Who is the manufacturer of Safety Blood Collection Sets for Single Use?

Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. filed the 510(k) submission for Safety Blood Collection Sets for Single Use (K202188).

What is the FDA product code for Safety Blood Collection Sets for Single Use?

JKA. It is classified under 21 CFR 862.1675 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for Safety Blood Collection Sets for Single Use?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Safety Blood Collection Sets for Single Use?

Improsafe Blood Collection Set (K123987).

Who can help prepare an FDA 510(k) submission like Safety Blood Collection Sets for Single Use?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Safety Blood Collection Sets for Single Use

K202188 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · JKA · Feb 19, 2021 · Clinical Chemistry

Device Facts

Record ID	K202188
Device Name	Safety Blood Collection Sets for Single Use
Applicant	Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Product Code	JKA · Clinical Chemistry
Decision Date	Feb 19, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1675
Device Class	Class 2

Intended Use

The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.

Device Story

Safety Blood Collection Sets for Single Use are sterile, single-use devices for routine venous blood collection. The device consists of a winged needle, flexible tubing, and a hub/luer connector system. The needle is inserted into the patient's vein; blood is collected into an evacuated tube or syringe. The device features a manual safety shield mechanism; after withdrawal, the user slides the shield over the needle until it locks with an audible click, protecting the user from accidental needlestick injury. Used by trained healthcare professionals in clinical settings. The device facilitates safe blood sampling and reduces sharps injury risk.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ISO 9626, ISO 7864, ISO 80369-7/20, ISO 23908, ISO 6009, and ISO 10993-1 (biocompatibility) verified performance and safety.

Technological Characteristics

Materials: SUS304 stainless steel needle, HDPE sheath, Polypropylene hub/shield, PVC tubing, ABS luer adapter, Isoprene rubber sleeve. Energy: None (manual). Connectivity: None. Sterilization: Ethylene Oxide (EO). Design: Winged needle with manual sliding safety shield, luer lock connectors. Complies with ISO 7864, ISO 23908, ISO 80369-7/20.

Indications for Use

Indicated for the collection of venous blood in patients requiring venipuncture. Used by trained healthcare professionals. Not indicated for intravenous administration of fluids.

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

Improsafe Blood Collection Set (K123987)

