The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.

Device Description

The blunts include two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is an 18G stainless needle tube with a luer slip hub. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. The hub is a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe. It is not intended to access the injection site on I.V. System. The blunt plastic cannula is a molded plastic blunt tipped cannula to penetrate pre-slit septum injection site on I.V. Safety Systems, which is designed for penetration with needleless I.V. access device, intended for injection and/or aspiration of fluid. It also has a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe to be filled. The blunt plastic cannula is used to replace hypodermic needles to prevent from the unintended injury by metal needle. These two products can be sold together in one immediate package or respectively in separate immediate packages.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) summary for a medical device (Blunt Fill Needle and Blunt Plastic Cannula), not an AI or software-as-a-medical-device (SaMD). Therefore, many of the requested fields (like "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop) performance," "effect size of how much human readers improve with AI vs without AI assistance," "sample size for the training set," etc.) are not applicable to this type of device and submission. The testing described is for physical characteristics of hardware, not performance of an algorithm.

Acceptance Criteria and Device Performance for Blunt Fill Needle and Blunt Plastic Cannula

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical medical device, the "acceptance criteria" are compliance with established international standards and comparison to a predicate device. The "performance" is demonstrated by passing these tests.

Acceptance Criteria (Standard / Test)	Reported Device Performance
ISO 594-1:1986 (Female Luer Slip Connector)	Passed - Evaluated for compatibility with standard male luer slip connector of the syringe for both blunt fill needle and blunt plastic cannula. (Implies compliance)
ISO 7864:1993 (Blunt Fill Needle)	Passed - Evaluated physical and chemical specifications of the blunt fill needle. (Implies compliance)
ISO 9626:1991 (Blunt Fill Needle)	Passed - Evaluated physical and chemical specifications of the blunt fill needle. (Implies compliance)
Surface Condition (Blunt Plastic Cannula)	Performed testing - No specific pass/fail criteria or results provided in the summary, but implies acceptable.
Comparison to Predicate Device (Blunt Plastic Cannula)	Performed comparison testing - "has similar performance with the predicate device."
ISO 10993 Standards (Biocompatibility)	Comply with ISO 10993 Standards. (Implies compliance)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample sizes for each bench test conducted. It states that "Bench tests were conducted."
Data Provenance: The tests were conducted by the manufacturer, ShanDong WeiGao Group Medical Polymer Co., Ltd, in China, to verify design specifications. This implies internal, prospective bench testing.

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

Not Applicable. This is a hardware medical device. "Ground truth" in the context of expert consensus is not relevant here. The "ground truth" is adherence to engineering standards and functional performance requirements.

4. Adjudication Method for the Test Set

Not Applicable. As the performance is based on objective measurements against engineering standards, an adjudication method for conflicting expert opinions is not relevant. The "adjudication" is the objective passing or failing of the specified tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not Applicable. This is not an AI/SaMD device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is not an AI/SaMD device.

7. The Type of Ground Truth Used

For the physical tests (e.g., luer slip connector compatibility, physical/chemical specs), the "ground truth" is defined by international engineering standards (ISO standards) and the functional performance requirements of the device (such as the ability to penetrate a vial stopper or connect to a syringe).
For biocompatibility, the "ground truth" is compliance with ISO 10993 Standards.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/SaMD device. There is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI model, this question is not relevant.

Summary

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Exhibit #1 510(k) Summary

1 3 2011 MAY

Exhibit #1 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number: K102328

Date of Submission: 03 MAY 2011 1.
1. Sponsor

ShanDong WeiGao Group Medical Polymer Co., Ltd No. 348, Shichang Road, Weihai Shandong, 264209, China Establishment Registration Number: 3007084575 Contact Person: · ( Ms. Suxia Zhao, Quality Manager T: +86-631-5621632 F: +86-631-2620522 E: zsx9001@sina.com

1. Submission Correspondent Ms. Diana Hong / Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd P.O. BOX 237-023 Shanghai, 200237, China T: +86-21-22815850 F: 240-238-7587 E: info@mid-link.net
1. Proposed Device Identification

Proposed Device Name: Blunts Proposed Device Model: Blunt Fill Needle and Blunt Plastic Cannula Regulation Name: needle, hypodermic, single lumen Classification: Class II Product Code: FMI Regulation Number: 21 CFR 880.5570

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5. Intended Use

The blunts include two models, which are blunt fill needle and blunt plastic cannula.

