hinscope is intended for spot-check vital signs measurement of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities. It is intended to be used by trained healthcare professionals.

hinscope is intended for spot-check measurements, in adults, of:

Non-Invasive blood pressure (NIBP) -
-Pulse rate (PR)
-Oxygen saturation (SpO2)

hinscope is not intended for use in high-acuity environments, such as intensive care units (ICU) or operating rooms. hinscope is not intended for use on acutely ill cardiac patients with the potential to develop life-threatening arrhythmias e.g. very fast atrial fibrillation. These patients should be monitored using a device with continuous electrocardiogram (ECG). hinscope is not a substitute for an ECG monitor.

hinscope is not intended for SpO2 and PR measurements in conditions of high motion or low perfusion.

Device Description

hinscope consists of the:

hinscope measurement unit
hinscope mobile application

hinscope consists of a vital sign measurement unit, that is positioned on the patient's upper arm, and a mobile application with a user interface which allows display of the vital sign data. hinscope is a combination of optical sensors and a sphygmomanometer cuff which provide measurements of the patient's pulse rate (PR) oxygen saturation (SpO2), and non-invasive blood pressure (NIBP).

PR and SpO2 are measured using a photoplethysmography (PPG) optical measurement method. PPG is a noninvasive technology that uses light sources (green, red and infrared) and photodetectors at the surface of skin to measure the volumetric variations of blood circulation. Blood pressured with the sphygmomanometer using an algorithm in which the cuff is slowly inflated while simultaneously sensing oscillations are no longer detected, the cuff deflates rapidly, and the signals are processed to determine systolic and diastolic pressures.

The vital sign measurement device communicates with a mobile application via wireless Bluetooth Low Energy (BLE) communication. The hinlab mobile application displays the blood pressure, SpO2 and pulse rate measurements.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Hinscope device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria	Reported Device Performance
SpO2 Accuracy (ARMS)	< 3.5% for the range 70-100% under steady-state and non-motion conditions (per ISO 80601-2-61:2017 and FDA Pulse Oximeters Guidance)	Passes the ARMS acceptance criteria of < 3.5% under steady state and non-motion conditions for the range 70-100%.
NIBP Accuracy (Difference)	Mean NIBP difference inferior or equal to 5 mmHg ± 8 mmHg for both SBP and DBP (per ISO 81060-2:2018 and AMD 1:2020)	Both validation criteria 1 and 2 were satisfied for SBP and DBP, with a mean NIBP difference inferior or equal to 5 mmHg ± 8 mmHg.
Electrical Safety	Compliance with IEC 60601-1	Passed
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	Passed
Pulse Rate Testing	Accuracy per ISO 80601-2-61 and FDA Pulse Oximeter Guidance (2007)	Passed
Usability	Compliance with FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices	Passed
Biocompatibility	Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-23	Passed
Wireless Radio Communication (Wireless Coexistence)	Compliance with USEMCSC C63.27-2021 and TIR69:2017/(R2020)	Passed
System Verification and Validation	Verification of software and firmware as recommended by FDA Guidance "Content of Premarket Submissions for Device Software Functions" (June 2023)	Passed
Risk Management	Compliance with ISO 14971	Passed
Software Life Cycle	Compliance with IEC 62304	Passed

