PHOENIX EPIDURAL & SPINAL NEEDLES

K990519 · Myco Medical Supplies, Inc. · BSP · Jun 2, 2000 · Anesthesiology

Device Facts

• Record ID: K990519
• Device Name: PHOENIX EPIDURAL & SPINAL NEEDLES
• Applicant: Myco Medical Supplies, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Jun 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.

Device Story

Phoenix Brand Spinal and Epidural Needles are sterile, single-use medical devices used by clinicians to administer local anesthetics for regional anesthesia. The device consists of a needle designed for insertion into the spinal or epidural space. By facilitating precise delivery of anesthetic agents, the device enables regional anesthesia for surgical or pain management procedures. It is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence based on device design and intended use.

Technological Characteristics

Spinal and epidural needles; sterile, single-use; intended for regional anesthesia delivery.

Indications for Use

Indicated for patients requiring regional anesthesia via injection of local anesthetics into the spinal or epidural space.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the top half of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with outstretched wings. The bird is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 2 20

Myco Medical Supplies, Inc. C/O Sam Kumar, President 113 Centre West Court Cary, NC 27513

Re : K990519 Trade Name: Dr. Japan's Phoenix Brand Spinal and Epidural Needles Requlatory Class: II Product Code: BSP Dated: March 6, 2000 Received: March 7, 2000

Dear Mr. Kumar:

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 Act (Act). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

{1}------------------------------------------------

## Page 2 - Mr. Sam Kumar

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "Misbranding by 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,
Mark Millikan

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Page 1 of 1

510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________ "Phoenix" Epidural and Spinal Needles.

Indication For Use:

Spinal and Epidural needles are to be used to inject local anesthetics into a patient to provide regional anesthesia.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Milheson

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K990515

X Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use_ _________

(Optional Format 1-2-96)

OR