ConMed Mixing and Delivery Kit

K142535 · Conmed Corporation · FMF · Apr 23, 2015 · General Hospital

Device Facts

• Record ID: K142535
• Device Name: ConMed Mixing and Delivery Kit
• Applicant: Conmed Corporation
• Product Code: FMF · General Hospital
• Decision Date: Apr 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CONMED Mixing and Delivery Kit is intended for delivery of allograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft or synthetic bone graft materials with IV fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

Device Story

Device is a single-use, disposable kit for orthopedic surgery; used by surgeons to mix and deliver bone graft materials. Kit components include a piston syringe, curved luer cannula, straight luer lock, obturator, and funnel. Surgeon manually mixes graft material with fluids (e.g., blood, plasma, bone marrow) within the syringe; then uses the syringe and cannula to deliver the mixture to the surgical site. Facilitates precise graft placement; improves handling of graft materials during orthopedic procedures.

Clinical Evidence

Bench testing only. Testing included reliability, transportation, biocompatibility, sterilization, shelf-life, and simulated use testing to demonstrate performance and substantial equivalence.

Technological Characteristics

Manual piston syringe system; includes cannula, obturator, and funnel. Materials are industry-standard for medical devices. Single-use, disposable. Sterilized. No electronic or software components.

Indications for Use

Indicated for patients requiring delivery of allograft or synthetic bone graft materials to orthopedic surgical sites. No specific age or gender contraindications provided.

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

• Arthrex Mixing and Delivery System (K121124)

Submission Summary (Full Text)

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and Drug Administratio
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Spring, MD 20993-00

April 23, 201

ONMED Corporation
Is. Dionne Sanders MS, I
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1311 Concept Boulevard
argo, Florida 33773

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de/Device Name: Conmed Mixing and Delivery
gulation Number: 21 CFR 880.5860
gulation Name: Piston Syring tory Class: Class rch 13, 20
March 24, Code: FM
March 13, 2

Sanders

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807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to

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http://www.fda.gov/ICECI/ResourcesForYou/Industry/
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Jennifer R. Stevenson-S

Ashar, M.D., M.B.A., F. vision of Surgical Device Evaluati
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Enclosure

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#### Indications for Use

510(k) Number (if known) K142535

Device Name CONMED Mixing and Delivery Kit

#### Indications for Use (Describe)

The CONMED Mixing and Delivery Kit is intended for delivery of allograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft or synthetic bone graft materials with IV fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

Type of Use (Select one or both, as applicable)

> 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 Conmed Corporation. The logo consists of the word "CONMED" stacked vertically, with the letters in black. To the right of the letters is the word "CORPORATION" stacked vertically in a smaller font, with a blue line separating it from the word "CONMED". Below the text is a blue square with a white swoosh inside.

# 0(k) SUMMA

#### SUBMITTE I

CONMED Corporation
1311 Concept Blvd.
Largo, Florida 33773

none: 727-399-53
ax: 727-399-5264

Dionne Sanders MS,
April 13, 2015 ontact Person:
ate Prepared:

#### DEVICE II

iston Syringe
Iston Syringe (21 CFR Part 880.586 NMED Mixing and Deliver Class II
FMF Name of Device:
Common Name : Name:
Classification Name:
Regullatory Collections:
Regullatory Collass:
Product Codes:

## REDICATE DEVIC III.

| Device Name: | Arthrex Mixing and Delivery System | | Proposed Device | Predicate Device |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|-------------------------------------------------|
| Company Name: | Arthrex, Inc. | | CONMED Mixing and Delivery Kit | Arthrex Mixing and Delivery System<br>(K121124) |
| 510(k) #: | K121124 | Manufacturer | CONMED Corporation | Arthrex, Inc. |
| Intended Use | For delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition it is designed to facilitate pre-mixing of allograft, autograft or synthetic bone graft materials with IV fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) and deemed necessary by the clinical use requirements. | Same | | |
| Components | 1 each - piston syringe (3ml) w/movable plunger and cap, funnel, long luer cannula, curved luer cannula, luer cap, obturator | 1 each – piston syringe w/movable plunger and cap (3ml or 14ml), straight delivery needle, curved delivery needle, luer cap, obturator, funnel*, articulating paddle elevator*<br>*some components sold separately | | |
| Technological<br>Characteristics | For mixing and delivery of allograft autograft and synthetic bone graft materials to all orthopedic sites. | Same | | |
| Materials | 18-month shelf life<br>3ml syringe fill capacity<br>Commonly used materials in the medical device industry | 5-year shelf life<br>3ml or 14ml syringe fill capacity<br>Same | | |

## EVICE DESCRIPTIC IV.

The CONMED Mixing and Delivery Kit consists of a piston syringe, curved luer
camula, straight luer lock, obturator, and finnel. The kit is supplied
a single use, disposable

## DICATIONS FOR US i A

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Image /page/4/Picture/0 description: The image shows the logo for ComEd Corporation. The word "COMED" is written vertically in large, bold, black letters. To the right of the word is a thin, blue line, and then the word "CORPORATION" is written vertically in smaller letters.

# COMPARISION OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE
PREDICATE DEVICE VI.

The CONMED Mixing and Delivery Kit is substantially equivalent in design,
manufacturing materials, intended use, principles of operation, and technical
s and the collect of safety or effectiveness.

The similarities and differences between the predicate and proposed mixing kits are:

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Image /page/5/Picture/0 description: The image shows the logo for CONMED Corporation. The text "CONMED" is stacked vertically in a bold, sans-serif font. Below the text is the word "CORPORATION" in a smaller, thinner font. Below the text is a blue square with a white, curved shape inside.

## ERFORMANCE DAT VII.

Testing has been completed to demonstrate that the CONMED Mixing and Delive
Kit performs as intended and is substantially equivalent to the predicate device.

Completed testing includes the followin

- Reliability
- .
- Transportation
Biocompatibilit
Sterilization ●
- .
- Shelf-life
- Simulated Use Testing .

### ONCLUSION VIII.

The CONNED Mixing and Delivery Kit has the interial weans trimamment
sother technal beries messes and series werivers werk met met
of the technology assessment of the comment