Winged Infusion Set is indicated for 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.

Safety Winged Infusion Set is indicated for 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.

Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Safety Blood Collection Set is indicated for venous blood collection. 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.

Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by trained healthcare professionals in accordance with the instructions. The safety shield to aid in the protection agamst accidental needle stick injury.

Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.

Device Description

The Blood Collection Set with Holder, Blood Collection Set, and Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector. The devices are individually wrapped and sterile with a luer port. The luer port can connect FDAcleared accessories like luer adapter, holder, etc.

The Safety Blood Collection Set with Holder, Safety Blood Collection Set, and Safety Winged Infusion Set are single-use, sterile, winged needles 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 and ensures the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without needle holder) is individually wrapped sterile with a luer port. The luer port can connect FDA-cleared accessories like luer adapter, holder, etc.

The safety feature is operated by releasing 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. There is no ability to clean and reuse these because the safety feature cannot be deactivated without bending the needle and rendering it unusable.

The devices are used for venous blood collection and/or the short-term infusion of intravenous fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions. It can be used with an intravascular administration set, syringe, or other device to administer fluids.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the U.S. FDA, which concerns the substantial equivalency of a medical device to legally marketed predicate devices. This type of submission focuses on demonstrating that a new device is "as safe and effective" as a predicate device and often relies on comparisons to known standards and existing devices rather than extensive clinical studies.

Therefore, the document does not describe a study that aims to prove that the device meets acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, F1-score for an AI algorithm, or human reader improvement with AI assistance).

Instead, the acceptance criteria and performance data provided in this document relate to the physical and functional performance, biocompatibility, sterilization, and packaging of a medical device (Winged Infusion Sets, Blood Collection Sets, and Needle Holders).

Here's an analysis of the provided information within the context of a medical device 510(k) submission, specifically addressing the points in your request where applicable, and noting where the information is not provided due to the nature of this type of submission (i.e., it's not an AI/ML device).

Analysis of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria:

This document describes the non-clinical performance testing conducted to support the substantial equivalence claim for physical medical devices (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). It does not pertain to an AI/ML device, and therefore, many of your specific questions related to AI/ML performance metrics, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable and are not found in this document.

The "acceptance criteria" here are compliance with recognized international and national standards for medical devices of this type. The "study" proving the device meets these criteria refers to the non-clinical performance testing conducted against these standards.

1. A table of acceptance criteria and the reported device performance

The document lists the standards that the device was tested against. The "reported device performance" is a blanket statement that "All the pre-determined acceptance criteria were met." There isn't a specific table with numerical performance metrics for each criterion; rather, it indicates compliance with the listed standards.

Category	Acceptance Criteria (Standards Complied With)	Reported Device Performance
Performance	- 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.- 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	"All the pre-determined acceptance criteria were met."
Biocompatibility	- ISO10993-5: 2009: In Vitro Cytotoxicity- ISO10993-10: 2021: Skin Sensitization- ISO10993-23: 2021: Intracutaneous Reactivity Test- ISO10993-11: 2017: Acute Systemic Toxicity- ISO10993-4:2017: Coagulation test- ISO10993-4: 2017: Complement activity (SC5b-9) Test- ISO10993-4: 2017: Hemolytic Properties Test- ISO10993-3: Ames Test- ISO10993-3: Mammalian Chromosome Aberration Test	"All the pre-determined acceptance criteria were met."
Sterilization	- ISO11135-1: Sterilization of health care products ethylene oxide part 1- ISO11737-1: Sterilization of medical devices-Microbiological Methods-Part 1- ISO11737-2: Sterilization of medical devices -- Microbiological methods - Part 2- ISO10993-7: Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals.- ANSI/AAMI ST72: Bacterial endotoxins - Test methods	"All the pre-determined acceptance criteria were met."
Packaging &Shelf Life	- ISO 11607-1:2006/(R) 2010: Packaging for terminally sterilized medical devices- ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration- ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices- ASTM D3078-02 (2021): Standard Test Method for Determination of Leaks in - Flexible Packaging by Bubble Emission.- ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials	"All the pre-determined acceptance criteria were met."

