Vein set is intended for vein puncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy

Safety vein set is intended for vein puncture to collect blood specimens. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

Blood collection needle (vein set type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

Blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

Safety blood collection needle (vein set type) is intended for use in the blood collection or short-term influsion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk injury.

Safety blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce stick injury

Device Description

The proposed device is a blood collection device that forms a passage between the patient's vein and a vacuum blood collection tube for collecting blood. The proposed device can also be used for short-term infusion. The proposed devices are divided into several types, some have safety devices and some do not have safety devices, and the safety mechanism helps to reduce the risk of needle stick injuries. The proposed devices are provided sterile, single use. The propose device can be used for vein collect blood/infusion as well as peripheral vein collect blood/infusion, but not central vein collect blood/infusion.

AI/ML Overview

The provided text details the 510(k) submission for several blood collection and intravenous administration devices. It focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a new, innovative device with a complex algorithm. Therefore, many of the questions about acceptance criteria, specific performance metrics, expert qualifications, and study designs for algorithmic performance (like MRMC studies) are not directly applicable or available in this document.

However, I can extract information related to the device's performance as demonstrated by the non-clinical tests conducted to support its substantial equivalence. The "acceptance criteria" here are largely defined by the requirements of the referenced ISO standards and general safety/effectiveness considerations for medical devices of this type.

Here's an attempt to answer your questions based on the provided text, while acknowledging its limitations for certain aspects:

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

The document doesn't explicitly state "acceptance criteria" as singular numerical targets for a new algorithm. Instead, it refers to conformity with established international standards for medical devices and safety features. The "reported device performance" is essentially the outcome of these tests, demonstrating compliance.

Acceptance Criteria (Implicit from Standards)	Reported Device Performance
Biocompatibility
In Vitro Cytotoxicity: No cytotoxicity	No Cytotoxicity (Comply with ISO 10993 requirements)
Skin Sensitization: No sensitization	No Sensitization (Comply with ISO 10993 requirements)
Intracutaneous Reactivity: No intracutaneous reactivity	No Intracutaneous Reactivity (Comply with ISO 10993 requirements)
Acute Systemic Toxicity: No systemic toxicity	No Systemic Toxicity (Comply with ISO 10993 requirements)
Hemolytic Properties: No hemolytic properties	No Hemolytic (Comply with ISO 10993 requirements)
Pyrogenicity: No pyrogenicity	No Pyrogen (Comply with ISO 10993 requirements)
In Vivo Thromboresistance: (Implicitly, desired outcome is no)	No (Comply with ISO 10993 requirements)
Complement Activation: (Implicitly, desired outcome is no)	No (Comply with ISO 10993 requirements)
Sterilization
Sterilization Method: EO Sterilized	EO sterilized (Same as predicate)
Sterility Assurance Level (SAL): 10^-6	10^-6 (Same as predicate)
Endotoxin Limit: 20EU per device	20EU per device (Same as predicate)
Physical/Performance
Conical fittings (Luer taper) per ISO 594-1 & 594-2	Complies with ISO 594-1:1986 and ISO 594-2:1998
Infusion sets for single use per ISO 8536-4	Complies with ISO 8536-4:2010
Sterile hypodermic needles per ISO 7864	Complies with ISO 7864:2016
Stainless steel needle tubing per ISO 9626	Complies with ISO 9626:2016
Particulate Matter testing per USP <788>	Complies with USP <788> Particulate Matter testing (Method 1)
Seal Strength per ASTM F88/F88M-15	Complies with ASTM F88/F88M-15
Detecting Seal Leaks per ASTM F1929-15	Complies with ASTM F1929-15
Safety Mechanism (for safety models)	Device safety mechanism performance
Simulated Clinical Study	Meet pre-established criteria

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

The document generally refers to "non clinical tests" and "simulated clinical study" without specifying the exact sample sizes (e.g., number of devices tested) for each specific test mentioned (e.g., cytotoxicity, seal strength). The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated, but the submission is from Jiangsu Kangbao Medical Equipment Co., Ltd. in China, implying testing was likely conducted in China or by labs contracted by them. The studies described are non-clinical and simulated clinical, not human clinical trials.

