(91 days)
Not Found
No
The device description focuses on mechanical components and configurations of suction catheters, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The primary function described is the suctioning of airway secretions, which is a supportive rather than a therapeutic/treatment function in itself.
No
Explanation: The device is a suction catheter used for removing airway secretions. Its intended use is therapeutic (suctioning), not diagnostic (identifying a disease or condition).
No
The device description clearly outlines physical components like suction catheters, protective sleeves, patient connectors, and irrigation ports, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Patients requiring suctioning of airway secretions." This describes a procedure performed directly on a patient to remove physical material from their airway.
- Device Description: The device is a suction catheter system designed to physically remove secretions. It involves tubing, a control valve, and potentially a protective sleeve and patient connector. These are all components for a physical intervention.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. This device does not involve the analysis of specimens outside the body.
The device is clearly intended for a therapeutic or procedural use directly on the patient's airway, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Indicated use - Patients requiring suctioning of airway secretions
Product codes
Not Found
Device Description
Hudson RCI intends to introduce a full range of suction catheters and configurations. In summary these are:
- Suction catheters only 1.
- Suction catheter with a protective sleeve only 2.
- Continuous ventilating suction catheter system with patient connector 3. and irrigation port
Each product incorporates the same suction catheter tubing and suction control valve. The differences are whether the device has -
-
protective sleeve for catheter
-
Incorporates a patient connector for direct attachment to the patient airway connector and ventilator circuit
-
Patient connector is a "Tee" or an "Angled" configuration which may also incorporate a swivel feature
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Neonates to adults
Intended User / Care Setting
Where removal of airway secretions is performed, generally, hospital, ICU settings, facilities with mechanical ventilator care, ER and EMS
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K872621, K902383, K902687, preamendment, K760371
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.
0
6.9
Image /page/0/Picture/1 description: The image shows a logo for Hudson RCI. The logo features a stylized "H" with a design that resembles lungs. The text "HUDSON RCI" is written below the symbol. The logo is black and white.
NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS
November 16, 1995
CATH-GUIDE
CATH-GUIDE
Hudson Respiratory Care Inc. 27711 Diaz Rd., P.O. Box 9020 Temecula, CA 92589-9020
Tel - (909) 676-5611 Fax - (909) 676-1578
Proprietary or Trade Name:
Suction catheter, tracheobronchial Common/Usual Name:
Intended Device:
Predicate Devices:
| Ballard Medical Products, Inc. | Trach Care Catheter | K872621 |
|---|---|---|
| Concord/Portex | Steri-cath | |
| Steri-cath double lumen | ||
| Maxi-Flo Suction Catheter | K902383 | |
| K902687 | ||
| preamendment | ||
| Davol | Sleeved suction catheter only | preamendment |
| Dryden Comoration | Vent-02-Cath | K760371 |
Device Description:
Hudson RCI intends to introduce a full range of suction catheters and configurations. In summary these are:
- Suction catheters only 1.
- Suction catheter with a protective sleeve only 2.
- Continuous ventilating suction catheter system with patient connector 3. and irrigation port
Each product incorporates the same suction catheter tubing and suction control valve. The differences are whether the device has -
- protective sleeve for catheter
C - ARC
1992 ZENITH 1989
AWARD
HUDSON RESPIRATORY CARE INC. 27711 Diaz Road · P.O. Box 9020 Temacula, CA 92589-9020 Tel. 909-676-5611 · Fax 909-676-1578
1
Non-Confidential Summary of Safety and Effectiveness (continued)
Device description: (continued)
-
Incorporates a patient connector for direct attachment to the patient airway connector and ventilator circuit
-
Patient connector is a "Tee" or an "Angled" configuration which may also incorporate a swivel feature
Intended use:
frameses
.
