INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330
Device Facts
| Record ID | K092129 |
|---|---|
| Device Name | INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 |
| Applicant | Intersurgical, Inc. |
| Product Code | BZE · Anesthesiology |
| Decision Date | May 18, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5270 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient's airway. Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients.
Device Story
The Intersurgical Heated Wire Breathing System and Humidification Chambers are respiratory accessories used in hospital settings. The breathing circuits (2026, 2026-CH) deliver humidified gas to patients; integrated heater wires minimize condensate formation. The humidification chambers (2310, 2320, 2330) interface with a heated humidifier base (e.g., F&P MR850) to hold water, which is heated to provide optimal humidification. The 2310 Auto-Fill chamber maintains a constant water level via a float mechanism; the 2320 and 2330 are manual-fill chambers, with the 2330 specifically designed for high-frequency ventilation and neonatal applications. These devices are operated by clinicians. The output—warmed, humidified gas—is delivered to the patient to prevent airway drying and improve respiratory comfort. Safety is maintained through compliance with ISO standards for resistance to flow, electrical safety, and biocompatibility.
Clinical Evidence
No clinical tests were performed. Substantial equivalence is supported by non-clinical bench testing, including resistance to flow, compliance, compressible volume, wire resistance, fill rates, humidity output, overflow, leakage, and tapers. Biocompatibility testing was conducted per ISO 10993-1.
Technological Characteristics
Materials: Flex tube (22mm diameter). Sensing/Actuation: Heated wire circuits for condensate control; float mechanism (2310) for auto-fill. Energy: Electrical heating of gas/water. Connectivity: Compatible with F&P MR850 heater bases. Sterility: Non-sterile. Standards: ISO 5367, ISO 9360, ISO 8185, ISO 5356, EN 12342, ISO 10993.
Indications for Use
Indicated for any patient using a heated humidifier to warm and humidify breathing gases before they enter the airway. Prescription use only.
Regulatory Classification
Identification
A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.
Predicate Devices
- Fisher & Paykel RT210 dual wire heated breathing circuit (K983112)
- Fisher & Paykel MR 290 Autofeed Humidification Chamber (K934140)
- Fisher & Paykel MR 210 Manual Feed Adult Chamber (K850647)
- Fisher & Paykel MR 225 Manual Feed Infant Chamber (K862923)
Related Devices
- K231380 — AirLife DuoTherm Humidification System · Vyaire Medical, Inc. · Aug 10, 2023
- K251448 — FL-10000U Respiratory Humidifier · Flexicare Medical Limited. · Jan 16, 2026
- K034026 — RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS · Fisher & Paykel Healthcare, Ltd. · Jan 12, 2005
- K110398 — RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS · Respironics, Inc. · Jun 1, 2011
- K140556 — CONCHASMART BREATHING CIRCUIT · Teleflex, Inc. · Sep 24, 2014
Submission Summary (Full Text)
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# Appendix C. 510(k) Summary of Safety and Effectiveness Page1
Name: INTERSURGICAL INCORPORATED Address: 417 Electronics Parkway Liverpool, NY 13088 Date: 05/18/2010 John Robinson VP - Operations Contact Person: Phone Number: 315-451-2900 315-451-3696 Fax Number:
1092129
MAY 1 8 2010
# Description of Device:
The 2026 and 2026-CH dual heated wire breathing circuits are classified as "Breathing System Heater" according to 21 CFR 868.5270. The breathing circuits form part of the respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the expired gas away from the patient. Heater wires in the inspiratory and expiratory limb minimizes the formation of condensate.
The 2310 Auto-Fill Humidification Chamber, 2320 Manual Fill Humidification Chamber and the 2330 Low Volume Manual Fill Humidification Chamber are classified as accessories to "Breathing System Heater" according to 21 CFR 868.5270. Chambers are an integral part of the breathing system and allow the system to interface with the heated humidifier base. Chambers are commonly used with heated wire breathing systems. The chamber simply slides into position on the hot plate of the base controller allowing the inspiratory gas to pass over the heated water. This provides optimum humidification to the patient.
The 2310 Auto-Fill Chamber offers a fixed level of water within the chamber, ensuring a constant system volume. The float mechanism along with the webs inside the chamber and baffles at the base of the 22mm male connectors, ensure that the chamber gives maximum humidity output without compromising resistance to flow.
The 2320 Manual-Fill Chamber is supplied with a complete fill set and clamp in order to manually control the water level in the chamber.
The 2330 Low-Volume Chamber is suitable for use with high frequency ventilation and many neonatal applications. The chamber is supplied with a fill set and clamp in order to manually control the water level in the chamber.
