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.

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

AI/ML Overview

The Medigard Blood Collection Device is a medical device designed to provide a safe and reliable method for collecting blood samples from a patient using standard evacuated blood collection tubes. Its primary function is to prevent accidental needle stick injuries to healthcare workers during and after the blood collection procedure. The device achieves this by retracting the needle into an evacuated sharps collection tube at the end of the procedure, making the needle inaccessible.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided text does not explicitly state quantitative acceptance criteria or detailed performance metrics. However, it indicates that the device must demonstrate safety and effectiveness, specifically in preventing needle sticks. The performance is assessed relative to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Prevention of accidental needle stick injuries.	Designed to prevent accidental needle stick injuries. Needle retracted via vacuum and cannot be accessed after retraction. (Demonstrated through Bench Testing and Simulated Use testing)
Effectiveness: Ability to enable withdrawal of blood samples.	Facilitates blood withdrawal from a patient into evacuated blood collection tubes. (Demonstrated through Bench Testing and Simulated Use testing)
Equivalence to Predicate Device: Similar intended use, materials, design (retraction of needle), where used, and target population.	Confirmed similar intended use, materials (plastic vs. plastic/metal), design (retraction of needle), healthcare facilities, and healthcare professionals. The difference in retraction mechanism (vacuum vs. spring) did not raise new safety/effectiveness questions.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states: "Bench Testing and Simulated Use testing were performed." However, it does not provide details on the sample size used for these tests.
The data provenance is not explicitly mentioned (e.g., country of origin). The testing type ("Bench Testing and Simulated Use testing") suggests controlled experimental conditions rather than real-world patient data. It is highly likely these were prospective tests designed for regulatory submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts used or their qualifications for establishing ground truth. Since the device's primary function is mechanical (needle retraction), ground truth would likely be established through objective observation and measurement of the retraction mechanism's functionality and the safe containment of the needle, rather than subjective expert interpretation, as would be the case for diagnostic imaging.

4. Adjudication Method for the Test Set:

Given the nature of the device (mechanical function for safety), there is no indication of an adjudication method like 2+1 or 3+1. Performance would likely be determined by direct observation of successful needle retraction and secure containment, with pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation is a critical component, to assess the impact of AI on reader performance. The Medigard Blood Collection Device is a mechanical safety device, not a diagnostic one.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The concept of "standalone performance" typically applies to AI algorithms that operate without human intervention. While the Medigard device's safety feature (needle retraction) is activated by the user, the retraction mechanism itself operates independently once triggered. The "Simulated Use testing" would assess this standalone mechanical performance. However, there's no explicit mention of an "algorithm only" study as that term is specific to AI. The testing performed focused on the device's mechanical function and safety features.

7. Type of Ground Truth Used:

The ground truth for this type of device would primarily be established through objective observation of the device's mechanical function and safety features. This would involve:

Successful needle retraction: Verifying that the needle retracts fully and effectively.
Secure containment: Confirming that the retracted needle is inaccessible and cannot cause a stick injury.
Usability: Assessing if the device can be used successfully for blood collection.

This is not a diagnostic device, so ground truth would not be pathology, outcomes data, or expert consensus on clinical findings.

8. Sample Size for the Training Set:

The document discusses "Bench Testing and Simulated Use testing" which are verification and validation tests, not machine learning model training. Therefore, there is no concept of a "training set" in the context of this device.

9. How the Ground Truth for the Training Set Was Established:

As there is no training set for this device (it's a mechanical device, not an AI/ML algorithm), this question is not applicable.

Summary

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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

807.92(a)(4)

807.92(a)(2)

807.92(a)(3)

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DEVICE INTENDED USE

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 CollectionTube Holder
Intended Use	Medical device to enable towithdrawal of blood samples from apatient The device is designed toprevent accidental needle stickinjuries during and after theprocedure The needle is retracted viaa vacuum, and can not be accessedafter retraction	Medical device to enablewithdrawal of blood samplesfrom a patient The device isdesigned to prevent accidentalneedle stick injuries The needleis retracted via a springmechanism
Material Composition	Plastic	Plastic and metal
Device Components	Two Components1 Collection tube for blood collection2 Vac tube for safety feature	One Component1 Collection tube with springmechanism
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 FeatureActivation Mechanism	A separate (Medigard) evacuatedcollection tube is inserted into theTube Holder to initiate activationThis couples with & releases the hub(containing needle) allowing it to beretracted into the tube via vacuumThe tube is automatically locked intothe holder preventing further access tothe needle	A cap at the opening of the TubeHolder is pressed closed todislocate the hub (containingneedle) This allows the spring todrive the hub into the rear of theholder thereby sheathing theneedle
Disposable volume i.e.Space occupied in asharps 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 ●

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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

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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

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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

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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)

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(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)
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Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K082511
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Regulation Number and Section

§ 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).