Safety Winged Blood Collection Sets

K211293 · Promisemed Hangzhou Meditech Co., Ltd. · FMI · Jun 25, 2021 · General Hospital

Device Facts

• Record ID: K211293
• Device Name: Safety Winged Blood Collection Sets
• Applicant: Promisemed Hangzhou Meditech Co., Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Jun 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

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 adaper 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, and optional tube holder. Used for blood collection or short-term IV infusion (up to 2 hours) under clinical supervision. Features integrated safety mechanism to prevent needlestick injuries; activated by pressing curved design with index finger while holding wings with thumb and middle finger, then withdrawing until audible 'click' confirms needle coverage. Operated by healthcare professionals in clinical settings. Output is successful blood draw or fluid delivery; safety mechanism protects user post-procedure. Benefits include reduced risk of accidental needlestick injury.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical bench testing, including physical, chemical, and biological performance verification against ISO standards (e.g., ISO 7864, ISO 8536-4, ISO 9626, ISO 23908) and biocompatibility testing (ISO 10993).

Technological Characteristics

Materials: Stainless steel needle, PVC tubing/wings, ABS sleeve/holder, PE cartridge, Nitrile rubber cover. Energy: None (manual). Dimensions: 21G, 23G, 25G; 10-30cm tubing. Connectivity: None. Sterilization: Ethylene Oxide (SAL 10^-6). Safety: Latch-type needle protection mechanism (ISO 23908).

Indications for Use

Indicated for blood collection and short-term (up to 2 hours) intravenous fluid infusion in patients requiring venipuncture, under direct 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

• Gemtier Medical (Shanghai) Inc. Safety Blood Collection Device for Single Use (K170276)

Submission Summary (Full Text)

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June 25, 2021

Promisemed Hangzhou Meditech Co., Ltd. % John Beasley Official Correspondent MedTech Review, LLC 257 Garnet Garden Street Henderson, Nevada 89015

Re: K211293

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: April 16, 2021 Received: April 26, 2021

Dear John Beasley:

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 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).

Sincerely,

Payal Patel Acting 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)

## K211293

### Device Name

Safety Winged Blood Collection Set - Needle Diameter (21, 23, 25 Guage) - Tube Length (10, 19, 30 cm) - HOLDER, SBC-xxxxH, Safety Winged Blood Collection Set - Needle Diameter (21, 23, 25 Guage) - Tube Length (10, 19, 30 cm) - ADAPTER, SBC-xxxx A: Safety Winged Blood Collection Set - Needle Diameter (21, 23, 25 Guage) - Tube Length (10, 19, 30 cm) - W/O Puncture, SBC-

#### 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 adaper 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 style="text-decoration: underline;">Prescription Use</span> (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/1 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 molecule graphic above the word "Promise" and a registered trademark symbol to the right of the word "med". There is a black line underneath the logo.

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

# 510(k) Summary

Updated: 06/18/2021

| Contact Details | | 21 CFR 807.92(a)(1) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------|
| Applicant Name | Promisemed Hangzhou Meditech Co., Ltd. | |
| Applicant Address | No. 12, Longtan Road, Cangqian Street, Yuhang District, Hangzhou City,<br>Zhejiang, 311121, CH | |
| Applicant Telephone Number | 865-718-8772985 | |
| Applicant Contact | Mr. Zearou Yang | |
| Applicant Contact Email | [e-mail] | |
| Correspondent Name | MedTech Review, LLC | |
| Correspondent Address | 257 Garnet Garden Street, Henderson, NV, 89015, US | |
| Correspondent Telephone<br>Number | 1-612-889-5168 | |
| Correspondent Contact | Mr. John Beasley, RAC (US) | |
| Correspondent Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Safety Winged Blood Collection Sets | |
| Common Name | Safety Blood Collection Device for Single Use | |
| Classification Name | NEEDLE, HYPODERMIC, SINGLE LUMEN | |
| Regulation Number | 880.5570 | |
| Product Code | FMI/FPA | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate [510(k)] # | Predicate Trade Name | Product Code |
| K170276 | Gemtier Medical (Shanghai) Inc. Safety Blood Collection Device<br>for Single Use | FMI/FPA |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for<br>blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical<br>supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can<br>be activated to cover the needle immediately following venipuncture to aid in the protection against<br>accidental needlestick injury. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a<br>flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection<br>and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The<br>blood-collection needle is designed to be covered with a safety mechanism, which can be activated to<br>cover the needle immediately following venipuncture to aid in the protection against accidental<br>needlestick injury. | | |

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Image /page/4/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green, and the word "med" is in blue. Above the word "Promise" is a green and blue atom-like structure. To the right of the word "Promisemed" is a circled R symbol.

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

## Indications for Use Comparison

21 CFR 807.92(a)(5)

Other than the difference in the name of the device and the fact that they are all connected to flexible tubing (these are sets), there are no differences in the indications for use of the subject device when compared to the predicate device.

