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.

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.

AI/ML Overview

The K022402 submission is for a Disposable Manometer, not an AI/ML device, so many of the requested categories (e.g., training set, number of experts, MRMC study) are not applicable. I will provide the information that is relevant to this traditional medical device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predicate Device K003497)	Reported Device Performance (VSI Disposable Manometer)
+/- 1 cm H2O / 0-10 cm H2O	+/- 1 cm H2O / 0-10 cm H2O
+/- 2 cm H2O / 10-40 cm H2O	+/- 2 cm H2O / 10-40 cm H2O
+/- 3 cm H2O / > 40 cm H2O	+/- 3 cm H2O / > 40 cm H2O
Range of Pressures Measured: 0-60 cm H2O	Range of Pressures Measured: 0-60 cm H2O
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.	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.
Intended for Single Patient, Multi-Use: Yes	Intended for Single Patient, Multi-Use: Yes
Prescription: Yes	Prescription: Yes
Intended Population: Any patient requiring airway pressure measurement.	Intended Population: Any patient requiring airway pressure measurement.
Intended Environment of Use: Home, Hospital, Physician Office, Sub-Acute Institutions, Emergency Services, anywhere airway pressure is measured.	Intended Environment of Use: Home, Hospital, Physician Office, Sub-Acute Institutions, Emergency Services, anywhere airway pressure is measured.
Materials (Polycarbonate, PC): Polycarbonate for manometer body and float.	Materials (Polycarbonate, PC): Polycarbonate to be used for manometer body and float.
Contains Latex: No	Contains Latex: No

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for performance testing or the exact data provenance (e.g., country of origin, retrospective/prospective). Instead, the submission relies on direct comparison of the proposed device's specifications and performance to a legally marketed predicate device (Engineered Medical System, Inc. - Pressure Manometer - K003497). The "Performance Accuracy" values listed in the table are the specified performance of the device, implying that testing was conducted to demonstrate conformance to these specifications to establish substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is a hardware medical device; its performance is based on physical accuracy measurements rather than expert-established ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is a hardware medical device where performance is measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI devices where human reader performance is being evaluated, often with and without AI assistance. This device is a measurement tool.

6. If a Standalone Study Was Done

Yes, implicitly a "standalone" performance evaluation was done in the sense that the VSI Disposable Manometer was tested to confirm it met the specified accuracy criteria. The submission states the device's performance accuracy:

+/- 1 cm H2O / 0-10 cm H2O
+/- 2 cm H2O / 10-40 cm H2O
+/- 3 cm H2O / > 40 cm H2O

These values are identical to the predicate device, indicating that the device's performance was measured and found to meet these specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is objective physical measurement of pressure accuracy against a calibrated standard.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device and does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device and does not have a "training set."

Summary

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K02240 2

Non-Confidential 510(k) Summary of Safety and Effectiveness

July 19, 2002

	July 17, 2012
Vital Signs, Inc.20 Campus RoadTotowa, NJ 07512	Telephone: (973) 790-1330Fax: (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:

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.

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Section 2 Page 2

Comparison to Predicate Device:

Attribute	Proposed Device	Engineered MedicalSystem, Inc. K003497
Intended Use	To provide visualindication of a patient'sairway pressure duringventilation. It may beattached to themanometer port orproximal port onventilation devices suchas resuscitation bags,hyperinflation bags,CPAP Mask, or CPAPCircuits.	Same
Intended for SinglePatient, Multi-Use	Yes	Yes
Prescription	Yes. Labeling willcarry: Caution U.S.Federal Law restrictsthis device to sale byor on the order of aphysician.	Yes
Intended Population	Any patient requiringairway pressuremeasurement.	Same
IntendedEnvironment of Use	Home, Hospital,Physician Office, Sub-Acute Institutions,Emergency Services,anywhere airwaypressure is measured.	Same
Design Features
Range of PressuresMeasured	0-60 cm H2O	0-60 cm H2O
Can be used ondifferent ventilationdevices	It may be attached tothe manometer port orproximal port onventilation devices suchas resuscitation bags,hyperinflation bags,CPAP Mask, or CPAPCircuits.	Same
MaterialsPolycarbonate, PC	Polycarbonate to beused for manometerbody and float.	Same
Contains Latex	No	No
PerformanceAccuracy cm H2Oover the range	VSI	Engineered MedicalSystem, 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

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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.

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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.

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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

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Section 4 Page 1

INDICATION FOR USE STATEMENT

510(k) Number: K022402

Device Name: Disposable Pressure Manometer

Indications for Use:

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_

Regulation Number and Section

§ 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).