MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT

K993268 · Mallinckrodt Dar S.R.L. · BTT · Apr 19, 2000 · Anesthesiology

Device Facts

• Record ID: K993268
• Device Name: MALLINCKRODT DAR HEATED WIRE BREATHING CIRCUIT
• Applicant: Mallinckrodt Dar S.R.L.
• Product Code: BTT · Anesthesiology
• Decision Date: Apr 19, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

The MALLINCKRODT DAR Heated Wire Breathing Circuit is a respiratory accessory used in clinical settings for anesthesia or mechanical ventilation. It consists of a smooth-bore breathing circuit with an integrated heating wire molded into the internal ribbing. The device connects to external ventilation/anesthesia heaters or heater/humidifiers, which control the heating element to warm breathing gases delivered to the patient. Some configurations include moisture traps to collect condensate. The device is operated by healthcare professionals in a clinical environment. By warming the gas pathway, the device helps maintain gas temperature, potentially reducing condensation and improving patient comfort during respiratory support.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility, performance, electrical safety, and electromagnetic compatibility testing, demonstrating compliance with designated voluntary standards and product specifications.

Technological Characteristics

Smooth-bore breathing circuit with integrated heating wire encased in internal ribbing. Materials are identical to standard breathing circuits. Available in adult, pediatric, and neonatal sizes. Compatible with multiple external heater/humidifiers. Meets ASTM standards. Sterilization status is specified as sterile or non-sterile depending on configuration.

Indications for Use

Indicated for adults, children, and infants undergoing anesthesia or mechanical ventilation in a health care facility.

Regulatory Classification

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.

Predicate Devices

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

Submission Summary (Full Text)

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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: | [e-mail] |

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 Gas<br>Humidifier |

## 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

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.

#### 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.

| | MALLINCKRODT<br>HWBC | MALLINCKRODT<br>Airway<br>Connectors with<br>Flex Tube | MARQUEST | Fisher &<br>Paykel |
|------------------------------------------------------------------|----------------------|--------------------------------------------------------|----------|--------------------|
| 510(k) number | N/A | K942392 | K962220 | K983112 |
| Use | | | | |
| Provides heated gas pathway to the<br>ventilation 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),<br>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 tube<br>with connectors | YES | Not<br>Applicable | NS* | NS* |
| Materials | | | | |
| Same materials as standard breathing<br>circuits | 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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, which is a symbol often associated with healthcare and medicine.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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