(540 days)
Not Found
No
The description focuses on signal acquisition and conversion, with no mention of AI/ML algorithms for interpretation or analysis.
No.
The device is a monitoring system that measures physiological parameters (fetal heart rate, uterine activity, maternal heart rate) rather than providing therapy or treatment.
No
This device is described as a sensor replacement that interfaces with existing fetal monitors to measure maternal heart rate, fetal heart rate, and uterine activity. While these measurements provide information, the document specifies its role in measuring these parameters, not in diagnosing conditions based on those measurements. Its function is to provide data to clinicians, who then use that data for diagnosis.
No
The device description explicitly lists multiple hardware components: an electrode array, a wireless transmitter, a computational base station, a power supply module, and adapters. It also mentions electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, the LaborView™ LV1000 Wireless Electrode System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The LaborView™ LV1000 works by detecting electrical signals on the surface of the maternal abdomen. It's a non-invasive sensor that measures physiological activity directly from the body.
- The intended use and device description clearly state it's a sensor system for measuring physiological parameters (FHR, UA, MHR) in vivo (within the living body). It's a monitoring device, not a device that analyzes biological samples.
Therefore, the LaborView™ LV1000 falls under the category of a medical device that performs physiological monitoring, not an IVD.
N/A
Intended Use / Indications for Use
The LaborView ™ LV1000 Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.
Product codes
OSP, HGM
Device Description
The LaborView™ LV1000 Wireless Electrode System is a uterine activity (UA), maternal (MHR) and fetal (FHR) heart rate sensor replacement intended to interface with existing Philips Avalon fetal monitors in hospital delivery environments. Labor View™ LV1000 Wireless Electrode System is comprised of an electrode array, a wireless transmitter ("Transmitter"), computational base station"), a power supply module, and adapters to connect to compatible fetal monitors. The electrode array is sensitive to changes in the electrical activity at the skin surface due to muscle contractions, maternal, and fetal ECG when placed on the expectant mothers abdomen. These signals are passed to the device, converted to a contraction curve, maternal heart rate (MHR), and fetal heart rate (FHR), and subsequently passed to the Philips monitor. All the components of LaborView™ LV1000 Wireless Electrode System work together with the compatible fetal monitors to complete a system that can detect maternal contractions, MHR and FHR during labor. The fetal monitor, in turn, may interface to a central monitoring system in order to conveniently present contraction information to clinicians.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maternal abdomen
Indicated Patient Age Range
The device is indicated for use on women who are at term (>36 completed weeks).
Intended User / Care Setting
healthcare professional in a clinical setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate.
The following tests were performed:
- Biocompatibility: Patient contacting components are in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
- Software Verification: Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
- Electrical Safety, EMC, and Wireless Capability: The subject devices were tested in compliance with ANSI/AAMI ES60601-1 and IEC 60601-1-2014. Sponsor provided documentation per FDA guidance document Radio Frequency Wireless Technology in Medical Devices.
- Performance Testing: Bench testing performed to verify specifications including: Electrode Array Verification, Transmitter (Front End) Verification, Base Station (Back End) Verification, Monitor Interface Cable Verification, System Validation, EC13 Compliance Verification for Maternal Heart Rate (MHR), Comparative Testing, Testing with compatible patient monitors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 884.2720 External uterine contraction monitor and accessories.
(a)
Identification. An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2020
OBMedical Company Paul E. Dryden Consultant 3630 SW 47th Avenue, Suite 201 Gainesville, FL 32608
Re: K190798
Trade/Device Name: LaborView™ LV1000 Wireless Electrode System Regulation Number: 21 CFR§ 884.2720 Regulation Name: External Uterine Contraction Monitor and Accessories Regulatory Class: II Product Code: OSP, HGM Dated: September 3, 2020 Received: September 8, 2020
Dear Paul E. Dryden:
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 statutes and regulations administered by other Federal agencies.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-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,
Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K190798
Device Name
Labor View TM LV1000 Wireless Electrode System
Indications for Use (Describe)
The LaborView ™ LV1000 Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K190798
| Date Prepared: | 18-Sep-20 | |
|---|---|---|
| Sponsor: | OBMedical Company | |
| 3630 SW 47th Ave, Suite 201 | ||
| Gainesville, FL 32608 | ||
| Tel - 352-354-2244 | ||
| Official Contact: | Minh Tam Nguyen, Director of Engineering | |
| Submission Correspondent: | Paul E. Dryden | |
| ProMedic, LLC | ||
| Tel – 239-307-6061 | ||
| Proprietary or Trade Name: | LaborView™ LV1000 Wireless Electrode System | |
| Common/Usual Name: | External uterine contraction monitor | |
| Regulation Number/ | ||
| Regulation Name: | 21 CFR 884.2720 (External uterine contraction monitor and | |
| accessories) | ||
| 21 CFR 884.2740 (Perinatal monitoring system) | ||
| Product Code: | OSP, uterine electromyographic monitor | |
| HGM, system, monitoring, perinatal | ||
| Regulatory Class: | Class II | |
| Review Panel: | Obstetrics/Gynecology | |
| Predicate Device: | K142583 | |
| Manufacturer: OB Medical | ||
| Device Name: LaborView LV1000 | ||
| The predicate device has not been subject to a design-related | ||
| recall |
Device Description:
The LaborView™ LV1000 Wireless Electrode System is a uterine activity (UA), maternal (MHR) and fetal (FHR) heart rate sensor replacement intended to interface with existing Philips Avalon fetal monitors in hospital delivery environments.
