EXSPIRON 1XI
Device Facts
| Record ID | K130170 |
|---|---|
| Device Name | EXSPIRON 1XI |
| Applicant | Respiratory Motion, Inc. |
| Product Code | BZK · Anesthesiology |
| Decision Date | May 29, 2013 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.1850 |
| Device Class | Class 2 |
Indications for Use
ExSpiron 1xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in adult (at least 21 years old) patients. ExSpiron 1xi is a non-invasive system that graphically displays lung volume against time and reports an approximate value of: Tidal volume, Respiratory rate, and Minute ventilation. ExSpiron 1xi measurements are used as an adjunct to other clinical information sources.
Device Story
ExSpiron 1xi is a non-invasive respiratory monitor for use in clinical settings by healthcare professionals. The system utilizes thoracic bioimpedance to measure lung volume; it employs a stabilized high-frequency current generator connected to two outer electrodes on a six-electrode torso PadSet. Four inner electrodes capture voltage signals, which are conditioned by an adaptive circuit and converted to digital form. A Windows 7 PC performs signal processing, calibration, and GUI management. The device displays real-time respiratory traces, tidal volume, respiratory rate, and minute ventilation. These outputs serve as an adjunct to other clinical information, assisting providers in patient monitoring and clinical decision-making.
Clinical Evidence
No new clinical testing was performed for this 510(k). The measurement algorithm and software are unchanged from the predicate device (K120087). Performance statistics were established in the clinical trials reported in the predicate submission.
Technological Characteristics
Thoracic bioimpedance measurement system. Components: 6-electrode disposable PadSet, patient cable, and Windows 7 PC. Safety standards: IEC 60601-1 (2nd Ed), IEC 60601-1-2. Cable/Electrode standards: AAMI/ANSI EC53:1995/(R)2008, AAMI/ANSI EC12:2000/(R)2010. Biocompatibility: ISO 10993-1 (prolonged skin contact).
Indications for Use
Indicated for monitoring breathing in adult patients (≥21 years) in healthcare facilities (e.g., post-operative, critical care).
Regulatory Classification
Identification
A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.
Predicate Devices
- ExSpiron Respiratory Monitor (K120087)
Submission Summary (Full Text)
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K130170
## 510(k) Summary ..
# MAY 2 9 2013
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| 510(k) Owner | Respiratory Motion, Inc. | | | | |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Address | 305 Second Avenue, Suite B | | | | |
| | Waltham, Massachusetts 02451 | | | | |
| Phone | 781-373-1636 | | | | |
| Fax | 781-373-1653 | | | | |
| Contact person | Jenny Freeman, MD | | | | |
| Date 510(k) | January 13, 2013 | | | | |
| Summary | | | | | |
| prepared | | | | | |
| Trade name | ExSpiron™ 1xi | | | | |
| Common name | Respiratory Monitor | | | | |
| Classifications | Monitoring spirometer | | | | |
| | Product code: BZK | | | | |
| | Regulation: 21 CFR 868.1850 | | | | |
| | | | | | |
| | Breathing frequency monitor | | | | |
| | Product code BZQ | | | | |
| | Regulation: 21 CFR 868.2375 | | | | |
| Predicate | ExSpiron Respiratory Monitor, cleared in 510(k) K120087. | | | | |
| devices | | | | | |
| Device | The ExSpiron 1xi system consists of: | | | | |
| Description | Bioimpedance measurement system: A stabilized high frequency current<br>generator is connected to two outer electrodes. The inner four electrodes are<br>connected to an adaptive circuit that conditions the resulting voltage signal<br>and converts it to digital form. Firmware performs signal acquisition and<br>relays data to the panel PC.<br>Computer: A Windows 7 PC performs signal processing and calibration,<br>and runs the graphical user interface (GUI). The PC takes user input from a<br>touch screen. The GUI is used for recording patient data and displaying the<br>respiratory trace as well as scalar values and trends for minute volume, tidal<br>volume, and respiratory rate.<br>Single Patient Use ExSpiron™ 1xi Electrode PadSet: An electrode<br>assembly containing six electrodes to be placed on the torso. It delivers<br>current and records impedance measurements. The electrode PadSet is also<br>used to perform subsystem checks prior to patient measurements. | | | | |
| Intended use | ExSpiron 1xi is indicated for use by healthcare professionals in healthcare facilities,<br>such as post-operative care and critical care units, to monitor breathing in adult (at<br>least 21 years old) patients.<br>ExSpiron 1xi is a non-invasive system that graphically displays lung volume against<br>time and reports an approximate value of:<br>Tidal volume,<br>●<br>Respiratory rate, and<br>Minute ventilation<br>� | | | | |
