The EasyPoint® Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure.

Device Description

The EasyPoint® Blood Collection Plus is a blood collection tube holder with an attached needle, and is intended to facilitate blood collection from patients. The device contains a sharps injury prevention feature (needlestick prevention feature - chamber, utilizing automated retraction technology) which covers the entire needle when activated. The EasyPoint® Blood Collection Plus aids in the prevention of needlestick injuries during normal handling and disposal, and prevents re-use of a contaminated needle. The EasyPoint® Blood Collection Plus allows for multiple sample draws from a single venipuncture. After blood collection is complete, the retraction mechanism is activated and the device disassembles itself by retracting the contaminated needle into the safety chamber. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. The safety mechanism can be activated using one step and allows the user's hands to remain behind the sharp during activation.

AI/ML Overview

This document is a 510(k) summary for the EasyPoint® Blood Collection Plus device, which is a blood collection tube holder with an attached needle and aims to prevent needlestick injuries. The document describes the device, its intended use, comparison to a predicate device (Vacutainer® Eclipse™ Blood Collection Needle), and performance data to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a direct table of "acceptance criteria" with a corresponding "reported device performance" per se. Instead, it describes various types of performance testing conducted and states that the device "meets requirements for its intended use" based on the results.

Here's an attempt to infer and organize the information into a table format based on the "VII. PERFORMANCE DATA" section:

Performance Test Category	Acceptance Criteria (Inferred from Test Type)	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1, ISO 14971, and FDA Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1" (i.e., non-cytotoxic, non-sensitizer, non-irritant, non-pyrogenic, non-hemolytic, no acute systemic toxicity).	"It was found to be non-cytotoxic, a non-sensitizer, a non-irritant, nonpyrogenic, non-hemolytic, and to not produce acute systemic toxicity."
Mechanical Testing	Compliance with applicable design requirements of ISO 7864 and ISO 9626. Performance tests for functionality (retraction) force, needle pullout force, rubber sleeve pullout force, needle cap separation force, puncture/penetration force, and no leak under pressure.	"Engineering and performance testing on the EasyPoint® Blood Collection Plus was performed according to applicable design requirements of ISO 7864 and ISO 9626. Performance tests were developed by Retractable Technologies, Inc. to measure the functionality (retraction) force, needle pullout force, rubber sleeve pullout force, needle cap separation force, puncture/penetration force, and to verify that the device does not leak under pressure." (The document states these tests were performed, implying successful meeting of criteria for each, but doesn't provide specific numerical results or thresholds).
Simulated Use Study	Device performs safely and effectively when used by a variety of healthcare workers in a simulated use scenario; comparable to currently legally marketed blood collection tube holders with regards to safety, ease of use, effective use, needlestick prevention, and device functionality.	"The study showed that the EasyPoint® Blood Collection Plus is comparable to currently legally marketed blood collection tube holders with regards to safety, ease of use. effective use, needlestick prevention, and device functionality."
Sterilization Validation	Compliance with ISO 11135 and achievement of a Sterility Assurance Level (SAL) of 10-6.	"Sterilization validation was performed according to ISO 11135...demonstrated that the sterilization process continues to be effective and to meet the sterility assurance level (SAL) of 10-6."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document mentions "Simulated Use Study" and "Mechanical Testing," but it does not explicitly state the numerical sample size for any of these tests. It refers to "Additional details and reports can be found in the body of this submission," implying these numbers would be in the full submission.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. The "Simulated Use Study" sounds like a prospective human factors validation study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: For the "Simulated Use Study," the document mentions "a variety of healthcare workers." It does not specify the number of experts or readers.
Qualifications of Experts: It refers to "healthcare workers," but does not detail their specific qualifications (e.g., years of experience, specific roles).

4. Adjudication method for the test set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set, especially in the context of user studies or performance evaluations requiring subjective assessments. Since these are performance tests for a physical device, and not an AI model, expert consensus or adjudication in the traditional sense might not apply in the same way.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This document is for a physical medical device (blood collection tube holder with needlestick prevention), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

As stated above, this is a physical device, not an algorithm. Therefore, a standalone performance evaluation of an algorithm does not apply and was not done. The mechanical and sterilization tests would be closest to "standalone" in that they test the device's inherent properties.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For a physical device, "ground truth" is established differently than for diagnostic algorithms.

