The Easy Point™ Needle is intended for use with syringes for general purpose fluid injection and/or aspiration, and venipuncture to obtain blood collection. The EasyPoint™ Needle aids in the prevention of needlestick injuries.

Device Description

The EasyPoint™ Needle is intended for general purpose percutaneous injection or aspiration of fluids and venipuncture to obtain blood collection. The device contains a sharps injury prevention feature (needlestick prevention feature-chamber) that covers the entire needle after use. Initially available in sizes of 23G and 25G x 1" and 25G x 5/8" for use with 3mL syringes or smaller.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the EasyPoint™ Needle:

This device is a Class II medical device (Needle, Hypodermic, Single Lumen), and the submission is a 510(k) Premarket Notification (K133635), indicating a pre-market pathway based on substantial equivalence to existing predicate devices, rather than a de novo approval or PMA which would typically involve more extensive clinical studies and a focus on specific performance metrics. Therefore, the "acceptance criteria" here primarily refer to demonstrating safety and effectiveness by being substantially equivalent to the predicate devices and meeting relevant engineering standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance	Comments
Engineering Performance	ISO 594-1 (Luer fittings)	Performed according to applicable design requirements.	Passed.
	ISO 594-2 (Luer fittings)	Performed according to applicable design requirements.	Passed.
	ISO 7864 (Sterile hypodermic needles)	Performed according to applicable design requirements.	Passed.
	ISO 7886 (Sterile hypodermic syringes)	Performed according to applicable design requirements.	Passed.
	ISO 9626 (Stainless steel needle tubing)	Performed according to applicable design requirements.	Passed.
	Liquid Leakage	Performed according to applicable design requirements.	Passed.
	Air Leakage	Performed according to applicable design requirements.	Passed.
	Dead Space	Performed according to applicable design requirements.	Passed.
	Needle Puncture Force	Performed according to applicable design requirements.	Passed.
	Functionality Force	Additional performance tests developed by Retractable Technologies, Inc.	Passed.
	Deactivation Force	Additional performance tests developed by Retractable Technologies, Inc.	Passed.
	Chamber Strength/Rigidity	Additional performance tests developed by Retractable Technologies, Inc.	Passed.
	Cannula/Hub Bond Strength	Additional performance tests developed by Retractable Technologies, Inc.	Passed.
Biocompatibility	ISO 10993	Acceptable results.	Passed.
Sterilization	ISO 11137 (Sterilization of healthcare products — Radiation)	Sterilization Validation performed to ensure sterility (SAL 10⁻⁶).	Passed.
Human Factors/Usability	Demonstrated safe and effective use by healthcare workers in a simulated use scenario.	Performed safely and effectively.	Passed.
Substantial Equivalence	Comparison to predicate devices (VanishPoint® Syringe and BD PrecisionGlide® single lumen needle) based on intended use, technology, and performance.	Devices are substantially equivalent; no new issues of safety and effectiveness raised.	Conclusion reached by applicant and affirmed by FDA.

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

Engineering Testing: The text does not specify the exact sample sizes for each engineering test (e.g., how many needles were tested for liquid leakage). It generally states that "Performance testing... was performed according to applicable design requirements" and "Additional performance tests were developed."
Simulated Use Study: The text does not specify the exact sample size (number of healthcare workers) for the simulated use study.
Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Retractable Technologies, Inc. The nature of the studies (engineering, simulated use) suggests prospective data collection for the purpose of this submission.
Biocompatibility & Sterilization: These are standard laboratory tests, and sample sizes are typically defined by the specific ISO standards.

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

Engineering Testing: Ground truth is established by the defined engineering standards (ISO) and the measurement systems used. No external experts are mentioned for establishing ground truth beyond standard engineering practices.
Simulated Use Study: The study involved "a variety of healthcare workers." The number and specific qualifications (beyond "healthcare workers") are not provided. The ground truth here would be the observed safe and effective use of the device by these users.

4. Adjudication Method for the Test Set:

Not applicable in the traditional sense for this type of submission. The performance against engineering standards is objective. For the simulated use study, the assessment would likely be observational, without a formal adjudication committee as might be found in a clinical trial.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic imaging devices where multiple readers interpret cases to assess diagnostic accuracy with and without AI assistance. The EasyPoint™ Needle is a medical device for fluid injection, aspiration, and blood collection, not a diagnostic imaging tool.

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

Not applicable. This device is a manual device (hypodermic needle) with a passive safety mechanism. There is no "algorithm" or AI component to assess standalone performance for. The "safety feature" is mechanical and integrated into the design.

