Hinscope

K241397 · Hinlab Sas · MSX · Nov 14, 2024 · Cardiovascular

Device Facts

• Record ID: K241397
• Device Name: Hinscope
• Applicant: Hinlab Sas
• Product Code: MSX · Cardiovascular
• Decision Date: Nov 14, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Indications for Use

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 Story

Hinscope is a spot-check vital signs monitor consisting of an upper-arm measurement unit and a mobile application. It utilizes optical sensors (green, red, infrared) for photoplethysmography (PPG) to measure pulse rate and SpO2, and a sphygmomanometer cuff for NIBP. The device is operated by trained healthcare professionals in professional facilities. The measurement unit communicates data via Bluetooth Low Energy (BLE) to the mobile application, which displays the results. The NIBP algorithm operates by inflating the cuff, sensing oscillations, and processing signals upon deflation to determine systolic and diastolic pressures. The device provides clinicians with point-of-care vital sign data to assist in patient assessment; it is not a substitute for continuous ECG monitoring.

Clinical Evidence

Clinical performance testing included an SpO2/PR study with 13 healthy adult subjects (varying BMI/skin tones) per ISO 80601-2-61, demonstrating ARMS <3.5% for 70-100% range. NIBP validation study included 85 subjects (41 male, 44 female) per ISO 81060-2:2018, meeting criteria with mean difference ≤5 mmHg ± 8 mmHg.

Technological Characteristics

Upper-arm cuff-based sphygmomanometer and PPG optical sensor (green/red/IR light sources). Connectivity via Bluetooth Low Energy (BLE) to mobile application. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 80601-2-61 (SpO2), and IEC 80601-2-30 (NIBP). Biocompatibility per ISO 10993 series.

Indications for Use

Indicated for spot-check vital signs measurement (NIBP, PR, SpO2) in adult patients within professional healthcare facilities (hospitals, skilled nursing). Contraindicated for high-acuity environments (ICU, OR), acutely ill cardiac patients prone to life-threatening arrhythmias, and conditions of high motion or low perfusion.

Regulatory Classification

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.

Predicate Devices

• Current Wearable Health Monitoring System (K191272)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 12px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED | |

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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: [phone]

Contact Person: Denys-Michel de Larouzière Chief Executive Officer Telephone: [phone]

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:

| Regulation<br>Number | Device | Medical<br>Specialty | Product<br>Code | Device<br>Class | Classification<br>Panel |
|----------------------|-----------------------------------------------------------------|----------------------|-----------------|-----------------|-------------------------|
| 870.2300 | System, Network and<br>Communication, Physiological<br>Monitors | Cardiovascular | MSX | Class 2 | Cardiovascular |

#### Secondary Product Codes:

| Regulation<br>Number | Device | Medical<br>Specialty | Product<br>Code | Device<br>Class | Classification<br>Panel |
|----------------------|-------------------------------------------------------|----------------------|-----------------|-----------------|-------------------------|
| 870.2700 | Oximeter | Cardiovascular | DQA | Class 2 | Cardiovascular |
| 870.1130 | System, Measurement, Blood-<br>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 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.

