(281 days)
The Macosta Medical B-Smart Nerve Block Injection Pressure Manometer is a device for measuring injection pressure during administration of peripheral nerve blocks.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "B-Smart Nerve Block Injection Pressure Manometer." It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided document does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. These details are typically found in the 510(k) summary or other supporting documentation submitted to the FDA, not in the clearance letter itself.
Therefore, I cannot provide the requested information based on the text provided.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Macosta Medical USA, LLC C/O Ms. Pamela Papineau Delphi Mcdical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432
Rc: K031128
Trade/Device Name: B-Smart Nerve Block Injection Pressure Manometer Regulation Number: 21 CFR 868.5140 Regulation Name: Kit, Conduction Anesthetic Regulatory Class: Class II Product Code: 73 CAZ Dated: October 17, 2003 Received: October 24, 2003
Dear Ms. Papineau:
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 prodicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device more comments, 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 gencral appear are provisions of the Act. The general controls provisions of the Act include controls provisions 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 (1171), It hay no cash 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 I fouse be ac riou that 22 a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of any with all the Act's requirements, including, but not limited to: registration
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Page 2 - Ms. Pamela Papineau
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 Office of Compliance at (301) 594-4646. 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/dsma/dsmamain.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
Enclosurc
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Indications for Use
510(k) Number (if known): K031128
B-Smart Nerve Block Injection Pressure Manometer Device Name:
Indications for Use:
The Macosta Medical B-Smart Nerve Block Injection Pressure Manometer is a rne Maooola Moulea. Be measuring injection pressure during administration of peripheral nerve blocks.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-the -Counter Use __ (21 CFR 807 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chuls
(Division Sign-Off) Division of Anesthesiology, General Hospital, Inter
510(k) Number:
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§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).