← Product Code [FOZ](/productcode/FOZ) · K112542

# YOMURA SAFETY I.V. CATHETER (K112542)

_Yomura Technologies, Inc. · FOZ · Feb 8, 2012 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K112542

## Device Facts

- **Applicant:** Yomura Technologies, Inc.
- **Product Code:** [FOZ](/productcode/FOZ.md)
- **Decision Date:** Feb 8, 2012
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5200
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## 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.

## Device Story

YOMURA Safety I.V. Catheter is a peripheral intravenous catheter designed for short-term vascular access. Device consists of a polyurethane catheter with radiopaque stripes and a stainless steel needle. Integrated safety mechanism features a needle guard that automatically extends and locks over the entire needle length upon withdrawal to prevent accidental needle stick injuries. Used in clinical settings by healthcare professionals for blood sampling, blood pressure monitoring, or fluid administration. Device facilitates venipuncture while providing sharps injury protection for the operator.

## Clinical Evidence

Bench testing only. Biocompatibility verified per ISO 10993 for communicating, circulating blood, prolonged exposure external devices. Functional performance testing conducted per ISO 10555.1. Safety feature performance validated against FDA guidance 'Medical devices with sharps injury prevention features' (2005).

## Technological Characteristics

Polyurethane catheter with radiopaque stripes; stainless steel needle; integrated needle guard safety mechanism. Dimensions/form factor: peripheral IV catheter. Energy source: none (manual). Sterilization: not specified. Standards: ISO 10993 (biocompatibility), ISO 10555.1 (functional performance).

## Regulatory 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.

## Predicate Devices

- PROTECTIV 2000 I.V. Catheter Safety System ([K962226](/device/K962226.md))
- Insyte Autoguard Catheter ([K000235](/device/K000235.md))

## Submission Summary (Full Text)

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K112542

# 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: | í<br>ﻟ<br>. 65<br>1<br>Acres of American Property<br>Annual parties and announce and experience and enclosed to |  |
|----------------|-----------------------------------------------------------------------------------------------------------------|--|
|                |                                                                                                                 |  |

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