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 to the provided document. The device is a physical medical instrument (vein set, blood collection needle), not an AI/algorithmic device that requires expert review to establish "ground truth" for interpretations of data like images or clinical signals. The "truth" here is determined by objective physical and biological measurements against established standards.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or performance evaluations where human experts are making subjective assessments and a consensus is needed. For physical medical devices tested against standards, the "ground truth" is determined by the test methodology itself (e.g., a tensile strength test yields a numerical result, a cytotoxicity test yields a "yes/no" result based on cellular response).

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

This question is not applicable. MRMC studies are used to evaluate the performance of diagnostic imaging aids or similar AI-powered tools that assist human readers. The submitted device is a physical sterile device for blood collection and IV administration, not an AI diagnostic tool.

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

This question is not applicable. The device described does not involve an algorithm.

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

For this type of device, the "ground truth" is based on:

Compliance with international standards: ISO standards (e.g., ISO 10993 for biocompatibility, ISO 594 for Luer fittings, ISO 7864 for needles) and US Pharmacopeia (USP <788>) for particulate matter.
Physical and chemical tests: Measuring attributes like seal strength, leak detection, mechanical properties, and material composition.
Biological tests: Assays for cytotoxicity, sensitization, systemic toxicity, pyrogenicity, hemolysis, etc.
Safety mechanism evaluation: Verification that the safety feature (for applicable models) functions as intended to prevent needle stick injuries, as evaluated in a "simulated clinical study" and "safety feature test".

8. The sample size for the training set

This question is not applicable, as there is no mention of an algorithm or training set for this physical medical device.

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

This question is not applicable, as there is no mention of an algorithm or training set for this physical medical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

Jiangsu Kangbao Medical Equipment Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O.Box 120-119, Shanghai, 200120 CHN

March 22, 2022

Re: K192681

Trade/Device Name: Vein Set, Safety vein set, Blood collection needle (vein set type), Blood collection needle (needle holder type), Safety blood collection needle (vein set type), Safety blood collection needle (needle holder type) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA, JKA

Dear Ms. Diana Hong :

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 July 28, 2020. Specifically, FDA is updating this SE Letter to correct the company name as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel by phone at 240-402-6029 or email at payal.patel(@fda.hhs.go.

Sincerely,

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

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Image /page/1/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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

July 28, 2020

Jiangsu Kangbao Medical Experiment Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K192681

Trade/Device Name: Vein set, Safety vein set, Blood collection needle (vein set type), Blood collection needle (needle holder type), Safety blood collection needle (vein set type), Safety blood collection needle (needle holder type)

Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA, JKA Dated: June 23, 2020 Received: June 25, 2020

Dear Diana Hong:

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.

{2}------------------------------------------------

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 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,

Payal Patel Acting Asst. Director, General Hospital 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) K192681

Device Name

Vein set, Safety vein set, Blood collection needle (vein set type), Blood collection needle (needle holder type), Safety blood collection needle (vein set type), Safety blood collection needle (needle holder type)

Indications for Use (Describe)

Blood collection needle (vein set type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

Blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

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)

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510(k) Summary: K192681

Date of Preparation: 7/22/2020

1. Sponsor Identification

Jiangsu Kangbao Medical Equipment Co., Ltd.

78#, North Suzhong Road Baoying 225800 Yangzhou PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: 3009742443

Contact Person: Rujun Tang Position: Management Representative Tel: +86-514-88223540 Fax: +86-514-88232089 Email: 76823131@qq.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net

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Identification of Proposed Device 3.
- Trade Name: Vein set

Safety vein set Blood collection needle (vein set type) Blood collection needle (needle holder type) Safety blood collection needle (vein set type) Safety blood collection needle (needle holder type)

Common Name: Blood Collecting Needle and Set

Regulatory Information Classification Name: Set, Administration, Intravascular Classification: II Product Code: FPA: JKA Regulation Number: 21 CFR 880.5440 Review Panel: General Hospital;

Identification of Predicate device 4.
Product Code: FPA 510(k) Number: K031279 Regulation Number: 21 CFR 880.5440 Product Name: SURSHIELD™ Safety Winged Blood Collection Set
Indications for Use 5.
Vein set is intended for vein puncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.