Study Details

Sample size used for the test set and the data provenance:
- SpO2 and Pulse Rate Study: 13 healthy adult subjects with varying BMIs and diverse skin tones. The provenance (e.g., country) of the data is not specified. The study appears to be prospective given it investigated accuracy in subjects.
- NIBP Validation Study: 85 subjects (41 males, 44 females) with an arm circumference of 22-32 cm. The provenance of the data is not specified. The study appears to be prospective as it was a validation study with subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the number of experts or their qualifications for establishing ground truth for either the SpO2/PR or NIBP studies. These studies rely on established reference methods (e.g., arterial blood gas measurements for SpO2, or a validated reference NIBP device) rather than expert consensus on images or interpretations.
Adjudication method for the test set:
- Adjudication methods (like 2+1 or 3+1) are typically used for studies involving human interpretation of medical images or data where expert consensus is needed to establish ground truth. Since these are performance accuracy studies for vital sign measurements, such adjudication methods are not applicable and are not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices where human readers interpret medical images. The Hinscope device measures vital signs directly and is not an AI-assisted diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, these were standalone performance studies of the Hinscope device (algorithm and hardware combined) to measure vital signs. The results reflect the device's inherent accuracy in measuring SpO2, Pulse Rate, and NIBP, independent of human interpretation or assistance for those specific measurements. The device is used by trained healthcare professionals, but the performance metrics described relate to the device's direct measurement capabilities.
The type of ground truth used:
- SpO2 and Pulse Rate: The ground truth for SpO2 accuracy typically involves comparison with fractional oxyhemoglobin (SaO2) determined from co-oximetry of arterial blood samples. Given the reference to ISO 80601-2-61, this highly accurate method is implied. For pulse rate, ground truth is often established using a reference ECG or arterial line.
- NIBP: The ground truth for NIBP accuracy typically involves comparison with invasive arterial blood pressure measurements or a highly accurate reference sphygmomanometer following a standardized protocol like ISO 81060-2.
The sample size for the training set:
- The document does not specify a sample size for a training set. This is common for devices that use established physiological measurement principles (like PPG for SpO2/PR or oscillometry for NIBP) rather than complex machine learning models that require extensive training data. While there might be internal algorithms or parameters that were developed and "trained," this document focuses on the validation studies and does not disclose details of hypothetical training data for these core physiological measurement methods.
How the ground truth for the training set was established:
- As no training set details are provided or implied for a machine learning model, information on how its ground truth was established is not available in these documents. The Hinscope's measurements rely on well-established physical principles rather than a learning-based model that would require a separate ground-truth-labeled training set as is typical for AI/ML-based diagnostic software.

Summary

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November 14, 2024

Hinlab SAS Denys-Michel De Larouzière President 11 rue Alfred de Musset Neuilly sur Seine, 92200 France

Re: K241397

Trade/Device Name: Hinscope Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm). Regulatory Class: Class II Product Code: MSX, DXN, DOA Dated: May 17, 2024 Received: October 15, 2024

Dear Denys-Michel De Larouzière:

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.

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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).

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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

Stephen C. Browning -S

LCDR Stephen Browning 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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K241397

Device Name

Hinscope

Indications for Use (Describe)

Hinscope is intended for spot-check vital signs measurement of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities. It is intended to be used by trained healthcare professionals.

Hinscope is intended for spot-check measurements, in adults, of:

· Non-Invasive Blood Pressure (NIBP)
· Pulse rate (PR)
· Oxygen saturation (SpO2)

Hinscope is not intended for use in high-acuity environments, such as intensive care units (ICU) or operating rooms.

Hinscope is not intended for use on acutely ill cardial to develop life-threatening arhythmias e.g. very fast atrial fibrillation. These patients should be monitored using a device with continuous electrocardiogram (ECG). Hinscope is not a substitute for an ECG monitor.

Hinscope is not intended for SpO2 and PR measurements in conditions of high motion or low perfusion.

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)
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510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

Submitter's Name: hinlab SAS

Submitter's Address: 11 rue Alfred de Musset 92200 Neuilly sur Seine France Telephone: +33 (0) 7 69 66 11 68

Contact Person: Denys-Michel de Larouzière Chief Executive Officer Telephone: +33 (0) 7 69 66 11 68

Date Prepared: May 10, 2024

Image /page/4/Picture/8 description: The image shows the logo for Hinlab. The logo consists of a rounded rectangle shape on the left side, with several horizontal lines inside. To the right of the shape is the word "hinlab" in lowercase letters.

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Device Classification Information Regarding hinscope

Primary Product Code:

RegulationNumber	Device	MedicalSpecialty	ProductCode	DeviceClass	ClassificationPanel
870.2300	System, Network andCommunication, PhysiologicalMonitors	Cardiovascular	MSX	Class 2	Cardiovascular

Secondary Product Codes:

RegulationNumber	Device	MedicalSpecialty	ProductCode	DeviceClass	ClassificationPanel
870.2700	Oximeter	Cardiovascular	DQA	Class 2	Cardiovascular
870.1130	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	DXN	Class 2	Cardiovascular

Device Trade Name: hinscope

Device Common Name: hinscope

Indications for Use

hinscope is intended for spot-check measurements, in adults, of:

Non-Invasive blood pressure (NIBP) -
-Pulse rate (PR)
-Oxygen saturation (SpO2)

hinscope is not intended for SpO2 and PR measurements in conditions of high motion or low perfusion.

Image /page/5/Picture/17 description: The image shows the logo for Hinlab. The logo consists of a rounded rectangle shape on the left, with several horizontal wavy lines inside. To the right of the shape is the word "hinlab" in a sans-serif font.

