(307 days)
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.
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.
The provided document describes a 510(k) submission for Interurgical Inc.'s heated wire breathing systems and humidification chambers, demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study. The "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices and relevant industry standards. The "study" refers to nonclinical tests performed to show comparability.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents performance characteristics of the proposed devices (Intersurgical 2026, 2310, 2320, 2330) and compares them to their respective predicate devices. The "acceptance criteria" can be inferred as being similar to or meeting the performance of the predicate devices and complying with relevant standards.
For the 2026 Heated Wire Breathing Circuit:
| Characteristic Compared | Predicate Device (F & P RT 210) Acceptance Criteria | 510(k) Device (2026) Reported Performance |
|---|---|---|
| Volume (ml) | 1460 | 1106 |
| Tube Length (m) | 1.93 Ins & 1.48 Exp | 2.27 Ins & 1.46 Exp |
| Wire Resistance (ohms) | 17.2 Ins & 12.2 Exp | 14.7 Ins & 11.9 Exp |
| Tube material and designated diameter | Flex tube 22mm | Flex tube 22mm |
| Compliance (ml/Kpa) | 13.3 | 11.2 |
| Resistance to Flow (mb) | 3.1 Ins & 3.3 Exp | 2.9 Ins & 2.6 Exp |
| Sterility | NON STERILE | NON STERILE |
| Biocompatibility | Compliant with ISO 10993 | Compliant with ISO 10993 |
| 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 |
For the 2310 Auto-Fill Humidification Chamber:
| Characteristic Compared | Predicate Device (F & P MR 290) Acceptance Criteria | 510(k) Device (2310) Reported Performance |
|---|---|---|
| Fill Volume (ml) | 355 But no fill lines | Full 369.9/ Max Line 147.1/ Min Line 51.1 |
| Weight (g) | 94 | 126 |
| Leakage (ml/min) | <0.5 | <0.5 |
| Compliance at empty (ml/mb) | 0.56 | 0.60 |
| Resistance to Flow (mb) | 0.4 | 0.6 |
| Moisture Output (mg/l) at 10 l/min | 47.4 | 46.6 |
| Evaluation of Maximum Flows (l/min) Horizontal/10 degrees | 165 / 157 | 194 / 171 |
| Sterility | NON STERILE | NON STERILE |
| Biocompatibility | Compliant with ISO 10993 | Compliant with ISO 10993 |
| 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 |
For the 2320 Manual Fill Humidification Chamber:
| Characteristic Compared | Predicate Device (F & P MR 210) Acceptance Criteria | 510(k) Device (2320) Reported Performance |
|---|---|---|
| Fill Volume (ml) | Full 445.3/Max 252.4 | Full 457.7/ Max Line 243.2/ Min Line 66 |
| Weight (g) | 55.9 | 93.4 |
| Leakage (ml/min) | 0.7 | < 0.5 |
| Compliance at empty (ml/mb) | 0.49 | 0.44 |
| Resistance to Flow mb at (60 l/min) | 0.1 | 0.1 |
| Moisture Output mg/l at (10 l/min) | 46.4 | 47.1 |
| Evaluation of Maximum Flows (l/min) Horizontal/10 degrees | 200/200 | 200/200 |
| Sterility | NON STERILE | NON STERILE |
| Biocompatibility | Compliant with ISO 10993 | Compliant with ISO 10993 |
| 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 |
For the 2330 Low Volume Manual Fill Humidification Chamber:
| Characteristic Compared | Predicate Device (F & P MR 225) Acceptance Criteria | 510(k) Device (2330) Reported Performance |
|---|---|---|
| Fill Volume (ml) | Full 308.1/ Max Line 193.5 | Full 307.4/ Max Line 190.6/ Min Line 62.5 |
| Weight (g) | 51.1 | 82.9 |
| Leakage (ml/min) | 3 | 0.5 |
| Compliance at empty (ml/mb) | 0.31 | 0.31 |
| Resistance to Flow mb at (60 l/min) | 0.2 | 0.1 |
| Moisture Output (mg/l) at 10 l/min | 46.3 | 46.4 |
| Evaluation of Maximum Flows (l/min) Horizontal/10 degrees | 130/140 | 130/140 |
| Sterility | NON STERILE | NON STERILE |
| Biocompatibility | Compliant with ISO 10993 | Compliant with ISO 10993 |
| 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 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state sample sizes for individual tests. It refers to "Test Results" and "Summary Conformance" with numerous page numbers (e.g., "See Pages 19 to 44 for Summary Conformance," "See Pages 45 to 86 for test reports"). The provenance of the data is retrospective, as the comparisons are made against existing predicate devices and in-house testing. The country of origin for the data is implied to be internal testing by Intersurgical Incorporated and Nelson Laboratories (for biocompatibility), likely in the USA where the company address is located, but it's not explicitly stated for all tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is based on objective measurements and compliance with established industry standards (ISO 5367, ISO 9360, ISO 8185, ISO 10993, ISO 5356, EN 12342), not expert consensus on qualitative data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments where expert agreement is needed to establish ground truth, which is not the case for these objective performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a technical device performance study, not an AI-assisted diagnostic study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This document describes the performance of a physical medical device (breathing circuit and humidification chambers), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth used for the device evaluation is based on:
- Established Industry Standards: ISO 5367, ISO 9360, ISO 8185, ISO 10993, ISO 5356, EN 12342.
