(140 days)
K 971763
Not Found
No
The description focuses on mechanical safety features (needle retraction) and does not mention any computational or data-driven capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
A therapeutic device is used to treat or cure a disease or medical condition. This device is for collecting blood samples and preventing needle stick injuries, which are diagnostic and safety functions, not therapeutic ones.
No
The device is described as a "blood collection device" used to "enable withdrawal of blood samples". Its primary function is to safely collect blood, not to diagnose a condition. It is designed to prevent needle stick injuries during the collection process.
No
The device description clearly outlines physical components (blood collection tube holder, evacuated sharps collection tube) and their function in a physical process (blood collection, needle retraction). It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enable withdrawal of blood samples from a patient" and "prevent accidental needle stick injuries." This describes a device used for the collection of a biological sample, not for the testing or analysis of that sample.
- Device Description: The description explicitly states that "Neither part comes into contact with the patient and no fluids flow through the Medigard Blood Collection Device to the patient." It also mentions that "Normal standard blood collection tubes and blood collection needles are used to collect blood samples as per normal standard procedures." This reinforces that the device is a tool for sample collection and safety, not for diagnostic testing.
- Lack of Diagnostic Function: There is no mention of the device performing any kind of test, analysis, or measurement on the blood sample itself. IVD devices are designed to provide information about a patient's health status through the examination of samples.
This device falls under the category of a medical device used for sample collection and safety, specifically designed to prevent needle stick injuries during blood draws. It is not an IVD because it does not perform any diagnostic function on the collected sample.
N/A
Intended Use / Indications for Use
Medical device to enable withdrawal of blood samples from a patient. The device is designed to prevent accidental needle stick injuries. The needle is retracted via a retraction tube.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Medigard Blood Collection Device Consists of two Parts 1) a blood collection tube holder and 2) an evacuated sharps collection tube Netther part comes into contact with the patient and no fluids flow through the Medigard Blood Collection Device to the patient Normal standard blood collection tubes and blood collection needles are used to collect blood samples as per normal standard procedures The device is intended to be used to provide a safe and reliable method of collection of blood samples from a patient using standard evacuated blood collection tubes The device is designed to prevent accidental needle stick injury At the end of the procedure, the needle is retracted into the Medigard evacuated sharps collection tube
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals / Healthcare facilities
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)
Bench Testing and Simulated Use testing were performed
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.
K 971763
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
K08,25'11
510(k) Summary 807.92(c)
JAN 1 6 2009
SPONSOR 807.92(a)(1) MEDIGARD LIMITED Company Name Suite 14A, Tedder Terraces Company Address 26-30 Tedder Avenue Main Beach, 4217 Queensland Australia 61 7 5528 0370 Telephone
Contact Person Dr Peter W Clark
Summary Preparation Date August 25, 2008
DEVICE NAME
- .
Trade Name Common/Usual Name Classification Name Regulation Number: Product Code Device Class
Blood Collection Tube Holder Needle, Hypodermic, Single Lumen CFR21 880 5570 FMI Class II
Medigard Blood Collection Device
PREDICATE DEVICE
Legally Marketed Equivalent Device Company Safe T Medical Devices
Product Blood Collection Tube Holder Vanish Point Small Tube Adapter ' Collection Device
510(k) # K 971763
DEVICE DESCRIPTION
The Medigard Blood Collection Device Consists of two Parts 1) a blood collection tube holder and 2) an evacuated sharps collection tube Netther part comes into contact with the patient and no fluids flow through the Medigard Blood Collection Device to the patient Normal standard blood collection tubes and blood collection needles are used to collect blood samples as per normal standard procedures The device is intended to be used to provide a safe and reliable method of collection of blood samples from a patient using standard evacuated blood collection tubes The device is designed to prevent accidental needle stick injury At the end of the procedure, the needle is retracted into the Medigard evacuated sharps collection tube
807.92(a)(4)
807.92(a)(2)
807.92(a)(3)
16
1
DEVICE INTENDED USE
7
807,92(a)(5)
The function of the Medigard Blood Collection Device is to provide a safe and reliable method for facılıtatıng blood withdrawal from a patient into evacuated blood collection tubes without exposing the healthcare worker to an accidental needle stick injury
COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)
| Features | Medigard Limited | Retractable Technology Inc.
