Weigao Disposable Empty Cartridge Syringe is intended for use in the withdrawal and administration of fluid in accordance with the best judgment of the physician.

Device Description

The subject device of Weigao Disposable Empty Cartridge Syringe is an empty cartridge syringe that consists of a hollow barrel and a movable plunger. The syringes are designed for manual use. The applicant syringe's main components are made of glass.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Weigao Disposable Empty Cartridge Syringe." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about comparative effectiveness studies (MRMC) or standalone performance.

The document primarily focuses on demonstrating that the device is substantially equivalent to a pre-existing device (K820164, Empty Sterile Carpuject® Cartridge) based on shared technical characteristics and safety/effectiveness.

Here's a breakdown of the information that can be extracted, and what is missing based on your request:

Information Present:

Device Name: Weigao Disposable Empty Cartridge Syringe
Intended Use: "Weigao Disposable Empty Cartridge Syringe is intended for use in the withdrawal and administration of fluid in accordance with the best judgment of the physician."
Predicate Device: K820164, Empty Sterile Carpuject® Cartridge (by Hospira, Inc.)
Testing Conducted (general):
- Biocompatibility tests (following ISO 10993)
- Performance bench tests (following ISO 11040-4, ISO 7886-1, ISO 9626)
Device Description: "an empty cartridge syringe that consists of a hollow barrel and a movable plunger. The syringes are designed for manual use. The applicant syringe's main components are made of glass."
Key Specifications Mentioned: "Model 1 ml Slim with scale marks (fixed with Needle 27G)"

Missing Information (Crucial for your request):

A table of acceptance criteria and the reported device performance: This document only states that performance bench tests were conducted following certain ISO standards (ISO 11040-4, ISO 7886-1, ISO 9626). It does not provide the specific acceptance criteria defined within those standards for this device, nor does it report the actual results of these tests (e.g., specific force measurements, leakage rates, etc.) against any criteria.
Sample sizes used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device and the testing refers to bench tests against standards, not diagnostic performance with human interpretation.
Adjudication method for the test set: Not applicable for this type of device and testing.
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 a physical medical device (syringe), not an AI-powered diagnostic system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used: For physical performance tests, the "ground truth" would be the engineering specifications and requirements outlined in the ISO standards. The document only lists the standards, not the specific pass/fail criteria from them.
The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Conclusion:

Based on the provided text, it's impossible to create the requested table of acceptance criteria and reported device performance, or to answer the majority of your questions. The document is a regulatory summary demonstrating substantial equivalence for a physical medical device, not a detailed study report for an AI or diagnostic tool. It indicates that certain types of tests were conducted according to international standards (ISO 10993, ISO 11040-4, ISO 7886-1, ISO 9626), but it does not specify the acceptance criteria used or the quantitative results achieved by the device.

Summary

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K08/241
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SEP - 8 2008

Attachment IV 510(k) Summary

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

The Assigned 510(k) Number is:

1. Applicant Device Information

Trade/Proprietary Name: Weigao Disposable Empty Cartridge Syringe

Common Name: Syringe, Piston

Classification Name: Syringe, Piston

Device Class: II

Product Code: FMF

Regulation Number: 880.5860

Intended Use:

Weigao Disposable Empty Cartridge Syringe is intended for use in the withdrawal and administration of fluid in accordance with the best judgment of the physician.

2. Submitter Information

Establishment Registration Name:

ShanDong WeiGao Group Medical Polymer Products Co., LTD No.312, Shichang Road Weihai, Shandong, China, 264209

Contact Person of the Submission: Ms. Diana Hong: Mr. Eric Chen Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, South Zhong Shan No.2 Road Shanghai, China 20020 Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong@mid-link.net

Eric.chen@mid-link.net

Shanghai MIDLINK Business Cosulting Co., Ltd

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Premarket Notification 510(k) Submission-510(k) Summary Report No .: A20071011

3. Predicate Device

Predicate device K820164 Trade/Proprietary Name: Empty Sterile Carpuject® Cartridge Common/Usual Name: Piston syringe. Classification Name: Syringe, piston

Submitter Name: Hospira, Inc.

Address: D-389, Bldg. H2 275 N. Field Drive Lake Forest, IL 60045 Attn: Diane Rennpferd Phone: (224) 212-5452 Fax: (224) 212-5401

4. Device Description

Specifications:

Model 1 ml Slim with scale marks (fixed with Needle 27G),

The applicant devices don't contain drug or biological products. They are not for life-supporting or life-sustaining. It is not for implant.

No antimicrobial or antithrombotic ingredient is applied on the applicant device.

No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.

No specific drug or biologic is applied with the applicant device.

5. Test Data

The biocompatibility tests are conducted following ISO 10993 as Appendix 1 Biocompatibility

Shanghai MIDLINK Business Cosulting Co., Ltd

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Test.

The performance bench tests follows ISO 11040-4, ISO 7886-1, ISO 9626 are provided as Appendix 2 Performance Test.

6. Substantially Equivalence

The applicant device is Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety.

Shanghai MIDLINK Business Cosulting Co., Ltd

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

SEP - 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ShanDong WeiGao Group Medical Polymer Products Company, Limited C/O Ms. Diana Hong General Manager Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, Zhongxin Zhongshan Mansion No. 19, Lane 999, Zhong Shan No. 2 Road(S) Shanghai CHINA 200030

Re: K081241

Trade/Device Name: WeiGao Disposable Empty Cartridge Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 28, 2008 Received: July 30, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
MAnuels-Lendims for //

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number: __________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Weigao Disposable Empty Cartridge Syringe is intended for use in the withdrawal and administration of fluid in accordance with the best judgment of the physician.

Prescription Use __ √ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. autor

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

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510(k) Number: K �8124 1

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).