I.V. Catheter for Single Use, including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors.

Device Description

The proposed device, I.V. Catheter for Single Use including Type I, Type Y and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. It is provided EO sterilized, latex free, prygon-free and DEHP-free. All types are available in four sized, which are 18G, 20G, 22G and 24G.

Type Straight Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and straight connector. Type Y I.V. Catheter for Single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle wing, catheter body, clamp and Y connector. And Type I I.V. Catheter for single Use consists of a sheath, slender catheter tubing, stainless steel needle, catheter hub, needle handle and vent fitting, Type Straight and Type Y are closed system while Type I is open system.

AI/ML Overview

The provided text describes a 510(k) summary for an I.V. Catheter for Single Use. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with detailed acceptance criteria and performance metrics typically found in efficacy studies for AI/software devices.

Therefore, much of the requested information, specifically related to acceptance criteria for device performance with specific metrics, study design for proving performance (e.g., sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance), and training set details, is not present in the provided document. The device is a physical medical device (I.V. catheter), not a software or AI device, which explains the absence of these types of details.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of explicit, quantitative acceptance criteria for device performance in the manner of diagnostic accuracy (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the statement that the device "met all design specifications" and was "substantially equivalent to the predicate device." The performance reported is that these design specifications were met during laboratory testing.

Acceptance Criteria (Implied)	Reported Device Performance
Met all design specifications	Laboratory testing confirmed all design specifications were met.
Substantially equivalent to predicate device (K991406)	Concluded to be substantially equivalent to the predicate device.
EO sterilized	Device is provided EO sterilized.
Latex-free	Device is latex-free.
Pyrogen-free	Device is pyrogen-free.
DEHP-free	Device is DEHP-free.

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

Sample Size for Test Set: Not specified. The document only mentions "Laboratory testing was conducted." No specific number of units tested is provided.
Data Provenance: Not specified. The testing was described as "Laboratory testing," implying internal testing by the manufacturer. The manufacturer is Weihai Jierui Medical Products Co., Ltd. in China.

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

Not applicable/Not specified. This information is typically relevant for studies validating diagnostic accuracy, often in AI or imaging devices, where human expert consensus forms the ground truth. Since this is a physical medical device (I.V. catheter), the "ground truth" would be objective measurements against design specifications, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

Not applicable/Not specified. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple experts when establishing ground truth, which is not relevant for the type of testing described for this physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a physical medical device, not a diagnostic or AI-powered system that would involve human readers interpreting cases. Therefore, an MRMC study is not relevant and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance assessment would be the objective measurements against its physical and material design specifications (e.g., strength, flow rate, biocompatibility, sterilization efficacy) as confirmed through laboratory tests. It is not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable. As described above, there is no training set for this type of device.

Summary

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K083429

Premarket Notification 510(k) Submission -- Chapter III 510(k) Summary Report No .: A2008-030-035

AUG 0 7 2009

Chapter III 510(k) Summary

I.V. Catheter for Single Use

As required by 21 CFR 807.92(k)

The assigned 510(k) Number is:

Date Prepared: November 15, 2008;
Sponsor Information

Weihai Jierui Medical Products Co., Ltd. No.348, Shichang Road, Weihai, Shandong, 264209, China

Contact Person: Mrs. Zhao Suxia, Quality Manager Tel: +86-631-5621632 Fax: +86-631-5620555 E-Mail: Zsx9001@sina.com

Submission Correspondent

Ms. Diana Hong Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongshan Zhongxin Mansion No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, China

Device Name and Classification: 4.

Device Trade Name: I.V. Catheter for Single Use Type: Type I, Type Y and Type Straight Device Classification Name: Intravascular Catheter . Product Code: FOZ Regulation Number: 880.5200 Device Class: II

Pg 1 of 2

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Premarket Notification 510(k) Submission - Chapter III 510(k) Summary Report No .: A2008-030-035

1. Predicate Device Identification:

K991406

Trade/Proprietary Name: TERUMO Surflo Flex I.V. Catheter Submitter Name: Terumo Medical Corporation

6. Intended Use:

I.V. Catheter for Single Use, including Type I, Type V and Type Straight, is intended to be inserted into a patient's vascular system for short term use to sample blood, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors.

7. Device Description:

Test Conclusion

Laboratory testing was conducted to validate and verify that I.V. Catheter for Single Use met all design specifications and was substantially equivalent to the predicate device.

9. Substantially Equivalent Conclusion:

The proposed device, Blood Transfusion Set, is substantially equivalent to the predicate device.

Ko&3429 pg z ofz
III-2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans and provide essential human services.

AUG 0 7 2009

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

Weihai Jierui Medical Products Company, Limited C/O Ms. Diana Hong Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, Zhongshan Zhongxin Mansion No. 19, Lane 999, Zhongshan No. 2 Road(S) Shanghai, 200030 CHINA

Re: K083429

Trade/Device Name: I.V. Catheter for Single Use Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: July 17, 2009 Received: July 22, 2009

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 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 (OS) 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/ucm115809.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.

for

Susan Runner, D.D.S., M.A. Acting Division 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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Premarket Notification Submission - Chapter II Indication fur Use Form Report No.: A2008-030-035

Indication for Use

510(k) Number:

Ko83429

Device Name: I.V. Catheter for Single Use

Indications for Use:

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)

Charles B. Day

Page 1 of 1

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

510(k) Number: K083429

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).