(160 days)
Not Found
No
The device description and performance studies focus on the mechanical safety mechanism of the I.V. catheter and do not mention any AI or ML components.
No
The device is used for sampling blood, monitoring blood pressure, or administering fluids intravenously, which are diagnostic and procedural functions, not therapeutic in nature. Its primary purpose is to facilitate access and reduce injury risk.
No
Explanation: The device is an I.V. catheter designed for administering fluids, monitoring blood pressure, or sampling blood, which are interventional or sample collection procedures, not diagnostic ones.
No
The device description clearly outlines physical components like a catheter, needle, and safety mechanism made of materials like polyurethane and stainless steel. The performance studies also focus on bench tests and material biocompatibility, indicating a hardware-based device.
No, 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 sampling blood, monitoring blood pressure, or administering fluids intravenously. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a physical device used for accessing the vascular system, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used in vivo (inside the body).
N/A
Intended Use / Indications for Use
The YOMURA Safety I.V. Catheter is to be inserted into patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The Yomura Safety I.V. Catheter consists of a catheter connected to a standard conical fitting, and a safety mechanism. Upon activation of the safety mechanism the needle guard covers the entire length of the needle. Therefore, the risks of needle stick injuries can be reduced.
The YOMURA Safety I.V. Catheter consists of an over needle peripheral catheter made of polyurethane material with radiopaque stripes. The stainless steel needle is placed in the catheter to maintain rigidity and to facilitate venipuncture. A safety mechanism constitutes a needle guard is built inside the device. Upon insertion and threading of the catheter, the needle guard extends to full length and locks into place to encapsulate the entire length of the needle. Thus adds in the prevention of accidental needle stick injuries.
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)
Various bench tests were performed to ensure that the Yomura Safety I.V. Catheter meets all functional and performance requirements for its intended use. Material biocompatibility is verified by performing all required tests specified by ISO 10993 for communicating, circulating blood, prolonged exposure" "external devices. Functional and performance tests were also carried out according to ISO 10555.1 and Safety feature was tested according to requirements provided by a 10555.5. guidance document issued by US FDA "Medical devices with sharps injury prevention features" issued on August 9, 2005.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Pre-market Notification for YOMURA Safety I.V. Catheters
Date: August 27, 2011
FEB - 8 2012
510(k) Summary of Safety and Effectiveness
1. Submitter
YOMURA Technologies Inc. No. 2-3, Kung 8th Road, Second Industrial Park Linkou District, Taipei 244 TAIWAN
Contact: Ms. Sherry Lin Phone: +886 2 8601 3839 Ext. 253
2. Name and Classification of Device
| Trade Name: | YOMURA Safety I.V. Catheters |
|---|---|
| Common/Usual Name: | IV Catheter |
| Classification Name: | Catheter, intravascular, therapeutic, short term, less |
| than 30 days |
Regulation Medical Specialty: General Hospital Review Panel: General Hospital Classification Number: 21CFR 880.5200 Product Code: FOZ
3. Predicate Device
| Trade Name | 510(k) Number | Decision Date |
|---|---|---|
| PROTECTIV 2000 I.V. Catheter Safety System | K962226 | 12/23/1996 |
| Insyte Autoguard Catheter | K000235 | 4/5/2000 |
4. Device Description
The Yomura Safety I.V. Catheter consists of a catheter connected to a standard conical fitting, and a safety mechanism. Upon activation of the safety mechanism the needle
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guard covers the entire length of the needle. Therefore, the risks of needle stick injuries can be reduced.
5. Indications for Use
The YOMURA Safety I.V. Catheter is to be inserted into patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.
6. Technological Characteristics
The YOMURA Safety I.V. Catheter consists of an over needle peripheral catheter made of polyurethane material with radiopaque stripes. The stainless steel needle is placed in the catheter to maintain rigidity and to facilitate venipuncture. A safety mechanism constitutes a needle guard is built inside the device. Upon insertion and threading of the catheter, the needle guard extends to full length and locks into place to encapsulate the entire length of the needle. Thus adds in the prevention of accidental needle stick injuries.
7. Performance Summary
Various bench tests were performed to ensure that the Yomura Safety I.V. Catheter meets all functional and performance requirements for its intended use. Material biocompatibility is verified by performing all required tests specified by ISO 10993 for communicating, circulating blood, prolonged exposure" "external devices. Functional and performance tests were also carried out according to ISO 10555.1 and Safety feature was tested according to requirements provided by a 10555.5. guidance document issued by US FDA "Medical devices with sharps injury prevention features" issued on August 9, 2005.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wing-like shapes, representing health, services, and human needs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Yomura Technologies Incorporated C/O Ms. Sherry Lin No. 2-3, Kung 800 Road, Second Industrial Park Linkou District, New Taipei City 244 Taiwan
FEB - 8 2012
Re: K112542
Trade/Device Name: YOMURA Safety I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Catheter, Intravascular, therapeutic, short term, less than 30 days Regulatory Class: Class II Product Code: FOZ Dated: January 30, 2012 Received: February 1, 2012
Dear Ms. Lin:
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. Lin
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 /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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for Anthony D. Watson.
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
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Indication for Use
510(k) Number (if known):
Device Name: YOMURA Safety I.V. Catheter
Indications for Use:
The YOMURA Safety I.V. Catheter is to be inserted into patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
light for REC Feb 9, 2012
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
| 510(k) Number: | í
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