BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB

K982797 · Luther Medical Products, Inc. · DYB · Nov 30, 1998 · Cardiovascular

Device Facts

• Record ID: K982797
• Device Name: BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB
• Applicant: Luther Medical Products, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Blunt T-Peel Plastic Sheath Introducer is used to facilitate placement of a peripherally inserted intravenous catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.

Device Story

Over-the-needle peel-away plastic sheath catheter introducer; includes integrated blunting feature to blunt needle tip post-venous access. Used by clinicians to facilitate intravascular catheter placement; reduces risk of accidental needlestick. Device functions by providing a shielded needle mechanism; activation force and override force are controlled to ensure safety. Healthcare providers use the device during standard venous access procedures; the blunting feature engages after access to protect the user. Benefits include improved safety for the operator during catheter insertion.

Clinical Evidence

Bench testing only. No clinical data provided. Testing evaluated the needlestick protection feature, confirming activation force within limits, puncture force of shielded needle exceeding unshielded, and override force meeting minimum requirements.

Technological Characteristics

Over-the-needle peel-away plastic sheath catheter introducer. Features integrated mechanical needle-blunting mechanism. No changes to materials or dimensions from previously qualified T-Peel introducer. Manual operation.

Indications for Use

Indicated for facilitating the placement of a peripherally inserted intravenous catheter through the skin into a vein in patients requiring venous access, while providing a needlestick protection feature.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Luther Medical Products, Inc. T-Peel Introducer (K924562)
• Bio-Plexus, Inc. Punctur-Guard® Blood Collection Needle (K895024)

Submission Summary (Full Text)

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K982797

NOV 30 1998

# 510(k) Summary

August 7, 1998

### General Information

- Luther Medical Products, Inc. Applicant: 14332 Chambers Road Tustin, CA 92780-6912 Phone: [phone] Fax: [phone]
- Kathleen Roberts Contact: [phone], ext. 216

| Common Name: | Catheter Introducer |
|----------------------|----------------------------------------|
| Trade Name: | Blunt T-Peel Plastic Sheath Introducer |
| Classification Name: | Catheter Introducer |

Predicate Devices

Luther Medical Products, Inc. T-Peel Introducer K924562

Bio-Plexus, Inc. Punctur-Guard® Blood Collection Needle K895024

Device Description

An over-the-needle peel-away plastic sheath catheter introducer which includes a blunting feature to blunt the tip of the needle after venous access.

#### Intended Use

Used to facilitate placement of an intravascular catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.

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## Comparison to Predicate Devices

Substantially equivalent to the T-Peel introducer with the addition of a needlestick protection feature that is comparable in safety and effectiveness to a similar feature in the Punctur-Guard® Blood Collection Needle.

## Tests

The T-Peel Plastic Sheath Introducer has been on the market for several years and was previously tested and qualified. There are no design, dimensional or material changes to the device. Therefore no testing of the catheter introduction features are necessary.

The additional needlestick protection feature of the Blunt T-Peel Plastic Sheath Catheter Introducer has been evaluated according to a documented test protocol. All test results were satisfactory and met the protocol's requirements. The activation force was within specified limits. The puncture force with the shielded needle exceeded that with the unshielded needle in all cases. The force to override the needle shielding feature exceeds the minimum requirements.

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Food and Drug Administration Rockville MD 20857

NOV 30 1998

Ms. Kathleen Roberts Regulatory Affairs Manager Luther Medical Products, Inc. 14332 Chambers Road Tustin, CA 92780-6912

Re : K982797 Blunt T-Peel Plastic Sheath Introducer Trade Name: Regulatory Class: II Product Code: DYB Dated: October 22, 1998 Received: October 23, 1998

Dear Ms. Roberts:

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 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 You may, therefore, market the device, subject to the Act (Act). 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Ms. Kathleen Roberts

under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and advertising 594-4586. of your device, please contact the Office of Compliance at (301) 594-Also, please note the regulation entitled, "Misbranding by 4639. reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K982797 510(k) Number:

Device Name:

Blunt T-Peel Plastic Sheath Introducer

Indications For Use:

The Blunt T-Peel Plastic Sheath Introducer is used to facilitate placement of a peripherally inserted intravenous catheter through the skin into a vein and when used according to the Directions For Use, may reduce the risk of an accidental needlestick.

A.D. Grant for T.J. Callahan

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number k982797

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V (Per 21 CFR 801.109)

OR

Over-The-Counter Use_