SUPERCATH Z3V

K050114 · Togo Medikit Co., Ltd. · FOZ · Jun 9, 2005 · General Hospital

Device Facts

• Record ID: K050114
• Device Name: SUPERCATH Z3V
• Applicant: Togo Medikit Co., Ltd.
• Product Code: FOZ · General Hospital
• Decision Date: Jun 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to administer fluids. The SUPERCATH Z3V is designed for short-term use (less than 30 days), is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.

Device Story

The Supercath Z3V is an intravascular catheter designed for short-term venous or arterial access and fluid administration. It features a built-in hemostatic valve to assist with compression hemostasis upon withdrawal of the introducer needle. To prevent accidental needlestick injuries, the device incorporates a telescope casing into which the introducer needle is retracted after use. The device is intended for use by healthcare professionals in clinical settings. By providing a secure access point and a safety mechanism for needle disposal, it facilitates fluid delivery while reducing the risk of sharps-related injuries to the clinician.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Polyurethane catheter; radiopaque; includes hemostatic valve and needle retraction mechanism (telescope casing). Sterilized via Ethylene Oxide (EtO). Available in multiple gauge sizes and needle lengths.

Indications for Use

Indicated for venous or arterial access and fluid administration in patients requiring short-term (less than 30 days) catheterization.

Regulatory Classification

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 PLUS Safety IV Catheter (K030571)
• Supercath IV (K864038)
• Supercath AV (K854773)

Submission Summary (Full Text)

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Supercath Z3V Premarket Notification

Attachment 8

JUN 9 - 2005

KOSO 114
Page 1 of 2

April 22, 2005

## 510(K) SUMMARY

## a. Company Name, Address:

TOGO MEDIKIT CO., LTD. 17148-6 Oaza-Hichiya Aza-Kamekawa, Hyuga-shi, Miyazaki-Ken, Japan 883-0062

#### b. Contact:

Kozo Nagayama, Director, Product Quality Center

## c. Date Prepared:

August 2, 2004

## d. Name of Device

Trade Name: SUPERCATH Z3V Common Name: Intravascular catheter Classification Name: Catheter, Intravascular (short-term)

#### e. Predicate Devices:

This device is substantially equivalent to "PROTECTIV PLUS Safety IV Catheter" (K030571) and Togo Medikit's Supercath IV (K864038) and Supercath AV (K854773).

#### f. Description of the Device:

The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to administer fluids. The SUPERCATH Z3V is designed for short-term use (less than 30 days), is intended to minimize inadvertent needlesticks or is intended to reduce accidental needlesticks.

The catheter hub has a built-in hemostatic valve, which assists compression hemostasis when the introducer needle is withdrawn following blood vessel puncture. The introducer needle is retracted into the telescope casing to prevent needle stick injury.

# g. Statement of Substantial Equivalence:

The SUPERCATH Z3V is substantially equivalent to the PROTECTIV PLUS Safety IV Catheter (K030571) and Togo Medikit's Supercath IV (K864038) and Supercath AV (K854773. See Comparison Table 1.

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## Table 1

| Factor | Supercath Z3V | PROTECTIV |
|-----------------------------------------|---------------|-----------|
| Same Intended Use | Yes | Yes |
| Polyurethane Catheter | Yes | Yes |
| Radiopaque Catheter | Yes | Yes |
| Flashback Visualization | Yes | Yes |
| Needle stick Injury Prevention Feature | Yes | Yes |
| Hemostatic Valve | Yes | No |
| EtO Sterilized | Yes | Yes |
| Single Sterile Wrapped | Yes | Yes |
| Multiple gauge Sizes and Needle Lengths | Yes | Yes |

# h. Conclusion

The SUPERCATH Z3V has the same intended use and similar technological characteristics as the PROTECTIV PLUS Safety IV Catheter (K030571) and similar component materials of prior Supercath models cleared by FDA. Thus, The SUPERCATH Z3V is substantially equivalent to the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 9 - 2005

Mr. Kozo Nagayama Director, Regulatory Affairs and Quality Assurance Togo Medikit Company Limited 17148 Oaza-Hichiya Aza Kamekawa Miyazaki-Ken Hyuga-Shi, 883-0062 JAPAN

Re: K050114

Trade/Device Name: Supercath Z3V Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: May 16, 2005 Received: May 17, 2005

Dear Mr. Nagayama:

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 such 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 – Mr. Nagayama

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sayte y. Michie Oms.

Chiú Lin, Ph.D. 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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April 22, 2005

Supercath Z3V Premarket Notification

INDICATIONS FOR USE

510(K) NUMBER (If known):

K050114

Supercath Z3V Device Name:

# Indications for Use:

Indications for Use:
The SUPERCATH Z3V intravascular catheter is intended to access vein or artery and to The SUPERCATH ZSV Intravascular catherer is interests to short-term use (less than 30 administer fitulds. The SUPERCATT ZSV is designed to thended to reduce accidental needlesticks.

Prescription Use

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Please do not write below this line - Continue on other page if necessary)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ana 2smm

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

510(k) Number: k050114