DR. JAPAN FACIL POINT SPINAL NEEDLE

K020934 · Myco Medical, Inc. · BSP · Oct 25, 2002 · Anesthesiology

Device Facts

• Record ID: K020934
• Device Name: DR. JAPAN FACIL POINT SPINAL NEEDLE
• Applicant: Myco Medical, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Oct 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For spinal administration of anesthetic agents to provide regional anesthesia.

Device Story

Dr. Japan Facil Point Spinal Needle is a medical device used for the spinal administration of anesthetic agents to provide regional anesthesia. It is intended for use by healthcare professionals in clinical settings. The device functions as a conduit for delivering medication into the spinal space. It is a manual, non-powered device.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Anesthesia conduction needle; manual device; class II; product code BSP.

Indications for Use

Indicated for patients requiring regional anesthesia via spinal administration of anesthetic agents.

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

Public Health Service

200 Corporate Boulevard ockville MD 20850

# OCT 2 5 2002

Mr. Sam Kumar President MYCO Medical, Incorporated 113 Centre West Court Cary, North Carolina 27513

Re: K020934

Trade/Device Name: Dr. Japan Facil Point Spinal Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: September 5, 2002 Received: September 20, 2002

Dear Mr. Kumar:

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.

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.

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Page 2 - Mr. Kumar

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 and additionally 21 CFR Part 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy Al Ulatowski 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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Page 1__of_1 .

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510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________

:

Device Name:

Indication For Use: '

For spinal administration of anesthetic agents to provide regional anesthesia.

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

Prescription Use > Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off)

(Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number

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### K021976 Page 1 Document Cover Sheet: Date of Submission: 13-JUN-2002 TANK HARTOREN AND THE BELLER FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON Description:

נו ווא היה מתחילה מתקנות מתחילת המועדות המונחים ומנור

עוד מערב מינער את קינג קינגע לאחר קינגע למענע מענט גענענט גענענט גענען ד

# 1 1180 000 0000 000 000 000 000 000 000 000 000 000 000 000 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

# Date of Scan:

# 29-OCT-2002

OBA 10/29/02
OBA 10/29/02

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| Document Expected | Page #<br>Start | Page #<br>End | Page In<br>Doc | Indexer |
|--------------------------|-----------------|---------------|----------------|---------|
| 510K Summary 25-OCT-2002 | 1 | 8 | 9 | |
| Total documents: 1 | | | | |
| Total document pages: 8 | | | | |
| Total separator pages: 1 | | | | |
| Total Scan pages: 10 | | | | |

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