TTCF is indicated for the treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients with a cuff deflated fenestrated tracheostomy tube. TTCF is indicated for hospital use in adult patients.

Device Description

The TTCF Gas Delivery System is a gas supply and humidification system mounted on a medical stand. Components include an oxygen blender, a flow meter, pressure relief valve, humidifier, and pressure monitor. A blended source of compressed air and oxygen allow choosing flow rate and FiO2 of the mixture. Flows are delivered at 6-15 LPM. Oxygen concentrations are available from 21% to 77%.

AI/ML Overview

The provided text describes a 510(k) submission for the CS Medical TTCF Gas Delivery System. This is a medical device, not an AI/ML software. Therefore, the questions regarding acceptance criteria, study details, ground truth, and expert evaluation are not applicable in the context of AI/ML performance.

The document primarily focuses on establishing "substantial equivalence" of the new device to a legally marketed predicate device (Transtracheal Systems, Inc., TTHF-1000, K981078). This involves demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Here's a breakdown of the information provided, re-contextualized to the device clearance process:

1. Acceptance Criteria and Reported Device Performance:

The concept of "acceptance criteria" for an AI/ML model's performance (e.g., sensitivity, specificity thresholds) is not relevant here. Instead, the "acceptance criteria" for device clearance are focused on demonstrating:

Hazard Analysis: Acceptable and mitigated potential hazards (following ISO 14971).
Electrical Safety: Demonstrated for individual components.
Effectiveness: Demonstrated for individual components by previous 510(k) clearance (i.e., the components themselves are already proven safe and effective).
Biocompatibility: Plastic materials meet ISO 10993.
Substantial Equivalence: The device is designed, labeled, and verified for performance and safety in a manner that makes it substantially equivalent to the predicate device.

Reported Device Performance (against the concept of substantial equivalence):

Indications for Use: Same as predicate device (treatment of hypoxemia with delivery of transtracheal high flows of heated and humidified air/oxygen mixture to self-breathing adult patients with a cuff deflated fenestrated tracheostomy tube).
High Flow Oxygenation: Same as predicate (high flow oxygenation for treatment of hypoxemia in self-breathing adult patient populations).
Heated/Humidified Air-Oxygen Mixtures: Same as predicate.
Open System Support: Both devices support an open system.
Flow Rates: Same as predicate (6-15 LPM delivering oxygen mixture up to 77%).

Differences noted but deemed not to impact substantial equivalence:

Intended Use Environment: TTHF-1000 for home use, TTCF for hospital use.
System Delivery Pressure: Substantially lower for the TTCF system at the catheter.
Oxygen Supply: TTCF uses facility piped oxygen, predicate uses an air compressor.

2. Sample Size for Test Set and Data Provenance:

This section is not applicable to traditional medical device clearance. No "test set" in the AI/ML sense (e.g., a dataset of images with ground truth labels) was used. The evaluation involves engineering testing and comparison to an existing device.

3. Number of Experts and their Qualifications:

This is not applicable. The evaluation does not involve clinical experts establishing ground truth for a dataset. The clearance process relies on regulatory experts at the FDA reviewing the manufacturer's provided documentation.

4. Adjudication Method:

This is not applicable. No adjudication of expert opinions on a dataset was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable. The device is a gas delivery system, not an AI diagnostic or assistive tool for human readers.

6. Standalone Performance Study:

This is not applicable in the AI/ML sense. The "effectiveness" of individual components was "demonstrated... by previous 510(k) clearance," meaning the sub-components had their own standalone performance verified previously. The current submission demonstrates the system's integration and safety.

7. Type of Ground Truth Used:

This concept is not applicable. There's no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of validating an AI/ML algorithm's performance. The "truth" in this context is adherence to safety standards, engineering specifications, and functional equivalence to a predicate device.

8. Sample Size for Training Set:

This is not applicable. The device is not an AI/ML algorithm, so there is no training set.

9. How Ground Truth for Training Set was Established:

This is not applicable for the same reason as above.

Summary

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K050381

510(k) Summary CS Medical Adult TTCF Gas Delivery System

JUL 1 3 2005

CS Medical, Inc. 6151 Songbird Circle Boulder, CO 80303 303-817-1789 303-337-5050 fax James Seiler, CEO

Prepared 7-11-05 L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 303-530-4774 fax

Device Name: CS Medical TTCF Gas Delivery System, Class II, 868.5330 BZR

Common Name: Transtracheal Continuous Flow (TTCF) Gas Delivery System

SE Predicate Device: Transtracheal Systems, Inc., TTHF-1000, K981078, 868.5450

Device Description:

Indications for Use:

Characteristics of proposed versus predicate device:

Both devices have the same indication for use, high flow oxygenation for treatment of hypoxemia in self breathing adult patient populations. Heated and humidified air-oxygen mixtures are the same. Both devices support an open system.

Flow rates are the same at 6-15 LPM delivering oxygen mixture up to 77%

Differences:

The TTHF-1000 is intended for home use and the TTCF for hospital use. The system delivery pressure at the catheter (patient interface) is substantially lower for the TTCF system. The TTCF oxygen supply is facility piped and the predicate from an air compressor.

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Non-Clinical Data:

Hazard Analysis following ISO 14971demonstrates acceptable and mitigated potential hazards.
Electrical safety is demonstrated for the individual components.
Effectiveness has been demonstrated for the individual components by previous 510(k) clearance.
Plastic materials meet ISO 10993 for biocompatibility.

Conclusion: The TTCF Gas Delivery System is designed, labeled, and verified for performance and safety. The device is substantially equivalent to the legally marketed predicate.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles a caduceus or a staff with a serpent entwined around it, representing health and medicine.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2005

CS Medical, Incorporated c/o Lewis Ward L. W. Ward and Associates, Incorporated 4655 Kirkwood Court Boulder, Colorado 80301

Re: K050381

Trade/Device Name: Transtracheal Continuous Flow Gas Delivery System Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: June 25, 2005 Received: June 27, 2005

Dear Mr. Ward:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Ward

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Qur Solom k
Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital 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):

Device Name: Transtracheal Continuous Flow Gas Delivery System ريني

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (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)

Aun Sylrom

Koris 98

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: _

Regulation Number and Section

§ 868.5330 Breathing gas mixer.

(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).