Safety Blood Collection Needles with/without Needle Holder

K220900 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · JKA · Aug 10, 2022 · Clinical Chemistry

Device Facts

• Record ID: K220900
• Device Name: Safety Blood Collection Needles with/without Needle Holder
• Applicant: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Aug 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

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.

Device Story

Safety blood collection needle used for routine venipuncture; facilitates multiple venous blood collections via vacuum tubes. Device consists of stainless steel needle tube, hub, and manually operated safety shield. Clinical personnel perform venipuncture; upon needle withdrawal, user slides safety shield over needle until it locks, providing sharps injury protection. Device configurations vary by gauge (18G-25G) and length (0.75"-1.5"). Benefits include reduced risk of accidental needle stick injuries to healthcare workers. Used in clinical settings.

Clinical Evidence

No clinical data. Bench testing only. Performance validated via simulated clinical use study (0% failure rate), physical performance testing (ISO 7864, ISO 9626, ISO 23908), biocompatibility (ISO 10993 series), sterility (EO, SAL 10^-6), and package integrity (ASTM D4169, F88, F1929, USP 1207).

Technological Characteristics

Materials: PP, PE, ABS, isoprene rubber, SUS 304. Principle: Manual venipuncture with integrated sliding safety shield. Energy: None (manual). Connectivity: None. Sterilization: Ethylene Oxide (EO). Standards: ISO 7864, ISO 9626, ISO 6009, ISO 23908, ISO 80369-7/20, ISO 10993, ASTM D4169, F88, F1929, F1980.

Indications for Use

Indicated for use with vacuum blood collection tubes for multiple venous blood collections in patients requiring venipuncture. Intended for use by clinical personnel.

Regulatory Classification

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.

Predicate Devices

• Safety Blood Collection Needle for Single Use / Safety Blood Collection Needle with Holder for Single Use (K212019)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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, [phone], [e-mail] Submission correspondent: Evan Hu, 86-18616124827, [e-mail]

## 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:

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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<br>(mm) | Gauge | Bevel | | Wall thickness<br>(mm) | | Needle length<br>(Inch and mm) | | | | | |
|--------------|-------|-------|----|------------------------|------|--------------------------------|-------------|--------------|--------------|--------------|--------------|
| | | LB | SB | RW | TW | ¾",<br>19mm | 1",<br>25mm | 1⅛",<br>28mm | 1¼",<br>32mm | 1⅜",<br>35mm | 1½",<br>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.

- 7. 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<br>/without Needle Holder | Safety Blood Collection Needle for<br>Single Use<br>Safety Blood Collection Needle with<br>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<br>use/Indications<br>for use | Safety blood collection needles<br>with/without needle holder are<br>intended to be used with vacuum blood<br>collection tubes for multiple collections<br>of venous blood. The safety shield is<br>intended to aid in the protection<br>against, accidental needle stick injuries. | The Blood Collection Needle/ The Blood<br>Collection Needle with Holder/ The<br>Blood Collection Set/ The Blood<br>Collection Set with Holder is intended to<br>be used with vacuum blood collection<br>tube for multiple collections of venous<br>blood.<br>The Safety Blood Collection Needle/ The<br>Safety Blood Collection Needle with<br>Holder/ The Safety Blood Collection<br>Set/ The Safety Blood Collection Set<br>with Holder is intended to be used with<br>vacuum blood collection tube for<br>multiple collections of venous blood.<br>The safety shield is intended to aid in<br>the protection against accidental<br>needle stick injury. | #1 |
| Configuration<br>and Material | (1) Bottom sheath (PP)<br>(2) Rubber cap (Isoprene rubber)<br>(3) Needle hub (PP)<br>(4) Connecting base (ABS)<br>(5) Safety sheath (PP)<br>(6) Needle tube (SUS 304)<br>(7) Upper sheath (PE)<br>(8) Needle holder (PP) | (1) Needle cover (PP)<br>(2) Needle sleeve (Isoprene rubber)<br>(3) Needle hub-Male (PP)<br>(4) Needle hub-Female (ABS)<br>(5) Safety shield (PP)<br>(6) Needle tube (SUS 304)<br>(7) Needle cap (PP)<br>(8) Holder (PP) | #2 |
| Needle<br>gauge<br>and length | 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G<br>¾", 1", 1⅛", 1 ¼", 1⅜", 1 ½", | 18G, 20G, 21G, 22G, 23G,25G<br>1 ½", ¾" | #3 |
| Sharps<br>prevention<br>function | Manually operated safety sheath<br>Comply with ISO 23908 | Manually operated safety sheath<br>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<br>SAL 10-6 | Sterilized by EO<br>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 <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 leakage<br>bubble emission | No bubbles observed attributable<br>to leaks, and no test fluid<br>attributable to a leak is inside a<br>specimen | Pass, no bubbles or fluid observed |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| ASTM F1929, dye penetration<br>testing | No dye penetrates into packaging | Pass, no dye penetrated into<br>package |
| ISO 11737-1/-2, USP <71>, sterility<br>testing – microbiological method | Negative result of micros culture | Negative |
| ISO 10993-7, EO/ECH residual<br>testing | EO <4mg/day<br>ECH <9mg/day | EO pass<br>ECH undetectable |
| ISO 10993-4, in-vitro hemolytic<br>testing | No hemolysis | No hemolysis |
| ISO 10993-5, in-vitro cytotoxicity<br>testing | No cytotoxicity | No cytotoxicity |
| ISO 10993-10, irritation and skin<br>sensitization testing | No irritation and no skin<br>sensitization | No irritation and no skin<br>sensitization |
| ISO 10993-11, acute systemic<br>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<br>testing | The average number of particles<br>present in the units tested should<br>not exceed 6000 per container<br>equal to or greater than 10 mm and<br>should not exceed 600 per<br>container equal to or greater than<br>25 mm. | Pass |
| ISO 23908 sharp injury protection –<br>activation and safe mode | Testing items with vary criteria<br>Refer to ISO 23908 Clause 4.2 and<br>Clause 4.3 | Pass |
| USP 41 <1207> rigid package<br>integrity evaluation | Testing items with vary criteria<br>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 |

- 9. Clinical Tests
Not Applicable

- 10. 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.