7. Type of Ground Truth Used:

Engineering Testing: Defined by international standards (ISO) and internal test protocols.
Biocompatibility: Defined by ISO 10993 standards and laboratory results.
Sterilization: Defined by ISO 11137 standards and validation results.
Simulated Use Study: Observational assessment of safe and effective use by target users (healthcare workers).

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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K133635

- JUN 1-7-2014`

6/16/14

ﺎ

PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR VANISHPOINT® BLOOD COLLECTION SET (21 CFR 807.92)

Applicant Name:	Retractable Technologies, Inc.511 Lobo LaneLittle Elm, TX 75068
Phone:	972-294-1010
Contact Person:	Rhonda WellsRegulatory Affairs Manager
Date of Summary Preparation:	June 16, 2014
Trade Name:	EasyPoint™ Needle
Common Name:	Needle, Hypodermic, Single Lumen
Regulation Number:	880.5570
Product Code	FMI: Hypodermic Single Lumen Needle
Device Classification:	Class II
Legally Marketed Substantially Equivalent Device:
	K021475 - BD Single Lumen Needle (PrecisionGlide™)K970803 - VanishPoint® Syringe
Description of Device:	The EasyPoint™ Needle is intended for general purposepercutaneous injection or aspiration of fluids and venipuncture toobtain blood collection.The device contains a sharps injury prevention feature (needlestickprevention feature-chamber) that covers the entire needle after use.Initially available in sizes of 23G and 25G x 1" and 25G x 5/8" foruse with 3mL syringes or smaller.
Intended Use:	The Easy Point™ Needle is intended for use with syringesfor general purpose fluid injection and/or aspiration, andvenipuncture to obtain blood collection.The EasyPoint™ Needle aids in the prevention of needlestickinjuries.
Engineering Testing:	Performance testing on the EasyPoint™ Needle was performedaccording to applicable design requirements of ISO 594-1, ISO 594-2, ISO 7864, ISO 7886 and ISO 9626. Those tests include, liquidleakage, air leakage, dead space and needle puncture force.Additional performance tests were developed by RetractableTechnologies, Inc. to measure the functionality force, deactivationforce, chamber strength/ rigidity, cannula/ hub bond strength.
Simulated Use Study:	A simulated use pre-market study was performed to demonstratethrough human factors validation testing that the EasyPoint™ Needle

す

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device performs safely and effectively when used by a variety of healthcare workers in a simulated use scenario.

Comparison of Technical Characteristics:

The subject EasyPoint™ Needle utilizes a retraction based safety mechanism like the predicate device VanishPoint® Syringe. The 2nd predicate device, BD PrecisionGlide® single lumen needle is available as a stand-alone needle but does not have an integrated safety mechanism. The BD single lumen needle is also available as a needle/barrel combination syringe. The EasyPoint™ Needle will initially be sold as a stand-alone needle for use with luer fitting devices. The VanishPoint® Syringe and BD single lumen needle are commercially available in various needle length and gauge sizes. Biocompatibility testing has been performed on the EasyPoint™ Needle in accordance with ISO 10993 with acceptable results.

Substantial Equivalence:

Conclusion:

The operation, similar design and materials between the subject device and the predicate devices do not raise new issues of safety and effectiveness when used as labeled: The intended use of the subject and predicate devices is virtually identical. In engineering testing, the subject device performed as well or better than the predicate devices. The Simulated Use Study demonstrates that the subject device will perform as intended. The necessary Biocompatibility testing was performed with acceptable results and a Sterilization Validation was performed according to ISO 11137 to ensure sterility of (SAL 106). It is our opinion that the devices are substantially equivalent.

The EasyPoint™ Needle is substantially equivalent to the Vanish Point® Syringe and BD PrecisionGlide® single lumen needle. The intended uses are the same No new concerns regarding safety and effectiveness were raised.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 17, 2014

Retractable Technologies, Incorporated Ms. Rhonda Wells Regulatory Affairs Manager 511 Lobo Lane Little Elm, TX 75068

Re: K133635

Trade/Device Name: EasyPoint™ Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, Hypodermic, Single Lumen Regulatory Class: Il Product Code: FMI Dated: March 18, 2014 Received: March 19, 2014

Dear Ms. Wells:

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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Page 2 - Ms. Wells

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mary Runner
-S FILA

Erin I. Keith, M.S. 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: January 31, 2017 Sea PRA Statement below.

510(k) Number (if known) KI33632

Device Name

Easy Point Needle

Indications for Use (Describe)

The Easy Point Needle is intended for use with syringes for general purpose fluid injections and venipuncture to obtain blood collection.

The Easy Point Needle aids the prevention of needlestick injuries.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE CHIP STORE CONTRACTOR FOR FOR FOR FOR FOR FOR CONTRACTOR CONTRACTOR COLLECT

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman -S Date: 2014.06.16 09:35:17 -04'00'

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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).