MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT

K990236 · Johnson & Johnson Medical, Div. of Ethicon, Inc. · FOZ · Aug 20, 1999 · General Hospital

Device Facts

• Record ID: K990236
• Device Name: MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT
• Applicant: Johnson & Johnson Medical, Div. of Ethicon, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Aug 20, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Johnson & Johnson Medical Intravascular Catheters are designed for single use. A properly placed I. V. catheter provides access to a viein or artery. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

Device Story

Single-use intravascular catheters provide venous or arterial access. Device inserted by clinician; used for infusion therapy. 16-24 gauge models compatible with power injectors (max 300 psi). Output is physical access to vascular system for fluid delivery. Benefits include reliable vascular access for various patient populations.

Clinical Evidence

Bench testing only. Data demonstrates that 16 to 24 gauge catheters are appropriate for use with power injectors rated for a maximum of 300 psi.

Technological Characteristics

Single-use intravascular catheters. No changes to materials, specifications, manufacturing, or sterilization processes compared to predicate devices. 16-24 gauge models rated for power injection up to 300 psi.

Indications for Use

Indicated for any patient population requiring venous or arterial access, considering patient size, infusion solution, and therapy duration. 16-24 gauge catheters are compatible with power injectors up to 300 psi.

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

• JELCO*, JELCO*-W, and JELCO* PLUS, I.V. Catheters (K990236)
• CATHLON* I.V. Catheters (K990236)
• OPTIVA* I.V. Catheters (K990236)
• PROTECTIV*, PROTECTIV*-W, PROTECTIV* PLUS, and PROTECTIV* PLUS-W I.V. Catheter Safety Systems (K990236)
• Becton-Dickinson INSYTE®, INSYTE®-w AND INSYTE® AUTOGUARD TM I.V. CATHETERS (K990236)

Submission Summary (Full Text)

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AUG 20 1999

## 510(k) Summary

K990236

| Date | August 16, 1999 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Linda G. Hill<br>Sr. Project Manager, Regulatory Affairs<br>Johnson & Johnson Medical, Division of Ethicon, Inc.<br>2500 East Arbrook Boulevard<br>Arlington, TX 76014-3631<br>Telephone: [phone]<br>Telefax: [phone] |
| Trade Names | <ul><li>JELCO*, JELCO*-W and JELCO* PLUS Intravascular (I.V.) Catheters</li><li>CATHLON* I.V. Catheters</li><li>OPTIVA* I.V. Catheters</li><li>PROTECTIV*, PROTECTIV*-W, PROTECTIV* PLUS and PROTECTIV* PLUS-W I.V. Catheter Safety Systems</li></ul> |
| Common Name | Intravascular Catheter |
| Classification | Intravascular Catheters have been classified by the General Hospital and<br>Personal Use Devices as Class II under 21 CFR Part 880.5200. The product<br>code assigned to these devices is FOZ. |
| Device Description | Intravascular catheters are single use devices which provide access to veins or<br>arteries. |
| | Continued on next page |

*Trademark

INSYTE, AUTOGUARD and VIALON are trademarks of Becton-Dickinson, Inc.

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### 510(k) Summary, Continued

| Indications | The intravascular catheters and safety systems are designed for single use. A properly placed intravascular catheter provides access to a vein or artery. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contra-indications | The devices are not designed, sold or intended for use except as indicated. |
| Predicate Devices | The intravascular catheters with the proposed additional indication for use (These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi) are substantially equivalent to the currently-marketed catheters: <ul><li>JELCO*, JELCO*-W, and JELCO* PLUS, I.V. Catheters</li><li>CATHLON* I.V. Catheters</li><li>OPTIVA* I.V. Catheters</li><li>PROTECTIV*, PROTECTIV*-W, PROTECTIV* PLUS, and PROTECTIV* PLUS-W I.V. Catheter Safety Systems</li><li>Becton-Dickinson INSYTE®, INSYTE®-w AND INSYTE® AUTOGUARD ^TM I.V. CATHETERS </li></ul> |

Continued on next page

*Trademark

INSYTE, AUTOGUARI) and VIAI.ON are trademarks of Becton-Dickinson, Inc.

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# 510(k) Summary, Continued

| Technological<br>Characteristics<br>Comparison | The Johnson & Johnson Medical (JJM) catheters have the same technological<br>characteristics as the predicate devices. The catheters with the proposed<br>additional indication for use are identical to the currently-marketed catheters.<br>No changes (materials, specifications, manufacturing and sterilization<br>processes) have been made to the currently-marketed catheters. The catheters<br>differ from the currently-marketed JJM catheters only in the instructions for<br>use which now include use of the 16 to 24 gauge catheters with power<br>injectors for which the maximum rated pressure is 300 psi. The use with<br>power injectors claim is the same as the Becton-Dickinson catheters claim for<br>use with power injectors. |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Data | Bench data demonstrates that the 16 to 24 gauge JJM catheters are appropriate<br>for use with power injectors rated for a maximum of 300 psi. |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR<br>Part 807, and based upon the information provided in this premarket<br>notification, Johnson & Johnson Medical, Division of Ethicon, Inc.,<br>concludes that the modified devices are safe, effective and substantially<br>equivalent to the predicate devices. |
| Other<br>Information | Johnson & Johnson Medical will update and include in this summary any<br>other information deemed reasonable necessary by the FDA. |

*Trademark

INSYTE, AUTOGUARD and VIALON are trademarks of Becton-Dickinson, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and body.

ﻬﺎ

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### AUG 20 1999

Ms. Linda G. Hill Sr. Project Manager, regulatory Affairs Johnson & Johnson Medical, Division Of Ethicon, Incorporated 2500 East Arbrook Boulevard 76014-3631 Arlington Texas

K990236 Re : Modification Of Jelco*, Jelco*-W And Jelco* Plus Trade Name: I.V. Catheters Requlatory Class: II Product Code: FOZ Dated: July 01, 1999 Received: July 02, 1999

Dear Ms. Hill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate bommerce 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Hill

This letter will allow you to begin marketing your device as This lected will arrow you co bogin manifaction. The Frankinding described in your from premation nevice to a legally marketed of substantial equivalence on foassification for your device and predicate actice rebaries to proceed to the market. thus, permics your acvice for your device on our labeling if you desire specific advice for your for your for in for institro regulation (21 crk Fare over and auther office of Compliance at diagnostic devices), prease concact circums on the promotion and in [phone]. Addictionally, Ese contact the Office of Also, please note the regulation Compliance at [phone]. Compilance at (3017-594-1059) Rise, Frience to premarket notification' (21 spranding by referenation on your responsibilities CFR 807.97). Crk 807.977. Other general division of Small under the Act may be Obcarned Iron Inter [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/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 Radioloqical Health

Enclosure

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#### Indications for Use

#### 1290236 510(k) Number:

#### Device Name: JELCO*, CATHLON* AND OPTIVA* I.V. Catheters and PROTECTIV* I.V. Catheter Safety Systems

Indications for Use:

Johnson & Johnson Medical Intravascular Catheters are designed for single use. A properly placed I. V. catheter provides access to a viein or artery. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.) ==============================================================================================================================================================================

Concurence of CDRH, Office of Device Evaluation (ODE)

Prescription Use A (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

*Trademark

Patricia Crescenti

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