- Performance Metrics of Legally Marketed Predicate Devices: The specific values for characteristics like volume, resistance to flow, weight, leakage, moisture output, etc., of the Fisher & Paykel predicate devices (RT210, MR 290, MR 210, MR 225).
- Laboratory Testing: For properties like biocompatibility (per ISO 10993) by Nelson Laboratories, and various electrical, mechanical, chemical, and thermal safety tests.
8. The Sample Size for the Training Set
Not applicable. This document pertains to a physical medical device and its performance testing, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
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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.
| CharacteristicCompared | [510(k) DEVICE]2026 | [PREDICATE DEVICE]F & P RT 210K983112 |
|---|---|---|
| 510K | ||
| Intended use: | Breathing system heaters are defined as a device thatis intended to warm breathing gases before theyenter a patient's airway. | Breathing system heaters are defined as a device that isintended to warm breathing gases before they enter apatient's airway. |
| Target Population | Any patient using a heatedhumidifier | Any patient using a heatedhumidifier |
| Indications for useWhere used | Instruction leafletHospital | Instruction leafletHospital |
| Product Labelling | Heated Wire BreathingCircuit | Heated Wire Breathing Circuit |
| Design &Performance: | Standards Used:ISO 5367 / ISO 9360 | Test Report 30889 located inAppendix F of initialsubmission |
| Volume (ml) | 1106 | 1460 |
| Tube Length (m) | 2.27 Ins & 1.46 Exp | 1.93 Ins & 1.48 Exp |
| Wire Resistance(ohms) | 14.7 Ins & 11.9 Exp | 17.2 Ins & 12.2 Exp |
| Tube material anddesignated diameter | Flex tube 22mm | Flex tube 22mm |
| Compliance (ml/Kpa) | 11.2 | 13.3 |
| Resistance to Flow(mb) | 2.9 Ins & 2.6 Exp | 3.1 Ins & 3.3 Exp |
| CharacteristicCompared | [510(k) DEVICE]2026 | [PREDICATE DEVICE]F & P RT 210 |
| Compatibility with theenvironment andother devices. SeePages 9 to 14 forCompatibility Study. | To be used with 2310humidification chamber andF&P MR850 heater bases.Product compatible withF & P MR 850. | To be used with F&P MR290humidification chamber andF&P MR850 heater bases. |
| Energy used and ordelivered | The raising of the deliveredgas temperature from 37 to40C increases its enthalpy. | The raising of the delivered gastemperature from 37 to 40Cincreases its enthalpy. |
| Sterility | NON STERILE | NON STERILE |
| Standards met: | ISO 5367ISO 10993ISO 8185ISO 5356EN 12342 | ISO 5367ISO 10993ISO 8185ISO 5356EN 12342 |
| Biocompatibility | Compliant with ISO 10993The materials all met the requirements ofthe biological tests for Cytotoxicity,Sensitization, Irritation, Genotoxicity -Ames Test, Gene Mutation - In VitroMouse Lymphoma and Implantation asdescribed in the biocompatibility testsperformed by Nelson Laboratories inAppendix G. | Compliant with ISO 10993 |
| Test Results: | See Pages 19 to 44 forSummary Conformance. | See Pages 45 to 86 for testreports. |
| Electrical safety | Compliant with ISO 8185See page 16B, pp 52 -55, 56, 57-60& 64-66 for electrical testing. | Compliant with ISO 8185 |
| Mechanical safety | Compliant with ISO 8185See page 16B and pp 78 -80 formechanical 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 |
| CharacteristicCompared | [510(k) DEVICE]2310 | [PREDICATE DEVICE]F & P MR 290 |
| 510K | K934140 | |
| Intended use: | Humidification Chambers areintended for use to hold waterrequired to humidify the airbeing delivered to patients. | Humidification Chambersare intended for use to holdwater required to humidifythe air being delivered topatients. |
