(267 days)
The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.
The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.
It is used by health professionals (doctor or nurse) specifically trained in this tool.
The CuffGuard has a pressure sensor and software that can monitor and automatically adjust the cuff pressure.
The accessories associated include:
- Connection tube with filter
- Power supply
- Micro USB connection cable
- Fixation clamp and its tilt block)
The FDA 510(k) clearance letter for CuffGuard specifies the device's technical characteristics and performance data to support its substantial equivalence to a predicate device. However, it does not include a detailed study proving the device meets specific acceptance criteria in a clinical context with human readers or standalone performance metrics. The provided document focuses on bench testing and software validation.
Here's an analysis based on the provided text, addressing the requested information to the extent possible:
Description of Acceptance Criteria and Device Performance
The acceptance criteria are implicitly defined by the comparison to the predicate device, the Hamilton Medical Intellicuff, and compliance with relevant electrical safety and software standards. The "reported device performance" is largely presented as a comparison to the predicate's specifications and confirmation of standard compliance.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Criterion | Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (CuffGuard) |
|---|---|---|
| Pressure Range | 5 – 50 cmH2O (Predicate) | 5 – 40 cmH2O |
| Accuracy of Control | +/- 2 cmH2O (Predicate) | +/- 2 cmH2O |
| Adjustment Accuracy | +/- 1 cmH2O (Predicate) | +/- 1 cmH2O |
| Display Accuracy | +/- 1 cmH2O (Predicate) | +/- 1 cmH2O |
| Electrical Safety | Compliant to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8 | Compliant to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8 |
| EMC | Compliant to IEC 60601-1-2 | Compliant to IEC 60601-1-2 |
| Software V&V | As recommended by FDA Guidance for Device Software Functions | Documentation provided, enhanced level |
| Leaks, Pressure, Alarms | Yes (Predicate) | Yes (Leak, Pressure, Stop sound, Audible, Visual) |
| Cuff Control | Yes (Predicate) | Yes (Deflate, Inflate, Time-limited hold) |
| Units Choice | Yes (Predicate) | Yes |
| Power | Battery and AC power supply (Predicate) | Battery and AC power supply |
| Portability | Yes (Predicate) | Yes |
Study Proving Acceptance Criteria:
The document states: "The following performance data were provided in support of the substantial equivalence determination." These data primarily consist of:
- Electrical safety and electromagnetic compatibility (EMC) testing: Conducted on the CuffGuard device, confirming compliance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, and IEC 60601-1-2 standards.
- Software Verification and Validation Testing: Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." The software documentation level for CuffGuard is "enhanced."
- Evaluation of Pressure Range Difference: The difference in pressure range (CuffGuard: 5-40 cmH2O vs. Predicate: 5-50 cmH2O) was "evaluated on the SW verification and validation." The justification states this difference is "not clinically significant" as 40 cmH2O is a "realistic physiological limit and common clinical practice."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not mention any clinical test set sample size, data provenance, or whether data was retrospective or prospective. The performance evaluation described is entirely non-clinical (bench testing and software validation).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as no clinical test set using expert ground truth is described in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable as no clinical test set requiring adjudication is described.
5. 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The CuffGuard is described as an "endotracheal tube cuff controller," a hardware device with embedded software for automatic pressure adjustment, not an AI-assisted diagnostic tool that human readers would interpret. The document explicitly states: "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate, nor its safety and effectiveness."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation (bench testing) was performed for the device's technical specifications and software functionality, but not in the context of an AI-driven "algorithm only" performance study. The device's core function is automatic pressure control, which is inherently "standalone" in its operation once user-defined parameters are set. The reported performance metrics (e.g., pressure accuracy, alarm functions) reflect this standalone operational capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the technical performance was based on engineering specifications, compliance with international standards (IEC 60601 series), and the established performance of the predicate device. For the software, the ground truth was derived from the requirements defined during the software development life cycle, validated through verification and validation testing against these requirements.
8. The sample size for the training set
This information is not applicable as the device is a cuff controller based on established physical principles and software logic, not a machine learning model that requires a "training set" for its core function as described.
