(53 days)
The O-GENESIS Graft Delivery System is intended to be used for the delivery of allograft, autograft or synthetic bone graft material to an orthopedic surgical site.
The O-GENESIS Graft Delivery System is designed to deliver allograft, autograft or synthetic bone graft material to an orthopedic surgical site. The system consists of a loading syringe, a loading plunger, a loading funnel, a delivery cannula and a delivery gun with an actuating trigger handle. The system is provided sterile and is for single-use only.
In this 510(k) submission, the O-GENESIS Graft Delivery System is a Class II medical device (piston syringe) intended for delivering bone graft material to an orthopedic surgical site. The submission aims to demonstrate substantial equivalence to a predicate device, the GraftGun Universal Graft Delivery System (K170675).
The device in question is a bone graft delivery system, not an AI/ML powered device, so many of the requested elements for AI/ML performance studies (e.g., ground truth, MRMC study, training data, number of experts for ground truth establishment, adjudication methods, standalone performance, effect size of human reader improvement with AI) are not applicable.
However, I can provide information regarding the acceptance criteria for the functional performance of the device and how the study proved these criteria were met, based on the provided text.
Acceptance Criteria and Reported Device Performance
The submission primarily focuses on the functional performance, material characteristics, and biocompatibility of the O-GENESIS Graft Delivery System compared to the predicate device. The acceptance criteria are implicitly derived from the successful completion of various tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Simulated Use | Successful loading and delivery of bone graft material from the cannula without issues, demonstrating proper function as intended. | "Testing was successful with all acceptance criteria met. (Loading of bone graft material into the cannula and delivery of bone graft material from the cannula using the graft delivery gun)." |
| Functional Verification (Design Requirements & Risk Analysis) | Specific force thresholds and integrity checks for key mechanical components (e.g., Delivery Gun Ratchet Plunger force, Plunger T-Handle strength, Syringe Body/Stopper force, Threaded Components interface) to ensure robust and safe operation. | "Functional verification testing based on design requirements and risk analysis was performed and included: Delivery Gun Ratchet Plunger force, Plunger T-Handle strength, Syringe Body/Stopper force, Threaded Components interface... Functional verification testing was successful with all acceptance criteria met." |
| Biocompatibility | Compliance with ISO 10993-1:2009 for biological evaluation of medical devices, specifically passing tests for Cytotoxicity, Sensitization, Acute Systemic Toxicity, and Material-Mediated Pyrogenicity. | "A biocompatibility evaluation was performed in accordance with ISO 10993-1:2009... and included testing for the following biocompatibility endpoints; Cytotoxicity, Sensitization, Acute Systemic Toxicity and Material-Mediated Pyrogenicity. Based on the evaluation and testing results the O-GENESIS Graft Delivery System is biocompatible and meets the requirements of ISO 10993-1:2009." |
| Sterility | Achievement of a Sterility Assurance Level (SAL) of 10^-6 via Gamma Irradiation. | "Provided Sterile Gamma Irradiation SAL 10^-6" (Matching predicate and demonstrating adherence to standard. Implies successful validation of the sterilization process.) |
| Single-Use | Designed and validated for single-use to prevent reuse complications. | "Yes" (Stated as a characteristic of both the subject and predicate devices, implying it was designed and validated as such.) |
| Volume Capacity | Capability to deliver graft material up to a specified volume (e.g., 6.6ml in cannula). | "Up to 6.6ml in cannula" (Confirmed in the comparison table, indicating the device meets its design specification for volume.) |
Details of the Study
-
Sample sizes used for the test set and the data provenance:
- The document states "Testing was performed using test units representative of the finished devices."
- Specific sample sizes for each test are not explicitly mentioned in this summary. For example, it doesn't specify how many devices were subjected to simulated use, or how many individual tests were performed for each functional verification parameter.
- Data Provenance: The studies were conducted by Orthofix, the device manufacturer, as part of their 510(k) submission. The data is prospective as it involves new testing of the manufactured device. The country of origin of the data is implicitly the United States, given the FDA submission.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device. This is a mechanical bone graft delivery system, not an AI/ML diagnostic or image analysis device that requires expert interpretation for ground truth. The "ground truth" here is the physical performance of the device (e.g., did it deliver the graft material, did the components withstand force, is it biocompatible). These are established through engineering and biological testing protocols, not expert consensus on medical images or diagnoses.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations (like radiology reads) to establish consensus ground truth. For mechanical and biological testing, results are objective (e.g., passed/failed a force test, biocompatible/not biocompatible based on standardized assays).
-
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, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical tool, not an AI-powered diagnostic system.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device integrates human operation (a surgeon uses the gun to deliver the graft), and there is no "algorithm only" component that would have standalone performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and adherence to established industry standards (e.g., ISO for biocompatibility).
- For Simulated Use and Functional Verification: The ground truth is the successful operation of the device according to its design specifications and the ability to perform its intended function (delivering graft material) without failure. This is determined by direct observation and quantitative measurements (e.g., force required, successful actuation cycles) against pre-defined engineering acceptance criteria.
- For Biocompatibility: The ground truth is established by laboratory test results (e.g., toxicity assays) conforming to the requirements of the ISO 10993-1:2009 standard.
- The "ground truth" for this device's performance is established by engineering specifications, physical measurements, and adherence to established industry standards (e.g., ISO for biocompatibility).
-
The sample size for the training set:
- Not applicable. This device is hardware; it does not involve an AI/ML model that requires a "training set" of data.
-
How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML model, there is no training set and therefore no ground truth establishment for a training set.
