Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535

K192092 · Seca GmbH & Co. KG · DXN · Jan 23, 2020 · Cardiovascular

Device Facts

• Record ID: K192092
• Device Name: Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535
• Applicant: Seca GmbH & Co. KG
• Product Code: DXN · Cardiovascular
• Decision Date: Jan 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The medical Vital Signs Analyzer seca mVSA 535 is a Spot-Check device used for non-invasive, discontinuous measurement and display of NIBP (blood pressure), SpO2 (oxygen saturation of arterial hemoglobin), TEMP (body temperature) and PR (pulse rate). The vital signs monitor model seca mVSA 535 is mainly used in inpatient facilities (hospitals, medical practices and care facilities) in accordance with national regulations and is intended to be used on adult and pediatric individuals (3 years of age or older). The seca mVSA 535 can be used in conjunction with an optional PC software accessory for data management, calculations and display of information. If used in conjunction with seca medical weight and height measurement devices the seca mVSA 535 can receive and display weight and height values.

Device Story

Portable, microprocessor-controlled vital signs analyzer; performs non-invasive, discontinuous spot-check measurements of NIBP, SpO2, body temperature, and pulse rate. Inputs: oscillometric blood pressure cuff, pulse oximetry sensor, and clinical thermometer (oral/axillary/rectal). Device performs self-check upon startup; processes sensor signals to calculate vital signs; displays results on integrated touchscreen. Used in clinical settings (hospitals, clinics) by healthcare providers. Optional PC software accessory enables data management and display. Can interface with seca weight/height measurement devices to receive and display anthropometric data. No alarms or arrhythmia detection. Benefits: provides clinicians with objective vital sign data to manage patient health conditions.

Clinical Evidence

Bench testing only. Performance validated via biocompatibility (ISO 10993), electrical safety (ANSI/AAMI ES60601-1), EMC (IEC 60601-1-2), and usability (IEC 62366). Device performance verified against ISO 80601-2-30 (NIBP), ISO 80601-2-56 (thermometer), and ISO 80601-2-61 (pulse oximeter). Software verification and validation completed for Moderate Level of Concern.

Technological Characteristics

Microprocessor-controlled; AC/DC powered; Lithium-ion battery. Oscillometric NIBP (300 mmHg max); Pulse Oximetry (70-100% range); Predictive/Direct clinical thermometer (COVIDIEN FILAC 3000). Touchscreen GUI. Connectivity: optional PC software accessory, interface with seca weight/height scales. Biocompatible materials per ISO 10993. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 80601-2-30, ISO 80601-2-56, ISO 80601-2-61.

Indications for Use

Indicated for non-invasive, discontinuous spot-check measurement of NIBP, SpO2, body temperature, and pulse rate in adult and pediatric patients (3 years or older) within inpatient facilities, hospitals, and medical practices.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• SunTech CT40 Spot-check Vital Signs Device (Model 260) (K160439)

Submission Summary (Full Text)

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January 23, 2020

Seca GmbH & Co. Kg % Oliver Eikenberg Senior Consultant QA/RA Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K192092

Trade/Device Name: seca mVSA 535 Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN. DOA. FLL Dated: December 19, 2019 Received: December 23, 2019

Dear Oliver Eikenberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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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# Indications for Use

510(k) Number (if known) K192092

Device Name seca mVSA 535

#### Indications for Use (Describe)

The medical Vital Signs Analyzer seca mVSA 535 is a Spot-Check device used for non-invasive, discontinuous measurement and display of NIBP (blood pressure), SpO2 (oxygen saturation of arterial hemoglobin), TEMP (body temperature) and PR (pulse rate).

The vital signs monitor model seca mVSA 535 is mainly used in inpatient facilities (hospitals, medical practices and care facilities) in accordance with nations and is intended to be used on adult and pediatric individuals (3 years of age or older).

The seca mVSA 535 can be used in conjunction with an optional PC software accessory for data management, calculations and display of information.

If used in conjunction with seca medical weight measurement devices the seca mVSA 535 can receive and display weight and height values.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> </span> <span style="font-size: 10pt;">☑</span> </div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> </span> <span style="font-size: 10pt;">☐</span> </div> |

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# 510(k) Summary seca mVSA 535 K192092

#### 1. Submission Sponsor

seca gmbh & co. kg Hammer Steindamm 3 – 25 D-22089 Hamburg, Germany Establishment Registration Number: 3003587684 Corinna Hatje – Regulatory Affairs Telephone Number: [phone] – 195 E-mail: [e-mail]

## 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Contact: Oliver Eikenberg, PhD Title: Senior Consultant, Quality & Regulatory Affairs

#### 3. Date Prepared

22/01/2020

## 4. Device Identification

| Trade/Proprietary Name(s): | seca mVSA 535 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Vital Signs Analyzer |
| Classification Name: | Noninvasive blood pressure measurement system. |
| Regulation number: | 21 CFR 870.1130 Non-invasive Blood Pressure Measurement System<br>21 CFR 870.2700 Oximeter<br>21 CFR 880.2910 Clinical electronic thermometer |
| Product Code: | DXN, DQA, FLL |
| Device Class: | Class II Classification |
| Panel: | Cardiovascular |

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# 5. Legally Marketed Predicate Device

SunTech CT40 Spot-check Vital Signs Device (Model 260), (Trade names CT40, Model 260, CT40 Spot-check Vital Signs Device), K160439, manufactured by SunTech Medical, NC, USA.

