The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier; the heated wires are intended to minimize condensation in the ventilator tubing.

Device Description

Breathing circuit that is intended to administer medical gases to a patient. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y piece. The heated wires are intended to minimize condensation in the ventilator tubing.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Hudson RCI Heated Wire Ventilator Circuit." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through a clinical study involving AI or human readers.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this document. This document outlines the physical and performance characteristics of the proposed device and compares them to a legally marketed predicate device to establish substantial equivalence.

Here's a breakdown of the relevant information from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the way a clinical study would for efficacy. Instead, it provides a comparison of specifications and performance tests between the proposed device and its predicate. The "acceptance criteria" are implied by the performance of the predicate device, which the new device aims to be substantially equivalent to or improve upon.

Feature / Performance Test (Predicate Device K881625)	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Proposed Device K031383)
Length	1.83 meters	1.52 meters
Resistance (per ISO 5367):
Inspiratory @ 30 LPM, air	0.9 cmH2O (0.09 kPa)/L/sec	0.8 cmH2O (0.08 kPa)/L/sec
Inspiratory @ 60 LPM, air	1.5 cmH2O (0.15 kPa)/L/sec	1.3 cmH2O (0.13 kPa)/L/sec
Inspiratory @ 90 LPM, air	2.2 cmH2O (0.22 kPa)/L/sec	1.9 cmH2O (0.19 kPa)/L/sec
Inspiratory @ 120 LPM, air	2.8 cmH2O (0.28 kPa)/L/sec	2.4 cmH2O (0.24 kPa)/L/sec
Expiratory @ 30 LPM, air	0.7 cmH2O (0.07 kPa)/L/sec	0.8 cmH2O (0.08 kPa)/L/sec
Expiratory @ 60 LPM, air	1.3 cmH2O (0.13 kPa)/L/sec	1.3 cmH2O (0.13 kPa)/L/sec
Expiratory @ 90 LPM, air	1.9 cmH2O (0.19 kPa)/L/sec	1.9 cmH2O (0.19 kPa)/L/sec
Expiratory @ 120 LPM, air	2.4 cmH2O (0.24 kPa)/L/sec	2.4 cmH2O (0.24 kPa)/L/sec
Compliance (per ISO 5367):
@ 60 cmH2O (6 kPa)	2.25 ml/ cmH2O	2.25 ml/ cmH2O
@ 90 cmH2O (8.8 kPa)	2.16 ml/ cmH2O	2.16 ml/ cmH2O
@ 110 cmH2O (11kPa)	2.22 ml/ cmH2O	2.22 ml/ cmH2O
Leak Rate	less than 60 ml/min @ 90 cmH2O	less than 60 ml/min @ 90 cmH2O
Materials of Construction (Key Differences)	Inspiratory circuit to humidifier adapter: High Density Polypropylene; Expiratory circuit to ventilator adapter: Low Density Polypropylene; Heated Wire Harness: copper conductor, polyethylene core, polyvinylchloride insulator; Wire connector: Brass with tin plate.	Inspiratory circuit to humidifier adapter: High Density Polyethylene; Expiratory circuit to ventilator adapter: Low Density Polyethylene; Heated Wire Harness: copper / nickel conductor, polyvinylchloride insulator; Wire connector: Phosphor bronz with tin/lead plate.
Design (Key Differences)	Inspiratory circuit to humidifier adapter: Single piece, right angle elbow adapter; Corrugated tubing: Seventy-two (72") inch; Expiratory circuit to ventilator adapter: Single piece, straight adapter; Heated Wire entry grommet: Insert molded; Heated Wire Harness: Single strand (Inspiratory & Expiratory).	Inspiratory circuit to humidifier adapter: Two piece, 60 degree angle adapter; Corrugated tubing: Sixty (60") inch; Expiratory circuit to ventilator adapter: Two piece, 60 degree angle adapter; Heated Wire entry grommet: Injection molded "clam shell grommet"; Heated Wire Harness: Seven strand (Inspiratory & Expiratory).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in a 510(k) summary for a physical device. The testing described (e.g., resistance, compliance, leak rate) is laboratory-based performance testing of the device itself, not a clinical study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no concept of "ground truth" or "experts" in the context of this device's performance testing described in the summary. The tests evaluate physical properties against established standards (ISO 5367).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical breathing circuit, not an AI-powered diagnostic device.

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

Not applicable. This is a physical breathing circuit, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this device's performance is derived from standardized physical measurements and engineering specifications, primarily based on the ISO 5367 standard for breathing tubes and connectors.

8. The sample size for the training set

Not applicable. There is no training set for this type of device submission.