| Target Population | Any patient using a heatedhumidifier | Any patient using a heatedhumidifier |
| Indications for use | Instruction leaflet | Instruction leaflet |
| Where used | Hospital | Hospital |
| Product Labelling | Auto Fill HumidificationChamber | Auto Fill HumidificationChamber |
| Design &Performance: | Standards Used:ISO 8185 / ISO 9360BS EN 12342 | Standards Used:ISO 8185 / ISO 9360BS EN 12342 |
| Fill Volume (ml) | Full 369.9/ Max Line 147.1/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(ml/mb) | 0.60 [2] | 0.56 [2] |
| Resistance to Flow(mb) | 0.6 [2] | 0.4 [2] |
| Moisture Output (mg/l)at 10 l/min | 46.6 [2] | 47.4 [2] |
| Evaluation ofMaximum Flows(l/min)Horizontal/10 degrees | 194 / 171 [2] | 165 / 157 [2] |
| Compatibility with theenvironment andother devices | To be used with I/S breathingcircuit and F&P MR850 heaterbases. | To be used with F&P breathingcircuits and F&P MR850heater bases. |
| Energy used and ordelivered | Electrical energy is used to raisethe temperature and humidity ofthe gas delivered to the patient. | Electrical energy is used toraise the temperature andhumidity of the gas deliveredto the patient. |
| Sterility | NON STERILE | NON STERILE |
| Characteristic | [510(k) Device] | [Predicate Device] |
| Compared | 2310 | F & P MR 290 |
| Standards met: | ISO 10993ISO 8185ISO 5356 | ISO 10993ISO 8185ISO 5356 |
| Biocompatibility | Compliant with ISO 10993The materials all met the requirements ofthe biological tests for Cytotoxicity,Sensitization, Irritation, Genotoxicity -Ames Test, Gene Mutation - In Vitro MouseLymphoma and Implantation as describedin the blocompatibility tests performed byNelson Laboratories in Appendix G. | Compliant with ISO 10993 |
| Test Results: | See Pages 19 to 44 forSummary Conformance. | See Pages 45 to 86 for testreports. |
| 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
| CharacteristicCompared | 510K | [510(k) DEVICE]2320 | [PREDICATE DEVICE]F & P MR 210 |
|---|---|---|---|
| 510K | K850647 | ||
| Intended use: | Humidification Chambers areintended for use to hold waterrequired to humidify the airbeing delivered to patients. | Humidification Chambersare intended for use to holdwater required to humidifythe air being delivered to patients. | |
| Target Population | Any patient using a heatedhumidifier | Any patient using a heatedhumidifier | |
| Indications for use | Instruction leaflet | Instruction leaflet | |
| Where used | Hospital | Hospital | |
| Product Labelling | Manual Fill HumidificationChamber | Manual Fill HumidificationChamber | |
| Design &Performance: | Standards Used:ISO 8185 / ISO 9360BS EN 12342 | Standards Used:ISO 8185 / ISO 9360BS EN 12342 | |
| Fill Volume (ml) | Full 457.7/ Max Line 243.2/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] | |
| CharacteristicCompared | [510(k) DEVICE]2320 | [PREDICATE DEVICE]F & P MR 210 | |
| Compliance at empty(ml/mb) | 0.44 [1] | 0.49 [1] | |
| Resistance to Flow mbat (60 l/min) | 0.1 [1] | 0.1 [1] | |
| Moisture Output mg/lat (10 l/min) | 47.1 [1] | 46.4 [1] | |
| Evaluation ofMaximum Flows(l/min)Horizontal/10 degrees | 200/200 [1] | 200/200 [1] | |
| Compatibility with theenvironment andother devices: | To be used with I/S breathingcircuit and F&P MR850 heaterbases. | To be used with F&P breathingcircuits and F&P MR850heater bases. | |
| Energy used and ordelivered | Electrical energy is used to raisethe temperature and humidity ofthe gas delivered to the patient. | Electrical energy is used toraise the temperature andhumidity of the gas deliveredto the patient. | |
| Sterility | NON STERILE | NON STERILE | |
