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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Graft Delivery Syringe. This document focuses on demonstrating substantial equivalence to existing devices, a regulatory pathway that typically does not involve clinical performance studies or the establishment of novel acceptance criteria based on device performance metrics like sensitivity and specificity.

Therefore, the information required to populate the table and answer questions 2-9 is not present in the provided text. The submission is based on a comparison to predicate devices, implying that if the new device is sufficiently similar to previously approved devices, it is considered safe and effective without needing to re-demonstrate its performance against specific acceptance criteria through new studies.

Here's a breakdown of why the information is unavailable in this document:

Acceptance Criteria and Reported Device Performance: This type of information is typically found in submissions for novel devices or devices undergoing performance trials. For a 510(k) submission based on substantial equivalence, the "performance" is primarily judged by its similarity to predicate devices, not by meeting new, pre-defined performance metrics.
Sample Size for Test Set and Data Provenance: As no new performance study is described, there's no "test set" in the context of clinical or diagnostic accuracy.
Number of Experts and Qualifications: Experts are not mentioned as being used to establish a "ground truth" for a performance study.
Adjudication Method: Not applicable as there's no performance study described that would require adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is a type of clinical study, and no such study is described.
Standalone Performance Study: No standalone clinical performance study is described. The equivalency is based on design and intended use, not on new performance data demonstrating accuracy, sensitivity, or specificity.
Type of Ground Truth: No ground truth is established as no performance study is detailed.
Sample Size for Training Set: Not applicable as this is a medical device, not an AI/ML diagnostic tool requiring a "training set" in the computational sense.
How Ground Truth for Training Set was Established: Not applicable for the same reason as above.

Conclusion:

The provided 510(k) summary for the Medtronic Graft Delivery Syringe does not contain the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment. This is consistent with a 510(k) pathway that relies on demonstrating substantial equivalence to predicate devices rather than proving de novo performance against new criteria.

Summary

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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

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).

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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.

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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

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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_

Regulation Number and Section

§ 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).