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

Not applicable. There is no training set for this type of device submission.

Summary

{0}------------------------------------------------

K031383

SMDA

JUL 0 7 2003

510(k) Summary

1.0 Date 6/25/03

2.0 Submitter

Hudson Respiratory Care, Inc. 27711 Diaz Road Temecula, California 92590

3.0 Contact Person

Charles Mierkiewicz Senior Regulatory Affairs Specialist

4.0 Telephone

(909) 676-5611 ext.1255

5.0 Proprietary Device Name (Circuit) Circuit #780-19, 20, 31, 32, 33, 34, 35, 51, 790-32, 52 5.1
6.0 Classification Name 6.1 (Circuit) Breathing Circuit
7.0 Common Name Breathing Circuit (Circuit) 7.1

8.0 Predicate Devices

(Circuit) Current Hudson RCI Adult Heated Wire Circuit cleared in 510(k) 8.1 submission K881625

9.0 Device Description

10.0 Intended Use

11.0 Patient Population

Adults

{1}------------------------------------------------

Comparison of Technological Characteristic. 12.0

{2}------------------------------------------------

{3}------------------------------------------------

{4}------------------------------------------------

8.8	Design:		8.8	Design
	8.8.1	Inspiratory circuit to humidifier adapter:Single piece, right angle elbow adapterwith heated wire entry and temperaturemonitoring ports.		8.8.1	Inspiratory circuit to humidifier adapter:Two piece, 60 degree angle adapter withheated wire entry and temperaturemonitoring ports.
	8.8.2	Corrugated tubing:Seventy-two (72") inch corrugated tubing		8.8.2	Corrugated tubing:Sixty (60") inch corrugated tubing .
	8.8.3	Inspiratory circuit to wye connector:22 mm ID x 22 mm OD connector with"cage" to anchor wire harness andprevent wire migration into wyeconnector.		8.8.3	Inspiratory circuit to wye connector:22 mm ID x 22 mm OD connector with"cage" to anchor wire harness andprevent wire migration into wyeconnector.
	8.8.4	Wye connector:Standard 60-degree (60°) entry and exitlegs, all legs have a 22 mm ODconnections, patient end includes a 15mm ID connection.		8.8.4	Wye connector:Standard 60-degree (60°) entry and exitlegs, all legs have a 22 mm ODconnections, patient end includes a15mm ID connection.
	8.8.5	Patient connector:Standard right angle patient connectorthat allows attachment to 15 mm ID and22 mm OD connector.		8.8.5	Patient connector:Standard right angle patient connectorthat allows attachment to 15 mm ID and22 mm OD connector.
	8.8.6	Expiratory circuit to wye connector:22 mm ID x 22 mm OD connector with"cage" to anchor wire harness andprevent wire migration into wyeconnector.		8.8.6	Expiratory circuit to wye connector:22 mm ID x 22 mm OD connector with"cage" to anchor wire harness andprevent wire migration into wyeconnector.
	8.8.7	Expiratory circuit to ventilator adapter:Single piece, straight adapter withheated wire entry port.		8.8.7	Expiratory circuit to ventilator adapter:Two piece, 60 degree angle adapter withheated wire entry port.
	8.8.8	Heated Wire entry grommet.Insert molded around heated wireharness then inserted into inspiratory orexpiratory adapter.		8.8.8	Heated Wire entry grommet:Injection molded "clam shell grommetthat is placed around wire.
	8.8.9	Inspiratory Heated Wire Harness:Single strand		8.8.9	Inspiratory Heated Wire Harness:Seven strand,
	8.8.10	Expiratory Heated Wire Harness:Single strand.		8.8.10	Expiratory Heated Wire Harness:Seven strand
8.9	Energy Used / Delivered21- volt system controlled by Hudson RCIConchaTherm controller.		8.9	Energy Used / Delivered21-volt system controlled by Hudson RCIConchaTherm controller.
8.10	Features		8.10	Features
	8.10.1 22 mm connectors			8.10.1 22 mm connectors
	8.10.2	Transparent corrugated tubing		8.10.2	Transparent corrugated tubing
	8.10.3	May be used on all Hudson RCI 21 voltheated wire humidifiers.		8.10.3	May be used on all Hudson RCI 21 voltheated wire humidifiers.
8.11	Method of OperationActs as a gas conduit between ventilator andpatient.		8.11	Method of OperationActs as a gas conduit between ventilator andpatient.
8.12	AccessoriesNone		8.12	AccessoriesNone
8.13	Safety CharacteristicsNo difference identified		8.13	Safety CharacteristicsNo difference identified

ﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

{5}------------------------------------------------

13.0 Conclusion

Based on the information contained in this special 510(k) submission, Hudson RCI has determined that the current Hudson RCI Cat. no. 780-19, 20, 31, 32, 33, 34, 35, 51, 790-32, 52. and the proposed Hudson RCI cat. No 780-19, 20, 31, 32, 33, 34, 35, 51, 790-32, 52 heated wire circuits are substantially equivalent to their respective predicate devices listed in this submission. These changes to the circuits are truly a modification to the existing Hudson RCI Heated Wire Circuit product line.

