(171 days)
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.
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
The provided document describes the seca mVSA 535, a vital signs analyzer intended for non-invasive, discontinuous measurement and display of NIBP (blood pressure), SpO2 (oxygen saturation), TEMP (body temperature), and PR (pulse rate). The study described is a non-clinical performance evaluation to demonstrate substantial equivalence to a predicate device, not a study demonstrating the device meets specific acceptance criteria in a clinical setting in the way a diagnostic AI would. Therefore, much of the requested information (like ground truth, expert qualifications, adjudication, MRMC studies, standalone performance with AI, training set details) is not applicable or cannot be extracted from this summary.
However, I can provide the available information regarding the performance data and acceptance criteria based on the regulatory submission.
1. A table of acceptance criteria and the reported device performance
The document states that the seca mVSA 535 "meets all the requirements" and "PASSED all testing" for various standards. It does not provide specific numerical acceptance criteria or reported device performance values for each vital sign parameter, but rather confirms compliance with the general requirements of the referenced standards.
| Parameter | Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, 5, 10 | PASSED all testing |
| Electrical Safety | ANSI/AAMI ES60601-1, IEC 60601-1-6 | PASSED required testing |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | PASSED required testing |
| Usability Engineering | IEC 62366 | PASSED required testing |
| Software Verification & Validation | IEC 62304 / FDA Guidance (Moderate Level of Concern) | PASSED required testing |
| Non-Invasive Sphygmomanometers (NIBP) | ISO 80601-2-30 | PASSED required testing |
| Clinical Thermometers (TEMP) | ISO 80601-2-56 | PASSED required testing |
| Pulse Oximeter Equipment (SpO2) | ISO 80601-2-61 | PASSED required testing |
| Risk Management | ISO 14971, EN ISO 14971 | All requirements met, risks reduced as far as possible |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the "test set" for the non-clinical performance data. It describes tests against standards, which typically involve specific test setups and reference devices rather than a patient-based "test set" in the context of clinical accuracy claims for an AI. The data provenance is also not detailed, as these are engineering and safety tests rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The non-clinical performance data relies on compliance with established technical standards, not expert-established ground truth from clinical readings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical performance evaluation focused on device functionality and safety against technical standards.
5. 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
Not applicable. The seca mVSA 535 is a vital signs measurement device, not an AI-assisted diagnostic tool for human readers. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm. The device performs automated, non-invasive measurements. Its performance is assessed against the requirements of the standards for such medical devices, which is essentially a "standalone" assessment of its measurement accuracy and safety.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance data is defined by the reference standards and calibrated instruments used in the testing outlined by ISO 80601-2-30 (sphygmomanometers), ISO 80601-2-56 (clinical thermometers), and ISO 80601-2-61 (pulse oximeters). These standards specify the methods and acceptable deviations for accuracy, rather than clinical ground truth from patient outcomes or expert consensus.
8. The sample size for the training set
Not applicable. This device does not employ a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not employ a machine learning algorithm that requires a training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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) | ☑ |
| 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 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: +49 40 20 00 00 – 195 E-mail: corinna.hatje@seca.com
2. Submission Correspondent
Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327.9997 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 System21 CFR 870.2700 Oximeter21 CFR 880.2910 Clinical electronic thermometer |
| Product Code: | DXN, DQA, FLL |
| Device Class: | Class II Classification |
| Panel: | Cardiovascular |
{4}------------------------------------------------
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.
