The Easy Cuff™ is simple in-line pressures monitor which contains a calibrated diaphragm which distends with increases in cuff pressure. It is also capable of inflating or deflating the cuff.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Easy Cuff™ device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated)	Reported Device Performance (Easy Cuff™)
Accuracy	+/- 5% up to 30 cmH₂O
	+/- 0.5 cm H₂O @ 10 cm H₂O
	+/- 1 cm H₂O @ 20 cm H₂O
	+/- 1.5 cm H₂O @ 30 cm H₂O
Operating Temperature	Accuracy across different temperatures
Drop Test	Accuracy after drop test
Repeatability	Inter-sample and Intra-sample testing for repeatability across the pressure range

Note: The document primarily outlines performance testing conducted rather than explicitly labeling each item as a "stated acceptance criteria" with a corresponding pass/fail value. The reported performance listed is extracted directly from the "Accuracy" and "Performance Testing" rows for the Easy Cuff™ in the comparison table with predicate devices.

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

The document does not specify the sample size used for the test set (number of devices tested) for the accuracy, temperature, or drop tests.

It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing appears to be bench testing, which typically does not involve patient data provenance in the same way clinical studies do.

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

This information is not provided in the document. The performance testing described (accuracy, temperature, drop test) is bench testing, which usually relies on calibrated instruments and defined standards to establish ground truth, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where multiple human readers assess cases and discrepancies need resolution. Since the described testing is bench testing for device accuracy and durability, an adjudication method is not applicable and therefore not mentioned.

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

No, an MRMC comparative effectiveness study was not done. The document describes bench testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device described, the Easy Cuff™, is a physical pressure monitor. It does not involve an algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable. The performance testing described is for the standalone physical device.

7. The Type of Ground Truth Used

The ground truth for the performance testing (accuracy, temperature, drop test) would be established using calibrated reference standards and instruments. For example, a calibrated pressure sensor would be used to provide the "true" pressure against which the Easy Cuff's readings are compared.

8. The Sample Size for the Training Set

Not applicable. The Easy Cuff™ is a mechanical pressure monitoring device, not an AI or algorithm-based system that requires a "training set" of data.

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

Not applicable. As the device is not AI/algorithm-based, there is no training set and therefore no ground truth establishment for a training set.

Summary

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510(k) Summary
Page 1 of 3 7-Feb-11

K102704 MAR 1 0 2011

Joan E. Spiegel, M.D.10 Coleman Ct.Natick, MA 01760	Tel - 617-935-3500
Official Contact:	Joan Spiegel, M.D.
Proprietary or Trade Name:	Easy Cuff™
Common/Usual Name:	Cuff, tracheal tube, inflatable (accessory)
Classification Name:	Cuff, tracheal tube, inflatable (accessory)BSK - 868.5730
Predicate Devices:	Posey Cufflator - K912723SunMed CuffAlert™ - K081805
Device Description:	The Easy Cuff™ is simple in-line pressures monitor whichcontains a calibrated diaphragm which distends with increases incuff pressure. It is also capable of inflating or deflating the cuff.
Indications for Use:	To measure and monitor intra-cuff pressures of endotracheal,supraglottic airways, or tracheostomy tubes.
Patient Population:	Patients who are intubated.
Environment of Use:	To be used under medical supervision in hospitals, pre-hospital(EMS), extended care facilities and outpatient clinics, where apatient may be intubated.
Contraindications:	None

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510(k) Summary

Attribute	ProposedEasy Cuff™™	PoseyCufflator™ - K912723	SunMedCuffAlert - K081805
Indications for Use	To inflate cuffs and to measure andmonitor intra-cuff pressures ofendotracheal, supraglottic airways, ortracheostomy tubes.	To inflate, measure and monitorcuff pressure	To measure and monitor intra-cuffpressures of endotracheal,supraglottic airways, ortracheostomy tubes.
Environments of use	To be used under medical supervisionin hospitals, pre-hospital (EMS),extended care facilities and outpatientclinics, where a patient may beintubated.	Not specified but the same	To be used under medicalsupervision in hospitals, pre-hospital(EMS), extended care facilities andoutpatient clinics, where a patientmay be intubated.
Patient population	Intubated patients	Intubated patients	Intubated patients
Single patient, disposable	Yes	No	Yes
Range of measured pressure	0 to 30 cm H₂O	0 to 120 cm H₂O	10 to 40 cm H₂O
Detection of "good range"	Color coded scale	Color coded scale	LED does not activate
Power	Manual	Manual	Battery operated
Accuracy	+/- 5% up to 30 cmH2O+/- 0.5 cm H2O @ 10 cm H2O+/- 1 cm H2O @ 20 cm H2O+/- 1.5 cm H2O @ 30 cm H2O	Not specified	+/- 2 cmH2O @ 10 cmH2O+/- 3 cmH2O @ 20-30 cmH2O+/- 4 cmH2O @ 40 cmH2O
Performance Testing	Inter-sample and Intra-sample testingfor accuracy and repeatability acrossthe pressure rangeTested for accuracy at differenttemperatures and after drop test	Not specified	Accuracy across the pressure rangeTested for accuracy at differenttemperaturesDrop test

