PROBLOC, HN SERIES AND PROLONG, PL SERIES

K050499 · Life-Tech, Inc. · BSP · May 17, 2005 · Anesthesiology

Device Facts

• Record ID: K050499
• Device Name: PROBLOC, HN SERIES AND PROLONG, PL SERIES
• Applicant: Life-Tech, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: May 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prolong is used to administer a patient conduction, regional, or local anesthesia. ProBloc is used in performance of regional anesthesia block.

Device Story

ProBloc (HN Series) and Prolong (PL Series) are anesthesia conduction needles. Used by clinicians to deliver regional or local anesthesia. Devices facilitate regional anesthesia blocks. No complex electronics, software, or automated processing involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Anesthesia conduction needles. Class II device (21 CFR 868.5150). Product code BSP.

Indications for Use

Indicated for administration of conduction, regional, or local anesthesia and performance of regional anesthesia blocks in patients requiring such procedures.

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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## MAY 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jeff Kasoff Director of Regulatory Affairs Life-Tech, Incorporated 4235 Greenbriar Drive Stafford, Texas 77477-3995

Re: K050499

Trade/Device Name: ProBloc, HN Series and Prolong, PL Series Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: February 25, 2005 Received: March 1, 2005

Dear Mr. Kasoff:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your secure mined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendments, or to do room Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 600; Drag, Drag, therefore, market the device, subject to the general approvin applicans of the Act. The general controls provisions of the Act include controls provided or 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 (1 WIT), it they of basyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ea. row roublish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Kasoff

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), r 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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U.S. Food and Drug Administration

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## Indications for Use

510(k) Number (if known): Unknown

Device Name: Modified Prolong, ProBloc

Indications for Use:

Prolong is used to administer a patient conduction, regional, or local anesthesia. ProBloc is used in performance of regional anesthesia block.

Quls

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

510(k) Number K050499

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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