To measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
The CuffAlert™ is not intended to replacement clinical judgment.

Device Description

The CuffAlert™ is a simple in-line pressure monitor which contains a calibrated diaphragm which distends with increases in cuff pressure.
One can set the maximum pressure limit from 10 to 40 cm H2O by rotating and locking a knob. Once set, it is placed on the pilot ballowing it to be in-line with the cuff. If the cuff exceeds the set pressure limit on the CuffAlert™ the diaphragm distends making contact with the battery, thus activating the red LED.
The accuracy of pressure measurement has been determined to be +/- 2 cm H2O @ 10 cm H2O; +/- 3 cm H2O @ 20 - 30 cm H2O; and +/- 4 cm H2O @ 40 cm H2O.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the CuffAlert™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Required Performance)	Reported Device Performance (CuffAlert™)
+/- 2 cm H₂O @ 10 cm H₂O	+/- 2 cm H₂O @ 10 cm H₂O
+/- 3 cm H₂O @ 20 - 30 cm H₂O	+/- 3 cm H₂O @ 20 - 30 cm H₂O
+/- 4 cm H₂O @ 40 cm H₂O	+/- 4 cm H₂O @ 40 cm H₂O

Note: The document describes the "accuracy of pressure measurement has been determined to be" these values. This language implies these are both the acceptance criteria and the (successful) reported performance.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study). It only states that the accuracy "has been determined."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information regarding the number of experts, their qualifications, or their involvement in establishing ground truth for any testing of the device.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a physical pressure monitor, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

The device is a physical pressure monitor and does not utilize an algorithm in the way a diagnostic AI would. Therefore, a "standalone (algorithm only)" performance study, as typically understood for AI, is not applicable and not mentioned. The stated accuracy is for the device's inherent mechanical function.

7. Type of Ground Truth Used

The ground truth for the accuracy assessment of a pressure monitor would typically be established by comparison against a calibrated reference standard pressure measurement device. While the document doesn't explicitly state "calibrated reference standard," in the context of pressure measurement accuracy, this is the implied method for "determining" the accuracy.

8. Sample Size for the Training Set

The document does not specify a training set sample size. This type of device (a mechanical pressure monitor) would not typically involve a "training set" in the context of machine learning or AI. Its performance is based on its design and physical calibration.

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

As there is no mention of a "training set" in the context of AI/ML, this information is not applicable to the CuffAlert™ device. Its ground truth (accuracy) would be established through physical calibration against known pressure standards.

Summary

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KOHISO5

NOV 14 2008

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 6-Nov-08

SunMed12393 Belcher Rd. # 450Largo, FL 33773	Tel - (727) 530-7099
Official Contact:	George Cranton, Director
Proprietary or Trade Name:	CuffAlert™
Common/Usual Name:	Cuff, tracheal tube, inflatable (accessory)
Classification Name:	Cuff, tracheal tube, inflatable (accessory)BSK - 868.5730
Predicate Devices:	Posey Cufflator - K912723Rusch Endotest - K951046

Device Description:

The CuffAlert™ is a simple in-line pressure monitor which contains a calibrated diaphragm which distends with increases in cuff pressure.

One can set the maximum pressure limit from 10 to 40 cm H2O by rotating and locking a knob. Once set, it is placed on the pilot ballowing it to be in-line with the cuff. If the cuff exceeds the set pressure limit on the CuffAlert™ the diaphragm distends making contact with the battery, thus activating the red LED.

The accuracy of pressure measurement has been determined to be +/- 2 cm H2O @ 10 cm H2O; +/- 3 cm H2O @ 20 - 30 cm H2O; and +/- 4 cm H2O @ 40 cm H2O.

Indications for Use:	To measure and monitor intra-cuff pressures of endotracheal,supraglottic airways, or tracheostomy tubes.The CuffAlert™ is not intended to replacement clinicaljudgment
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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Non-Confidential Summary of Safety and Effectiveness	Page 2 of 2	6 Nov 08
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	6-Nov-08
Attribute	Proposed CuffAlert™	Posey Cufflator™K912723	RuschEndotestK951046
Indications for Use	To measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.	Monitor cuff pressure	Monitor cuff pressure
Environments 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.	Not specified	Not specified
Patient population	Intubated patients	Intubated patients	Intubated patients
Single patient, disposable	Yes	No	No
Range of measured pressure	10 to 40 cm H₂O	0 to 120 cm H₂O	N/A
Detection of “good range”	LED does not activate	Color coded scale	Color coded scale
Power	Battery operated	Manual	Manual
Accuracy	+/- 2 cm H₂O @ 10 cm H₂O+/- 3 cm H₂O @ 20 – 30 cm H₂O+/- 4 cm H₂O @ 40 cm H₂O	Not specified	Not specified

Differences Between Other Legally Marketel Predicate Devices:
There are no significant differences that affect the safety or effectiveness of the intended devices of the pred

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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2008

SunMed C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

Rc: K081805

Trade/Device Name: CuffAlert™ Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BSK Dated: November 6, 2008 Received: November 7, 2008

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 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 Eederal 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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clare

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

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Indications for Use Statement

Page 1 of 1

510(k) Number: K081805 (To be assigned)

CuffAlert™ Device Name:

Indications for Use:

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

The CuffAlert™ is not intended to replacement clinical judgment.

Pationts who are intubated.

Environment of Use:

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

Prescription Use	XX
(Part 21 CFR 801 Subpart D)

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)

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081805

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).