(268 days)
No
The device description and performance studies focus on the physical properties, heating function, and disinfection methods of a heated breathing tube. There is no mention of data processing, algorithms, or learning capabilities.
Yes
Explanation: The device is intended to provide warmed and/or humidified breathing gases to a patient's airway, which suggests a direct effect on a physiological function or pathological condition, making it a therapeutic device.
No
This device is described as a heated wire breathing tube intended to provide warmed and/or humidified breathing gases. Its function is to deliver already prepared gases to a patient's airway, not to diagnose any condition or measure physiological parameters for diagnostic purposes.
No
The device description clearly indicates it is a physical heated tubing component that warms air and reduces condensation, requiring disinfection and physical testing. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide warmed and/or humidified breathing gases to a patient's airway. This is a therapeutic function, not a diagnostic one.
- Device Description: The description focuses on warming air and reducing condensation in a breathing circuit. This relates to supporting respiration, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on electrical, mechanical, and temperature control aspects, as well as cleaning and disinfection efficacy. These are relevant to a respiratory support device, not an IVD.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is to modify the air delivered to the patient, which is a direct therapeutic intervention.
N/A
Intended Use / Indications for Use
The Philips Respironics Reusable Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and multi-patient use in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for patients weighing over 10 kg (22lbs). It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics A-Series System One Heated Humidifier.
Product codes (comma separated list FDA assigned to the subject device)
BZE
Device Description
The Philips Respironics Reusable Heated Tubing warms air, or breathable gas, as it travels to and from the respiratory patient along the breathing circuit of a respiratory system. It reduces condensation that can form in breathing circuit. The Philips Respironics Reusable Heated Tubing is disinfected between patients through one of the following chemical methods: Cidex. or Cidex OPA. It is alternatively disinfected through the following thermal method: 75 °C for 30 minutes.
The Philips Respironics Reusable Heated Tubing has a proprietary connector with two locking tabs (unchanged) that makes it compatible with the Philips Respironics System One Humidifier (K113068) and Philips Respironics A-Series System One Heated Humidifier (K121623).
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
patients weighing over 10 kg (22lbs)
Intended User / Care Setting
single-patient reuse in the home and multi-patient use in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities.
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
Extensive performance testing was performed pre and post cleaning and disinfection treatments to demonstrate performance and functionality was unaffected as a result of these changes. The post disinfection performance testing included mechanical testing, electrical testing, and temperature accuracy under environmentally controlled conditions. These include electrical continuity, visual inspection, microscopic inspection of connectors, temperature control and humidity control.
The device will be released for distribution after testing for the following, under worst case conditions, with passing results: cleaning efficacy, disinfection efficacy and removal of disinfectant residue. Cleaning efficacy and disinfection efficacy testing will be performed in accordance with AAMI TIR No.12-2010, AAMI TIR No. 30-2011, ASTM E1837-96 (2007), and the "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants" – FDA CDRH, January 3, 2000. Removal of disinfectant residue testing will be performed in accordance with ISO 10993 Part 5: Tests for in vitro cytotoxicity, or ISO 10993 Part 17: Establishment of allowable limits for leachable substances
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Philips Respironics Reusable Heated Tubing was tested and meets all applicable requirements of the following standards:
- . ISO 8185, edition 3, Humidifiers for Medical Use - General Requirements for Humidification Systems
- IEC 60601-1, edition 3, Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance
- IEC 60601-1-2, edition 2.1, Medical electrical equipment, Part 1: General requirements for safety. 2. Collateral standard: Electromagnetic compatibility - Requirements and tests
All patient contacting and gas path materials used in the device have been previously cleared by the FDA. The modification of the present device was adding the ability to reuse the device between patients. Extensive performance testing was performed pre and post cleaning and disinfection treatments to demonstrate performance and functionality was unaffected as a result of these changes. The post disinfection performance testing included mechanical testing, electrical testing, and temperature accuracy under environmentally controlled conditions. These include electrical continuity, visual inspection, microscopic inspection of connectors, temperature control and humidity control.
The device will be released for distribution after testing for the following, under worst case conditions, with passing results: cleaning efficacy, disinfection efficacy and removal of disinfectant residue. Cleaning efficacy and disinfection efficacy testing will be performed in accordance with AAMI TIR No.12-2010, AAMI TIR No. 30-2011, ASTM E1837-96 (2007), and the "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants" – FDA CDRH, January 3, 2000. Removal of disinfectant residue testing will be performed in accordance with ISO 10993 Part 5: Tests for in vitro cytotoxicity, or ISO 10993 Part 17: Establishment of allowable limits for leachable substances.
The performance testing demonstrates that the subject device, Philips Respironics Reusable Heated Tubing is substantially equivalent to as the predicate device, Respironics Disposable Tubing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Respironics Disposable Heated Wire Circuits (K110398)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Philips Respironics System One Humidifier (K113068), Philips Respironics A-Series System One Heated Humidifier (K121623)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 14, 2014
Respironics, Inc. Alexander L. Friedman, Ph.D. Senior Regulatory Engineer 1740 Golden Mile Highway Monroeville, PA 15416
Re: K140424
Trade/Device Name: Philips Respironics Reusable Heated Tubing Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing System Heater Regulatory Class: II Product Code: BZE Dated: October 20, 2014 Received: October 21, 2014
Dear Dr. Friedman:
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.
