(165 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical measurement and adherence to standards, with no mention of AI or ML.
No
The device is a manometer used to measure inspiratory force, not to provide therapy.
Yes
Explanation: The device measures negative inspiratory force, which is a physiological parameter used to assess respiratory muscle strength and readiness for weaning from mechanical ventilation. This measurement provides diagnostic information about a patient's respiratory status.
No
The device description clearly describes a physical, disposable manometer designed to connect to an endotracheal tube and includes mechanical components like an occlusion knob and a memory pointer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "indicate inspiratory force." This is a measurement of a physiological parameter (respiratory muscle strength) within the body, not an analysis of a sample taken from the body (like blood, urine, tissue, etc.).
- Device Description: The device connects to an endotracheal tube and measures pressure during inhalation. This is a direct measurement of a physical force related to respiration.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer is used to indicate inspiratory force. Federal law (USA) restricts this device to sale by or on the order of a physician.
The Mercury Medical Negative Inspiratory Force (NIF) Disposable Manometer is used to indicate inspiratory force.
Product codes (comma separated list FDA assigned to the subject device)
73 BXR
Device Description
The Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer is designed to connect to an endotracheal tube. To record the maximum inspiratory pressure, the occlusion knob is held down during patient inhalation. The knob is released immediately after measurement. A memory pointer identifies and remains at the maximum inspiratory pressure to -60cm H2O. Rotating the memory pointer knob counterclockwise resets the memory pointer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital/Transport
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Data: Performance and specifications of the device are consistent with all requirements for this device type specified by ISO 5356-1: 1987 - Anesthetic and Respiratory Equipment-Conical connectors-Part 1: Cones and Sockets. ASTM F1054 - Standard Specification for Conical Fittings of 15mm and 22mm sizes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
DHD Medical Products Negative Inspiratory Force Monitoring Kit
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1780 Inspiratory airway pressure meter.
(a)
Identification. An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.(b)
Classification. Class II (performance standards).
0
ENCLOSURE L FEB - 3 2004
Premarket Notification (510(k) - Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer
Summary of Safety and Effectiveness
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 January 29, 2004
Mercury Enterprises, Inc./Mercury Medical 11300 49th St. N. Clearwater, Fl. 33762 Tel: (800) 237-6418 Fax: (727) 572-4501
Official Contact: Karen Seltzer QA/RA Manager
Proprietary or Trade Name: Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer
Common/Usual Name: NIF Manometer
Classification: Class II, BXR, 21 CFR 868.1780
Classification Name: Airway Pressure Meter (Inspiratory Force)
Device: Negative Inspiratory Force (NIF) Disposable Manometer
Predicate Devices: DHD Medical Products Negative Inspiratory Force Monitoring Kit
Device Description:
The Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer is designed to connect to an endotracheal tube. To record the maximum inspiratory pressure, the occlusion knob is held down during patient inhalation. The knob is released immediately after measurement. A memory pointer identifies and remains at the maximum inspiratory pressure to -60cm H2O. Rotating the memory pointer knob counterclockwise resets the memory pointer.
1
ENCLOSURE L
Premarket Notification (510(k) - Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer
Non-Confidential Summary of Safety and Effectiveness
Page 2 of 2 January 29, 2004
Indicated Use:
The Mercury Medical® Negative Inspiratory Force (NIF) Disposable Manometer is used to indicate inspiratory force. Federal law (USA) restricts this device to sale by or on the order of a physician.
Technical Characteristics: The device has the same technical characteristics for measuring negative pressure as the DHD Medical Products NIF Monitoring kit predicate device.
Non-Clinical Data: Performance and specifications of the device are consistent with all requirements for this device type specified by ISO 5356-1: 1987 - Anesthetic and Respiratory Equipment-Conical connectors-Part 1: Cones and Sockets. ASTM F1054 - Standard Specification for Conical Fittings of 15mm and 22mm sizes.
Environment of Use: Hospital/Transport
Conclusions: The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of three abstract shapes resembling waves or stylized human figures, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 3 2004
Mr. Wayne Glover QA/RA Engineer Mercury Medical Inc. 11300 49th St. N. Clearwater, FL 33762
Re: K032593
Trade/Device Name: Mercury Medical Negative Inspiratory Force (NIF) Disposable Manometer Regulation Number: 21 CFR 868.1780 Regulation Name: Meter, Airway Pressure (Inspiratory Force) Regulatory Class: Class II Product Code: 73 BXR Dated: December 18, 2003 Received: December 19, 2003
Dear Mr. Glover:
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 cnactment 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.
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
3
Page 2 - Mr. Wayne Glover
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.
Chris Lins, Ph.D.
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
4
Indication for Use
| 510(k) Number (if known): | K032593 |
|---|---|
| Device Name: | Negative Inspiratory Force (NIF) Disposable Nanometer |
| Intended Use: | The Mercury Medical Negative Inspiratory Force (NIF) Disposable Manometer is used to indicate inspiratory force. |
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L.A. Winterhausen
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
2 510(k) Number:
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