Safety blood collection needles with/without needle holder are intended to be used with vacuum blood collection tubes for multiple collections of venous blood. The safety shield is intended to aid in the protection against, accidental needle stick injuries.

Device Description

The Safety blood collection needles with/without needle holder is used in routine venipuncture procedures. That is composed of a bottom sheath, rubber cap, needle hub, connecting base, safety shield, needle tube, upper sheath, and optional needle holder, which are made from PP, PE, ABS, rubber, and SUS materials. The proposed device has various configurations and sizes, differing in various colors for easy recognition by use. The threaded hub is one side that connects with the needle holder, which is used to quide the needle into a vacuum blood collection tube. This end of the needle is shorter and is fitted with a rubber cap and a needle hub. The Safety blood collection needles with /without needle holder are manufactured from tubular stainless steel sharpened at both ends that are attached: - The opposite end of the needle tube is ¾" ~ 1 ½″ for blood collection and is fitted with a protective sleeve. - The needle hub and protective cap protect the needle tube. The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use. The safety feature is easily operated by releasing 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device: "Safety Blood Collection Needles with/without Needle Holder." This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing. It does not contain information about a clinical study involving human-in-the-loop performance, expert ground truth establishment for a test set in a diagnostic AI context, or MRMC studies.

Therefore, many of the requested details about acceptance criteria, study design, and expert involvement (points 2-5, 7-9) are not applicable or cannot be extracted from this specific document, as it pertains to a physical medical device (blood collection needles) rather than a diagnostic AI or imaging device requiring extensive validation with human readers and expert-adjudicated ground truth.

However, I can extract the acceptance criteria and performance data for the non-clinical tests that were performed.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The device, "Safety Blood Collection Needles with/without Needle Holder," was evaluated through non-clinical performance testing against various international standards to demonstrate its safety and effectiveness.

Standard/Test Description	Acceptance Criteria	Reported Device Performance
ISO 7864, needle performance testing	Refer to ISO 7864 clause 4	Meet performance requirements
ISO 9626, needle tube performance testing	Refer to ISO 9626 clause 5	Meet performance requirements
ISO 6009, needle hub color	Refer to ISO 6009 clause 3	Meet color code requirements
ASTM F88, packaging sealing strength testing	Sealing strength >1.5N/15mm	Pass, round 1.8N/15mm
ASTM D3078-2, package leakage bubble emission	No bubbles observed attributable to leaks, and no test fluid attributable to a leak is inside a specimen	Pass, no bubbles or fluid observed
ASTM F1929, dye penetration testing	No dye penetrates into packaging	Pass, no dye penetrated into package
ISO 11737-1/-2, USP <71>, sterility testing – microbiological method	Negative result of micro culture	Negative
ISO 10993-7, EO/ECH residual testing	EO <4mg/day; ECH <9mg/day	EO pass; ECH undetectable
ISO 10993-4, in-vitro hemolytic testing	No hemolysis	No hemolysis
ISO 10993-5, in-vitro cytotoxicity testing	No cytotoxicity	No cytotoxicity
ISO 10993-10, irritation and skin sensitization testing	No irritation and no skin sensitization	No irritation and no skin sensitization
ISO 10993-11, acute systemic toxicity testing	No acute systemic toxicity	No acute systemic toxicity
ISO 10993-11, pyrogens testing	No pyrogens	No evidence of pyrogens
USP <85>, endotoxin testing	<20EU/device	Pass
USP <788>, residual particles testing	The average number of particles present in the units tested should not exceed 6000 per container equal to or greater than 10 mm and should not exceed 600 per container equal to or greater than 25 mm.	Pass
ISO 23908 sharp injury protection – activation and safe mode	Testing items with varying criteria; Refer to ISO 23908 Clause 4.2 and Clause 4.3	Pass
USP 41 <1207> rigid package integrity evaluation	Testing items with varying criteria; Refer to USP <1207.2>	Pass
Simulated clinical study	<1% failures under 95% CL	0% failures.
ISO 80369, luer connector	Vary criteria refer to ISO 80369	Pass

