(88 days)
Yes
The description explicitly mentions a "proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort," which is characteristic of a machine learning approach.
No
The device is described as a non-invasive monitor that displays lung volume, minute ventilation, tidal volume, and respiratory rate, and its measurements are used as an "adjunct to other clinical information." It monitors breathing but does not directly treat or alleviate a medical condition.
No
The device is described as a non-invasive monitor that graphically displays lung volume against time and reports approximate values for Minute Ventilation (MV), Tidal volume (TV), and Respiratory Rate (RR). It is used to "monitor breathing" and its measurements are "used as an adjunct to other clinical information." It does not identify or diagnose a disease or condition, but rather provides physiological parameters for monitoring purposes.
No
The device description explicitly states that the system consists of hardware components including a Monitor containing a bioimpedance measurement system and a tablet PC, patient cables, and electrode padsets.
Based on the provided information, the ExSpiron 2Xi is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- ExSpiron 2Xi Function: The ExSpiron 2Xi is a non-invasive monitor that measures respiratory parameters (Minute Ventilation, Tidal Volume, Respiratory Rate) by applying a current to the patient's torso and measuring impedance. It does not involve the collection or analysis of specimens from the body.
- Intended Use: The intended use is to monitor breathing in patients, not to analyze biological samples for diagnostic purposes.
Therefore, the ExSpiron 2Xi falls under the category of a non-invasive physiological monitor, not an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The provided text indicates "Control Plan Authorized (PCCP) and relevant text Not Found".
Intended Use / Indications for Use
ExSpiron 2Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least 1 - year of age.
ExSpiron 2Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:
- Minute Ventilation (MV)
- Tidal volume (TV)
- Respiratory Rate (RR)
ExSpiron 2Xi measurements are used as an adjunct to other clinical information.
Product codes
BZK, BZQ
Device Description
The ExSpiron 2Xi Respiratory Monitor System consists of:
Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure.
Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC.
Computer: A tablet PC performs signal processing and calibration and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate.
Patient Cables and Electrode Padsets that are also included in the system but were cleared in previous 510(k)s: K130170, K162131, K173181
ExSpiron Patient Cable: A reusable cable that connects the ExSpiron 2Xi Monitor to the Electrode PadSet.
Single patient use ExSpiron Electrode PadSet: A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Torso (implied from electrode placement)
Indicated Patient Age Range
at least 1 - year of age
Intended User / Care Setting
healthcare professionals in healthcare facilities, such as post-operative care and critical care units
Description of the training set, sample size, data source, and annotation protocol
A software algorithm calculates respiratory parameters using a proprietary, non-linear, regressive model trained with a dataset containing respiratory data from a large historical cohort.
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Test Protocol
Accuracy Test Protocol
System Power Verification Test
System Battery Verification Test
Internal Usability Testing
Nurse Call Test
User Manual Verification Test
Do by Analysis Test This tests requirements that need static analysis, calculations, and visual inspection.
Bench Accuracy:
MV 1.57%
TV - 2.28%
RR - 1.55%
The accuracy of the proposed device is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ExSpiron 1Xi Respiratory Monitor, marketed by Respiratory Motion, Inc, Watertown, MA (K173181)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2019
Respiratory Motion, Inc. Susan Hamann Director of Quality and Regulatory 80 Coolidge Hill Road Watertown, Massachusetts 02472
Re: K192595
Trade/Device Name: ExSpiron 2Xi Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: Class II Product Code: BZK, BZO Dated: December 2, 2019 Received: December 3, 2019
Dear Susan Hamann:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Michael Ryan Division Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192595
Device Name ExSpiron 2Xi
Indications for Use (Describe)
ExSpiron 2Xi is indicated for use by healthcare professionals in healthcare facilities, such as post-operative care and critical care units, to monitor breathing in patients at least 1 - year of age.
