(220 days)
The device is intended to be used for the spot measurement of respiration rate of an adult patient in a hospital and clinical setting. It is not a vital signs monitor or an apnea monitor.
The device is indicated for use as suitable for use on adult patients. It should not be used on patients that exhibit uncontrolled limb movement.
The SleepMinder Breathing Frequency Indicator BM07 consists of
- A small sensor unit that can stand on a desk top or shelf. The sensor . unit emits a very low power radio signal that is aimed at the patient. The sensor utilizes the reflected radio signal to measure the chest movement of the patient, and thus discern the respiration rate. The sensor has no part that is in contact with the patient.
- The sensor data is transmitted to a PC running a proprietary display . program. The validated transmission method to the PC is a BlueTooth wireless link.
- . The PC display program runs a proprietary algorithm to extract the respiration rate from the sensor movement data. The program displays
- The respiration rate, and o
- Indicates whether there is a valid target, whether the o target is moving too much for a breathing signal to be indentified or the signal is clear enough for a breathing rate to be calculated.
This submission focuses on establishing substantial equivalence to previously cleared predicate devices rather than defining specific acceptance criteria for a new device and then proving the device meets those criteria through a detailed study with quantitative performance metrics. While "Performance Data" is mentioned, the description provided is general and qualitative.
Here's an analysis based on the provided text, highlighting the limitations due to the nature of the 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria are not explicitly stated in the provided text (e.g., "accuracy must be within X breaths per minute"), a typical table format cannot be generated. Instead, the performance is described in relation to a predicate device.
| Acceptance Criteria (Implied / Qualitative) | Reported Device Performance |
|---|---|
| Device functions as intended and breathing rate observed is as expected (comparable to predicate). | "In all instances, the SleepMinder Breathing Frequency Indicator BM07 functioned as intended and breathing rate observed was as expected." |
| Satisfactory performance in presence of typical RF interference. | "Validation testing was also carried out to confirm that the BM07 sensor continued to perform satisfactorily in the presence of typical potential RF interference emitters." |
| Breathing rate calculation stable across multiple devices. | "...and also that the breathing rate calculation was stable across a number of individual examples of the device." |
| Meets general market and scientific expectations of accuracy. | "Performance data collected against the SOMNOscreen predicate device demonstrate that the SleepMinder Breathing Frequency Indicator BM07 meets general market and scientific expectations of accuracy, as does the Kai R-Spot 100." |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: 24 volunteer subjects.
- Data Provenance: Not explicitly stated, but the company is BiancaMed Ltd, located in Dublin, Ireland. The study involved "volunteer subjects," implying prospective data collection for the validation testing. It is not specified if the subjects represented diverse geographical locations or were all from Ireland.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- The ground truth for the test set was established using a predicate device, the SOMNOscreen Plus RC Easy [K060708]. This device uses chest effort bands to measure breathing rate.
- The text does not mention the use of human "experts" (e.g., radiologists) to establish ground truth; rather, it relies on the established measurement capabilities of a cleared medical device.
4. Adjudication Method for the Test Set
- No explicit adjudication method (like 2+1 or 3+1) is described. The comparison was directly between the SleepMinder BM07 and the SOMNOscreen Plus RC Easy. The SOMNOscreen's data was processed after the recording session to display a breathing rate against time, and the BM07's recordings were similarly processed for comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. The study was a comparison of a new device (BM07) against a predicate device (SOMNOscreen) for stand-alone performance, not an assessment of human readers with vs. without AI assistance. Therefore, no effect size for human reader improvement is provided.
6. Standalone Performance Study
- Yes, a standalone study was done. The "Validation testing" and "overall performance" testing described were for the SleepMinder Breathing Frequency Indicator BM07 itself, directly comparing its output to the SOMNOscreen Plus RC Easy. This evaluates the algorithm's performance without a human in the loop for interpreting the raw sensor data. The PC program displays the respiration rate, which a human then reads.
7. Type of Ground Truth Used
- The ground truth used was measurement from a predicate medical device (SOMNOscreen Plus RC Easy [K060708]) using chest effort bands, which is considered a direct and established method for measuring breathing rate. This could be interpreted as a form of "reference standard" or "gold standard" for breathing rate measurement in this context.
8. Sample Size for the Training Set
- The provided text does not mention a training set or its sample size. The document describes validation testing against a predicate device, which implies evaluation of a complete, already-developed algorithm. If the algorithm involves machine learning, information about its training would typically be in an earlier development stage document, not necessarily explicitly detailed in a 510(k) summary focused on substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned, there is no information provided on how its ground truth was established.
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V. 510(K) SUMMARY
K103631
JUL 2 1 2011
510(k) SUMMARY
BiancaMed Ltd's SleepMinder Breathing Frequency Indicator (BM07)
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
BiancaMed Ltd, Nova UCD, Belfield, DUBLIN 4, Ireland
+373 1 716 3755 Phone: +373 1 716 3709 (attn P Phillips, BiancaMed) Facsimile: Email: paul.phillips@biancamed.com
Contact Person: Paul Phillips
Date Prepared: 7th December 2010
Name of Device
SleepMinder Breathing Frequency Indicator (model BM07)
Common or Usual Name
Breathing Frequency Monitor
Classification Name/ CFR Reference /Product Code
Class II, Breathing Frequency Monitor, 21.CFR.868.2375 , Product code BZQ,
Predicate Devices
- Kai Sensors Kai R-Spot 100, Breathing Frequency Monitor, [K090273]. .
