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.

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the AG Cuffill device's acceptance criteria and study findings:

Acceptance Criteria and Device Performance Study for Hospitech AG Cuffill

The Hospitech AG Cuffill is a disposable, hand-held device designed to measure and manually regulate intra-cuff pressure of endotracheal, tracheotomy, and Laryngeal Mask Airway (LMA) tubes. The device's performance was evaluated through non-clinical testing to demonstrate its safety and effectiveness.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Accuracy	Accuracya throughout its lifetime at different pressure measurements is within ±1 mmHg.
Design Compliance	The AG Cuffill design is according to specifications.
Manufacturing Quality	The Acceptance Test Protocol is the manufacturing test to be performed on each item before packaging, ensuring quality control.
Predicate Device Comparison	AG Cuffilla accuracy is within its specifications and is better than the Posey Cufflator (predicate device).

Note: The document specifies that "AG Cuffill accuracy is within its specifications and is better than the Posey Cufflator." This implies that "better than" the predicate is a form of acceptance criterion, or at least a favorable outcome.

2. Sample Size and Data Provenance for Test Set

The document is a 510(k) summary for the AG Cuffill and primarily focuses on non-clinical performance testing. It does not describe a clinical study with a "test set" in the context of patient data. Instead, it refers to tests conducted on the device itself.

Sample Size for Test Set: Not applicable in the context of human subjects or patient data. The tests were performed on the device.
Data Provenance: Not applicable in the context of human subjects or patient data (e.g., country of origin, retrospective/prospective). The data originated from internal performance testing conducted by the manufacturer, Hospitech Respiration Ltd.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. The ground truth for the device's performance (e.g., accuracy against a known standard) would have been established through calibrated reference instruments and defined specifications, not expert interpretation of patient data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. Device performance tests rely on objective measurements against pre-defined specifications or calibrated reference standards, not on adjudication of subjective interpretations.

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

Was an MRMC study done? No. The document describes non-clinical performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Algorithm Performance Study

Was a standalone study done? Yes, in a sense, as the performance tests listed are for the device's inherent functionality. The "Accuracy Verification Performance Test" and "Comparison Test with predicate device" provide standalone performance data for the AG Cuffill as a device, showing its accuracy (within ±1 mmHg) and comparison to a predicate.

7. Type of Ground Truth Used

The ground truth for the stated performance metrics was established through device specifications and calibrated measurement standards. For example, the accuracy was determined by comparing the AG Cuffill's readings against a precise, calibrated pressure measuring system across different pressure ranges. The "Comparison Test with predicate device" used the predicate device's measured performance as a comparative 'ground truth' or benchmark.

8. Sample Size for Training Set

The document does not describe a machine learning algorithm that requires a "training set." Therefore, information on a training set sample size is not applicable.

9. How Ground Truth for Training Set Was Established

As there is no mention of a training set for a machine learning algorithm, this is not applicable. The device's functionality is based on direct physical measurement, not on AI algorithms trained on data.

Summary

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510(K) SUMMARY

3 2013 MAY

Hospitech AG Cuffill 510(k) Number K 122721

Applicant's Name:	Hospitech Respiration Ltd20 Hamagshimim StreetKiryat Matalon,Petach-Tikva, 49250Israel.TEL: 972-3-919-1648,FAX: 972-3-919-1647
Contact Person:	Yoram Levy, Qsite31 Haavoda St.Binyamina, Israel 30500Tel (972)4-638-8837Fax (972)4-638-0510Yoram@qsitemed.com
Trade Name:	AG Cuffill TM
Common Name:	Endotracheal cuff pressure regulator
Preparation Date:	Aug 31, 2012
Classification:	Classification Name: cuff, tracheal tube, inflatableProduct Code: BSKRegulation No: 21 CFR 868.5750Class: IIClassification Panel: Anesthesiology
Device Description:	.

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.
1. IEC 60601-1-2:2004 Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
1. 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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1. 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	DesignVerification	AG CuffillDesignVerification	The test results show that theAG Cuffill design is accordingto the specification.
2	AccuracyVerificationPerformanceTest	AG CuffillAccuracyVerificationPerformance Test	The test shows that theaccuracy of the AG Cuffillthroughout its life time atdifferent pressuremeasurements is within ±1mmHg.
3	ATPAcceptanceTest	AG Cuffill ATPAcceptance Testprotocol	The Acceptance Test Protocolis the manufacturing test to beperformed to each item beforepackaging
4	ComparisonTest withpredicatedevice	AG CuffillPressure AccuracyPerformance vs.Posey Cufflatorpredicate device	AG Cuffill accuracy is within itsspecifications and is better thanthe 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

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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;

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).