(226 days)
None
No
The device description and intended use describe a manual mixing and delivery system for bone graft materials, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as facilitating the mixing and delivery of bone graft materials, not as directly treating a condition or disease.
No
The device is described as a kit for mixing and delivering bone graft materials to orthopedic surgical sites, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components (piston syringe, curved luer camula, straight luer lock, obturator, and finnel) and describes it as a kit, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery and mixing of bone graft materials for orthopedic surgical sites. This is a surgical procedure involving the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The components listed (syringe, cannula, obturator, funnel) are tools used for handling and delivering materials during surgery. They are not designed for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on preparing and delivering materials in vivo (within the body) during surgery.
N/A
Intended Use / Indications for 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.
Product codes
FMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all orthopedic surgical sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 has been completed to demonstrate that the CONMED Mixing and Delivery Kit performs as intended and is substantially equivalent to the predicate device. Completed testing includes the following: Reliability, Transportation, Biocompatibility, Sterilization, Shelf-life, Simulated Use Testing.
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
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Enclosure
2
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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3
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 | |
| (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* | ||
| *some components sold separately | ||||
| Technological | ||||
| Characteristics | For mixing and delivery of allograft autograft and synthetic bone graft materials to all orthopedic sites. | Same | ||
| Materials | 18-month shelf life | |||
| 3ml syringe fill capacity | ||||
| Commonly used materials in the medical device industry | 5-year shelf life | |||
| 3ml or 14ml syringe fill capacity | ||||
| 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
INDCATIONS FOX Coaterials of Children Colleged on States Prospect of Stream
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4
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:
5
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