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 Catheter is constructed of clear, latex-free plastics with a radiopaque stripe for identification by x-ray. A rounded tip facilitates insertion and minimizes potential mucous irritation or injury. The catheter is 4 mm O.D. used within an adult Portex Blue Line Fenestrated Tracheostomy Tube. Inner diameter is 3.1 mm in 11.5, 13.5 and 15.5 cm lengths. The distal end is an 11 mm connector capable of attaching to the CS Medical Mid-section Hose. The catheter is supplied sterile and designed as single patient use.

AI/ML Overview

The provided text describes a medical device, the CS Medical Adult TTCF Catheter and Mid Section Hose, and its 510(k) submission. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the format requested.

The document is a 510(k) summary and FDA clearance letter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study against predefined acceptance criteria.

Here's what can be inferred and what is missing relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing. The document explicitly states "Non-Clinical Data" but presents findings as general statements of equivalence or mitigation, not as specific acceptance criteria with corresponding quantified performance results.

Acceptance Criteria	Reported Device Performance
Missing	Missing

2. Sample size used for the test set and the data provenance:

Missing. No information on a "test set" or specific study subjects (sample size) is provided. The non-clinical data points refer to material testing and flow rate comparisons, which typically wouldn't involve a "test set" in the context of human subject data. The data provenance is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Missing. This information is relevant for studies involving expert review (e.g., imaging studies). No such study or expert involvement is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Missing. As no test set with expert adjudicated ground truth is mentioned, an adjudication method is not applicable.

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:

Missing. This type of study (MRMC, AI assistance) is not mentioned and is typically associated with AI/software-as-a-medical-device (SaMD) rather than a physical catheter.

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

Missing. This is also relevant for SaMD and does not apply to this physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Missing. For the "Non-Clinical Data" mentioned, the "ground truth" would be engineering specifications and standards (e.g., ISO 10993 for biocompatibility, measured flow rates) rather than clinical ground truth types like pathology or expert consensus.

8. The sample size for the training set:

Missing. No training set is applicable or mentioned for this type of device submission.

9. How the ground truth for the training set was established:

Missing. As no training set is mentioned, this information is not applicable.

Summary of available information related to performance/safety (Non-Clinical Data):

The document only provides general statements about non-clinical data:

Non-Clinical Data:
1. Materials meet ISO 10993 for biocompatibility.
2. Flow rates are comparable to the predicate and accurate (6-15 LPM for CS Medical device vs. 6-12 LPM for predicate).
3. Potential hazards are identified and mitigated.
4. The catheter is designed, labeled, and verified for performance and safety.

This information indicates that engineering and biocompatibility testing was performed, and the performance (flow rates) was compared to the predicate device to establish substantial equivalence. However, it does not detail specific acceptance criteria, study methodologies, or quantitative results in the manner requested for a detailed performance study.

Summary

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510(k) Summary CS Medical Adult TTCF Catheter and Mid Section Hose

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

Prepared 6-9-05 L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 303-530-4774 fax

Device Name: Transtracheal Continuous Flow (TTCF) Catheter Common Name and Classification: Tube, Tracheostomy, Class II, 868.5800 BTO Predicate Device: Scoop-1 Catheter, Transtracheal Systems, Inc. and Transtracheal Systems, Inc. TTHF-1000 Mid Section Hose

Device Description:

Indications for Use:

Characteristics of proposed versus predicate devices:

Intended Use: Both the CS Medical and Transtracheal catheters and hose are used for high flow supplemental oxygen for the treatment of hypoxemia. Catheters are available in three lengths. The products are intended for use in open systems.

Flow rates are comparable at 6-12 LPM for the Transtracheal and 6-15 LPM for the CS Medical device.

Both products are designed for adults.

Both catheters have radiopaque stripes used for location during x-ray. Catheters are sold sterile.

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Differences:

Differences.

The TTCF catheter is introduced via tracheostomy tube where the SCOOP-1 Catheter is introduced via a tracheocutaneous fistulous tract.

miroduced via a trachedualleda ilstallous track
2. The TTCF Catheter has a standard 15 mm tracheostomy tube connector where the SCOOP-1 Catheter attaches to the neck via a flange and securing necklace.

Catherer and includes to the TTCF Gas Delivery System via an 11 mm connector and 3. The Fref Catheter connector attaches to the Gas Delivery System via a standard female luer connector.

comicelor.
4. Recommended use for the TTCF Catheter is limited to 24 hours to prevent mucous build-up, 4. Recommended as 10. "Le "Le" and promote general hygiene in hospital patients versus longer periods for the predicate which is intended for use in the home.

Non-Clinical Data:

Materials meet ISO 10993 for biocompatibility.
Flow rates are comparable to the predicate and accurate.
How faces are companse to the possible and mitigated potential hazards.
The catheter is designed, labeled, and verified for performance and safety.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the circle's perimeter.

Public Health Service

JUL 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050379

Trade/Device Name: Transtracheal Continuous Flow Catheter Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy tube and tube cuff Regulatory Class: II Product Code: BTO 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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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 fu
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 Catheter

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)

Amy Julian

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

510(k) Number:

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.