(202 days)
None
No
The description focuses on the physical components and heating mechanism of a breathing circuit, with no mention of AI or ML technologies.
No
The device is described as a heated breathing circuit intended to warm breathing gases, not to directly treat a medical condition or disease. It functions as an accessory to ventilation/anesthesia systems.
No
Explanation: The device is intended to warm breathing gases for patients undergoing anesthesia or mechanical ventilation, which is a therapeutic or supportive function, not a diagnostic one.
No
The device description explicitly states it consists of physical components like breathing circuits, a resistor, and potentially traps for moisture collection. It is a hardware device with an electrical connection for heating control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to warm breathing gases for patients undergoing anesthesia or mechanical ventilation. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a breathing circuit with a heating element. It facilitates the delivery of warmed gases to the patient's respiratory system. It does not analyze biological samples or provide information about a patient's health status based on in vitro testing.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely related to the physical properties of the breathing gas.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
BTT, CAI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults, children, and infants
Intended User / Care Setting
Health care facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility, performance, electrical safety, and electromagnetic compatibility testing demonstrate that Mallinckrodt DAR HWBC comply with designated voluntary standards and fulfill product specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Gas |
| 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.
1
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
HWBC | MALLINCKRODT
Airway
Connectors with
Flex Tube | MARQUEST | Fisher &
Paykel |
|------------------------------------------------------------------|----------------------|--------------------------------------------------------|----------|--------------------|
| 510(k) number | N/A | K942392 | K962220 | K983112 |
| Use | | | | |
| Provides heated gas pathway to the
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),
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
with connectors | YES | Not
Applicable | NS* | NS* |
| Materials | | | | |
| Same materials as standard breathing
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.
3
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