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

Device Description

The Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals.

The Blood Collection Needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is ¾" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that permits identification and acts as a seal integrity.

The Safety Blood Collection Set is delivered sterile and is intended for single use only.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Jiangsu Shenli Medical Production Co., Ltd.'s Safety Blood Collection Set (K163093). The document primarily focuses on establishing substantial equivalence to a predicate device, the Improsafe Blood Collection Set (K123987), rather than a detailed study proving the device meets specific acceptance criteria through a clinical or performance study with human readers or AI.

Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) is not applicable to this type of submission, which relies on demonstrating equivalence through technical characteristics and compliance with standards.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All of the pre-determined acceptance criteria were met," but it does not provide a table with specific quantitative acceptance criteria alongside corresponding test results. It lists the types of performance tests conducted.

Test Category	Acceptance Criteria (Not explicitly stated in document, but implied by "pre-determined" and compliance with standards)	Reported Device Performance
Sterility	Compliance with relevant standards (e.g., ISO 11135 for EO sterilization)	Met
Toxin in bacteria	Within acceptable limits (Implied)	Met
Reducing Substance	Within acceptable limits (Implied)	Met
Metal Ion	Within acceptable limits (Implied)	Met
pH Value	Within acceptable range (Implied)	Met
Residue after evaporation	Within acceptable limits (Implied)	Met
Ultraviolet absorbency degree	Within acceptable limits (Implied)	Met
EO gas residue	Below specified maximum levels (e.g., ISO 10993-7)	Met
ECH gas residue	Below specified maximum levels (Implied, often part of general residue testing)	Met
Particle pollution	Below specified maximum limits (Implied, often referenced in ISO standards for medical devices)	Met
Connection firmness	Complying with ISO 7864 (e.g., 21G > 44N)	Met (21G > 44N)
Needle Tube	Mechanical properties meet standards (Implied)	Met
Lubricant	Performance and safety meet standards (Implied)	Met
Needle Handle	Mechanical integrity meets standards (Implied)	Met
Rubber Sleeve	Material and function meet standards (Implied)	Met
Leakage	No leaks under specified conditions (Implied, often referenced in ISO standards)	Met
Flow Rate	Meets specified flow rate (Implied, often crucial for blood collection efficiency)	Met
Length of needle tube	Within specified tolerances (Implied)	Met
Needle tip	Sharpness and integrity meet standards (Implied)	Met
Needle base to connection base	Dimensions and integrity meet standards (Implied)	Met
Flexing tube	Flexibility and integrity meet standards (Implied)	Met
Protective safety sheath	Functionality of safety mechanism (Implied, e.g., smooth activation, secure locking)	Met
Biocompatibility	Complying with ISO 10993-1 (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility)	Met

2. Sample size used for the test set and the data provenance

Sample Size: This document does not specify the sample sizes used for each of the performance tests listed. For typical device clearance, these would be engineering tests, not clinical studies with human participants.
Data Provenance: The tests were performed to demonstrate substantial equivalence for a device manufactured by Jiangsu Shenli Medical Production Co., Ltd. (China). The data would therefore originate from testing conducted by or for this company, likely in China or by contracted laboratories. The nature of these tests is retrospective in the sense that they were conducted on already manufactured devices to demonstrate compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device submission. The "ground truth" here is compliance with established engineering standards and design specifications, verified through laboratory testing, not expert interpretation of medical images or conditions.

4. Adjudication method for the test set

This information is not applicable. Adjudication typically refers to the resolution of conflicting expert opinions in clinical studies. For engineering performance tests, results are usually compared against predefined objective criteria.

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 information is not applicable. This submission is for a physical medical device (blood collection set), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI effect sizes are irrelevant.

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

This information is not applicable, as the device is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the device's performance is adherence to established national and international standards for medical devices (e.g., ISO 7864 for needles, ISO 10993-1 for biocompatibility) and its own design specifications. This is confirmed through laboratory and engineering testing.

8. The sample size for the training set

This information is not applicable, as this is not an AI/machine learning device.

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

This information is not applicable, as this is not an AI/machine learning device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2017

Jiangsu Shenli Medical Production Co., Ltd % Charles Mack Principal Engineer IRC 7808 Rush Creek Drive Pasco. Washington 99301

Re: K163093

Trade/Device Name: Safety Blood Collection Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: February 8, 2017 Received: February 22, 2017

Dear Charles Mack:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang -S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K163093

Device Name Safety Blood Collection Set

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Jiangsu Shenli Medical Production Co., Ltd.

K163093

510(k) Summary (21 CFR §807.92)

SubmitterInformation
	Submitter Name:	Jiangsu Shenli Medical Production Co., Ltd.
	Address:	No 20, Changzheng Road, Zhenglu,Changzhou City, Jiangsu Province, China 213111
	Contact Person:	Ms. Tina CaiGeneral Managercharliemack@irc-us.com931-625-4938
	Date of Preparation:	March 13, 2017
Subject Device
	Trade Name:	Safety Blood Collection Set
	Common Name:	Hypodermic single lumen needle
	Regulation Number:	21 CFR §880.5570
	Regulation Name:	Hypodermic single lumen needle
	Regulatory Class:	II
	Product Code:	FMI
	Classification Panel:	General Hospital
PredicateDevice
	Trade Name:	Improve Blood Collection Set and Improsafe Blood Collection Set
	510(k) Reference:	K123987
	Common Name:	Hypodermic single lumen needle
	Regulation Number:	21 CFR §880.5570
	Regulation Name:	Hypodermic single lumen needle
	Regulatory Class:	II
	Product Code:	FMI

Purpose of Submission

This is a new submission of a Safety Blood Collection set. There have been no previous submissions of this product.

