(32 days)
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No
The summary describes a mechanical system for mixing and delivering bone graft materials and fluids. There is no mention of AI, ML, image processing, or any other computational analysis of data that would indicate the presence of AI/ML.
No
The device is described as a "Graft Delivery System" intended for delivering bone graft materials and facilitating pre-mixing. It acts as a tool to prepare and deliver substances, rather than directly providing a therapeutic effect itself. Its function is to assist in a surgical procedure, not to treat a condition directly.
No
This device is for delivering graft materials and pre-mixing them; it does not diagnose conditions.
No
The device description explicitly lists several physical components including a manifold, manifold housing, graft chamber, and accessory syringes, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site" and "to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specified blood components". This describes a device used during surgery to prepare and deliver materials to a patient's body.
- Device Description: The description focuses on the physical components used for mixing and delivery to a surgical site.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided text does not mention any analysis of specimens or diagnostic purposes.
The device is clearly intended for use in vivo (within the body) during a surgical procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
Product codes
FMF
Device Description
The Smith & Nephew Graft Delivery System is used to conveniently pre-mix desired fluid components and bone graft materials, with delivery of the resultant mixture to an orthopedic surgical site. The system contains several components including a manifold, manifold housing, graft chamber, and accessory syringes.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
orthopedic surgical site
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
A review of the test data indicated that the Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
AUG 2 3 2004
Summary of Safety and Effectiveness Smith & Nephew, Inc. Graft Delivery System
Contact Person and Address
Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-6566
Device Description
The Smith & Nephew Graft Delivery System is used to conveniently pre-mix desired fluid components and bone graft materials, with delivery of the resultant mixture to an orthopedic surgical site. The system contains several components including a manifold, manifold housing, graft chamber, and accessory syringes.
Device Classification Name
21 CFR 880.5860 Piston Syringe, Class II
Indications for Use
The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
Test Data
A review of the test data indicated that the Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components.
Substantial Equivalence Information
The substantial equivalence of the Smith & Nephew Graft Delivery System is substantiated by its similarities in design features, principal of operation, indications for use, and material composition as existing graft delivery components and syringes distributed by other competitive predicate systems.
1
Image /page/1/Picture/1 description: The image shows a logo with a stylized bird in flight. The bird is composed of three curved lines, suggesting movement and freedom. The bird is encircled by a dotted line, forming a circular border around the logo. The logo is simple, clean, and conveys a sense of dynamism and aspiration.
Public Health Service
AUG 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kun P. Kelly Project Manager. Regulatory and Clinical Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116
Re: K041976
Trade/Device Name: Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: July 19, 2004 Received: july 22, 2004
Dear Ms. Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device w on a re row 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 for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of provised in accordance with the provisions of the Federal Food. Drug, de reces mar na re over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such 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.
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 ( FR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Kim P. Kelly
This letter will allow you to begin marketing your device as described in your Section 510(k) prematics notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miternational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
tal Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Smith & Nephew Graft Delivery System Indications Statement
The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, playma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
Prescription Use X (Per 21 CFR 801, Subpart D)
OR
Over-The Counter Use (Per 21 CFR 807, Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Miriam C. Proust
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________