The predicate device has not been subject to a design related recall.

## 6. Indication for Use Statement

The medical Vital Signs Analyzer seca mVSA 535 is a Spot-Check device used for non-invasive, discontinuous measurement and display of NIBP (blood pressure), SpO2 (oxygen saturation of arterial hemoglobin), TEMP (body temperature) and PR (pulse rate).

The vital signs monitor model seca mVSA 535 is mainly used in inpatient facilities (hospitals, medical practices and care facilities) in accordance with national regulations and is intended to be used on adult and pediatric individuals (3 years of age or older).

The seca mVSA 535 can be used in conjunction with an optional PC software accessory for data management, calculations and display of information.

If used in conjunction with seca medical weight and height measurement devices the seca mVSA 535 can receive and display weight and height values.

#### 7. Device Description

The seca mVSA 535 is a portable, non-invasive, reusable microprocessor-controlled, AC or DC-powered Vital Signs Analyzer providing discontinuous Spot-Check measurements of vital sign parameters of a patient (adult and pediatric individuals >3 years) in a clinical settings (hospitals, medical practices and care facilities). The vital sign data help clinicians to manage and monitor health conditions of patients.

The seca mVSA 535 is used by a health care provider (HCP) in a clinical setting, only. During the start the seca mVSA 535 performs a self-check. The user is not required to perform any special maintenance and/or calibration activities. Users do not require any special training other than the provided instructions for use.

The seca mVSA 535 does not include alarms or arrhythmia detection.

The following vital signs are measured:

- . Blood pressure (NIBP),
- . Oxygen saturation of arterial hemoglobin (SpO₂)
- . Body temperature (TEMP) (oral/axillary/rectal)
- . Pulse rate (PR) – this parameter is not measured but determined while measuring blood pressure or SpO2

## 8. Substantial Equivalence Discussion

The following table compares the seca mVSA 535 to the predicate device with respect to indications for use, principles of operation, technological characteristics and performance specifications. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