K971763 |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | Medigard Blood Collection Device | Vanish Point® Blood Collection
Tube Holder |
| Intended Use | Medical device to enable to
withdrawal of blood samples from a
patient The device is designed to
prevent accidental needle stick
injuries during and after the
procedure The needle is retracted via
a vacuum, and can not be accessed
after retraction | Medical device to enable
withdrawal of blood samples
from a patient The device is
designed to prevent accidental
needle stick injuries The needle
is retracted via a spring
mechanism |
| Material Composition | Plastic | Plastic and metal |
| Device Components | Two Components
1 Collection tube for blood collection
2 Vac tube for safety feature | One Component
1 Collection tube with spring
mechanism |
| Product Design - Safety | Safety feature activated by user | Safety feature activated by user |
| Feature Mode of | Needle retracted via vacuum and can | Needle retracted by a spring |
| Operation | not be accessed after retraction | mechanism |
| Product Design -
Safety Feature
Activation Mechanism | A separate (Medigard) evacuated
collection tube is inserted into the
Tube Holder to initiate activation
This couples with & releases the hub
(containing needle) allowing it to be
retracted into the tube via vacuum
The tube is automatically locked into
the holder preventing further access to
the needle | A cap at the opening of the Tube
Holder is pressed closed to
dislocate the hub (containing
needle) This allows the spring to
drive the hub into the rear of the
holder thereby sheathing the
needle |
| Disposable volume i.e.
Space occupied in a
sharps container | Approx 28cc | Approx 35cc |
| Sterilization | Non-sterile | Non-sterile |
| Biocompatibility | Device does not contact patient | Device does not contact patient |
Substantial Equivalence Discussion of Sımilarities and Differences:
The Medigard Blood Collection Device is similar to the Vanish Point Blood Collection Tube Holder in
- Intended Use prevention of needle sticks by the safe retraction of the needle .
- Materials plastic (Medigard), plastic/metal (Vanish Point) .
- Design Retraction of Needle ●
2
- Where used Healthcare facılıtıes o
- Target Population Healthcare professionals .
- Performance Testing -Bench Testing and Simulated Use Testing o
Differences
1-7
- · Method of Retraction Vacuum (Medigard) Spring mechanism (Vanısh Poınt)
The Medigard Blood Collection Device introduces no new questions concerning the safety or effectiveness and is thus substantially equivalent to the predicate device
SAFETY and EFFECTIVENESS 807.92(b)
Bench Testing and Simulated Use testing were performed
3
Image /page/3/Picture/1 description: The image shows a logo with a stylized eagle design. The eagle is composed of three thick, curved lines that suggest the wings and body. The logo is encircled by text that reads "HUMAN SERVICES USA". The text is arranged in a circular fashion around the eagle, with the words "HUMAN" and "SERVICES" at the top and "USA" at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2009
Medigard Limited C/O Mr E J Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114
Re K082511
Trade/Device Name Medigard Blood Collection Device Regulation Number 21 CFR 880 5570 Regulation Name Hypodermic Single Lumen Needle Regulatory Class II Product Code FMI Dated December 7, 2008 Received December 11, 2008
Dear Mr Smith
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 undications 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 provise 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 800 In addition, FDA may publish further announcements concerning your device in the Federal Register
4
Page 2 - Mr Smith
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
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115 Also, please note the regulation entitled, "Misbranding by 1eference to premarket notification" (21CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the 1eporting of device adverse events (Medical Device Reporting (MDR)), please contact the DIVISION of Surveillance Systems at 240-276-3464 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,
Anthony E. Watson Jr.
Ginette Y Michaud, M D Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K082511
Device Name: Medigard Blood Collection Device
Indications For Use:
Medical device to enable withdrawal of blood samples from a patient. The device is designed to prevent accidental needle stick injuries. The needle is retracted via a retraction tube.
Prescription Use V (Part 21 CFR 801 Subpart D) .
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
","
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K082511 |
|---|---|
| ---------------- | --------- |