The safety blood collection needle without a needle holder is intended to be used with a vacuum blood collection tube to collect venous blood. The safety shield is intended to protect against accidental needle stick injury.

Device Description

The proposed device is a blood collection device to form a channel between the patient's vein and the evacuated blood collection tube intended for blood collection. The Pipe pluq piercing needle is designed with a rubber cap, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needle stick injury. The product is to be used by appropriately trained healthcare professionals only in accordance with these instructions. The Safety blood collection needles without needle holders are manufactured from tubular stainless steel sharpened at both ends that are attached as follows:

-The threaded hub has one side that is to connect with the needle holder, which is used to guide the needle into a vacuum blood collection tube. This end of the needle is shorter and fitted with a rubber cap and a needle hub.
-The opposite end of the needle tube is 3/4"-1 1/2" for blood collection and is fitted with a protective sleeve.
The needle hub and protective cap protect the needle tube.
The safety feature is easily operated through the release of a latch mechanism whereby the user slides a safety shield over the needle as it is removed from the patient. Once the needle is covered, the safety shield locks in place. This mechanism is substantially equivalent to that of the predicate device.
The devices are packaged as sterile, single-use, and single-patient use only.
The proposed device is comprised of the components listed below:
1. Bottom sheath
1. Rubber cap
1. Needle hub
1. Connecting base
1. Safety shield
1. Needle tube
1. Upper sheath

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Safety Blood Collection Needle (Without Needle Holder)". This notification primarily focuses on establishing "substantial equivalence" to a predicate device, rather than providing detailed acceptance criteria and a comprehensive study report in the way scientific literature or a clinical trial would. Therefore, some of the requested information, particularly regarding specific numerical performance metrics, sample sizes for test/training sets, expert qualifications, and effect sizes for AI, is either not applicable or not explicitly stated in the document.

Based on the provided text, here's an analysis of the acceptance criteria and supporting information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with applicable international standards (ISO, AAMI, ASTM) and demonstrating performance equivalent to the predicate device. The reported performance is generally stated as "Complies with" or "Identical," implying that the device met the requirements of these standards. Exact numerical values for performance are not typically included in a 510(k) summary unless there's a specific, quantifiable, and comparative requirement to highlight.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Performance (e.g., needle sharpness, strength)	Complies with ISO 9626 (Stainless steel needle tubing requirements), ISO 7864 (Sterile hypodermic needles requirements), ISO 80369-7 (Small-bore connectors), ISO 80369-20 (Common test methods), ISO 23908 (Sharps injury protection), ISO 6009 (Color coding for identification)
Biocompatibility (tissue interaction, toxicity)	Complies with ISO 10993-1 (Biological evaluation), ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Intracutaneous Reactivity), ISO 10993-11 (Acute Systemic Toxicity, Pyrogen Test), ISO 10993-4 (Hemolytic Properties, Complement activity, Coagulation - PPT Test)
Sterilization Efficacy (elimination of microorganisms)	Complies with ISO 11135-1 (Ethylene oxide sterilization), ISO 11737-1/2 (Microbiological methods), ISO 10993-7 (Ethylene Oxide Residuals), AAMI/ANSI ST72 (Bacterial endotoxins)
Package Integrity & Shelf Life (maintaining sterility)	Complies with AAMI/ANSI/ISO 11137-1 (Radiation sterilization), AAMI/ANSI/ISO 11737-2 (Sterility tests), AAMI/ANSI/ISO 11607-1 (Packaging requirements), ASTM F1929 (Dye Penetration), ASTM F1980 (Accelerated Aging), ASTM D3078 (Bubble Emission), DIN58953-6 (Microbial barrier testing), ASTM F88/F88M (Seal Strength)
Safety Mechanism Effectiveness (prevention of needlesticks)	Identical to predicate: "The safety shield is intended to prevent needle sticks." (Implicitly meets predicate's acceptance for this feature)
Indications for Use	Substantially equivalent to predicate, designed for venous blood collection with vacuum tubes and protection against accidental needle stick injury.
Operating Mode	Identical (Manual)
Sterile Status	Identical (Yes)
Single Patient Use	Identical (Yes)

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

Sample Size: The document does not specify the exact sample sizes used for each performance test. It refers to compliance with standards like ISO and ASTM, which typically outline specific testing methodologies and required sample quantities. For instance, ISO 2859-1 (Sampling procedures for inspection by attributes) is mentioned, indicating statistically derived sample sizes for lot-by-lot inspection, but the actual number of units tested is not reported.
Data Provenance: The testing was non-clinical ("Non-Clinical Performance Testing"). The origin of the data is the manufacturer's testing, conducted to demonstrate compliance with international standards. There is no mention of country of origin for the data itself, only the manufacturer's location (Anhui, China). The data is implicitly "retrospective" in the sense that it was generated for this specific submission to demonstrate compliance.

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

This information is not applicable in the context presented. The document describes a medical device (a blood collection needle), not an AI/ML-based diagnostic system that requires expert interpretation for ground truth establishment. The "ground truth" for this device's performance is objective measurements against established engineering and biological standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or AI/ML evaluations where there might be disagreement among human annotators or evaluators. For the engineering and biological tests described (e.g., tensile strength, sterility, biocompatibility), the results are objective measurements against defined criteria, not subjective interpretations requiring adjudication.

