(106 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data processing.
No
The device is used for blood collection and short-term infusion of fluids, which are diagnostic and supportive procedures, not therapeutic ones that treat a condition.
No
The device is indicated for venous blood collection and/or short-term infusion of intravenous fluids, not for diagnostic purposes.
No
The device description clearly outlines physical components such as a winged needle, flexible tubing, Luer connector, and a safety mechanism, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "venous blood collection and/or the short-term infusion of intravenous fluids". This describes a procedure performed on the patient's body (in vivo), not a test performed on a sample taken from the body (in vitro).
- Device Description: The description details a "winged needle bonded to flexible tubing with a Luer connector" and a safety mechanism. This is consistent with a device used for accessing a vein for blood draw or fluid administration.
- Lack of IVD Characteristics: There is no mention of analyzing a sample, detecting analytes, or providing diagnostic information based on a sample. The device's function is purely for accessing the circulatory system.
Therefore, this device falls under the category of a medical device used for blood collection and fluid administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Product codes
FMI, FPA
Device Description
The Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector. The Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.
The Safety Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation, ensuring the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.
The safety feature is easily operated by releasing a latch mechanism whereby the user slides a winged cover over the needle removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable.
The Blood Collection / Infusion Set (with/without needle holder) and Safety Blood Collection / Infusion Set (with/without needle holder) are used for venous blood collection and/or the short-term infusion of intravenous fluids. It can be used with an intravascular administration set or a syringe or other device to administer fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Safety Blood Collection / Infusion Set (with/without needle holder) and Blood Collection/Infusion set (with/without needle holder) met all requirements of related international standards, including biocompatibility, sterility, and product specifications. These tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing:
Performance Testing:
- ISO 8536-4-2019 Infusion equipment for medical use —Part 4: Infusion sets for single-use, gravity feed
- ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- -ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use -Requirements and test methods
- ISO 80369-7 First edition 2016-10-15 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20 First edition 2015-05-15, small-bore connectors for liquids and gases in healthcare applications part 20: common test methods. (General I (QS/RM))
- ISO 23908 First edition 2011-06-11 Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use Colour coding for identification
- ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
- USP 788 Particulate Matter in Injections -
- Flowrate and Priming volume of tubing l
Biocompatibility:
The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: externally communicating devices, contact circulating blood for limited contact (
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2022
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K214075
Trade/Device Name: Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FPA Dated: March 18, 2022 Received: March 24, 2022
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 may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gang Peng 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K214075
Device Name
Safety Blood Collection / Infusion Set (with/without needle holder) Blood Collection / Infusion Set (with/without needle holder)
Indications for Use (Describe)
The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healtheare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the shortterm infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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."
3
K214075 510(k) SUMMARY
Submitter Information:
| Preparation Date: | April 3, 2022 |
|---|---|
| Manufacturer's Name and Address: | Anhui Hongyu Wuzhou Medical |
| Manufacturer Co., Ltd. | |
| No. 2 Guanyin Road, Economic | |
| Development Zone, Taihu, Anqing City, | |
| Anhui Province, China 246400 | |
| Mr. Bingyi Xiang | |
| General Manager | |
| Tel: +86-556 5129666 | |
| Fax: +86-556 4249999 | |
| birrell@hongyu-wuzhou.com | |
| Submission Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Safety Blood Collection / Infusion Set |
| (with/without needle holder) | |
| Blood Collection / Infusion Set | |
| (with/without needle holder) | |
| Common Name(s): | Needle, hypodermic, single lumen |
| Intravascular administration set | |
| Regulation Name(s): | Needle, hypodermic, single lumen |
| Intravascular administration set | |
| Regulation Number(s): | 21CFR 880.5570 |
| Product Code: | FMI, FPA |
| Device Class: | Class II |
| Predicate Device: | K173757 |
| VACUETTE EVOPROTECT Safety Blood | |
| Collection/Infusion Set | |
| Greiner Bio-One NA Inc |
4
Device Description:
The Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector. The Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.
