(84 days)
The ProLong-EX permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is infileated for use up to 72 hours, and is for adult art paid.atric use.
Not Found
This is a 510(k) clearance letter for the ProLong-EX Continuous Nerve Block Set. It states that the device is substantially equivalent to legally marketed predicate devices. This type of regulatory submission typically does not include detailed performance studies with acceptance criteria, sample sizes, expert involvement, or training set information as would be found in a Premarket Approval (PMA) application or a de novo submission.
Therefore, based on the provided document, I cannot extract the information requested regarding acceptance criteria and the study proving the device meets them. The document primarily focuses on the regulatory approval process through substantial equivalence.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2007
Mr. Jeff Kasoff, RAC Director of Regulatory Affairs Life-Tech, Incorporated 4235 Greenbriar Drive Stafford, Texas 77477
Re: K072050
Trade/Device Name: ProLong-EX Continuous Nerve Block Set Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: July 24, 2007 Received: July 30, 2007
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 (OS) 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 Office of Compliance at (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sutie y. Michael Duds.
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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Indications for Use
510(k) Number (if known): K072050
Device Name: ProLong-EX Continuous Nerve Block Set
Indications For Use:
The ProLong-EX permits placement of catheters next to
nerves and nerve plexus for continuous nerve block
anesthesia or analgesia techniques. It is infileated
for use up to 72 hours, and is for adult art paid.atric use.
Part 21 CFR 801 Subpart D)
AND/OR
CFR 801 Submart C
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mith Mnd
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of
510(k) Numb
品牌:中国营销馆 | 阿拉尔 |
510(k) Number: K072050
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).