(67 days)
Not Found
No
The description focuses on the physical components and performance specifications of a breathing circuit with heated wires, with no mention of AI or ML.
Yes
The device is a ventilator circuit, which is used to administer medical gases to a patient as part of a ventilation system. Ventilation is a therapeutic intervention for respiratory support.
No
The device is described as a "conduit for respiratory gas between a patient and a ventilator" and its function is to "administer medical gases to a patient." Its purpose is to facilitate gas delivery and minimize condensation in tubing, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical breathing circuit with heated wires, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a "conduit for respiratory gas between a patient and a ventilator." It's used to deliver gases to the patient and remove exhaled gases from the patient. This is a direct interaction with the patient's respiratory system, not the analysis of a specimen taken from the patient.
- Intended Use: The intended use is to facilitate ventilation and minimize condensation in the tubing, not to diagnose a condition or provide information about a patient's health based on a specimen.
The device is a component of a respiratory support system, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
BTT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Connects to an endotracheal or tracheostomy tube.
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison of Technological Characteristic:
Length: Proposed device is 1.52 meters, predicate is 1.83 meters.
Resistance (test method per ISO 5367): Proposed device has slightly lower inspiratory resistance at 30 LPM (0.8 cmH2O vs 0.9 cmH2O) and similar values at higher LPM compared to the predicate. Expiratory resistance values are similar for both.
Compliance (test method per ISO 5367): Values are similar for both devices (2.25 ml/ cmH2O @ 60 cmH2O, 2.16 ml/ cmH2O @ 90 cmH2O, 2.22 ml/ cmH2O @ 110 cmH2O).
Leak Rate: Both are less than 60 ml/min @ 90 cmH2O.
Size: Proposed device is 5.0 foot (1.52 meter) ventilator circuit, predicate is 6.0 foot (1.83 meter) ventilator circuit.
Materials of Construction: Inspiratory circuit to humidifier adapter: Proposed device uses High Density Polyethylene, predicate uses High Density Polypropylene. Expiratory circuit to ventilator adapter: Proposed device uses Low Density Polyethylene, predicate uses Low Density Polypropylene. Heated Wire Harness: Proposed device uses copper / nickel conductor, predicate uses copper conductor. Wire connector: Proposed device uses Phosphor bronz with tin/lead plate, predicate uses Brass with tin plate.
Design: Inspiratory circuit to humidifier adapter: Proposed device is two piece, 60 degree angle, predicate is single piece, right angle. Corrugated tubing: Proposed device is 60" inch, predicate is 72" inch. Expiratory circuit to ventilator adapter: Proposed device is two piece, 60 degree angle, predicate is single piece, straight. Heated Wire entry grommet: Proposed device is Injection molded "clam shell grommet", predicate is Insert molded. Inspiratory Heated Wire Harness: Proposed device is Seven strand, predicate is Single strand. Expiratory Heated Wire Harness: Proposed device is Seven strand, predicate is Single strand.
Energy Used / Delivered: Both use a 21-volt system controlled by Hudson RCI ConchaTherm controller.
Features, Method of Operation, and Safety Characteristics are identified as having no difference.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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
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.
10.0 Intended Use
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.
11.0 Patient Population
Adults
1
| 3.1 | Identification of Predicate Device
Hudson RCI Heated Wire Ventilator Circuits K
881625 | 8.1 | Identification of Proposed Device
Hudson RCI Heated Wire Ventilator Circuits K031383 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 8.2 | Product Labeling | 8.2 | Product Labeling |
| | 8.2.1 Seven (7) general Warnings that apply to
all ventilator circuits.
8.2.1.1 Be sure all connections are
secure.
8.2.1.2 Test and install the circuit in
accordance with the ventilator
manufacturer's instructions
before use.
8.2.1.3 Verify that all unused ports are
capped.
8.2.1.4 Be sure that the temperature
probe is properly placed.
(Placement of the probe near a
radiant warmer or inside an
isolette may cause erroneous
temperature readings. For
accurate reading, verify that the
probe is fully inserted into the air
stream.
8.2.1.5 Always maintain adequate flow
rates through the tubing to
prevent overheating of the
circuit.
