(160 days)
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.
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.
The provided text is a 510(k) Pre-market Notification for a medical device, the YOMURA Safety I.V. Catheter. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for establishing novel performance or clinical efficacy through new studies with specific acceptance criteria as you've outlined. Therefore, much of the requested information regarding detailed study design, sample sizes for test and training sets, expert qualifications, and AI-related metrics is not applicable to this document.
The document primarily focuses on bench testing to show that the device meets functional and performance requirements and is safe for its intended use, largely by demonstrating compliance with established international standards and FDA guidance.
Here's a breakdown of the available information based on your request, with an explanation of why certain criteria are not met by this type of document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of acceptance criteria with corresponding performance metrics in the way one might expect for a clinical study evaluating a diagnostic device. Instead, it refers to compliance with established standards.
| Acceptance Criteria (Inferred from Standards & Guidance) | Reported Device Performance |
|---|---|
| Material Biocompatibility: Compliance with ISO 10993 for communicating, circulating blood, prolonged exposure (external devices). | "Material biocompatibility is verified by performing all required tests specified by ISO 10993..." |
| Functional and Performance: Compliance with ISO 10555.1 and ISO 10555.5 for over-needle peripheral catheters. | "Functional and performance tests were also carried out according to ISO 10555.1 and 10555.5." |
| Safety Feature (Needle Stick Injury Prevention): Compliance with requirements in FDA guidance document "Medical devices with sharps injury prevention features" (August 9, 2005). | "Safety feature was tested according to requirements provided by a guidance document issued by US FDA 'Medical devices with sharps injury prevention features'..." |
| Mechanical Integrity/Design: The needle guard covers the entire length of the needle upon activation. | "Upon activation of the safety mechanism the needle guard covers the entire length of the needle." |
| Ease of Use/Functionality: Needle guard extends to full length and locks into place to encapsulate the entire length of the needle upon insertion and threading of the catheter. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size for the bench tests performed. Typically, for compliance with ISO standards, specific numbers of units are tested, but these details are not provided in this summary.
- Data Provenance: The tests were performed by the manufacturer, YOMURA Technologies Inc., based in Linkou District, Taipei, TAIWAN. The tests are "bench tests," meaning they were conducted in a laboratory setting, not on human subjects. They are inherently "retrospective" in the sense that they are conducted on manufactured devices as part of the validation process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This device is an I.V. catheter with a safety mechanism, not an AI-driven diagnostic device. "Ground truth" in the context of expert consensus (e.g., for image interpretation) is not relevant here. The ground truth for these tests is defined by the technical specifications of the device and the requirements of the standards (e.g., successful activation of safety mechanism, material strength, biocompatibility).
4. Adjudication Method for the Test Set
- Not Applicable. As this involves bench testing against predefined standards, there is no need for expert adjudication in the manner described (e.g., 2+1 review for medical imaging). The results of the physical and material tests are objectively measured against the criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI Assistance
- Not Applicable. This is a physical medical device, not an AI-based diagnostic tool. No human readers or AI assistance are involved in its primary function or the safety tests described.
6. 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 or AI.
7. The Type of Ground Truth Used
- The ground truth for the performance and safety tests is based on technical specifications, established international standards (ISO 10993, ISO 10555.1, ISO 10555.5), and specific FDA guidance document requirements. For example:
- For biocompatibility: Whether the material passes the tests outlined in ISO 10993.
- For functional performance: Whether the catheter meets the physical and leakage requirements of ISO 10555.
- For the safety mechanism: Whether the needle guard fully covers the needle and locks as intended, as per FDA guidance.
Pathology or outcomes data are not used as ground truth for these specific bench tests.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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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.
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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: | íﻟ. 651Acres of American PropertyAnnual parties and announce and experience and enclosed to | |
|---|---|---|
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§ 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).