(30 days)
Not Found
No
The device description and intended use clearly describe a purely mechanical device for visual pressure indication, with no mention of computational processing, algorithms, or learning capabilities.
No
The device measures airway pressure for ventilation, it does not directly treat or prevent a medical condition.
No
The device provides visual indication of airway pressure during ventilation, which is a measurement used for monitoring, not for diagnosing a disease or condition.
No
The device description explicitly details physical components like a flexible nipple, polycarbonate housing, float, and stainless steel spring, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide visual indication of a patient's airway pressure during ventilation." This is a measurement of a physiological parameter (pressure within the airway) directly on the patient, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device components (nipple, housing, float, spring) are designed for mechanical pressure measurement and display, not for analyzing biological samples.
- 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 measures a physical parameter directly related to the patient's respiratory system.
N/A
Intended Use / Indications for Use
To provide visual indication of a patient's airway pressure during Ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
The Disposable Pressure Manometer will be used to provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
Product codes (comma separated list FDA assigned to the subject device)
CAP
Device Description
The VSI disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: A flexible nipple for attachment to a sampling/pressure port, Clear polycarbonate (PC) housing with a printed pressure scale, PC float with indication and a double ended stainless steel spring.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Any patient requiring airway pressure measurement.
Intended User / Care Setting
Home, Physician Office, Outdoor Environments, Hospital, Sub-acute Institutions, Emergency Services, anywhere airway pressure is measured.
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)
Not Found
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.
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
§ 868.2600 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).
0
K02240 2
Non-Confidential 510(k) Summary of Safety and Effectiveness
July 19, 2002
| July 17, 2012 | |
|---|---|
| Vital Signs, Inc. | |
| 20 Campus Road | |
| Totowa, NJ 07512 | Telephone: (973) 790-1330 |
| Fax: (973) 790-7587 | |
| Official Contact: | David L. Najjar - Manager of Quality |
| Proprietary or Trade Name: | Disposable Manometer |
| Common/Usual Name: | Pressure Manometer |
| Classification Name: | Airway Pressure Monitor (Per CFR 868.2600) |
| Device: | Disposable Manometer |
| Predicate Device: | Engineered Medical System, Inc. - Pressure Manometer - |
| K003497 |
Device Description:
The VSI disposable pressure manometer is a means of providing visual indication of patient airway pressure during ventilation. The device consists of: A flexible nipple for attachment to a sampling/pressure port, Clear polycarbonate (PC) housing with a printed pressure scale, PC float with indication and a double ended stainless steel spring.
Intended Use:
Indicated Use:
To provide visual indication of a patient's airway pressure during Ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
Environment of Use:
Home, Physician Office, Outdoor Environments, Hospital, Sub-acute Institutions, Emergency Services, anywhere airway pressure is measured.
1
Section 2 Page 2
Comparison to Predicate Device:
| Attribute | Proposed Device | Engineered Medical
System, Inc. K003497 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use | To provide visual
indication of a patient's
airway pressure during
ventilation. It may be
attached to the
manometer port or
proximal port on
ventilation devices such
as resuscitation bags,
hyperinflation bags,
CPAP Mask, or CPAP
Circuits. | Same |
| Intended for Single
Patient, Multi-Use | Yes | Yes |
| Prescription | Yes. Labeling will
carry: Caution U.S.
Federal Law restricts
this device to sale by
or on the order of a
physician. | Yes |
| Intended Population | Any patient requiring
airway pressure
measurement. | Same |
| Intended
Environment of Use | Home, Hospital,
Physician Office, Sub-
Acute Institutions,
Emergency Services,
anywhere airway
pressure is measured. | Same |
| Design Features | | |
| Range of Pressures
Measured | 0-60 cm H2O | 0-60 cm H2O |
| Can be used on
different ventilation
devices | It may be attached to
the manometer port or
proximal port on
ventilation devices such
as resuscitation bags,
hyperinflation bags,
CPAP Mask, or CPAP
Circuits. | Same |
| Materials
Polycarbonate, PC | Polycarbonate to be
used for manometer
body and float. | Same |
| Contains Latex | No | No |
| Performance
Accuracy cm H2O
over the range | VSI | Engineered Medical
System, Inc. |
| | +/- 1 cm H2O / 0-10 | +/- 1 cm H2O / 0-10 |
| | +/- 2 cm H2O / 10-40
+/- 3 cm H2O / > 40 | +/- 2 cm H2O / 10-40
+/- 3 cm H2O / > 40 |
2
Section 2 page 3
Device Equivalency:
The VSI Disposable Pressure Manometer is viewed as substantially equivalent to the Engineered Medical System, Inc., DPM™, which has been cleared to market under 510(k) K003497.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2002
Mr. David L. Najjar Manager of Quality Vital Signs, Incorporated 20 Campus Road Totowa, New Jersey 07512
Re: K022402
Trade/Device Name: Disposable Pressure Manometer Regulation Number: 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: II Product Code: CAP Dated: July 19, 2002 Received: July 23, 2002
Dear Mr. Najjar:
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.
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.
4
Page 2 - Mr. Najjar
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 (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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
Latuca Cicecite/for.
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4 Page 1
INDICATION FOR USE STATEMENT
510(k) Number: K022402
Device Name: Disposable Pressure Manometer
Indications for Use:
The Disposable Pressure Manometer will be used to provide visual indication of a patient's airway pressure during ventilation. It may be attached to the manometer port or proximal port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP Mask or CPAP Circuits.
Concurrence of CDRH, Office of Device Evaluation (ODE)
or Over-the-counter use ________________ Prescription Use V (Per CFR 801.109)
foAuluthesn
Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices KOZZOB 510(k) Number_