ExSpiron 2Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of:
-
Minute Ventilation (MV)
-
Tidal volume (TV)
-
Respiratory Rate (RR)
ExSpiron 2Xi measurements are used as an adjunct to other clinical information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary – Special 510(k) K192595
| 510(k) Owner: | Respiratory Motion, Inc. |
|---|---|
| Address: | 80 Coolidge Hill Road |
| Watertown, MA USA 02472 | |
| Phone: | 781-373-1636 |
| Fax: | 781-373-1653 |
| Contact person: | Jenny Freeman, MD |
| Date 510(k) Summary prepared and type of 510(k): | December 12, 2019 Special 510(k) |
| Trade name: | ExSpiron 2Xi |
| Common name: | Respiratory Monitoring System |
| Classifications: | Regulation Number: 21 CFR 868.1850 |
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| Regulation Name: | Monitoring Spirometer |
|---|---|
| Regulatory Class: | II |
| Product Code: | BZK, BZQ |
| Predicate devices: | ExSpiron 1Xi Respiratory Monitor, marketed by Respiratory Motion, Inc, Watertown, MA (K173181). |
| Device Description: | The ExSpiron 2Xi Respiratory Monitor System consists of: |
| Monitor: The Monitor contains a bioimpedance measurement system and a tablet PC housed within a single enclosure. | |
| Bioimpedance measurement system: The Monitor incorporates a stabilized high frequency current generator and an adaptive circuit that conditions the resulting voltage signal and converts it to digital form. Firmware within the Monitor performs signal acquisition and relays data to the tablet PC. | |
| Computer: A tablet PC performs signal processing and calibration and runs the graphical user interface (GUI). The PC takes user input from a touch screen through a virtual keyboard and mouse. The GUI is used for recording patient data and displaying the respiratory trace as well as scalar values and trends for minute ventilation, tidal volume, and respiratory rate. | |
| Patient Cables and Electrode Padsets that are also included in the system but were cleared in previous 510(k)s: K130170, K162131, K173181 | |
| ExSpiron Patient Cable: A reusable cable that connects the ExSpiron 2Xi Monitor to the Electrode PadSet. | |
| Single patient use ExSpiron Electrode PadSet: A Single-Patient Use Electrode PadSet is placed on the skin of the patient's torso. It delivers current to, and records impedance measurements from, the skin. | |
| Intended use: | ExSpiron 2Xi is indicated for use by healthcare professionals in healthcare facilities, such as postoperative care and critical care units, to monitor breathing in patients at least one year of age. ExSpiron 2Xi is a non-invasive monitor that graphically displays lung volume against time and reports an approximate value of: |
| • Minute Ventilation (MV) | |
| • Tidal volume (TV) | |
| • Respiratory rate (RR) | |
| ExSpiron 2Xi measurements are used as an adjunct to other clinical information |
5
Special 510(k) Summary Continued
Comparison to cleared device
| ExSpiron® 2Xi | ExSpiron® 1Xi (Predicate) | ||
|---|---|---|---|
| Characteristic | Proposed Device | (K173181) | Comment |
| Intended Use | ExSpiron 2Xi is indicated for use by | ||
| healthcare professionals in | |||
| healthcare facilities, such as | |||
| postoperative care and critical care | |||
| units, to monitor breathing in | |||
| patients at least one year of age. | |||
| ExSpiron 2Xi is a non-invasive | |||
| monitor that graphically displays | |||
| lung volume against time and | |||
| reports an approximate value of: | |||
| • Minute Ventilation (MV) | |||
| • Tidal volume (TV) | |||
| • Respiratory rate (RR) | |||
| ExSpiron 2Xi measurements are | |||
| used as an adjunct to other clinical | |||
| information. | ExSpiron 1Xi is indicated for use by | ||
| healthcare professionals in | |||
| healthcare facilities, such as | |||
| postoperative care and critical care | |||
| units, to monitor breathing in | |||
| patients at least one year of age. | |||
| ExSpiron 1Xi is a non-invasive | |||
| monitor that graphically displays | |||
| lung volume against time and | |||
| reports an approximate value of: | |||
| • Minute Ventilation (MV) | |||
| • Tidal volume (TV) | |||
| • Respiratory rate (RR) | |||
| ExSpiron 1Xi measurements are | |||
| used as an adjunct to other clinical | |||
| information. | Both the proposed device and the | ||
| predicate have identical Intended | |||
| Use | |||
| Technology | Measurement is by thoracic | ||
| bioimpedance. | Measurement is by thoracic | ||
| bioimpedance. | Both the proposed device and the | ||
| predicate have identical fundamental | |||
| scientific technology. | |||
| Volume | |||
| Measurements | Tidal volume | ||
| Minute volume | |||
| Volume vs. time chart | Tidal volume | ||
| Minute volume | |||
| Volume vs. time chart | Both the proposed device and the | ||
| predicate measure the same | |||
| respiratory volumes. | |||
| Rate | |||
| Measurements | Respiratory rate (breaths/min) | Respiratory rate (breaths/min) | Both the proposed device and the |
| predicate measure respiratory rate. | |||
| Safety | IEC 60601-1, including electrical | ||
| and mechanical safety | IEC 60601-1, including electrical | ||
| and mechanical safety | Both the proposed device and the | ||
| predicate have an equivalent | |||
| electrical safety profile and are | |||
| compliant with IEC 60601-1. | |||
| Energy Source | The bioimpedance output signal is | ||
| generated internally to the | |||
| ExSpiron Monitor. It is a low | |||
| current signal at approximately 50 | |||
| kHz. | The bioimpedance output signal is | ||
| generated internally to the | |||