Safety vein set is intended for vein puncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to

{6}------------------------------------------------

cover the needle immediately after use to minimize risk of accidental needle stick.

Blood collection needle (vein set type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

Blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.

Safety blood collection needle (vein set type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk of needle stick injury.

1. Device Description
  The proposed device is a blood collection device that forms a passage between the patient's vein and a vacuum blood collection tube for collecting blood. The proposed device can also be used for short-term infusion. The proposed devices are divided into several types, some have safety devices and some do not have safety devices, and the safety mechanism helps to reduce the risk of needle stick injuries. The proposed devices are provided sterile, single use. The propose device can be used for vein collect blood/infusion as well as peripheral vein collect blood/infusion, but not central vein collect blood/infusion.

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Substantially Equivalent (SE) Comparison 7.

ITEM	Proposed Device	Predicate Device K031279	Remark
Product code	FPA	FPA	Same
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Same
Class	II	II	Same
Indications for Use	Vein set is intended for vein puncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.	The TERUMOO SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.The TERUMOB SURSHIELD™ SAFETY BLOOD WINGED COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after USC to minimize risk of accidental needlestick.	Different
Configuration	Protective Cover of Patient-end Needle	Protective Cover of Patient-end Needle	Different

	Needle TubeDouble WingFlexible TubeNeedle HubProtective Cap	Needle TubeDouble WingSafety SheathFlexible TubeNeedle HubProtective Cap
Operate mode	Manual	Manual	Same
Safety Mechanism	No	Yes	Different
Label/Labeling	Conform with Part 801	Conform with Part 801	Same

Table 1 Comparison of Technology Characteristics for Vein set

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Different-Indications for use, configuration and safety mechanism

The Configuration of the proposed device is different from the predicate device. There is no safety mechanism in the propose device, and the predicate device has a safety mechanism. Whether there is a safety mechanism or not will not affect the indication for use of the equipment itself. The two devices both can be used for blood collection and infusion. Therefore, this difference is not determined to affect substantially equivalence on safety and effectiveness.

Needle gauge andlength	21G3/4"	19G, 21G, 23G, 25G3/4"	Different
Flexible tubelength	300±5mm	19G: 300mm21G: 300mm23G: 180mm or 300mm25G: 180mm or 300mm	Different
Patient-contact material
Needle Tube	ABS (Acrylonitrile ButadieneStyrene)	Unknown	Different
Flexible Tube	PVC (Polyvinyl Chloride)
Needle Tube	Stainless steel

Different-Needle gauge

The needle gauge for proposed device is different from the predicate device. However, this difference is just in dimension. This difference does not affect indication for use. And the needle gauge of proposed product needle is included in the needle gauge of the predicate product. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Different-Flexible tube length

The flexible tube length for the proposed device is 300mm, while the flexible tube length for predicate device is available in two different lengths, which are 180mm. However, the flexible tube length for the proposed device is same as the predicate device for 21G specification. Therefore, this difference is not

{9}------------------------------------------------

considered to affect substantially equivalence on safety and effectiveness.

Different-Patient-contact material

The patient-contact material for predicate device is unknown. However, the biocompatibility test for proposed device has been conducted and the test result conform with requirements of ISO 10993 standards. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Biocompatibility

Biocompatibility
In VitroCytotoxicity	No Cytotoxicity	Comply with ISO 10993requirements	Same
Skin Sensitization	No Sensitization
IntracutaneousReactivity	No Intracutaneous Reactivity
Acute SystemicToxicity	No Systemic Toxicity
HemolyticProperties	No Hemolytic
Pyrogen	No Pyrogen
In VivoThromboresistance	No
ComplementActivation	No
Sterilization
Method	EO sterilized	EO sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20EU per device	20EU per device	Same

