ANNE Limb

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. May 28, 2024 Sibel Health Inc. Sarah Coughlin Regulatory Affairs Manager 2017 N Mendell St. Suite 2SE Chicago, Illinois 60614 Re: K240305 Trade/Device Name: ANNE Limb Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, FLL Dated: Mav 7, 2024 Received: May 7, 2024 Dear Sarah Coughlin: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Jennifer W. Shih -S Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) ### K240305 Device Name ANNE Limb ### Indications for Use (Describe) The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient undergoes significant motion or is active. The ANNE Limb Sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is indicated for use as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) Summary #### -Submitter: Sibel Health Inc. 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859 Official Correspondent: Sarah Coughlin, Regulatory Affairs Manager 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859 Date Prepared: 04/26/2024 #### . Device Information Name of Device: ANNE Limb 510K Number: K240305 Classification Name: Oximeter Regulation: 21 CFR §870.2700 Regulatory Class: Class II Product Classification Code: DQA, FLL #### III. Predicate Device Trade Name: ANNE One 510(k): K223711 Device Manufacturer: Sibel Health Inc. #### IV. Device Description The ANNE Limb sensor is a wearable, bio-integrated sensor that collects real-time biosignals including photoplethysmography (PPG) and temperature. The ANNE Limb sensor has on-device processing of raw data for the calculation of SpO2 and pulse rate. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data. #### V. Indications for Use The ANNE Limb Sensor is a pulse oximeter intended for continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, and skin temperature. The ANNE {4}------------------------------------------------ Limb Sensor is not intended to monitor or measure SpO2 or pulse rate while the patient undergoes significant motion or is active. The ANNE Limb Sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is indicated for use as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients. #### VI. Performance Data The following consensus standards and bench testing were used to evaluate the safety and performance of ANNE Limb: - . Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2 Edition 4.0 2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015. - . Biocompatibility testing according to ISO 10993-5:2009 and ISO 10993-10:2010 for patient contacting materials. - Wireless coexistence testing according to ANSI IEEE C63.27-2017. ● - . Software verification and validation testing according to IEC 62304:2015 and the FDA quidance document. Content of Premarket Submissions for Software Contained in Medical Devices. - Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC . 60601-2-47:2012. - . Shelf life testing of the adhesive to demonstrate safety and performance over the intended device life cycle. - Bench testing to demonstrate the mechanical durability of the sensors. ● - Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Enqineering to Medical Devices. - . Performance testing of pulse rate and skin temperature. - . Cybersecurity evaluation according to the FDA quidance document. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions #### VII. Clinical Studies SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013. Enrolled subjects had skin tones varying from Fitzpatrick 2-5, with two subjects having darker skin pigmentation (Fitzpatrick 5). The average root mean square error (ARMS) was 2.31%, meeting the requirements of the above-mentioned standard. {5}------------------------------------------------ #### VIII. Conclusion The results of the substantial equivalence assessment, taken together with safety and performance testing data, demonstrate that ANNE Limb's performance characteristics are substantially equivalent to the predicate device in both technology and intended use. | Subject device<br>Sibel Health Inc. | Predicate device<br>Sibel Health Inc. | Variances / Equivalence | | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | ANNE Limb | ANNE One | | | 510(k) Number | | K223711 | | | Class | II | II | Equivalent | | Product Code | DQA, FLL | DRG, DQA, FLL, KMI, MWI,<br>MWJ | Similar<br>The MWJ, MWI, KMI, and<br>DRG product codes represent<br>functionalities supported by the<br>ANNE One predicate device<br>that are not part of the<br>intended use of the subject<br>device.<br>Both devices share the DQA<br>and FLL product codes. | | Regulation<br>Number and<br>Regulation<br>Name | 870.2700<br>Oximeter | 870.2910<br>Transmitters and Receivers,<br>Physiological Signal,<br>Radiofrequency | Different<br>The primary product codes are<br>different. The predicate device<br>also has the DQA product code<br>for oximetry. | | Indications for<br>Use | The ANNE Limb Sensor is a<br>pulse oximeter intended for<br>continuous monitoring of<br>functional oxygen saturation of<br>arterial hemoglobin (SpO2),<br>pulse rate, and skin<br>temperature. The ANNE Limb<br>Sensor is not intended to<br>monitor or measure SpO2 or<br>pulse rate while the patient<br>undergoes significant motion or<br>is active. The ANNE Limb<br>Sensor communicates with<br>compatible software<br>applications for the display,<br>storage, and analysis of data.