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May 1, 2020
Orthofix Troy Brooks, RAC Director, Regulatory Affairs 3451 Plano Parkway Lewisville, Texas 75056
Re: K200606
Trade/Device Name: O-GENESIS Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: March 6, 2020 Received: March 9, 2020
Dear Troy Brooks:
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 and Part 809); 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) K200606
Device Name O-GENESIS™ Graft Delivery System
Indications for Use (Describe)
The O-GENESIS Graft Delivery System is intended to be used for the delivery of allograft, autograft or synthetic bone graft material to an orthopedic surgical site.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, bold letters. A small trademark symbol is located to the right of the "X" in "ORTHOFIX".
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510(k) Summary
O-GENESIS™ Graft Delivery System
510(k) Owner Information:
| Name: | Orthofix |
|---|---|
| Address: | 3451 Plano ParkwayLewisville, TX 75056 |
| Phone Number: | 214-937-2047 |
| Fax Number: | 214-937-3322 |
| Email: | TroyBrooks@Orthofix.com |
| FDA Registration Number: | 2183449 |
| Contact Person: | Troy Brooks, RACDirector, Regulatory AffairsOrthofix |
| Date Prepared: | April 24, 2020 |
| Name of Device: | |
| Trade Name /Proprietary Name: | O-GENESIS Graft Delivery System |
| Common Name: | Graft Delivery Device |
| Classification Name: | Piston Syringe |
| Product Code: | FMF |
| Regulatory Class: | Class II – 21 CFR 880.5860 |
| Review Panel: | General Hospital |
| Predicate Device: | K170675 - GraftGun Universal Graft Delivery System(SurGenTec LLC) |
Reason for 510(k) Submission:
Orthofix is submitting this Traditional 510(k) premarket notification for the new O-GENESIS Graft Delivery System.
Device Description:
The O-GENESIS Graft Delivery System is designed to deliver allograft, autograft or synthetic bone graft material to an orthopedic surgical site. The system consists of a loading syringe, a loading plunger, a loading funnel, a delivery cannula and a delivery gun with an actuating trigger handle. The system is provided sterile and is for single-use only.
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Image /page/4/Picture/0 description: The image shows the Orthofix logo. The logo consists of a blue abstract shape on the left and the word "ORTHOFIX" in black letters on the right. The abstract shape is a stylized representation of a circle with a gap in the middle. The word "ORTHOFIX" is written in a bold, sans-serif font, and there is a registered trademark symbol next to the "X".
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Indications for Use:
The O-GENESIS Graft Delivery System is intended to be used for the delivery of allograft, autograft or synthetic bone graft material to an orthopedic surgical site.
Technological Characteristics of the Device Compared to the Predicate Device:
The technological characteristics of the O-GENESIS Graft Delivery System are similar to the predicate device in terms of intended use, indications for use, and fundamental technology, including basic design, sterility and operating principle. There are no significant differences between the subject device and the predicate that raise new issues regarding safety or effectiveness. The table below compares the key technological characteristics of the subject device to the predicate device.
| Comparator | Subject DeviceO-GENESISGraft Delivery System(K200606) | Predicate DeviceGraftGun UniversalGraft Delivery System(K170675) |
|---|---|---|
| Product Code | FMF | FMF |
| Classification | Class II - 21 CFR 880.5860 | Class II - 21 CFR 880.5860 |
| Intended Use | Delivery of graft material to anorthopedic surgical site. | Delivery of graft material to anorthopedic surgical site. |
| OperatingPrinciple | Graft material expressed from acannula via a plunger, operated bya ratchet-actuated handle.Graft material expressed from thecannula directly to the surgical site. | Graft material expressed from a grafttube via a plunger, operated by aratchet-actuated handle.Graft material expressed from a grafttube directly to the surgical site. |
| VolumeCapacity | Up to 6.6ml in cannula | Up to 7.5ml in graft tube (cannula) |
| Direct PatientContactingMaterial | HDPE DMDA-8904 HEALTH+HEPE DMDA-8907 NT7(High Density Polyethylene) | PolypropylenePolycarbonate |
| Single-Use | Yes | Yes |
| Sterility | Provided SterileGamma IrradiationSAL 10-6 | Provided SterileGamma IrradiationSAL 10-6 |
Performance Data:
Testing was conducted for the O-GENESIS Graft Delivery System to confirm the device performs as intended. Testing was performed using test units representative of the finished devices. Testing included simulated use, functional verification, and biocompatibility evaluation.
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Image /page/5/Picture/0 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left and the word "ORTHOFIX" in black letters on the right. The abstract shape is a stylized representation of a circle or sphere, with three curved lines that converge at a point. The word "ORTHOFIX" is written in a bold, sans-serif font.
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Simulated use testing included loading of bone graft material into the cannula and delivery of bone graft material from the cannula using the graft delivery gun. Testing was successful with all acceptance criteria met.
Functional verification testing based on design requirements and risk analysis was performed and included:
- Delivery Gun Ratchet Plunger force
- Plunger T-Handle strength
-
Syringe Body/Stopper force - Threaded Components interface
Functional verification testing was successful with all acceptance criteria met.
A biocompatibility evaluation was performed in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1, and included testing for the following biocompatibility endpoints; Cytotoxicity, Sensitization, Acute Systemic Toxicity and Material-Mediated Pyrogenicity. Based on the evaluation and testing results the O-GENESIS Graft Delivery System is biocompatible and meets the requirements of ISO 10993-1:2009.
Conclusion:
Based upon similarities in intended use, indications for use, and fundamental technology, including basic design, sterility and operating principle, the O-GENESIS Graft Delivery System is substantially equivalent to the predicate device.
§ 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).