{10}------------------------------------------------

ITEM	Proposed Device	Predicate Device K031279	Remark
Product code	FPA	FPA	Same
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Same
Class	II	II	Same
Indications for Use	Safety vein set is intended forvein puncture to collect bloodspecimens for patients. It isalso indicated for intravenousadministration of fluids afterremoving the attached lueradapter from the bloodcollection set connector andattaching a syringe, or othercompatible/appropriate device.This device may be used forany patient population withconsideration given to patientsize, appropriateness for thesolution being infused, andduration of therapy.Additionally, after withdrawof the needle from thepatient's vein, the attachedneedle safety shield can bemanually activated to coverthe needle immediately afteruse to minimize risk ofaccidental needle stick.	TheTERUMO0SURSHIELD™SAFETYBLOODWINGEDCOLLECTION SET is awinged blood collection needleintended for venipuncture tocollect blood specimens frompatients.TheTERUMOBSURSHIELD™SAFETYWINGEDBLOODCOLLECTION SET is alsoindicated for intravenousadministration of fluids afterremoving the attached lueradapter from the bloodcollection set connector andattaching a syringe, or othercompatible/appropriatedevice. This device may beused for any patient populationwith consideration given topatient size, appropriateness forthe solution being infused, andduration of therapy.Additionally, after withdraw ofthe needle from the patient'svein, the attached needle safetyshield can be manuallyactivated to cover the needleimmediately after USC tominimize risk of accidentalneedlestick.	Same
Configuration	Protective Cover ofPatient-end Needle	Protective Cover of Patient-end Needle	Same
	Needle TubeDouble WingSafety SheathFlexible TubeNeedle HubProtective Cap	Needle TubeDouble WingSafety SheathFlexible TubeNeedle HubProtective Cap
Operate mode	Manual	Manual	Same
Safety Mechanism	Yes	Yes	Same
Label/Labeling	Conform with Part 801	Conform with Part 801	Same
Needle gauge andlength	21G3/4"	19G, 21G, 23G, 25G3/4"	Different
Flexible tubelength	300±5mm	19G: 300mm21G: 300mm23G: 180mm or 300mm25G: 180mm or 300mm	Different
Patient-contact material
Needle Tube	ABS (Acrylonitrile ButadieneStyrene)
Flexible Tube	PVC (Polyvinyl Chloride)	Unknown	Different
Safety Sheath	PP (Polypropylene)
Needle Tube	Stainless steel

Table 2 Comparison of Technology Characteristics for Safety vein set

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Different-Needle gauge

Different-Flexible tube length

Different-Patient-contact material

{12}------------------------------------------------

Biocompatibility
In VitroCytotoxicity	No Cytotoxicity	Comply with ISO 10993requirements	Same
Skin Sensitization	No Sensitization
IntracutaneousReactivity	No Intracutaneous Reactivity
Acute SystemicToxicity	No Systemic Toxicity
HemolyticProperties	No Hemolytic
Pyrogen	No Pyrogen
In VivoThromboresistance	No
ComplementActivation	No
Sterilization
Method	EO sterilized	EO sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20EU per device	20EU per device	Same

{13}------------------------------------------------

Item	Proposed Device	Predicate Device K031279	Remark
Product code	FPA	FPA	Same
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Same
Class	II	II	Same
Indications for Use	Blood collection needle (vein set type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids.	The TERUMOO SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients.The TERUMOB SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after USC to minimize risk of accidental needlestick.	Different
Configuration	Protective Cover of Patient-end NeedleNeedle TubeDouble WingFlexible TubeNeedle HubNon-activated Needle	Protective Cover of Patient-end NeedleNeedle TubeDouble WingSafety SheathFlexible TubeNeedle Hub	Different
		Protective Cap
Operate mode	Manual	Manual	Same
Safety Mechanism	No	Yes	Different
Label/Labeling	Conform with Part 801	Conform with Part 801	Same

Table 3 Comparison of Technology Characteristics for Blood collection needle (vein set type)

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Different-Indications for use, configuration and safety mechanism

The Configuration of the proposed device is different from the predicate device. There is no safety mechanism and have non-patient end needle in propose device, and the predicate device have a safety mechanism and no non-patient end needle. Whether there is a safety mechanism and non-patient end needle or not will not affect the indication for use of the equipment itself. The two devices both can be used for blood collection and infusion. Therefore, this difference is not determined to affect substantially equivalence on safety and effectiveness.

