(174 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a tracheostomy tube, with no mention of AI or ML capabilities.
Yes
The device is described as providing an "artificial airway" and assisting "in the treatment of a variety of respiratory diseases and airway management," which indicates a therapeutic purpose.
No
Explanation: The device is used to provide an artificial airway for treatment and airway management. It does not diagnose conditions or diseases.
No
The device description clearly describes a physical medical device (tracheostomy tube) made of materials and secured with a tie strap, with in-vitro performance testing focused on physical properties like bond strength and burst strength. There is no mention of software as a component or the primary function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To provide tracheal access for airway management." This describes a device used in vivo (within the body) to facilitate breathing, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details a physical tube inserted into the trachea to create an artificial airway. This is a therapeutic and supportive device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are typically used to test samples from the body to diagnose diseases, monitor conditions, or screen for health issues. This device's function is purely mechanical and related to airway management.
N/A
Intended Use / Indications for Use
To provide tracheal access for airway management.
Product codes (comma separated list FDA assigned to the subject device)
73 JOH
Device Description
These devices are used to provide an artificial airway, in order to assist in the treatment of a variety of respiratory diseases and airway management in adults. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the devices are then secured in place with a tiestrap around the patient's neck, which is attached to the tracheostomy tube's swivel neck plate/flange. Once in place, these devices provide a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment. The intended use of the modified devices will continue to be provision of tracheal access for airway management in adults.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neck and trachea
Indicated Patient Age Range
adults
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)
A. In-vitro performance data:
Test: Tie Strap Hole Strength
Predicate Device Test Results: 26.7 lbs force (SCT)
Modified Device Test Results: 45.8 lbs force
CEN Standard Requirements: No requirement for this test parameter
Test: Outer cannula body to Trach Head Base Bond Strength
Predicate Device Test Results: 143.0 lbs force (SCT)
Modified Device Test Results: 55.0 lbs force
CEN Standard Requirements: No requirement for this test parameter
Test: Trach Head Base-to-Head Cap Bond
Predicate Device Test Results: N/A
Modified Device Test Results: 90.5 lbs force
CEN Standard Requirements: No requirement for this test parameter
Test: Cuff Burst Strength
Predicate Device Test Results: 8.3 lbs force (SCT)
Modified Device Test Results: 6.6 lbs force
CEN Standard Requirements: No requirement for this test parameter
Test: 15mm Connector Disconnect Force
Predicate Device Test Results: 19.1 lbs force (SCT)
Modified Device Test Results: 19.4 lbs force
CEN Standard Requirements: No requirement for this test parameter
Test: Neck Plate to Trach Tube Body Attachment Strength
Predicate Device Test Results: 42.1 lbs force (DCT)
Modified Device Test Results: 27.7 lbs force
CEN Standard Requirements: minimum 11.3 lbs force
B. Clinical Data: Clinical data was not necessary, since device performance can be adequately assessed by in-vitro testing.
In conclusion, the similarities to the predicate devices, in conjunction with the physical integrity test results, demonstrate that the proposed modifications to these devices do not impact 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.
K890194A, K962173, K861463, K861462, K810106, K871204, K912230
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
§ 868.5800 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
7411261
Appendix F
Page 1 of 4
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510(k) Class II SUMMARY
| Date Submitted: | April 2, 1997 |
|---|---|
| Submitter: | Mallinckrodt Medical, Inc. |
| Owner/Operator Number #1925021, | |
| 675 McDonnell Blvd. | |
| St. Louis, MO 63134 | |
| Contact Person: | Michael Schoeck, Regulatory Affairs Associate |
| Mallinckrodt Medical, Inc. | |
| 675 McDonnell Blvd. | |
| St. Louis, MO 63134 (corporate offices) | |
| (314) 895-2318 (phone) or (314) 895-2344 (fax) | |
| Device Name: | Shiley Extended Length, Disposable Cannula, Tracheostomy Tube |
| Common Name and Classification: | Tracheostomy Tube and tube cuff. 21 CFR 868.5800 |
Predicate Devices:
| Predicate Device Names | Product Designations | 510(k) Number | |
|---|---|---|---|
| 1. | Smiths Industries Medical Systems | ||
| (SIMS), Profile Tracheostomy | |||
| Tubes with Portex Flexible Inner | |||
| Cannulas. | "100/528/xxx" for 'Profile' Tracheostomy | ||
| Tube with Flexible Inner Cannula | |||
| "100/522/xxx" for Separate Flexible Inner | |||
| Cannulas (sold separate from Tracheostomy | |||
| tubes ) | |||
| (where "xxx" is the O/D size) | Marketed in Europe | ||
| since approx. 1992 (see | |||
| product literature in | |||
| Appendix C). No | |||
| 510(k) filed in USA | |||
| (Mallinckrodt owns the | |||
| U.S. patent). | |||
| 2. | Specialized Tracheostomy Tubes | "MODIFIED xxx" (where xxx is the | |
| usual product designation of the modified | |||
| tube) | K890194A, 7/20/89 | ||
| 3. | Shiley Disposable Cannula, Low | ||
| Pressure, Cuffed Tracheostomy | |||
| Tube with Soft Swivel Neck Flange | |||
| feature. | DCT and DIC (standard Disposable Inner | ||
| Cannula included with DCT Tracheostomy | |||
| Tube) | K962173, 10/4/96 | ||
| 4. | Shiley Sleep Apnea Cuffed and | ||
| Cuffless Tracheostomy Tubes | SLP (cuffed) | ||
| SCS (cuffless) | K861463, 5/6/86 | ||
| K861462, 5/6/86 | |||
| 5. | Shiley Single Cannula | ||
| Tracheostomy Tube | SCT | K810106, 2/2/81 |
1
| Predicate Device Names | Product Designations | 510(k) Number |
|---|---|---|
| 6. Mallinckrodt Cuffed Tracheal Tube | Hi-Lo Tracheal Tubes | K871204, 4/21/87 |
| 7. Mallinckrodt Critical Care | ||
| Broncho-Cath Right Endobronchial | ||
| Tube with CPAP Valve | 85815, 85816, 85817, and 85818 | K912230, 8/22/91 |
Device Description:
1
These devices are used to provide an artificial airway, in order to assist in the treatment of a variety of respiratory diseases and airway management in adults. After insertion in place through a tracheotomy incision in the patient's neck and trachea, the devices are then secured in place with a tiestrap around the patient's neck, which is attached to the tracheostomy tube's swivel neck plate/flange. Once in place, these devices provide a secure artificial airway for spontaneous breathing or direct hook-up to ventilation or anesthesia equipment.