8.2.1.6 If condensation collects within
the breathing circuit, drain the
circuit frequently to avoid water
collection at the patient's airway.
8.2.1.7 If ancillary equipment is placed
in line, use appropriate adaptors
to insure that all connections are
secure. | | 8.2.1 Seven (7) general Warnings that apply to
all ventilator circuits.
8.2.1.1 Be sure all connections are
secure.
8.2.1.2 Test and install the circuit in
accordance with the ventilator
manufacturer's instructions
before use.
8.2.1.3 Verify that all unused ports are
capped.
8.2.1.4 Be sure that the temperature
probe is properly placed.
(Placement of the probe near a
radiant warmer or inside an
isolette may cause erroneous
temperature readings. For
accurate reading, verify that the
probe is fully inserted into the air
stream.
8.2.1.5 Always maintain adequate flow
rates through the tubing to
prevent overheating of the
circuit.
8.2.1.6 If condensation collects within
the breathing circuit, drain the
circuit frequently to avoid water
collection at the patient's airway.
8.2.1.7 If ancillary equipment is placed
in line, use appropriate adaptors
to insure that all connections are
secure. |
| | 8.2.2 Four (4) Warnings that apply to heated
wire ventilator circuits.
8.2.2.1 When using heated-wire
ventilator circuits, be sure that
the electrical requirements of the
circuit and the heated humidifier
are compatible. In compatibility
may result in melting of
corrugated tubing or heated wire
element failure.
8.2.2.2 Do not allow the circuit to rest on
the patient's bare skin.
8.2.2.3 Do not cover with sheets,
blankets, towels, clothing or
other materials.
8.2.2.4 Do not stretch or "milk" the
tubing.
8.2.3 One (1) Caution: Federal law (USA) | | 8.2.2 Four (4) Warnings that apply to heated
wire ventilator circuits.
8.2.2.1 When using heated-wire
ventilator circuits, be sure that
the electrical requirements of the
circuit and the heated humidifier
are compatible. In compatibility
may result in melting of
corrugated tubing or heated wire
element failure.
8.2.2.2 Do not allow the circuit to rest
on the patient's bare skin.
8.2.2.3 Do not cover with sheets,
blankets, towels, clothing or
other materials.
8.2.2.4 Do not stretch or "milk" the
tubing. |
| 8.2.3
8.2.4
8.2.5
8.2.6 | 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 | 8.2.3
8.2.4
8.2.5
8.2.6 | 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 Use
Act and a conduit for gas delivery to a patient. | 8.3 | Intended Use
Act and a conduit for gas delivery to a patient. |
| 8.4 | Anatomical Sites
Connects to an endotracheal or tracheostomy tube. | 8.4 | Anatomical Sites
Connects to an endotracheal or tracheostomy tube. |
| 8.5
Results | Specifications & Performance Test | 8.5
Results | Specifications & Performance Test |
| | 8.5.1 Length: 1.83 meters
8.5.2 Resistance (test method per ISO 5367):
8.5.2.1 Inspiratory:
0.9 cmH2O (0.09 kPa)/L/sec @ 30 LPM, air
1.5 cmH2O (0.15 kPa)/L/sec @ 60 LPM, air
2.2 cmH2O (0.22 kPa)/L/sec @ 90 LPM, air
2.8 cmH2O (0.28 kPa)/L/sec @ 120 LPM, air
8.5.2.2 Expiratory:
0.7 cmH2O (0.07 kPa)/L/sec @30 LPM, air
1.3 cmH2O (0.13 kPa)/L/sec @ 60 LPM, air
1.9 cmH2O (0.19 kPa)/L/sec @ 90 LPM, air
2.4 cmH2O (0.24 kPa)/L/sec @ 120 LPM, air
8.5.3 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 meters
8.5.2 Resistance (test method per ISO 5367):
8.5.2.1 Inspiratory:
0.8 cmH2O (0.08 kPa)/L/sec @ 30 LPM, air
1.3 cmH2O (0.13 kPa)/L/sec @ 60 LPM, air
1.9 cmH2O (0.19 kPa)/L/sec @ 90 LPM, air
2.4 cmH2O (0.24 kPa)/L/sec @ 120 LPM, air
8.5.2.2 Expiratory:
0.8 cmH2O (0.08 kPa)/L/sec @ 30 LPM, air
1.3 cmH2O (0.13 kPa)/L/sec @ 60 LPM, air
1.9 cmH2O (0.19 kPa)/L/sec @ 90 LPM, air
2.4 cmH2O (0.24 kPa)/L/sec @ 120 LPM, air