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 Device<br>hinscope | Primary Predicate<br>Current Wearable Health<br>Monitoring System | Comment |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | System, Network and<br>Communication, Physiological<br>Monitors | System, Network and<br>Communication,<br>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 Product<br>Code | DQA DXN | FLL DQA BZQ DRG BZG | Equivalent to primary<br>predicate for claimed<br>measurement<br>parameters |
| Target Population | Adult | Adult | Identical |
| Environment | Professional healthcare facilities | Professional healthcare<br>facilities & home | Equivalent. The<br>subject device is<br>intended for use in<br>professional healthcare<br>facilities, which is a<br>subpart of the<br>predicate device's<br>environment. There<br>are no safety or<br>effectiveness concerns<br>arising from these<br>differences. |
| Property | Proposed Device<br>hinscope | Primary Predicate<br>Current Wearable Health<br>Monitoring System | Comment |
| Intended<br>Use/Indications for Use | hinscope is intended for spot-<br>check vital signs measurement of<br>adult patients in professional<br>healthcare facilities, such as<br>hospitals or skilled nursing<br>facilities. It is intended to be used<br>by trained healthcare<br>professionals.<br><br>hinscope is intended for spot-<br>check measurements, in adults,<br>of:<br>- Non-Invasive blood pressure<br>(NIBP)<br>- Pulse rate (PR)<br>- Oxygen saturation (SpO2)<br><br>hinscope is not intended for use in<br>high-acuity environments, such as<br>intensive care units (ICU) or<br>operating rooms.<br><br>hinscope is not intended for use on<br>acutely ill cardiac patients with the<br>potential to develop life-threatening arrhythmias e.g. very<br>fast atrial fibrillation. These<br>patients should be monitored using<br>a device with continuous<br>electrocardiogram (ECG).<br>hinscope is not a substitute for an<br>ECG monitor.<br><br>hinscope is not intended for SpO2<br>and PR measurements in<br>conditions of high motion or low<br>perfusion. | The Current Wearable Health<br>Monitoring System is<br>intended for reusable bedside,<br>mobile and central multi-<br>parameter, physiologic patient<br>monitoring of adult patients in<br>professional healthcare<br>facilities, such as hospitals or<br>skilled nursing facilities, or<br>their own home. It is intended<br>for monitoring of patients by<br>trained healthcare<br>professionals.<br><br>The Current Wearable Health<br>Monitoring System is<br>intended to provide visual and<br>audible physiologic multi-<br>parameter alarms. The Current<br>Wearable Health Monitoring<br>System is intended for<br>temperature monitoring where<br>temperature at the upper arm<br>is clinically indicated.<br><br>The Current Wearable Health<br>Monitoring System is<br>intended for continuous<br>monitoring of the following<br>parameters in adults:<br>Pulse rate<br>Oxygen saturation<br>Temperature<br>Movement<br><br>The Current Wearable Health<br>Monitoring System is<br>intended for intermittent or<br>spot-check monitoring, in<br>adults, of: | Equivalent. The<br>subject device has<br>similar indications as<br>the predicate for non-invasive blood<br>pressure, pulse rate<br>and oxygen saturation. |
| Property | Proposed Device<br>hinscope | Primary Predicate<br>Current Wearable Health<br>Monitoring System | Comment |
| | | Respiration rate<br>Non-invasive blood pressure<br>Lung function & spirometry<br>Weight<br>The Current Wearable Health<br>Monitoring System is not<br>intended for use on acutely ill<br>cardiac patients with the<br>potential to develop life<br>threatening arrhythmias e.g.<br>very fast atrial fibrillation. For<br>these patients, they should be<br>monitored using a device with<br>continuous ECG. The Current<br>Wearable Health Monitoring<br>System is not a substitute for<br>an ECG Monitor.<br>The Current Wearable Health<br>Monitoring System is not<br>intended for SpO2 monitoring<br>in conditions of high motion<br>or 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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Image /page/7/Picture/3 description: The image shows the logo for "hinlab". The logo consists of a rounded rectangle shape on the left side, which contains four horizontal wavy lines inside. To the right of this shape is the word "hinlab" in a simple, 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

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

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.

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.

#### 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 applicable<br>standards for electrical safety (IEC 60601-1). | Passed |
| EMC | hinscope was tested to confirm that it met the applicable<br>standards for electromagnetic compatibility (EMC) (IEC 60601-<br>1-2). | Passed |
| Pulse Rate Testing | hinscope was tested to confirm the accuracy of pulse rate<br>monitoring of the system in accordance with ISO 80601-2-61 and<br>the FDA Pulse Oximeters - Premarket Notification Submissions:<br>Guidance for Industry and FDA Staff, 2007. | Passed |
| Usability Testing | hinscope was assessed with regards to usability for compliance<br>with FDA Guidance Applying Human Factors and Usability<br>Engineering to Medical Devices. | Passed |
| Biocompatibility Testing | Testing and analysis of hinscope has demonstrated compliance to<br>ISO 10993-1, ISO 10993-5, ISO 10993-10 and ISO 10993-23. | Passed |
| SpO2 Testing | Ensure the accuracy and communication of the SpO2 functions<br>within hinscope per ISO 80601-2-61 and the FDA SpO2<br>guidance: Pulse Oximeters - Premarket Notification Submissions<br>Guidance for Industry and Food and Drug Staff, March 4, 2013. | Passed |
| Wireless Radio<br>Communication<br>(Wireless Coexistence) | hinscope was tested in accordance to USEMCSC C63.27-2021<br>and TIR69:2017/(R2020) to ensure the device can communicate<br>via 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.