MEDLINE EPIDURAL AND SPINAL NEEDLES

K110194 · Medline Industries, Inc. · BSP · Jun 17, 2011 · Anesthesiology

Device Facts

• Record ID: K110194
• Device Name: MEDLINE EPIDURAL AND SPINAL NEEDLES
• Applicant: Medline Industries, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Jun 17, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Medline Epidural and Spinal Needles are sterile, single-use devices designed for the administration of local anesthetics to achieve regional anesthesia. The needles are used by clinicians in clinical settings to access the epidural or spinal space. The device functions as a conduit for anesthetic delivery. It is a manual, mechanical instrument without electronic or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual anesthesia conduction needle; stainless steel construction; sterile, single-use; no electronic components or software.

Indications for Use

Indicated for patients requiring regional anesthesia via injection of local anesthetics.

Regulatory Classification

Identification

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

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Matt Clausen Regulatory Affairs Specialist Medline, Industries, Incorporated One Medline Place Mundelein, Illinois 60060

JUN 1 7 2011

Re: K110194

Trade/Device Name: Medline Epidural and Spinal Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: June 2, 2011 Received: June 3, 2011

Dear Mr. Clausen:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Clausen

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Anthony O. Watson

Anthony D. Watson, B.S., M.S., M.B.A. 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):

Device Name:

## Medline Epidural and Spinal Needles

Indications For Use:

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

Prescription Use_X (Part 21 CFR 801 Subpart D) OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence

(Division Sign Off)

(Division Sign-C 11 Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K11019