(281 days)
Not Found
None
No
The summary describes a pressure manometer, a device for measuring physical pressure. There is no mention of AI, ML, image processing, or any other computational technology typically associated with AI/ML in medical devices.
No
The device measures injection pressure but does not directly treat a condition.
No
The device measures injection pressure during a medical procedure but does not diagnose a condition or disease.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The name "Pressure Manometer" suggests a potential hardware component for pressure measurement.
Based on the provided information, the Macosta Medical B-Smart Nerve Block Injection Pressure Manometer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The description states the device is for "measuring injection pressure during administration of peripheral nerve blocks." This is a measurement taken during a medical procedure performed on the patient's body, not on a sample taken from the body.
Therefore, the device's function falls outside the scope of in vitro diagnostics. It is a medical device used in a clinical setting for a procedure performed directly on a patient.
N/A
Intended Use / Indications for Use
The Macosta Medical B-Smart Nerve Block Injection Pressure Manometer is a device for measuring injection pressure during administration of peripheral nerve blocks.
Product codes
73 CAZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three figures representing health and well-being. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is black and white.
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
1
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
2
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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