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Summary and comparison of technological characteristics

Summary of Substantial Equivalence

The following predicate device has been that hinscope can claim equivalence with and these are detailed below.

General Comparison

Property	Proposed Devicehinscope	Primary PredicateCurrent Wearable HealthMonitoring System	Comment
Common Name	System, Network andCommunication, PhysiologicalMonitors	System, Network andCommunication,Physiological Monitors	N/A
Device Manufacturer	hinlab SAS	Current Health Ltd	N/A
Device Classification	II	II	Identical
510(k) Number	K241397	K191272	N/A
Primary Product Code	MSX	MSX	Identical
Secondary ProductCode	DQA DXN	FLL DQA BZQ DRG BZG	Equivalent to primarypredicate for claimedmeasurementparameters
Target Population	Adult	Adult	Identical
Environment	Professional healthcare facilities	Professional healthcarefacilities & home	Equivalent. Thesubject device isintended for use inprofessional healthcarefacilities, which is asubpart of thepredicate device'senvironment. Thereare no safety oreffectiveness concernsarising from thesedifferences.
Property	Proposed Devicehinscope	Primary PredicateCurrent Wearable HealthMonitoring System	Comment
IntendedUse/Indications for Use	hinscope is intended for spot-check vital signs measurement ofadult patients in professionalhealthcare facilities, such ashospitals or skilled nursingfacilities. It is intended to be usedby trained healthcareprofessionals.hinscope is intended for spot-check measurements, in adults,of:- Non-Invasive blood pressure(NIBP)- Pulse rate (PR)- Oxygen saturation (SpO2)hinscope is not intended for use inhigh-acuity environments, such asintensive care units (ICU) oroperating rooms.hinscope is not intended for use onacutely ill cardiac patients with thepotential to develop life-threatening arrhythmias e.g. veryfast atrial fibrillation. Thesepatients should be monitored usinga device with continuouselectrocardiogram (ECG).hinscope is not a substitute for anECG monitor.hinscope is not intended for SpO2and PR measurements inconditions of high motion or lowperfusion.	The Current Wearable HealthMonitoring System isintended for reusable bedside,mobile and central multi-parameter, physiologic patientmonitoring of adult patients inprofessional healthcarefacilities, such as hospitals orskilled nursing facilities, ortheir own home. It is intendedfor monitoring of patients bytrained healthcareprofessionals.The Current Wearable HealthMonitoring System isintended to provide visual andaudible physiologic multi-parameter alarms. The CurrentWearable Health MonitoringSystem is intended fortemperature monitoring wheretemperature at the upper armis clinically indicated.The Current Wearable HealthMonitoring System isintended for continuousmonitoring of the followingparameters in adults:Pulse rateOxygen saturationTemperatureMovementThe Current Wearable HealthMonitoring System isintended for intermittent orspot-check monitoring, inadults, of:	Equivalent. Thesubject device hassimilar indications asthe predicate for non-invasive bloodpressure, pulse rateand oxygen saturation.
Property	Proposed Devicehinscope	Primary PredicateCurrent Wearable HealthMonitoring System	Comment
		Respiration rateNon-invasive blood pressureLung function & spirometryWeightThe Current Wearable HealthMonitoring System is notintended for use on acutely illcardiac patients with thepotential to develop lifethreatening arrhythmias e.g.very fast atrial fibrillation. Forthese patients, they should bemonitored using a device withcontinuous ECG. The CurrentWearable Health MonitoringSystem is not a substitute foran ECG Monitor.The Current Wearable HealthMonitoring System is notintended for SpO2 monitoringin conditions of high motionor low perfusion.

Image /page/6/Picture/7 description: The image shows the logo for Hinlab. The logo consists of a rounded rectangle on the left side with horizontal wavy lines inside. To the right of the rectangle is the word "hinlab" in a sans-serif font, with a small dot above the "i".

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Device Description

hinscope consists of the:

hinscope measurement unit
hinscope mobile application

Image /page/8/Picture/9 description: The image shows the logo for Hinlab. The logo consists of a rounded rectangle shape on the left, with several horizontal wavy lines inside. To the right of the shape is the word "hinlab" in lowercase letters.

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measure the volumetric variations of blood circulation. Blood pressured with the sphygmomanometer using an algorithm in which the cuff is slowly inflated while simultaneously sensing oscillations are no longer detected, the cuff deflates rapidly, and the signals are processed to determine systolic and diastolic pressures.

