The SCIS will be used to inflate to 25±2 cmH2O the cuff of a high-volume, low-pressure endotracheal tube that has been intubated by a trained medical professional.

Device Description

The Spiritus Cuff Inflation Syringe (SCIS) is a disposable syringe that will initially inflate the cuff on an endotracheal tube (ETT) to a pressure of 79 cmH2O ± an average standard deviation of 9 cmH2O to create a proper seal with the patients trachea and then automatically decrease the pressure in the cuff to a final pressure of 25cm H2O ± an average standard deviation of 2 cmH2O. The SCIS is designed in the form of a syringe to reflect current practice of using a syringe to inflate the cuff. The device is made of medical grade ISO approved plastic material. The SCIS is intended as a single patient use disposable device.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Spiritus Cuff Inflation Syringe (SCIS)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Target Performance)	Reported Device Performance (Spiritus Cuff Inflation Syringe - SCIS)
Initial Cuff Inflation Pressure: 79 cmH2O ± an average standard deviation of 9 cmH2O (for sealing)	79 cmH2O ± an average standard deviation of 9cm (achieved)
Final Cuff Pressure: 25 cmH2O ± an average standard deviation of 2 cmH2O	25 cmH2O ± an average standard deviation of 2cmH2O (achieved)
Precision of Cuff Pressure Measurement: Not explicitly stated as acceptance, but comparison shows.	±2 cmH2O

Note: The provided text is a 510(k) summary and discusses substantial equivalence to predicate devices rather than detailing a dedicated study with acceptance criteria and results. The "reported device performance" above is derived from the device description and the claim of achieving these specific pressure outcomes automatically. The 510(k) process focuses on demonstrating substantial equivalence, not necessarily on a formal study proving acceptance criteria in the same way a PMA would.

The provided document is a 510(k) Summary, which is a premarket notification to the FDA. For such submissions, a comprehensive "study" proving device performance against detailed acceptance criteria, especially for a new technology, is often not presented in a single, dedicated clinical trial report within the summary. Instead, the focus is on demonstrating substantial equivalence to already legally marketed predicate devices.

Based on the document, the "study" demonstrating the device meets the acceptance criteria is implicit within the technical description and comparison to predicate devices:

Study Type (Implicit): Technical performance evaluation/bench testing demonstrating the automatic inflation and pressure reduction capabilities of the device. This is inferred from the declarative statements about the device's function and the comparison against predicate devices which also achieve specific pressure ranges.

Specific Information Points:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The document describes the device's intended performance and capabilities, and compares it to predicate devices. It does not provide details of a specific test set size (e.g., number of devices tested, number of inflation cycles).
- Data Provenance: Not specified. This would typically be from bench testing conducted by the manufacturer, but no details are given. It is not mentioned as clinical data (retrospective or prospective) from patient use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Number of Experts: Not applicable/not specified. The device's performance (pressure inflation/reduction) is a physical measurement, not a subjective interpretation requiring expert consensus on a "ground truth" in the diagnostic imaging sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable/none. As this is a mechanical device performing a specific physical function, expert adjudication of results in the traditional sense is not relevant. The device's internal mechanics are designed to achieve the specified pressure through engineering rather than human judgment.
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:
- MRMC Study: No. This is a medical device (syringe for cuff inflation), not a diagnostic algorithm or AI-powered tool. An MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, implicitly. The device is designed to automatically perform the inflation and pressure reduction. The human simply operates the syringe; the mechanical design handles the pressure regulation automatically. The text states: "the SCIS device establishes high and low cuff pressures automatically" and "Automatically set by device mechanical design."
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Mechanical measurement of physical pressure. The "ground truth" for the device's function is the absolute pressure within the cuff, measured by appropriate pressure sensors during design and testing.
The sample size for the training set:
- Sample Size for Training Set: Not applicable. This is a mechanical device, not an AI or machine learning algorithm that requires a "training set."
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. As above, no training set or AI is involved.

Summary

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APPENDIX B

MAY 25 2012

510(K) Summary Page 1 of 3 March 28th, 2012

1129/5

Spiritus Technologies LLC12005 W. 100th TerraceLenexa, KS 66215	Tel: 913-205-5493
Official contact:	Brandon Close, President
Proprietary or Trade Name:	Spiritus Cuff Inflation Syringe (SCIS)
Common / Usual Name:	Cuff Inflation Syringe, Accessory
Classification Name:	Inflatable Tracheal Tube Cuff (accessory)BSK – 868.5750
Predicate Devices:	Posey Cufflator® - K912723Mallinckrodt Tracheal Tube Cuff – K885216

Device Description:

Mallinckrodt Lanz Tracheal Tube Cuff - K791045

Indications for Use:	The SCIS will be used to inflate to 25cmH2O ± an average standarddeviation of 2 cmH2O the cuff of a high-volume, low-pressureendotracheal tube that has been intubated by a trained medicalprofessional.
Patient Population:	Patient who is to be intubated.
Environment of Use:	It will be used under medical supervision in hospitals, pre-hospitals(Emergency Medical Services), hospital emergency rooms and intensivecare units, extended care facilities, and out-patient clinics where patientsmay be intubated.
Contraindications:	Tracheal tubes designed for pediatric patients or bronchial cuffs ofdouble lumen tubes.

