(171 days)
Not Found
No
The device description and performance studies indicate a purely mechanical pressure monitoring and inflation/deflation system without any mention of AI or ML.
No
The device is used to inflate cuffs and measure/monitor pressure, not to treat a disease or condition. It is a diagnostic and measurement tool for intubated patients.
No
The device measures and monitors intra-cuff pressures, which is a measurement function, not a diagnostic one. It does not identify the presence or absence of a disease or condition.
No
The device description explicitly states it "contains a calibrated diaphragm" and is "capable of inflating or deflating the cuff," indicating it includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to inflate cuffs and measure/monitor intra-cuff pressures of airway tubes. This is a direct physiological measurement and manipulation within the body, not an analysis of samples taken from the body.
- Device Description: The device is described as an in-line pressure monitor that distends with pressure and can inflate/deflate the cuff. This mechanism is mechanical and directly interacts with the airway device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
To inflate cuffs and to measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
Product codes
BSK
Device Description
The Easy Cuff™ is simple in-line pressures monitor which contains a calibrated diaphragm which distends with increases in cuff pressure. It is also capable of inflating or deflating the cuff.
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. Population is defined not by age but by those that have an airway which has a cuff which needs to be inflated / deflated, and the pressure measured and monitored.
Intended User / Care Setting
To be 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Inter-sample and Intra-sample testing for accuracy and repeatability across the pressure range. Tested for accuracy at different temperatures and after drop test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
+/- 5% up to 30 cmH2O
+/- 0.5 cm H2O @ 10 cm H2O
+/- 1 cm H2O @ 20 cm H2O
+/- 1.5 cm H2O @ 30 cm H2O
Predicate Device(s)
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
510(k) Summary
Page 1 of 3 7-Feb-11
.
.
:
K102704 MAR 1 0 2011
| Joan E. Spiegel, M.D.
10 Coleman Ct.
| Natick, MA 01760 | Tel - 617-935-3500 |
|---|---|
| Official Contact: | Joan Spiegel, M.D. |
| Proprietary or Trade Name: | Easy Cuff™ |
| Common/Usual Name: | Cuff, tracheal tube, inflatable (accessory) |
| Classification Name: | Cuff, tracheal tube, inflatable (accessory) |
| BSK - 868.5730 | |
| Predicate Devices: | Posey Cufflator - K912723 |
| SunMed CuffAlert™ - K081805 | |
| Device Description: | The Easy Cuff™ is simple in-line pressures monitor which |
| contains a calibrated diaphragm which distends with increases in | |
| cuff pressure. It is also capable of inflating or deflating the cuff. | |
| Indications for Use: | To measure and monitor intra-cuff pressures of endotracheal, |
| supraglottic airways, or tracheostomy tubes. | |
| 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 a | |
| patient may be intubated. | |
| Contraindications: | None |
1
510(k) Summary
.
.
| Attribute | Proposed
Easy Cuff™™ | Posey
Cufflator™ - K912723 | SunMed
CuffAlert - K081805 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | To inflate cuffs and to measure and
monitor intra-cuff pressures of
endotracheal, supraglottic airways, or
tracheostomy tubes. | To inflate, measure and monitor
cuff pressure | To measure and monitor intra-cuff
pressures of endotracheal,
supraglottic airways, or
tracheostomy tubes. |
| 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 but the same | To be used under medical
supervision in hospitals, pre-hospital
(EMS), extended care facilities and
outpatient clinics, where a patient
may be intubated. |
| Patient population | Intubated patients | Intubated patients | Intubated patients |
| Single patient, disposable | Yes | No | Yes |
| Range of measured pressure | 0 to 30 cm H₂O | 0 to 120 cm H₂O | 10 to 40 cm H₂O |
| Detection of "good range" | Color coded scale | Color coded scale | LED does not activate |
| Power | Manual | Manual | Battery operated |
| Accuracy | +/- 5% up to 30 cmH2O
+/- 0.5 cm H2O @ 10 cm H2O
+/- 1 cm H2O @ 20 cm H2O
+/- 1.5 cm H2O @ 30 cm H2O | Not specified | +/- 2 cmH2O @ 10 cmH2O
+/- 3 cmH2O @ 20-30 cmH2O
+/- 4 cmH2O @ 40 cmH2O |
| Performance Testing | Inter-sample and Intra-sample testing
for accuracy and repeatability across
the pressure range
Tested for accuracy at different
temperatures and after drop test | Not specified | Accuracy across the pressure range
Tested for accuracy at different
temperatures
Drop test |
Differences Between DC and AC
-
Direction of Current:
- DC: Current flows in one direction only.