The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid.

The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.

1. Predicate Device Identification
  510(k) Number: K974006 Product Name: BD TwinPak Manufacturer: Becton and Dickinson Company
Device Description 7.
The blunts include two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is an 18G stainless needle tube with a luer slip hub. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. The hub is a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe. It is not intended to access the injection site on I.V. System. The blunt plastic cannula is a molded plastic blunt tipped cannula to penetrate pre-slit septum injection site on I.V. Safety Systems, which is designed for penetration with needleless I.V. access device, intended for injection and/or aspiration of fluid. It also has a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe to be filled. The blunt plastic cannula is used to replace hypodermic needles to prevent from the unintended injury by metal needle. These two products can be sold together in one immediate package or respectively in separate immediate packages.
1. Non-Clinical Test Conclusion
  Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.
Female Luer Slip Connector of both blunt fill need and blunt plastic cannula were tested per a) ISO 594-1:1986 to evaluate whether it could be compatible with standard male luer slip connector of the syringe.
b) Blunt Fill Needle was tested per ISO 7864:1993 and ISO9626:1991 to evaluate its physical and chemical specifications.
c) There is no international performance standard established for blunt plastic cannula. The sponsor has performed the testing on surface condition of the blunt plastic cannula, and comparison test between the proposed and predicate device.

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Substantially Equivalent Analysis and Conclusion 9.

Item	Proposed Device	Predicate Device
	Blunts	BD TwinPak, K974006
Indications for Use	The blunts include two models, which areblunt fill needle and blunt plastic cannula.The blunt fill needle is used in conjunctionwith a syringe to penetrate the vial/ampoulesstopper intended for injection or aspiration offluid. The blunt plastic cannula is used inconjunction with a syringe to access thepre-slit septum covering injection sites onI.V. System intended for injection oraspiration of fluid.	Substantially Equivalent
Components	Blunt Fill NeedleBlunt Plastic Cannula	Substantially Equivalent
Blunt Fill Needle Gauge	18 G	20 G
Material
Blunt Fill Needle	Stainless Steel	Substantially Equivalent
Blunt Plastic Cannula	Polycarbonate	Polypropylene
Sterilization
SAL	10-6	Substantially Equivalent
Method	Radiation	Substantially Equivalent
Biocompatibility	Comply with ISO 10993 Standards	Substantially Equivalent
Safety and Effectiveness	Various performance tests conducted todemonstrate the safety and effectiveness ofthe proposed device.	Some comparison tests conducted that theproposed device has similar performancewith the predicate device.

Table 1 Comparison of Technological Characteristic

Compared with the identified predicate device, the proposed device has same indications, component and design features as well as the sterilization requirements. They are different in Needle Gauge of Blunt Fill Needle and Material of Blunt Plastic, but these differences are approved not to affect the safety and effectiveness equivalence between the predicate and proposed device.

The proposed device, Blunts including Blunt Fill Needle and Blunt Plastic Cannula, is determined to be Substantially Equivalent (SE) to the predicate device, BD TwinPak as cleared in K974006, in respect of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Shandong Weigao Group Medical Polymer Company, Limited C/O Ms. Diana Hong Shanghai Mid-Link Business Consultants Company, Limited P.O Box 237-023 Shanghai, China 200237

MAY 1 3 2011

Re: K102328

Trade/Device Name: Blunts Model: Blunt Fill Needle and Plastic Cannula Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 3, 2011 Received: May 6, 2011

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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Page 2- Ms. Hong

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours.

Zh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Exhibit #2 Indications for Use

510(k) Number: K102328 Device Name: Blunts Model: Blunt Fill Needle and Blunt Plastic Cannula

Indications for Use:

The blunts include two models, which are blunt fill needle and blunt plastic cannula.

The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid.

The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

Page 1 of 1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhi C. 5/10/11

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K102328

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).