(53 days)
Not Found
No
The device description and performance studies focus on mechanical delivery of bone graft material and do not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is described as a "Graft Delivery System" intended for the delivery of bone graft material to an orthopedic surgical site. It does not perform a therapeutic function itself, but rather facilitates the delivery of material that may be used therapeutically.
No
No
The device description explicitly lists physical components (loading syringe, loading plunger, loading funnel, delivery cannula, delivery gun) and describes testing related to their physical performance (force, strength, biocompatibility), indicating it is a hardware device.
Based on the provided information, the O-GENESIS Graft Delivery System 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 in vivo (within the body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device components (syringes, cannulas, delivery gun) are designed for the physical delivery of material during surgery. They do not perform any diagnostic analysis of biological samples.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze blood, tissue, or any other biological sample for diagnostic purposes.
IVD devices are typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The O-GENESIS Graft Delivery System's function is purely for the physical delivery of therapeutic material during surgery.
N/A
Intended Use / 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.
Product codes
FMF
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.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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".
Page 1/3
510(k) Summary
O-GENESIS™ Graft Delivery System
510(k) Owner Information:
| Name: | Orthofix |
|---|---|
| Address: | 3451 Plano Parkway |
| Lewisville, TX 75056 | |
| Phone Number: | 214-937-2047 |
| Fax Number: | 214-937-3322 |
| Email: | TroyBrooks@Orthofix.com |
| FDA Registration Number: | 2183449 |
| Contact Person: | Troy Brooks, RAC |
| Director, Regulatory Affairs | |
| Orthofix | |
| 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".
Page 2/3
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 Device
O-GENESIS
Graft Delivery System
(K200606) | Predicate Device
GraftGun Universal
Graft 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 an
orthopedic surgical site. | Delivery of graft material to an
orthopedic surgical site. |
| Operating
Principle | Graft material expressed from a
cannula via a plunger, operated by
a ratchet-actuated handle.
Graft material expressed from the
cannula directly to the surgical site. | Graft material expressed from a graft
tube via a plunger, operated by a
ratchet-actuated handle.
Graft material expressed from a graft
tube directly to the surgical site. |
| Volume
Capacity | Up to 6.6ml in cannula | Up to 7.5ml in graft tube (cannula) |
| Direct Patient
Contacting
Material | HDPE DMDA-8904 HEALTH+
HEPE DMDA-8907 NT7
(High Density Polyethylene) | Polypropylene
Polycarbonate |
| Single-Use | Yes | Yes |
| Sterility | Provided Sterile
Gamma Irradiation
SAL 10-6 | Provided Sterile
Gamma Irradiation
SAL 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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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.