The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility.

Device Description

The MALLINCKRODT DAR Heated Wire Breathing Circuit consists of the existing smooth bore breathing circuits (K942392, Airway Connectors with Flex Tube) into which a resistor has been molded into the inside of the external rib. Heating is controlled by ventilation/anesthesia breathing heaters or heater/humidifiers to which the MALLINCKRODT DAR Heated Wire Breathing Circuits are electrically connected. Some HWBC configurations may include traps for collection of the condensed moisture from patient exhalation or from humidification. Devices will be available in a variety of configurations.

AI/ML Overview

The provided document (K993268) describes a 510(k) premarket notification for the MALLINCKRODT DAR Heated Wire Breathing Circuit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with acceptance criteria that would typically be seen for novel devices.

Therefore, the document does not contain information regarding:

A table of acceptance criteria and reported device performance.
Sample sizes, data provenance, or details of a test set.
Number of experts or their qualifications for establishing ground truth.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone algorithm performance studies.
Type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Instead, the document states:

1. Acceptance Criteria and Device Performance:

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate devices. The performance of the device is assessed through compliance with designated voluntary standards and fulfillment of product specifications, rather than specific performance metrics against clinical acceptance criteria.

The document states:
"Biocompatibility, performance, electrical safety, and electromagnetic compatibility testing demonstrate that Mallinckrodt DAR HWBC comply with designated voluntary standards and fulfill product specifications."

No specific quantifiable performance metrics or acceptance thresholds are provided in the document. The substantial equivalence claim is based on:

Intended Use: "The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility." This is consistent with the predicate devices.
Design: Shared characteristics with predicate devices (e.g., smooth bore, standard airway connectors, various configurations).
Operational Characteristics: Provides a heated gas pathway, used for anesthesia and respiratory therapy, compatible with humidifiers.
Materials of Construction: "Same materials as standard breathing circuits."
Performance: "Meets ASTM standards" (implying standard performance criteria rather than novel device-specific criteria).

The comparison table (Table 1) highlights shared characteristics with predicate devices across Use, Sterility, Design, Materials, and Performance, indicating that the new device meets similar functional and safety attributes as the legally marketed predicate devices without defining new performance acceptance criteria.

Summary

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K993268

1. SPONSOR/APPLICANT NAME, ADDRESS, TELEPHONE NUMBER

MALLINCKRODT DAR S.R.L. via G. Bove, 2/4/6/8 I-41037 Mirandola, (MODENA), ITALY

Contact Person:	Giuseppe Tomasini
Telephone:	011 39 0535 617922
E-mail:	giuseppe.tomasini@mkg.com

Date of Summary Preparation: April 13, 2000

2. DEVICE NAME

Proprietary Name:	MALLINCKRODT DAR Heated Wire Breathing Circuit
Common/Usual Name:	Heated Breathing Circuits
Classification Name:	Accessory to Breathing System Heater or Respiratory GasHumidifier

3. IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED

MALLINCKRODT DAR Airway Connectors with Flex Tube (K943292) Marquest Heating Wire Breathing Circuit and Limbs (K962220) Fisher & Paykel (K983112)

4. DEVICE DESCRIPTION

ട. INTENDED USE

The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility.

A STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE 6.

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DEVICE COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) CITED

MALLINCKRODT DAR S.R.L. makes the claim of substantial equivalence based on intended use, design, operational characteristics, and materials of construction. A side-by-side comparison of the MALLINCKRODT DAR Heated Wire Breathing Circuits to the systems cited is provided in Table 1 below.

	MALLINCKRODTHWBC	MALLINCKRODTAirwayConnectors withFlex Tube	MARQUEST	Fisher &Paykel
510(k) number	N/A	K942392	K962220	K983112
Use
Provides heated gas pathway to theventilation circuitry	YES	NO	YES	YES
Used for anesthesia	YES	YES	YES	YES
Used for respiratory therapy	YES	YES	YES	YES
Used for heated humidifiers	YES	NO	YES	YES
Compatible with multiple humidifiers	YES	NO	NO	NO
Indicated for single patient use	YES	YES	YES	YES
Reprocessing/re-use contraindicated	YES	YES	NS*	NS*
Sterility
Sterile	YES	YES	NS*	NS*
Non sterile	YES	YES	NS*	NS*
Design
Available in adult (A), pediatric (P),and neonatal (N) sizes	A, P, N	A, P, N	A	NS*
Smooth bore	YES	YES	NS*	NS*
Corrugated or reinforced	YES	YES	NS*	NS*
Transparent	YES	YES	NS*	NS*
Standard airway connectors	YES	YES	YES	YES
Circuits with various components	YES	YES	YES	YES
Heating wire	Encased	None	Free	Free
Available as the Heated Single tubewith connectors	YES	NotApplicable	NS*	NS*
Materials
Same materials as standard breathingcircuits	YES	YES	YES	YES
Performance
Meets ASTM standards	YES	YES	YES	NS*

			Table 1. Comparison of the HWBC with Predicate Devices

*Not specified

7. TESTING

Biocompatibility, performance, electrical safety, and electromagnetic compatibility testing demonstrate that Mallinckrodt DAR HWBC comply with designated voluntary standards and fulfill product specifications.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2000

Mr. Giuseppe Tomasini Mallinckrodt DAR S.R.L. Via G. Bove 2/4/6/8 41037 Mirandola, Modena ITALY

Re: K993268 Mallinckrodt DAR S.R.L. Heated Wire Breathing Circuit (HWBC) Requlatory Class: I (one), II (two) Product Code: BTT, CAI Dated: January 19, 2000 Received: January 20, 2000

Dear Mr. Tomasini:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Giuseppe Tomasini

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

for HW with John for

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K993268

Device Name: MALLINCKRODT DAR Heated Wire Breathing Circuit

Indications for Use:

The MALLINCKRODT DAR Heated Wire Breathing Circuit is intended to warm breathing gases for adults, children, and infants undergoing anesthesia or mechanical ventilation within a health care facility.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
Prescription Use (Per 21 CFR 801.109)	OR Over-The-Counter Use

510(k) SUMMARY

MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT

(PER 21 CFR 807.92)

April 13, 2000

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).