Regarding the other requested information:

Sample size used for the test set and the data provenance: The document mentions "Simulated Clinical Use Study" with a result of "0% failures," but it does not specify the sample size used for this simulation. All other tests are non-clinical, involving material property and performance testing on device components/samples rather than a "test set" in the context of an AI algorithm or human subject data. The data provenance is implicitly from laboratory testing conducted by the manufacturer (Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.) in China, as indicated by the submitter's address. The studies are non-clinical (laboratory).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert readers or ground truth establishment for diagnostic purposes. The "ground truth" for the non-clinical tests is established by adherence to the specified ISO/ASTM standards and their methodologies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No human reader adjudication process is described as this is not a diagnostic AI or imaging study.
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: Not applicable. This document does not describe an MRMC study or AI assistance for human readers. This is a physical medical device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests are the objective measurements and adherence to the technical specifications and performance requirements detailed in the cited ISO and ASTM standards (e.g., specific force for sealing strength, absence of bubbles for leakage, negativity for sterility, specified chemical residual limits).
The sample size for the training set: Not applicable. This device is not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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August 10, 2022

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Evan Hu Marketing & Technical Manager Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, Shanghai 201114 China

Re: K220900

Trade/Device Name: Safety Blood Collection Needles with/without Needle Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: June 10, 2022 Received: July 11, 2022

Dear Evan Hu:

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

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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) 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 (QS) 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 medical devices and radiation-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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K220900

Device Name

Safety Blood Collection Needles with/without Needle Holder

Indications for Use (Describe)

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)

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K220900 510(k) SUMMARY

1. Preparation Date: 8/10/2022

2. Submitter

Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Address: No.2 Guanyin Road, Taihu Economic Development Zone, Anging City, Anhui Province, 246400, China Contact person: Bingyi Xiang, +86-556 5129666, hwj1@hongyu-wuzhou.cn Submission correspondent: Evan Hu, 86-18616124827, Evan.hu@mind-link.net

3. Device

Trading Name: Safety Blood Collection Needles with/without Needle Holder Common Name: Blood Collection Tubes, Vials, Systems, Serum Separators Regulation Name: Blood specimen collection device Requlation Number: 21 CFR 862.1675 Classification: Class II Product code: JKA

4. Predicate device

Primary predicate device: Safety Blood Collection Needle for Single Use / Safety Blood Collection Needle with Holder for Single Use - K212019

5. Device description

The threaded hub is one side that connects with the needle holder, which is used to quide the needle into a vacuum blood collection tube. This end of the needle is shorter and is fitted with a rubber cap and a needle hub.

The Safety blood collection needles with /without needle holder are manufactured from tubular stainless steel sharpened at both ends that are attached:

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The opposite end of the needle tube is ¾" ~ 1 ½″ for blood collection and is fitted with a protective sleeve.
The needle hub and protective cap protect the needle tube.

The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use. The safety feature is easily operated by releasing 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.

Size(mm)	Gauge	Bevel		Wall thickness(mm)		Needle length(Inch and mm)
		LB	SB	RW	TW	¾",19mm	1",25mm	1⅛",28mm	1¼",32mm	1⅜",35mm	1½",38mm
0.5	25G	✓	✓	0.18	0.23	✓	✓	✓	✓	✓	✓
0.55	24G	✓	✓	0.22	0.27	✓	✓	✓	✓	✓	✓
0.6	23G	✓	✓	0.25	0.29	✓	✓	✓	✓	✓	✓
0.7	22G	✓	✓	0.3	0.35	✓	✓	✓	✓	✓	✓
0.8	21G	✓	✓	0.4	0.42	✓	✓	✓	✓	✓	✓
0.9	20G	✓	✓	0.48	0.49	✓	✓	✓	✓	✓	✓
1.1	19G	✓	✓	0.58	0.6	✓	✓	✓	✓	✓	✓
1.2	18G	✓	✓	0.7	0.73	✓	✓	✓	✓	✓	✓

Table. 1. Device specifications

Note: "v" means that it is available to this configuration.

