AG GUFFILL

K122721 · Hospitech Respiration , Ltd. · BSK · May 3, 2013 · Anesthesiology

Device Facts

• Record ID: K122721
• Device Name: AG GUFFILL
• Applicant: Hospitech Respiration , Ltd.
• Product Code: BSK · Anesthesiology
• Decision Date: May 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5750
• Device Class: Class 2

Indications for Use

The Hospitech AG Cuffill is intended to measure and regulate the intra-cuff pressure of endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs). The Hospitech AG Cuffill is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated.

Device Story

AG Cuffill is a disposable, battery-powered, handheld device for measuring and manually regulating intra-cuff pressure of endotracheal, tracheotomy, and LMA tubes. Configured as a syringe with an embedded pressure gauge, it is operated by clinicians in hospitals, EMS, and clinics. The device provides direct pressure readings to the user, enabling manual adjustment of cuff inflation to maintain appropriate pressure levels. This helps ensure proper airway sealing and reduces risks associated with over- or under-inflation of the cuff. The device is limited to 100 operations and is intended for single-patient use.

Clinical Evidence

Bench testing only. Performance testing included design verification, accuracy verification (accuracy within ±1 mmHg throughout device lifetime), and comparative testing against the Posey Cufflator. No clinical data presented.

Technological Characteristics

Handheld, battery-powered syringe-based pressure gauge. Disposable, single-patient use, limited to 100 operations. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for measuring and regulating intra-cuff pressure of endotracheal tubes, tracheotomy tubes, and laryngeal mask airways (LMAs) in intubated patients across hospital, pre-hospital (EMS), extended care, and outpatient clinical settings under medical supervision.

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)
• CuffAlert (K081805)
• Easy Cuff (K102704)
• PYTON (K092733)

Submission Summary (Full Text)

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# 510(K) SUMMARY

3 2013 MAY

# Hospitech AG Cuffill 510(k) Number K 122721

| Applicant's Name: | Hospitech Respiration Ltd<br>20 Hamagshimim Street<br>Kiryat Matalon,<br>Petach-Tikva, 49250<br>Israel.<br>TEL: [phone],<br>FAX: [phone] |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite<br>31 Haavoda St.<br>Binyamina, Israel 30500<br>Tel [phone]<br>Fax [phone]<br>[e-mail] |
| Trade Name: | <i>AG Cuffill</i> TM |
| Common Name: | Endotracheal cuff pressure regulator |
| Preparation Date: | Aug 31, 2012 |
| Classification: | Classification Name: cuff, tracheal tube, inflatable<br>Product Code: BSK<br>Regulation No: 21 CFR 868.5750<br>Class: II<br>Classification Panel: Anesthesiology |
| Device Description: | . |

The AG Cuffill is a disposable hand held measuring device intended to measure and manually regulate intra-cuff pressure of Endotracheal, Tracheotomy and LMAs tubes. AG Cuffill is configured as a syringe and consists of a sensitive pressure gauge

Hospitech AG Cuffill – 510k Notification

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embedded within the syringe plunger. AG Cuffill is battery powered. AG Cuffill is intended for one patient; it is limited to 100 operations and can be cleaned with disinfectant.

#### Intended Use Statement:

The Hospitech AG Cuffill is intended to measure and regulate the intra-cuff pressure of endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs).

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

Substantial equivalence to the following predicate device is Predicate Devices: claimed:

| Device Name | 510k No | Date of Clearance |
|-----------------|---------|-------------------|
| Posey Cufflator | K912723 | July 20 1991 |
| CuffAlert | K081805 | Nov 14 2008 |
| Easy Cuff | K102704 | March 10 2011 |
| PYTON | K092733 | Feb 26 2010 |

#### Performance Standards

AG Cuffill complies with the following standards:

- 1. IEC 60601-1:2005/2006 Medical electrical Equipment -- Part 1: General requirements for safety.
- 2. IEC 60601-1-2:2004 Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- 3. IEC 60601-1-6:2006, Medical Electrical Equipment -- Part 1-6: General requirements for basic safety and essential performances -Collateral Standard: Usability.

Hospitech AG Cuffill - 510k Notification

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- 4. ISO 10993-1:2009 Biological evaluation of medical devices Part 1 : Evaluation and testing within a risk management process.
# Non clinical Performance Testing

The following performance tests were conducted:

| # | Name of test | References | Results |
|---|-------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Design<br>Verification | AG Cuffill<br>Design<br>Verification | The test results show that the<br>AG Cuffill design is according<br>to the specification. |
| 2 | Accuracy<br>Verification<br>Performance<br>Test | AG Cuffill<br>Accuracy<br>Verification<br>Performance Test | The test shows that the<br>accuracy of the AG Cuffill<br>throughout its life time at<br>different pressure<br>measurements is within ±1<br>mmHg. |
| 3 | ATP<br>Acceptance<br>Test | AG Cuffill ATP<br>Acceptance Test<br>protocol | The Acceptance Test Protocol<br>is the manufacturing test to be<br>performed to each item before<br>packaging |
| 4 | Comparison<br>Test with<br>predicate<br>device | AG Cuffill<br>Pressure Accuracy<br>Performance vs.<br>Posey Cufflator<br>predicate device | AG Cuffill accuracy is within its<br>specifications and is better than<br>the Posey Cufflator |

Performance testing demonstrated that the AG Cuffill meets its specifications and is as safe and effective as the cleared predicate devices.

#### Materials and Biocompatibility

The AG Cuffill or the air pumped from it does not come in direct or indirect contact with the patient or the user. Therefore according to ISO 10993-1 there is no need for these parts to be biocompatible.

# Comparison to the Predicate Devices and substantial Equivalence

The intended use of the AG Cuffill is identical to the intended use of its predicate devices.

Hospitech AG Cuffill - 510k Notification

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All predicates, similar to the AG Cuffill, are designed to measure and regulate intracuff pressure.

The device principle of operation and technology of the AG Cuffill is similar to that of its predicate devices. The structural differences between the AG Cuffill and its predicate devices do not raise any new questions of safety or efficacy. Moreover, the performance testing and usability study demonstrated that the AG Cuffill is as safe and effective and performs as well as or better than the predicate devices. Thus, the AG Cuffill is substantially equivalent to its predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

5)

#### May 3, 2013

Hospitech Respiration Limited C/O Mr. Yoram Levy Osite 31 Haavoda Street Binyamina, Israel 30500

Re: K122721

Trade/Device Name: AG Cuffill Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: II Product Code: BSK Dated: April 17, 2013 Received: May 1, 2013

Dear Mr. Levy:

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. 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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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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 [phone] or [phone] or at its Internet address

· http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer
-S FDA

for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

#### 510(k) Number (if known): K122721

Device Name:

### AG Cuffill

Indications for Use:

The Hospitech AG Cuffill is intended to measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways).

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

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 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 and Devices 510(k) Number

> Lester W. Schulthe 2013.05.03 16:50 =04'00'

Hospitech AG Cuffill – 510k Notification

(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dent

510(k) Number;