Specific tests performed for Packaging and Shelf Life: Accelerated Aging Test, Simulated shipping distribution testing, Visual inspection, Performance Inspection (Chemical performance and Physical performance), Sterile Test, Vacuum Leak Test, Dye penetration test, Tensile Seal Strength Test.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for each test mentioned (e.g., how many devices were tested for tensile strength, biocompatibility, etc.). The data provenance is not explicitly stated in terms of country of origin but is implied to be from the manufacturer's testing (Jiangsu Kangbao Medical Equipment Co., Ltd, China). The testing is non-clinical, likely conducted retrospectively for the purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. This is not an AI/ML device that requires expert-established ground truth from, for example, medical images. The "ground truth" here is adherence to specified engineering, material, and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not an AI/ML device requiring human review/adjudication of outputs.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device. "Clinical Data: No clinical study is included in this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device is physical and material science standards (e.g., ISO, ASTM standards for materials, performance, sterilization, and packaging). Compliance with these established industry standards constitutes the "ground truth" for device safety and effectiveness in this context.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no training set in the AI sense. The manufacturing processes and designs would be "trained" in an engineering sense over time and through quality control, but this is not data for an algorithm.

9. How the ground truth for the training set was established

Not applicable, as there is no AI/ML training set. The "ground truth" for manufacturing and design would be engineering specifications and quality control parameters.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo 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.

December 22, 2023

Jiangsu Kangbao Medical Equipment Co., Ltd Wenbin Fan Deputy General Manager 78#, North Suzhong Road, Baoying Yangzhou, Jiangsu 225800 China

Re: K232881

Trade/Device Name: 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 Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FMI, FPA Dated: November 21, 2023 Received: November 22, 2023

Dear Wenbin Fan:

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.

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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" (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 QS 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.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director

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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) K232881

Device Name

Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder

Indications for Use (Describe)

Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K232881

Preparation Date:	December 22, 2023
Manufacturer's Name and Address:	Jiangsu Kangbao Medical Equipment Co., Ltd78#, North Suzhong RoadBaoying, Yangzhou, Jiangsu, China 225800Tel. +86-514-88223540Fax +86-514-88232089
Corresponding Official:	Charles Mack
Telephone Number:	931-625-4938
Email Address:	charliemack@irc-us.com
Trade Name:	Winged Infusion Set.Safety Winged Infusion Set,Blood Collection Set,Blood Collection Set withHolder.Safety Blood Collection Set,Safety Blood Collection set with Holder,Needle Holder
Common Name(s):	Tubes, Vials, Systems, SerumSeparators, Blood Collection
Regulation Name(s):	Blood specimen collection device
Regulation Number(s):	21 CFR 862.1675
Primary Product Code:Subsequent Product Codes:	JKAFMI, FPA
Device Class:	Class II

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Primary Predicate Device:	K193074
Trade Name:	Bevel Up Holder
Common Name:	tubes, vials, systems, serum separators, bloodcollection
Regulation Number:	21 CFR 862.1675
Product Code:	JKA
Predicate Device:	K214075
Trade Name:	Safety Blood Collection / Infusion Set (with/withoutneedle holder), Blood Collection/ Infusion Set (with/without needle holder)
Common Name:	needle, hypodermic, single lumen
Regulation Number:	21 CFR 880.5570
Product Code:	FMI, FPA

Device Description:

Indications for Use

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Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.

Safety Blood Collection set with Holder is indicated for venous blood collection. 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 aqainst accidental needle stick injury.

Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles, and tubes. It is to be used by trained healthcare professional only.

