Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient' s vascular system through the needle inserted into the vein.

Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needlesticks.

Device Description

The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. The device contains a conical fitting provides a standard female luer lock connector which may connect to an I.V. administration set with a male conical fitting. And the infusion needle is inserted patient's vein. Then the solution will be administered from the I.V. administration set through the infusion needle into patient vascular by gravity.

AI/ML Overview

The provided document is a 510(k) summary for injection needles. Medical devices like this generally do not have specific "acceptance criteria" in the same way an AI/ML diagnostic device would for performance metrics such as sensitivity, specificity, or AUC. Instead, they are evaluated against established performance standards and guidelines for similar predicate devices.

However, I can extract information related to the device's testing and compliance, which serves a similar purpose to demonstrating that the device "meets acceptance criteria" for its type.

Here’s a summary based on the provided text, structured to align with your request as much as possible for a medical device of this nature:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device (Disposable Infusion Needle), the "acceptance criteria" are mainly conformance to recognized international and industry standards, and demonstration of equivalency to predicate devices. Performance is reported through successful compliance with these standards and a simulated clinical study.

Acceptance Criteria (Standards/Tests)	Reported Device Performance
Material & Physical Properties
ISO 9626:1991+AMENDMENT 1 2001 (Stainless steel needle tubing)	Complied (Non-clinical tests demonstrated compliance.)
ISO 7864:1993 (Sterile hypodermic needles for single use)	Complied (Non-clinical tests demonstrated compliance.)
ASTM F 88/F88M-09 (Seal strength of flexible barrier materials)	Complied (Non-clinical tests demonstrated compliance.)
ASTM F1140/F1140M-13 (Internal pressurization failure resistance of packages)	Complied (Non-clinical tests demonstrated compliance.)
Biocompatibility
ISO 10993 (Series)	Conformed (General statement of conformance with ISO 10993 within the comparison table; specific tests listed below also demonstrate compliance.)
ISO 10993-1:2009 (Evaluation and testing within a risk management process)	Complied (Non-clinical tests demonstrated compliance.)
ISO 10993-5:2009 (Tests for in vitro cytotoxicity)	Complied (Non-clinical tests demonstrated compliance.)
ISO 10993-10:2010 (Test for irritation and delayed-type hypersensitivity)	Complied (Non-clinical tests demonstrated compliance.)
ISO 10993-11:2006 (Tests for systemic toxicity)	Complied (Non-clinical tests demonstrated compliance.)
ASTM F 756-13 (Assessment of hemolytic properties of materials)	Complied (Non-clinical tests demonstrated compliance.)
Sterilization & Packaging
USP37-NF32 <85> (Bacterial Endotoxins Limit)	Complied (Non-clinical tests demonstrated compliance.)
ISO 10993-7:2008 (Ethylene oxide sterilization residuals)	Complied (Non-clinical tests demonstrated compliance.)
ISO 11135-1:2007 (Ethylene oxide sterilization - Requirements)	Complied (Non-clinical tests demonstrated compliance.)
ISO 11737-2:2009 (Sterility tests in definition, validation, maintenance)	Complied (Non-clinical tests demonstrated compliance.)
Safety Feature Performance
FDA Guidance: Medical Devices with Sharps Injury Prevention Feature (August 9, 2005)	Successful (A simulated clinical study was performed to evaluate the safety mechanism and "The results demonstrated that the proposed device met the pre-established criteria.")

2. Sample Size for the Test Set and Data Provenance

Sample Size (for simulated clinical study): Not explicitly stated. The document only mentions "A simulated clinical study was performed..." without specifying the number of devices or trials.
Data Provenance: The study was a "simulated clinical study" performed by the manufacturer (Jiangyin Caina Technology Co., Ltd. in China) in accordance with FDA guidance. The data is retrospective in the sense that it was generated for the 510(k) submission, not as a prospective clinical trial on human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. For a simulated clinical study evaluating a safety mechanism, "ground truth" would typically be established based on engineering specifications and successful activation/functionality of the safety feature as observed by study personnel, rather than expert consensus on medical imaging or diagnoses.

4. Adjudication Method for the Test Set

This information is not provided. Given it's a simulated clinical study for a mechanical safety feature, a formal adjudication panel as found in diagnostic studies is unlikely. Performance would be assessed objectively against pre-established pass/fail 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

There was no MRMC comparative effectiveness study done. This device is a physical medical instrument (infusion needle), not an AI/ML-based diagnostic or assistive technology for human readers.

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

There was no standalone algorithm performance study done. This device does not involve an algorithm.

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

For the simulated clinical study of the safety mechanism, the "ground truth" would be the functional performance of the safety sheath as designed and measured against predetermined engineering and safety specifications (e.g., successful locking, prevention of needlesticks in a simulated environment). This is based on objective, repeatable tests rather than clinical outcomes or diagnostic interpretations.

