Safety Winged Blood Collection Sets

K243806 · Promisemed Hangzhou Meditech Co., Ltd. · FMI · Jan 10, 2025 · General Hospital

Device Facts

• Record ID: K243806
• Device Name: Safety Winged Blood Collection Sets
• Applicant: Promisemed Hangzhou Meditech Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Jan 10, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

Device Story

Safety Winged Blood Collection Set; single-use sterile venipuncture needle with flexible tubing; optional luer adapter/tube holder. Used for blood collection via vacuum tubes or short-term IV infusion. Features integrated safety mechanism activated post-venipuncture to prevent needlestick injuries. Operated by clinicians in clinical settings. Device connects to vacuum tubes (EN 14820) for blood draw or IV sets (ISO 8536-4) for infusion. Safety mechanism covers needle after use. Benefits include reduced risk of accidental needlestick injury to healthcare personnel.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation included visual inspection, dimensional analysis, and performance testing of the safety mechanism and needle assembly per ISO standards.

Technological Characteristics

Single-use sterile winged needle; stainless steel tubing (ISO 9626); safety mechanism (PP); color-coded per ISO 6009. Dimensions: 21G-25G; 10cm-30cm lengths. Sterility: SAL 10^-6. Complies with ISO 8536-4 (infusion) and ISO 23908 (sharps protection).

Indications for Use

Indicated for patients requiring venipuncture for blood collection or short-term intravenous fluid infusion (up to 2 hours under clinical supervision). No specific age or gender restrictions; contraindicated for use beyond 2 hours or without clinical supervision.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• Safety Winged Blood Collection Sets (K211293)

Submission Summary (Full Text)

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Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City, 311121 China

Re: K243806

Trade/Device Name: Safety Winged Blood Collection Sets Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FPA Dated: December 6, 2024 Received: December 11, 2024

Dear Zearou Yang:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

David Walloschek

David Wolloscheck, Ph.D. 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) K243806

Device Name Safety Winged Blood Collection Sets

### Indications for Use (Describe)

The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------|--|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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Image /page/4/Picture/0 description: The image shows the logo for Promisemed. The logo is blue and green, with the word "Promisemed" in a stylized font. The "P" is green, and the rest of the word is blue. There is a green molecule graphic above the "P". There is a registered trademark symbol in the upper right corner of the logo.

# K243806-510(k) Summary

### Date prepared: 2025-01-09

| 1. Manufacturer[21 CFR 807.92 (a) (1)] | |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Name | Promisemed Hangzhou Meditech Co., Ltd. |
| Address | No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China. |
| Contact Person | Zearou Yang |
| Phone | [phone] |
| Fax | [phone] |
| Email | [e-mail] |
| 2. Device [21 CFR 807.92 (a) (2)] | |
| Name | Safety Winged Blood Collection Sets |
| Common Name | Safety Blood Collection Device for Single Use |
| Classification Name | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Regulation Number | 21 CFR 880.5570 |
| Class | Class II |
| Product Code | FMI, FPA |
| 3. Legally Marketed Predicate Device[21 CFR 807.92 (a) (3)] | |
| Predicate Name | Safety Winged Blood Collection Sets |
| 510(k) Number | K211293 |
| Product Code | FMI, FPA |
| Reference Devices | No reference devices were used in this submission. |
| 4. Device Description [21 CFR 807.92 (a) (4)] | |

The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

#### 5. Indication for use [21 CFR 807.92 (a) (5)]

The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

#### 6. Indications for Use Comparison [21 CFR 807.92 (a) (5)]

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Image /page/5/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green and the word "med" is in blue. There is a blue molecular structure above the "o" in "Promise" with a green circle at the top. There is a registered trademark symbol in the upper right corner of the image.

## Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.

The indication of subject device is same as the predicate device.

#### 7. Comparison of Technological Characteristic [21 CFR 807.92 (q) (6)]

The subject device has the same technological characteristics as the predicate device. The similarities above between the subject device and predicate device do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding effectiveness and safety. We concluded the subject device is substantially equivalent to the identified predicate device.