These changes are being implemented at this time for cost effectiveness as well as addressing failure modes discovered over time with the current heated wire product offering.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes above a wavy line.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 7 2003

Mr. Charles Mierkiewicz Senior Regulatory Affairs Specialist Hudson Respiratory Care, Incorporated 27711 Diaz Road P.O. Box 9020 Temecula, California 92590

Re: K031383

Trade/Device Name: Hudson RCI Heated Wire Circuit Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: June 26, 2003 Received: June 27, 2003

Dear Mr. Mierkiewicz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA); 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{7}------------------------------------------------

Page 2 - Mr. Mierkiewicz

Please be advised that FDA`s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runpe

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Page of_

510(k) Number (if known): K031383

Device Name: Hudson RCI Heated Wire Circuit

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devic

510(k) Number: K031383

(Optional Format 3-10-98)

Regulation Number and Section

§ 868.5450 Respiratory gas humidifier.

(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).

3.1	Identification of Predicate DeviceHudson RCI Heated Wire Ventilator Circuits K881625	8.1	Identification of Proposed DeviceHudson RCI Heated Wire Ventilator Circuits K031383
8.2	Product Labeling	8.2	Product Labeling
	8.2.1 Seven (7) general Warnings that apply toall ventilator circuits.8.2.1.1 Be sure all connections aresecure.8.2.1.2 Test and install the circuit inaccordance with the ventilatormanufacturer's instructionsbefore use.8.2.1.3 Verify that all unused ports arecapped.8.2.1.4 Be sure that the temperatureprobe is properly placed.(Placement of the probe near aradiant warmer or inside anisolette may cause erroneoustemperature readings. Foraccurate reading, verify that theprobe is fully inserted into the airstream.8.2.1.5 Always maintain adequate flowrates through the tubing toprevent overheating of thecircuit.8.2.1.6 If condensation collects withinthe breathing circuit, drain thecircuit frequently to avoid watercollection at the patient's airway.8.2.1.7 If ancillary equipment is placedin line, use appropriate adaptorsto insure that all connections aresecure.		8.2.1 Seven (7) general Warnings that apply toall ventilator circuits.8.2.1.1 Be sure all connections aresecure.8.2.1.2 Test and install the circuit inaccordance with the ventilatormanufacturer's instructionsbefore use.8.2.1.3 Verify that all unused ports arecapped.8.2.1.4 Be sure that the temperatureprobe is properly placed.(Placement of the probe near aradiant warmer or inside anisolette may cause erroneoustemperature readings. Foraccurate reading, verify that theprobe is fully inserted into the airstream.8.2.1.5 Always maintain adequate flowrates through the tubing toprevent overheating of thecircuit.8.2.1.6 If condensation collects withinthe breathing circuit, drain thecircuit frequently to avoid watercollection at the patient's airway.8.2.1.7 If ancillary equipment is placedin line, use appropriate adaptorsto insure that all connections aresecure.
	8.2.2 Four (4) Warnings that apply to heatedwire ventilator circuits.8.2.2.1 When using heated-wireventilator circuits, be sure thatthe electrical requirements of thecircuit and the heated humidifierare compatible. In compatibilitymay result in melting ofcorrugated tubing or heated wireelement failure.8.2.2.2 Do not allow the circuit to rest onthe patient's bare skin.8.2.2.3 Do not cover with sheets,blankets, towels, clothing orother materials.8.2.2.4 Do not stretch or "milk" thetubing.8.2.3 One (1) Caution: Federal law (USA)		8.2.2 Four (4) Warnings that apply to heatedwire ventilator circuits.8.2.2.1 When using heated-wireventilator circuits, be sure thatthe electrical requirements of thecircuit and the heated humidifierare compatible. In compatibilitymay result in melting ofcorrugated tubing or heated wireelement failure.8.2.2.2 Do not allow the circuit to reston the patient's bare skin.8.2.2.3 Do not cover with sheets,blankets, towels, clothing orother materials.8.2.2.4 Do not stretch or "milk" thetubing.