8. The sample size for the training set

There is no training set for this type of medical device. The device is not an AI/ML model that requires training data.

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

Not applicable, as there is no training set.

Summary

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

December 14, 2015

Jiangyin Caina Technology Co., Ltd c/o Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K152323

Trade/Device Name: Disposable Infusion Needle, Safelock Disposable Infusion Needle Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration set Regulatory Class: II Product Code: FPA Dated: November 10, 2015 Received: November 13, 2015

Dear Ms. 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. 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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Tina Kiang -S

for Erin I. Keith, M.S. 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) K152323

Device Name Safelock Disposable Infusion Needle Disposable Infusion Needle

Indications for Use (Describe)

Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient' s vascular system through the needle inserted into the vein.

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

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

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K152323 510(k) Summary

510(k) Submitter

Jiangyin Caina Technology Co., Ltd.

No.2, Taifu Road, Huashi Town, Jiangyin, Jiangsu, 214421, China Contact Person: Jun Lu Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu@cainamedical.com

Date of Preparation: 10/20/2015

Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

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

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

Device Name

Trade Name: Disposable Infusion Needle Safelock Disposable Infusion Needle Common Name: Intravenous Infusion Needle

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

Predicate Device

Predicate Device 510(k) Number: K070362 Product Name: SURFLO Winged Infusion Set

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Reference Device 510(k) Number: K132153 Product Name: SafeTouch PSV winged Infusion Set with/without filter

Device Description

Intended Use

Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein.

Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the safety sheath is designed to prevent accidental needle sticks.

Technological Characteristics

Table 1 Comparison of Technology Characteristics
Item	Proposed Device	Predicate DeviceK070362	Reference DeviceK132153
Product	Disposable InfusionNeedleSafelock DisposableInfusion Needle	SURFLO ® WingedInfusion Set	SafeTouch PSVwinged Infusion Setwith/without filter
Product Code	FPA	FPA	FOZ
RegulationNumber	880.5440	880.5440	880.5200
Indications forUse	Disposable Infusion Needleis intended to administerfluid by using an infusion setto a patient' s vascularsystem through the needleinserted into the vein.Safelock Disposable InfusionNeedle is intended toadminister fluid by using aninfusion set to a patient's	The Surflo Winged InfusionSet is intended to access theperipheral vascular system,for intravenousadministration of fluidsand/or withdrawal of bloodspecimens using a syringe,luer adapter, or othercompatible/appropriatedevices	The Safe Touch PSVWinged Infusion Setwith/without filter isintended to be used forinsertion into apatient's vascularsystem for single useas an indwelling deviceto administer fluidsintravenously

Table 1 Comparison of Technology Characteristics

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	vascular system through theneedle inserted into the vein,and the safety sheath isdesigned to preventaccidental needle sticks.		Secondly it is designedwith an active sharpfeature that requiresphysical action by theclinician to preventaccidental needlesticks.
Intended Use	To administer fluid into thevein	To administer fluid into thevein and withdraw bloodspecimens	To administer fluidsinto the vein
Safety Feature	The Safelock DisposableInfusion needle is lockedin safety sheath bywithdraw safety needlehandle backward	None	The Safe Touch PSVWinged infusion setneedle is locked insafety sheath bywithdraw safetyneedle handlebackward
Sterile	EO sterilized	EO sterilized	EO sterilized
Blood sampling	None	Yes	None
Single Use	Single use	Single use	Single Use
Performance	Complied with ISO9626:1991,AMENDMENT 1 2001and ISO 7864:1993	Complied with ISO9626:1991, AMENDMENT1 2001 and ISO 7864:1993	Complied with ISO9626:1991, AMENDMENT1 2001 and ISO 7864:1993
Biocompatibility	Conform with ISO 10993	Conform with ISO 10993	Conforms with ISO10993

The subject devices are equivalent to the predicate devices with respect to technological characteristics. They shared the same operational principle, intended use, materials, biocompatibility, and sterilization.

Non-Clinical Test Conclusion

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

ISO 9626:1991+AMENDMENT 1 2001 Stainless steel needle tubing for the manufacture of medical devices;
ISO 7864: 1993 Sterile hypodermic needles for single use
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;

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ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;
ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages;
USP37-NF32 <85> Bacterial Endotoxins Limit.
♪ ISO 11135-1:2007 Sterilization of health care products -Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
A ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
A ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
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 delayed-type hypersensitivity
ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials. The test provided in this submission include:

Simulated Clinical Study performed on the proposed device:

A simulated clinical study was performed according to FDA Guidance for Industry and FDA Staff. Medical Devices 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.

Conclusion

Based on the non-clinical tests above, the proposed devices are determined to be Substantially Equivalent (SE) to the 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.