The VACLOK™ Syringe Kit is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The VACLOK™ Syringe Kit can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.

Device Description

The VACLOK™ Syringe is a polycarbonate piston syringe modified to include tins on the plunger and a stopping pin in the barrel. The plunger can be pulled back and turned to lock the fins back with the barrel pin.

AI/ML Overview

This 510(k) premarket notification for the VACLOK™ Syringe Kit does not contain the detailed information required to fulfill the request. This document is a summary of safety and effectiveness that primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study reports with acceptance criteria and performance data.

Here's why the requested information cannot be extracted from the provided text:

Type of Device: The VACLOK™ Syringe Kit is a physical medical device (piston syringe) used for aspiration and delivery of fluids, not an AI/Software as a Medical Device (SaMD). The concepts typically associated with AI/SaMD performance evaluation, such as acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, and standalone performance, are generally not applicable or reported in the same way for traditional hardware devices in a 510(k) submission focused on substantial equivalence.
Focus of 510(k): The core of this 510(k) submission is to demonstrate that the VACLOK™ Syringe is "substantially equivalent" to already legally marketed predicate devices (Bone Graft Syringe K023088 and Merit Control Syringe K994253) in terms of design features, materials, and intended use. This approach relies on the predicate devices having already established their safety and effectiveness through their own clearance or premarket approval, or by being "grandfathered" devices (marketed before May 28, 1976).
Lack of Specific Study Data: The document explicitly states: "The safety and effectiveness of the VACLOK™ Syringe is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." It does not present a new clinical study or performance study with defined acceptance criteria and statistical results typical for demonstrating the performance of a novel or significantly modified device, especially not an AI/SaMD.

Therefore, I cannot provide the requested table and study details. The provided text does not contain:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, or details of a study that would use such.
Information on experts, ground truth establishment, or adjudication methods.
MRMC comparative effectiveness study data or effect sizes.
Standalone performance data (as it's a hardware device not an algorithm).
Types of ground truth.
Training set sample size or how ground truth was established for a training set.

The submission relies on a comparison to predicate devices, implying that their established safety and effectiveness data (which are not detailed here) are sufficient for the VACLOK™ Syringe.

Summary

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K060095

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FEB 1 0 2006

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the VACLOK™ Syringe.

Submitted By:	Wright Medical Technology, Inc.
Date:	January 10, 2006
Contact Person:	Wesley L. Reed
	Regulatory Affairs Specialist
Proprietary Name:	VACLOK™ Syringe Kit
Common Name:	Piston Syringe
Classification Name and Reference:	21 CFR 880.5860 Piston syringe -- Class II
Device Product Code and Panel Code:	FMF/General Hospital-80

DEVICE INFORMATION

A. INTENDED USE

The VACLOK ™ Syringe Kit is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The VACLOK ™ Syringe Kit can be used to mix bone graft materials with aspirated fluids and deliver the composite grafi material to the orthopedic surgical site.

B. DEVICE DESCRIPTION

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The design features, material, and indications for use of the VACLOK™ Syringe are substantially equivalent or identical to the previously cleared Bone Graft Syringe (K023088) and the Merit Control Syringe (K994253). The safety and effectiveness of the VACLOK™ Syringe is adequately supported by the substantial equivalence information. materials information, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (USA). The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2006

Mr. Wesley L. Reed Regularly Affairs Specialist Wright Medical Technology, Inc. 5677 Airline Rd. Arlington, Tennessee 38002

Re: K060095

Trade/Device Name: Vaclok™ syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: January 10, 2006 Received: January 13, 2006

Dear Mr. Reed:

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. Wesley L. Reed

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchund
for
Mark N. Melkon

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K Dio0095

Device Name: VACLOK™ Syringe Kit

Indications For Use:

Prescription Use (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)

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Barbara Buellun

storative. and Neurological

510(k) Number K060095

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).