the tests are focused on physical and functional properties and not on subjective interpretation, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned in the document. The tests seem to have pass/fail criteria based on objective measurements or observations.
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:
This is a device for delivering bone graft material, not a diagnostic imaging or AI-assisted device. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not an algorithm-only device. It is a physical medical device. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance tests appears to be based on engineering specifications and established functional requirements for a graft delivery system. For example, for the "Ink scratchoff test," the ground truth would be that the markings must remain legible, and for the "Tube burst test," the tube must not burst under anticipated stress. For sterility, the ground truth is a sterility assurance level (SAL) of 10-6, which is an industry standard.
8. The sample size for the training set:
This is a physical medical device, not an AI/Machine Learning algorithm. Therefore, the concept of a "training set" in the context of data for model training is not applicable and no such sample size is mentioned.
9. How the ground truth for the training set was established:
As above, this is not an AI/ML device, so the concept of a training set and its ground truth establishment is not applicable.
§ 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).