PENCIL POINT NEEDLE

K041843 · Epimed International, Inc. · BSP · Aug 24, 2004 · Anesthesiology

Device Facts

• Record ID: K041843
• Device Name: PENCIL POINT NEEDLE
• Applicant: Epimed International, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Aug 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For the administration of anesthetic agents to provide regional anesthesia. Not for use with an Epidural Catheter.

Device Story

Blunt Nerve Block Needle; stainless steel cannula with atraumatic distal tip; includes stainless steel stylet with molded plastic hub. Device used for administration of anesthetic agents to provide regional anesthesia. Sterile, single-use, disposable device available in various lengths and gauges. Operated by clinicians in clinical settings. Device facilitates regional anesthesia delivery; atraumatic tip design intended to minimize tissue trauma during insertion.

Clinical Evidence

No clinical data; submission based on physical and technical similarity to predicate devices.

Technological Characteristics

Stainless steel cannula; atraumatic distal tip; stainless steel stylet; molded plastic hub. Sterile, single-use, disposable. Available in various lengths and gauges. No electronic or software components.

Indications for Use

Indicated for the administration of anesthetic agents to provide regional anesthesia in patients requiring such procedures. Not for use with an Epidural Catheter.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• Pajunk Sprotte Needles (K911260, K911221, K911202)

Submission Summary (Full Text)

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AUG 2 4 2004

K041843

# Section II

# 510(K) Summary

# Company Information:

Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 [phone] Contact: Christopher B. Lake Manager of QA/RA

# Trade Name:

Blunt Nerve Block Needle

## Common Name:

Pencil Point Needle

## Product Class/Classification:

Class II

### Predicate Device(s):

Pajunk Sprotte Needles (K911260, K911221, K911202)

# Description:

The Blunt Nerve Block Needle consists of a stainless steel cannula with an atraumatic distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a stainless steel wire shaft and a molded plastic hub.

The Blunt Nerve Block Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.

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#### Intended Use:

For the administration of anesthetic agents to provide regional anesthesia. Not for use with an Epidural Catheter.

#### Comparison to Predicate:

The Blunt Nerve Block Needle has similar physical and technical characteristics to the Pajunk Sprotte Needles.

#### Non-Clinical Data:

Submission is based upon similar physical characteristics and intended use to the predicate devices. No bench testing of performance characteristics was conducted.

#### Conclusion:

The comparison to the predicate device demonstrates that the Blunt Nerve Block Needle is safe and effective and is substantially equivalent to the predicate device(s).

Epimed International, Inc.

Chasl

Christopher B. Lake Manager of Regulatory Affairs/Quality Assurance

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2004

Mr. Christopher B. Lake Manager of Regulatory Affairs/ Quality Assurance Epimed International, Incorporated 141 Sal Landrio Drive Crossroads Business Park Johnstown, New York 12095

Re: K041843

Trade/Device Name: Blunt Nerve Block Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: July 7, 2004 Received: July 13, 2004

Dear Mr. Lake:

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. Lake

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/dsma/dsmamain.html

Sincerely yours,

Chin Lin, Ph.D.

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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# Indications for Use

510(k) Number (if known): was koy 1843

Device Name: Blunt Nerve Block Needle Indications for Use:

The Blunt Nerve Block Needle is intended for the administration of anesthetic agents to provide regional anesthesia.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cui Suom

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

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510(k) Number:

KOHK4