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 information is not applicable. The device is not an AI-assisted diagnostic or interpretation tool. It is a physical medical device (blood collection needle). Therefore, an MRMC study and AI-related effect sizes are irrelevant to this submission.

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

This information is not applicable. The device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on objective measurements defined by nationally and internationally recognized standards. These include:

Engineering Specifications: Standards like ISO 9626 (stainless steel needle tubing), ISO 7864 (hypodermic needles), ISO 80369 series (small-bore connectors), ISO 23908 (sharps injury protection), ASTM F88/F88M (seal strength), etc., which define measurable physical and chemical properties and test methods.
Biological Standards: ISO 10993 series (biocompatibility) provides established methods for assessing biological safety (e.g., cytotoxicity, sensitization, systemic toxicity).
Microbiological Standards: ISO 11135-1 (sterilization), ISO 11737-1/2 (microbiological methods) define criteria for sterility and validation of sterilization processes.
Clinical Outcomes/Pathology: This type of ground truth is not used here, as no clinical data or pathology results are reported for the device itself.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML system that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As the device is not an AI/ML system, there is no training set and therefore no ground truth established for it in that context.

Summary

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October 21, 2022

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K222141

Trade/Device Name: Safety Blood Collection Needle (Without Needle Holder) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FMI Dated: July 22, 2022 Received: July 25, 2022

Dear Charles Mack:

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. 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

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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) 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,

David Wolloscheck, Ph.D. For Payal Patel 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) K222141

Device Name

Safety Blood Collection Needle (Without Needle Holder)

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image contains a logo for Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. The logo consists of a stylized graphic with a red plus sign and blue intertwined shapes, followed by the company's name in both Chinese and English. The Chinese characters read "安徽宏宇五洲医疗器械股份有限公司", while the English translation is "ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD".

510(k) SUMMARY

K222141

1. Submitter Information

Preparation Date:		October 21, 2022
Manufacturer'sName andAddress:		Anhui Hongyu Wuzhou MedicalManufacturer Co., Ltd.No. 2 Guanyin Road, EconomicDevelopment Zone, Taihu, Anqing City,Anhui Province, China 246400Tel: +86-0556 5129666
Corresponding Official:		Charles Mack
Telephone Number:		931-625-4938
Email Address:		charliemack@irc-us.com
2. Device
Trade Name:		Safety Blood Collection Needle (WithoutNeedle Holder)
Common Name:		Blood Collection Tubes, Vials, Systems,Serum Separators
Regulation Name:		Blood specimen collection device
Regulation Number:		21 CFR 862.1675
Primary Product Code:		JKA
Secondary Product Code:		FMI
Device Class:		Class II
Predicate Device:		K200027Safety Blood Collection Needle withoutHolder

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3. Device Description:

-The threaded hub has one side that is to connect with the needle holder, which is used to guide the needle into a vacuum blood collection tube. This end of the needle is shorter and fitted with a rubber cap and a needle hub.
-The opposite end of the needle tube is 3/4"-1 1/2" for blood collection and is fitted with a protective sleeve.

The needle hub and protective cap protect the needle tube.

The safety feature is easily operated through the release of a latch mechanism whereby the user slides a safety shield over the needle as it is removed from the patient. Once the needle is covered, the safety shield locks in place. This mechanism is substantially equivalent to that of the predicate device.

The devices are packaged as sterile, single-use, and single-patient use only.

The proposed device is comprised of the components listed below:

1. Bottom sheath
1. Rubber cap
1. Needle hub
1. Connecting base
1. Safety shield
1. Needle tube
1. Upper sheath

4. Indications for Use

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Feature	Proposed Device	Predicate Device	Discussion
510(K)	K222141	K200027	N/A
DeviceName	Safety Blood CollectionNeedle (Without NeedleHolder)	Safety Blood Collection Needlewithout Holder	N/A
ProductCode	JKA, FMI	JKA, FMI	Identical
Indicationfor Use	The safety bloodcollection needle withoutneedle holder is intendedto be used with vacuumblood collection tube forthe collection of venousblood. The safety shieldis intended to aid in theprotection againstaccidental needle stickinjury.	The Safety Blood CollectionNeedle with/without holder isintended to be used with vacuumblood collection tube for thecollection of venous blood. Thesafety shield is intended to aid inthe protection against accidentalneedle stick injury.The Blood Collection Needlewith/without holder is intended tobe used with vacuum bloodcollection tube for the collectionof venous blood.The Luer access device- holderwith preattached multiple sampleadapter is a sterile, non-invasivedevice used to connect deviceswith male or female luerconnectors to blood collectiontubes for the collection of blood.	Note 1
Operatingmode	Manual	Manual	Identical
SafetyMechanism	The safety shield isintended to preventneedle sticks.	The safety shield is intended inorder to avoid needle sticks.	Identical
Sterile	Yes	Yes	Identical

Comparison of Technological Characteristics with the Predicate Device 5.

