(213 days)
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 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:
- 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.
The provided text describes a 510(k) premarket notification for a medical device (blood collection tube holders) and provides a summary of its characteristics and limited performance testing. However, it does not include the detailed type of information you've requested about acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/human-in-the-loop system.
The document is for a Class II medical device (Hypodermic Single Lumen Needle accessory) – a physical blood collection tube holder – not an AI/software as a medical device (SaMD) or a device that directly leverages AI for diagnostic or treatment purposes. Therefore, the concepts of "ground truth," "expert consensus," "MRMC studies," "training set," or "AI assistance" are not applicable to this particular FDA submission.
The "Performance Testing - Non-Clinical" section details physical performance tests relevant to a blood collection tube holder, such as:
- ISO 80369-7: Mating with bidirectional blood collection needle.
- ASTM F 1980-2007: Accelerated aging for sterility (though the device itself is non-sterile, the packaging would need to maintain sterility if it were a sterile product).
- Simulated Use Testing: 500 samples with 100% successful use, no device failures, and no incomplete enclosures of the sharp. This appears to be a functional test rather than a clinical study.
Therefore, it is not possible to fill out the requested table or answer the questions based on the provided document because the document describes a physical medical device and its mechanical/functional testing, not an AI-powered device or a study involving human readers or AI performance metrics.
The document's purpose is to demonstrate substantial equivalence to a predicate device based on similar indications, technology, and performance, primarily concerning the physical characteristics and safety mechanism of the blood collection tube holder.
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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.
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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
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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.
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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 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.
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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:
-
- 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.
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® SafetyBlood CollectionTube Holder and theRELI® BloodCollection TubeHolder are intendedto enable withdrawalof blood samplesfrom a patient.The RELI® SafetyBlood CollectionTube Holder isdesigned to preventaccidental needlestick injuries. | The VACUETTE®QUICKSHIELD withSNAPPY Tube Holderis to be used togetheronly withVACUETTE® BloodCollection Needlesand VACUETTE®Blood CollectionTubes as a system inroutine venipunctureprocedures. Thesedevices are to beused by properlytrained healthcareprofessionals only inaccordance withthese instructions. | Similar |
| Material | |||
| Holder Material | Polypropylene | Polypropylene | Same |
| Sharp Safety Feature | Polypropylene | Polypropylene | Same |
| Safety Feature Design | |||
| Principle of Operation | External safety featuredesigned to tofullyencapsulate the needleby manual activation.Safety feature spins180°for easeofpositioning during use. | External safety featuredesigned tofullyencapsulate the needleby manual activation.Safety feature spins180°for ease easeofpositioning during use. | Same |
COMPARISON OF TECHNICAL CHARACTERISTICS
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| 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 healthcareapplications - Part 7: Connectors for intravascular or hypodermicapplications Mating with the bidirectional blood collection needle |
| ASTM F 1980-2007 | Standard guide for accelerated aging of sterile barrier systems formedical 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
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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.
§ 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).