- Somnomedics SOMNOscreen Plus RC Easy, Ventilatory Effort Recorder, [K060708]
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Intended Use / Indications for Use
The device is intended to be used for the spot measurement of respiration rate of an adult patient in a hospital and clinical setting. It is not a vital signs monitor or an apnea monitor.
The device is indicated for use as suitable for use on adult patients. It should not be used on patients that exhibit uncontrolled limb movement.
Product Description
The SleepMinder Breathing Frequency Indicator BM07 consists of
- A small sensor unit that can stand on a desk top or shelf. The sensor . unit emits a very low power radio signal that is aimed at the patient. The sensor utilizes the reflected radio signal to measure the chest movement of the patient, and thus discern the respiration rate. The sensor has no part that is in contact with the patient.
- The sensor data is transmitted to a PC running a proprietary display . program. The validated transmission method to the PC is a BlueTooth wireless link.
- . The PC display program runs a proprietary algorithm to extract the respiration rate from the sensor movement data. The program displays
- The respiration rate, and o
- Indicates whether there is a valid target, whether the o target is moving too much for a breathing signal to be indentified or the signal is clear enough for a breathing rate to be calculated.
Technological Characteristics
The BM07 utilizes a 5.8GHz pulsed radar as its sensor technology. The Kai R-Spot utilizes a 2.4GHz continuous wave radar as it sensor technology. Both frequencies are in common use as radiolocation frequencies and are in license-free portions of the electromagnetic spectrum. The choice of centre frequency and pulsed or continuous wave are merely design and cost decisions: the lower frequency will require a larger antenna and so determine the device size and continuous wave radar is slightly cheaper than pulsed
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radar to fabricate. There are no significant differences in the technological characteristics between the 2 devices.
Performance Data
Initially, the basic performance envelope of the BM07 was established in terms of the maximum effective range and the effects of different target aspects. These tests were carried out using the SOMNOscreen predicate device as a comparator device for the measurement of breathing rate. The SOMNOscreen has chest effort bands and so measures breathing rate by direct contact with the subject. However, it does not have a real-time readout, the data has to be processed after the end of the recording session and the breathing rate displayed in a graph against time. The BM07 recordings were similarly processed to facilitate comparison.
Validation testing was also carried out to confirm that the BM07 sensor continued to perform satisfactorily in the presence of typical potential RF interference emitters and also that the breathing rate calculation was stable across a number of individual examples of the device.
Finally, the overall performance of the system was tested on 24 volunteer subjects, of varying gender, height and BMI, against the SOMNOscreen Plus RC Easy [K060708] predicate device, which is classified as a ventilatory effort recorder, to replicate the bench tests of the Kai Spot.
In all instances, the SleepMinder Breathing Frequency Indicator BM07 functioned as intended and breathing rate observed was as expected.
Substantial Equivalence
The application cites 2 predicate devices:
- . The Kai Sensors R-Spot 100 [K090273] is an RF-based non-contact breathing indicator. It is used to establish substantial equivalence in technology and intended use of the BM07 to a previously cleared device. Despite the company's best efforts, the Kai R-Spot 100 could not be procured for use in side-by-side performance testing, and so the performance testing was carried out against a SOMNOscreen Plus RC Easy.
- The SOMNOscreen Plus RC Easy [K060708] is a portable Ventilatory . Effort recorder. The chest effort bands of the SOMNOscreen were used to collect the chest breathing effort and thus calculate the breathing
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rate. The SOMNOscreen does not give a real time indication; the data is processed after the end of the recording session.
The SleepMinder Breathing Frequency Indicator BM07 is as safe and effective as the Kai Sensors Kai R-Spot 100. The SleepMinder Breathing Frequency Indicator BM07 has the same intended uses and similar indications, technological characteristics, and principles of operation as the Kai R-Spot 100. The minor technological differences between the SleepMinder Breathing Frequency Indicator BM07 and the Kai R-Spot 100 device raise no new issues of safety or effectiveness. Performance data collected against the SOMNOscreen predicate device demonstrate that the SleepMinder Breathing Frequency Indicator BM07 meets general market and scientific expectations of accuracy, as does the Kai R-Spot 100. Thus, the SleepMinder Breathing Frequency Indicator BM07 is substantially equivalent to the predicate devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a stylized representation of an eagle and the text "DEPARTMENT OF HEALTH & HUM" arranged in a semi-circular fashion. The eagle is depicted with three curved lines forming its body and wings, giving it a modern and abstract appearance. The text is positioned to the left of the eagle, following the curve of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Paul Phillips BiancaMed Limited Novaucd, Belfield Innovation P University College Dublin Belfield, Dublin Ireland 4
JUL 2 1 2011
Re: K103631
Trade/Device Name: SleepMinder Breathing Frequency Indicator (model BM07) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: BZQ Dated: July 12, 2011 Received: July 15, 2011
Dear Mr. Phillips:
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 - Mr. Phillips
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/CDRHOffi ces/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.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/Industrv/default.htm.
Sincerely yours.
Anthony 0, m
Anthony 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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IV. INDICATIONS FOR USE STATEMENT
Indications for Use Statement
510(k) Number (if known):___K103631
Device Name: SleepMinder Breathing Frequency Indicator (model BM07)
Indications for Use:
The device is intended for the spot measurement of respiration rate of an adult patient in a hospital and clinical setting. It is not a vital signs monitor or an apnea monitor.
The device is suitable for use on adult patients. It should not be used on patients that exhibit uncontrolled limb movement.
Prescription Use __ X (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices
-BM07-AF 10503 P Atts 6 7 Eruik) Number
Page __ of ___________________________________________________________________________________________________________________________________________________________________
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§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).