# Predicate Devices:
The 2026 dual wire heated breathing circuit is substantially equivalent to the Fisher & Paykel RT210 dual wire heated breathing circuit. The 2310 Auto-Fill Humidification Chamber is substantially equivalent to the Fisher & Paykel MR 290 Autofeed Humidification Chamber. The 2320 Manual Fill Humidification Chamber is substantially equivalent to the Fisher & Paykel MR 210 Manual Feed Adult Chamber. The 2330 Low Volume Manual Fill Humidification Chamber is substantially equivalent to the Fisher & Paykel MR 225 Manual Feed Infant Chamber.
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# Appendix C. 510(k) Summary of Safety and Effectiveness Page 2
# Intended Use:
Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient's airway.
Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients.
# Technological Characteristics Summary:
The intended use of the heated wire breathing circuit is comparable to the referenced predicate device. The comparison of the data shows similar values for the key performance characteristics. Proposed heated wire devices show similar values for compliance, volume, resistance to flow, wire resistance and tube length.
| Characteristic<br>Compared | [510(k) DEVICE]<br>2026 | [PREDICATE DEVICE]<br>F & P RT 210<br>K983112 |
|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510K | | |
| Intended use: | Breathing system heaters are defined as a device that<br>is intended to warm breathing gases before they<br>enter a patient's airway. | Breathing system heaters are defined as a device that is<br>intended to warm breathing gases before they enter a<br>patient's airway. |
| Target Population | Any patient using a heated<br>humidifier | Any patient using a heated<br>humidifier |
| Indications for use<br>Where used | Instruction leaflet<br>Hospital | Instruction leaflet<br>Hospital |
| Product Labelling | Heated Wire Breathing<br>Circuit | Heated Wire Breathing Circuit |
| Design &<br>Performance: | Standards Used:<br>ISO 5367 / ISO 9360 | Test Report 30889 located in<br>Appendix F of initial<br>submission |
| Volume (ml) | 1106 | 1460 |
| Tube Length (m) | 2.27 Ins & 1.46 Exp | 1.93 Ins & 1.48 Exp |
| Wire Resistance<br>(ohms) | 14.7 Ins & 11.9 Exp | 17.2 Ins & 12.2 Exp |
| Tube material and<br>designated diameter | Flex tube 22mm | Flex tube 22mm |
| Compliance (ml/Kpa) | 11.2 | 13.3 |
| Resistance to Flow<br>(mb) | 2.9 Ins & 2.6 Exp | 3.1 Ins & 3.3 Exp |
| Characteristic<br>Compared | [510(k) DEVICE]<br>2026 | [PREDICATE DEVICE]<br>F & P RT 210 |
| Compatibility with the<br>environment and<br>other devices. See<br>Pages 9 to 14 for<br>Compatibility Study. | To be used with 2310<br>humidification chamber and<br>F&P MR850 heater bases.<br>Product compatible with<br>F & P MR 850. | To be used with F&P MR290<br>humidification chamber and<br>F&P MR850 heater bases. |
| Energy used and or<br>delivered | The raising of the delivered<br>gas temperature from 37 to<br>40C increases its enthalpy. | The raising of the delivered gas<br>temperature from 37 to 40C<br>increases its enthalpy. |
| Sterility | NON STERILE | NON STERILE |
| Standards met: | ISO 5367<br>ISO 10993<br>ISO 8185<br>ISO 5356<br>EN 12342 | ISO 5367<br>ISO 10993<br>ISO 8185<br>ISO 5356<br>EN 12342 |
| Biocompatibility | Compliant with ISO 10993<br>The materials all met the requirements of<br>the biological tests for Cytotoxicity,<br>Sensitization, Irritation, Genotoxicity -<br>Ames Test, Gene Mutation - In Vitro<br>Mouse Lymphoma and Implantation as<br>described in the biocompatibility tests<br>performed by Nelson Laboratories in<br>Appendix G. | Compliant with ISO 10993 |
| Test Results: | See Pages 19 to 44 for<br>Summary Conformance. | See Pages 45 to 86 for test<br>reports. |