Indications for Use

Safety Blood Collection Set and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needle stick injury.

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Device Description

The Safety Blood Collection Set is delivered sterile and is intended for single use only.

Technological Characteristics

Feature	Proposed Device	Predicate Device
Company	Jiangsu Shenli Medical Production Co., Ltd	Innovative Medical Technologies, Incorporated
FDA510(K) Number	K163093	K123987
Device Name	Safety Blood Collection Set	Improsafe Blood Collection Set
FDA Classification	Same	21CFR880.5570, Product code- FMI
Indication for Use	Safety Blood Collection Set and blood collectiontube/syringe are used together for the collection ofvenous blood. The winged needle is designed witha safety shield which can be activated to coverthe needle immediately following blood collection toaid in the protection against accidental needlestick injury.	Improve Blood Collection Set and Improsafe Blood Collection Set arewinged blood collection needles with flexible tubing and a female lueradapter intended for venipuncture to obtain blood samples frompatients. Some reorder numbers are provided with a male luer adapter.The male luer adapter contains a non- patient needle end for puncturingthe stopper of an evacuated blood collection tube. Those without a maleluer adapter are provided with a protective cap on the end of the femaleluer adapter. The Improsafe Blood Collection Set is provided with anattached safety shield for covering the used needle prior to disposal.After withdrawal of the needle from the patient's vein, the attachedsafety shield can be manually activated to cover the needle immediatelyafter use to minimize risk of accidental needle stick. The Improve BloodCollection Set and Improsafe Blood Collection Set is also indicated forshort-term (up to 2 hours) intravenous administration of fluids and maybe used for any patient population with consideration given to patientsize, appropriateness for the solution being infused and duration oftherapy. For devices that include the male liter adapter: after removingthe attached male luer adapter from the blood collection set, connect thefemale luer adapter to a syringe or other compatible/appropriate device.
Feature	The needle is locked in safety sheath by slide thetranslucent yellow safety shield forward with pullingthe tubing backward until an audible click is heard.	The needle is completely retracted and locked by slide the translucentyellow safety shield forward with pullingthe tubing backward until an audible click is heard.
Material:
Needle sheath	PE	HDPE

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Needle tube	SUS304	SUS304
Needle holder	Ethylene/propylene copolymer	Polypropylene
Safety shield	Polypropylene	Polypropylene
Flexing tube	PVC	PVC
Rub sleeve	Polyisoprene	Rubber (Synthetic)
Luer adapter	ABS	ABS
Lubricate	Medical Highly Activated Silicone	Unknown
Colors:
21G	Green	Green
Length	3/4" x 12"(needle length x tube length)	3/4" x 12"(needle length x tube length)
Gauge	21G	21G, 23G, 25G
Hub/Needle bond strengthBiocompatibility	Complying with ISO7864:21G>44N	Complying with ISO7864:21G>44N23G>34N
	Complying with ISO10993-1In Vitro Cytotoxicity Test (ISO10993-5) SkinSensitization Test (ISO10993-10) IntracutaneousReactivity Test (ISO10993-10)Acute Systemic Toxicity Test (ISO10993-11)Haemocompatibility:-In Vitro Hemolytic Properties Test (ASTM F756-13)-Coagulation Test (ISO10993-4)-Complement Activity (ISO10993-4)	Complying with ISO10993-1
Sterilization	EO	EO
Sterile	Yes	Yes
SAL	10-6	10-6
Disposable	Yes	Yes
Single Patient Use	Yes	Yes

The predicate device (K123987) has two devices types cleared for marking; Improsafe and Improve. The subject device is claiming substantial equivalence to the Improsafe device. The indications for use between the predicate device and subject device are similar as both used in routine venipunture. However, the subject device is not intended for intravenous medication adminstration. The minor differences in indications for use between subject and predicate device do not raise different questions of safety or effectiveness. All the labeling and characteristics of the submitted Safety Blood Collection Set is the same as the predicate devices and most typical Safety Blood Collection Sets currently on the market. The basic design of the submitted device specifications is substantially the same as the predicate, with differences in the plastic material. Though the plastic material is different, biocompatibility characteristics of the subject and predicate devices are equivalent.

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Summary of Performance Tests

The following performance testing was performed to demonstrate substantial equivalence of the subject device Safety Blood Collection Set, and applicable standards:

Sterility ●
Toxin in bacteria ●
. Reducing Substance
Metal Ion ●
pH Value ●
Residue after evaporation
Ultraviolet absorbency degree
EO gas residue ●
ECH gas residue ●
Particle pollution
Connection firmness
Needle Tube .
Lubricant ●
Needle Handle
Rubber Sleeve
Leakage ●
Flow Rate ●
Length of needle tube ●
Needle tip ●
Needle base to connection base ●
Flexing tube ●
Protective safety sheath ●

All of the pre-determined acceptance criteria were met.

Summary of Substantial Equivalence

Based on the indications for use, technological characteristics, and performance testing, the subject Safety Blood Collection Set has demonstrated to be substantially equivalent to the predicate IMPROSAFE Blood Collection Set.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).