Related Devices

K232308 — Monarch Blood Collection Set · The Monarch Company · Dec 4, 2023
K163093 — Safety Blood Collection Set · Jiangsu Shenli Medical Production Co., Ltd. · Mar 14, 2017
K011786 — VACUETTE SAFETY BLOOD COLLECTION SET · Greiner Vacuette North America, Inc. · Jul 12, 2001
K013164 — SURSHIELD SAFETY WINGED BLOOD COLLECTION SET · Terumo Medical Corp. · Oct 15, 2001
K232881 — Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder · Jiangsu Kangbao Medical Equipment Co., Ltd. · Dec 22, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 23, 2021 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249 Re: K202188 Trade/Device Name: Safety Blood Collection Sets for Single Use Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FMI Dear Charles Mack: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 19, 2021. Specifically, FDA is updating this SE Letter to include the secondary product code (FMI) as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6029, Payal.Patel@fda.hhs.gov. Sincerely, # James M. Simpson Jr - ## S7 For 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 19, 2021 Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249 Re: K202188 Trade/Device Name: Safety Blood Collection Sets for Single Use Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: January 8, 2021 Received: January 19, 2021 Dear Charles Mack: 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 mav, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {2}------------------------------------------------ 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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # James M. Simpson Jr - ## S7 For 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 {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K202188 Device Name Safety Blood Collection Sets for Single Use #### Indications for Use (Describe) The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury. | Type of Use (Select one or both, as applicable) | |---------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # K202188 510(k) SUMMARY | Preparation Date: | February 23, 2021 | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer's Name and Address: | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. No. 2 Guanyin Road, Economic Development Zone, Taihu, Anqing City, Anhui Province China246400 Mr. Bingyi Xiang General Manager Tel: +86-556 5129666 Fax: +86-556 4249999 Email: birrell@hongyu-wuzhou.com, FDA Establishment Registration No.: 3012116434 | | Corresponding Official: | IRC USA 2950 E Lindrick Dr., Chandler, Arizona 85249, USA Mr. Charles Mack PRINCIPAL ENGINEER Tel: 931-6254938 Email: charliemack@irc-us.com | | Telephone Number: | 931-625-4938 | | Email Address: | charliemack@irc-us.com | | Trade Name: | Safety Blood Collection Sets for Single- Use | | Common Name(s): | Blood collection | | Regulation Name(s): | Blood specimen collection device | | Regulation Number(s): | 21CFR862.1675 | | Product Code: | JKA (Primary) FMI (Secondary) | | Device Class: | Class II | | Predicate Device: | Innovative Medical Technologies, Inc. Improsafe Blood Collection Set K133097 | {5}------------------------------------------------ ### Device Description: The Safety Blood Collection Sets for Single Use are used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately the following venipuncture to aid in the protection against accidental needlestick injury. The Safety Blood Collect Sets is compatible for use with a tube and syringe. The product is to be used by appropriately trained healthcare professionals, only following the product instructions. The Blood Collection needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. - The hub is threaded on one side to connect to the needle holder, which is used to । guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber cap and a needle holder. - The opposite end of the needle is 3/4" long for withdrawing blood and is fitted with a needle sheath. The needle holder and needle sheath protect the needle. The safety feature is operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is substantially equivalent to the predicate device. The proposed devices are packaged as sterile, single-use, and single patient use only. The proposed device consists of ten components: - 1. needle holder - 2. rubber sleeve - 3. puncture needle - 4. needle hub (male luer lock connector) - 5. connect base (female luer lock connector) - 6. flexing tube - 7. safety shield - 8. wings - 9. patient-end tube needle - 10. needle sheath {6}------------------------------------------------ The subject device is classified as externally communicating devices, contact circulating blood for limited contact (<24 h) duration according to ISO10993-1 Fourth edition 2009-10-15 Annex A Table A.1-Evaluation tests for consideration. #### Intended Use / Indications for Use The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needle stick injury. {7}------------------------------------------------ | Feature | Subject Device | Predicate Device | Discussion /Comment | |-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | Innovative Medical Technologies, Incorporated | N/A | | FDA510(K) Number | K202188 | K123987 | N/A | | Device Name | Safety Blood Collection Set for Single- Use | Improsafe Blood Collection Set | N/A | | Primary product code | 21CFR862.1675, JKA | 21CFR862.1675, JKA | N/A | | Secondary product code | 21CFR880.5570, FMI | | | | Indication for Use | The Safety Blood Collection Set for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needle stick injury. | Improve Blood Collection Set and Improsafe Blood Collection Set are winged blood collection needles with flexible tubing and a female luer adapter intended for venipuncture to obtain blood samples from patients. Some reorder numbers are provided with a male luer adapter. The male luer adapter contains a non-patient needle end for puncturing the stopper of an evacuated blood collection tube. Those without a male luer adapter are provided with a protective cap on the end of the female luer adapter. The Improsafe Blood Collection Set is provided with an attached safety shield for covering the used needle prior to disposal. After withdrawal of the needle from the patient's vein, the attached safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick. The Improve Blood Collection Set and Improsafe Blood Collection Set is also indicated for short-term (up to 2 hours) intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. For devices that include the male liter adapter: after removing the attached male luer adapter from the blood collection set, connect the female luer adapter to a syringe or other compatible/appropriate device. | The indications for use of venipuncture to obtain blood samples from patients are the same between the subject device and the predicate device. The predicate device can be provided without a male luer adapter, where this is not available in the subject devices. The predicate device is indicated for short-term (up to 2 hours) intravenous administration of fluids, while subject device is not indicated for intravenous administration of fluids. | | Feature | Subject Device | Predicate Device | Discussion /Comment | | Safe Feature | The needle is locked in a safety sheath by slide the safety shield forward with pulling the tubing backward until an audible click is heard. | The needle is wholly retracted and locked by slide the safety shield forward by pulling the tubing backward until an audible click is heard. | Both devices have the same operation. | | Material | | | | | Needle sheath | HDPE | HDPE | Same material | | Needle tube | SUS304 | SUS304 | Same material | | Needle holder | Polypropylene | None. | The subject device is available with a needle holder, while the predicate is not. | | Safety shield | Polypropylene | Polypropylene | Same material | | Flexing tube | PVC | PVC | Same material | | Rub sleeve | Gather Isoprene Rubber | Rubber (Synthetic) | Although the rub sleeve material is different between subject device and the predicate device, both conform to the same ISO10993-1 standards requirement. | | Luer adapter | ABS | ABS | Same Material | | Lubricant | Silicone oil | Unknown | Although the predicate device's lubricant material is unknown, both conform to the same ISO10993-1 standards requirement. | | Adhesive | Epoxy Resin | Unknown | Although the predicate device's adhesive material is unknown, both conform to the same ISO10993-1 standards requirement. | | Colors of wing | Green | Green | Same color, no difference. | | Colors of the safety shield | Translucent blue | Translucent yellow | The color of the safety shield is different. The subject device is translucent blue, while the predicate device is translucent yellow. Both conform to the same ISO 10993-1 standard. | | Length | 3/4" x 12"(needle length x tube length) | 3/4" x 12"(needle length x tube length) | No differences. | | Gauge | 21G | 21G, 23G, 25G | The predicate has two additional sizes. There is no difference in the 21G. | | Hub/Needle bond strength | Complies with ISO7864: 21G>44N | Complies with ISO7864: 21G>44N 23G>34N 25G>22N | Both comply with ISO7864. | | Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | There is no difference, as both comply with ISO10993-1 | | Performance | Complies with ISO 9626 ISO 7864 ISO 80369-7 ISO 80369-20 ISO 23908 ISO 6009 | Complies with ISO 9626 ISO 7864 ISO 594-1 ISO 594-2 ISO 23908:2011 ISO 10555-1 ASTM F2132- Needle penetration | Both devices demonstrate compliance with ISO standards showing safe and effective use per the Indications for use. | | Sterilization | EO | EO…