(28 days)
Not Found
No
The description focuses on the mechanical design of a syringe and does not mention any computational or data-driven features indicative of AI/ML.
No.
The device is a syringe used for aspiration and delivery of fluids and graft materials, not for treating a disease or condition itself.
No
The VACLOK™ Syringe Kit is described as a piston syringe for aspiration and delivery of fluids and bone graft materials, indicating a therapeutic or procedural use rather than a diagnostic one.
No
The device description clearly states it is a physical syringe made of polycarbonate with a piston, fins, and a stopping pin, indicating it is a hardware device.
Based on the provided information, the VACLOK™ Syringe Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration and delivery of body fluids and bone graft materials within the body during orthopedic surgery. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details a mechanical syringe for manipulating fluids and materials, not a device designed to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on the properties of the aspirated fluids.
The device is clearly intended for surgical procedures involving the collection and delivery of materials within a patient's body.
N/A
Intended Use / Indications for 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 graft material to the orthopedic surgical site.
Product codes
FMF
Device Description
The VACLOK™ Syringe is a polycarbonate piston syringe modified to include fins 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopedic surgical site
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)
Not Found
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
Page 1 of 1
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
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.
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.
1
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.
2
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
3
Indications for Use
510(k) Number (if known): K Dio0095
Device Name: VACLOK™ Syringe Kit
Indications For 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 graft material to the orthopedic surgical site.
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)
1 of 1
Barbara Buellun
storative. and Neurological
510(k) Number K060095