Biocompatibility: Ground truth is established by adherence to recognized ISO standards and FDA guidance, and the results of laboratory tests.
Mechanical Testing: Ground truth is established by engineering specifications, ISO standards (ISO 7864, ISO 9626), and internal performance test criteria validated by the manufacturer (e.g., force measurements, leak tests).
Simulated Use Study: Ground truth is established by observed performance of the device by healthcare workers against predefined safety, ease of use, and functionality metrics, with comparability to legally marketed predicate devices. This involves observed user actions and outcomes.
Sterilization Validation: Ground truth is established by adherence to ISO standards (ISO 11135) and achieving the specified sterility assurance level (SAL).

8. The sample size for the training set

This document is for a physical device, not an AI model. Therefore, there is no "training set" in the AI sense.

9. How the ground truth for the training set was established

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

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Retractable Technologies, Inc. Becky Piroga Regulatory Affairs Manager 511 Lobo Lane Little Elm. Texas 75068

Re: K202325

Trade/Device Name: EasyPoint Blood Collection Plus Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA. FMI Dated: March 1, 2021 Received: March 9, 2021

Dear Becky Piroga:

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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

James M. Simpson Jr

-57

for Paval Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K202325

Device Name EasyPoint® Blood Collection Plus

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K202325 510(k) SUMMARY EASYPOINT® BLOOD COLLECTION PLUS (21 CFR 807.92)

I. SUBMITTER	Retractable Technologies, Inc.511 Lobo LaneLittle Elm, TX 75068
FDA Registration:	1647137
Phone:	972-294-1010
Fax:	972-294-4400
Contact Person:	Becky Piroga, Regulatory Affairs Manager
Date Prepared:	November 15, 2019
II. DEVICE
Name of Device:	EasyPoint® Blood Collection Plus
Common Name:	Blood collection tube holder with attached needle
Classification Name:	-Tubes, vials, systems, serum separators, blood collection (21CFR 862.1675)
Regulatory Class:	II
Product Codes:	JKA, FMI
510k Number:	K202325

IV. DEVICE DESCRIPTION

III. PREDICATE DEVICE

K982541 - Vacutainer® Eclipse™ Blood Collection Needle

The EasyPoint® Blood Collection Plus allows for multiple sample draws from a single venipuncture. After blood collection is complete, the retraction mechanism is activated and the device disassembles itself by retracting the contaminated needle into the safety chamber. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. The safety mechanism can be activated using one step and allows the user's hands to remain behind the sharp during activation.

V. INDICATIONS FOR USE

The device contains a sharps injury prevention feature which covers the entire needle when activated. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. VI. COMPARISON TO THE PREDICATE DEVICE

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Feature	Subject Device:EasyPoint® BloodCollection Plus	Predicate Device:Vacutainer® Eclipse™Blood Collection Needle	Comparison
Device ClassificationName	Hypodermic single lumenneedle	Hypodermic single lumenneedle	Same
Regulatory Class	II	II	Same
FDA Product Code	JKA, FMI	FMI	Same, with additionalcategory (blood collection)
Intended Use	Intended for use withevacuated blood collectiontubes for venous bloodcollection, while aiding inthe prevention ofneedlestick injuries andcontaminated needleexposure.	Designed for use withVacutainer® BloodCollection NeedleHolders in performingvenipuncture to obtainblood samples.	Same, except theEasyPoint® BloodCollection Plus is alreadyattached to a bloodcollection tube holder (noneed for a separateaccessory device).*Comparison tests wereperformed usingVacutainer® Eclipse™Blood Collection Needlewith Pre-attached Holder.
Indications for Use	May be used for bloodcollection for diagnosticpurposes of any patientpopulation withconsideration given topatient size, perinstitutional protocol.Single Use Only. SuppliedSterile.	May be used for bloodcollection for diagnosticpurposes. Recommendsreferring to institutionalprotocol for venipunctureprocedures; does notrestrict usage to aparticular patientpopulation.Single Use Only.Supplied Sterile.	Same. Neither providescriteria for population-specific use of the product.Both products recommendreferring to institutionalprotocol for appropriatevenipuncture procedures.Both products are suppliedsterile and are indicated forsingle use only. Bothproducts are indicated forblood collection fordiagnostic purposes.
Needle Gauge Sizeused in comparisonstudies	21G x 1 ¼"	21G x 1 ¼"	Same
Additional NeedleGauge Sizes Available	22G x 1 ¼"	22G x 1 ¼"	Same