SPIRITUS TECHNOLOGIES

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510

piritus Cuff Inflator Syringe – SCIS – Comparison to Predicate Products

ETT Cuff Inflator(accessory) Attributes	SCISTM	Cufflator®	MallinckrodtHi-Lo Tracheal Tube	Mallinckrodt Hi-Lo LanzTracheal Tube (510k ref: GV-10 Lanz Pressure Valve)
Indications for Use(summary)	Inflates tracheal tube cuff topressure of 25±2 cmH2O	Inflates/deflates and monitorsinflatable tracheal tube cuffpressure	Patient airway management(tracheal tube)	-Patient airway management(tracheal tube)-Inflates and regulates inflatabletracheal tube cuff pressure (Lanzvalve)
Classification/Regulation/Code	BSK - Inflatable TrachealTube Cuff (accessory)	BSK - Inflatable Tracheal TubeCuff (accessory)	BSK - Inflatable Tracheal TubeCuff (accessory)	BTR - Tube, Tracheal (w/woconnector)
510(k) Number	K112915	K912723	K871204	K791045
Patient Population	Intubated patients - singlepatient - disposable	Intubated patients - reusable	Intubated patients - singlepatient - disposable	Intubated patients - singlepatient - disposable
Single patient, disposable	YES	NO	YES	YES
Environments of Use	Under medical supervision inhospitals, pre-hospitals (EMS),emergency rooms (ER),extended care facilities, out-patient clinics where patientmay be intubated.	Under medical supervision inhospitals, pre-hospitals (EMS),emergency rooms (ER),extended care facilities, out-patient clinics where patientmay be intubated.	Under medical supervision inhospitals, pre-hospitals (EMS),emergency rooms (ER),extended care facilities, out-patient clinics where patientmay be intubated.	Under medical supervision inhospitals, pre-hospitals (EMS),emergency rooms (ER),extended care facilities, out-patient clinics where patientmay be intubated.
Final Cuff Inflation Pressure	25±2 cmH20	0 to 120 cmH2O (set by user)	Not Specified	26±2 cmH20
Precision of Cuff PressureMeasurement	±2 cml-120*	±3.8 cmH2O	Not Specified	±2 cmH2O
Establishing final pressure	Automatically set by devicemechanical design	Manually set by user	Manually set by user	Automatically set by devicemechanical design
Power	Manual	Manual	NA	Manual
Contraindications	None	None	None	None

SPIRITUS TECHNOLOGIE

Page: 4 of 9

REV A

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510(K) Summary Page 3 of 3 February 10th, 2012

The Spiritus Cuff Inflation Syringe, SCIS, is viewed as substantially equivalent to the predicate devices listed below:

Posey Cufflator (K912723) - Both the Cufflator and SCIS are cuff inflation devices used in medical environments where patients are intubated. Both devices are used to temporarily inflate the cuff to elevated pressures between 60-90 cmH20 to seat the cuff against the patient's trachea; both devices utilize valves to drop this elevated pressure down to 22-32 cmH2O. Whereas the Cufflator user sets these pressures manually by referring on the Cufflator instruction manual, the SCIS device establishes high and low cuff pressures automatically (79 cmH2O ± an average standard deviation of 9cm and 25 cmH2O ± and average standard deviation of 2cmH2O respectively). SCIS does not monitor pressure as does the Cufflator, yet the SCIS instruction manual calls for the subsequent use of Minimum Occluding Volume and Minimum Leak techniques in conjunction with an intra-cuff pressure measuring device.

Mallinckrodt Hi-Lo Tracheal Tube (K871204) -- The materials found in the cuff inflation valve of the Hi-Lo Tracheal Tube include a stainless steel spring, a plastic housing, and a rubber gasket; these materials are substantially equivalent to those present in SCIS. Furthermore, the instruction manual for the Hi-Lo Tube calls for the use of a standard syringe to inflate the Hi-Lo cuff. Since SCIS functions as a syringe, this procedure is substantially equivalent.

Mallinckrodt Hi-Lo Tracheal Tube with Lanz Pressure Valve (K791045) - Both the Lanz valve and SCIS are used to automatically inflate the cuff to a specific pressure. Furthermore, the final cuff pressures left by Lanz and SCIS are substantially equivalent (26 cmH2O ± an average standard deviation of 2 cmH2O and 25cmH2O± an average of 2cmH2O respectively). Lastly, the instruction manual of the Hi-Lo Lanz Tracheal Tube, like that of the Hi-Lo Tube, calls for the use of a standard syringe to inflate the Hi-Lo cuff.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Mr. Brandon W. Close President Spiritus Technologies. LLC 12005 West 100th Terrace Lenexa. Kansas 66215

MAY 25 2012

Re: K112915

Trade/Device Name: Spiritus Cuff Inflation Syringe (SCIS) Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: II Product Code: BSK Dated: May 14, 2012 Received: May 15, 2012

Dear Mr. Close:

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. 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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Page 2- Mr. Close

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hn. for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

510(k) Number: K112915

Device Name: Spiritus Cuff Inflation Syringe (SCIS)

Indications for Use:

The SCIS will be used to inflate to 25±2 cmH2O the cuff of a high-volume, low-pressure endotracheal tube that has been intubated by a trained medical professional.

Patient Population:

Patient who is to be intubated.

Environment of Use:

It will be used under medical supervision in hospitals (Emergency Medical Services), hospital emergency rooms and intensive care units, extended care facilities, and out-patient clinics where patients may be intubated.

Prescription Use XX

Over-the-counter use __

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulten

510(k) Number: U_1129/5

SPIRITUS TECHNOLOGIES

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).