- AC: Current changes direction periodically.
-
Frequency:
- DC: Frequency is zero.
- AC: Frequency is typically 50 Hz or 60 Hz.
-
Voltage:
- DC: Voltage is constant.
- AC: Voltage varies sinusoidally.
-
Applications:
- DC: Used in batteries, electronic devices, and some motors.
- AC: Used in household appliances, power transmission, and most industrial equipment.
-
Generation:
- DC: Generated by batteries, solar cells, and DC generators.
- AC: Generated by AC generators (alternators).
-
Transmission:
- DC: Not suitable for long-distance transmission due to high losses.
- AC: Can be transmitted over long distances with minimal losses using transformers.
-
Storage:
- DC: Can be stored in batteries.
- AC: Cannot be stored directly; it must be converted to DC first.
-
Waveform:
- DC: Straight line.
- AC: Sine wave.
-
Reactance:
- DC: No reactance (only resistance).
- AC: Has both resistance and reactance (inductive and capacitive).
-
Examples:
- DC: Batteries, solar panels, USB power.
- AC: Wall outlets, power grids, generators.
Differences Between Other Legally Marketed Predicate Devices:
There are no significant differences that affect the safety or effectiveness of the intended device as compared
.
2
510(k) Summary Page 3 of 3 7-Feb-11
The Easy Cuff™ is viewed as substantially equivalent to the predicate devices because:
Indications -
The Easy Cuff™ is intended to allow one to inflate the cuff, measure and monitor the pressure in the cuff. This is identical to the predicates -
Posey Cufflator - K912723 - inflates, measures and monitors pressure
SunMed CuffAlert – K081805 – measures and monitors cuff pressure only it does not have an active component to inflate the cuff
Technology -
The Easy Cuff™ uses a diaphragm / bellows which moves in relationship to the measured pressure. This nearly identical to the predicate SunMed which uses a diaphragm to measure pressure and the deflection of the diaphragm will activate the LED sensor - SunMed CuffAlert -K081805.
Materials -
There are no materials in the gas and fluid pathway.
Environment of Use -
The environment of use is wherever one would want to measure cuff pressure, which is identical to predicate - Posey Cufflator - K912723 and SunMed CuffAlert - K081805
Patient Population -
Population is defined not by age but by those that have an airway which has a cuff which needs to be inflated / deflated, and the pressure measured and monitored.
This is identical to predicate - Posey Cufflator - K912723 and SunMed CuffAlert - K081805
Performance Testing -
We performed equivalent bench testing, including accuracy, high and low temperature and drop testing and the Easy Cuff™ performed as intended and its accuracy is substantially equivalent to the SunMed Cuff Alert (K081805).
These tests were equivalent to the testing required of the predicates.
3
Image /page/3/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 three lines representing its wings and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenne Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Joan Spiegel, MD C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodstage Drive Bonita Springs, Florida 34134
Re: K102704
MAR 1 0 250
Trade/Device Name: Easy Cuff™ Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BSK Dated: February 7, 2011 Received: February 8, 2011
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 equival mative 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.
4
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); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 1 5809 htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
Page 1 of 1
510(k) Number:
K102704 (To be assigned)
Easy Cuff™ Device Name:
Indications for Use:
To inflate cuffs and to measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.
Patient population:
Patient who are intubated
Environment 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.
Prescription Use XX (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 Sigil-Only Division Control, Dental Devices
510(k) Number: