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.

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.).

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Cuffix device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with human-in-the-loop or standalone AI performance. Therefore, many of the requested details, particularly those related to AI algorithm validation (like MRMC studies, training/test set sample sizes for AI, expert adjudication, etc.), are not present in this document.

However, based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table format. Instead, it describes performance characteristics and compares them to predicate devices. The closest to acceptance criteria are the "Accuracy" and "Cuff pressure intended use range" specifications.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Cuffix)
Cuff pressure intended use range	20-30 cmH2O (for active regulation)	20-30 cmH2O (for active regulation)
Accuracy	+/- 3 cmH2O	+/- 3 cmH2O
Operation time	Not explicitly stated as a criterion, but a characteristic	Up to 2 weeks
Connection to pilot balloon	Yes	Yes
Single patient use	Yes	Yes
Provided sterile	No	No

Note: The table above is constructed from the comparative table provided in the document. The "Acceptance Criteria (Implied)" column reflects what the Cuffix device aims to achieve, as demonstrated by its own specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Animal and clinical performance data was not included." This implies there was no "test set" in the context of clinical data for performance evaluation in human subjects. The comparative testing mentioned appears to be non-clinical (e.g., bench testing, laboratory evaluations).

Therefore, information on sample size for a clinical test set and data provenance (country, retrospective/prospective) is not available in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Since no clinical test set or human-in-the-loop study involving interpretations (e.g., radiology images) was performed, there were no experts used to establish ground truth in the context of diagnostic or clinical assessment.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was described.

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

No MRMC study was done. This is a device for measuring and regulating tracheal tube cuff pressure, not an image-based diagnostic AI device. The comparison is primarily against predicate devices based on technical specifications and non-clinical performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

The Cuffix is a hardware device with an active pressure monitoring and passive pressure regulation mechanism. It is not an AI algorithm in the sense of a standalone diagnostic or predictive AI. Its "performance" is based on its physical properties and mechanical/electronic accuracy.

7. Type of Ground Truth Used

The "ground truth" for the Cuffix device's performance would have been established through:

Bench testing: Using calibrated pressure sensors/manometers as a reference standard to verify the Cuffix's pressure measurement accuracy.
Engineering specifications and tests: For characteristics like battery life, response time, kinking resistance, etc.

It is not expert consensus, pathology, or outcomes data in the clinical sense, as the evaluation is primarily focused on the device's physical and functional performance, not its diagnostic or clinical interpretation capabilities.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that involves a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/machine learning device.

Summary

{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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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.

{4}------------------------------------------------

5.4 DEVICE DESCRIPTION

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 CuffPressure Controller
510k Number	--	K122721	K833327
DeviceClassification	2	2	2
ClassificationProduct Code	BSK	BSK	BSK
RegulationNumber	868.5750	868.5750	868.5750
Intended Use	The Cuffix is intendedto measure andregulate, throughpassive control, theintracuff pressure ofEndotracheal tubes,	The Hospitech AGCuffill is intended tomeasure and regulatethe intra-cuff pressureof Endotracheal tubes,Tracheotomy tubes and	To maintain theHVLP (high volumelow pressure) cuffpressure, of anendotracheal tubewithin the range of
	Cuffix	AG Cuffill	PressureEasy CuffPressure Controller
	Tracheotomy tubes andLaryngeal MasksAirways (LMAs)(supraglottic airways).The device is intendedfor single patient use,under medicalsupervision in hospitals,pre-hospital (EMS),extended care facilitiesor outpatient clinics,where a patient may beintubated	Laryngeal MasksAirways (LMAs)(supraglottic airways).The Hospitech AGCuffill is used undermedical supervision inhospitals, pre-hospital(EMS), extended carefacilities and outpatientclinics, where a patientmay be intubated.	20 to 30 cm H2Othrough passivecontrol.
Prescriptionuse	Yes	Yes	Yes
Technical Characteristics
Type ofcontrol	Passive	Active- syringeinflation by user	Passive
Cuff pressureintended userange	20-30cmH2O	0-99cmH2O	20-30cmH2O
Internalpressurereservoir(balloon)	Elastic inner balloonthat expands andcontracts as air flowsto and from the cuff	No internal pressurereservoir	Elastic inner balloonthat expands andcontracts as air flowsto and from the cuff
Numericalpressure screen	Yes	Yes	No
Alarm whenpressure is outof range	Yes - blinking red light	No	No
Accuracy	$\u00b13cmH2O$	$+2cmH2O$	N/A
Dampingfunction of airflow from cuffto the balloon	Yes	N/A	No
Free flow ofair from theballoon to thecuff	Yes	N/A	Yes
Continuousmonitoring ofcuff pressure	Yes	No	Yes
Continuousstabilization ofcuff pressure	Yes	No	Yes
Inflation bysyringe or cuffpressure	Yes	N/A	Yes
	Cuffix	AG Cuffill	PressureEasy CuffPressure Controller
Connection topilot balloonusing luerconnector	Yes	Yes	Yes
Single patientuse	Yes	No	Yes
Operation time	Up to 2 weeks	100 operations(measurements)	Not limited
Patient contact	Does not come in director indirect contact withthe patient or the user	Does not come indirector indirect contact withthe patient or the user	Does not come indirector indirect contactwith the patient orthe user
Providedsterile	No	No	No

{5}------------------------------------------------

{6}------------------------------------------------

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.

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).