Technological Characteristics

A comparative review of hinscope with the predicate device found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent to the predicate device.

Conclusion from nonclinical and clinical tests

Non-Clinical Tests (Performance/Physical Data)

Verification and validation activities established the safety and performance of the subject device based on the following tests, which were all passed:

Test Name	Test Description	Results
Electrical Safety	hinscope was tested to confirm that it met the applicablestandards for electrical safety (IEC 60601-1).	Passed
EMC	hinscope was tested to confirm that it met the applicablestandards for electromagnetic compatibility (EMC) (IEC 60601-1-2).	Passed
Pulse Rate Testing	hinscope was tested to confirm the accuracy of pulse ratemonitoring of the system in accordance with ISO 80601-2-61 andthe FDA Pulse Oximeters - Premarket Notification Submissions:Guidance for Industry and FDA Staff, 2007.	Passed
Usability Testing	hinscope was assessed with regards to usability for compliancewith FDA Guidance Applying Human Factors and UsabilityEngineering to Medical Devices.	Passed
Biocompatibility Testing	Testing and analysis of hinscope has demonstrated compliance toISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-23.	Passed
SpO2 Testing	Ensure the accuracy and communication of the SpO2 functionswithin hinscope per ISO 80601-2-61 and the FDA SpO2guidance: Pulse Oximeters - Premarket Notification SubmissionsGuidance for Industry and Food and Drug Staff, March 4, 2013.	Passed
Wireless RadioCommunication(Wireless Coexistence)	hinscope was tested in accordance to USEMCSC C63.27-2021and TIR69:2017/(R2020) to ensure the device can communicatevia wireless radio in its intended environment.	Passed

Image /page/9/Picture/10 description: The image shows the logo for Hinlab. The logo consists of a rounded rectangle with horizontal lines inside, followed by the word "hinlab" in a sans-serif font. The "i" in "hinlab" has a circular dot above it.

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Test Name Test Description Results System Verification and The system verification and validation testing was performed to Passed Validation Testing verify the software and firmware of hinscope as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" (June 2023). Risk Management hinscope was tested and confirmed to meet all the applicable Passed requirements for application of risk management to medical Device per ISO 14971. Software Life Cycle hinscope was tested and confirmed to meet all the applicable Passed requirements for software life cycle per IEC 62304. Non-Invasive Blood Pressure The device was tested according to IEC 80601-2-30: Medical Passed (NIBP) Testing electrical equipment - Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers.

hinlab SAS Traditional 510(k) For hinscope

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" (June 2023).

Animal Studies

No animal studies were conducted as part of submission to prove substantial equivalence.

Clinical Performance Testing

The clinical performance study investigated the accuracy of blood oxygen saturation and pulse rate performance in 13 healthy adult subjects with varying BMIs and diverse skin tones. The study was conducted in accordance with ISO 80601-2-61:2017 and Pulse Oximeters – Premarket Notifications [510(k)s] Guidance for Industry and Food and Drug Administration Staff (issued: March 4, 2013). The results of the study provide supporting evidence that the SpO2 accuracy performance of hinscope passes the ARMS acceptance criteria of <3.5% under steady state and non-motion conditions for the range 70-100%.

The non-invasive blood pressure (NIBP) validation study was conducted in accordance with the universal standard validation protocol (AAMI/ESH/ISO) as outlined in ISO 81060-2:2018 and its amendment, ISO 81060-2:2018/Amd 1:2020. The study included 85 subjects (41 males, 44 females) with an arm circumference of 22-32 cm. Both validation criteria 1 and 2 were satisfied for SBP and DBP, with a mean NIBP difference inferior or equal to 5 mmHg ± 8 mmHg.

Safety and Effectiveness/Conclusion

Based on the information presented in these 510(k) premarket notifications hinscope is considered substantially equivalent. hinscope is as safe and effective as the currently marketed predicate device.

Image /page/10/Picture/12 description: The image shows the logo for Hinlab. The logo consists of a rounded rectangle shape on the left, with several horizontal wavy lines inside. To the right of the shape is the word "hinlab" in a simple, sans-serif font, with a small dot above the "i".

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hinlab SAS Traditional 510(k)

For hinscope

Based on testing and comparison with the predicate device, hinscope indications or results.

Image /page/11/Picture/4 description: The image shows the logo for "hinlab". The logo consists of a rounded rectangle shape on the left side, which contains several horizontal wavy lines inside. To the right of this shape is the word "hinlab" in a simple, sans-serif font.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).