PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C

K082923 · Life-Tech, Inc. · CAC · Oct 24, 2008 · Anesthesiology

Device Facts

• Record ID: K082923
• Device Name: PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C
• Applicant: Life-Tech, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Oct 24, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The indended use of the froleng is for for loveye thesia and analyesia via blockade of perspieral no

Device Story

ProLong Continuous Nerve Block Set facilitates local anesthesia and analgesia through peripheral nerve blockade. Device consists of components for nerve block procedures; used by clinicians in clinical settings. Provides continuous delivery of anesthetic agents to target nerves; aids in pain management. Benefits patient by enabling regional anesthesia for surgical or post-operative pain control.

Clinical Evidence

Bench testing only.

Technological Characteristics

Anesthesia conduction kit; includes components for peripheral nerve blockade. Class II device (Product Code: CAC).

Indications for Use

Indicated for local anesthesia and analgesia via peripheral nerve blockade.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2008

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

Re: K082923

Trade/Device Name: ProLong Continuous Nerve Block Set PL50, PL100, PL-40C, PL-50C, Pl-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAC Dated: September 29, 2008 Received: October 1, 2008

Dear Mr. Kasoff:

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.

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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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Th: Samuel Rerdms for "

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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Attachment 2

## Indications for Use

510(k) Number (if known):

Device Name: Prolong Confisioners News Block Set Indications For Use: The indended use of the froleng is for for loveye thesia and analyesia via blockade of perspieral no

Prescription Use (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)

Ahmed.

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

510(k) Number:

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