8.2.38.2.48.2.58.2.6	One (1) Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.General directions for use.Circuit specification: Approximately 72 inches (patient connection to machine).Company name and address	8.2.38.2.48.2.58.2.6	One (1) Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.General directions for use.Circuit specification: Approximately 1.52 meters (patient connection to machine)Company name and address
8.3	Intended UseAct and a conduit for gas delivery to a patient.	8.3	Intended UseAct and a conduit for gas delivery to a patient.
8.4	Anatomical SitesConnects to an endotracheal or tracheostomy tube.	8.4	Anatomical SitesConnects to an endotracheal or tracheostomy tube.
8.5Results	Specifications & Performance Test	8.5Results	Specifications & Performance Test
	8.5.1 Length: 1.83 meters8.5.2 Resistance (test method per ISO 5367):8.5.2.1 Inspiratory:0.9 cmH2O (0.09 kPa)/L/sec @ 30 LPM, air1.5 cmH2O (0.15 kPa)/L/sec @ 60 LPM, air2.2 cmH2O (0.22 kPa)/L/sec @ 90 LPM, air2.8 cmH2O (0.28 kPa)/L/sec @ 120 LPM, air8.5.2.2 Expiratory:0.7 cmH2O (0.07 kPa)/L/sec @30 LPM, air1.3 cmH2O (0.13 kPa)/L/sec @ 60 LPM, air1.9 cmH2O (0.19 kPa)/L/sec @ 90 LPM, air2.4 cmH2O (0.24 kPa)/L/sec @ 120 LPM, air8.5.3 Compliance (test method per ISO 5367):2.25 ml/ cmH2O @ 60 cmH2O (6 kPa)2.16 ml/ cmH2O @ 90 cmH2O (8.8 kPa)2.22 ml/ cmH2O @ 110 cmH2O (11kPa)8.5.4 Leak Rate:less than 60 ml/min @ 90 cmH2O		8.5.1 Length: 1.52 meters8.5.2 Resistance (test method per ISO 5367):8.5.2.1 Inspiratory:0.8 cmH2O (0.08 kPa)/L/sec @ 30 LPM, air1.3 cmH2O (0.13 kPa)/L/sec @ 60 LPM, air1.9 cmH2O (0.19 kPa)/L/sec @ 90 LPM, air2.4 cmH2O (0.24 kPa)/L/sec @ 120 LPM, air8.5.2.2 Expiratory:0.8 cmH2O (0.08 kPa)/L/sec @ 30 LPM, air1.3 cmH2O (0.13 kPa)/L/sec @ 60 LPM, air1.9 cmH2O (0.19 kPa)/L/sec @ 90 LPM, air2.4 cmH2O (0.24 kPa)/L/sec @ 120 LPM, air8.5.3 Compliance (test method per ISO 5367):2.25 ml/ cmH2O @ 60 cmH2O (6 kPa)2.16 ml/ cmH2O @ 90 cmH2O (8.8 kPa)2.22 ml/ cmH2O @ 110 cmH2O (11kPa)8.5.4 Leak Rate:less than 60 ml/min @ 90 cmH2O
8.6	Size6.0 foot (1.83 meter) ventilator circuit	8.6	Size5.0 foot (1.52 meter) ventilator circuit
8.7	Materials of Construction8.7.1 Inspiratory circuit to humidifier adapter:High Density Polypropylene8.7.2 Corrugated tubing:Polyethylene/EVA blend8.7.3 Inspiratory circuit to wye connector:	8.7	Materials of Construction8.7.1 Inspiratory circuit to humidifier adapter:High Density Polyethylene8.7.2 Corrugated tubing:Polyethylene/EVA blend8.7.3 Inspiratory circuit to wye connector:
	Low Density Polypropylene		Low Density Polypropylene
8.7.4	Wye connector:Low Density Polypropylene	8.7.4	Wye connector:Low Density Polypropylene
8.7.5	Patient connector:Low Density Polypropylene	8.7.5	Patient connector:Low Density Polypropylene
8.7.6	Expiratory circuit to wye connector:Low Density Polypropylene	8.7.6	Expiratory circuit to wye connector:Low Density Polypropylene
8.7.7	Expiratory circuit to ventilator adapter:Low Density Polypropylene	8.7.7	Expiratory circuit to ventilator adapter:Low Density Polyethylene
8.7.8	Heated Wire entry grommet:Polyvinylchloride	8.7.8	Heated Wire entry grommet:Polyvinylchloride
8.7.9	Heated Wire Harness:copper conductor, polyethylene core,polyvinylchloride insulator.	8.7.9	Heated Wire Harness:copper / nickel conductor,polyvinylchloride insulator.
	8.7.10 Wire connector:Brass with tin plate.		8.7.10 Wire connector:Phosphor bronz with tin/lead plate.