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Needle Holder

Feature	Subject Device	Predicate Device	Discussion
510(K)	K232881	K193074	-
Device Name	Needle Holder	BEVEL UP HOLDER	-
Indication forUse	The Needle Holder is used for the collection of bloodspecimen into the blood collection tubes in routinevenipuncture procedures. It is used with bloodcollection sets, needles, and tubes. It is to be used bytrained healthcare professional only.	The Bevel Up Holder is used for the collection of bloodinto blood collection tubes in routine venipunctureprocedures. It is used with blood collection sets,needles, and tubes. The device is to be used by trainedhealthcare professional only.	Identical
ProductConfiguration	Clear plastic holder	Clear plastic holder	Identical
Material	Polypropylene	Polypropylene	Identical
Sterility	They are not sterilized when provided alone.Sterilized when provided attached to the bloodcollection set	Not sterilized	Note 1
Packaging	Bulk pack in poly bag or Blister packaging	Bulk pack in poly bag	Note 2
Use	Single use	Single use	Identical
Biocompatibility	Complies with ISO 10993-1	Complies with ISO 10993-1	Identical
Shelf Life	Complies with ASTM F1980 5 years	3 years	Note 3
Feature	Subject Device	Predicate Device	Discussion
510(K)	K232881	K214075
Device Name	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	Safety Blood Collection / Infusion Set (with/without needleholder).Blood Collection / Infusion Set (with/without needle holder)
Indication for Use	Winged Infusion Set is indicated for the short-terminfusion of intravenous fluids for 2 hours or less. It is tobe used by appropriately trained healthcareprofessionals in accordance with the instructions.Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. Itis to be used by appropriately trained healthcareprofessionals in accordance with the instructions. Thesafety shield is intended to aid in the protection againstaccidental needle stick injury.Blood Collection Set is indicated for venous bloodcollection. It is to be used by appropriately trainedhealthcare professionals in accordance with theinstructions.Blood Collection Set with Holder is indicated forvenous blood collection. It is to be used by appropriatelytrained healthcare professionals in accordance with theinstructions.	The Safety Blood Collection / Infusion Set (with/withoutneedle holder) is indicated for venous blood collectionand/or the short-term infusion of intravenous fluids for 2hours or less. It is to be used by appropriately trainedhealthcare professionals in accordance with theinstructions. The safety shield is intended to aid in theprotection against accidental needle stick injury.The Blood Collection / Infusion Set (with/withoutneedle holder) is indicated for venous blood collectionand/or the short-term infusion of intravenous fluids for 2hours or less. It is to be used by appropriately trainedhealthcare professionals in accordance with theinstructions.	SimilarNote 1
Feature	Subject Device	Predicate Device	Discussion
510(K)	K232881	K214075	-
	Safety Blood Collection Set is indicated for venousblood collection. It is to be used by appropriately trainedhealthcare professionals in accordance with theinstructions. The safety shield is intended to aid in theprotection against accidental needle stick injury.Safety Blood Collection set with Holder is indicatedfor venous blood collection. It is to be used byappropriately trained healthcare professionals inaccordance with the instructions. The safety shield isintended to aid in the protection against accidentalneedle stick injury.Needle Holder is used for the collection of bloodspecimen into the blood collection tubes in routinevenipuncture procedures. It is used with blood collectionsets, needles and tubes. It is to be used by trainedhealthcare professional only.
Safety Feature	The needle is locked in safety sheath after use for theSafety Blood Collection / Winged Infusion Set(with/without needle holder). Slide the safety shieldforward and pull the tubing backward until an audibleclick is heard.There is no safety mechanism for the Blood CollectionSet / Winged Infusion Set (with/without needle holder).	For the Safety Blood Collection / Infusion Set (with/withoutneedle holder), the needle is locked in safety sheath afteruse by sliding the safety shield forward with pulling thetubing backward until an audible click is heard.For the Blood Collection / Infusion Set (with/without needleholder), no safety mechanism.	Identical
Material
Needle tube	SUS304	SUS304	Identical
Flexing tube	PVC	PVC	Identical
Luer adapter	ABS	ABS	Identical
Needle sheath	HDPE	HDPE	Identical
Safety shield	Polypropylene	Polypropylene	Identical
Rub sleeve	Gather Isoprene Rubber	Gather Isoprene Rubber	Identical
Feature	Subject Device	Predicate Device	Discussion
510(K)	K232881	K214075	-
Lubricate	Silicone oil	Silicone oil
Adhesive	Epoxy Resin	Epoxy Resin
Needle Gauge	18G, 19G, 20G, 21G, 22G, 23G,24G, 25G, 26G, 27G	18G, 19G, 20G, 21G, 22G,23G, 24G, 25G, 26G, 27G;	Identical
Needle Length	1/2" - 1 1/8"	1/2" - 1 1/8"	Identical
Flexing tubing Length	4"; 7½"; 12"	7½"; 12"	Note 2
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 9626ISO 7864ISO 80369-7ISO 80369-20ISO 23908ISO 6009ISO 8536-4	Complies with ISO 9626ISO 7864ISO 80369-7ISO 80369-20ISO 23908ISO 6009ISO 8536-4	Identical
Sterilization	EO	EO	Identical
Sterile	Yes	Yes	Identical
SAL	10-6	10-6	Identical
Disposable	Yes	Yes	Identical
Single Patient Use	Yes	Yes	Identical
Shelf life	ASTM F 1980 5 years	ASTM F 1980 5 years	Identical