Needle gauge andlength	21G3/4"	19G, 21G, 23G, 25G3/4"	Different
Flexible tubelength	300±5mm	19G: 300mm21G: 300mm23G: 180mm or 300mm25G: 180mm or 300mm	Different
Patient-contact material
Needle Tube	ABS (Acrylonitrile Butadiene Styrene)	Unknown	Different
Flexible Tube	PVC (Polyvinyl Chloride)
Needle Tube	Stainless steel

Different-Needle gauge

Different-Flexible tube length

The flexible tube length for the proposed device is 300mm, while the flexible tube length for predicate device is available in two different lengths, which are 180mm and 300mm. However, the flexible tube length for the proposed device is same as the predicate device for 21G specification. Therefore, this difference is not considered to affect substantially equivalence on safety and effectiveness.

Different-Patient-contact material

{15}------------------------------------------------

this difference does not affect substantially equivalence on safety and effectiveness.
Biocompatibility
InVitroCytotoxicity	No Cytotoxicity	Same
Skin Sensitization	No Sensitization
IntracutaneousReactivity	No Intracutaneous Reactivity
Acute SystemicToxicity	No Systemic Toxicity
HemolyticProperties	No Hemolytic
Pyrogen	No Pyrogen
In VivoThromboresistance	No
ComplementActivation	No	Comply with ISO 10993requirements
Sterilization
Method	EO sterilized	EO sterilized
SAL	10-6	10-6
Endotoxin Limit	20EU per device	20EU per device

{16}------------------------------------------------

ITEM	Proposed Device	Predicate Device K031279	Remark
Product code	FPA	FPA	Same
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Same
Class	II	II	Same
Indications for Use	Blood collection needle (needleholder type) is intended for usein the blood collection orshort-term infusion (up to 2hours) of intravenous fluids.	The TERUMOO SURSHIELD™SAFETY WINGED BLOODCOLLECTION SET is a wingedblood collection needle intended forvenipuncture to collect bloodspecimens from patients.The TERUMOB SURSHIELD™SAFETY WINGED BLOODCOLLECTION SET is alsoindicated for intravenousadministration of fluids afterremoving the attached luer adapterfrom the blood collection setconnector and attaching a syringe, or other compatible/appropriatedevice. This device may be used forany patient population withconsideration given to patient size,appropriateness for the solutionbeing infused, and duration oftherapy.Additionally, after withdraw of theneedle from the patient's vein, theattached needle safety shield can bemanually activated to cover theneedle immediately after USC tominimize risk of accidentalneedlestick.	Different
Configuration andmaterial	Protective Cover of Patient-endNeedleNeedle TubeDouble Wing	Protective Cover of Patient-endNeedleNeedle TubeDouble Wing	Different
	Flexible tubeNeedle Hub	Safety SheathFlexible TubeNeedle Hub

Table 4 Comparison of Technology Characteristics for Blood collection needle (needle holder type)

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	Needle Holder	Protective Cap
Operate mode	Manual	Manual	Same
Safety Mechanism	No	Yes	Different
Label/Labeling	Conform with Part 801	Conform with Part 801	Same

Different-Indications for use, configuration and safety mechanism

Needle gauge andlength	21G3/4"	19G, 21G, 23G, 25G3/4"	Different
Flexible tubelength	300±5mm	19G: 300mm21G: 300mm23G: 180mm or 300mm25G: 180mm or 300mm	Different

Needle Tube	ABS (Acrylonitrile ButadieneStyrene)
Flexible Tube	PVC (Polyvinyl Chloride)	Unknown	Different
Needle Tube	Stainless steel

Different-Needle gauge

The needle gauge for proposed device is different from the predicate device. However, this difference is just in dimension. This difference does not affect indication for use. And the needle gauge of product needle is included in the needle gauge of the predicate product. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Different-Flexible tube length

Different-Patient-contact material

The patient-contact material for proposed device is different from the predicate device. However, the

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Biocompatibility
In VitroCytotoxicity	No Cytotoxicity	Comply with ISO 10993requirements	Same
Skin Sensitization	No Sensitization
IntracutaneousReactivity	No Intracutaneous Reactivity
Acute SystemicToxicity	No Systemic Toxicity
HemolyticProperties	No Hemolytic
Pyrogen	No Pyrogen
In VivoThromboresistance	No
ComplementActivation	No
Sterilization
Method	EO sterilized	EO sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20EU per device	20EU per device	Same

biocompatibility test for proposed device has been conducted and the test result conform with requirements of ISO 10993 standards. Therefore, this difference does not affect substantially equivalence on safety and

