GRIPPER PLUS NEEDLE

K021999 · Deltec, Inc. · FPA · Aug 13, 2002 · General Hospital

Device Facts

• Record ID: K021999
• Device Name: GRIPPER PLUS NEEDLE
• Applicant: Deltec, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.

Device Story

The GRIPPER PLUS™ Needle is a non-coring infusion needle for implanted ports. It features a passive needle-stick protection mechanism consisting of a base and hinged arm. Upon removal from the port, the hinge allows the needle to be retracted and locked into a capture well, confirmed by an audible click. This mechanism protects the needle tip from exposure after use. The device is used by healthcare professionals in clinical settings for fluid administration or withdrawal. It is available in various gauges and lengths, with or without a slit-septum injection site cap. The primary benefit is the reduction of accidental needlestick injuries and associated bloodborne pathogen exposure for the operator.

Clinical Evidence

No clinical studies were conducted. Evidence consists of bench testing and simulated-use testing performed by healthcare professionals in accordance with FDA's 1995 guidance on sharps injury prevention features. Testing confirmed the protection feature successfully activated in all attempts and that the device functions according to specifications. Biocompatibility testing was also performed.

Technological Characteristics

Non-coring stainless steel needle; PVC tubing plasticized with TOTM; passive hinged needle-stick protection mechanism with audible locking feature. Available in 19, 20, and 22 gauges; lengths 0.625 to 1.25 inches. Standalone device; non-electronic.

Indications for Use

Indicated for administration into or withdrawal of fluids from implanted ports in patients requiring vascular access. Designed to reduce risk of accidental needlestick injuries to healthcare professionals.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• GRIPPER® Needle (Deltec, Inc.)
• Huber Plus Safety Infusion Set (NowMedical)

Submission Summary (Full Text)

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AUG 1 3 2002

K021999

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## GRIPPER PLUSTM Needle

June 18, 2002

#### I. GENERAL INFORMATION

| Applicant's Name and Address: | Deltec, Inc.<br>1265 Grey Fox Road<br>St. Paul, MN 55112 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lisa J. Stone<br>Manager, Regulatory Affairs |
| Common/Usual Name: | Administration Set |
| Proprietary Name: | GRIPPER PLUS™ Needle |
| Equivalence Device Comparison: | GRIPPER® Needle<br>(manufactured by Deltec, Inc.)<br>Huber Plus Safety Infusion Set<br>(manufactured by NowMedical) |

#### II. DEVICE DESCRIPTION

The GRIPPER PLUS™ Needle is similar in design to the current GRIPPER® Needle, with the incorporation of a passive needle stick protection feature. The protection feature is made of a base and arm with a hinge on one end. As the needle is removed from a portal the hinge allows the needle to be pulled back and locked into the capture well in the base. There is an audible "click" when the needle is captured. The device is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The needle tip is fully protected after deployment of the needle stick protection feature and will not disengage with normal handling such that the needle tip becomes exposed.

The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.

#### Ш. INTENDED USE OF THE DEVICE

The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.

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### DEVICE COMPARISON IV.

| | GRIPPER PLUSTM<br>Needle | Huber Plus Safety<br>Infusion Set | GRIPPER® Needle |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------|
| MANUFACTURER | Deltec, Inc. | NowMedical | Deltec, Inc. |
| INDICATIONS FOR<br>USE | The GRIPPER PLUSTM<br>Needle is indicated for<br>the administration into or<br>withdrawal of fluids from<br>implanted ports. It is<br>designed to help protect<br>against exposure to<br>bloodborne pathogens<br>caused by accidental<br>needlestick injuries. | To be used with<br>implanted vascular ports. | Intended for the<br>administration into or<br>withdrawal of fluids from<br>implanted ports. |
| NONCORING NEEDLE | YES | YES | YES |
| NEEDLE-STICK<br>PREVENTION<br>FEATURE | YES | YES | NO |
| NEEDLE GAUGES | 22<br>20<br>19 | 22<br>20<br>19 | 22<br>20<br>19 |
| NEEDLE LENGTHS<br>(inches) | 0.625<br>0.75<br>1.0<br>1.25 | 0.5<br>0.75<br>1.0<br>1.25<br>1.5 | 0.625<br>0.75<br>1.0<br>1.25 |
| NEEDLE MATERIAL | Stainless Steel | Stainless Steel | Stainless Steel |
| TUBING DIMENSIONS<br>(Nominal) | | | |
| I.D.<br>O.D.<br>Length | 0.047 in.<br>0.103 in.<br>8.0 in. | 0.046 in.<br>0.091 in.<br>9 in. | 0.047 in.<br>0.103 in.<br>8.0 in. |
| TUBING MATERIAL | PVC plasticized with<br>TOTM | PVC (non-DEHP) | PVC plasticized with<br>TOTM |
| AVAILABLE WITH OR<br>WITHOUT INJECTION<br>SITE | YES | YES | YES |

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#### V. SUMMARY OF STUDIES

#### Functional Testing A.

In-vitro testing and simulated use testing was conducted in accordance with the FDA "Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Prevention Features," dated March 1995.

Biocompatibility testing was conducted on the device components.

#### B. Clinical Studies

Clinical studies were not deemed necessary regarding the GRIPPER PLUSTM Needles due to their similarity in materials, design and function to the current GRIPPER® Needle and Huber Plus Safety Infusion Set. The device was evaluated by health care professionals during a simulated use test and was found to be acceptable for its intended use.

#### ﺰ Conclusion Drawn from the Studies

The results of the testing indicated that the GRIPPER PLUS™ Needles function according to specifications and the materials used in the device are biocompatible. Simulated use testing indicated that the device's protection feature successfully activated during all attempts. Therefore, this product is considered acceptable for human use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human figures or silhouettes, arranged in a row, with their heads slightly overlapping.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 1 3 2002

Mr. Edward W. Numainville Vice President, RA/OA SIMS Deltec. Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112

Re: K021999

Trade/Device Name: GRIPPER PLUSTM Needle Regulation Number: 880.5440 and 880.5570 Regulation Name: Intravascular Administration Set and Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FPA and FMI Dated: June 18, 2002 Received: June 19, 2002

Dear Ms. Numainville:

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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## Page 2 - Mr. Numainville

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

11. 11. 11. 11.

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.

JSAWintAronson for.

Timothy A. Ulatowski 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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Ko2,1999

510(k) Number (if known):

Device Name: GRIPPER PLUS™ Needle

Indications for Use:

"The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries."

(PLEASE 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

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

510(k) Number: K021999

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