GRIPPER MICRO NEEDLE

K072059 · Smiths Medical MD, Inc. · FMI · Nov 1, 2007 · General Hospital

Device Facts

• Record ID: K072059
• Device Name: GRIPPER MICRO NEEDLE
• Applicant: Smiths Medical MD, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Nov 1, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Indications for Use

This product is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.

Device Story

GRIPPER® Micro Needle is an intravascular administration set for implanted ports; consists of inserter, infusion site, extension tubing, and luer fitting. Inserter features sharp trocar needle and retractor arm; infusion site includes septum and blunt cannula. Operation: trocar needle inserted through septum/cannula into port; retractor arm activated to remove trocar needle, leaving blunt cannula in port. Trocar needle tip captured in inserter to prevent needlestick injury; inserter discarded. Blunt cannula design prevents needlestick injury during extraction. Used by clinicians in clinical settings for fluid administration/withdrawal.

Clinical Evidence

No clinical data. Bench testing and design verification testing were performed to confirm the device meets established acceptance criteria.

Technological Characteristics

Intravascular administration set; includes inserter with trocar needle, infusion site with septum and blunt cannula, extension tubing, and luer fitting. Mechanical operation for needle retraction and safety capture. Class II device.

Indications for Use

Indicated for administration into or withdrawal of fluids from implanted ports. Designed to protect against accidental needlestick injuries.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• GRIPPER PLUS® needle

Submission Summary (Full Text)

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K07-2059

# SMITHS MEDICAL MD, INC. 510(k) Premarket Notification

GRIPPER® Micro Needle 510(k) Summary

NOV ~ 1 2007

### I. Applicant (Sponsor) Name and Address

Smiths Medical MD, Inc. 1265 Grey Fox Road St. Paul, MN 55112 Establishment Reg. No.: 2183502

### II. Contact Name and Phone

Brian Haugstad Senior Regulatory Affairs Associate Company Phone: [phone] Company Fax: [phone]

## III. Device Trade/Proprietary Name

GRIPPER® Micro Needle

## IV. Device Classification/Common Name/Panel

Administration Set

21 CFR Reference: §880.5440 21 CFR Common Name: Intravascular Administration Set Classification: Class II Product Code: FPA Review Panel: General Hospital

# V. Identification of Predicate Device

The Smiths Medical MD, Inc. GRIPPER® Micro needle is substantially equivalent to the Smiths Medical MD, Inc. GRIPPER PLUS® needle.

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'K072059

# SMITHS MEDICAL MD, INC. 510(k) Premarket Notification

# GRIPPER® Micro Needle 510(k) Summary

#### VI. Device Description

The GRIPPER® Micro needle is compromised of the inserter and the infusion site with extension tubing and a standard luer fitting; there are versions either with or without needless access connector y-site. The inserter incorporates a sharp trocar needle and retractor arm. The infusion site incorporates a small septum and an attached blunt cannula. Fully assembled, the inserter and infusion site are combined with the trocar needle inserted through the septum and cannula. After insertion of the cannula and trocar into the implanted port, the inserter retractor arm is activated removing the trocar needle from the cannula and infusion site septum leaving the blunt cannula in the implanted port. The trocar needle tip is captured in the inserter to prevent needle stick injury, and the inserter is discarded. Upon removal of the infusion site from the implanted port, the blunt cannula is designed to further prevent needle stick injury that may result from rebounding action during infusion site extraction.

### VII. Intended Use of the Device

The GRIPPER® Micro needle is designed for the administration into or withdrawal of fluids from implanted ports.

#### VIII. Indications for Use

The GRIPPER® Micro needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.

### IX. Summary of Studies

#### A. Functional Testing

The GRIPPER® Micro needle met all established acceptance criteria for performance testing and design verification testing.

#### B. Clinical Studies

Clinical studies for the GRIPPER® Micro needle was deemed not necessary due to its similarity in materials, design and function to current Smiths Medical MD, Inc. devices.

#### C. Conclusions Drawn from the Studies

Based upon the information provided; the GRIPPER® Micro needle meets all acceptance criteria for performance testing and design verification testing. Therefore, this product is considered acceptable for human use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 2007

Mr. Brian L. Haugstad Senior Regulatory Affairs Associate Smiths Medical MD, Incorporated 1265 Grey Fox Road Saint Paul, Minnesota 55112

Re: K072059

Trade/Device Name: GRIPPER® Micro Needle Regulation Number: 21 CFR 880.5540 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 12, 2007 Received: October 15, 2007

Dear Mr. Haugstad:

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. Haugstad

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 yours,

Clive

Chiu 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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# SMITHS MEDICAL MD, INC. 510(k) Premarket Notification

GRIPPER® Micro Needle Indications for Use

510(k) Number (if known): TBD

K072059

Device Name: GRIPPER® Micro Needle

Indications for Use:

______________________________________________________________________________________________________________________________________________________________________________

This product is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against accidental needlestick injuries.

Prescription Use Over-The Counter Use _______________Per 21 CFR 801.109)

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

______________________________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

fine him

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________