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| | Subject Device | Predicate Device | Device<br>Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | seca gmbh & co. kg (GERMANY) | SunTech Medical (USA) | |
| Trade Name | medical Vital Sings Analyzer 535<br>(seca mVSA 535) | CT40 Spot-check Vital Signs Device<br>(Model 260) | |
| 510(k) Number | Unknown | K160439 | NA |
| Product Code | DXN, DQA, FLL | | Same |
| Regulation Number | 21 CFR 870.1130 Non-invasive Blood Pressure Measurement System | | Same |
| Regulation Name | 21 CFR 870.2700 Oximeter<br>21 CFR 870.2910 Clinical electronic thermometer | | |
| Regulation Panel | Cardiovascular | | Same |
| Prescription Use | Yes | Yes | Same |
| Indications for Use | The medical Vital Signs Analyzer seca<br>mVSA 535 is a Spot-Check device used<br>for non-invasive, discontinuous<br>measurement and display of NIBP<br>(blood pressure), SpO2 (oxygen<br>saturation of arterial hemoglobin),<br>TEMP (body temperature) and PR<br>(pulse rate).<br>The vital signs monitor model seca<br>mVSA 535 is mainly used in inpatient<br>facilities (hospitals, medical practices<br>and care facilities) in accordance with<br>national regulations and is intended<br>to be used on adult and pediatric<br>individuals (3 years of age or older).<br>The seca mVSA 535 can be used in<br>conjunction with an optional PC<br>software accessory for data<br>management, calculations and<br>display of information.<br>If used in conjunction with seca<br>medical weight and height<br>measurement devices the seca mVSA<br>535 can receive and display weight<br>and height values. | The SunTech CT40 (Model 260) is a<br>non-invasive oscillometric spot check<br>vital signs device. The CT40 is capable of<br>measuring and displaying brachial<br>systolic and diastolic blood pressure,<br>heart rate, percent oxygenated<br>hemoglobin (SpO2) and body<br>temperature on children 3 years of age<br>to adults.<br><br>This device is intended for use by a<br>qualified clinician when it is necessary<br>to take one or more vital signs<br>measurements on a patient.<br><br>The CT40 is only for measurement,<br>recording, and display. It makes no<br>specific diagnoses. | Similar |
| Target Population | Adult and pediatric patients over the<br>age of 3 years | Adult and pediatric patients over the<br>age of 3 years | Same |
| Primary Location of<br>Use | Physician's office, clinic, research<br>center (under supervision of physician) | Physician's office, clinic, research<br>center (under supervision of physician) | Same |
| Device variants | Pre-defined configurations in<br>production:<br>- NIBP + SpO2<br>- NIBP + TEMP<br>- NIBP + SpO2 + TEMP | configurations can be retrofit (optional):<br>- NIBP only<br>- NIBP + SpO2<br>- NIBP + TEMP<br>- NIBP + SpO2 + TEMP | Similar |
| Physiological<br>parameters<br>(measured,<br>calculated) | Non-invasive Blood pressure (NIBP)<br>Temperature (TEMP)<br>Oxygen saturation of arterial<br>hemoglobin (SpO2)<br>Pulse rate (calculated via NIBP or SpO2) | Non-invasive Blood pressure (NIBP)<br>Temperature (TEMP)<br>Oxygen saturation of arterial<br>hemoglobin (SpO2)<br>Heart Rate (calculated via NIBP or SpO2) | Same |
| | Subject Device | Predicate Device | Device Comparison |
| Manufacturer | seca gmbh & co. kg (GERMANY) | SunTech Medical (USA) | |
| Trade Name | medical Vital Sings Analyzer | CT40 Spot-check Vital Signs | |
| | 535 (seca mVSA 535) | Device (Model 260) | |
| Non invasive Blood pressure (NIBP) | | | |
| Mode of Operation | Oscillometric (deflation/inflation) | Oscillometric (deflation, auscultatory) | Similar |
| Measurement mode | Single automatic, repetitive automatic<br>(3 consecutive measurements) | Single automatic, repetitive automatic<br>(5 consecutive measurements) | Similar |
| Measurement type | Systolic Pressure (SYS)<br>Diastolic Pressure | Systolic Pressure (SYS)<br>Diastolic Pressure (DIA) | Same |
| Max. cuff pressure | 300 mmHg | 300 mmHg | Same |
| Measurement range | Systolic (Adult/Ped.): 25-280 mmHg | Systolic (Adult): 40-260 mmHg<br>Systolic (Pediatric): 40-230mmHg | Similar,<br>seca does not have<br>a neonatal mode,<br>but instead has a<br>broader<br>measurement<br>range. Both devices<br>cover ranges<br>around the normal<br>blood range 120/80<br>mmHg |
| | Diastolic (Adult/Ped.): 10-220 mmHg | Diastolic (Adult): 25-200 mmHg<br>Diastolic (Pediatric): 20-160 mmHg | |
| | Oxygen saturation of arterial hemoglobin (SpO2) | | |
| Mode of Operation | Pulse Oximetry | Pulse Oximetry | Same |
| Measurement range | 70-100 % | 70-100 % | Same |
| | Body temperature (TEMP) | | |
| Modes of Operation for<br>measuring sites<br>(different modules) | Direct, predictive for oral, axillary,<br>rectal measurement temperature<br>(COVIDIEN FILAC 3000) | Direct, predictive for oral, axillary,<br>rectal measurement | Same |
| Power Supply | 100-240 VAC / 50-60 Hz | 100-240 VAC, 50-60Hz | Similar |
| Battery type | Lithium Ion | Lithium Ion | |
| Nominal Voltage/Capacity | 11.25 V / 2950 mAh | 7.2 V / 6600 mAh | |
| Alarm functionality | No built-in Alarm functionality<br>(spot check use only). | No built-in Alarm functionality<br>(spot check use only). | Same |
| Operation | Graphical User Interface with touch control | LCD-Display with button control | Similar |
| Software | Software program is built into the<br>device used to process, store and<br>display information | Software program is built into the<br>device used to process, store and<br>display information | Same |
| EMC/EC testing | IEC 60601-1, IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 80601-2-30, ISO 80601-2-56<br>ISO 80601-2-61 | IEC 60601-1, IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 80601-2-30, ISO 80601-2-56<br>ISO 80601-2-61 | Same |
| Biocompatibility | ISO 10993 series | ISO 10993 series | Same |

# Table 5A – Comparison of Characteristics for seca mVSA 535 versus CT40 Spot-check Vital Signs Device (Model 260)

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# Table 5A – Comparison of Characteristics for seca mVSA 535 versus CT40 Spot-check Vital Signs Device (Model 260)

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#### 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of seca mVSA 535 and in showing substantial equivalence to the predicate device, seca gmbh & co. kg completed the following tests, where the seca mVSA 535 meets all the requirements for overall design, EMC testing and biocompatibility results confirming that the design output meets the design inputs and specifications for the device.

The seca gmbh & co. kg passed all the testing in accordanc…