1
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 contact the Division of Industry and Consumer Education 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. 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.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4 Indications for Use
Indications for Use
510(k) Number (if known): K140424
Device Name: Philips Respironics Reusable Heated Tubing
The Philips Respironics Reusable Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and multi-patient use in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with non-invasive ventilation for patients weighing over 10 kg (22lbs). It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics A-Series System One Heated Humidifier.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
3
510(k) Summary
| Date of Submission | 18 February 2014 |
|---|---|
| Date of Preparation | 14 November 2014 |
| 510(k) Owner | Respironics, Inc. |
| 1001 Murry Ridge Lane | |
| Murrysville, PA 15668 | |
| (724) 387-5311 | |
| (724) 387-3999 (fax) | |
| Official Contact | Alexander L. Friedman, Ph.D. |
| Senior Regulatory Affairs Engineer | |
| Sleep & Diagnostics Business Unit | |
| Proprietary Name | Philips Respironics Reusable Heated Tubing |
| Common/Usual Name | Heated Breathing Tube |
| Classification | Class II |
| Classification Name / | |
| Product Code | BZE – Breathing system, heater |
| Regulation Number | 868.5270 |
| Predicate Device(s) | Respironics Disposable Heated Wire Circuits (K110398) |
Intended Use:
The Philips Respironics Reusable Heated Tubing is a heated wire breathing tube intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. It is indicated for single-patient reuse in the home and multi-patient use in clinical settings, such as hospitals, institutions, sleep laboratories, and sub-acute care facilities. It may be used with noninvasive ventilation for patients weighing over 10 kg (22lbs). It is compatible with the Philips Respironics System One Heated Humidifier and Philips Respironics A-Series System One Heated Humidifier.
Device Description:
The Philips Respironics Reusable Heated Tubing warms air, or breathable gas, as it travels to and from the respiratory patient along the breathing circuit of a respiratory system. It reduces condensation that can form in breathing circuit. The Philips Respironics Reusable Heated
4
Tubing is disinfected between patients through one of the following chemical methods: Cidex. or Cidex OPA. It is alternatively disinfected through the following thermal method: 75 °C for 30 minutes.
The Philips Respironics Reusable Heated Tubing has a proprietary connector with two locking tabs (unchanged) that makes it compatible with the Philips Respironics System One Humidifier (K113068) and Philips Respironics A-Series System One Heated Humidifier (K121623).
Summary of Technological Characteristics of Device Compared to the Predicate Devices
The Philips Respironics Reusable Heated Tubing has the following similarities in the technological characteristics to the previously cleared predicate device. Respironics Disposable Heated Wire Circuits (K110398):
- . Same operating principle
- Same scientific concepts that form the basis for the device
- I Same technology
- Similar materials used
- I Similar device design and physical properties
The Philips Respironics Reusable Heated Tubing has the following differences in the technological characteristics to the previously cleared device (K110398):
- I The device may be used by multiple patients
Summary of Non-Clinical Performance Data
The Philips Respironics Reusable Heated Tubing was tested and meets all applicable requirements of the following standards:
- . ISO 8185, edition 3, Humidifiers for Medical Use - General Requirements for Humidification Systems
- IEC 60601-1, edition 3, Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance
- IEC 60601-1-2, edition 2.1, Medical electrical equipment, Part 1: General requirements for safety. 2. Collateral standard: Electromagnetic compatibility - Requirements and tests
All patient contacting and gas path materials used in the device have been previously cleared by the FDA. The modification of the present device was adding the ability to reuse the device between patients. Extensive performance testing was performed pre and post cleaning and disinfection treatments to demonstrate performance and functionality was unaffected as a result of these changes. The post disinfection performance testing included mechanical testing, electrical testing, and temperature accuracy under environmentally controlled conditions. These
5
include electrical continuity, visual inspection, microscopic inspection of connectors, temperature control and humidity control.
The device will be released for distribution after testing for the following, under worst case conditions, with passing results: cleaning efficacy, disinfection efficacy and removal of disinfectant residue. Cleaning efficacy and disinfection efficacy testing will be performed in accordance with AAMI TIR No.12-2010, AAMI TIR No. 30-2011, ASTM E1837-96 (2007), and the "Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants" – FDA CDRH, January 3, 2000. Removal of disinfectant residue testing will be performed in accordance with ISO 10993 Part 5: Tests for in vitro cytotoxicity, or ISO 10993 Part 17: Establishment of allowable limits for leachable substances
Assessment of Non-Clinical Performance Data
The performance testing demonstrates that the subject device, Philips Respironics Reusable Heated Tubing is substantially equivalent to as the predicate device, Respironics Disposable Tubing.
Clinical Data
Use of heated tubing on respiratory systems is a proven technology and is well accepted by the medical community. Bench testing is sufficient to demonstrate safety and efficacy of the Philips Respironics Reusable Heated Tubing, as was the case with the predicate device.
Conclusions
Conclusions drawn from the passing nonclinical tests (discussed above) demonstrate that the device is as safe, as effective, and performs as safe and as effective as the predicate device, and is substantially equivalent to the predicate device.