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Feature	Proposed Device	Predicate Device	Discussion
Sterilization	EO	EO	Identical
Sterility (SAL)	10-6	10-6	Identical
Configurationand material	Bottom sheath (Non-patient Needle Cap) (PP)The upper sheath (Patient Needle Cap) (PE)Holder (N/A)Rubber Cap/Sleeve (Isoprene Rubber)Non- patient Needle Tube (Stainless Steel)Patient Needle Tube (Stainless Steel)Needle hub (ABS)Safety shield (PP)Lubricant- Silicone-based oils	Non-patient Needle Cap (PP)Patient Needle Cap (PP)Holder (PP)Rubber Sleeve (Case Gather Isoprene Rubber)Non- patient Needle Tube (Stainless Steel)Patient Needle Tube (Stainless Steel)Needle Hub (PP or MABS)Safety Shield(PP)Lubricant- Silicone-based oils	DifferentNote 2
Needle gauge	25G, 24G, 23G, 22G, 21G, 20G, 19G, 18G	27G, 25G, 23G, 22G, 21G, 20G, 18G	Note 3
Needle Length	3/4", 1", 1 1/8", 1 1/4",1 2/5", 1 1/2"	1", 1 1/4", 1 1/2"	Note 4
Performance	Complies with ISO7864, ISO9626, ISO 23908	Complies with ISO9626, ISO 23908	Identical
Biocompatibility	Complies with ISO10993-1	Complies with ISO10993-1	Identical
Single PatientUse	Yes	Yes	Identical

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Discussion:

Note 1: IFU

The predicate device included three devices: Blood Collection Needle with/without holder; Safety Blood Collection Needle with/without holder and Luer access deviceholder with preattached multiple sample adapter; We only choose "Safety Blood Collection Needle with/without holder" as the predicate device, and the difference is that the subject device doesn't include needle holder, but the intended use is exactly same as the predicate device. The difference doesn't raise new questions on the safety and effectiveness of the subject device.

Note 2: Material

Although the material of the subject device is not fully exactly the same as predicate device, they conform to the same ISO10993-1 biocompatibility standards.

Note 3: Needle Gauge

The needle gauge of the subject devices is not fully exactly the same as the predicate device, but they still conform to the same applicable performance standards of ISO 9626. Therefore, the difference does not raise new questions about the safety and effectiveness of the proposed device.

Note 4: Needle Length

The needle length of the subject devices is available more in size than the predicate device, but they conform to the same applicable performance standards per ISO 7864. Therefore, the difference does not raise new questions about the safety and effectiveness of the proposed device.

6. Performance Testing

To establish substantial equivalence to the identified predicate device, we performed the tests noted below on the subject devices. The testing results proved that the subject device complies with the applicable standards requirement and is substantially equivalent to the predicate devices.

Non-Clinical Performance Testing

Testing was performed to evaluate the functional performance and safety of the subject device with the following standards:

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Performance:

ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use -Requirements and test methods

ISO 80369-7 First edition 2016-10-15 Corrected version 2016-12-01 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

ISO 80369-20 First edition 2015-05-15 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

ISO 23908 First edition 2011-06-11 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters, and needles used for blood sampling

ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use - Colour coding for identification

ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]

Biocompatibility

ISO 10993-5: 2009 In Vitro Cytotoxicity ISO 10993-10: 2010 Skin Sensitization ISO 10993-10: 2010 Intracutaneous Reactivity ISO 10993-11: 2017 Acute Systemic Toxicity ISO 10993-4: 2017 & ASTM F756-17: Hemolytic Properties ISO 10993-4: 2017 Complement activity ISO 10993-4:2017 Coagulation - PPT Test ISO10993-11: 2017 USP 43-NF38 <151> Pyrogen Test

Sterilization Validation:

ISO11135-1:Sterilization of health care products - ethylene oxide - part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices.

ISO11737-1:Sterilization of medical devices-Microbiological methods-Part 1: Determination of the population of microorganisms on the product.

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ISO11737-2: Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process.

ISO 10993-7: Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals.

AAMI / ANSI ST72: Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing.

Package and Shelf Life:

AAMI/ANSI/ISO 11137-1:2006/(R) 2010 Sterilization of health care products -Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

AAMI/ANSI/ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process

AAMI/ANSI/ISO 11607-1:2006/(R) 2010 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems, 3ed.

ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM D3078-02 (2021), Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission. (Sterility)

DIN58953-6: 2016 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized.

ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials

The package integrity test, as noted below, was conducted for the sterilization package of the subject devices by accelerated aging testing followed by simulated shipping distribution testing:

Accelerated Aging Test

Simulated shipping distribution testing

Visual inspection

Performance Inspection (Chemical performance and Physical performance)

Sterile Test

Vacuum Leak Test

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Dye penetration test Agar Contact-Attack Test Tensile Seal Strength Test

Clinical Performance Data

No clinical data was submitted in this submission.

Conclusions:

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Safety Blood Collection Needle (Without Needle Holder) is substantially equivalent to the predicate cleared under K200027 concerning the indications for use, target populations, treatment method, and technological characteristics.

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.