(70 days)
Not Found
No
The summary describes a mechanical syringe for delivering graft material and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks any description of training or test sets, performance metrics, or image processing, which are typical indicators of AI/ML in medical devices.
No
Explanation: The device is intended to deliver graft material, not to treat a disease or condition itself.
No
The device is described as a 'Graft Delivery Syringe' intended to mix and deliver graft materials, which is a therapeutic or delivery function, not a diagnostic one.
No
The device description clearly states it is a "Graft Delivery Syringe," which is a physical medical device used to mix and deliver materials. There is no mention of software as the primary or sole component.
Based on the provided information, the Medtronic Graft Delivery Syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mix and deliver graft materials to orthopedic surgical sites within the body. IVDs are used to examine specimens outside the body to provide information about a patient's health.
- Device Description: The description focuses on delivering material to a surgical site, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples in vitro. The device's function is purely mechanical delivery.
Therefore, the Medtronic Graft Delivery Syringe falls under the category of a surgical instrument or device used for delivering materials during a procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic Graft Delivery Syringe is intended to provide the surgeon with a means to mix autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic bone graft materials and to deliver these materials to all orthopaedic surgical sites.
Product codes
FMF
Device Description
The purpose of this application is to notify the FDA of our intent to market the Medtronic Graft Delivery Syringe as a means to deliver graft material to an orthopedic surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all orthopaedic surgical sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K043261, K003286, K011087, K023074, K030208
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.
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
Medtronic Graft Delivery Syringe 510(K) Summary - K062986 December 2006
DEC - 8 2006
-
I. Company: Medtronic USA, Inc. 1800 Pyramid Place Memphis, TN 38132
Contact: Christine Scifert Group Director, Regulatory Affairs (901) 396-3133 -
II. Proposed Proprietary Trade Name: Medtronic Graft Delivery Syringe Classification Name: Piston Syringe Product Code: FMF Regulation No .: 880.5860
III. Product Description/Purpose of Application
The purpose of this application is to notify the FDA of our intent to market the Medtronic Graft Delivery Syringe as a means to deliver graft material to an orthopedic surgical site.
IV. Indications
The Medtronic Graft Delivery Syringe is intended to provide the surgeon with a means to mix autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic bone graft materials and to deliver these materials to all orthopaedic surgical sites.
V. Substantial Equivalence
Documentation was provided which demonstrated the Medtronic Graft Delivery Syringe to be substantially equivalent to previously cleared graft delivery systems such as Harvest Technologies Corp.'s Harvest Graft Delivery System, (K043261, SE 03/11/05), Depuy's Symphony Graft Delivery System, K003286 (01/18/01), the Imbibe Piston Syringe (K011087, SE 09/19/01), the Imbibe Bone Marrow Aspiration Syringe (K023074, SE 03/11/03) and the Imbibe II Piston Syringe, (K030208, SE 04/16/03).
1
Public Health Service
Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Sofamor Danek % Mr. Lee Grant Supervisor, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132
DEC - 8 2006
Re: K062986
Trade/Device Name: Medtronic Graft Delivery Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: November 10, 2006 Received: November 13, 2006
Dear Mr. Grant:
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. 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.
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 CFR 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.
2
Page 2 - Mr. Lee Grant
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
December - 2006
510(k) Number (if known): K062986
Medtronic Graft Delivery Syringe Device Name:
Indications for Use: The Medtronic Graft Delivery Syringe is intended to provide the surgeon with a means to mix autologous blood or bone marrow with allograft, demineralized bone, or synthetic bone graft materials and to deliver these materials to all orthopaedic surgical sites.
Prescription Use ---------x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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 (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_