| Electrical safety | Compliant with ISO 8185<br>See page 16B, pp 52 -55, 56, 57-60<br>& 64-66 for electrical testing. | Compliant with ISO 8185 |
| Mechanical safety | Compliant with ISO 8185<br>See page 16B and pp 78 -80 for<br>mechanical testing. | Compliant with ISO 8185 |
| Chemical Safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Thermal safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Radiation safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Characteristic<br>Compared | [510(k) DEVICE]<br>2310 | [PREDICATE DEVICE]<br>F & P MR 290 |
| 510K | | K934140 |
| Intended use: | Humidification Chambers are<br>intended for use to hold water<br>required to humidify the air<br>being delivered to patients. | Humidification Chambers<br>are intended for use to hold<br>water required to humidify<br>the air being delivered to<br>patients. |
| Target Population | Any patient using a heated<br>humidifier | Any patient using a heated<br>humidifier |
| Indications for use | Instruction leaflet | Instruction leaflet |
| Where used | Hospital | Hospital |
| Product Labelling | Auto Fill Humidification<br>Chamber | Auto Fill Humidification<br>Chamber |
| Design &<br>Performance: | Standards Used:<br>ISO 8185 / ISO 9360<br>BS EN 12342 | Standards Used:<br>ISO 8185 / ISO 9360<br>BS EN 12342 |
| Fill Volume (ml) | Full 369.9/ Max Line 147.1/<br>Min Line 51.1 [3] | 355 But no fill lines [3] |
| Weight (g) | 126 [3] | 94 [3] |
| Leakage (ml/min) | <0.5 [2] | <0.5 [2] |
| Compliance at empty<br>(ml/mb) | 0.60 [2] | 0.56 [2] |
| Resistance to Flow<br>(mb) | 0.6 [2] | 0.4 [2] |
| Moisture Output (mg/l)<br>at 10 l/min | 46.6 [2] | 47.4 [2] |
| Evaluation of<br>Maximum Flows<br>(l/min)<br>Horizontal/10 degrees | 194 / 171 [2] | 165 / 157 [2] |
| Compatibility with the<br>environment and<br>other devices | To be used with I/S breathing<br>circuit and F&P MR850 heater<br>bases. | To be used with F&P breathing<br>circuits and F&P MR850<br>heater bases. |
| Energy used and or<br>delivered | Electrical energy is used to raise<br>the temperature and humidity of<br>the gas delivered to the patient. | Electrical energy is used to<br>raise the temperature and<br>humidity of the gas delivered<br>to the patient. |
| Sterility | NON STERILE | NON STERILE |
| Characteristic | [510(k) Device] | [Predicate Device] |
| Compared | 2310 | F & P MR 290 |
| Standards met: | ISO 10993<br>ISO 8185<br>ISO 5356 | ISO 10993<br>ISO 8185<br>ISO 5356 |
| Biocompatibility | Compliant with ISO 10993<br>The materials all met the requirements of<br>the biological tests for Cytotoxicity,<br>Sensitization, Irritation, Genotoxicity -<br>Ames Test, Gene Mutation - In Vitro Mouse<br>Lymphoma and Implantation as described<br>in the blocompatibility tests performed by<br>Nelson Laboratories in Appendix G. | Compliant with ISO 10993 |
| Test Results: | See Pages 19 to 44 for<br>Summary Conformance. | See Pages 45 to 86 for test<br>reports. |
| Electrical safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Mechanical safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Chemical Safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Thermal safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Radiation safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
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Appendix C. 510(k) Summary of Safety and Effectiveness Page 3
The intended use of the humidification chambers are comparable to the referenced predicate devices. The comparison of the data shows similar values for the key performance characteristics. Proposed humidification chambers show similar values for fill volume, compressible volume, compliance, leakage, weight, moisture output, resistance to flow and evaluation of maximum flows.
