The Accucuff Cuff Pressure Indicator is intended to monitor intra-cuff pressures of endotracheal, supraglottic airways or tracheostomy tubes. The device is indicated for the patients from pediatric to adult who have an artificial airway and for which the user would like to monitor cuff pressure.

Device Description

The Accucuff™ Cuff Pressure Indicator is intended to monitor the cuff pressure of endotracheal, supraglottic airways or tracheostomy tubes. It is designed with different color coded zones to indicate the normal, negative and positive pressure. The black marker on the device will be moved when the cuff pressure is changed. The device is available in 10-20 cmH2O, 20-29 cmH2O and 40-60 cmH2O three different models to accommodate the intended populations from pediatric to adult.

AI/ML Overview

The provided text describes the Accucuff Cuff Pressure Indicator, a device intended to monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal "acceptance criteria" table from a study, but rather a comparison table (Table 1) outlining the proposed device's specifications against predicate devices, and then details of non-clinical tests performed. We can extract the relevant performance metrics and the proposed device's performance from these sections.

Performance Characteristic	Acceptance Criteria (Implicit from Predicate & Standards)	Reported Device Performance (Accucuff Cuff Pressure Indicator)
Pressure Range	Not explicitly stated as acceptance criteria, but compared to predicate ranges: Predicate 1: 0~~80cm H2O, Predicate 2: 0~~30cm H2O	AC0100P: 10~~20cm H2OAC0100B: 20~~29cm H2OAC0100R: 40~60cm H2O (Available in three different models to cover different ranges)
Pressure Accuracy	Predicate 1: +/-5cm H2O up to 80cm H2OPredicate 2: +/-5% H2O up to 30cm H2O, +/-0.5cm H2O up @ 10cm H2O, +/-1cm H2O up @ 20cm H2O, +/-1.5cm H2O up @ 30cm H2O	10~~20cm H2O: +/-2cm H2O20~~29cm H2O: +/-2cm H2O40~60cm H2O: +/-4cm H2O (Stated as less than Predicate 2 in some ranges, but more than Predicate 1)
Biocompatibility	Conform with ISO 10993 requirements (implied by predicate, explicitly tested)	No cytotoxicity, No skin sensitization, No irritation. Conforms with ISO 10993-1, ISO 10993-5, ISO 10993-10.
Sterilization	Effective sterilization (implied by sterile predicate)	EO sterilization, 10^-6 SAL, established and validated per ISO 11135.
Conical Fitting	Compliance with ISO 594-1:1986	Complies with ISO 594-1:1986.
Package Integrity	Maintain integrity (implied by ASTM standards)	Complies with ASTM F88/F88M-15 and ASTM F1929-15. Tested after accelerated aging.
Environmental Stability	Maintain performance after exposure to temp/transport (implied by tests)	Pressure Accuracy tested after exposure to cold and hot temperature. Performance maintained after Simulated Transportation Test.
Repeatability	Maintain consistent pressure accuracy (implied by "Repeatability Pressure Accuracy Test")	Test performed, results indicate compliance (details not provided, but implies acceptance).

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

The document describes non-clinical tests, not human subject clinical trials. Therefore, there is no "test set" in the context of patient data (e.g., medical images, patient records). The samples used would be individual units of the Accucuff Cuff Pressure Indicator device. The specific number of devices tested for each non-clinical test (e.g., how many units for pressure accuracy, how many for biocompatibility) is not provided.

There is no data provenance related to country of origin of data or retrospective/prospective nature, as this was not a clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. As this was a non-clinical device performance study, there was no "ground truth" to be established by human experts in a diagnostic or clinical context. The "ground truth" for the device's performance relies on objective measurements against established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set:

Not applicable, as there was no test set requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size:

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical study is included in this submission."

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The Accucuff Cuff Pressure Indicator is a mechanical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply. The non-clinical tests evaluated the device's inherent mechanical performance.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests was established through:

Established engineering and performance standards: Such as ISO 594-1 for conical fittings.
Biocompatibility standards: ISO 10993 series for cytotoxicity, irritation, and skin sensitization.
Packaging standards: ASTM F88/F88M-15 and ASTM F1929-15 for seal strength and leak detection.
Internal design specifications: For characteristics like pressure range and accuracy, evaluated against the specified values.
Reference measurements: The "Pressure Accuracy Test" and "Repeatability Pressure Accuracy Test" would have involved comparing the device's readings against a calibrated reference pressure measurement device.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

Summary

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Tianjin Medis Medical Device Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, China, 200120

Re: K182548

Trade/Device Name: Accucuff Cuff Pressure Indicator Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: September 7, 2018 Received: September 17, 2018

Dear Diana Hong:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 D. Courtney -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182548

Device Name Accucuff Cuff Pressure Indicator

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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K182548

1. Date of Preparation: 12/26/2018
1. Sponsor Identification

Tianjin Medis Medical Device Co., Ltd.

