Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and safety features of a blood collection device, with no mention of AI or ML technology.

Therapeutic

No
The primary intended use of the device is for blood collection, and while it can be used for short-term fluid administration, it is not described as treating or preventing a disease or condition, which is the definition of a therapeutic device.

Diagnostic

No

This device is intended for blood collection and fluid infusion, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly describes a physical blood collection device with needles and safety mechanisms, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Intended Use: The intended use of this device is for collecting blood specimens and intravenous administration of fluids. While blood is collected, the device itself is a tool for the collection process and fluid delivery, not for performing a diagnostic test on the collected blood.
Device Description: The description focuses on the physical mechanism of blood collection and infusion, including safety features to prevent needle sticks. It does not describe any components or processes related to analyzing the collected blood for diagnostic purposes.
Lack of Diagnostic Information: The text does not mention any diagnostic tests being performed by or with this device. There is no mention of analyzing biomarkers, detecting pathogens, or providing any diagnostic results.

Therefore, this device is a medical device used for blood collection and fluid administration, but it does not fit the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

Product codes (comma separated list FDA assigned to the subject device)

FPA, JKA

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.

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

any patient population

Intended User / Care Setting

Not Found

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)

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

ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
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
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 devices;

Biocompatibility

ISO 10993-5:2009 Biological evaluation of medical Devices-Part 5: Tests for in Vitro Cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and skin sensitization.
ISO 10993-4:2017 Biological Evaluation of Medical Devices--Part 4: Selection of Tests for Interactions with Blood
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 -- Requirements for the development, validation and routine control of a sterilization process for medical devices
USP Particulate Matter testing (Method 1)

Sterility

USP 41-NF 36 Bacterial Endotoxins Tests
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals.
ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K031279

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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

1

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,

P

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

3

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)

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

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

5

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.

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 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.

7

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 Tube
Double Wing
Flexible Tube
Needle Hub
Protective Cap	Needle Tube
Double Wing
Safety Sheath
Flexible Tube
Needle Hub
Protective 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

8

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 and
length | 21G
3/4" | 19G, 21G, 23G, 25G
3/4" | Different |
|----------------------------|------------------------------------------|------------------------------------------------------------------------|-----------|
| Flexible tube
length | 300±5mm | 19G: 300mm
21G: 300mm
23G: 180mm or 300mm
25G: 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

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 Vitro
Cytotoxicity	No Cytotoxicity	Comply with ISO 10993
requirements	Same
Skin Sensitization	No Sensitization
Intracutaneous
Reactivity	No Intracutaneous Reactivity
Acute Systemic
Toxicity	No Systemic Toxicity
Hemolytic
Properties	No Hemolytic
Pyrogen	No Pyrogen
In Vivo
Thromboresistance	No
Complement
Activation	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 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 cover
the needle immediately after
use to minimize risk of
accidental needle stick.	The
TERUMO0
SURSHIELD™
SAFETY
BLOOD
WINGED
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.	Same
Configuration	Protective Cover of
Patient-end Needle	Protective Cover of Patient-end Needle	Same
	Needle Tube
Double Wing
Safety Sheath
Flexible Tube
Needle Hub
Protective Cap	Needle Tube
Double Wing
Safety Sheath
Flexible Tube
Needle Hub
Protective Cap
Operate mode	Manual	Manual	Same
Safety Mechanism	Yes	Yes	Same
Label/Labeling	Conform with Part 801	Conform with Part 801	Same
Needle gauge and
length	21G
3/4"	19G, 21G, 23G, 25G
3/4"	Different
Flexible tube
length	300±5mm	19G: 300mm
21G: 300mm
23G: 180mm or 300mm
25G: 180mm or 300mm	Different
Patient-contact material
Needle Tube	ABS (Acrylonitrile Butadiene
Styrene)
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

11

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 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.

12

Biocompatibility
In Vitro
Cytotoxicity	No Cytotoxicity	Comply with ISO 10993
requirements	Same
Skin Sensitization	No Sensitization
Intracutaneous
Reactivity	No Intracutaneous Reactivity
Acute Systemic
Toxicity	No Systemic Toxicity
Hemolytic
Properties	No Hemolytic
Pyrogen	No Pyrogen
In Vivo
Thromboresistance	No
Complement
Activation	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 Needle
Needle Tube
Double Wing
Flexible Tube
Needle Hub
Non-activated Needle	Protective Cover of Patient-end Needle
Needle Tube
Double Wing
Safety Sheath
Flexible Tube
Needle 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)

14

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 and
length | 21G
3/4" | 19G, 21G, 23G, 25G
3/4" | Different |
|----------------------------|---------------------------------------|------------------------------------------------------------------------|-----------|
| Flexible tube
length | 300±5mm | 19G: 300mm
21G: 300mm
23G: 180mm or 300mm
25G: 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

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 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

