RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder

K173279 · Myco Medical Supplies, Inc. · FMI · May 14, 2018 · General Hospital

Device Facts

• Record ID: K173279
• Device Name: RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
• Applicant: Myco Medical Supplies, Inc.
• Product Code: FMI · General Hospital
• Decision Date: May 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The RELI® Safety Blood Collection Tube Holder and the RELI® Blood Collection Tube Holder are intended to enable withdrawal of blood samples from a patient. The RELI® Safety Blood Collection Tube Holder is designed to prevent accidental needle stick injuries.

Device Story

Device is a manual blood collection tube holder used during routine venipuncture; compatible with conventional multi-sample needles (up to 1.5"). Safety version includes a user-activated shield to encapsulate the needle post-procedure, preventing accidental needle sticks. Activation occurs via one-handed thumb press or by pressing against a stable surface; audible click confirms engagement. Used in clinical settings by healthcare professionals. Device does not contact the patient. Benefits include reduced risk of sharps injuries for clinicians during disposal.

Clinical Evidence

Bench testing only. Simulated use testing performed with 500 samples by intended users; 100% success rate in needle encapsulation with no device failures. Accelerated aging testing conducted per ASTM F 1980-2007 for 3 and 5-year intervals.

Technological Characteristics

Material: Polypropylene. Form factor: Tube holder with integrated manual safety shield. Connectivity: None. Energy source: Manual. Sterilization: Non-sterile. Compatibility: Standard multi-sample needles up to 1.5 inches. Standards: ISO 80369-7 (connectors), ASTM F 1980-2007 (accelerated aging).

Indications for Use

Indicated for use by healthcare professionals to enable blood sample withdrawal from patients via venipuncture, utilizing conventional multi-sample needles up to 1.5 inches in length.

Regulatory Classification

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.

Predicate Devices

• VACUETTE QUICKSHIELD with SNAPPY Tube Holder (K113505)

Reference Devices

• VACUETTE Blood Collection Needle with View Window (K061483)
• VACUETTE Multi-Sample Needles (K973620)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym and full name are written in blue.

May 14, 2018

MYCO Medical Supplies, Inc. % E. J. Smith Smith Associates 1468 Harwell Ave. Crofton. Maryland 21114

Re: K173279

Trade/Device Name: RELI® Safety Blood Collection Tube Holder and RELI® Blood Collection Tube Holder Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle

Regulatory Class: Class II Product Code: FMI Dated: April 10, 2018 Received: April 13, 2018

Dear E. J. 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 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{1}------------------------------------------------

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K173279

Device Name

RELI® Safety Blood Collection Tube Holder and RELI® Blood Collection Tube Holder

#### Indications for Use (Describe)

The RELI® Safety Blood Collection Tube Holder and the RELI® Blood Collection Tube Holder are intended to enable withdrawal of blood samples from a patient.

The RELI® Safety Blood Collection Tube Holder is designed to prevent accidental needle stick injuries.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete. and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# K173279 510k Summary

## SPONSOR

Company Name: Company Address:

Telephone: Fax:

Contact Person: Title: Email Summary Preparation Date:

## DEVICE NAME

Trade Name:

Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class: Classification Panel:

## PREDICATE DEVICE

Trade name:

510k: Common /Usual Name: Regulation Number: Regulation Name: Regulatory Class: Product Code: Classification Panel:

MYCO Medical 2015 Production Drive Apex, NC 27539

919-460-2535 919-460-2536

Sanjiv Kumar President & CEO [e-mail] September 29, 2017

RELI® Safety Blood Collection Tube Holder and RELI® Blood Collection Tube Holder Evacuated Blood Collection Tube Holder Needle, Hypodermic, Single Lumen 21 CFR 880.5570 FMI II General Hospital

VACUETTE QUICKSHIELD with SNAPPY Tube Holder K113505 Evacuated Blood Collection Tube Holder 21 CFR 880.5570 Needle, Hypodermic, Single Lumen II FMI General Hospital

## DEVICE DESCRIPTION

The RELI® Safety Blood Collection Tube Holder and RELI® Blood Collection Tube Holder are intended to be used in combination with conventional multiple sample blood collection needles (up to 1 ½" in length) and vacutainers for safe handling and disposal immediately following routine venipuncture procedures.

The Safety Blood Collection Tube Holder is designed with a user activated safety shield to cover the needle immediately following venipuncture procedure to help prevent needle stick injuries and safely dispose of the device in compliance with OSHA requirements.

