(328 days)
No
The description focuses on passive and active pressure monitoring and control mechanisms, with no mention of AI or ML algorithms for analysis, prediction, or decision-making. The performance studies are standard device testing, not AI/ML model validation.
No
The a therapeutic device is one that treats or heals a disease or condition. This device does not treat or heal; it monitors and regulates the intracuff pressure of tubes and airways.
No
The device measures and regulates intracuff pressure. While it provides a display of the pressure (a measurement), its primary stated purpose is to "measure and regulate" and it functions as a "cuff pressure controlling device." It helps maintain a desired pressure rather than diagnosing a medical condition.
No
The device description explicitly states it is a "battery-operated cuff pressure controlling device" with a "device body" housing "passive pressure mechanism component" and "active pressure monitoring mechanism," indicating it is a hardware device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for measuring and regulating intracuff pressure of airway tubes. This is a direct physiological measurement and control function related to patient care, not an in vitro test performed on biological samples.
- Device Description: The description details a battery-operated device that connects to the pilot balloon of airway tubes to monitor and control air pressure. This aligns with a medical device used for patient management, not a diagnostic test performed outside the body.
- No mention of biological samples: There is no mention of the device interacting with or analyzing any biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVDs.
- Performance Studies: The performance studies described are related to the device's functionality, electrical safety, and comparison to similar devices used for pressure management, not diagnostic accuracy based on biological sample analysis.
In summary, the Cuffix is a medical device used for monitoring and controlling pressure within airway cuffs, which is a direct patient care function, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Cuffix is intended to measure and regulate, through passive control, the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.
Product codes (comma separated list FDA assigned to the subject device)
BSK
Device Description
The Cuffix is a battery-operated cuff pressure controlling device which is intended to be used with ventilation tubes (ETT, Tracheostomy, LMA) It is a single patient-use, non-sterile device designed to be used continuously for up to 14 days. The device is connected to the pilot balloon of airways with inflatable air-filled cuffs via the device's extension line. The operating range of the Cuffix is 0-99 cmH2O. The device body houses the passive pressure mechanism component as well as the active pressure monitoring mechanism which displays the cuff pressure on the digital screen. An indicator light provides an additional visual aid to indicate whether the cuff pressure is at the correct pressure (green) or is the pressure is out of the set range (red). The elastic band hanger allows to attach the Cuffix as needed (e.g., to the ventilation circuit, the patient bed rail, etc.).
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
under medical supervision in hospital (EMS), extended care facilities or outpatient clinics
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)
Non-Clinical Performance Testing: The Cuffix device has undergone and successfully passed the following tests:
- Shelf-life
- EMC and electrical safety
- Performance verification and validation testing (including: battery life, line kinking, response time, detachment force testing, etc.)
- Comparative testing (to both Cuffill and PressureEasy predicates)
- Compliance with ISO 80369
Animal and Clinical Performance Testing: Animal and clinical performance data was not included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 3 cmH2O
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 13, 2020
Biovo Technologies Ltd. % Bosmat Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269
Re: K192611
Trade/Device Name: Cuffix Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: August 10, 2020 Received: August 11, 2020
Dear Bosmat Friedman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192611
Device Name Cuffix
Indications for Use (Describe)
The Cuffix is intended to measure and regulate, through passive control, the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
[as required by section 807.92(c)] Cuffix 510(k) Number K192611
5.1 SUBMITTER
Applicant's Name:
Biovo Technologies Ltd. 23 HaMelacha St., P.O.B 11419 Rosh HaAyin, Israel, 4809173 Phone: +972-72-2151115
Contact Person:
Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 647-975-3974 bosmat.f@promedoss.com
Date Prepared:
August 10, 2020
5.2 DEVICE
Trade Name: Cuffix
Classification Code: Name: Cuff, Tracheal Tube, Inflatable Product Code: BSK Regulation No: 868.5750 Class: 2 Review Panel: Anesthesiology
5.3 PREDICATE DEVICE
Primary predicate device:
-
AG Cuffill, manufactured by Hospitech Respiration Ltd., cleared under ● K122721, product code: BSK
Reference device: -
PressureEasy Cuff Pressure Controller, manufactured by Smith Medical Inc., cleared under K833327, product code: BSK.
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5.4 DEVICE DESCRIPTION
The Cuffix is a battery-operated cuff pressure controlling device which is intended to be used with ventilation tubes (ETT, Tracheostomy, LMA) It is a single patient-use, non-sterile device designed to be used continuously for up to 14 days. The device is connected to the pilot balloon of airways with inflatable air-filled cuffs via the device's extension line. The operating range of the Cuffix is 0-99 cmH2O. The device body houses the passive pressure mechanism component as well as the active pressure monitoring mechanism which displays the cuff pressure on the digital screen. An indicator light provides an additional visual aid to indicate whether the cuff pressure is at the correct pressure (green) or is the pressure is out of the set range (red). The elastic band hanger allows to attach the Cuffix as needed (e.g., to the ventilation circuit, the patient bed rail, etc.).
