The CuffTrek is intended to measure and regulate the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supractottic airways). The device is intended for single patient use from pediatric to adult, under medical supervision in hospitals, prehospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated. It is for disposable single patient use.

Device Description

The device is a battery-operated cuff pressure-controlling device 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 7 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 device is 0-99 cmH2O. The device body houses 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 or if the pressure is out of the set range of 20-30 cmH2O (red).

AI/ML Overview

The provided text is a 510(k) summary for the device "CuffTrek," an inflatable tracheal tube cuff pressure regulator. It outlines the device's characteristics, indications for use, comparison to predicate devices, and performance testing.

However, the document primarily focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, rather than detailing a clinical study with a rigorously defined acceptance criteria table and performance study results as requested in the prompt. The document explicitly states "Clinical Study: Not applicable."

Therefore, I cannot extract the information required for a comprehensive answer regarding acceptance criteria and a study proving the device meets them via a clinical study. The document describes non-clinical performance testing.

If the request refers to non-clinical acceptance criteria and performance data, I can extract information related to accuracy, response time, and the types of tests conducted. Based on the provided text, here's what can be extracted for non-clinical performance:

Non-Clinical Performance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Accuracy: ±2 cmH2O	Accuracy: ±2 cmH2O (Identical to Predicate)
Operating Range: 0-99 cmH2O	Operating Range: 0-99 cmH2O (Identical)
Cuff Pressure Range: 20-30 cmH2O	Cuff Pressure Range: 20-30 cmH2O (Identical)
Alarm when pressure is out of range	Yes - blinking red light (Same as reference device)
Continuous monitoring of cuff pressure	Yes (Same as reference device)
Inflation by syringe function	Yes (Identical)
Connection to pilot balloon using luer connector	Yes (Identical)
Operation time	up to 7 days (Verified by performance test)
Fluid leakage resistance	Test conducted, expected to comply with requirements
Sub-atmospheric pressure air leakage resistance	Test conducted, expected to comply with requirements
Stress cracking resistance	Test conducted, expected to comply with requirements
Resistance to separation from axial load	Test conducted, expected to comply with requirements
Resistance to separation from unscrewing	Test conducted, expected to comply with requirements
Resistance to overriding	Test conducted, expected to comply with requirements
Response time	Test conducted, expected to comply with requirements
Repeatability pressure accuracy	Test conducted, expected to comply with requirements
Pressure accuracy exposure to cold and hot temperature	Test conducted, expected to comply with requirements
Inflation and deflation functions	Test conducted, expected to comply with requirements
Battery Shelf Life	Test conducted, expected to comply with requirements

Regarding the other points of the prompt, based on the provided text:

Sample sizes used for the test set and the data provenance:
- The document mentions "Performance Testing" and "Non-Clinical Study" but does not specify the sample sizes (e.g., number of devices, number of measurements) for these tests.
- Data provenance: Not explicitly stated, but implies laboratory testing of the device. Given the manufacturer's address in Shanghai, China, the testing could have occurred there or elsewhere. It is non-clinical performance data, not patient data (retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this was a non-clinical device performance study, not a study involving expert human interpretation or ground truth establishment from patient data.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this was a non-clinical device performance study, not a study involving expert human interpretation.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a MRMC study was not done. The document explicitly states "Clinical Study: Not applicable." This device is a measurement and regulation device, not an AI diagnostic tool requiring human reader studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, performance testing of the device itself (analogous to "standalone" for a physical device) was done. This includes tests like accuracy, response time, fluid leakage, etc. The results are summarized in the table above where specific values are mentioned (e.g., accuracy ±2 cmH2O). The document states that "Non-clinical tests were conducted to verify that the proposed devices met all design specifications."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance tests, the "ground truth" would be established by calibrated laboratory standards and measurement equipment, comparing the device's output to known inputs or reference measurements. For example, for pressure accuracy, the device's reading would be compared against a high-accuracy reference pressure meter.
The sample size for the training set:
- Not applicable. This is not a machine learning/AI model that requires a "training set." It is a physical medical device.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this physical device.

