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

AI/ML Overview

The provided document describes a medical device, the CATH-GUIDE suction catheter, and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria, device performance, a specific study proving acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop studies.

The document is a "Non-CONFIDENTIAL SUMMARY OF SAFETY AND EFFECTIVENESS" from 1995, which is typical for a 510(k) submission to the FDA. This type of submission relies heavily on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed clinical study with quantitative performance metrics against predefined acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document, as it focuses on qualitative comparisons of features and intended use.

Here's what can be inferred or explicitly stated based on the provided text, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantitative metrics. The "acceptance criteria" in this context are implicitly that the device's characteristics and performance are "substantially equivalent" to the predicate devices.
Reported Device Performance: No quantitative performance metrics (e.g., suction pressure, flow rates, efficacy in clearing secretions) are reported. The performance is described qualitatively through features like "Allows ventilation during suctioning" or "Reduces patient oxygen desaturation," and these are compared to predicate devices.

Missing: Specific numeric or measurable acceptance criteria and corresponding reported performance data from a dedicated study.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable/not provided. This document describes the device and compares its features to predicates; it does not detail a study involving a "test set" of patients or data.
Data Provenance: Not applicable. The "data" here is primarily a comparison of device specifications and intended use with existing marketed devices.

Missing: Information on a test set, its size, or provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable/not provided. There is no mention of a test set with ground truth established by experts.

Missing: Information on experts or ground truth establishment.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not provided. There is no test set or adjudication process described.

Missing: Information on an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

MRMC Study: No. This document does not describe any MRMC study.
Effect Size: Not applicable.

Missing: Information on an MRMC study or effect size.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.

Standalone Performance: Not applicable. This is a physical medical device (suction catheter), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

Missing: This question is not relevant to the described device type.

7. The type of ground truth used.

Type of Ground Truth: Not applicable/not provided. No ground truth is mentioned. The basis for evaluating the device is its comparison to predicate devices, focusing on design features, materials, intended use, and general performance claims (e.g., "Allows ventilation during suctioning").

Missing: Explicit ground truth definition.

8. The sample size for the training set.

Training Set Sample Size: Not applicable/not provided. This document does not describe a machine learning algorithm or a training set.

Missing: Information on a training set.

9. How the ground truth for the training set was established.

Ground Truth Establishment for Training Set: Not applicable/not provided. As there's no training set mentioned, this information is not relevant.

Missing: Information on ground truth establishment for a training set.

Conclusion from the document:

The document serves as a regulatory submission (likely 510(k)) to demonstrate that the CATH-GUIDE suction catheter is substantially equivalent to existing predicate devices. The "comparison to predicate devices" tables are the core of this demonstration. The conclusion explicitly states: "No differences which would affect the intended use, the application, the safety or the effectiveness... have been identified." This statement is the "proof" that the device meets regulatory requirements for market clearance based on substantial equivalence, rather than a proof against specific, quantitative acceptance criteria from a de novo study.

Summary

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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

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-cathSteri-cath double lumenMaxi-Flo Suction Catheter	K902383 K902687preamendment
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

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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:

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 VentilatingSystems			Standard CatheterOnly
Attribute	Hudson RCISoft Tech	BallardTrach Care	Concord-PortexSteri-cath	Hudson RCICatheter &sleevedversions	C/PMaxiflostandardcatheter only	Davolsleevedcatheter
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 endotrachealand 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 endotrachealand tracheostomy tubes	Yes	Yes	Yes	No	No	No
: markings indicating length	Yes	Yes	Yes	Yes	Yes	Yes
Attribute	Continuous Ventilating			Standard Catheter
	Hudson RCISoft Tech	SystemsBallardTrach Care	Concord-PortexSteri-cath	Hudson RCICatheter &sleevedversions	C / PMaxiflostandardcatheter only	Davolsleevedcatheter
Design (continued)
Has marking indicating whenfully 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 toventilator circuit and airwayconnector	Yes	Yes	Yes	N/A	N/A	N/A
Normally closed Suction controle	No	Yes	Yes	No	No	No
Normally open suction controlvalve	Yes	No	No	Yes	Yes	Yes
Permits suctioning and ventilationto be done at the same time	Yes	Yes	Yes	No	No	No
Has a method, washer or duckbillvalve to isolate the sleeve fromthe patient circuit	Yes	Yes	Yes	No	No	No
Catheter is completely out ofpatient circuit when withdrawn	Yes	No	No	Yes	Yes	Yes
Connects to suction tubing	Yes	Yes	Yes	Yes	Yes	Yes
Patient adapter - 15 / 22 mmfittings	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 patientairway connector and ventilatorcircuit when not in use	Yes	Yes	Yes	N/A	N/A	N/A
Lumen for secretion flowobstructed by suction valvecontrol open/close mechanism	No	Yes	Yes	No	No	No
Has a filter in Suction ControlValve to reduce aerosols fromcontaminating environment	Yes	No	No	Yes	No	No
Suction control valve lockoutto prevent accidental suctioning	Yes	Yes	No	Yes	No	No
Comparison to predicate devices (continued)	Continuous VentilatingSystems			Standard CatheterOnly

Attribute	Hudson RCISoft Tech	BallardTrach Care	Concord-PortexSteri-cath	Hudson RCICatheter &sleevedversions	C / PMaxiflostandardcatheter only	Davolsleevedcatheter
Materials
Catheter - PVC	Yes	Yes	Yes	Yes	Yes	Yes
Patient adapter and suctioncontrol valve	PS, PP,PE, ABS	PS, ABS	PS, ABS	PS, PP,PE, ABS	PS,PP,PE	PS, PP,PE
Duckbill valve / catheterwiper - 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 prefilledsaline / water vials	Yes	Yes	Yes	No	No	No
Packaged with flex tube	Yes	Yes	Yes	N/A	N/A	N/A
Packaged with Airwaydisconnect wedge	Yes	No	Yes	N/A	N/A	N/A
Performance
Allows ventilation duringsuctioning	Yes	Yes	Yes	No	No	No
Reduces patient oxygendesaturation	Yes	Yes	Yes	No	No	No
Filter media in suction controlvalve reduces potential contaminationof environment from aerosols
generated during suctioning	Yes	No	No	Yes	No	No

: |

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Non-Confidential Summary of Safety and Effectiveness

Comparison to predicate devices (continued)

ﺎ

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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.

Regulation Number and Section

§ 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.