(258 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on electrical signal processing and radio transmission, not AI/ML algorithms.
No
The device is described as a "monitoring system" that "non-invasively measures abdominal fetal heart rate (aFHR), abdominal uterine activity (aToco), and abdominal maternal heart rate (aHR)." This indicates a diagnostic or monitoring function, not a therapeutic one (treatment or direct intervention for disease/condition).
Yes
The device is indicated for non-invasive monitoring of maternal heart rate, fetal heart rate, and uterine activity, which involves measuring physiological parameters to assess the health status of the mother and fetus. Monitoring these parameters helps healthcare professionals identify potential issues and determine appropriate interventions, fitting the definition of a diagnostic device that aids in identifying or characterizing health conditions.
No
The device description explicitly mentions hardware components: the Avalon CL Fetal & Maternal (F&M) Pod and the Avalon CL Fetal & Maternal (F&M) Patch, which are physical devices that pick up electrical signals and transmit data. The performance studies also include non-clinical tests related to hardware, such as electrical, mechanical, and thermal safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Avalon CL Fetal & Maternal (F&M) Pod & Patch is a monitoring system that non-invasively measures physiological signals (heart rate and uterine activity) from the surface of the maternal abdomen using electrodes. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "non-invasive monitoring" and describes the measurement of signals from the maternal abdomen.
Therefore, the device falls under the category of a medical device for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Avalon CL Fetal & Maternal (F&M) Pod & Patch is a device indicated for use by healthcare professionals in a clinical setting for non-invasive monitoring of maternal heart rate (aHR), fetal heart rate (aFHR), and uterine activity (aToco) in women who are at >36 completed weeks, in labor, with singleton pregnancy, using surface electrodes on the maternal abdomen.
Product codes
HGM, OSP, DRX, OUG
Device Description
The Avalon CL Fetal & Maternal (F&M) Pod and the Avalon CL Fetal & Maternal (F&M) Patch is a beltless battery-powered maternal-fetal monitoring system that non-invasively measures abdominal fetal heart rate (aFHR), abdominal uterine activity (aToco), and abdominal maternal heart rate (aHR).
The Avalon CL Fetal & Maternal (F&M) Pod & Patch is part of the Philips 'Avalon Cableless (CL) Solution' Family and consists of the following components:
- Avalon CL Fetal & Maternal (F&M) Patch (PN: 989803196341) .
- . Avalon CL Fetal & Maternal (F&M) Pod (PN: 866488)
The Avalon CL Fetal & Maternal (F&M) Patch is a single-use disposable adhesive electrode patch designed to be affixed to the maternal abdomen.
The Avalon CL Fetal & Maternal (F&M) Pod is a reusable device which, when connected to the Avalon CL Fetal & Maternal (F&M) Patch, picks up electrical signals and converts it to Short Range Radio (SRR).
The operating range is typically 'in-room', unless the subject device is used in conjunction with the Avalon CL Wide Range Pod (PN: 866487), an optional accessory.
The Avalon CL Fetal & Maternal Pod communicates the data measurement values to the Avalon CL Base Station using Short-Range Radio (SRR). The Avalon CL Base Station in turn relays the information to the connected Philips Fetal-Maternal (FM) Monitor (i.e., FM20, FM30, FM40, and FM50).
The Avalon CL Fetal & Maternal Pod's software release version is D.05.23.
The Avalon CL Fetal & Maternal Pod utilizes identical software infrastructure and radio from the cleared Philips IntelliVue CL Pods (K101600) - NiBP and SpO2 devices. The IntelliVue CL Pods have a similar purpose and are used in similar environments as the Avalon Pod.
The Avalon CL F&M Patch does not have software in a medical device (SiMD). No software resides in the Avalon CL Fetal & Maternal Patch.
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
Women who are at >36 completed weeks, in labor, with singleton pregnancy.
Intended User / Care Setting
Healthcare professionals 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 Tests - Recognized Consensus Standards: Avalon CL F&M Pod & Patch passed all safety tests for demonstrated compliance with various consensus standards (ISO 10993-5, ISO 10993-10, ANSI AAMI ES60601-1, IEC 60601-1-2, IEEE ANSI C63.27, IEC/TR 60601-4-2, IEC 60601-1-8, IEC 62133-2).
Non-Clinical Tests:
- Sterilization and Shelf Life: Sterilization is not applicable to the Avalon CL F&M Pod &Patch. The Avalon CL F&M Patch is single-use, the Pod is reusable and verified for cleaning/disinfection.
