Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a blood collection needle with a safety shield. There is no mention of AI or ML in the intended use, device description, or performance testing sections.

Therapeutic

No.
This device is a blood collection needle used for diagnostic purposes (collecting blood samples), not for treating a disease or condition.

Diagnostic

No

The device is a safety blood collection needle, which is used for collecting blood samples. It does not analyze, interpret, or diagnose medical conditions; its sole purpose is the safe collection of blood.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components made of materials like PP, PE, ABS, rubber, and SUS, and the performance studies include physical and material testing. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the collection of venous blood using vacuum blood collection tubes. It is a tool for obtaining a sample, not for performing a diagnostic test on the sample itself.
Device Description: The description details the physical components and function of a blood collection needle and optional holder. It does not describe any reagents, assays, or analytical components used to test a sample.
Lack of Diagnostic Function: The device's purpose is to safely and effectively draw blood. It does not analyze the blood or provide any diagnostic information about the patient's health.
Performance Studies: The performance studies focus on the physical characteristics, sterility, and safety features of the needle, not on the accuracy or reliability of a diagnostic test.

In vitro diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool for obtaining the specimen, not for the diagnostic process itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

JKA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical performance testing was conducted in conformance with the following standards:

Physical performance testing: ISO 7864:2016, ISO 9626:2016, ISO 6009:2016, ISO 23908:2011, ISO 80369-7:2016, ISO 80369-20:2015, and Simulated Clinical Use Study per Guidance for Industry and FDA Staff, Medical Devices with Sharps Injury Prevention Features. Key results: All tests met performance requirements, color code requirements, sealing strength, and showed no bubbles/fluid in package leakage, no dye penetration, 0% failures in simulated clinical study, and all luer connector tests passed.
Sterility, Shipping and Shelf-Life: ISO 10993-7:2008/AMD 1:2019, ASTM D4169-16, ASTM F1140: 2020, ASTM F88: 2015, ASTM D3078-2: 2013, ASTM F1929: 2015, ASTM F1980-16, ASTM F1886/F1886M-16, USP 41 , , . Key results: Negative for sterility, EO passed and ECH undetectable. Shelf life of 5 years is validated.
Biocompatibility testing: ISO10993-1:2018, ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, USP 40, , , . Key results: No hemolysis, no cytotoxicity, no irritation and no skin sensitization, no acute systemic toxicity, no pyrogens, endotoxin and residual particles passed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Simulated clinical study: 0% failures.
ASTM F88, packaging sealing strength testing: Pass, round 1.8N/15mm (Acceptance criteria: Sealing strength >1.5N/15mm)
ISO 10993-7, EO/ECH residual testing: EO pass, ECH undetectable (Acceptance criteria: EO , endotoxin testing: Pass (Acceptance criteria: , residual particles testing: Pass (Acceptance criteria: 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.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K212019

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

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

1

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)

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.

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 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:

4

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

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.

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 for
Single Use
Safety Blood Collection Needle with
Holder 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
Intended
use/Indications
for use	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.	The Blood Collection Needle/ The Blood
Collection Needle with Holder/ The
Blood Collection Set/ The Blood
Collection Set with Holder is intended to
be used with vacuum blood collection
tube for multiple collections of venous
blood.
The Safety Blood Collection Needle/ The
Safety Blood Collection Needle with
Holder/ The Safety Blood Collection
Set/ The Safety Blood Collection Set
with Holder is intended to be used with
vacuum blood collection tube for
multiple collections of venous blood.
The safety shield is intended to aid in
the protection against accidental
needle stick injury.	#1
Configuration
and 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
Needle
gauge
and length	18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G
¾", 1", 1⅛", 1 ¼", 1⅜", 1 ½",	18G, 20G, 21G, 22G, 23G,25G
1 ½", ¾"	#3
Sharps
prevention
function	Manually operated safety sheath
Comply with ISO 23908	Manually operated safety sheath
Comply with ISO 23908	Same
Performance	Comply with ISO 7864 and ISO 9626	Comply with ISO 7864 and ISO 9626	Same
Sterility method	Sterilized by EO
SAL 10-6	Sterilized by EO
SAL 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 Package Integrity Evaluation-Sterile Products; Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation; 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, Bacterial Endotoxins Test
(g) USP 40, Sterility Test
(h) USP 40, 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 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 , sterility
testing – microbiological method | Negative result of micros culture | Negative |
| ISO 10993-7, EO/ECH residual
testing | EO , endotoxin testing | , 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 vary criteria
Refer to ISO 23908 Clause 4.2 and
Clause 4.3 | Pass |
| USP 41 rigid package
integrity evaluation | Testing items with vary criteria
Refer to USP | Pass |
| Simulated clinical study |