| | ExSpiron 1xi measurements are used as an adjunct to other clinical information<br>sources. | | | | |
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| Comparison of | Characteristic | ExSpiron 1xi | ExSpiron | Comment | | | |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|----------|---------------------------------|--|--|--|
| technological | Intended Use | See above | Same | The Indications for Use are not | | | |
| characteristics | | | | changed in this Special 510(k). | | | |
| | Technology | Measurement | Same | The fundamental technology is | | | |
| | | is by thoracic | | not changed | | | |
| | | bioimpedance. | | | | | |
| | Volume | Tidal volume | Same | No change | | | |
| | Measurements | | | | | | |
| | | Minute | | | | | |
| | | volume | | | | | |
| | | | | | | | |
| | | Volume vs. | | | | | |
| | | time chart | | | | | |
| | Rate | Respiratory | Same | No change | | | |
| | Measurements | rate | | | | | |
| | | (breaths/min) | | | | | |
| | Safety | IEC 60601-1, | Same | No change | | | |
| | | second edition | | | | | |
| Nonclinical | Performance testing addressed specific modifications to the Monitor, Patient Cable, | | | | | | |
| performance | and Electrode PadSet as follows: | | | | | | |
| testing: | Software Verification & Validation | | | | | | |
| | | | | | | | |
| | Safety Testing - IEC 60601-1 2nd Edition | | | | | | |
| | Electromagnetic Compatibility - IEC 60601-1-2 | | | | | | |
| | ExSpiron 1Xi System Test Plan | | | | | | |
| | | Patient Cable Design Verification - Included testing to all the relevant | | | | | |
| | sections of AAMI / ANSI EC53:1995/(R) 2008, ECG Cables and Leadwires | | | | | | |
| | Electrode PadSet Design Verification - Included testing to all the relevant | | | | | | |
| | section of AAMI / ANSI EC12:2000/(R)2010, Disposable ECG Electrodes | | | | | | |
| | & AAMI / ANSI EC53:1995/(R) 2008, ECG Cables and Leadwires | | | | | | |
| | Electrode - Biocompatibilty - ANSI/AAMI/ISO 10993-1 (Skin, prolonged | | | | | | |
| | duration) | | | | | | |
| | All performance testing conducted on modifications to the Monitor, Patient | | | | | | |
| | Cable, and Electrode Padset were completed with successful | | | | | | |
| | results. Performance testing raised no new safety or efficacy concerns and | | | | | | |
| | demonstrated substantial equivalence to the predicate device. | | | | | | |
| Clinical | No clinical testing was performed for this 510(k). The measurement algorithm and | | | | | | |
| performance | software are unchanged from the predicate. Measurement performance statistics | | | | | | |
| testing: | were determined by clinical trials reported in the predicate 510(k), K120087. | | | | | | |
| Conclusions | Based on the comparisons of intended use and on the results of testing, the ExSpiron<br>I xi is substantially equivalent in intended use, safety, and effectiveness to the | | | | | | |
| regarding safety | ExSpiron respiratory monitor. | | | | | | |
| and | | | | | | | |
| effectiveness: | | | | | | | |
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2013
Jenny Freeman, M.D. President Respiratory Motion 305 Second Avenue, Suite B WALTHAM, M.A., 02451
Re: K130170
Trade/Device Name: ExSpiron™ 1xi Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: II Product Code: BZK, BZQ Dated: April 26, 2013 Received: April 29, 2013
Dear Ms. Freeman:
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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### Page 2 - Ms. Freeman
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kwame O. Ulmer -S for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and
Dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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## Indications For Use
510(k) Number (if known): K 130170 Device Name: ExSpiron 1xi Indications for Use:
ExSpiron 1xi is indicated for use by healthcare professionals in healthcare facilities, such as postoperative care and critical care units, to monitor breathing in adult (at least 21 years of age) patients.
ExSpiron 1xi is a non-invasive system that graphically displays lung volume against time and reports an approximate value of:
- Tidal volume, .
- . Respiratory rate, and
- Minute ventilation. *
ExSpiron 1xi measurements are used as an adjunct to other clinical information sources.
# Lester Wª 2013.05 29 10
(Division Sign-Off) Division of Anesthesiology, General Hospital Intection Control, Dental Devices
K130170 510 (k) Number:
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