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,

15

this difference does not affect substantially equivalence on safety and effectiveness.
Biocompatibility
In
Vitro
Cytotoxicity	No Cytotoxicity	Same
Skin Sensitization	No Sensitization
Intracutaneous
Reactivity	No Intracutaneous Reactivity
Acute Systemic
Toxicity	No Systemic Toxicity
Hemolytic
Properties	No Hemolytic
Pyrogen	No Pyrogen
In Vivo
Thromboresistance	No
Complement
Activation	No	Comply with ISO 10993
requirements
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 (needle
holder 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 and
material	Protective Cover of Patient-end
Needle
Needle Tube
Double Wing	Protective Cover of Patient-end
Needle
Needle Tube
Double Wing	Different
	Flexible tube
Needle Hub	Safety Sheath
Flexible Tube
Needle Hub

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

17

	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

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 and
length | 21G
3/4" | 19G, 21G, 23G, 25G
3/4" | Different |
|----------------------------|-------------|------------------------------------------------------------------------|-----------|
| Flexible tube
length | 300±5mm | 19G: 300mm
21G: 300mm
23G: 180mm or 300mm
25G: 180mm or 300mm | Different |

| Needle Tube | ABS (Acrylonitrile Butadiene
Styrene) | | |
|---------------|------------------------------------------|---------|-----------|
| 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

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

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

18

Biocompatibility
In Vitro
Cytotoxicity	No Cytotoxicity	Comply with ISO 10993
requirements	Same
Skin Sensitization	No Sensitization
Intracutaneous
Reactivity	No Intracutaneous Reactivity
Acute Systemic
Toxicity	No Systemic Toxicity
Hemolytic
Properties	No Hemolytic
Pyrogen	No Pyrogen
In Vivo
Thromboresistance	No
Complement
Activation	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

19

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 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.	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.	Same
Configuration and
material	Protective Cover of Patient-end
Needle
Needle Tube
Double Wing
Safety Sheath
Flexible tube	Protective Cover of Patient-end
Needle
Needle Tube
Double Wing
Safety Sheath
Flexible Tube	Different
	Needle Hub
Non-patient end Needle	Needle Hub
Protective 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)

20

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 and

length
21G
3/4"	19G, 21G, 23G, 25G
3/4"		Different
Flexible tube
length	300±5mm	19G: 300mm
21G: 300mm
23G: 180mm or 300mm
25G: 180mm or 300mm	Different

Patient-contact material
Needle Tube	ABS (Acrylonitrile Butadiene
Styrene)
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

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 considered to affect substantially equivalence on safety and effectiveness.

21

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

| In
Vitro
Cytotoxicity | No Cytotoxicity | Comply with ISO 10993
requirements | Same |
|---------------------------------|------------------------------|---------------------------------------|------|
| Skin Sensitization | No Sensitization | | |
| Intracutaneous
Reactivity | No Intracutaneous Reactivity | | |
| Acute Systemic
Toxicity | No Systemic Toxicity | | |
| Hemolytic
Properties | No Hemolytic | | |
| Pyrogen | No Pyrogen | | |
| In
Vivo
Thromboresistance | No | | |
| Complement
Activation | No | | |
| Sterilization | | | |
| Method | EO sterilized | EO sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20EU per device | 20EU per device | Same |

22

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 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.	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.	Same
Configuration and
material	Protective Cover of Patient-end
Needle
Needle Tube
Double Wing
Safety Sheath	Protective Cover of Patient-end
Needle
Needle Tube
Double Wing
Safety Sheath	Different
	Needle Hub
Non-patient end Needle
Needle Holder	Needle Hub
Protective 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)

23

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 and
length | 21G
3/4" | 19G, 21G, 23G, 25G
3/4" | Different |
|----------------------------|------------------------------------------|------------------------------------------------------------------------|-----------|
| Flexible tube
length | 300±5mm | 19G: 300mm
21G: 300mm
23G: 180mm or 300mm
25G: 180mm or 300mm | Different |
| Patient-contact material | | | |
| Needle Tube | ABS (Acrylonitrile Butadiene
Styrene) | 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

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 considered to affect substantially equivalence on safety and effectiveness.

24

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 Vitro
Cytotoxicity | No Cytotoxicity | Comply with ISO 10993
requirements | Same |
|------------------------------|------------------------------|---------------------------------------|------|
| Skin Sensitization | No Sensitization | | |
| Intracutaneous
Reactivity | No Intracutaneous Reactivity | | |
| Acute Systemic
Toxicity | No Systemic Toxicity | | |
| Hemolytic
Properties | No Hemolytic | | |
| Pyrogen | No Pyrogen | | |
| In Vivo
Thromboresistance | No | | |
| Complement
Activation | 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

25

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 Particulate Matter testing (Method 1) A

Sterility

A USP 41-NF 36 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.

26

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.