6. Indications for use/Intended use

1. Comparison of technological characters between proposed and predicate devices

Characters	Proposed device	Primary predicate device	Remark
	K220900	K212019
Product name	Safety Blood Collection Needles with/without Needle Holder	Safety Blood Collection Needle forSingle UseSafety Blood Collection Needle withHolder for Single Use	-
Product code	JKA	JKA	Same
Regulation No.	21 CFR 862.1675	21 CFR 862.1675	Same

Table 2. Characters comparison

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Class	II	II	Same
Intendeduse/Indicationsfor use	Safety blood collection needleswith/without needle holder areintended to be used with vacuum bloodcollection tubes for multiple collectionsof venous blood. The safety shield isintended to aid in the protectionagainst, accidental needle stick injuries.	The Blood Collection Needle/ The BloodCollection Needle with Holder/ TheBlood Collection Set/ The BloodCollection Set with Holder is intended tobe used with vacuum blood collectiontube for multiple collections of venousblood.The Safety Blood Collection Needle/ TheSafety Blood Collection Needle withHolder/ The Safety Blood CollectionSet/ The Safety Blood Collection Setwith Holder is intended to be used withvacuum blood collection tube formultiple collections of venous blood.The safety shield is intended to aid inthe protection against accidentalneedle stick injury.	#1
Configurationand Material	(1) Bottom sheath (PP)(2) Rubber cap (Isoprene rubber)(3) Needle hub (PP)(4) Connecting base (ABS)(5) Safety sheath (PP)(6) Needle tube (SUS 304)(7) Upper sheath (PE)(8) Needle holder (PP)	(1) Needle cover (PP)(2) Needle sleeve (Isoprene rubber)(3) Needle hub-Male (PP)(4) Needle hub-Female (ABS)(5) Safety shield (PP)(6) Needle tube (SUS 304)(7) Needle cap (PP)(8) Holder (PP)	#2
Needlegaugeand length	18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G¾", 1", 1⅛", 1 ¼", 1⅜", 1 ½",	18G, 20G, 21G, 22G, 23G,25G1 ½", ¾"	#3
Sharpspreventionfunction	Manually operated safety sheathComply with ISO 23908	Manually operated safety sheathComply with ISO 23908	Same
Performance	Comply with ISO 7864 and ISO 9626	Comply with ISO 7864 and ISO 9626	Same
Sterility method	Sterilized by EOSAL 10-6	Sterilized by EOSAL 10-6	Same
Biocompatibility	Comply with ISO 10993 serials	Comply with ISO 10993 serials	Same

Notes:

#1: Intended use/indication for use

The predicate device is a bundle of different devices that comprises (1)Blood Collection Needle for Single Use, (2)Safety Blood Collection Needle for Single Use, (3)Blood Collection Needle with Holder for Single Use, (4)Safety Blood Collection Needle with Holder for Single Use, (5)Blood Collection Set for Single Use, (6)Safety Blood Collection Set for Single Use,

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(7)Blood Collection Set with Holder for Single Use, and (8)Safety Blood Collection Set with Holder for Single Use. The proposed device only compares with (2) and (4), included in the predicate device. Therefore, it does not affect the safety and effectiveness comparison that can be considered substantially equivalent.

#2: configuration and materials

Most of the materials used by the proposed device and the predicate device are the same, except for the upper sheath/needle cap. The proposed device uses PE, but the predicate device uses PP. However, the biocompatibility testing of the proposed device proves to be safe and complies with ISO 10993. Therefore, it does not affect the safety and effectiveness comparison that can be considered substantially equivalent.

#3: Needle gauge and length

The proposed device has a broader range of needle gauges and lengths than the predicate device. The performance testing of all specifications of the proposed device proves to be safe and effective and complies with ISO 9626 and ISO 7864. Therefore, it does not affect the safety and effectiveness comparison that can be considered substantially equivalent.

