Who is the manufacturer of Cuffix?

Biovo Technologies , Ltd. filed the 510(k) submission for Cuffix (K192611).

What is the FDA product code for Cuffix?

BSK. It is classified under 21 CFR 868.5750 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for Cuffix?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Cuffix?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Cuffix

K192611 · Biovo Technologies , Ltd. · BSK · Aug 13, 2020 · Anesthesiology

Device Facts

Record ID	K192611
Device Name	Cuffix
Applicant	Biovo Technologies , Ltd.
Product Code	BSK · Anesthesiology
Decision Date	Aug 13, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5750
Device Class	Class 2

Intended 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.

Device Story

Battery-operated, single-patient-use device for continuous (up to 14 days) monitoring and passive regulation of intracuff pressure for ETT, tracheotomy tubes, and LMAs. Connects to pilot balloon via extension line. Device contains passive pressure mechanism (elastic inner balloon) and active monitoring mechanism. Displays pressure on digital screen; provides visual feedback via indicator light (green for set range, red for out-of-range). Attaches to ventilation circuit or bed rail via elastic band. Used by clinicians in hospitals, EMS, and clinics. Provides continuous pressure stabilization and monitoring; alerts clinicians to pressure deviations; helps maintain cuff pressure within safe limits to potentially reduce complications associated with over- or under-inflation.

Clinical Evidence

No clinical or animal data provided. Evidence consists of bench testing, including shelf-life, EMC, electrical safety, performance verification (battery life, line kinking, response time, detachment force), and comparative testing against predicates. Compliance with ISO 80369 confirmed.

Technological Characteristics

Battery-operated, non-sterile, single-patient-use device. Features passive pressure control via elastic inner balloon and active electronic monitoring. Operating range 0-99 cmH2O; accuracy ±3 cmH2O. Includes digital display, LED status indicator, and luer connector for pilot balloon. Designed for up to 14 days of continuous use.

Indications for Use

Indicated for patients requiring intubation (Endotracheal, Tracheotomy, or Laryngeal Mask Airways) in hospital, EMS, extended care, or outpatient settings. For single patient use under medical supervision.

Regulatory Classification

Identification

An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

Predicate Devices

AG Cuffill (K122721)

Reference Devices

PressureEasy Cuff Pressure Controller (K833327)

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Submission Summary (Full Text)

{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) #### 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 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 | {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.