9. How the ground truth for the training set was established
This information is not applicable as no training set for a machine learning model is mentioned or relevant to the described device. The "ground truth" for the device's functional performance was established through engineering design, compliance with regulatory standards, and validation against specification requirements.
FDA 510(k) Clearance Letter - CuffGuard
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 12, 2025
Idmed
Perrine Moelle
Quality & Regulatory Affairs Director
3 rue John Maynard Keynes
Marseille, 13013
France
Re: K243562
Trade/Device Name: CuffGuard
Regulation Number: 21 CFR 868.5750
Regulation Name: Inflatable Tracheal Tube Cuff
Regulatory Class: Class II
Product Code: BSK
Dated: July 7, 2025
Received: July 7, 2025
Dear Perrine Moelle:
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.
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"
U.S. FOOD & DRUG ADMINISTRATION
August 12, 2025
Idmed
Perrine Moelle
Quality & Regulatory Affairs Director
3 rue John Maynard Keynes
Marseille, 13013
France
Re: K243562
Trade/Device Name: CuffGuard
Regulation Number: 21 CFR 868.5750
Regulation Name: Inflatable Tracheal Tube Cuff
Regulatory Class: Class II
Product Code: BSK
Dated: July 7, 2025
Received: July 7, 2025
Dear Perrine Moelle:
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.
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 2
K243562 - Perrine Moelle Page 2
(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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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.
Page 3
K243562 - Perrine Moelle Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
| Submission Number (if known) | K243562 |
|---|---|
| Device Name | CuffGuard |
Indications for Use (Describe)
The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
510(k) Summary
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter
Submitter: IDMED
Hotel Technoptic
2 rue Marc Donadille
13013 Marseille France
+33 (0)974 980 541
Establishment Registration Number: N° DUNS 260233256
Contact person: Perrine MOLLE
Quality & Regulatory Affairs Director
E-mail: p.molle@idmed.fr
Date Summary Prepared: 2025/07/03
2. Device
Trade Name: CuffGuard (references CG-MU_ID and CG-MU_DR)
Common/Usual Name: Tracheal tube cuff Pressure Controller
Regulation Name: Inflatable tracheal tube cuff
Classification Regulation: 21 CFR 868.5750
Product Code: BSK
Regulatory Class: Class II
3. Predicate device
Predicate Device: Intellicuff, manufactured by Hamilton Medical, K150893
1.1. Device description
The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical
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510(k) – CuffGuard 5-2
ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.
It is used by health professionals (doctor or nurse) specifically trained in this tool.
The CuffGuard has a pressure sensor and software that can monitor and automatically adjust the cuff pressure.
The accessories associated include:
- Connection tube with filter
- Power supply
- Micro USB connection cable
- Fixation clamp and its tilt block)
At a high level, the comparison of the subject and predicate devices is based on the following table:
| Features | CuffGuard | Intellicuff |
|---|---|---|
| Product code | BSK | BSK |
| Regulation number | 868.5750 | 868.5750 |
| Class | II | II |
| Indication for use | ||
| Intended use | The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff. | The IntelliCuff device is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation |
| Environment of use | In a professional health care setting such as hospital or health care facility: in an Intensive Care Unit, an Operating Room and during intra-hospital transportation. | Intensive care units, operating rooms, and during interhospital transport:- In the intensive care ward or in the recovery room- In the operation room during intubation narcosis- For emergency medical care or primary care- During transport within and outside of the hospitalDuring transfer by rescue vehicles, ship, jet, or helicopter |
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510(k) – CuffGuard 5-3
| Features | CuffGuard | Intellicuff |
|---|---|---|
| Product code | BSK | BSK |
| Regulation number | 868.5750 | 868.5750 |
| Class | II | II |
| User | Health professional (doctor or nurse) specifically trained in this tool | Trained and qualified professionals under the supervision of a doctor and within the limits of the technical specifications indicated |
| Patient population | Adult and pediatric | Adults, pediatrics, and neonates, who are intubated with ETT or TT |
| Contraindication | None known. Note that any contraindication to the use of the endotracheal tube will result in a contraindication to the use of the CuffGuard | None identified in the IFU |
Principle of operation and performances