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ITEM	Proposed Device	Predicate Device K031279	Remark
Product code	FPA	FPA	Same
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Same
Class	II	II	Same
Indications for Use	Safety blood collection needle(vein set type) is intended for usein the blood collection orshort-term infusion (up to 2hours) of intravenous fluids. Thedevice is designed with a safetymechanism to help reduce therisk of needle stick injury.	The TERUMOO SURSHIELD™SAFETY WINGED BLOODCOLLECTION SET is a wingedblood collection needle intendedfor venipuncture to collect bloodspecimens from patients.The TERUMOB SURSHIELD™SAFETY WINGED BLOODCOLLECTION SET is alsoindicated for intravenousadministration of fluids afterremoving the attached lueradapter from the blood collectionset connector and attaching asyringe, or othercompatible/appropriate device.This device may be used for anypatient population withconsideration given to patientsize, appropriateness for thesolution being infused, andduration of therapy.Additionally, after withdraw ofthe needle from the patient's vein,the attached needle safety shieldcan be manually activated tocover the needle immediatelyafter USC to minimize risk ofaccidental needlestick.	Same
Configuration andmaterial	Protective Cover of Patient-endNeedleNeedle TubeDouble WingSafety SheathFlexible tube	Protective Cover of Patient-endNeedleNeedle TubeDouble WingSafety SheathFlexible Tube	Different
	Needle HubNon-patient end Needle	Needle HubProtective Cap
Operate mode	Manual	Manual	Same
Safety Mechanism	Yes	Yes	Same
Label/Labeling	Conform with Part 801	Conform with Part 801	Same

Table 5 Comparison of Technology Characteristics for Safety blood collection needle (vein set type)

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Different-Configuration

The Configuration of the proposed device is different from the predicate device. There is no non-patient end needle in predicate device, and the proposed device have non-patient end needle. Whether there is a non-patient end needle or not will not affect the indication for use of the equipment itself. The two devices both can be used for blood collection and infusion. Both the proposed device and the predicate has a safety mechanism to Therefore, this difference is not determined to affect substantially equivalence on safety prevent needle stick. and effectiveness.

Needle gauge andlength
21G3/4"	19G, 21G, 23G, 25G3/4"		Different
Flexible tubelength	300±5mm	19G: 300mm21G: 300mm23G: 180mm or 300mm25G: 180mm or 300mm	Different

Patient-contact material
Needle Tube	ABS (Acrylonitrile ButadieneStyrene)
Flexible Tube	PVC (Polyvinyl Chloride)	Unknown	Different
Safety Sheath	PP (Polypropylene)
Needle Tube	Stainless steel

Different-Needle gauge

The needle gauge for proposed device is different from the predicate device. However, this difference is just in dimension. This difference does not affect indication for use. And the needle gauge of proposed product needle is included in the needle gauge of the product. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Different-Flexible tube length

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Different-Patient-contact material

The patient-contact material and biocompatibility for proposed device is different from the predicate device. However, the biocompatibility test for proposed device has been conducted and the test result conform with requirements of ISO 10993 standards. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Biocompatibility

InVitroCytotoxicity	No Cytotoxicity	Comply with ISO 10993requirements	Same
Skin Sensitization	No Sensitization
IntracutaneousReactivity	No Intracutaneous Reactivity
Acute SystemicToxicity	No Systemic Toxicity
HemolyticProperties	No Hemolytic
Pyrogen	No Pyrogen
InVivoThromboresistance	No
ComplementActivation	No
Sterilization
Method	EO sterilized	EO sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20EU per device	20EU per device	Same