At a high level, the subject and predicate devices are based on the following same technological elements:

| Item of<br>description | Cleared device<br>(K211293) | Modified device | Comments on<br>Similarities/<br>Differences | Safety/Effectiveness<br>Statement |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common<br>name | Safety Blood Collection<br>Device for Single Use | No change | N/A | No new concerns.<br>Common name is<br>same. |
| Classification<br>name | NEEDLE, HYPODERMIC,<br>SINGLE LUMEN (21 CFR<br>880.5570) | No change | N/A | No new concerns. The<br>classification name<br>remains consistent. |
| Device class | Class II | No change | N/A | No new concerns. The<br>device remains in<br>Class II, indicating no<br>change in risk level. |
| Product<br>Code | FMI, FPA | No change | N/A | No new concerns. The<br>product code remains<br>the same, reflecting<br>no change in device<br>functionality. |
| General<br>description | The Promisemed Safety Blood<br>Collection sets are single-use,<br>sterile, venipuncture needles<br>used for blood collection or<br>short-term infusion of<br>intravenous fluids (up to 2<br>hours under direct clinical<br>supervision). The blood-<br>collection needle is designed<br>to be covered with a safety<br>mechanism, which can be<br>activated to cover the needle<br>immediately following<br>venipuncture to aid in the<br>protection against accidental<br>needlestick injury. | No change | N/A | No new concerns.<br>The change to add a<br>new model (RBC) does<br>not introduce new<br>risks as the<br>fundamental<br>technology and<br>operation remain the<br>same. |
| Principle of<br>operation | When the Safety winged<br>blood collection set is used<br>for venous blood collection.<br>The principle is that the<br>device is connected with the<br>vacuum blood collection tube<br>(met with EN 14820), the<br>negative pressure generated<br>by the vacuum blood<br>collection tube draws human<br>blood out, and the blood<br>enters the vacuum blood<br>collection tube, and the<br>needle is pulled out to<br>complete the blood<br>collection. | No change | N/A | No new concerns.<br>The principles of<br>operation remain<br>unchanged, ensuring<br>consistent<br>performance. |
| | | | | |
| Indication of<br>use | When the Safety winged<br>blood collection set is used<br>for short-term infusion. The<br>principle is that the device is<br>connected with IV set through<br>by Luer connector, and<br>medicinal solution enters the<br>human body through the<br>infusion set (met with ISO<br>8536-4) under the action of<br>gravity or thrust, and the<br>needle is pulled out to<br>complete the injection.<br>The safety winged blood<br>collection set is single-use,<br>sterile, winged venipuncture<br>needle bonded to a flexible<br>tubing with or without a luer<br>adaper and/or tube holder.<br>The device is used for blood<br>collection and/or the short-<br>term infusion of intravenous<br>fluids (up to 2 hours under<br>direct clinical supervision).<br>The blood-collection needle is<br>designed to be covered with a<br>safety mechanism, which can<br>be activated to cover the<br>needle immediately following<br>venipuncture to aid in the<br>protection against accidental<br>needlestick injury. | No change | N/A. | No new concerns.<br>The change to add a<br>new model (RBC) does<br>not introduce new<br>indications as the<br>fundamental<br>technology and<br>operation remain the<br>same. |
| Model | SBC | RBC is added. | Model RBC is<br>added. | No new concerns.<br>The change to add a new<br>model (RBC) does not<br>introduce new<br>indications as the<br>fundamental technology<br>and operation remain<br>the same. |
| Type | SBC: Type H, A, S<br>Remain no change | RBC: Type H, A, S | Model RBC is<br>added. | No new concerns.<br>The addition of a new<br>model (RBC) does not<br>affected the safety and<br>effectiveness which type<br>is remain same. |
| Needle size | 21G, 23G, 25G | RBC: 21G, 22G, 23G,<br>24G, 25G | 22G, 24G is<br>added. | No new concerns.<br>The broader needle<br>gauge expands options<br>without altering the<br>device's safety or<br>effectiveness. |
| Needle<br>length | 10cm, 19cm, 30cm | No change | N/A | No new concerns.<br>The addition of a new<br>model (RBC) does not<br>affected the safety and<br>effectiveness which<br>needle length is remain<br>same. |
| Color | SBC: Remain no change | RBC:<br>Gauge   Color | Color of 22G,<br>24G is added. | No new concerns.<br>The broader needle<br>gauge expands options<br>without altering the<br>device's safety or<br>effectiveness. The color<br>system is in accordance<br>with ISO 6009<br>requirement. |
| Tubing<br>length | Remain no change | No change. | N/A | No new concerns.<br>The addition of a new<br>model (RBC) does not<br>affected the safety and<br>effectiveness which type<br>is remain same. |
| Schematic<br>diagram | SBC: Remain no change | RBC is same with SBC<br>exempt the safety<br>protective mechanism. | The<br>configuration is<br>similar that<br>operation<br>method is<br>same. | No new concerns.<br>The addition of a new<br>model (RBC) does not<br>introduce new risks as<br>the fundamental<br>technology and<br>operation remain the<br>same. |
| Material | Remain no change.<br>Safety<br>protective<br>mechanism is ABS. | RBC: Safety protective<br>mechanism is PP.<br>Others component are<br>same with SBC exempt<br>the safety protective<br>mechanism. | Safety<br>protective<br>mechanism<br>material is<br>difference<br>which it is only<br>contact intact<br>skin as limited<br>exposure (A). | No new concerns.<br>Material of RBC is PP<br>which it is only contact<br>intact skin as limited<br>exposure (A), does not<br>introduce new risks<br>about biocompatibility<br>safety. |
| Sterility | SAL of 10-6<br>Remain no change | No change. | N/A | No new concerns.<br>The addition of a new<br>model (RBC) does not<br>introduce new risks as<br>the fundamental<br>technology and<br>operation remain the<br>same. |
| Shelf life | 3 years<br>Remain no change | No change. | N/A | No new concerns.<br>The addition of a new<br>model (RBC) does not<br>introduce new risks as<br>the shelf life remain the<br>same. |
| | | 21G     Deep<br>green<br>22G     Black<br>23G     Deep<br>blue<br>24G     Medium<br>purple<br>25G     Orange | | |

