Allograft MIS Delivery System

K201338 · Lifenet Health · FMF · Jul 13, 2020 · General Hospital

Device Facts

• Record ID: K201338
• Device Name: Allograft MIS Delivery System
• Applicant: Lifenet Health
• Product Code: FMF · General Hospital
• Decision Date: Jul 13, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.

Device Story

The Allograft MIS Delivery System is a sterile, single-use, disposable device used in orthopedic surgery to deliver hydrated allograft bone graft material. The system comprises a 5 cc cannula (containing the graft), a plunger, a dispenser, and two end caps. The surgeon operates the dispenser with one hand to advance the plunger, which expresses the graft material from the cannula directly into the surgical site. The device is designed to be preloaded with graft material at a registered graft facility before being shipped to the surgical facility. By providing a controlled, incremental delivery mechanism, the device assists the surgeon in placing bone graft material accurately, potentially improving surgical efficiency and patient outcomes during orthopedic procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility, dimensional and fit verification, functional verification (mechanical extrusion and simulated use), and package performance/stability. All specified acceptance criteria were met.

Technological Characteristics

Cannula material: medical grade polypropylene. Mechanism: ratchet-actuated handle for incremental plunger advancement. Capacity: 5 cc. Sterilization: Gamma irradiation (dispenser/plunger) and Ethylene Oxide (cannula/end caps). Single-use, disposable. No software or electronic components.

Indications for Use

Indicated for delivery of hydrated allograft bone graft material to orthopedic surgical sites in patients requiring bone grafting procedures.

Regulatory Classification

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.

Predicate Devices

• Graftgun Universal Graft Delivery System (K180937)

Submission Summary (Full Text)

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July 13, 2020

LifeNet Health Brittany Beasley Global Regulatory Affairs Program Manager 1864 Concert Drive Virginia Beach, Virginia 23453

Re: K201338

Trade/Device Name: Allograft MIS Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: May 19, 2020 Received: May 20, 2020

Dear Brittany Beasley:

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 ([e-mail]) or phone [phone] 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201338

Device Name Allograft MIS Delivery System

Indications for Use (Describe)

The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.

| Type of Use (Select one or both, as applicable) | <table><tr><td><div> <input type="checkbox"/> </div></td><td><div> <input type="checkbox"/> </div></td></tr></table> | <div> <input type="checkbox"/> </div> | <div> <input type="checkbox"/> </div> |
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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/1 description: The image is the logo for LifeNet Health. The logo features a blue and green circular icon with a white figure inside, followed by the words "LifeNet Health" in blue and green. Below the name is the tagline "Saving Lives. Restoring Health. Giving Hope."

# 510(k) Summary

## Allograft MIS Delivery System

| Submitter Information: | |
|------------------------|--------------------------------------------------------------------|
| Name: | LifeNet Health |
| Address: | 1864 Concert Drive<br>Virginia Beach, Virginia 23453 |
| Contact: | Brittany Beasley, RAC<br>Global Regulatory Affairs Program Manager |
| Phone: | [phone] |
| Email: | [e-mail] |
| Date Prepared: | July 10, 2020 |
| Device Information: | |
| Trade Name: | Allograft MIS Delivery System |
| Common Name: | Graft Delivery Device |
| Regulation Name: | Piston Syringe |
| Regulation Number: | 21 CFR 880.5860 |
| Regulatory Class: | Class II |
| Product Code: | FMF |
| Proposed Panel: | General Hospital |
| Predicate Device: | |
| Name: | Graftgun Universal Graft Delivery System (K180937 |
| Manufacturer: | SurGenTec LLC |

## Device Description:

The Allograft MIS Delivery System is a sterile, single-use, disposable graft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery system consists of: a cannula for containing and delivering the allograft material to the surgical site; a plunger to express the allograft material from the cannula; a dispenser to advance the plunger down the length of the cannula; and two end caps to retain the allograft material in the cannula prior to system assembly.

The cannula component is a 5 cc straight, open bore tube with a double threaded interface that mates with two end caps which are removed prior to cannula attachment to the dispenser. The dispenser is designed for single-hand, incremental delivery of graft materials and may be used to dispense multiple cannulas for a single patient.

