FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837

K051860 · Epimed International, Inc. · MIA · Aug 22, 2005 · Anesthesiology

Device Facts

• Record ID: K051860
• Device Name: FLEXIBLE INTRODUCER CANNULA, MODEL 135-1837
• Applicant: Epimed International, Inc.
• Product Code: MIA · Anesthesiology
• Decision Date: Aug 22, 2005
• 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.

Device Story

Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub and a stainless steel introducer needle. The device is used by clinicians to facilitate epidural placement for the administration of anesthetic agents. The stainless steel needle is used to introduce the cannula and is removed after placement. The device functions as a conduit for regional anesthesia delivery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on physical and technical comparisons.

Technological Characteristics

Device consists of a plastic cannula with a molded plastic hub and a stainless steel introducer needle. Class II device (21 CFR 868.5150).

Indications for Use

Indicated for epidural placement to elicit regional anesthesia in patients requiring such procedures. Prescription use only.

Regulatory Classification

Identification

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

Predicate Devices

• Custom Medical Concepts Spinal Cord Access Epidural Introducer System (K904380)

Submission Summary (Full Text)

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## 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

#### Date Prepared:

July 6, 2005

#### Trade Name:

Flexible Introducer Cannula

#### Common Name:

Anesthesia Conduction Needle

#### Product Class/Classification:

Class II - MIA, 21 CFR 868.5150

#### Predicate Device(s):

Custom Medical Concepts Spinal Cord Access Epidural Introducer System (K904380)

#### Description:

The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is also packaged with a stainless steel introducer needle which is removed after the device has been placed.

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#### Intended Use:

For the administration of anesthetic agents to provide regional anesthesia.

## Comparison to Predicate:

The Flexible Introducer Cannula has similar physical and technical characteristics to the predicate device and a similar intended use to the predicate device.

## Conclusion:

The testing performed and comparison to the predicate device demonstrates that the Flexible Introducer Cannula is safe and effective and is substantially equivalent to the predicate device.

Epimed International, Inc.

Pell

Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2005

Mr. Christopher Lake Manager of QA/RA Epimed International, Incorporated 141 Sal Landrio Drive Johnstown, New York 12095

Re: K051860

Trade/Device Name: Flexible Introducer Cannula, Model 135-1837 Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: MIA Dated: July 6, 2005 Received: July 12, 2005

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 may or can been 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 r hat 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 or any I vith 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 promaticated 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,

Siran Rumpe

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): K051860

Device Name: Flexible Introducer Cannula

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The Flexible Introducer Cannula is intended for the epidural placement, directly The Flexible Introducer cannuid is Inventour of the opents to elicit regional anesthesia.

Prescription Use X (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)

Amy Slocum

(Division Sic ness boy Ceneral Hospital, not Control ್ತ

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