<br>The device is indicated for use<br>as an aid to diagnosis and<br>treatment by healthcare<br>professionals in general care<br>patients who are 12 years of<br>age or older in clinical and | ANNE One is a wireless<br>monitoring platform indicated<br>for the measurement of<br>electrocardiography (ECG)<br>waveforms, heart rate,<br>respiratory rate, functional<br>oxygen saturation of arterial<br>hemoglobin (SpO2), pulse rate,<br>activity, body position, fall<br>detection, skin temperature,<br>and body temperature by<br>qualified healthcare<br>professionals in home and<br>healthcare settings. ANNE One<br>is compatible with third-party,<br>FDA-cleared devices for<br>noninvasive blood pressure,<br>SpO2, pulse rate, and body<br>temperature measurements.<br>The device is indicated for<br>monitoring ECG waveforms<br>and heart rate on ambulatory | Similar<br>The subject device utilizes the<br>same sensor and algorithms<br>for the calculation of SpO2,<br>pulse rate, and skin<br>temperature as the Limb<br>Sensor of the predicate device,<br>ANNE One. The ANNE One<br>predicate had additional<br>outputs including ECG, heart<br>rate, respiratory rate, and body<br>position. This difference does<br>not affect the substantial<br>equivalence of the output<br>parameters indicated for use in<br>the subject device. | | | home environments. The<br>device is not intended for use<br>on critical care patients. | patients. The device is not<br>intended to monitor or measure<br>respiratory rate, SpO2, pulse<br>rate, or noninvasive blood<br>pressure while the patient<br>undergoes significant motion or<br>is active.<br>ANNE One continuously<br>monitors the orientation of<br>patients to aid in the prevention<br>of pressure ulcers for at-risk<br>patients. The system provides<br>visual notification when the<br>patient's position has not<br>changed from a preset<br>threshold of time.<br>The device is intended for use<br>on general care patients who<br>are 12 years of age or older as<br>a general patient monitor to<br>provide continuous<br>physiological information as an<br>aid to diagnosis and treatment.<br>The data from ANNE One are<br>transmitted wirelessly for<br>display, storage, and analysis.<br>The device is not intended for<br>use on critical care patients. | | | Target<br>Population | 12 years of age and older | 12 years of age and older | Equivalent | | Use<br>Environment | Home and healthcare settings | Home and healthcare settings | Equivalent | | Reprocessing | Reusable on multiple patients. | Reusable on a single patient. | Similar<br>The subject device is reusable<br>on multiple patients. Validation<br>of the cleaning process and<br>mechanical testing<br>demonstrate that this<br>difference does not impact<br>substantial equivalence. | | Sensor<br>Placement | Finger | Finger and Chest | Similar<br>Placement of the ANNE Limb<br>sensor on the finger is the<br>same between the subject and<br>predicate devices. The<br>predicate device includes an<br>additional sensor, the ANNE<br>Chest Sensor, that is worn on<br>the chest. The ANNE Chest<br>sensor is not part of the scope | | | | | of the subject device. | | Heart Rate | Not Applicable | 30-270 bpm<br>(the greater of ± 10% or ± 5 bpm) | Not Applicable | | Respiratory<br>Rate | Not Applicable | Accelerometer-derived<br>8 - 30 bpm<br>(± 3 bpm RMSE) | Not Applicable | | Skin<br>Temperature | 73.4°F - 109.4°F (±0.54°F)<br>23°C - 43°C (±0.3°C) | 73.4°F - 109.4°F (±0.54°F)<br>23°C - 43°C (±0.3°C) | Equivalent | | SpO2 | $A_{RMS}$ ≤ 3% (range 70-100%) | $A_{RMS}$ ≤ 3% (range 70-100%) | Equivalent | | Pulse Rate | 30-300 bpm (±3 bpm RMSE) | 30-300 bpm (±3 bpm RMSE) | Equivalent | | Activity | Not Applicable | Accelerometer | Not Applicable | | Posture | Not Applicable | Body Position<br>Fall Detection | Not Applicable | | Non-Invasive<br>Blood Pressure<br>(NIBP) | Not Applicable | 0 - 300 mmHg<br>(± 3 mmHg) | Not Applicable | | Data | Data is transmitted wirelessly<br>via Bluetooth from the sensor<br>to the Sibel SDK, which may<br>be integrated within software<br>applications for the display and<br>storage of data. | Data is transmitted wirelessly<br>via Bluetooth from the sensors<br>to a mobile device. Data may<br>be downloaded for later<br>storage and analysis. | Similar<br>The subject device allows<br>communication with compatible<br>software applications for the<br>display, storage, and analysis<br>of data. | | Notification | No notification ability. | Provides visual notification on<br>patient orientation. | Similar<br>The subject device provides a<br>visual notification on patient<br>orientation. | {6}------------------------------------------------ {7}------------------------------------------------