The Safety Blood Collection / Infusion Set (with/without needle holder) is a single-use, sterile, winged needle bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation, ensuring the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without a needle holder) is individually wrapped and sterile with a luer port. The luer port can connect FDA cleared accessories like luer adapter, holder, etc.
The safety feature is easily operated by releasing a latch mechanism whereby the user slides a winged cover over the needle removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these devices because the safety feature cannot be deactivated without bending the needle and rendering it unusable.
The Blood Collection / Infusion Set (with/without needle holder) and Safety Blood Collection / Infusion Set (with/without needle holder) are used for venous blood collection and/or the short-term infusion of intravenous fluids. It can be used with an intravascular administration set or a syringe or other device to administer fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions.
5
| Blood Collection / Infusion Set | Individually wrapped and sterile, allowing set to be used with a luer system. |
|---|---|
| Blood Collection Set (without needle holder) | Individually wrapped and sterile with Luer Adapter (for use with e.g. Standard Needle holder). |
| Blood Collection Set (with needle holder) | Individually wrapped and sterile, ready to be used forblood collection. |
| Safety Blood Collection / Infusion Set | Individually wrapped and sterile, allowing set to be used with a luer system. |
| Safety Blood Collection Set (without needle holder) | Individually wrapped and sterile with Luer Adapter (for use with e.g. Standard Needle holder). |
| Safety Blood Collection Set (with needle holder) | Individually wrapped and sterile, ready to be used forblood collection. |
The proposed device consists of the components defined below:
-
- needle holder
-
- rubber sleeve
-
- puncture needle
-
- needle hub (male luer lock connector)
-
- connect base (female luer lock connector)
-
- flexing tube
-
- safety shield
-
- wings
-
- patient-end tube needle
-
- needle sheath
-
- Protective cap
Indications for Use
The Safety Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Blood Collection / Infusion Set (with/without needle holder) is indicated for venous blood collection and/or the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
6
SE Comparison Table
| Feature | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| Company | Anhui Hongyu Wuzhou | ||
| Medical Manufacturer Co., Ltd. | Greiner Bio-One NA Inc | - | |
| FDA510(K) | |||
| Number | K214075 | K173757 | - |
| Device Name | Safety Blood Collection / | ||
| Infusion Set (with/without | |||
| needle holder); | |||
| Blood Collection / Infusion Set | |||
| (with/without needle holder) | VACUETTE | ||
| EVOPROTECT | |||
| Safety Blood | |||
| Collection / Infusion | |||
| Set | - | ||
| Product code | FMI, FPA | FMI, FPA | - |
| CFR | 880.5570 | 880.5570 | - |
| Indication for | |||
| Use | The Safety Blood Collection / | ||
| Infusion Set (with/without | |||
| needle holder) is indicated for | |||
| venous blood collection and/or | |||
| the short-term infusion of | |||
| intravenous fluids for 2 hours | |||
| or less. It is to be used by | |||
| appropriately trained | |||
| healthcare professionals in | |||
| accordance with the | |||
| instructions. The safety shield | |||
| is intended to aid in the | |||
| protection against accidental | |||
| needle stick injury. |
The Blood Collection / Infusion
Set (with/without needle
holder) is indicated for venous
blood collection and/or the
short-term infusion of
intravenous fluids for 2 hours
or less. It is to be used by
appropriately trained
healthcare professionals in
accordance with the
instructions. | The VACUETTE
EVOPROTECT
Safety Blood
Collection/Infusion
Set is indicated for
venous blood
collection and/or the
short-term infusion of
intravenous fluids. It
is to be used by
appropriately trained
healthcare
professionals in
accordance with the
instructions. | Note 1 |
| Feature | Subject Device | Predicate Device | Discussion |
| Safe Feature | For the Safety Blood Collection / Infusion Set
(with/without needle holder), the needle is locked in the
safety sheath after using the safety shield by pulling the
tubing backward until an audible click is heard.