Summary

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March 7, 2025

Shanghai Longmann Tech Co., Ltd. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249

Re: K242642

Trade/Device Name: CuffTrek Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: February 12, 2025 Received: February 12, 2025

Dear Charles Mack:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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assistance/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,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)
------------------------------	--

K242642

Device Name

CuffTrek

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY K

September 2, 2024 Preparation Date: Shanghai Longmann Tech Co., Ltd. Manufacturer's Name and Address: Room 2106, No.3, Lane791, Lingling Road Shanghai, China 200030 Tel. +86-139-01718104 Corresponding Official: Charles Mack 931-625-4938 Telephone Number: Email Address: charliemack@irc-us.com CuffTrek™ Trade Name: Common Name(s): Inflatable tracheal tube cuff Regulation Name(s): cuff, tracheal tube, inflatable Requlation Number(s): 21CFR868.5750 Primary Product Code: BSK Subsequent Product Codes: Device Class: Class II Predicate Device: K122721 Trade Name: AG Cuffill Common Name: Inflatable tracheal tube cuff Regulation Number(s): 21CFR868.5750 Product Code: BSK Reference Device: K192611 Trade Name: Cuffix Common Name: Inflatable tracheal tube cuff Regulation Number(s): 21CFR868.5750 Product Code: BSK

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Device Description:

Principles of Operation:

The device is a new single-use medical device whose purpose is to continuously measure the pressure inside an endotracheal tube balloon while in use so that it remains within safe limits. The inflation status of the balloon is displayed on a digital screen at a glance from a distance.

Indications for Use

The CuffTrekTM is intended to measure and regulate the intracuff pressure of Endotracheal tubes, Tracheotomy tubes and Laryngeal Masks Airways (LMAs) (supraglottic airways). The device is intended for single patient use from pediatric to adult, under medical supervision in hospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated. It is for disposable single patient use.

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Characteristics	Subject device	Predicate device	Reference device	Discussion
Device Name	CuffTrek™	AG Cuffill	Cuffix	-
510(K) Number	Pending	K122721	K192611	-
Regulation Name	Inflatable Tracheal Tube Cuff	Inflatable Tracheal Tube Cuff	Inflatable Tracheal Tube Cuff	-
Common name	Cuff Pressure Regulator	Cuff Pressure Regulator	Cuff Pressure Regulator	-
CFR	868.5750	868.5750	868.5750	-
Product code	BSK	BSK	BSK	-
Indication for use	The CuffTrek™ is intended to measureand regulate the intracuff pressure ofEndotracheal tubes, Tracheotomy tubes,and Laryngeal Masks Airways (LMAs)(supraglottic airways). The device isintended for single-patient use frompediatric to adult, under medicalsupervision in hospitals, pre-hospital(EMS), extended care facilities andoutpatient clinics, where a patient maybe intubated.It is for disposable single-patient use.	The Hospitech AG Cuffill is intended tomeasure and regulate the intra-cuffpressure of Endotracheal tubes,Tracheotomy tubes, and LaryngealMasks Airways (LMAs) (supraglotticairways). The Hospitech AG Cuffill isused under medical supervision inhospitals, pre-hospital(EMS), extendedcare facilities, and outpatient clinics,where a patient may be intubated.	The Cuffix is intended to measureand regulate, through passivecontrol, the intracuff pressure ofEndotracheal tubes, Tracheotomytubes, and Laryngeal MasksAirways (LMAs) (supraglotticairways). The device is intendedfor single-patient use undermedical supervision in hospitals,pre-hospital (EMS), extended carefacilities, or outpatient clinics,where a patient may be intubated.	Identical toPredicateNote 1
Prescription Use	Prescription	Prescription	Prescription	Identical
Types of airway towhich it can be used	Endotracheal tubesTracheotomy tubesLaryngeal Masks Airways(LMAs)(supraglottic airways)	Endotracheal tubesTracheotomy tubesLaryngeal Masks Airways (LMAs)(supraglottic airways)	Endotracheal tubesTracheotomy tubesLaryngeal Masks Airways (LMAs)(supraglottic airways)	Identical
Cuff pressure range	20-30 cmH2O	20-30 cmH2O	20-30 cmH2O	Identical