5.5 INDICATIONS FOR USE
The Cuffix is intended to measure and regulate, through passive control, the intracuff pressure of Endotracheal tubes. Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use, under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics, where a patient may be intubated.
5.6 SUBSTANTIAL EQUIVALENCE
The Cuffix has the same intended use and substantially similar technological characteristics as both the primary predicate device and reference device. Furthermore, comparative testing has demonstrated that the device performs similarly to both the Cuffill and PressureEasy predicate devices. Consequently, it is clear that the Cuffix is as safe and effective as its primary predicate and reference devices without raising any new safety and/or effectiveness concerns. Any differences between the devices have been addressed through testing and validations and, therefore, negate any safety or effectiveness concerns.
| | Cuffix | AG Cuffill | PressureEasy Cuff
Pressure Controller |
|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 510k Number | -- | K122721 | K833327 |
| Device
Classification | 2 | 2 | 2 |
| Classification
Product Code | BSK | BSK | BSK |
| Regulation
Number | 868.5750 | 868.5750 | 868.5750 |
| Intended Use | The Cuffix is intended
to measure and
regulate, through
passive control, the
intracuff pressure of
Endotracheal tubes, | The Hospitech AG
Cuffill is intended to
measure and regulate
the intra-cuff pressure
of Endotracheal tubes,
Tracheotomy tubes and | To maintain the
HVLP (high volume
low pressure) cuff
pressure, of an
endotracheal tube
within the range of |
| | Cuffix | AG Cuffill | PressureEasy Cuff
Pressure Controller |
| | Tracheotomy tubes and
Laryngeal Masks
Airways (LMAs)
(supraglottic airways).
The device is intended
for single patient use,
under medical
supervision in hospitals,
pre-hospital (EMS),
extended care facilities
or outpatient clinics,
where a patient may be
intubated | 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. | 20 to 30 cm H2O
through passive
control. |
| Prescription
use | Yes | Yes | Yes |
| Technical Characteristics | | | |
| Type of
control | Passive | Active- syringe
inflation by user | Passive |
| Cuff pressure
intended use
range | 20-30cmH2O | 0-99cmH2O | 20-30cmH2O |
| Internal
pressure
reservoir
(balloon) | Elastic inner balloon
that expands and
contracts as air flows
to and from the cuff | No internal pressure
reservoir | Elastic inner balloon
that expands and
contracts as air flows
to and from the cuff |
| Numerical
pressure screen | Yes | Yes | No |
| Alarm when
pressure is out
of range | Yes - blinking red light | No | No |
| Accuracy | $\u00b13cmH2O$ | $+2cmH2O$ | N/A |
| Damping
function of air
flow from cuff
to the balloon | Yes | N/A | No |
| Free flow of
air from the
balloon to the
cuff | Yes | N/A | Yes |
| Continuous
monitoring of
cuff pressure | Yes | No | Yes |
| Continuous
stabilization of
cuff pressure | Yes | No | Yes |
| Inflation by
syringe or cuff
pressure | Yes | N/A | Yes |
| | Cuffix | AG Cuffill | PressureEasy Cuff
Pressure Controller |
| Connection to
pilot balloon
using luer
connector | Yes | Yes | Yes |
| Single patient
use | Yes | No | Yes |
| Operation time | Up to 2 weeks | 100 operations
(measurements) | Not limited |
| Patient contact | Does not come in direct
or indirect contact with
the patient or the user | Does not come in
direct
or indirect contact with
the patient or the user | Does not come in
direct
or indirect contact
with the patient or
the user |
| Provided
sterile | No | No | No |
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5.7 PERFORMANCE DATA
Non-Clinical Performance Testing:
The Cuffix device has undergone and successfully passed the following tests:
- Shelf-life -
- -EMC and electrical safety
- Performance verification and validation testing (including: battery life, line kinking, response time, detachment force testing, etc.)
- -Comparative testing (to both Cuffill and PressureEasy predicates)
- Compliance with ISO 80369 -
Animal and Clinical Performance Testing:
Animal and clinical performance data was not included.
5.8 CONCLUSION
Biovo Technologies Ltd. believes that Cuffix is substantially equivalent to the AG Cuffill primary predicate device and the PressureEasy reference device. It does not introduce new indications for use, has substantially equivalent technological and performance characteristics, and therefore does not introduce different questions safety and effectiveness.