There is no safety mechanism for the Blood Collection /
Infusion Set (with/without needle holder). | The needle is completely retracted and locked by sliding
the safety shield forward and pulling the tubing backward
until an audible click is heard. | Note 2 |
| Material | | | |
| Needle tube | SUS304 | SUS304 | Identical |
| Flexing tube | PVC | PVC | Identical |
| Luer adapter | ABS | ABS | Identical |
| Needle sheath | HDPE | PP | Note 3 |
| Safety shield | Polypropylene | PC | |
| Rub sleeve | Gather Isoprene Rubber | Unknown | |
| Lubricate | Silicone oil | Unknown | |
| Adhesive | Epoxy Resin | UV cured adhesive | |
| Needle Gauge | 18G, 19G, 20G, 21G, 22G,
23G, 24G, 25G, 26G, 27G; | 21G, 23G, 25G | Note 4 |
| Needle Length | 1/2" - 1 1/8" | 3/4' | |
| Flexing tubing
Length | 7½"; 12" | 4"; 7½"; 12" | Note 5 |
| Hub/Needle
bond strength | Complies with ISO7864 | Complies with
ISO7864 | Identical |
| Biocompatibility | Complies with ISO10993-1 | Complies with
ISO10993-1 | Identical |
| Performance | Complies with
ISO 9626
ISO 7864
ISO 80369-7
ISO 80369-20
ISO 23908
ISO 6009
ISO 8536-4 | Complies with
ISO 9626
ISO 7864
ISO 80369-7
ISO 80369-20
ISO 23908
ISO 6009
ISO 8536-4 | Identical |
| Sterilization | EO | Rx | Note 6 |
| Sterile | Yes | Yes | Identical |
| SAL | 10^-6 | 10^-6 | Identical |
| Disposable | Yes | Yes | Identical |
| Single Patient
Use | Yes | Yes | Identical |
7
8
Note 1
The subject devices include two configurations, with the safety mechanism and without safety mechanism, but the predicate device only includes one configuration with a safety mechanism. Although the configuration is different, the indication for use is the same, and both can be used for blood collection and infusion. Therefore, the difference is not determined to affect substantially equivalence on safety and effectiveness.
Note 2
For the Safety Blood Collection / Infusion Set (with/without needle holder), the safety mechanism is the same as predicate device:
There is no safety mechanism for the Blood Collection / Infusion Set (with/without needle holder).
Whether there is a safety mechanism will not affect the indication for the use of the devices; both can be used for blood collection and infusion. Therefore, the difference is not determined to affect substantially equivalence on safety and effectiveness.
Note 3
Although the material of these components of subject devices are different from predicate devices (or some unknown for predicate device), they conform to the same ISO10993-1 biocompatibility standards; Therefore, the difference does not raise new questions on the safety and effectiveness of the proposed method device.
Note 4
The subject devices' needle gauge and needle length are available in more sizes than the predicate device, but they conform to the same applicable performance standards as the predicate device; Therefore, the difference does not raise new questions on the safety and effectiveness of the proposed method device.
Note 5
The subject device has two sizes, same as the predicate device, but the predicate device has an additional one size:
They conform to the same applicable performance standards. Therefore, this difference is not considered to affect safety and effectiveness substantially.
Note 6
The sterilization method is different; The subject device's sterilization is validated per ISO11135 and achieves the same SAL of 10° as the predicate device. The difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device
9
Performance Testing
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Safety Blood Collection / Infusion Set (with/without needle holder) and Blood Collection/Infusion set (with/without needle holder) met all requirements of related international standards, including biocompatibility, sterility, and product specifications. These tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing
Performance Testing
- ISO 8536-4-2019 Infusion equipment for medical use —Part 4: Infusion sets for single-use, gravity feed
- ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- -ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use -Requirements and test methods
- ISO 80369-7 First edition 2016-10-15 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20 First edition 2015-05-15, small-bore connectors for liquids and gases in healthcare applications part 20: common test methods. (General I (QS/RM))
- ISO 23908 First edition 2011-06-11 Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- ISO 6009 Fourth edition 2016-08-01 Hypodermic needles for single use Colour coding for identification
- ISO 2859-1 Second edition 1999-11-15 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
- USP 788 Particulate Matter in Injections -
- Flowrate and Priming volume of tubing l
10
Biocompatibility
The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: externally communicating devices, contact circulating blood for limited contact (