Materials forComponents inCommon	Needle Cap:Polypropylene	Needle Cap:Polypropylene	Same except for needleholder and needle adhesive.
	Needle Cannula:304 Stainless Steel	Needle Cannula:304 Stainless Steel
	Needle Lubricant:Silicone Lubricant	Needle Lubricant:Silicone Lubricant
	Needle Adhesive:UV Cure Adhesive	Needle Adhesive:Epoxy Resin
	Needle Holder:Polycarbonate	Needle Holder:Polystyrene
	Needle Rubber Sleeve:Synthetic PolyisopreneRubber (not made withnatural rubber latex)	Needle Rubber Sleeve:Synthetic Rubber (notmade with natural rubberlatex)
	Tube Holder:Polypropylene	Tube Holder*:Polypropylene
Materials forComponents thatDiffer	Retraction Spring:304 Stainless Steel	Collar:PolystyreneSafety Shield:Polypropylene	N/A
	Device Body:Polypropylene
	Tube Holder Connector:Polypropylene
Safety Mechanism	Automated RetractionTechnology	Hinged Safety Shield	The EasyPoint® BloodCollection Plus utilizes aretraction safetymechanism, which retractsthe contaminated needleinto a safety chamber usingautomated retractiontechnology. TheVacutainer® Eclipse™Blood Collection Needleutilizes a safety shield safetymechanism, which coversthe contaminated needleafter use using a hingedsafety shield activated withthumb pressure.
Sterilization Method	Ethylene Oxide	Radiation	The sterilization methodsare different, but bothprovide the same level ofsterility assurance. Bothproducts, through validatedsterilization methods to theirrespective ISO standards(ISO 11135 and ISO
			11137), guarantee a SAL of10-6.
Biocompatibility	ISO 10993-1Cytotoxicity, etc [list tests]	ISO 10993-1	Same. Both productsconform to ISO 10993-1,Biological evaluation ofmedical devices –Evaluation and testingwithin a risk managementprocess.
Precautions andSymbols Indicated onPackaging	-Sterile (EO)-Do not re-use-Do not use if package isdamaged-Not Made With NaturalRubber Latex-LOT number-Expiration Date-Non-toxic-Non-pyrogenic-Consult instructions foruse	-Sterile (R)-Do not re-use-Do not use if package isdamaged-Not Made With NaturalRubber Latex-LOT number-Expiration Date-Keep away from sunlight-Caution	Similar. Biocompatibilityand cytotoxicity testing hasbeen performed byRetractable Technologies,Inc. to validate the claims ofNon-toxic and Non-pyrogenic.

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Additional information on performance and material comparison studies can be found in the body of this submission.

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VII. PERFORMANCE DATA

Biocompatibility Testing

A Biological Safety Evaluation (BSE) of the EasyPoint® Blood Collection Plus was conducted in accordance with ISO 10993-1, ISO 14971, and the FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1." It was found to be non-cytotoxic, a non-sensitizer, a non-irritant, nonpyrogenic, non-hemolytic, and to not produce acute systemic toxicity. Additional details and reports can be found in the body of this submission.

Mechanical Testing

Engineering and performance testing on the EasyPoint® Blood Collection Plus was performed according to applicable design requirements of ISO 7864 and ISO 9626. Performance tests were developed by Retractable Technologies, Inc. to measure the functionality (retraction) force, needle pullout force, rubber sleeve pullout force, needle cap separation force, puncture/penetration force, and to verify that the device does not leak under pressure. Additional details and reports can be found in the body of this submission.

Simulated Use Study

A simulated use pre-market study was conducted to demonstrate through human factors validation testing that the EasyPoint® Blood Collection Plus device performs safely and effectively when used by a variety of healthcare workers in a simulated use scenario. The study showed that the EasyPoint® Blood Collection Plus is comparable to currently legally marketed blood collection tube holders with regards to safety, ease of use. effective use, needlestick prevention, and device functionality. Additional details, including the final report from the pre-market study, can be found in the body of this submission.

Sterilization Validation

Sterilization validation was performed according to ISO 11135 = "Sterilization of healthcare products – Ethylene Oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices." The sterilization chamber and process used to sterilize the EasyPoint® Blood Collection Plus has been successfully used for many other products manufactured by Retractable Technologies, Inc. This revalidation to specifically address the addition of the EasyPoint® Blood Collection Plus demonstrated that the sterilization process continues to be effective and to meet the sterility assurance level (SAL) of 10t6. Additional details and reports can be found in the body of this submission.

VIII. CONCLUSION

Results of testing have demonstrated that the EasyPoint® Blood Collection Plus meets requirements for its intended use. The EasyPoint® Blood Collection Plus is substantially equivalent to its predicate device, the Vacutainer® Eclipse™ Blood Collection Needle, The intended uses are the same, the materials are effectively the same, and no new concerns regarding safety and effectiveness were raised during comparison testing.

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.