Indicated use - Patients requiring suctioning of airway secretions
Targeted population - Neonates to adults
Environment of use - Where removal of airway secretions is performed, generally, hospital, ICU settings, facilities with mechanical ventilator care, ER and EMS
Comparison to predicate devices:
| | Continuous Ventilating
Systems | | | Standard Catheter
Only | | | |
|----------------------------------------------------------------------------------------------------------|-----------------------------------|----------------------------------|------------------------------|-------------------------------------------------|-----------------------------------------------|------------------------------|--|
| Attribute | Hudson RCI
Soft Tech | Ballard
Trach Care | Concord-Portex
Steri-cath | Hudson RCI
Catheter &
sleeved
versions | C/P
Maxiflo
standard
catheter only | Davol
sleeved
catheter | |
| Use | | | | | | | |
| Indicated for airway suctioning | Yes | Yes | Yes | Yes | Yes | Yes | |
| Can be placed in-circuit | Yes | Yes | Yes | No | No | No | |
| Used on pediatric and adults | Yes | Yes | Yes | Yes | Yes | Yes | |
| Indicated as a disposable | Yes | Yes | Yes | Yes | Yes | Yes | |
| Indicated for 24 hour use | Yes | Yes | Yes | No | No | No | |
| Can be used with endotracheal
and tracheostomy tubes | Yes | Yes | Yes | Yes | Yes | Yes | |
| Design | | | | | | | |
| Lightweight construction | Yes | Yes | Yes | Yes | Yes | Yes | |
| Various diameters of catheters | Yes | Yes | Yes | Yes | Yes | Yes | |
| Different lengths for endotracheal
and tracheostomy tubes | Yes | Yes | Yes | No | No | No | |
| : markings indicating length | Yes | Yes | Yes | Yes | Yes | Yes | |
| Attribute | Continuous Ventilating | | | Standard Catheter | | | |
| | Hudson RCI
Soft Tech | Systems
Ballard
Trach Care | Concord-Portex
Steri-cath | Hudson RCI
Catheter &
sleeved
versions | C / P
Maxiflo
standard
catheter only | Davol
sleeved
catheter | |
| Design (continued) | | | | | | | |
| Has marking indicating when
fully withdrawn | Yes | Yes | Yes | N/A | N/A | N/A | |
| Single lumen design | Yes | Yes | Yes | Yes | Yes | Yes | |
| Double lumen design | Yes | Yes | Yes | No | No | No | |
| Has irrigation port(s) | Yes | Yes | Yes | No | No | No | |
| Has a protective sleeve | Yes | Yes | Yes | No / Yes | No | Yes | |
| Patient adapter connector to
ventilator circuit and airway
connector | Yes | Yes | Yes | N/A | N/A | N/A | |
| Normally closed Suction control
e | No | Yes | Yes | No | No | No | |
| Normally open suction control
valve | Yes | No | No | Yes | Yes | Yes | |
| Permits suctioning and ventilation
to be done at the same time | Yes | Yes | Yes | No | No | No | |
| Has a method, washer or duckbill
valve to isolate the sleeve from
the patient circuit | Yes | Yes | Yes | No | No | No | |
| Catheter is completely out of
patient circuit when withdrawn | Yes | No | No | Yes | Yes | Yes | |
| Connects to suction tubing | Yes | Yes | Yes | Yes | Yes | Yes | |
| Patient adapter - 15 / 22 mm
fittings | Yes | Yes | Yes | N/A | N/A | N/A | |
| Offer swivel capabilities | Yes | Yes | Yes | N/A | N/A | N/A | |
| Can be left attached to patient
airway connector and ventilator
circuit when not in use | Yes | Yes | Yes | N/A | N/A | N/A | |
| Lumen for secretion flow
obstructed by suction valve
control open/close mechanism | No | Yes | Yes | No | No | No | |
| Has a filter in Suction Control
Valve to reduce aerosols from
contaminating environment | Yes | No | No | Yes | No | No | |
| Suction control valve lockout
to prevent accidental suctioning | Yes | Yes | No | Yes | No | No | |
| Comparison to predicate devices (continued) | Continuous Ventilating
Systems | | | Standard Catheter
Only | | | |
| | | | | | | | |
| Attribute | Hudson RCI
Soft Tech | Ballard
Trach Care | Concord-Portex
Steri-cath | Hudson RCI
Catheter &
sleeved
versions | C / P
Maxiflo
standard
catheter only | Davol
sleeved
catheter | |
| Materials | | | | | | | |
| Catheter - PVC | Yes | Yes | Yes | Yes | Yes | Yes | |
| Patient adapter and suction
control valve | PS, PP,
PE, ABS | PS, ABS | PS, ABS | PS, PP,
PE, ABS | PS,PP,
PE | PS, PP,
PE | |
| Duckbill valve / catheter
wiper - PVC or silicone | Yes | Yes | Yes | N/A | N/A | N/A | |
| Sleeve - PE | Yes | Yes | Yes | N/A / Yes | N/A | Yes | |
| Packaging | | | | | | | |
| Offered sterile | Yes | Yes | Yes | Yes | Yes | Yes | |
| ickaged with prefilled
saline / water vials | Yes | Yes | Yes | No | No | No | |
| Packaged with flex tube | Yes | Yes | Yes | N/A | N/A | N/A | |
| Packaged with Airway
disconnect wedge | Yes | No | Yes | N/A | N/A | N/A | |
| Performance | | | | | | | |
| Allows ventilation during
suctioning | Yes | Yes | Yes | No | No | No | |
| Reduces patient oxygen
desaturation | Yes | Yes | Yes | No | No | No | |
| Filter media in suction control
valve reduces potential contamination
of environment from aerosols | | | | | | | |
| generated during suctioning | Yes | No | No | Yes | No | No | |
: |
2
Non-Confidential Summary of Safety and Effectiveness
Comparison to predicate devices (continued)
ﺎ
3
Non-Confidential Summary of Safety and Effectiveness (continued)
B. Conclusion
No differences which would affect the intended use, the application, the safety or the No differeness between the Hudson RCI oral suction catheters described in this ellectiveness betwoon the reasons of the end cated above, have been identified.
72