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ITEM	Proposed Device	Predicate Device K031279	Remark
Product code	FPA	FPA	Same
Regulation No.	21 CFR 880.5440	21 CFR 880.5440	Same
Class	II	II	Same
Indication for Use	Safety blood collection needle(needle holder type) is intendedfor use in the blood collection orshort-term infusion (up to 2hours) of intravenous fluids. Thedevice is designed with a safetymechanism to help reduce therisk of needle stick injury.	The TERUMOO SURSHIELD™SAFETY WINGED BLOODCOLLECTION SET is a wingedblood collection needle intendedfor venipuncture to collect bloodspecimens from patients.The TERUMOB SURSHIELD™SAFETY WINGED BLOODCOLLECTION SET is alsoindicated for intravenousadministration of fluids afterremoving the attached lueradapter from the blood collectionset connector and attaching asyringe, or othercompatible/appropriatedevice. This device may be usedfor any patient population withconsideration given to patientsize, appropriateness for thesolution being infused, andduration of therapy.Additionally, after withdraw ofthe needle from the patient's vein,the attached needle safety shieldcan be manually activated tocover the needle immediatelyafter USC to minimize risk ofaccidental needlestick.	Same
Configuration andmaterial	Protective Cover of Patient-endNeedleNeedle TubeDouble WingSafety Sheath	Protective Cover of Patient-endNeedleNeedle TubeDouble WingSafety Sheath	Different
	Needle HubNon-patient end NeedleNeedle Holder	Needle HubProtective Cap
Operate mode	Manual	Manual	Same
Safety Mechanism	Yes	Yes	Same
Label/Labeling	Conform with Part 801	Conform with Part 801	Same

Table 6 Comparison of Technology Characteristics for Safety blood collection needle (needle holder type)

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Different-Configuration

The Configuration of the proposed device is different from the predicate device. There is no non-patient end needle in predicate device, and the proposed device have non-patient end needle. Both proposed device and the predicate has safety mechanism to prevent needle stick. The two devices both can be used for blood collection and infusion. Therefore, this difference is not determined to affect substantially equivalence on safety and effectiveness.

Needle gauge andlength	21G3/4"	19G, 21G, 23G, 25G3/4"	Different
Flexible tubelength	300±5mm	19G: 300mm21G: 300mm23G: 180mm or 300mm25G: 180mm or 300mm	Different
Patient-contact material
Needle Tube	ABS (Acrylonitrile ButadieneStyrene)	Unknown	Different
Flexible Tube	PVC (Polyvinyl Chloride)
Safety Sheath	PP (Polypropylene)
Needle Tube	Stainless steel

Different-Needle gauge

The needle gauge for proposed device is different from the predicate device. However, this difference is just in dimension. This difference does not affect indication for use. And the needle gauge of proposed product needle is included in the needle gauge of the product. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Different-Flexible tube length

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Different-Patient-contact material

The patient-contact material for proposed device is different from the predicate device. However, the biocompatibility test for proposed device has been conducted and the test result conform with requirements of ISO 10993 standards. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

Biocompatibility

In VitroCytotoxicity	No Cytotoxicity	Comply with ISO 10993requirements	Same
Skin Sensitization	No Sensitization
IntracutaneousReactivity	No Intracutaneous Reactivity
Acute SystemicToxicity	No Systemic Toxicity
HemolyticProperties	No Hemolytic
Pyrogen	No Pyrogen
In VivoThromboresistance	No
ComplementActivation	No
Sterilization
Method	EO sterilized	EO sterilized	Same
SAL	10-6	10-6	Same
Endotoxin Limit	20EU per device	20 EU per device	Same

8. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

Performance Testing

A ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
A ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed

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A ISO 7864: 2016 Sterile hypodermic needles for single use - Requirements and test methods
ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical A devices;

Biocompatibility

ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in A Vitro Cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for A irritation and skin sensitization.
A ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood
A ISO 10993-11:2017 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide --A Requirements for the development, validation and routine control of a sterilization process for medical devices
USP<788> Particulate Matter testing (Method 1) A

Sterility

A USP 41-NF 36 <85> Bacterial Endotoxins Tests
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene > oxide sterilization residuals.
A ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials
A ASTM F1929- 15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration

Simulated Clinical Study

A simulated clinical study was performed on proposed device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

Safety Feature Test

The safety feature test was performed on both proposed device and predicate device to determine safety feature. The results demonstrated that the proposed device did not show a significant difference from predicate device.

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Clinical Test Conclusion 9.

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the legally marketed predicate devices.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.