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Appendix C. 510(k) Summary of Safety and Effectiveness Page 5
| Characteristic<br>Compared | 510K | [510(k) DEVICE]<br>2320 | [PREDICATE DEVICE]<br>F & P MR 210 |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 510K | | | K850647 |
| Intended use: | | Humidification Chambers are<br>intended for use to hold water<br>required to humidify the air<br>being delivered to patients. | Humidification Chambers<br>are intended for use to hold<br>water required to humidify<br>the air being delivered to patients. |
| Target Population | | Any patient using a heated<br>humidifier | Any patient using a heated<br>humidifier |
| Indications for use | | Instruction leaflet | Instruction leaflet |
| Where used | | Hospital | Hospital |
| Product Labelling | | Manual Fill Humidification<br>Chamber | Manual Fill Humidification<br>Chamber |
| Design &<br>Performance: | | Standards Used:<br>ISO 8185 / ISO 9360<br>BS EN 12342 | Standards Used:<br>ISO 8185 / ISO 9360<br>BS EN 12342 |
| Fill Volume (ml) | | Full 457.7/ Max Line 243.2/<br>Min Line 66 [6] | Full 445.3/Max 252.4 [6] |
| Weight (g) | | 93.4 [1] | 55.9 [1] |
| Leakage (ml/min) | | < 0.5 [6] | 0.7 [1] |
| Characteristic<br>Compared | [510(k) DEVICE]<br>2320 | [PREDICATE DEVICE]<br>F & P MR 210 | |
| Compliance at empty<br>(ml/mb) | 0.44 [1] | 0.49 [1] | |
| Resistance to Flow mb<br>at (60 l/min) | 0.1 [1] | 0.1 [1] | |
| Moisture Output mg/l<br>at (10 l/min) | 47.1 [1] | 46.4 [1] | |
| Evaluation of<br>Maximum Flows<br>(l/min)<br>Horizontal/10 degrees | 200/200 [1] | 200/200 [1] | |
| Compatibility with the<br>environment and<br>other devices: | To be used with I/S breathing<br>circuit and F&P MR850 heater<br>bases. | To be used with F&P breathing<br>circuits and F&P MR850<br>heater bases. | |
| Energy used and or<br>delivered | Electrical energy is used to raise<br>the temperature and humidity of<br>the gas delivered to the patient. | Electrical energy is used to<br>raise the temperature and<br>humidity of the gas delivered<br>to the patient. | |
| Sterility | NON STERILE | NON STERILE | |
| Standards met: | ISO 10993<br>ISO 8185<br>ISO 5356 | ISO 10993<br>ISO 8185<br>ISO 5356 | |
| Biocompatibility | Compliant with ISO 10993 The<br>materials all met the requirements of the<br>biological tests for Cytotoxicity.<br>Sensitization, Irritation, Genotoxicity<br>Ames Test, Gene Mutation - In Vitro Mouse<br>Lymphoma and Implantation as described<br>in the biocompatibility tests performed by<br>Nelson Laboratories in Appendix G. | Compliant with ISO 10993 | |
| Test Results: | See Pages 19 to 44 for<br>Summary Conformance. | See Pages 45 to 86 for test<br>reports. | |
| Electrical safety | Compliant with ISO 8185 | Compliant with ISO 8185 | |
| Mechanical safety | Compliant with ISO 8185 | Compliant with ISO 8185 | |
| Chemical Safety | Compliant with ISO 8185 | Compliant with ISO 8185 | |
| Thermal safety | Compliant with ISO 8185 | Compliant with ISO 8185 | |
| Radiation safety | Compliant with ISO 8185 | Compliant with ISO 8185 | |
:
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### Appendix C. 510(k) Summary of Safety and Effectiveness Page 6
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| Appendix C. 510(k) Summary of Safety and Effectiveness Page 7 | | |
|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Characteristic<br>Compared | [510(k) DEVICE]<br>2330 | [PREDICATE DEVICE]<br>F & P MR 225 |
| 510K | | K862923 |
| Intended use: | Humidification Chambers are<br>intended for use to hold water<br>required to humidify the air<br>being delivered to patients. | Humidification Chambers<br>are intended for use to hold<br>water required to humidify<br>the air being delivered to<br>patients. |
| Target Population | Any patient using a heated<br>humidifier | Any patient using a heated<br>humidifier |
| Indications for use | Instruction leaflet | Instruction leaflet |
| Where used | Hospital | Hospital |
| Product Labelling | Low Volume Manual Fill<br>Humidification Chamber | Low Volume Manual Fill<br>Humidification Chamber |
| Design &<br>Performance: | Standards Used:<br>ISO 8185 / ISO 9360<br>BS EN 12342 | Standards Used:<br>ISO 8185 / ISO 9360<br>BS EN 12342 |
| Fill Volume (ml) | Full 307.4/ Max Line 190.6/<br>Min Line 62.5 [7] | Full 308.1/ Max Line 193.5 [7] |
| Weight (g) | 82.9 [4] | 51.1 [1] |
| Leakage (ml/min) | 0.5 [1] | 3 [1] |
| Compliance at empty<br>(ml/mb) | 0.31 [5] | 0.31 [5] |
| Resistance to Flow mb<br>at (60 l/min) | 0.1 [7] | 0.2 [6] |
| Moisture Output (mg/l)<br>at 10 l/min | 46.4 [1] | 46.3 [1] |
| Evaluation of<br>Maximum Flows<br>(l/min)<br>Horizontal/10 degrees | 130/140 [1] | 130/140 [1] |
| Compatibility with the<br>environment and<br>other devices | To be used with I/S breathing<br>circuit and F&P MR850 heater<br>bases. | To be used with F&P breathing<br>circuits and F&P MR850<br>heater bases. |
| Energy used and or<br>delivered | Electrical energy is used to raise<br>the temperature and humidity of<br>the gas delivered to the patient. | Electrical energy is used to<br>raise the temperature and<br>humidity of the gas delivered<br>to the patient. |
