(148 days)
Not Found
No
The device description and performance studies focus on standard gas delivery and humidification components, with no mention of AI or ML capabilities.
Yes
The device is indicated for the "treatment of hypoxemia," which is a medical condition, making it a therapeutic device.
No
The device is described as a "gas supply and humidification system" intended for treatment of hypoxemia, delivering air/oxygen mixtures. Its components (blender, flow meter, humidifier, pressure monitor) and function are focused on delivering therapeutic gases, not on diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components including an oxygen blender, flow meter, pressure relief valve, humidifier, and pressure monitor, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "treatment of hypoxemia with delivery of transtracheal high flows of a heated and humidified air/oxygen mixture to self-breathing patients". This describes a therapeutic intervention, not a diagnostic test performed on in vitro samples.
- Device Description: The device description details a gas delivery and humidification system. This aligns with a respiratory support device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the TTCF Gas Delivery System is a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BZR
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%.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospital use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
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%.
Indications for Use:
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.
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.
1
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.
2
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.
3
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
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: Transtracheal Continuous Flow Gas Delivery System ريني
Indications for Use:
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.
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: _