Differences Between DC and AC

Direction of Current:
- DC: Current flows in one direction only.
- AC: Current changes direction periodically.
Frequency:
- DC: Frequency is zero.
- AC: Frequency is typically 50 Hz or 60 Hz.
Voltage:
- DC: Voltage is constant.
- AC: Voltage varies sinusoidally.
Applications:
- DC: Used in batteries, electronic devices, and some motors.
- AC: Used in household appliances, power transmission, and most industrial equipment.
Generation:
- DC: Generated by batteries, solar cells, and DC generators.
- AC: Generated by AC generators (alternators).
Transmission:
- DC: Not suitable for long-distance transmission due to high losses.
- AC: Can be transmitted over long distances with minimal losses using transformers.
Storage:
- DC: Can be stored in batteries.
- AC: Cannot be stored directly; it must be converted to DC first.
Waveform:
- DC: Straight line.
- AC: Sine wave.
Reactance:
- DC: No reactance (only resistance).
- AC: Has both resistance and reactance (inductive and capacitive).
Examples:
- DC: Batteries, solar panels, USB power.
- AC: Wall outlets, power grids, generators.

Differences Between Other Legally Marketed Predicate Devices:
There are no significant differences that affect the safety or effectiveness of the intended device as compared

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510(k) Summary Page 3 of 3 7-Feb-11

The Easy Cuff™ is viewed as substantially equivalent to the predicate devices because:

Indications -

The Easy Cuff™ is intended to allow one to inflate the cuff, measure and monitor the pressure in the cuff. This is identical to the predicates -

Posey Cufflator - K912723 - inflates, measures and monitors pressure

SunMed CuffAlert – K081805 – measures and monitors cuff pressure only it does not have an active component to inflate the cuff

Technology -

The Easy Cuff™ uses a diaphragm / bellows which moves in relationship to the measured pressure. This nearly identical to the predicate SunMed which uses a diaphragm to measure pressure and the deflection of the diaphragm will activate the LED sensor - SunMed CuffAlert -K081805.

Materials -

There are no materials in the gas and fluid pathway.

Environment of Use -

The environment of use is wherever one would want to measure cuff pressure, which is identical to predicate - Posey Cufflator - K912723 and SunMed CuffAlert - K081805

Patient Population -

Population is defined not by age but by those that have an airway which has a cuff which needs to be inflated / deflated, and the pressure measured and monitored.

This is identical to predicate - Posey Cufflator - K912723 and SunMed CuffAlert - K081805

Performance Testing -

We performed equivalent bench testing, including accuracy, high and low temperature and drop testing and the Easy Cuff™ performed as intended and its accuracy is substantially equivalent to the SunMed Cuff Alert (K081805).

These tests were equivalent to the testing required of the predicates.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 10903 New Hampshire Avenne Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Joan Spiegel, MD C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodstage Drive Bonita Springs, Florida 34134

Re: K102704

MAR 1 0 250

Trade/Device Name: Easy Cuff™ Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BSK Dated: February 7, 2011 Received: February 8, 2011

Dear Mr. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equival mative 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- Mr. Dryden

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/ ucm 1 1 5809 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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 Statement

Page 1 of 1

510(k) Number:

K102704 (To be assigned)

Easy Cuff™ Device Name:

Indications for Use:

To inflate cuffs and to measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.

Patient population:

Patient who are intubated

Environment of use:

To be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated.

Prescription Use XX (Part 21 CFR 801 Subpart D) 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)

(Division Sign-Off) (Division Sigil-Only Division Control, Dental Devices

510(k) Number:

Regulation Number and Section

§ 868.5750 Inflatable tracheal tube cuff.

(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).