### Technological Comparison

21 CFR 807.92(a)(6)

Compared with the predicate device, the subject device is identical in mechanism of action, materials, needle point, sterilization method, and biocompatibility. The subject device has the same performance specifications except for needle length. Through performance bench testing, the subject device and the predicate device demonstrated to be substantially equivalent.

| Specification | Predicate Device | Subject Device | Discussion of<br>Differences |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Safety Blood Collection<br>Device for Single Use | Safety Winged Blood<br>Collection Sets | The subject device brings<br>attention to the "wings" in<br>the device name, as well<br>as properly defines the<br>device as a "set".<br><br>The differences do not<br>introduce any new<br>concerns for safety or<br>efficacy. |
| K number | K170276 | K211293 | - |
| Product code and<br>classification name | FMI, Needle,<br>Hypodermic, Single<br>Lumen | FMI, Needle<br>Hypodermic, Single<br>Lumen | No difference |
| Indications for use | The SAFETY BLOOD<br>COLLECTION DEVICE<br>FOR SINGLE USE is a<br>single-use, sterile,<br>winged venipuncture<br>needle bonded to a<br>flexible tubing with or<br>without a luer adapter<br>and/or tube holder.<br>The SAFETY BLOOD<br>COLLECTION DEVICE<br>FOR SINGLE USE is<br>used for blood<br>collection and/or the<br>short-term infusion of<br>intravenous fluids (up<br>to 2 hours under direct<br>clinical supervision).<br>The venipuncture<br>needle is designed to | The safety winged<br>blood collection set is<br>single-use, sterile,<br>winged venipuncture<br>needle bonded to a<br>flexible tubing with or<br>without a luer adapter<br>and/or tube holder.<br>The device is used for<br>blood collection and/or<br>the short-term infusion<br>of intravenous fluids<br>(up to 2 hours under<br>direct clinical<br>supervision). The<br>blood-collection needle<br>is designed to be<br>covered with a safety<br>mechanism, which can<br>be activated to cover | Difference in the name of<br>the device and the fact<br>that they are all<br>connected to flexible<br>tubing (these are sets).<br>The differences do not<br>introduce any new<br>concerns for safety or<br>efficacy. |
| Specification | Predicate Device | Subject Device | Discussion of<br>Differences |
| | be covered with a<br>safety mechanism,<br>which can be activated<br>to cover needle<br>immediately following<br>venipuncture to aid in<br>the protection against<br>accidental needlestick<br>injury. | the needle immediately<br>following venipuncture<br>to aid in the protection<br>against accidental<br>needlestick injury. | |
| Indicated for infusion | Yes | Yes | No difference |
| Single use | Yes | Yes | No difference |
| Mechanism of safety<br>blood collection | Latch mechanism:<br>press both sides of the<br>safety mechanism to<br>release the lock first<br>and then slide the<br>safety mechanism to<br>activate. | Latch mechanism:<br>Place the index finger<br>on the curved design to<br>press gently, hold the<br>two wings by the thumb<br>finger and middle finger<br>and withdraw the wings<br>back to activate the<br>safety mechanism until<br>hearing sound of<br>CLICK. The click is a<br>sign that the Safety<br>mechanism has been<br>correctly activated | The subject device<br>requires use of one finger<br>to press the release and<br>incorporates the wings for<br>activating the safety<br>mechanism.<br>The differences do not<br>introduce any new<br>concerns for safety or<br>efficacy. |
| Materials: | | | |
| Venipuncture Needle | Stainless Steel | Stainless Steel | No difference |
| Tubing | PVC | PVC | No difference |
| Wing | PVC | PVC | No difference |
| Sleeve | PE | ABS | No difference |
| Retractable Cartridge | PE | PE | No difference |
| Luer adapter | PP | PVC | No difference |
| Tube Holder | PP | ABS | No difference |
| Blood collection needle<br>protector | PP | PE | No difference |
| Rubber cover | Synthetic Rubber | Nitrile Rubber | Predicate device<br>unspecified.<br>The use of nitrile rubber<br>does not introduce any<br>new concerns for safety<br>or efficacy. |
| Specification | Predicate Device | Subject Device | Discussion of<br>Differences |
| Components: | | | |
| Tubing, Wing, Luer<br>connectors | Yes | Yes | No difference |
| Plastic sleeve,<br>venipuncture needle<br>stand | Yes | Yes | No difference |
| Luer adapter, tube<br>holder, blood collection<br>needle, protection<br>mechanism | Yes | Yes | No difference |
| Performance: | | | |
| Needle Gauge Sizes | 21G, 23G, 25G | 21G, 23G, 25G | No difference |
| Tubing Length | 10 cm to 35 cm | 10 cm, 19cm, 30 cm | No difference |
| Needle Length | 20mm | 19mm | The needle length of the<br>subject device is shorter<br>in length (19mm) as<br>compared to the<br>predicate device (20mm).<br>The short needle length<br>allows the phlebotomist to<br>insert it at a shallow angle<br>that can increase the<br>ease of use and<br>therefore, does not<br>introduce any new<br>concerns for safety or<br>efficacy. |
| Needle Point | 3-bevel | 3-bevel | No difference |
| Sterile | Ethylene Oxide | Ethylene Oxide | No difference |
| Non-pyrogen | Yes | Yes | No difference |
| Shelf life | 3 years | 3 years | No difference |
| Biocompatibility | Cytotoxicity, Skin<br>Sensitization, Irritation,<br>Acute Systemic<br>Toxicity, Hemolysis,<br>Pyrogenicity, Bacterial<br>Endotoxins testing<br>have passing results | Cytotoxicity, Skin<br>Sensitization, Irritation,<br>Acute Systemic<br>Toxicity, Hemolysis,<br>Pyrogenicity, Bacterial<br>Endotoxins testing<br>have passing results | No difference |
| Physical<br>performance | Needle appearance and cleanliness | ISO 7864:2016, clause 4.3 | |
| | Needle Size color code | ISO 6009:2016 | |
| | Needle Particulate contamination | USP<788>, METHOD 1, Test 1.B | |
| | Bonding<br>strength: | Needle and hub | ISO 7864:2016, clause 4.12 |
| |…