Note 1

When the needle holder of the subject device is provided alone for sale, it is not sterilized the same as the predicate device.

When the needle holder of the subject device is provided and attached to the blood collection as part of the system conforming to the applicable standards. The needle holded attached to the blood collection set is EO sterlized in accordance with ISO11135-1:

Second edition 2014. Therefore, the difference does not raise new questions about the safety and effectiveness of the subject device.

Note 2

More packaging types of the subject device are available than the predicate device, but they conform to the same andards. Therefore, this difference does not raise new or different questions of safety and effectiveness.

Note 2

The subject device has a shelf life longer than the prodical device was tested to applicable performance standards and

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the design outputs met the design inputs over the proposed 5 year shelf life. Therefore, the different questions of safety and effectiveness.

Blood Collection/Infusion Set

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Note 1

The indication for use of subject devices. The wording is slightly different; each subject device's IFU is listed individually for explicit identification (blood collection or infect for sales individually). It does not raise new questions of safety or effectiveness.

Note 2

The flexing tubing length of the subject devices is available in more sizes than the predicates, but the same applicable performance standards. Therefore, this difference does not raise new questions of safety or effectiveness.

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Non-Clinical Performance Testing

Testing was performed to evaluate the functional performance and safety of the subject device with the following standards:

Performance

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

Biocompatibility

The subject device is classified as external communication device and contact circulating blood for limited contact (duration ≤ 24 h).

-ISO10993-5: 2009 In Vitro Cytotoxicity
ISO10993-10: 2021 Skin Sensitization -
-ISO10993-23: 2021 Intracutaneous Reactivity Test
ISO10993-11: 2017 Acute Systemic Toxicity -
ISO10993-4:2017 Coagulation test -
-ISO10993-4: 2017 Complement activity (SC5b-9) Test
-ISO10993-4: 2017 Hemolytic Properties Test
ISO10993-3 Ames Test -
-ISO10993-3 Mammalian Chromosome Aberration Test

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Sterilization:

The devices are EO sterilized. The sterilization was conducted according to the following standards:

ISO11135-1 Sterilization of health care products ethylene oxide part 1: i requirements for the development, validation, and routine control of a sterilization process for medical devices.
ISO11737-1 Sterilization of medical devices-Microbiological Methods-Part 1: - Determination of the population of microorganisms on the product.
-ISO11737-2 Sterilization of medical devices -- Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process.
ISO10993-7 Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals.
-ANSI/AAMI ST72 Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing.

Packaging and Shelf Life:

ISO 11607-1:2006/(R) 2010 Packaging for terminally sterilized medical devices -. Part 1: Requirements for materials, sterile barrier systems and packaging systems, 3ed.
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM D3078-02 (2021), Standard Test Method for Determination of Leaks in - Flexible Packaging by Bubble Emission. (Sterility)
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials

The tests were conducted as noted below:

Accelerated Aging Test -
Simulated shipping distribution testing
-Visual inspection
Performance Inspection (Chemical performance and Physical performance) -
-Sterile Test
Vacuum Leak Test -
Dye penetration test -
-Tensile Seal Strength Test

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All the pre-determined acceptance criteria were met.

Clinical Data: No clinical study is included in this submission.

Conclusions:

Based on the verification test results, the subject device, Jiangsu Kangbao Medical Equipment Co., Ltd, 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 and Needle Holder conforms to the requirements of the exact standard, such as performance and biocompatibility, as the predicate devices. The subject device uses the same fundamental scientific technology and indications for use and functionality. The differences do not raise new questions about the safety and effectiveness of the proposed device.

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
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.(b)
Classification. Class II.