NIPRO SAFELET CATH

K013287 · Nipro Medical Corp. · FOZ · Dec 3, 2001 · General Hospital

Device Facts

• Record ID: K013287
• Device Name: NIPRO SAFELET CATH
• Applicant: Nipro Medical Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Dec 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids intravenously.

Device Story

Intravascular catheter for short-term vascular access; used for blood sampling, blood pressure monitoring, or fluid administration. Device consists of cannula with beveled tip and proximal filter cap. Available in two lengths (Type L: 1.5-2.5 inches; Type S: 0.75-1.25 inches) and six gauges (14, 16, 18, 20, 22, 24G). Operated by clinicians in clinical settings. Provides access to vascular system; facilitates fluid delivery and diagnostic monitoring.

Clinical Evidence

No clinical data provided; substantial equivalence based on technical characteristics and design similarities to predicate device.

Technological Characteristics

Intravascular catheter; beveled cannula tip; proximal filter cap. Available in 14-24 gauge sizes. Lengths range from 0.75 to 2.5 inches. Class II device (21 CFR 880.5200).

Indications for Use

Indicated for patients requiring short-term vascular access for blood sampling, blood pressure monitoring, or intravenous fluid administration.

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

• Nipro Medical Corporation intravascular catheter (K960051)

Submission Summary (Full Text)

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## DEC 0 3 2001

## K013287 SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO SAFELET CATH

\$ 807.92 (a) (1)

Contact Person: Eiji Shinozaki

Date of Summary Preparation:

& 807.92 (a)(2)

Trade Name:

Common Name:

Classification Name:

eptember 27, 2001

NIPRO MEDICAL CORPORATION 3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: [phone] Fax: [phone]

Nipro Safelet Cath

Intravascular catheter

Intravascular catheter (for short-term use) (§ 880.5200)

§ 807.92 (a)(3)

Legally Marketed Substantially Equivalent Device: Marketed in U.S. under K960051.

\$ 908.92 (a)(4)

Description of Device:

The devices we intend to market are intravascular catheters as described in 21 CFR 880.5200. The subject devices are similar to catheters currently marketed by Nipro Medical Corporation under K960051. Two types of catheters will be available: the container cases types L (long) and S (short). Type L catheters have needles 1 1/2 to 2 1/2 inches long and Type S have needles ¾ to 1 ¼ inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22 and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.

\$ 807.92 (a)(5)

## Intended Use:

The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids intravenously.

## § 807.92 (a)(6)

Comparison of Technical Characteristics:

Nipro Safelet Cath produced in Brazil and in Thailand are similar. Nipro Medical Corporation manufactures the subject devices in Brazil rather than in Thailand. Given the similarities outlined in Table 7, there is no question of their substantial equivalence.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be a bird or abstract design, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 3 2001

Ms. Kaelyn B. Hadley Consultant Nipro Medical Corporation 1384 Copperfield Court Lexington, Kentucky 40514

Re: K013287

Trade/Device Name: Nipro Safelet Cath Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 27, 2001 Received: October 2, 2001

Dear Ms. Hadley:

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.

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) number (if known): ΚΩΙ??? Η Ο Α 3 ΑΣ 7 Device name: Nipro® Safelet Cath

Device hame: I sipro - Barelet Cath is intended to be inserted into a patient's vascular rindications for abort-term use to sample blood or administer fluids intravenously.

(Do not write below this line- continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The- Counter-Use (optional Format 1-2-9 )

Atricia Lucent

(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, and General Hospital ក្រូវលូ(k) Number