K Number

Device Name

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

Manufacturer

MYCO Medical Supplies, Inc.

Date Cleared

2018-05-14

(213 days)

Product Code

FMI CLA DEV

Regulation Number

880.5570

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 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. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K113505

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical safety features and user interaction, with no mention of AI or ML algorithms for analysis, prediction, or decision-making.

Therapeutic

Explanation: The device is intended for blood sample collection and prevention of needle stick injuries, not for treating or diagnosing any medical condition. It's an accessory to a venipuncture procedure rather than a therapeutic instrument itself.

Diagnostic

This device is a blood collection tube holder designed to facilitate the withdrawal of blood samples and prevent needle stick injuries. It is an accessory for blood collection and not used for diagnosing diseases or conditions.

SaMD (Software as a Medical Device)

The device description clearly details a physical blood collection tube holder with a safety shield mechanism, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, the RELI® Safety Blood Collection Tube Holder and the RELI® Blood Collection Tube Holder are not IVD (In Vitro Diagnostic) devices.

Here's why:

Intended Use: The intended use is to "enable withdrawal of blood samples from a patient." This is a device used for the collection of a biological sample, not for the testing or analysis of that sample to provide diagnostic information.
Device Description: The description focuses on the physical design and function of the tube holder for safe blood collection and disposal. It does not mention any components or processes related to analyzing the blood itself.
Lack of Diagnostic Function: IVD devices are designed to perform tests on biological samples (like blood) to provide information about a patient's health status, diagnose diseases, or monitor treatment. This device does not perform any such diagnostic function.

The device is a tool used in the process of obtaining a sample that may later be used in an IVD test, but the device itself is not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FMI

Device Description

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.

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 -

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.

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

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)

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
applications - Part 7: Connectors for intravascular or hypodermic
applications Mating with the bidirectional blood collection needle
ASTM F 1980-2007	Standard guide for accelerated aging of sterile barrier systems for
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 with no device failures and no incomplete enclosures of the sharp.

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.

K113505

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

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).

Summary

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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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 PRAStaff@fda.hhs.gov

"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."

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 skumar@mvcomedical.com 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 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 -

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.

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
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.	The VACUETTE®
QUICKSHIELD with
SNAPPY Tube Holder
is to be used together
only with
VACUETTE® Blood
Collection Needles
and VACUETTE®
Blood Collection
Tubes as a system in
routine venipuncture
procedures. These
devices are to be
used by properly
trained healthcare
professionals only in
accordance with
these instructions.	Similar
Material
Holder Material	Polypropylene	Polypropylene	Same
Sharp Safety Feature	Polypropylene	Polypropylene	Same
Safety Feature Design
Principle of Operation	External safety feature
designed to to
fully
encapsulate the needle
by manual activation.
Safety feature spins
180°
for ease
of
positioning during use.	External safety feature
designed to
fully
encapsulate the needle
by manual activation.
Safety feature spins
180°
for ease ease
of
positioning during use.	Same

COMPARISON OF TECHNICAL CHARACTERISTICS

	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
applications - Part 7: Connectors for intravascular or hypodermic
applications Mating with the bidirectional blood collection needle
ASTM F 1980-2007	Standard guide for accelerated aging of sterile barrier systems for
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

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.