(121 days)
No
The device description and performance studies focus on mechanical modifications and in-vitro testing, with no mention of AI or ML.
Yes.
The device is a tracheostomy tube, which is used to provide an artificial airway for "treatment of a variety of respiratory diseases and airway management in adults," directly indicating its therapeutic purpose.
No
The device is a tracheostomy tube used to provide an artificial airway for respiratory management, not to diagnose a condition.
No
The device description clearly details a physical medical device (tracheostomy tube) with a modified hardware component (swivel neck plate/flange). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "provision of tracheal access for airway management in adults." This describes a device used in vivo (within the body) to facilitate breathing, not a test performed in vitro (outside the body) on biological samples to diagnose or monitor a condition.
- Device Description: The description details a physical device inserted into the trachea to create an artificial airway. This is a therapeutic and supportive device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with IVD devices.
The device described is a tracheostomy tube, which is a medical device used for airway management.
N/A
Intended Use / Indications for Use
The intended use of the modified devices with continue to be provision of tracheal access for airway management in adults.
Product codes
Not Found
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.
Each device described in this present notification will be essentially identical to an existing Shiley Tracheostomy Tube. The only modification to each of these nine marketed devices will be replacement of the current stiff swivel neck plate/flange with a soft, contoured swivel neck plate/flange to facilitate conformity to individual neck anatomies and, thus. improve patient comfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's 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: 32.1 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: 22.7 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 soft swivel neck plate/flange modification to these devices does not impact safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K792222, K811033, K812302, K811447, K843729, K865061, K880614, K945513, K810106
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
OCT 4 1996
Appendix E Page 1 of 3
510(k) Class II SUMMARY
Date Submitted: May 31, 1996
- Submitter: Mallinckrodt Medical, Inc. Establishment Registration Number 2029387, 18691 Jamboree Road Irvine, CA 92715
- Contact Person: Michael Schoeck, Regulatory Affairs Associate Mallinckrodt Medical, Inc. 675 McDonnell Blvd. Hazelwood, MO 63134 (corporate offices) (314) 895-2318 (phone) or (314) 895-2355 (fax)
- Device Name: Shiley Tracheostomy Tubes
Common Name and Classification: Tracheostomy Tube and tube cuff, 21 CFR 868.5800
Predicate Devices:
| Predicate Device Name | Product Designation | 510(k) Number | |
|---|---|---|---|
| 1. | Shiley Low Pressure, Cuffed Tracheostomy Tube | LPC | K792222, 12/18/79 |
| K811033, 5/13/81 | |||
| 2. | Shiley Fenestrated, Low Pressure, Cuffed Tracheostomy | ||
| Tube | FEN | K812302, 9/8/81 | |
| 3. | Shiley Cuffless Tracheostomy Tubes | CFS (non-fenestrated) | |
| CFN (fenestrated) | pre-amendment | ||
| 5. | Shiley Disposable Cannula, Low Pressure, Cuffed | ||
| Tracheostomy Tube | DCT | K811447, 6/26/81 | |
| 6. | Shiley Disposable Cannula, Fenestrated, Low Pressure, | ||
| Cuffed Tracheostomy Tube | DFEN | K843729, 10/19/84 | |
| K865061, 1/15/87 | |||
| 7. | Shiley Disposable Cannula, Cuffless Tracheostomy | ||
| Tubes | DCFS (non-fenestrated) | ||
| DCFN (fenestrated) | K880614, 3/9/88 | ||
| 8. | Shiley Pediatric/Neonatal Tracheal Tubes | PED | |
| NEO | K945513, 1/13/95 | ||
| 9. | Shiley Single Cannula Tracheostomy Tube | SCT | K810106, 2/2/81 |
:' .
1
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.
Each device described in this present notification will be essentially identical to an existing Shiley Tracheostomy Tube. The only modification to each of these nine marketed devices will be replacement of the current stiff swivel neck plate/flange with a soft, contoured swivel neck plate/flange to facilitate conformity to individual neck anatomies and, thus. improve patient comfort.
| Products Which will Incorporate the new Soft Swivel Neck Plate/flange | Product Designation) | |
|---|---|---|
| 1. | Shiley Low Pressure, Cuffed Tracheostomy Tube | LPC |
| 2. | Shiley Fenestrated, Low Pressure, Cuffed Tracheostomy Tube | FEN |
| 3. | Shiley Cuffless Tracheostomy Tube (non-fenestrated) | CFS |
| 4. | Shiley Cuffless Tracheostomy Tube (fenestrated) | CFN |
| 5. | Shiley Laryngectomy Tube | LGT |
| 6. | Shiley Disposable Cannula, Low Pressure, Cuffed Tracheostomy Tube | DCT |
| 7. | Shiley Disposable Cannula, Fenestrated, Low Pressure, Cuffed | |
| Tracheostomy Tube | DFEN | |
| 8. | Shiley Disposable Cannula, Cuffless Tracheostomy Tube (non-fenestrated) | DCFS |
| 9. | Shiley Disposable Cannula, Cuffless Tracheostomy Tube (fenestrated) | DCFN |
Intended Use:
The intended use of the modified devices with continue to be provision of tracheal access for airway management in adults.
Comparison of Technological Characteristics of Subject Versus Predicate Devices:
Similarities:
- The modified tracheostomy tubes will be identical to their respective predicate devices in intended use, . indications for use, ID, OD, length, # of fenestrations, location and size of fenestrations, cannula bend, and in their packaged accessories.
- . The modified trach tubes will feature a soft (not rigid) neck plate design like the predicate PED/NEO and SCT devices.
- All materials used in the modified tracheostomy tubes and their packaged accessories will remain the ● same as the predicate devices. Only the configuration and materials of the swivel neck plate/flange on each device will change.
- The product designations (i.e., model #'s) for each of the modified Trach Tubes will remain the same. .
2
- Since the soft swivel neck plate/flange is used clinically in the same way as the previous rigid swivel . neck plate/flange, it will be unnecessary to modify the Instructions for Use.
Differences:
- The swivel neck plate/flanges have changed from a uniformly rigid polycarbonate design to a . configuration which combines both rigid and soft biocompatible plastic materials.
The new neck plate/flange will feature a rigid copolyester core for strength. The pins upon which the neck plate/flange swivels (after connection to the main body of the Trach tube) are part of this rigid inner core.
Soft PVC will then be overmolded around the rigid core to form the outer surface of the swivel neck plate/flange. Thus, the outer surface of the neck plate will be soft and flexible along the edges.
- . The soft swivel neck plate/flange will also be slightly larger and more contoured than the current design to facilitate patient comfort.
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) | 32.1 lbs force | No requirement for this
test parameter |
| Neck Plate to Trach Tube Body
Attachment Strength: | 42.1 lbs force
(DCT) | 22.7 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 soft swivel neck plate/flange modification to these devices does not impact safety or effectiveness.
Summary:
The data presented demonstrate that the proposed modification (soft swivel neck plate/flange) 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.