(171 days)
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No
The document describes a standard vital signs monitor with microprocessor control for basic measurements and data display. There is no mention of AI, ML, or any advanced analytical capabilities beyond standard vital sign determination. The performance studies listed are for standard medical device safety and performance, not AI/ML model validation.
No
The device is described as a "Spot-Check device used for non-invasive, discontinuous measurement and display of NIBP, SpO2, TEMP and PR" and helps "clinicians to manage and monitor health conditions of patients," but it does not treat or cure any conditions.
Yes
The device is a Vital Signs Analyzer that measures and displays parameters like blood pressure, oxygen saturation, and body temperature. While it provides "data to help clinicians to manage and monitor health conditions of patients," it does not explicitly state it provides a diagnosis. However, the measurement of vital signs is a fundamental component of diagnostic processes, as deviations from normal ranges often indicate underlying medical conditions. Therefore, by providing this critical information, it serves a diagnostic function.
No
The device description explicitly states it is a "portable, non-invasive, reusable microprocessor-controlled, AC or DC-powered Vital Signs Analyzer" and lists hardware components like NIBP, SpO2, and TEMP measurement capabilities. While it mentions optional PC software, the core device is hardware-based.
Based on the provided information, the seca mVSA 535 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- seca mVSA 535 Function: The seca mVSA 535 measures vital signs (blood pressure, oxygen saturation, temperature, and pulse rate) non-invasively and discontinuously directly from the patient's body. It does not analyze samples taken from the body.
The device description clearly states that it is a "Spot-Check device used for non-invasive, discontinuous measurement and display of NIBP, SpO2, TEMP and PR." This aligns with the definition of a vital signs monitor, not an IVD.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DXN, DQA, FLL
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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult and pediatric individuals (3 years of age or older).
Intended User / Care Setting
inpatient facilities (hospitals, medical practices and care facilities)
The seca mVSA 535 is used by a health care provider (HCP) in a clinical setting, only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
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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) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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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 System |
| 21 CFR 870.2700 Oximeter | |
| 21 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.
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| | Subject Device | Predicate Device | Device
Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Oximeter
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
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. | The SunTech CT40 (Model 260) is a
non-invasive oscillometric spot check
vital signs device. The CT40 is capable of
measuring and displaying brachial
systolic and diastolic blood pressure,
heart rate, percent oxygenated
hemoglobin (SpO2) and body
temperature on children 3 years of age
to adults.
This device is intended for use by a
qualified clinician when it is necessary
to take one or more vital signs
measurements on a patient.
The CT40 is only for measurement,
recording, and display. It makes no
specific diagnoses. | Similar |
| Target Population | Adult and pediatric patients over the
age of 3 years | Adult and pediatric patients over the
age of 3 years | Same |
| Primary Location of
Use | Physician's office, clinic, research
center (under supervision of physician) | Physician's office, clinic, research
center (under supervision of physician) | Same |
| Device variants | Pre-defined configurations in
production:
- NIBP + SpO2
- NIBP + TEMP
- NIBP + SpO2 + TEMP | configurations can be retrofit (optional):
- NIBP only
- NIBP + SpO2
- NIBP + TEMP
- NIBP + SpO2 + TEMP | Similar |
| Physiological
parameters
(measured,
calculated) | Non-invasive Blood pressure (NIBP)
Temperature (TEMP)
Oxygen saturation of arterial
hemoglobin (SpO2)
Pulse rate (calculated via NIBP or SpO2) | Non-invasive Blood pressure (NIBP)
Temperature (TEMP)
Oxygen saturation of arterial
hemoglobin (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 mmHg
Systolic (Pediatric): 40-230mmHg | Similar,
seca does not have
a neonatal mode,
but instead has a
broader
measurement
range. Both devices
cover ranges
around the normal
blood range 120/80
mmHg |
| | Diastolic (Adult/Ped.): 10-220 mmHg | Diastolic (Adult): 25-200 mmHg
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
measuring 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 the
device used to process, store and
display information | Software program is built into the
device used to process, store and
display information | Same |
| EMC/EC testing | IEC 60601-1, IEC 60601-1-2
IEC 60601-1-6
IEC 80601-2-30, ISO 80601-2-56
ISO 80601-2-61 | IEC 60601-1, IEC 60601-1-2
IEC 60601-1-6
IEC 80601-2-30, ISO 80601-2-56
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)
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.