(262 days)
Not Found
No
The device description and intended use are for a standard endotracheal tube and stylet, with no mention of software, algorithms, or any features that would suggest AI/ML capabilities. The lack of information on training/test sets and performance studies further supports this conclusion.
No.
The device is an endotracheal tube used for airway management, which is a supportive rather than a therapeutic function.
No
The device, an endotracheal tube, is intended for intubation and airway management, which are therapeutic and management functions, not diagnostic ones. There is no mention of it being used to detect, monitor, or identify a disease or condition.
No
The device description clearly states it is constructed of Polyvinylchloride and includes physical components like a tube, cuff, tip, connector, and stylet, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "oral or nasal intubation and for airway management." This describes a procedure performed directly on a patient to manage their airway, not a test performed on a sample taken from a patient to diagnose a condition or provide information about their health status.
- Device Description: The device is an endotracheal tube, a physical device used to maintain an open airway. It does not involve reagents, calibrators, or other components typically associated with in vitro diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
In summary, the MedSource Endotracheal Tube and Pre-Loaded Endotracheal Tube and Stylet are medical devices used for a therapeutic/procedural purpose (airway management), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management.
Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.
Product codes (comma separated list FDA assigned to the subject device)
BTR, BSR
Device Description
MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet:
• Constructed of Polyvinylchloride
• Single lumen tube with or without a cuff;
• Tapered tip with Murphy Eye;
• Clear medical-grade tubing(polyvinyl) with graduations;
• Connector with check valve;
• Pre-loaded with Stylet having a low friction coating;
• Various sizes
• Sterile Single-Use Device
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were conducted for safety or effectiveness.
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.
K925505, K925506, K952100, K031794, K042683
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
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for MedSource International. The logo features a stylized cross made of horizontal lines, with the name "MedSource" in a bold, italicized font. Below the name is the word "INTERNATIONAL" in a smaller, non-italicized font.
Koro39
Image /page/0/Picture/2 description: The image shows a logo with an ambulance above a globe. The ambulance is depicted in a simple, black-and-white line drawing, with a visible cross symbol on its side. Below the ambulance, a globe is represented by a grid of curved lines, suggesting a global or international scope. The letters 'TM' are visible in the bottom right corner of the image.
5346 Shoreline Drive, Mound, MN 55364
October 26, 2008 | | | | | | | | |
SECTION 510(K) Summary র্বাচন করে পার্টি করে একটি পার্টি পাট করে না বিশ্বকাপ করে আমার প্রকল্পে করে আমার প
This 510(K) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
| Submitter's | MedSource International, LLC |
|---|---|
| Information: | 5346 Shoreline Drive |
| Mound, MN 55364 | |
| O: | (952) 472-0131 |
| F: | (952) 472-0136 |
| FDA Establishment Registration No.: | 3003674698 |
OCT 2 7 2008
Contact Person: Howard Cooper Quality Consultant EQACT, INC. 317-826-4398 (0) 317-523-2314 (C) htc@eqact.com
1
SECTION 510(K) Summary
| Device Names: | |||
|---|---|---|---|
| Trade/Proprietary | |||
| Names: | (1) MedSource Endotracheal Tube | ||
| (with and without cuff), (stylet sold separately) | |||
| (2) MedSource Pre-Loaded Endotracheal Tube and Stylet | |||
| (Pre-loaded ET Tube with Stylet; with and without cuff). | |||
| Common/Usual | |||
| Name: | Endotracheal Tube; Tracheal Tube; Trach Tube; ET Tube. | ||
| (with and without connector), (cuffed and uncuffed), | |||
| (with and without stylet) | |||
| Common/Usual | |||
| Name: | Stylet. | ||
| Classifications: | |||
| Endotracheal Tube | Stylet | ||
| Panel: | |||
| Regulatory Reference: | |||
| Classification Name: | |||
| Product Code: | |||
| Device Class | Anesthesiology | ||
| 21 CFR §868.5730 | |||
| Tracheal Tube | |||
| BTR | |||
| Class II | Anesthesiology | ||
| 21 CFR §868.5790 | |||
| Tracheal Tube Stylet | |||
| BSR | |||
| Class I; 510k Exempt | |||
| Description: | |||
| MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet: | |||
| • Constructed of Polyvinylchloride | |||
| • Single lumen tube with or without a cuff; | |||
| • Tapered tip with Murphy Eye; | |||
| • Clear medical-grade tubing(polyvinyl) with graduations; | |||
| • Connector with check valve; | |||
| • Pre-loaded with Stylet having a low friction coating; | |||
| • Various sizes | |||
| • Sterile Single-Use Device | |||
| Intended Use: |
Indications for Use: MedSource Endotracheal Tube:
The device is intended for oral or nasal intubation and for airway management.
Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.
Prescription Use: (21 CFR 801(D)) Yes
2
Technological Characteristics: 10 comments of 1 comments of 1
| Characteristics | MedSource | Predicate Devices |
|---|---|---|
| Materials of Construction | Polyvinyl Chloride | Equivalent |
| Sizes | Typical product sizes | Same |
| Method of Use | Manual | Manual |
| Murphy's Eye | Yes | Yes |
| Pilot Balloon | Yes | Yes |
| With & Without Stylet | Yes | Yes |
Standards
| Standard | Title | Status of Compliance |
|---|---|---|
| ISO 5361:1999 | ISO 5361:1999, Anaesthetic and respiratory equipment - Tracheal tubes and connectors | Compliant to applicable sections |
| ISO10993-1 | ||
| edition-1997-12-15 | (2nd Biological Evaluation Of Medical Devices— | |
| Part 1: Evaluation and Testing | Compliant to applicable sections per testing |
| Substantial Equivalence Discussion | ||
|---|---|---|
| Description | MedSource | Predicate Devices |
| Device | (1) MedSource Endotracheal Tube | |
| (with and without cuff), (stylet sold separately) |
(2) MedSource Pre-Loaded Endotracheal Tube and Stylet
(Pre-loaded ET Tube with Stylet; with and without cuff). | K925505; K925506
Rusch™ Flexi-Set® Cuffed ET Tube and Stylet Set
K952100 K031794
EndoFlex™ Tracheal Tube
K042683
Well Lead™ ET Tube |
| Intended Use | The device is intended for oral or nasal intubation and for airway management. | Exact or similar wording |
| Materials of
Construction | Polyvinyl Chloride | Equivalent |
| Single Use/Sterile | Yes | Yes |
| Murphy's Eye | Yes | Yes |
| Pilot Balloon | Yes, as applicable to product | Yes, as applicable to product |
| With & Without
Stylet | Yes | Yes |
| Instructions for
Use | Similar or identical wording for all devices | |
3
October 26, 2008
Conclusion:
Based on the following, it can be concluded that the MedSource Endotracheal Tube is substantially equivalent to the predicate devices listed above:
-
- Intended use is the same.
-
- Materials of construction or the same or equivalent.
-
- Both the MedSource and the predicate devices have product features such as a Murphy's Eye and Pilot balloon.
-
- Instructions for use are the same.
Clinical Studies .
No clinical studies were conducted for safety or effectiveness.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2008
MedSource International, LLC C/O Mr. Howard T. Cooper President EQACT, Incorporated 11715 Fox Road, Suite 400-180 Indianapolis, Indiana 46236
Re: K080339
Trade/Device Name: MedSource Endotracheal Tube (with and without Cuff), (Stylet Sold Separately) MedSource Pre-Loaded Endotracheal Tube and Stylet (with and without Cuff)
Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: September 24, 2008 Received: September 24, 2008
Dear Mr. Cooper:
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.
5
Page 2 - Mr. Cooper
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Himmelsfrend und frey
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
6
Indications for Use Statement
SECTION 4
510(k) Number: Initial Submission Device Names: Common or Usual Names: Endotracheal Tube; ET Tube; Tracheal Tube; Trach Tube Proprietary Names: (1) MedSource Endotracheal Tube (with and without cuff), (stylet sold separately); (2) MedSource Pre-Loaded Endotracheal Tube and Stylet (with and without cuff). Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management.
Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylef: The device is intended for oral or nasal intubation and for airway management.
Prescription Use: (21 CFR 801 (D)) Yes
Over-the-Counter Use: (21 CFR 801 (C)} No
Please do not write below this line. Continue on another page if needed. Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080339