(240 days)
Not Found
No
The description details a manual, hand-held device with a pressure gauge. There is no mention of AI, ML, or any computational processing beyond basic pressure measurement and display.
No.
The device's intended use is to measure and regulate pressure, and it does not directly treat or diagnose a disease or condition. While it supports patient care, its function is primarily monitoring and managing an intubated patient's airway, rather than providing therapeutic intervention itself.
Yes
The device is described as a "measuring device intended to measure and manually regulate intra-cuff pressure," and it includes a "sensitive pressure gauge." The intended use is to "measure and regulate the intra-cuff pressure" of medical tubes. This act of measuring a physiological parameter (pressure) for medical purposes, even if also used for regulation, falls under the definition of a diagnostic activity.
No
The device description explicitly states it is a "disposable hand held measuring device configured as a syringe and consists of a sensitive pressure gauge embedded within the syringe plunger" and is "battery powered," indicating it is a physical hardware device, not software only.
Based on the provided information, the Hospitech AG Cuffill is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "measure and regulate the intra-cuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs)". This is a measurement of a physical parameter within a medical device (the cuff), not a diagnostic test performed on a biological sample from the human body.
- Device Description: The device is described as a "disposable hand held measuring device intended to measure and manually regulate intra-cuff pressure". This aligns with a physical measurement tool, not a device used for in vitro diagnostic testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (chemicals, proteins, DNA, etc.)
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition.
The AG Cuffill is a device used to manage the pressure of a medical device (the airway cuff) within a patient, which is a different category of medical device than an IVD.
N/A
Intended Use / 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.
Product codes
BSK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance tests were conducted:
- Design Verification: The test results show that the AG Cuffill design is according to the specification.
- Accuracy Verification Performance Test: The test shows that the accuracy of the AG Cuffill throughout its life time at different pressure measurements is within ±1 mmHg.
- ATP Acceptance Test: The Acceptance Test Protocol is the manufacturing test to be performed to each item before packaging.
- Comparison Test with predicate device: AG Cuffill accuracy is within its specifications and is better than the Posey Cufflator.
Performance testing demonstrated that the AG Cuffill meets its specifications and is as safe and effective as the cleared predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K912723, K081805, K102704, K092733
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a globe-like design with horizontal and vertical lines, with a large, stylized letter "H" in the center. The text "Hospitech Respiration" is written below the logo.
510(K) SUMMARY
3 2013 MAY
Hospitech AG Cuffill 510(k) Number K 122721
| Applicant's Name: | Hospitech Respiration Ltd
20 Hamagshimim Street
Kiryat Matalon,
Petach-Tikva, 49250
Israel.
TEL: 972-3-919-1648,
FAX: 972-3-919-1647 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda St.
Binyamina, Israel 30500
Tel (972)4-638-8837
Fax (972)4-638-0510
Yoram@qsitemed.com |
| Trade Name: | AG Cuffill TM |
| Common Name: | Endotracheal cuff pressure regulator |
| Preparation Date: | Aug 31, 2012 |
| Classification: | Classification Name: cuff, tracheal tube, inflatable
Product Code: BSK
Regulation No: 21 CFR 868.5750
Class: II
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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Image /page/1/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a stylized globe with horizontal lines and a large, bold letter "H" in the center. The letter "H" is set against a dark, semi-circular background, and the words "Hospitech Respiration" are printed in a simple font below the globe.
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:
-
- IEC 60601-1:2005/2006 Medical electrical Equipment -- Part 1: General requirements for safety.
-
- IEC 60601-1-2:2004 Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests.
-
- 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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Image /page/2/Picture/0 description: The image shows the Hospitech Respiration logo. The logo features a stylized globe with horizontal lines and a large letter "H" in the center. The letter "H" is black and has a serif font. Below the logo, the words "Hospitech Respiration" are written in a simple, sans-serif font.
-
- 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 | ||
| Verification | AG Cuffill | ||
| Design | |||
| Verification | The test results show that the | ||
| AG Cuffill design is according | |||
| to the specification. | |||
| 2 | Accuracy | ||
| Verification | |||
| Performance | |||
| Test | AG Cuffill | ||
| Accuracy | |||
| Verification | |||
| Performance Test | The test shows that the | ||
| accuracy of the AG Cuffill | |||
| throughout its life time at | |||
| different pressure | |||
| measurements is within ±1 | |||
| mmHg. | |||
| 3 | ATP | ||
| Acceptance | |||
| Test | AG Cuffill ATP | ||
| Acceptance Test | |||
| protocol | The Acceptance Test Protocol | ||
| is the manufacturing test to be | |||
| performed to each item before | |||
| packaging | |||
| 4 | Comparison | ||
| Test with | |||
| predicate | |||
| device | AG Cuffill | ||
| Pressure Accuracy | |||
| Performance vs. | |||
| Posey Cufflator | |||
| predicate device | AG Cuffill accuracy is within its | ||
| specifications and is better than | |||
| 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
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.
5
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;