8.5.3 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 | Size
6.0 foot (1.83 meter) ventilator circuit | 8.6 | Size
5.0 foot (1.52 meter) ventilator circuit |
| 8.7 | Materials of Construction
8.7.1 Inspiratory circuit to humidifier adapter:
High Density Polypropylene
8.7.2 Corrugated tubing:
Polyethylene/EVA blend
8.7.3 Inspiratory circuit to wye connector: | 8.7 | Materials of Construction
8.7.1 Inspiratory circuit to humidifier adapter:
High Density Polyethylene
8.7.2 Corrugated tubing:
Polyethylene/EVA blend
8.7.3 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. |
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 adapter | |||||
| with heated wire entry and temperature | |||||
| monitoring ports. | 8.8.1 | Inspiratory circuit to humidifier adapter: | |||
| Two piece, 60 degree angle adapter with | |||||
| heated wire entry and temperature | |||||
| monitoring 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 and | |||||
| prevent wire migration into wye | |||||
| connector. | 8.8.3 | Inspiratory circuit to wye connector: | |||
| 22 mm ID x 22 mm OD connector with | |||||
| "cage" to anchor wire harness and | |||||
| prevent wire migration into wye | |||||
| connector. | |||||
| 8.8.4 | Wye connector: | ||||
| Standard 60-degree (60°) entry and exit | |||||
| legs, all legs have a 22 mm OD | |||||
| connections, patient end includes a 15 | |||||
| mm ID connection. | 8.8.4 | Wye connector: | |||
| Standard 60-degree (60°) entry and exit | |||||
| legs, all legs have a 22 mm OD | |||||
| connections, patient end includes a15 | |||||
| mm ID connection. | |||||
| 8.8.5 | Patient connector: | ||||
| Standard right angle patient connector | |||||
| that allows attachment to 15 mm ID and | |||||
| 22 mm OD connector. | 8.8.5 | Patient connector: | |||
| Standard right angle patient connector | |||||
| that allows attachment to 15 mm ID and | |||||
| 22 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 and | |||||
| prevent wire migration into wye | |||||
| connector. | 8.8.6 | Expiratory circuit to wye connector: | |||
| 22 mm ID x 22 mm OD connector with | |||||
| "cage" to anchor wire harness and | |||||
| prevent wire migration into wye | |||||
| connector. | |||||
| 8.8.7 | Expiratory circuit to ventilator adapter: | ||||
| Single piece, straight adapter with | |||||
| heated wire entry port. | 8.8.7 | Expiratory circuit to ventilator adapter: | |||
| Two piece, 60 degree angle adapter with | |||||
| heated wire entry port. | |||||
| 8.8.8 | Heated Wire entry grommet. | ||||
| Insert molded around heated wire | |||||
| harness then inserted into inspiratory or | |||||
| expiratory adapter. | 8.8.8 | Heated Wire entry grommet: | |||
| Injection molded "clam shell grommet | |||||
| that 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 / Delivered | ||||
| 21- volt system controlled by Hudson RCI | |||||
| ConchaTherm controller. | 8.9 | Energy Used / Delivered | |||
| 21-volt system controlled by Hudson RCI | |||||
| ConchaTherm 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 volt | ||||
| heated wire humidifiers. | 8.10.3 | May be used on all Hudson RCI 21 volt | |||
| heated wire humidifiers. | |||||
| 8.11 | Method of Operation | ||||
| Acts as a gas conduit between ventilator and | |||||
| patient. | 8.11 | Method of Operation | |||
| Acts as a gas conduit between ventilator and | |||||
| patient. | |||||
| 8.12 | Accessories | ||||
| None | 8.12 | Accessories | |||
| None | |||||
| 8.13 | Safety Characteristics | ||||
| No difference identified | 8.13 | Safety Characteristics | |||
| No 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:
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.
(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)