| Principe of operation | Software-controlled pressure supervision and automatic pressure adjustmentPressure sensorUse of ambient / room air | Software-controlled pressure supervision and automatic pressure adjustmentPressure sensorUse of ambient / room air |
| Type of control | Automatic | Automatic |
| Pressure range | 5 – 40 cmH2O | 5 – 50 cmH2O |
| Accuracy of the control | +/- 2cmH2O | +/- 2cmH2O |
| Adjustement of accuracy | +/- 1cmH2O | +/- 1cmH2O |
| Display of accuracy | +/- 1cmH2O | +/- 1cmH2O |
Technology characteristics
| Leak alarm | Yes | Yes |
| Pressure alarm | Yes | Yes |
| Stop sound alarm | Yes | Yes |
| Audible alarm | Yes | Yes |
| Visual alarm | Yes | Yes |
| Deflate Cuff | Yes | Yes |
| Inflate Cuff | Yes | Yes |
| Time-limited hold | Yes | Yes |
| Choice of unit | Yes | Yes |
| Energy | Battery and AC power supply | Battery and AC power supply |
| Portable device | Yes | Yes |
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510(k) – CuffGuard 5-4
| Features | CuffGuard | Intellicuff |
|---|---|---|
| Product code | BSK | BSK |
| Regulation number | 868.5750 | 868.5750 |
| Class | II | II |
| General safety | Compliant to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8 | Compliant to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-12 |
Biological characteristics
| Patient contact material | NA, no patient contact | NA, no patient contact |
1.2. Indications for use
The CuffGuard is an endotracheal tube cuff controller designed to continuously monitor and maintain user-defined endotracheal tube cuff pressure for patients (adults and pediatrics) who require mechanical ventilation and who are intubated with endotracheal tube including cuff in the ICU, OR and for intra-hospital transport.
The following differences exist between subject and predicate device:
- The subject device is not indicated to be used on tracheostomy tube (TT)
- The subject device is not indicated to be used on neonate population of patient
- The subject device is not indicated to be used during transfer by rescue vehicles, ship, jet or helicopter
However, these differences do not raise questions of safety and effectiveness, because:
- the indication not applicable for the subject device (Tracheostomy tube),
- the population not applicable for the subject device (neonate),
- the environment of use not applicable for the subject device (transfer by rescue vehicles, ship, jet, or helicopter),
are not considered for the comparison.
The subject device and its predicate device are both used in the same clinical conditions or purposes (adult or pediatric patients requiring mechanical ventilation for whom the cuff pressure of an endotracheal tube (ETT) is monitored) and are used by the same kind of users (trained medical professional). They have the same principle of operation, using a pressure sensor and air pump).
4. Comparison of technological characteristics with the predicate device
The technological principle of the subject device is to maintain and automatically adjust thanks to embedded software, the cuff pressure of intubating tubes using a pressure sensor and a pump.
The following technological difference exists between subject device and its predicate device:
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510(k) – CuffGuard 5-5
- The pressure range of the subject device is not as wide as its predicate device
However, this difference is supported by performance data (Software verification or safety test reports). Furthermore, this difference does not raise different questions of safety and effectiveness and does not negatively affect the clinical performances for the following reason:
- Difference of pressure range has been evaluated on the SW verification and validation. Furthermore, this difference is not clinically significant as the use of pressure range until 40 cm H2O appears as a realistic physiological limit and as a common clinical practice used as shown on various publications.
5. Performance data
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the CuffGuard device. The system complies with the IEC 60601-1, IEC 60601-1-6 and IEC 60601-1-8 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." The documentation level for CuffGuard software is enhanced.
Animal and Clinical Studies
No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate, nor its safety and effectiveness.
6. Conclusions
Based on its intended use, design principles, and technological characteristics, the CuffGuard device was found to be as safe, as effective, and performs comparably to the predicate device.
The technological differences identified do not raise new questions of safety and effectiveness as the non-clinical and clinical literature data support the safety of the device and the hardware and software verification and validation demonstrate that the CuffGuard device should perform as intended in the specified use conditions.
§ 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).