No.15-A, Saida One Avenue, Xiqing Economic Development Area, Tianjin, P.R. China

Establishment Registration Number: 3004992992

Contact Person: Yongzhi Wu Position: Quality Manager Tel: +86- 13920213115 Fax: +86-22- 83988486 Email: wuyongzhi3115@126.com

Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Accucuff™ Cuff Pressure Indicator Common Name: Cuff Pressure Indicator

Regulatory Information

Classification Name: Cuff, Tracheal Tube, Inflatable Classification: II; Product Code: BSK Regulation Number: 21CFR 868.5750 Review Panel: Anesthesiology

Device Description

Intended Use Statement:

The Accucuff™ Cuff Pressure Indicator is intended to monitor intra-cuff pressures of endotracheal, supraglottic airways or tracheostomy tubes. The device is indicated for the patients from pediatic to adult who have an artificial airway and for which the user would like to monitor cuff pressure.

న. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K142103 Trade Name: Cuff Pilot™

Predicate Device 2 510(k) Number: K102704 Trade Name: Easy Cuff™

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	Table 1 Comparison of Technology Characteristics

Item	Proposed Device	Predicate Device 1	Predicate Device 2	method	pressure		pressure
Product Code	BSK	K142103	K102704	Types of airways to which it can be used	Supraglottic airway	Supraglottic airway	Supraglottic airway
Regulation Number	868.5750	868.5750	868.5750		Endotracheal tube		Endotracheal tube
Class	CLASS II	CLASS II	CLASS II		Tracheostomy tube		Tracheostomy tube
Intended Use	The AccucuffTM Cuff Pressure Indicator is intended to monitor intra-cuff pressures of endotracheal, supraglottic airways or tracheostomy tubes. The device is indicated for the patients from pediatric to adult who have an artificial airway and for which the user would like to monitor cuff pressure.	To monitor intra-cuff pressures of supraglottic airwaysPatient population:Patients who have an artificial airway and for which the user would like to monitor cuff pressure, pediatric to adult.Environment of UseTo be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may have an artificial airway. It may also be used in MRI suites when attached to airways that are MR conditional or MR Safe.	To inflate cuffs and to measure and monitor intra-cuff pressures of endotracheal, supraglottic airways, or tracheostomy tubes.Patient population:Patient who are intubated.Environment of useTo be used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities and outpatient clinics, where a patient may be intubated	Sterile	EO sterilization, 10-6	Non-sterile, sterile	Non-sterile
Range of measured pressure	AC0100P: 10~~20cm H2OAC0100B: 20~~29cm H2OAC0100R: 40~60cm H2O	0~80cm H2O	0~30cm H2O	Single Use	Single Use	Single Use	Single Use
Pressure accuracy	10~~20cm H2O :+/-2cm H2O20~~29cm H2O: +/-2cm H2O40~60cm H2O: +/-4cm H2O	+/-5cm H2O up to 80cm H2O	+/-5% H2O up to 30cm H2O+/-0.5cm H2O up @ 10cm H2O+/-1cm H2O up @ 20cm H2O+/-1.5cm H2O up @ 30cm H2O	Material	Polycarbonate (PC);Silicone	Unknown	Unknown
Pressure indication	Black mark that move with changes in	Bellows that move with changes in pressure	Bellows that move with changes in	Biocompatibility
Cytotoxicity	No cytotoxicity	Conform with ISO 10993 requirements	Conform with ISO 10993 requirements
Skin Sensitization	No skin sensitization
Irritation	No irritation

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Intended Use

The proposed device has the indication of monitoring in endotracheal and trachestomy in addition to monitoring the pressure of supraglotic airway compared with the predicate device K142103. However, the two additional indications are covered by predicate device K102704. Therefore, this difference does not raise different safety and effectiveness questions.

Pressure Range

The range of measured pressure for proposed devices individually compared. The proposed device is available in three different pressure ranges. However, pressure range compared with the specifications of the predications of the predicates cleared previously.

Pressure Accuracy

The pressure accuracy for proposed devices. Although the pressure accuracy for prossure accuracy for proposed device is less than

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predicate device K102704, the proposed device has a more than predicate device K142103. Therefore, the accuracy difference does not raise different safety and effectiveness questions.

Airway Type

The type of airway for which the proposed device is different from predicate device K142103. The proposed device has the additional airway of monitoring endotracheal tube and tracheostomy tube which are identical to predicate device K102704.

Sterilization

The proposed device is provided sterile which is different from the sterilization method is established and validated per ISO 11135, which ensures the effectiveness of sterilization.

Material

The biocompatibility test (per ISO 10993) has been performed on the results do not show any adverse effect, which demonstrates biocompatibility of the proposed device.

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Non-Clinical Test Summary 6.
Non-clinical tests were conducted to verify that the proposed device met all the design specifications to establish Substantial Equivalence (SE) with the predicate devices. Test items include:

Conical fitting Performance Test Pressure Accuracy Test Repeatability Pressure Accuracy Test Pressure Accuracy Test exposure to cold and hot temperature Simulated Transportation Test Package Integrity Test Pressure Accuracy and Package Integrity after Accelerated Aging

The test results demonstrate that the proposed device complies with the following standards:

A ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment-Part 1: General requirement
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity;
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization;
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed device is Substantially Equivalent (SE) to the predicate devices.

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).