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Image /page/6/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is written in green and the word "med" is written in blue. Above the "P" in "Promise" is a green and blue graphic that looks like a chemical structure. To the right of the word "Promisemed" is a circled R, indicating that the logo is a registered trademark.

# Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, P. R. China.

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Image /page/7/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a combination of green and blue colors. The "P" is green, while the rest of the letters are blue. There is a molecule graphic above the word "Promisemed" and a registered trademark symbol to the right of the word.

# Promisemed Hangzhou Meditech Co., Ltd.

No. 1388 Cangxing Street, Canggian Community, Yuhang District, Hanazhou City 311121 Theiland P R China

To support substantial equivalence to the predicate device, Promisemed Hangzhou Meditech Co., Ltd. completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met.

Verification and Validation Activities - Design Changes:

- � Model RBC: Visual inspections were conducted on unit packaging to ensure RBC labeling is correct.
- � Needle size, color and schematic diagram: Full performance was tested, including appearance, dimension, safety mechanism, labeling, etc. and found to comply with drawing requirements.

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Image /page/8/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green and the word "med" is in blue. There is a green and blue molecule graphic above the "o" in "Promise". There is a registered trademark symbol to the right of the word "Promisemed".

Applicable standards:

- ISO 6009:2016, Hypodermic needles for single use Colour coding for identification. -
- ISO 8536-4: 2019, Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed.
- -ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods.
- -ISO 23908:2011, Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
- Material: the material of the subject device (RBC) safety protective mechanism has been changed to PP � from polypropylene (ABS), which only contacts the intact skin as limited exposure (A). Material PP has been used in the PROMISEMED's own legally marketed device (K230715) wing hub. K230715's biocompatibility testing (Externally communicating device, in contact with circulating blood with prolonged exposure B) was performed in accordance with ISO 10993-1 to support this change and does not raise new or different questions of safety and effectiveness, e.g. In vitro cytotoxicity testing in accordance with ISO 10993-5:2009.

All verification and validation tests passed without deviations, confirming that the subjective device meet the necessary design specifications and regulatory requirements. The tests demonstrated that the product modifications did not introduce any new risks related to safety or effectiveness when compared to the predicate device.

#### 9. Clinical test [21 CFR 807.92 (b) (2)]

No clinical test is included in this submission.

### 10. Conclusion [21 CFR 807.92 (b) (3)]

Based on the information provided within this 510(k) submission, the subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.