The intended use of the modified devices will continue to be provision of tracheal Intended Use: access for airway management in adults.
Comparison of Technological Characteristics of Subject Versus Predicate Devices:
Similarities:
- . The new devices will be available in extended lengths, up to 105mm (compared to the standard Shilev DCT). These lengths are comparable to the predicate Shiley Specialized Tracheostomy Tubes.
- .
- . The new devices will be available in cuffed and uncuffed versions.
- Like predicate Shiley tracheostomy tubes, each Extended Length tracheostomy tube will be packaged . with an obturator and neckstrap.
- Soft Swivel Neck Flange: This feature was found to be substantially equivalent to the current stiff . swivel neck flange design in 510(k) #K962173 (cleared 10/4/96).
- The new devices' inflation cuffs will utilize the same material used in the Mallinckrodt Broncho-Cath . Endobronchial Tube.
Differences:
- . Non-arcuate tracheostomy tube shapes (compared to the arcuate standard Shiley DCT): The Extended Length Tracheostomy Tubes devices will vary in tube length along the proximal end of the tube (before the curvature of the tube) or along the distal end of the tube (after the curvature of the
2
tube), in order to accommodate unique anatomical needs. Comparable non-arcuate trach tube shapes are currently available in the predicate Shiley Specialized Trach Tubes and the Shiley Sleep Apnea Trach Tubes.
- Flexible extended length, disposable Inner Cannula. In order to accommodate the extended proximal . and distal section lengths of these new devices, it was necessary to develop a more flexible Disposable Inner Cannula. The new flexible Extended Length Inner Cannula ("XIC") has a "corrugated" appearance which allows the inner cannula increased lateral flexibility, while maintaining appropriate column strength. The predicate SIMS Profile device a flexible disposable Inner Cannula.
- . The new XIC Disposable Inner Cannula terminates in an integral 15mm push-lock Connector (current 15mm connectors on standard Disposable Inner Cannulae (DIC) feature an integral snap-lock connector design).
- . More flexible Outer Cannula body than the standard Shiley DCT (comparable to the predicate Mallinckrodt Hi-Lo Tracheal Tubes).
Performance/Clinical Data:
A. In-vitro performance data:
| Test | Predicate Device
Test Results | Modified Device Test
Results | CEN Standard
Requirements |
|--------------------------------------------------------|----------------------------------|---------------------------------|-------------------------------------------|
| Tie Strap Hole Strength: | 26.7 lbs force
(SCT) | 45.8 lbs force | No requirement for this
test parameter |
| Outer cannula body to Trach Head
Base Bond Strength | 143.0 lbs force
(SCT) | 55.0 lbs force | No requirement for this
test parameter |
| Trach Head Base-to-Head Cap
Bond | N/A | 90.5 lbs force | No requirement for this
test parameter |
| Cuff Burst Strength | 8.3 lbs force
(SCT) | 6.6 lbs force | No requirement for this
test parameter |
| 15mm Connector Disconnect Force | 19.1 lbs force
(SCT) | 19.4 lbs force | No requirement for this
test parameter |
| Neck Plate to Trach Tube Body
Attachment Strength: | 42.1 lbs force
(DCT) | 27.7 lbs force | minimum 11.3 lbs force |
- B. Clinical Data: Clinical data was not necessary, since device performance can be adequately assessed by in-vitro testing.
In conclusion, the similarities to the predicate devices, in conjunction with the physical integrity test results, demonstrate that the proposed modifications to these devices do not impact safety or effectiveness.
3
Summary:
The data presented demonstrate that the proposed modifications (extended proximal and distal lengths, flexible spiral inner cannula design) to Shiley Tracheostomy Tubes does not impact device performance characteristics and, thus, does not raise new safety and efficacy questions. This information supports the conclusion that the modified Shiley Tracheostomy Tubes and accessories are substantially equivalent in intended use, operation, and characteristics, as compared to existing legally marketed devices.
4
Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
SEP 2 5 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Michael B. Schoeck Mallinckrodt Inc. 675 McDonnell Boulevard P.O. Box 5840 St. Louis, Missouri 63134
Re: K971267 Shiley Extended Length, Disposable Cannula, Tracheostomy Tubes (Models XCS-D, XCS-P, XLT-D, and XLT-P) Regulatory Class: II (two) Product Code: 73 JOH Dated: July 25, 1997 Received: July 28, 1997
Dear Mr. Schoeck:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Paqe 2 - Mr. Michael B. Schoeck
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Calyahan, Ph.D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
K971267 510(k) Number (if known): ______________________________________________________________________________________________________________________________________________________________________________
Device Name: Shiley Extended Length, Disposable Cannula, Tracheostomy Tubes (Models XCS-D, XCS-P, XLT-D, and XLT-P)
Indications for Use:
To provide tracheal access for airway management.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | |
| (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices | (Optional Format 1-2-96) |
| 510(k) Number |