{4}------------------------------------------------

The safety shield can be activated by gently pressing the shield toward the needle in one of two ways without the need for user to approach the sharp end:

- 1) Press shield toward exposed needle on a stable surface or -
2) With thumb behind the shield, press shield onto exposed needle.

An audible click is heard when the safety shield has been properly activated and the Safety Blood Collection Tube Holder with enclosed needle is safe to discard.

The Safety Blood Collection Tube Holder is clear with safety shield available in clear, blue, or orange color options. The Blood Collection Tube Holder is clear. The devices can be used with conventional multi-sample needles up to 1 ½ inches in length.

## DEVICE INDICATIONS FOR USE

The RELI® Safety Blood Collection Tube Holder and the RELI® Blood Collection Tube Holder are intended to enable withdrawal of blood samples from a patient.

The RELI® Safety Blood Collection Tube Holder is designed to prevent accidental needle stick injuries.

| Parameter | Subject Device | Predicate Device | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K173279 | K113505 | |
| Indications for Use | The RELI® Safety<br>Blood Collection<br>Tube Holder and the<br>RELI® Blood<br>Collection Tube<br>Holder are intended<br>to enable withdrawal<br>of blood samples<br>from a patient.<br>The RELI® Safety<br>Blood Collection<br>Tube Holder is<br>designed to prevent<br>accidental needle<br>stick injuries. | The VACUETTE®<br>QUICKSHIELD with<br>SNAPPY Tube Holder<br>is to be used together<br>only with<br>VACUETTE® Blood<br>Collection Needles<br>and VACUETTE®<br>Blood Collection<br>Tubes as a system in<br>routine venipuncture<br>procedures. These<br>devices are to be<br>used by properly<br>trained healthcare<br>professionals only in<br>accordance with<br>these instructions. | Similar |
| Material | | | |
| Holder Material | Polypropylene | Polypropylene | Same |
| Sharp Safety Feature | Polypropylene | Polypropylene | Same |
| Safety Feature Design | | | |
| Principle of Operation | External safety feature<br>designed to to<br>fully<br>encapsulate the needle<br>by manual activation.<br>Safety feature spins<br>180°<br>for ease<br>of<br>positioning during use. | External safety feature<br>designed to<br>fully<br>encapsulate the needle<br>by manual activation.<br>Safety feature spins<br>180°<br>for ease ease<br>of<br>positioning during use. | Same |

## COMPARISON OF TECHNICAL CHARACTERISTICS

{5}------------------------------------------------

| | A one-handed activation by thumb or pressing the safety shield on the needle on a flat surface. | A one-handed activation by thumb or pressing the safety shield on the needle on a flat surface. | |
|---------------------------------|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Sharp Activation Feature | Stable surface or thumb | Stable surface or thumb | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Needle Recommendation and sizes | For use with conventional multi-sample needles up to 1 ½ inches in length. | For use only with VACUETTE® Blood Collection Needle with View Window (K061483) and VACUETTE® Multi-Sample Needles (K973620). | Same except the RELI® can be used with standard blood collection needles not to exceed 1 ½" in length |
| Biocompatibility | Device does not contact patient | Device does not contact patient | Same |

Discussion of Similarities and Difference:

Similarities:

The RELI® Safety Blood Collection Tube Holder is similar to the predicate device in Indications for Use, Principle of Operation of the safety feature and technological characteristics.

# Differences:

The RELI® Safety Blood Collection Tube Holder differs from the predicate device in the use of standard multi sample needles not to exceed 1½" length rather than a proprietary needle supplied with the holder. The difference does not introduce different questions of safety and effectiveness.

# Performance Testing - Non-Clinical

The following performance testing was conducted on the RELI® Safety Blood Collection Tube Holder to demonstrate substantial equivalence of the subject device K173279.

| Standard | Title |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 80369-7 | Small-bore connectors for liquids and gases in healthcare<br>applications - Part 7: Connectors for intravascular or hypodermic<br>applications Mating with the bidirectional blood collection needle |
| ASTM F 1980-2007 | Standard guide for accelerated aging of sterile barrier systems for<br>medical devices. (Sterility) Safety Blood Collection Device – 3 year accelerated aging Safety Blood Collection Device – 5 year accelerated aging |

Performance Simulated use testing by the intended users was completed using 500 samples of the RELI® Safety Blood Collection Tube Holder with 100% successful use

{6}------------------------------------------------

with no device failures and no incomplete enclosures of the sharp.

# CONCLUSION

Based upon the technology characteristics and safety performance testing, it is the conclusion of MYCO Medical Supplies, Inc., that the RELI® Safety Blood Collection Tube Holder and the RELI® Blood Collection Tube Holder are substantially equivalent to the predicate device.