CUFFALERT

K081805 · Sunmed · BSK · Nov 14, 2008 · Anesthesiology

Device Facts

• Record ID: K081805
• Device Name: CUFFALERT
• Applicant: Sunmed
• Product Code: BSK · Anesthesiology
• Decision Date: Nov 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5750
• Device Class: Class 2

Intended Use

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

Device Story

CuffAlert™ is an in-line pressure monitor for endotracheal, supraglottic, or tracheostomy tube cuffs. Device features a calibrated diaphragm that distends when cuff pressure exceeds a user-defined limit (10-40 cm H2O). When the limit is exceeded, the diaphragm contacts a battery-powered circuit, activating a red LED visual alarm. Used in hospitals, pre-hospital (EMS), extended care, and outpatient clinics under medical supervision. Provides real-time visual feedback to clinicians to assist in maintaining appropriate cuff pressure, potentially reducing risks associated with over-inflation or under-inflation of airway cuffs.

Clinical Evidence

Bench testing only. Accuracy of pressure measurement was validated at +/- 2 cm H2O at 10 cm H2O, +/- 3 cm H2O at 20-30 cm H2O, and +/- 4 cm H2O at 40 cm H2O.

Technological Characteristics

In-line pressure monitor with calibrated diaphragm. Battery-operated LED alarm system. Pressure range: 10 to 40 cm H2O. Single-patient, disposable design.

Indications for Use

Indicated for intubated patients requiring monitoring of intra-cuff pressures for endotracheal, supraglottic, or tracheostomy tubes. No contraindications.

Regulatory Classification

Identification

An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

Predicate Devices

• Posey Cufflator (K912723)
• Rusch Endotest (K951046)

Submission Summary (Full Text)

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KOHISO5

NOV 14 2008

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 6-Nov-08

| SunMed<br>12393 Belcher Rd. # 450<br>Largo, FL 33773 | Tel - [phone] |
|------------------------------------------------------|---------------------------------------------------------------|
| 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)<br>BSK - 868.5730 |
| Predicate Devices: | Posey Cufflator - K912723<br>Rusch 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,<br>supraglottic airways, or tracheostomy tubes.<br>The CuffAlert™ is not intended to replacement clinical<br>judgment |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Patients who are intubated. |
| Environment of Use: | To be used under medical supervision in hospitals, pre-hospital<br>(EMS), extended care facilities and outpatient clinics, where a<br>patient may be intubated. |
| Contraindications: | None |

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| Non-Confidential Summary of Safety and Effectiveness | Page 2 of 2 | 6 Nov 08 |
|------------------------------------------------------|-------------|----------|
|------------------------------------------------------|-------------|----------|

| | 6-Nov-08 | | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|------------------------------|
| Attribute | Proposed CuffAlert™ | Posey Cufflator™<br>K912723 | Rusch<br>Endotest<br>K951046 |
| 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<br>+/- 3 cm H₂O @ 20 – 30 cm H₂O<br>+/- 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 [phone]. 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 [phone] or [phone] 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.

| <b>Prescription Use</b> | <u>XX</u> |
|-----------------------------|-----------|
| (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 of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K081805