RK EPIDURAL NEEDLE

K072005 · Epimed International · BSP · Feb 7, 2008 · Anesthesiology

Device Facts

• Record ID: K072005
• Device Name: RK EPIDURAL NEEDLE
• Applicant: Epimed International
• Product Code: BSP · Anesthesiology
• Decision Date: Feb 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.

Device Story

RK Epidural Needle is a sterile, single-use, disposable device consisting of a stainless steel cannula with a ground beveled distal tip and a molded plastic hub. A stainless steel stylet with a molded plastic hub is included. The device is used by clinicians to facilitate single drug injections or the placement of epidural catheters. It is available in various lengths and gauges. The device functions as a standard conduction needle for anesthetic delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel cannula with ground beveled distal tip; molded plastic hub; stainless steel stylet; sterile, single-use, disposable; available in various lengths and gauges.

Indications for Use

Indicated for patients requiring single drug injection or placement of an epidural catheter (Epimed Spring Guided or traditional).

Regulatory Classification

Identification

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

Predicate Devices

• Epimed International Epidural Needle (K030562)
• Epimed International RX Epidural Needle (K053318)

Submission Summary (Full Text)

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K072005

## 510(K) Summary

#### Company Information:

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

FEB - 7 cubs

#### Date Prepared:

September 7, 2006

## Trade Name:

RK Epidural Needle

#### Common Name:

Epidural Needle

#### Product Class/Classification:

Class II 868.5150 Needle, Conduction, Anesthetic

#### Predicate Device(s):

Epimed International Epidural Needle (K030562) Epimed International RX Epidural Needle (K053318)

#### Description:

The RK Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stainless steel stylet with a molded plastic hub is also provided with the device.

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

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#### Intended Use:

The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.

#### Comparison to Predicate:

The RK Epidural Needle has similar physical and technical characteristics to the Epimed International Epidural Needles marketed under K030562 and K053318.

## Conclusion:

The comparison to the predicate devices demonstrates that the RK Epidural Needle is safe and effective and is substantially equivalent to the predicate devices.

Epimed International, Inc.

Katie Peters

Katie Peters Manager of Quality Assurance/Regulatory Affairs

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

Public Health Service

FEB - 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Epimed International, Incorporated C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K072005

Trade/Device Name: RK Epidural Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: January 22, 2008 Received: January 24, 2008

Dear Mr. Kogoma:

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. Kogoma

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.

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): |< 0 フ 2 0 0 S

Device Name: RK Epidural Needle

Indications For Use: The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Min Khin

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

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510(k) Number: K072005