(261 days)
Not Found
No
The description focuses on the physical components and intended use of a standard I.V. catheter, with no mention of AI, ML, or any computational processing beyond basic laboratory testing for performance.
No
The device is described as being used to administer fluids intravenously or to sample blood, which are diagnostic or supportive functions, not therapeutic.
No
The device is an I.V. catheter used for administering fluids, sampling blood, or placing monitoring equipment, not for diagnosing a condition. Its function is to provide access to the vascular system, not to identify or characterize diseases.
No
The device description clearly outlines physical components like a sheath, tubing, needle, and connectors, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be inserted into a patient's vascular system for direct patient care (sampling blood, administering fluids, placing monitoring equipment). This is a direct interaction with the patient's body.
- Device Description: The description details a physical device designed for insertion into the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro). IVDs are used to test samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor conditions.
This device is a medical device, specifically an I.V. catheter, used for direct patient treatment and monitoring, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
FOZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
Premarket Notification 510(k) Submission - Chapter III 510(k) Summary Report No .: A2008-030-035
-
- 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:
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.
- 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
2
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.
3
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
4
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:
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.
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