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 Description

The ExSpiron 1xi system consists of:
Bioimpedance measurement system: A stabilized high frequency current generator is connected to two outer electrodes. The inner four electrodes are connected to an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware performs signal acquisition and relays data to the panel PC.
Computer: A Windows 7 PC performs signal processing and calibration, and runs the graphical user interface (GUI). The PC takes user input from a touch screen. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute volume, tidal volume, and respiratory rate.
Single Patient Use ExSpiron™ 1xi Electrode PadSet: An electrode assembly containing six electrodes to be placed on the torso. It delivers current and records impedance measurements. The electrode PadSet is also used to perform subsystem checks prior to patient measurements.

AI/ML Overview

The ExSpiron™ 1xi respiratory monitor is indicated for use by healthcare professionals in healthcare facilities to monitor breathing in adult (at least 21 years old) patients. It is a non-invasive system that graphically displays lung volume against time and reports approximate values for Tidal Volume, Respiratory Rate, and Minute Ventilation. The measurements are used as an adjunct to other clinical information sources.

The provided documentation does not contain a table of acceptance criteria or reported device performance for this specific 510(k) submission (K130170). The submission is a Special 510(k) where the manufacturer states that "No clinical testing was performed for this 510(k). The measurement algorithm and software are unchanged from the predicate. Measurement performance statistics were determined by clinical trials reported in the predicate 510(k), K120087." This means that the device's performance relies on the data submitted for its predecessor, the ExSpiron Respiratory Monitor (K120087).

However, based on the information provided for K130170:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, no specific acceptance criteria or reported performance for the ExSpiron™ 1xi is provided in this document as it references the predicate device. For the predicate device, K120087, the performance statistics would have been determined through clinical trials. Without access to K120087, these specific details cannot be provided here.

The document states that changes for K130170 were related to:

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 (AAMI / ANSI EC53:1995/(R) 2008)
Electrode PadSet Design Verification (AAMI / ANSI EC12:2000/(R)2010, AAMI / ANSI EC53:1995/(R) 2008)
Electrode - Biocompatibility - ANSI/AAMI/ISO 10993-1

All performance testing for these modifications was reported as successful, raising no new safety or efficacy concerns and demonstrating substantial equivalence to the predicate device.

2. Sample Size for Test Set and Data Provenance:

Sample Size for Test Set: Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed. The measurement performance statistics were determined by clinical trials reported in the predicate 510(k), K120087.
Data Provenance: Not applicable for this specific 510(k). For the predicate device (K120087), this information would be detailed in its submission. It's likely that the data would be prospective, given the nature of clinical trials for device performance. Country of origin not specified in the current document.

3. Number of Experts and Qualifications for Ground Truth - Test Set:

Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed. The ground truth for the predicate device's clinical trials (K120087) would have been established through a reference standard method, but the number and qualifications of experts are not described in this document.

4. Adjudication Method for the Test Set:

Not applicable for this specific 510(k) (K130170) as no new clinical testing was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done for this specific 510(k) (K130170). The device is a monitor that reports values, not an AI for interpretation requiring human readers.

6. Standalone (Algorithm Only) Performance Study:

Yes, implicitly. The statement that "The measurement algorithm and software are unchanged from the predicate" implies that the core algorithm's performance was evaluated in a standalone manner during the clinical trials for the predicate device (K120087). This 510(k) (K130170) focuses on modifications to hardware components and software updates that do not alter the fundamental measurement algorithm.

7. Type of Ground Truth Used:

For the performance statistics referenced from the predicate K120087, the ground truth for respiratory measurements (Tidal Volume, Respiratory Rate, Minute Ventilation) would typically be established using a gold standard reference measurement system (e.g., highly accurate spirometry, capnography, or volumetric respirators) rather than expert consensus on images or pathology. The document does not specify the exact ground truth method used in the predicate study.

8. Sample Size for the Training Set:

Not applicable for this 510(k) (K130170). The clinical trials for the predicate device (K120087) would have involved a patient sample. The document does not provide this information.

9. How Ground Truth for the Training Set Was Established:

Not applicable for this 510(k) (K130170). For the predicate device's clinical trials, the ground truth would have been established using a gold standard reference measurement system, as mentioned in point 7.

Summary

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K130170

510(k) Summary ..

MAY 2 9 2013

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

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 currentgenerator is connected to two outer electrodes. The inner four electrodes areconnected to an adaptive circuit that conditions the resulting voltage signaland converts it to digital form. Firmware performs signal acquisition andrelays data to the panel PC.Computer: A Windows 7 PC performs signal processing and calibration,and runs the graphical user interface (GUI). The PC takes user input from atouch screen. The GUI is used for recording patient data and displaying therespiratory trace as well as scalar values and trends for minute volume, tidalvolume, and respiratory rate.Single Patient Use ExSpiron™ 1xi Electrode PadSet: An electrodeassembly containing six electrodes to be placed on the torso. It deliverscurrent and records impedance measurements. The electrode PadSet is alsoused to perform subsystem checks prior to patient measurements.
Intended 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 (atleast 21 years old) patients.ExSpiron 1xi is a non-invasive system that graphically displays lung volume againsttime and reports an approximate value of:Tidal volume,●Respiratory rate, andMinute ventilation�
	ExSpiron 1xi measurements are used as an adjunct to other clinical informationsources.

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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 ExSpironI xi is substantially equivalent in intended use, safety, and effectiveness to the
regarding safety	ExSpiron respiratory monitor.
and
effectiveness:

: . .

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

. .

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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)

Regulation Number and Section

§ 868.1850 Monitoring spirometer.

(a)
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.(b)
Classification. Class II (performance standards).