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Characteristics	Subject device	Predicate device	Reference device	Discuss
Operating range	0-99 cmH2O	0-99 cmH2O	0-99 cmH2O	Identical
Pressure display	Digital screen	Digital screen	The pointer indicates the rangeof pressure values	Identical
Alarm whenpressure is outof range	Yes - blinking red light	No	Yes - blinking red light	Note 2
Continuousmonitoring ofcuff pressure	Yes	No	Yes	Note 2
Accuracy	$\pm$ 2 cmH2O	±2 cmH2O	±3 cmH2O	IdenticaltoPredicate
Inflation bysyringe	Yes	Yes	Yes	Identical
Connection topilot balloonusing luerconnector	Yes	Yes	Yes	Identical
Operation time	up to 7 days	100 operations (measurements)	Up to 2 weeks	Note 3
Patient contact	Does not come in direct or indirectcontact with the patient or the user	Does not come in direct or indirectcontact with the patient or the user	Does not come in direct orindirect contact with thepatient or the user	Identical
Provided sterile	No	No	No	Identical
Type of control	Active control: syringe inflation by user	Active control: syringe inflation by user	Active control: syringe inflationby the user. Passive control:elastic inner balloon	IdenticaltoPredicateNote 4

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Discussion:

Note 1:

The subject device's IFU is identical to the predicate and specifies the populations additionally. The reference device has an additional passive control feature that is not included by the subject device. The subject device is disposable for single-patient use only and cannot be reused if disconnected from the pilot balloon of the ventilation tube.

Note 2:

The predicate device is unavailable for continuous monitoring and has no alarm function. The subject device is available for continuous monitoring and has an additional alarm function for continuous cuff pressure monitoring, the same as the reference device. It will be alarmed by a red light when pressure is out of the preferred range of 20-30 cmHzO, the same as the reference device. The performance test verifies it, and the difference doesn't raise new questions on the safety and effectiveness of the subject device.

Note 3:

The operation time of the subject device is different from that of the predicate devices but within the scope of reference devices. The performance test verified this. The difference doesn't raise new questions about the safety and effectiveness of the subject device.

Note 4:

The subject device only has active control by syringe, the same as the predicate and reference device. The reference device has additional passive control by an elastic inner balloon to maintain the pressure but still needs to use active control by syringe to regulate/adjust the pressure when alarm the pressure is out of the preferred range

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Performance Testing

To establish substantial equivalence to the identified predicate devices, we compared the tests below on the subject devices, CuffTrek™, and the testing results provided evidence that the devices comply with the requirements and are substantially equivalent to the predicate device.

Non-Clinical Study:

Non-clinical tests were conducted to verify that the proposed devices met all design specifications and were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed devices comply with the following standards:

Safety and EMC

To verify the basic safety and essential performance of the CuffTrek™, we performed the below test:

ANSI/AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & - A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION -Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Performance Data:

ISO 80369-7 Second edition 2021-05 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
-ISO 80369-20 First edition 2015-05-15 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods

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Test conducted:

Fluid leakage -
Sub-atmospheric pressure air leakage -
Stress cracking -
-Resistance to separation from axial load
Resistance to separation from unscrewing -
Resistance to overriding -
Response time -
-Pressure accuracy test
Repeatability pressure accuracy test -
Pressure accuracy test exposure to cold and hot temperature -
Inflation and deflation functions -
Operation time -
Battery Shelf Life -
Comparative Testing (to CuffTrekTM and the predicate AG Cuffill ) -

Biocompatibility

N/A.

The subject device does not come in direct or indirect contact with the patient or the user, the same as the predicate device.

Clinical Study:

Not applicable.

Conclusion:

Based on the above-listed tests, the CuffTrek™ fully complies with the applicable standards requirement and does not raise new safety issues and effectiveness of the devices, demonstrating that it is identical to the predicate device in safety and effectiveness properties.

END

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).