| Standards met: | ISO 10993ISO 8185ISO 5356 | ISO 10993ISO 8185ISO 5356 | |
| Biocompatibility | Compliant with ISO 10993 Thematerials all met the requirements of thebiological tests for Cytotoxicity.Sensitization, Irritation, GenotoxicityAmes Test, Gene Mutation - In Vitro MouseLymphoma and Implantation as describedin the biocompatibility tests performed byNelson Laboratories in Appendix G. | Compliant with ISO 10993 | |
| Test Results: | See Pages 19 to 44 forSummary Conformance. | See Pages 45 to 86 for testreports. | |
| 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
{6}------------------------------------------------
| Appendix C. 510(k) Summary of Safety and Effectiveness Page 7 | ||
|---|---|---|
| CharacteristicCompared | [510(k) DEVICE]2330 | [PREDICATE DEVICE]F & P MR 225 |
| 510K | K862923 | |
| Intended use: | Humidification Chambers areintended for use to hold waterrequired to humidify the airbeing delivered to patients. | Humidification Chambersare intended for use to holdwater required to humidifythe air being delivered topatients. |
| Target Population | Any patient using a heatedhumidifier | Any patient using a heatedhumidifier |
| Indications for use | Instruction leaflet | Instruction leaflet |
| Where used | Hospital | Hospital |
| Product Labelling | Low Volume Manual FillHumidification Chamber | Low Volume Manual FillHumidification Chamber |
| Design &Performance: | Standards Used:ISO 8185 / ISO 9360BS EN 12342 | Standards Used:ISO 8185 / ISO 9360BS EN 12342 |
| Fill Volume (ml) | Full 307.4/ Max Line 190.6/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(ml/mb) | 0.31 [5] | 0.31 [5] |
| Resistance to Flow mbat (60 l/min) | 0.1 [7] | 0.2 [6] |
| Moisture Output (mg/l)at 10 l/min | 46.4 [1] | 46.3 [1] |
| Evaluation ofMaximum Flows(l/min)Horizontal/10 degrees | 130/140 [1] | 130/140 [1] |
| Compatibility with theenvironment andother devices | To be used with I/S breathingcircuit and F&P MR850 heaterbases. | To be used with F&P breathingcircuits and F&P MR850heater bases. |
| Energy used and ordelivered | Electrical energy is used to raisethe temperature and humidity ofthe gas delivered to the patient. | Electrical energy is used toraise the temperature andhumidity of the gas deliveredto the patient. |
| CharacteristicCompared | [510(k) DEVICE]2330 | [PREDICATE DEVICE]F & P MR 225 |
| Sterility | NON STERILE | NON STERILE |
| Standards met: | ISO 10993ISO 8185ISO 5356 | ISO 10993ISO 8185ISO 5356 |
| Biocompatibility | Compliant with ISO 10993 Thematerials all met the requirements of thebiological tests for Cytotoxicity,Sensitization, Irritation, Genotoxicity -Ames Test, Gene Mutation - In Vitro MouseLymphoma and Implantation as describedin the biocompatibility tests performed byNelson Laboratories in Appendix G. | Compliant with ISO 10993 |
| Test Results: | See Pages 19 to 44 forSummary Conformance. | See Pages 45 to 86 for testreports. |
| 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 |
・・・・・・・・
. . · ·--- ····
:
:
: . . .
----ーーーー
·
.
:
·
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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.
{8}------------------------------------------------
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.
Premarket Notification [510(k)] Number
{9}------------------------------------------------
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.
{10}------------------------------------------------
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:
§ 868.5270 Breathing system heater.
(a)
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.(b)
Classification. Class II (performance standards).