Labor View™ LV1000 Wireless Electrode System is comprised of an electrode array, a wireless transmitter ("Transmitter"), computational base station"), a power supply module, and adapters to connect to compatible fetal monitors. The electrode array is sensitive to changes in the electrical activity at the skin surface due to muscle contractions, maternal, and fetal ECG when placed on the expectant mothers abdomen. These signals are passed to the device,
4
converted to a contraction curve, maternal heart rate (MHR), and fetal heart rate (FHR), and subsequently passed to the Philips monitor.
All the components of LaborView™ LV1000 Wireless Electrode System work together with the compatible fetal monitors to complete a system that can detect maternal contractions, MHR and FHR during labor. The fetal monitor, in turn, may interface to a central monitoring system in order to conveniently present contraction information to clinicians.
Indications for Use:
The LaborView™ LV1000 Wireless Electrode System is a transabdominal electromyography and electrocardiography intrapartum maternal-fetal sensor. It works non-invasively via surface electrodes on the maternal abdomen with appropriate monitors to measure fetal heart rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is indicated for use on women who are at term (>36 completed weeks), in labor, with singleton pregnancies. It is intended for use by a healthcare professional in a clinical setting.
Comparison of Intended Use and Technological Characteristics:
The following table compares the subject device to the predicate with respect to the indications for use and technological characteristics:
5
| | Predicate Device
LaborView LV1000 | Subject Device
LaborView™ LV1000 Wireless Electrode System |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K142583 | K190798 |
| Indications for
Use | LaborView LV1000 Wireless Electrode System is a transabdominal
electromyography and electrocardiography intrapartum maternal-
fetal sensor. It works non-invasively via surface electrodes on the
maternal abdomen with appropriate monitors to measure fetal heart
rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It
is indicated for use on women who are at term (>36 completed
weeks), in labor, with singleton pregnancies. It is intended for use
by a healthcare professional in a clinical setting | The LaborView™ LV1000 Wireless Electrode System is a
transabdominal electromyography and electrocardiography intrapartum
maternal-fetal sensor. It works non-invasively via surface electrodes on
the maternal abdomen with appropriate monitors to measure fetal heart
rate (FHR), uterine activity (UA), and maternal heart rate (MHR). It is
indicated for use on women who are at >36 completed weeks, in labor,
with singleton pregnancies. It is intended for use by a healthcare
professional in a clinical setting. |
| Patient
population | It is intended for use on women who are at term (>36 completed
weeks), in labor, with singleton pregnancies, using surface
electrodes on the maternal abdomen | It is intended for use on women who are at term (>36 completed weeks),
in labor, with singleton pregnancies, using surface electrodes on the
maternal abdomen |
| Prescriptive
Environments of
use | Trained medical personnel | Trained medical personnel |
| | Clinical settings | Clinical settings |
| Data collected
from sensor array | Uterine Activity (UA)
Fetal Heart rate (FHR)
Maternal Heart rate (MHR) | Uterine Activity (UA)
Fetal Heart rate (FHR)
Maternal Heart rate (MHR) |
| Components of
the "system" | Electrodes placed on abdomen (an array)
Front-end wirelessly transmit data to receiver
Back-end receiver connects to cleared fetal monitor
Monitor to process and display data* | Electrodes placed on abdomen (an array)
Front-end wirelessly transmit data to receiver
Back-end receiver connects to cleared fetal monitor
Monitor to process and display data* |
| | * Does not include the monitor | * Does not include the monitor |
| Technology of
measuring | Transabdominal electromyography and electrocardiography signals | Transabdominal electromyography and electrocardiography signals |
| Information
displayed | On graphical monitor* | On graphical monitor* |
| | *Utilizes the existing monitor to display the information | *Utilizes the existing monitor to display the information |
| Patient interface | Surface electrodes (array) -Single patient use, disposable | Surface electrodes (array) -Single patient use, disposable |
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The subject and predicate devices have the same intended use, i.e., measuring FHR, MHR, and UA. The subject and predicate devices have the same design, technology, and FHR output. They have different MHR and UA ranges. However, these differences do not raise different questions of safety and effectiveness
Non-Clinical Testing Summary:
Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:
Biocompatibility
Patient contacting components are in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
Software Verification
Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
Electrical Safety, EMC, and Wireless Capability
The subject devices were tested in compliance with the following:
- ANSI/AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for . basic safety and essential performance
- . IEC 60601-1-2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
The sponsor provided documentation and recommended testing in accordance with FDA guidance document Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff issued August 14, 2013
Performance Testing
Bench testing was performed to verify the performance to specifications of the proposed device and included the following:
- Electrode Array Verification .
- Transmitter (Front End) Verification ●
- Base Station (Back End) Verification
- Monitor Interface Cable Verification
- System Validation ●
- EC13 Compliance Verification for Maternal Heart Rate (MHR) ●
- . Comparative Testing
- Testing with compatible patient monitors
Substantial Equivalence Conclusion:
The comparison and analysis above have demonstrated that the LaborView™ LV1000 Wireless Electrode System is as safe and effective as the predicate device and supports a determination of substantial equivalence to the predicate device.