| ExSpiron Monitor. It is a low | |||
| current signal at approximately 50 | |||
| kHz. | Both the proposed device and the | ||
| predicate have equivalent energy | |||
| source. | |||
| Power | |||
| Management | |||
| Board | Board is external to the tablet | ||
| computer. | Board is internal to the tablet | ||
| computer. | Functionality of Power Management | ||
| Board remains unchanged. The two | |||
| boards are substantially equivalent. | |||
| Data Acquisition | |||
| Board | Digital Data Acquisition Board. | Analog Data Acquisition Board. | Updated Data Acquisition Board |
| performs the same core functions as | |||
| the predicate along with built in Nurse | |||
| Call Circuitry and additional electric | |||
| isolation. Safety and effectiveness of | |||
| differences have been addressed | |||
| through relevant performance testing. | |||
| Algorithm | A software algorithm calculates | ||
| respiratory parameters using a | |||
| proprietary, non-linear, | |||
| regressive model trained | |||
| with a dataset containing | |||
| respiratory data from a | |||
| large historical cohort. | A software algorithm calculates | ||
| respiratory parameters using a | |||
| proprietary, non-linear, regressive | |||
| model trained with a dataset | |||
| containing respiratory data from a | |||
| large historical cohort. | Both the proposed device and the | ||
| predicate have the same | |||
| fundamental algorithm | |||
| Enclosure | Injection molded plastic (ABS) | ||
| housing, flame-retardant. | Formed plastic (ABS) housing, | ||
| flame-retardant. | Both the proposed device and the | ||
| predicate have equivalent enclosure | |||
| material. | |||
| Graphical User | |||
| Interface | Graphical User Interface allowed | ||
| input of demographic patients at | |||
| least 1 year of age. | Graphical User Interface allowed | ||
| input of demographic patients at | |||
| least 1 year of age. | The Graphical User Interface is | ||
| different in the proposed device | |||
| owing to the different size of tablets | |||
| used in the devices, however the | |||
| content is equivalent. | |||
| EMC/EMI | |||
| Compliance | IEC 60601-1-2 compliant | IEC 60601-1-2 compliant | Both the proposed device and the |
| predicate are 60601-1-2 compliant. | |||
| Electrode PadSet | Single-patient use, | ||
| biocompatible, printed padset. | Single-patient use, biocompatible, | ||
| printed padset. | Both the proposed device and the | ||
| predicate use the same electrode | |||
| padset. | |||
| Impedance | |||
| Measurement | |||
| Range | 15 Ohms to 180 Ohms | 15 Ohms to 180 Ohms | Both the proposed device and the |
| predicate have the same | |||
| measurement range. | |||
| Tablet Computer | Linux tablet computer. | Windows tablet computer. | The proposed device and the |
| predicate use different tablet | |||
| computers. The functions of the | |||
| tablet remain the same. | |||
| Nurse Call Relay | Nurse call relay is contained | ||
| within the monitor. | Nurse call relay module is an | ||
| accessory to the monitor. | A nurse call relay has been integrated | ||
| into the monitor in the proposed | |||
| device. Performance testing was | |||
| conducted to demonstrate | |||
| substantial equivalence. | |||
| Biocompatibility | Neither the Monitor nor the | ||
| Patient Cable are intended for | |||
| patient contact. The Electrode | |||
| PadSet is biocompatible. | Neither the Monitor nor the Patient | ||
| Cable are intended for patient | |||
| contact. The Electrode PadSet is | |||
| biocompatible. | Both the proposed device and the | ||
| predicate are biocompatible. | |||
| Usability | IEC 60601-1-6 compliant | IEC 60601-1-6 compliant | Usability Testing was performed to |
| demonstrate that the 2Xi is equivalent | |||
| to the 1Xi when used by intended | |||
| users in the intended environment. | |||
| Bench Accuracy | |||
| MV 1.57% | |||
| TV - 2.28% | |||
| RR - 1.55% | MV 1.78% | ||
| TV - 2.39% | |||
| RR - 1.38% | The accuracy of the proposed device | ||
| is substantially equivalent to the | |||
| predicate. |
6
7
Additional Information:
Summary of Performance and Bench Testing Performed – All the testing passed the verification and validation requirements. The list of tests performed is as follows:
-
- Software Test Protocol
-
- Accuracy Test Protocol
-
- System Power Verification Test
-
- System Battery Verification Test
-
- Internal Usability Testing
-
- Nurse Call Test
-
- User Manual Verification Test
-
- Do by Analysis Test This tests requirements that need static analysis, calculations, and visual inspection.
Summary of Clinical Testing performed –Design changes to device were confirmed and validated by performance and bench testing. Clinical testing was not required.
Summary of Biocompatibility testing - Additional testing was not required for the ExSpiron 2Xi. The Padset and cables are identical to previous submissions for the ExSpiron 1Xi. The monitor and patient cables are not intended for patient contact.
Conformance to Standards applicable to the device – The ExSpiron 2Xi met the applicable requirements specified in the standards. The standards used are:
-
- ANSI AAMI IEC 60601-1:2005/(R)2012 And A1:2012 (Consolidated Text)
-
-
-
- ANSI AAMI IEC 60601-1-6:2010/AMD1:2013
-
- ANSI AAMI IEC 62304:2006/A1:2016
-
- ANSI AAMI IEC 62366-1:2015
-
- ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007)
- ANSI AAMI IEC 62133-2:2017 8.
Conclusion: Based on the testing and evaluations performed on the ExSpiron 2Xi, the device is as safe, as effective, and is substantially equivalent to the predicate device.