{5}------------------------------------------------
| Subject Device | Predicate Device | DeviceComparison | |
|---|---|---|---|
| Manufacturer | seca gmbh & co. kg (GERMANY) | SunTech Medical (USA) | |
| Trade Name | medical Vital Sings Analyzer 535(seca mVSA 535) | CT40 Spot-check Vital Signs Device(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 Oximeter21 CFR 870.2910 Clinical electronic thermometer | ||
| Regulation Panel | Cardiovascular | Same | |
| Prescription Use | Yes | Yes | Same |
| Indications for Use | The medical Vital Signs Analyzer secamVSA 535 is a Spot-Check device usedfor non-invasive, discontinuousmeasurement and display of NIBP(blood pressure), SpO2 (oxygensaturation of arterial hemoglobin),TEMP (body temperature) and PR(pulse rate).The vital signs monitor model secamVSA 535 is mainly used in inpatientfacilities (hospitals, medical practicesand care facilities) in accordance withnational regulations and is intendedto be used on adult and pediatricindividuals (3 years of age or older).The seca mVSA 535 can be used inconjunction with an optional PCsoftware accessory for datamanagement, calculations anddisplay of information.If used in conjunction with secamedical weight and heightmeasurement devices the seca mVSA535 can receive and display weightand height values. | The SunTech CT40 (Model 260) is anon-invasive oscillometric spot checkvital signs device. The CT40 is capable ofmeasuring and displaying brachialsystolic and diastolic blood pressure,heart rate, percent oxygenatedhemoglobin (SpO2) and bodytemperature on children 3 years of ageto adults.This device is intended for use by aqualified clinician when it is necessaryto take one or more vital signsmeasurements on a patient.The CT40 is only for measurement,recording, and display. It makes nospecific diagnoses. | Similar |
| Target Population | Adult and pediatric patients over theage of 3 years | Adult and pediatric patients over theage of 3 years | Same |
| Primary Location ofUse | Physician's office, clinic, researchcenter (under supervision of physician) | Physician's office, clinic, researchcenter (under supervision of physician) | Same |
| Device variants | Pre-defined configurations inproduction:- NIBP + SpO2- NIBP + TEMP- NIBP + SpO2 + TEMP | configurations can be retrofit (optional):- NIBP only- NIBP + SpO2- NIBP + TEMP- NIBP + SpO2 + TEMP | Similar |
| Physiologicalparameters(measured,calculated) | Non-invasive Blood pressure (NIBP)Temperature (TEMP)Oxygen saturation of arterialhemoglobin (SpO2)Pulse rate (calculated via NIBP or SpO2) | Non-invasive Blood pressure (NIBP)Temperature (TEMP)Oxygen saturation of arterialhemoglobin (SpO2)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(3 consecutive measurements) | Single automatic, repetitive automatic(5 consecutive measurements) | Similar |
| Measurement type | Systolic Pressure (SYS)Diastolic Pressure | Systolic Pressure (SYS)Diastolic Pressure (DIA) | Same |
| Max. cuff pressure | 300 mmHg | 300 mmHg | Same |
| Measurement range | Systolic (Adult/Ped.): 25-280 mmHg | Systolic (Adult): 40-260 mmHgSystolic (Pediatric): 40-230mmHg | Similar,seca does not havea neonatal mode,but instead has abroadermeasurementrange. Both devicescover rangesaround the normalblood range 120/80mmHg |
| Diastolic (Adult/Ped.): 10-220 mmHg | Diastolic (Adult): 25-200 mmHgDiastolic (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 formeasuring sites(different modules) | Direct, predictive for oral, axillary,rectal measurement temperature(COVIDIEN FILAC 3000) | Direct, predictive for oral, axillary,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(spot check use only). | No built-in Alarm functionality(spot check use only). | Same |
| Operation | Graphical User Interface with touch control | LCD-Display with button control | Similar |
| Software | Software program is built into thedevice used to process, store anddisplay information | Software program is built into thedevice used to process, store anddisplay information | Same |
| EMC/EC testing | IEC 60601-1, IEC 60601-1-2IEC 60601-1-6IEC 80601-2-30, ISO 80601-2-56ISO 80601-2-61 | IEC 60601-1, IEC 60601-1-2IEC 60601-1-6IEC 80601-2-30, ISO 80601-2-56ISO 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)
{6}------------------------------------------------
Table 5A – Comparison of Characteristics for seca mVSA 535 versus CT40 Spot-check Vital Signs Device (Model 260)
{7}------------------------------------------------
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 accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility evaluation and biocompatibility testing of seca mVSA 535 for patient-contacting materials including chemical characterization, cytotoxicity, sensitization and irritation reactivity, per ISO 10993-1, 5, 10; PASSED all testing
- . Electrical safety testing per ANSI/AAMI ES60601-1, IEC 60601-1-6: PASSED required testing
- . Electromagnetic Compatibility testing per IEC 60601-1-2: PASSED required testing
- . Usability engineering testing per IEC 62366: PASSED required testing
- . Software verification and validation testing has been completed on a functional level for a Moderate Level of Concern software including system compatibility testing, risk analysis per IEC 62304/FDA Guidance: PASSED required testing
- . Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers per ISO 80601-2-30, PASSED required testing
- . Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement per ISO 80601-2-56, PASSED required testing
- . Particular requirements for basic safety and essential performance of pulse oximeter equipment per ISO 80601-2-61, PASSED required testing
- . Risk Management per ISO 14971 and EN ISO 14971; all requirements were met and risks reduced as far as possible.
10. Statement of Substantial Equivalence
lt has been shown in this 510(k) submission that the minor differences between the seca mVSA 535 and the Predicate Device do not raise any new questions regarding its safety and effectiveness. Technological product characteristics, performance testing and compliance with voluntary standards, demonstrate that the seca mVSA 535 device is substantially equivalent to the predicate device in terms of design, components, materials, principals of operation, performance characteristics, and intended use.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
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.(b)
Classification. Class II (performance standards).