(143 days)
The Pressure Manometer is used to provide visual indication of patient's airway pressure during ventilation. It may be attached by flexible tubing to devices providing expiratory pressure such as resuscitation bags, hyperinflation bags, CPAP Masks or Circuits.
The NF-009 Pressure Manometer is a low pressure gauge with a range of -20 to 80 cmH2O in marked increments of 1 cm H2O. The gauge has color coding green, yellow and red. The Manometer provides visual indication of airway pressure during ventilation or resuscitation.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the NF-009 Pressure Manometer:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on Predicate Devices) | Reported Device Performance (NF-009) | Meets Criteria? |
|---|---|---|
| Accuracy: +/- 3 cmH2O for measurements < 15 cmH2O | Within 1 cmH2O of Reference and Digital Gauge | Yes |
| Accuracy: +/- 5 cmH2O for measurements > 15 cmH2O | Within 1 cmH2O of Reference and Digital Gauge | Yes |
| Equivalence to test devices | Performs equivalently to test devices | Yes |
| Operates within the accuracy information specified for predicate devices (overall range) | Within 1 cmH2O of Reference and Digital Gauge (implying it meets/exceeds predicate) | Yes |
Note: The acceptance criteria are indirectly stated by referring to the accuracy of the predicate devices. The NF-009 significantly exceeds these criteria with a reported accuracy of within 1 cmH2O across its operational range.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "the comparison table" and implies testing across the operational range, but no specific number of measurements or devices tested is provided.
- Data Provenance: Not specified. It's an internal company test ("Performance Data"), but details on whether it's retrospective or prospective, or country of origin, are absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Experts Used: Not applicable. The ground truth was established by a "Reference Gauge" and a "Digital Gauge," which are instruments, not human experts.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was based on instrument readings, not expert human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
-
MRMC Study: No. This device is a manometer, a direct measurement tool. Its performance is assessed against reference instruments, not human interpretation in a multi-reader, multi-case study.
-
Effect Size of Human Readers Improvement: Not applicable.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: Yes, in essence. The "Performance Data" section describes the NF-009's accuracy when measured against other gauges. This is a standalone performance assessment of the device, independent of human interaction beyond operating the device and reading the values. It's not an algorithm, but a mechanical device.
7. The Type of Ground Truth Used
- Ground Truth Type: Instrumental/Reference Standard. The accuracy was determined by comparing the NF-009's readings to those of a "Reference Gauge" and a "Digital Gauge."
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device is a mechanical manometer, not a machine learning algorithm, therefore there is no training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no training set.
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JUN 1 0 2011
Attachment B 510(k) Summary of Safety and Effectiveness
Applicant:
NeoForce Group Inc 35 Commerce Drive Ivyland, Pa 18974 Registration Number: 3005599562
Contact Person:
Monica Ferrante VP Regulatory Ph 215-672-6800 Fax 215-672-1123
Device trade/proprietary name:
NF-009 Pressure Manometer
Device common/usual/classification name;
Airway Pressure Monitor
Classification:
Anesthesiology 21 CFR 868.2600 Airway Pressure Monitor, CAP, Class II
Performance Standards:
None applicable
Predicate Device:
Pre-Amendment Pressure Manometer Anesthesia Associates Inc. K954486 Mercury Medical Disposable Color Coded Manometer K040991 Ambu Inc. Disposable Pressure Manometer K072021 NeoPIP Infant Resuscitation Device K092085 Ispira Resuscitation System K102649 NeoPIP Infant Resuscitator with Flow meter
Device Description
The NF-009 Pressure Manometer is a low pressure gauge with a range of -20 to 80 cmH2O in marked increments of 1 cm H2O. The gauge has color coding green, yellow and red. The Manometer provides visual indication of airway pressure during ventilation or resuscitation.
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Intended Use
The Pressure Manometer is used to provide visual indication of patient's airway pressure during ventilation. It may be attached by flexible tubing to devices providing expiratory pressure such as resuscitation bags, hyperinflation bags, CPAP Masks or Circuits.
Performance Data
The NF-009 Pressure Manometer performs equivalently to the test devices and is within the accuracy information specified for the predicate devices over the operational range. The accuracy for the predicate devices is shown in the comparison table with the worst case values +/-3 cm H2O for measurements less than 15 cm H2O and +/- 5 cm H2O greater than 15 cm H2O. The NF-009 is within 1 cm H2O of the Reference Gauge and the Digital Gauge.
The Performance Data demonstrate equivalence to the predicated devices.
Substantial Eguivalence
The NF-909 Pressure Manometer is believed to be substantially equivalent to currently marketed pressure manometer devices with regards to intended use, safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird-like shape, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 0 2011
Ms. Monica Ferrante VP Regulatory NeoForce Group, Incorporated 35 Commerce Drive Ivyland, Pennsylvania 18974
Re: K110119
Trade/Device Name: Pressure Manometer Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: May 23, 2011 Received: May 23, 2011
Dear Ms. Ferrante:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Ferrante
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
for
Anthony D. Watson, B.S., M.S., M.B.A. 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
Indication for Use Statement
510(k) Number:
Device Name: Pressure Manometer
Indications for Use:
The Pressure Manometer is used to provide visual indication of patient's airway pressure during ventilation. It may be attached by flexible tubing to devices providing expiratory pressure such as resuscitation bags, hyperinflation bags, CPAP Masks or Circuits.
(Please do not write below this line continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
X OR
(Division Sign Off)
Over-the-Counter Use
(Optional Format 1/2/96)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110119
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).