Non-clinical performance testing 8.
The non-clinical tests of this proposed device are tested in conformance with the following standards.
(1) Physical performance testing:
(a) ISO 7864:2016, Sterile hypodermic needles for single use.
(b) ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Device.
(c) ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
(d) ISO 23908:2011 SHARPS INJURY PROTECTION REQUIREMENTS AND TEST METHODS -SHARPS PROTECT
(e) ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare application-Part 7: Connectors for intravascular or hypodermic applications
(f) ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
(q) Simulated Clinical Use Study was conducted per the Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features
(2) Sterility, Shipping and Shelf-Life:
(a) ISO 10993-7:2008/AMD 1:2019 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants.
(b) ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems

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(c) ASTM F1140: 2020, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
(d) ASTM F88: 2015, Standard Test Method for Seal Strength of Flexible Barrier Materials
(e) ASTM D3078-2: 2013, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
(f) ASTM F1929: 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
(g) ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices
(h) ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
(i) USP 41 <1207> Package Integrity Evaluation-Sterile Products; <1207.1> Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation; <1207.2> Package Integrity Leak Test Technologies.
Shelf life of 5 years is validated per ASTM F1980-16, Standard Guidance for Accelerated (i) Aging of Sterile Barrier Systems for Medical Devices
(3) Biocompatibility testing:
(a) ISO10993-1:2018, Biological evaluation of medical devices Part 1 : Evaluation and testing within a risk management process.
(b) ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.
(c) ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
(d) ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization.
(e) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
(f) USP 40, <85> Bacterial Endotoxins Test
(g) USP 40, <71> Sterility Test
(h) USP 40, <788>Particulate matter in injection

Briefly, performance testing summary as shown in table 3

Table 3. A summary of the performance/biocompatibility testing results

Standard/Test description	Acceptance criteria	Results
ISO 7864, needle performance testing	Refer to ISO 7864 clause 4	Meet performance requirements
ISO 9626, needle tube performance testing	Refer to ISO 9626 clause 5	Meet performance requirements
ISO 6009, needle hub color	Refer to ISO 6009 clause 3	Meet color code requirements
ASTM F88, packaging sealing strength testing	Sealing strength >1.5N/15mm	Pass, round 1.8N/15mm

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ASTM D3078-2, package leakagebubble emission	No bubbles observed attributableto leaks, and no test fluidattributable to a leak is inside aspecimen	Pass, no bubbles or fluid observed
ASTM F1929, dye penetrationtesting	No dye penetrates into packaging	Pass, no dye penetrated intopackage
ISO 11737-1/-2, USP <71>, sterilitytesting – microbiological method	Negative result of micros culture	Negative
ISO 10993-7, EO/ECH residualtesting	EO <4mg/dayECH <9mg/day	EO passECH undetectable
ISO 10993-4, in-vitro hemolytictesting	No hemolysis	No hemolysis
ISO 10993-5, in-vitro cytotoxicitytesting	No cytotoxicity	No cytotoxicity
ISO 10993-10, irritation and skinsensitization testing	No irritation and no skinsensitization	No irritation and no skinsensitization
ISO 10993-11, acute systemictoxicity testing	No acute systemic toxicity	No acute systemic toxicity
ISO 10993-11, pyrogens testing	No pyrogens	No evidence of pyrogens
USP <85>, endotoxin testing	<20EU/device	Pass
USP <788>, residual particlestesting	The average number of particlespresent in the units tested shouldnot exceed 6000 per containerequal to or greater than 10 mm andshould not exceed 600 percontainer equal to or greater than25 mm.	Pass
ISO 23908 sharp injury protection –activation and safe mode	Testing items with vary criteriaRefer to ISO 23908 Clause 4.2 andClause 4.3	Pass
USP 41 <1207> rigid packageintegrity evaluation	Testing items with vary criteriaRefer to USP <1207.2>	Pass
Simulated clinical study	<1% failures under 95% CL	0% failures.
ISO 80369, luer connector	Vary criteria refer to ISO 80369	Pass

1. Clinical Tests
  Not Applicable
1. Conclusion
  The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The subject device is substantially equivalent to the predicate device with respect to indications for use 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.