CATH-GUIDE

K955645 · Hudson Respiratory Care, Inc. · BSY · Mar 12, 1996 · Anesthesiology

Device Facts

• Record ID: K955645
• Device Name: CATH-GUIDE
• Applicant: Hudson Respiratory Care, Inc.
• Product Code: BSY · Anesthesiology
• Decision Date: Mar 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6810
• Device Class: Class 1
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

CATH-GUIDE is a range of suction catheters for airway secretion removal. Configurations include standard suction catheters, sleeved catheters, and continuous ventilating suction systems. Systems feature patient connectors (Tee or Angled, optional swivel) for integration into ventilator circuits, allowing simultaneous suctioning and ventilation. Devices are used in hospitals, ICUs, ERs, and EMS settings by clinicians. Operation involves manual suction control via a valve; some models include a filter to reduce aerosol contamination. The device benefits patients by facilitating secretion clearance while maintaining ventilation and reducing oxygen desaturation. Output is the physical removal of airway secretions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Materials: Catheter (PVC), Patient adapter/valve (PS, PP, PE, ABS), Sleeve (PE), Valve/wiper (PVC or silicone). Design: Single lumen, various diameters/lengths, 15/22 mm patient adapter fittings. Connectivity: Standalone, manual operation. Sterilization: Sterile. No software or electronic components.

Indications for Use

Indicated for patients from neonates to adults requiring suctioning of airway secretions. No specific contraindications listed.

Regulatory Classification

Identification

A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.

Predicate Devices

• Trach Care Catheter (k872621)
• Steri-cath (k902383)
• Steri-cath double lumen (k902687)
• Maxi-Flo Suction Catheter (preamendment)
• Sleeved suction catheter only (preamendment)
• Vent-02-Cath (k760371)

Submission Summary (Full Text)

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K955645
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# NON-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS

November 16, 1995

Hudson Respiratory Care Inc.
27711 Diaz Rd., P.O. Box 9020
Temecula, CA 92589-9020
Tel - [phone]
Fax - [phone]

**Official Contact:**
Arden P. Morley
Director of Regulatory Affairs

**Proprietary or Trade Name:**
CATH-GUIDE

**Common/Usual Name:**
Suction catheter, tracheobronchial

**Intended Device:**
CATH-GUIDE

**Predicate Devices:**

| Ballard Medical Products, Inc. | Trach Care Catheter | k872621 |
| --- | --- | --- |
| Concord/Portex | Steri-cath | k902383 |
| | Steri-cath double lumen | k902687 |
| | Maxi-Flo Suction Catheter | preamendment |
| Davol | Sleeved suction catheter only | preamendment |
| Dryden Corporation | Vent-02-Cath | k760371 |

**Device Description:**

Hudson RCI intends to introduce a full range of suction catheters and configurations. In summary these are:

1. Suction catheters only
2. Suction catheter with a protective sleeve only
3. Continuous ventilating suction catheter system with patient connector 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*

ZENITH AMARO 1992
ZENITH AMARO 1989
HUDSON RESPIRATORY CARE INC.
27711 Diaz Road • P.O. Box 9020
Temecula, CA 92589-9020
Tel [phone] • Fax [phone]
109

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# 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:

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:

| Attribute | Continuous Ventilating Systems | | | Standard Catheter Only | | |
| --- | --- | --- | --- | --- | --- | --- |
| | Hudson RCI Soft Tech | Ballard Trach Care | Concord-Portex Steri-cath | Hudson RCI Catheter & sleeved versions | C / P Maxillo standard catheter only | David 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 |
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# Non-Confidential Summary of Safety and Effectiveness (continued)

| Comparison to predicate devices (continued) | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Attribute | Continuous Ventilating Systems | | | Standard Catheter Only | | |
| | Hudson RCI Soft Tech | Ballard Trach Care | Concord-Portex Start-cath | Hudson RCI Catheter & sleeved versions | C / P Maxillo standard catheter only | Devol 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 valve | 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 |

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# Non-Confidential Summary of Safety and Effectiveness (continued)

| Comparison to predicate devices (continued) | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Attribute | Continuous Ventilating Systems | | | Standard Catheter Only | | |
| | Hudson RCI Soft Tech | Ballard Trach Care | Concord-Portex Steri-cath | Hudson RCI Catheter & sleeved versions | C / P Maxillo 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 |
| Packaged 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 |

## B. Conclusion

No differences which would affect the intended use, the application, the safety or the effectiveness between the Hudson RCI oral suction catheters described in this submission, and the legally marketed predicate devices listed above, have been identified.

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