| Characteristic<br>Compared | [510(k) DEVICE]<br>2330 | [PREDICATE DEVICE]<br>F & P MR 225 |
| Sterility | NON STERILE | NON STERILE |
| Standards met: | ISO 10993<br>ISO 8185<br>ISO 5356 | ISO 10993<br>ISO 8185<br>ISO 5356 |
| Biocompatibility | Compliant with ISO 10993 The<br>materials all met the requirements of the<br>biological tests for Cytotoxicity,<br>Sensitization, Irritation, Genotoxicity -<br>Ames Test, Gene Mutation - In Vitro Mouse<br>Lymphoma and Implantation as described<br>in the biocompatibility tests performed by<br>Nelson Laboratories in Appendix G. | Compliant with ISO 10993 |
| Test Results: | See Pages 19 to 44 for<br>Summary Conformance. | See Pages 45 to 86 for test<br>reports. |
| Electrical safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Mechanical safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Chemical Safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Thermal safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Radiation safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
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Appendix C. 510(k) Summary of Safety and Effectiveness Page 8
[1] Results taken from MGI_15605_CC_2330, MR225 and 2320, MR210
Comparison Issue 1
[2] Results taken from
2310 (17.50mm MAX line)MK IV TR AR,MS 02 03 2009.doc
[3] Results taken from AW 15731 CC Fluid and gas volumes for MK2 and MK4 Chambers_issue1.doc [3]
[4] Results taken from AW CC Fill volume of manual fill, low volume humid chamber issue 1.Book1 (2).xls
[5] Results taken from TO 2002 Compliance chamber.doc
[6] Results taken from CC_AW_31655_MF 2320 & F&P M225 Chamber Testing issue1.doc
[7] Results taken from MGI 15605 CC 2330, Low volume chamber measurements Issue 1.doc
Note: See pages 67 to 75C for the attached reports detailing the information for the Humidification Chambers.
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# Summary of Testing:
Nonclinical tests submitted to demonstrate substantial equivalence for the Heated Wire Breathing Circuit include Resistance to Flow, Compliance, Compressible Volume and Wire Resistance. Tests were performed to calculate the running temperature of the Heated Wire Breathing Circuit.
Nonclinical tests submitted to demonstrate substantial equivalence for the Humidification Chambers include Rates of Fill, Chamber Critical Dimensions, Resistance to Flow, Fill Volume, Compliance, Humidity Output, Overflow, Leakage and Tapers.
All materials used in the heated wire breathing circuit and humidification chambers have been evaluated according to tests outlined in ISO 10993-1. The only exception being the tube hanger and tubing clips on the heated wire breathing circuit. These two components are on the outside of the device and do not contact the patient.
No clinical tests have been performed on the Heated Wire Breathing Circuit or the Humidification Chambers.
# Conclusions Demonstrating Safety, Effectiveness and Performance:
Intersurgical Incorporated has demonstrated that the proposed devices are safe and effective. They are considered to be substantially equivalent to the currently marketed predicate devices which have been previously reviewed for market clearance by the FDA.
K092129
Premarket Notification [510(k)] Number
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Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest wings or feathers.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Intersurgical, Incorporated C/O Michael Zalewski RA/QA Specialist Sleep & Home Respiratory Group 417 Electronics Parkway Liverpool, New York 13088
MAY 1 8 2010
Re: K092129
Trade/Device Name: Intersurgical Heated Wire Breathing System and Humidification Chambers Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: II Product Code: BZE, BTT Dated: May 10, 2010 Received: May 17, 2010
Dear Michael Zalewski:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.ida.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
the R.S.M.
nthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
## Enclosure
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### INDICATION FOR USE FORM 10.
Page 8C
510(k) Number (if known): K092129
Device Name: 2026 - Heated Wire Breathing System 2026-CH - Heated Wire Breathing System with Auto-Fill Chamber
Indications For Use: Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient's airway.
Prescription Use _XX (Per 21 CFR 801 Subpart D)
ーーーーーーーーーーーーーーーー
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH,
L Schulthess
(Division Sign-Üff) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Page 1 of 2
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### 10. INDICATION FOR USE FORM
Page 8D
510(k) Number (if known): K092129
Device Name: 2310 - Auto-Fill Humidification Chamber 2320 - Manual Fill Humidification Chamber 2330 - Low Volume Manual Fill Humidification Chamber
Indications For Use: Humidification chambers are intended for use to hold water required to humidify the air being delivered to patients.
Prescription Use XX (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
L. Schulther
'G'
510(k) K092129
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 2 of 2
1092129 510(k) Number:
