(235 days)
Not Found
No
The device description and intended use focus on mechanical pressure regulation and do not mention any AI/ML components or capabilities.
No.
The device's primary function is to inflate an endotracheal tube cuff for sealing purposes, which is a supportive function in a medical procedure rather than directly treating a disease or condition.
No
The device's function is to inflate and regulate the pressure in the cuff of an endotracheal tube, which is a therapeutic rather than a diagnostic action. It does not identify a disease, condition, or provide a diagnosis.
No
The device description explicitly states it is a "disposable syringe" made of "medical grade ISO approved plastic material," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The SCIS is a mechanical device used to inflate the cuff of an endotracheal tube. It directly interacts with a medical device (the ETT) and the patient's airway, but it does not analyze any biological samples from the patient.
- Intended Use: The intended use is to inflate a cuff to a specific pressure, which is a physical action, not a diagnostic test.
The device is a medical device used in a clinical setting for patient care, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
BSK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's trachea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
It will be used under medical supervision in hospitals, pre-hospitals (Emergency Medical Services), hospital emergency rooms and intensive care units, extended care facilities, and out-patient clinics where patients may be intubated.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
APPENDIX B
MAY 25 2012
510(K) Summary Page 1 of 3 March 28th, 2012
1129/5
| Spiritus Technologies LLC
12005 W. 100th Terrace
| Lenexa, 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® - K912723 |
| Mallinckrodt Tracheal Tube Cuff – K885216 |
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.
Mallinckrodt Lanz Tracheal Tube Cuff - K791045
| Indications for Use: | The SCIS will be used to inflate to 25cmH2O ± an average standard
deviation of 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, pre-hospitals
(Emergency Medical Services), hospital emergency rooms and intensive
care units, extended care facilities, and out-patient clinics where patients
may be intubated. |
| Contraindications: | Tracheal tubes designed for pediatric patients or bronchial cuffs of
double lumen tubes. |
SPIRITUS TECHNOLOGIES
1
510
piritus Cuff Inflator Syringe – SCIS – Comparison to Predicate Products
| ETT Cuff Inflator
(accessory) Attributes | SCISTM | Cufflator® | Mallinckrodt
Hi-Lo Tracheal Tube | Mallinckrodt Hi-Lo Lanz
Tracheal Tube (510k ref: GV-
10 Lanz Pressure Valve) |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
(summary) | Inflates tracheal tube cuff to
pressure of 25±2 cmH2O | Inflates/deflates and monitors
inflatable tracheal tube cuff
pressure | Patient airway management
(tracheal tube) | -Patient airway management
(tracheal tube)
-Inflates and regulates inflatable
tracheal tube cuff pressure (Lanz
valve) |
| Classification/Regulation/
Code | BSK - Inflatable Tracheal
Tube Cuff (accessory) | BSK - Inflatable Tracheal Tube
Cuff (accessory) | BSK - Inflatable Tracheal Tube
Cuff (accessory) | BTR - Tube, Tracheal (w/wo
connector) |
| 510(k) Number | K112915 | K912723 | K871204 | K791045 |
| Patient Population | Intubated patients - single
patient - disposable | Intubated patients - reusable | Intubated patients - single
patient - disposable | Intubated patients - single
patient - disposable |
| Single patient, disposable | YES | NO | YES | YES |
| Environments of Use | Under medical supervision in
hospitals, pre-hospitals (EMS),
emergency rooms (ER),
extended care facilities, out-
patient clinics where patient
may be intubated. | Under medical supervision in
hospitals, pre-hospitals (EMS),
emergency rooms (ER),
extended care facilities, out-
patient clinics where patient
may be intubated. | Under medical supervision in
hospitals, pre-hospitals (EMS),
emergency rooms (ER),
extended care facilities, out-
patient clinics where patient
may be intubated. | Under medical supervision in
hospitals, pre-hospitals (EMS),
emergency rooms (ER),
extended care facilities, out-
patient clinics where patient
may be intubated. |
| Final Cuff Inflation Pressure | 25±2 cmH20 | 0 to 120 cmH2O (set by user) | Not Specified | 26±2 cmH20 |
| Precision of Cuff Pressure
Measurement | ±2 cml-120* | ±3.8 cmH2O | Not Specified | ±2 cmH2O |
| Establishing final pressure | Automatically set by device
mechanical design | Manually set by user | Manually set by user | Automatically set by device
mechanical design |
| Power | Manual | Manual | NA | Manual |
| Contraindications | None | None | None | None |
SPIRITUS TECHNOLOGIE
Page: 4 of 9
REV A
2
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.
3
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.
4
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
5
Image /page/5/Picture/0 description: The image shows a word that is heavily obscured by a black rectangle. The visible parts of the word suggest it might be "APPENDIX". The black rectangle covers most of the word, making it difficult to read.
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
or
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