(141 days)
Not Found
No
The summary describes a standard, disposable tracheostomy tube made of PVC, with no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The performance studies focus on material properties and dimensional conformity to standards.
No
The device is described as a tracheostomy tube for airway management, which is a supportive and management tool, not one that treats a disease or condition therapeutically.
No
Explanation: The device is described as a "single patient disposable tracheostomy tube for airway management". Its purpose is to facilitate breathing in tracheostomized patients, which is a therapeutic function, not a diagnostic one. It does not measure, analyze, or detect any medical condition.
No
The device description clearly states it is a physical tracheostomy tube made from PVC, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "airway management of tracheostomotized patients." This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and materials of the tracheostomy tube, which are relevant to its function in maintaining an airway.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for diagnosing a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This tracheostomy tube is used in vivo (inside the body) for airway management.
N/A
Intended Use / Indications for Use
The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.
Product codes
BTO
Device Description
The tracheostomy tubes are made from the raw material of PVC for medical use, with the The trachetoney wave. The tracheostomy tubes have such good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility.
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
Not Found
Intended User / Care Setting
Not Found
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
The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1 and ISO 5366-3.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K0512684
FEB 1 7 2005
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | Well Lead Medical Instruments Ltd
Jinhu Industrial Estate, Hualong, Panyu,
Guangzhou City, China 511434 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|
| | Phone: +8620 84752978
Fax: +8620 84758224 |
| Contact Person: | Huan Guang Yuan, han@welllead.com.cn |
| Date of Summary: | October 1, 2004 |
| Trade/Proprietary Name: | Well Lead Tracheostomy Tubes |
| Classification Name: | Tracheostomy Tube |
| Product Code: | BTO |
| Predicate Device: | Rusch Tracheofix Set, Cuffed and Uncuffed - K021764 |
| Intended Use: | The device is a single patient disposable tracheostomy
tube for airway management of tracheostomotized
patients. |
Device Description:
The tracheostomy tubes are made from the raw material of PVC for medical use, with the The trachetoney wave. The tracheostomy tubes have such good performances as the tube with appropriate hardness, the cuff with big capacity and low pressure, smooth tube and excellent biocompatibility.
Device Performance:
The dimension, design, material, sterility and packaging of Well Lead tracheostomy tubes are conformed with ISO 5366-1 and ISO 5366-3.
Device Comparison: The device has the same dimensions and design as the predicate device (Section 9).
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation. The seal is presented in black and white, giving it a formal and official appearance.
Public Health Service
FEB 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Well Lead Medical Instruments Limited C/O Mr. Arthur J. Ward Regulatory Consultant AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K042684
Trade/Device Name: Well Lead Tracheostomy Tube Regulation Number: 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: II Product Code: BTO Dated: January 3, 2005 Received: January 6, 2005
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have roviewed your secure mined 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 merslate commerce priors that have been reclassified in accordance with the provisions of Amendinents, or to actrices and motic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of an 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 If your device is classified (500 additional controls. Existing major regulations affecting (1 MA), it may of subject to tach of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsther announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Ward
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements Incall that I DX mas made a actessiand regulations administered by other Federal agencies. of the Act of ally I oderal title Act sequirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Part 607), laceling (21 CFR Pat 820) regulation (21 CFR Part 820); and if requirents as sectionic 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) I mis letter will anow Jourse of Journalial equivalence of your device to a premairer notification and 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), rryou desire specific and 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 maj obtain 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,
Solita H. Michio m.D.
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
3
Indications for Use
K042684 510(k) Number (if known):
Device Name: Well Lead Tracheostomy Tubes
Indications for Use: The device is a single patient disposable tracheostomy tube for airway management of tracheostomotized patients.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
liii Julion
Page 1 of 1
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042684