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Image /page/4/Picture/1 description: The image is a logo for LifeNet Health. The logo features a blue and green circular icon with a stylized human figure in the center. To the right of the icon is the text "LifeNet Health" in blue and green. Below the text is the tagline "Saving Lives. Restoring Health. Giving Hope." in blue.

## Indications for Use:

The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.

## Comparison of Technological Characteristics to the Predicate:

| | | Graftgun Universal Graft Delivery<br>System<br>(predicate device) | Allograft MIS<br>Delivery System<br>(subject device) |
|-----------|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | Applicant | SurGenTec | LifeNet Health |
| | Regulation No. &<br>Name | 21 CFR 880.5860,<br>Piston Syringe | 21 CFR 880.5860,<br>Piston Syringe |
| | Procode | FMF | FMF |
| | 510(K) Number | K180937 | K201338 |
| | Labeling | Indications for use | The Graftgun Universal Graft<br>Delivery System is intended to be<br>used for the delivery of hydrated<br>allograft, autograft, or synthetic bone<br>graft material to an orthopedic<br>surgical site. |
| | Prescription /<br>OTC Use | Prescription Use | Prescription Use |
| | Type of Use | Single, Disposable | Single, Disposable |
| Design | Mechanism of<br>operation | Graft material expressed from graft<br>tube via a plunger, operated by a<br>ratchet-actuated handle. Material<br>expressed from graft tube directly to<br>graft site. | Graft material expressed from<br>cannula via a plunger, operated by a<br>ratchet-actuated handle. Material<br>expressed from graft cannula<br>directly to graft site. |
| | Patient-contact<br>materials | Graft tube - Medical grade<br>polypropylene<br>Loading Device/Syringe Tube -<br>Medical grade polycarbonate<br>Radiopaque ring marker - Medical<br>grade stainless steel - 316L, 316F,<br>304H, 304HC and ABS | Graft cannula - Medical grade<br>polypropylene |
| | Graft<br>Tube/Cannula | Option of having the 5cc graft tube<br>provided clean to a graft facility,<br>preloaded with graft, packaged,<br>sterilized and shipped to the surgical<br>facility prior to the surgical<br>procedure. | Cannula provided sterile to a graft<br>facility, preloaded with graft,<br>packaged, and shipped to the<br>surgical facility prior to the surgical<br>procedure. |
| | Radiopaque<br>marker | Yes | No |
| | Volume capacity | Up to 5 cc | Up to 5 cc |
| | Volume markings | Yes | No |
| | | Graftgun Universal Graft Delivery<br>System<br>(predicate device) | Allograft MIS<br>Delivery System<br>(subject device) |
| Sterility | Sterility Claim /<br>SAL | Sterile, SAL 1 x 10-6<br>(see Note 1) | Sterile, SAL 1 x 10-6<br>(see Note 2) |
| | Sterilization<br>Method | Gamma irradiation | Dispenser & Plunger:<br>Gamma irradiation<br>Cannula & End caps:<br>Ethylene Oxide |
| | | Note 1: Graft tubes are provided to a<br>registered graft facility. Their<br>sterilization process is validated as<br>per their internal accepted standards<br>prior to the prefilled tubes being<br>shipped. | Note 2: Cannulas and end caps are<br>provided to a registered graft<br>facility. Their manufacturing steps<br>conform to Current Good Tissue<br>Practice requirements under 21<br>CFR 1271, Subpart D. |

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Image /page/5/Picture/0 description: The image is the logo for LifeNet Health. The logo consists of a blue and green circle with a person in the center, followed by the words "LifeNet Health" in blue and green. Below the words "LifeNet Health" is the tagline "Saving Lives. Restoring Health. Giving Hope."

## Performance Data:

The following testing was performed on the subject device to demonstrate substantial equivalence:

- Biocompatibility
- 트 Dimensional and fit verification
- I Functional verification
- -Mechanical extrusion
- -Simulated use
- 트 Package performance and stability

Testing was performed on samples that represented the finished device and all specified acceptance criteria were met.

## Conclusion:

The Allograft MIS Delivery System is substantially equivalent to the Graftgun dispensing unit of the Graftgun Universal Graft Delivery System in intended use, mechanism of operation, patientcontacting materials, and intent to supply the device to a registered graft facility prior to the surgical facility. The differences between the subject device and the predicate device are minor and do not impact the safety and effectiveness of the subject device as demonstrated by the provided performance testing.