- Biocompatibility: Patient contacting components met acceptance criteria in cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10) tests.
- Software/Firmware & Cybersecurity/Interoperability: The device converts electrical signals to usable signals, relays numerical results, and utilizes identical software infrastructure and radio from cleared Philips IntelliVue CL Pods (K101600). Verification and Validation (V&V) testing conducted for safety, performance, interoperability, and effectiveness. Software documentation provided per FDA guidance (June, 2023) and cybersecurity documentation per 2023 FDA guidance.
- EMC, Wireless, Electrical, Mechanical and Thermal Safety: Subject devices met acceptance criteria per listed standards and 2022 FDA guidance.
- Performance Bench: Subject devices met acceptance criteria for various performance tests including: labelling and pouch sealing inspection, impedance/tensile strength/pull-off force/noise level/conductivity/offset voltage/defibrillation overload for new and aged patches, in vivo testing for integrity/detachment/reattachment/performance after shower and usage, peel-off force of electrodes, and MHR/FHR/UA accuracy after storage at various temperatures, signal transmission continuity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(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 on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
July 2, 2024
Philips Medizin Systeme Boeblingen GmbH Peng Cui Principal Regulatory Affairs Specialist 222 Jacobs Street Cambridge, Massachusetts 02141
Re: K233440
Trade/Device Name: Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: II Product Code: HGM, OUG, OSP, DRX Received: May 31, 2024
Dear Peng Cui:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
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 -S
Monica D. Garcia, PhD 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
3
Indications for Use
510(k) Number (if known) K233440
Device Name
Avalon CL Fetal & Maternal (F&M) Pod (866488); Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
Indications for Use (Describe)
The Avalon CL Fetal & Maternal (F&M) Pod & Patch is a device indicated for use by healthcare professionals in a clinical setting for non-invasive monitoring of maternal heart rate (aHR), fetal heart rate (aFHR), and uterine activity (aToco) in women who are at >36 completed weeks, in labor, with singleton pregnancy, using surface electrodes on the maternal abdomen.
| 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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Image /page/4/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered horizontally and there is white space above and below the word.
Traditional 510(k) 510(k) Summary
510K SUMMARY K233440
| 1. Submitter | |
|---|---|
| Date Prepared: | July 1, 2024 |
| Submitter/Owner: | Philips Medizin Systeme Böblingen, GmbH |
| Hewlett-Packard-Strasse 2 | |
| Böblingen, 71034 Germany | |
| Phone: +49 7031 4630 | |
| Fax: 07031-463 -2202 | |
| FDA Registration: FDA #9610816 | |
| Key Contact: | Trang Adams |
| Regulatory Affairs Manager (CAD MCS/OBS) | |
| trang.adams@philips.com | |
| Official Correspondent: | Peng Cui |
| Principle Regulatory Specialist (CAD MCS/OBS) | |
| peng.cui@philips.com | |
| 510(k) Submission Type: | Traditional 510(k) |
| 2. Device | |
|---|---|
| Trade Name(s): | Avalon CL Fetal & Maternal (F&M) Pod (866488) |
| Avalon CL Fetal & Maternal (F&M) Patch (989803196341) | |
| Common Name: | Fetal and Maternal monitoring- Pod & Patch |
| Regulation Name / | |
| Regulation Number: | 21 CFR 884.2740 (Perinatal monitoring system and accessories) |
| Primary Product Code: | HGM (System, Monitoring, Perinatal) |
| Secondary Product Codes: | OSP (Uterine Electromyographic Monitor) |
| DRX (Electrode, Electrocardiograph) | |
| OUG (Medical Device Data System) | |
| Regulatory Class: | Class II |
| Review Panel: | Obstetrics/Gynecology |
Image /page/4/Picture/7 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield is a white circle with two wavy lines across the middle. There are also four stars, two above the wavy lines and two below. The word "PHILIPS" is written in white at the top of the shield.
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Image /page/5/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is white.
| 3. Predicate Device | |||
|---|---|---|---|
| 510(k) No. | Company Name & Device Name | Product Code | |
| Predicate | |||
| Device: | K140862 | Company: GE Healthcare | |
| Device Name: Monica Novii Wireless Patch | |||
| System | HGM | ||
| The predicate device has not been subject to a design-related recall. |
4. Device Description [21CFR 807.92 (a) (4)]
The Avalon CL Fetal & Maternal (F&M) Pod and the Avalon CL Fetal & Maternal (F&M) Patch is a beltless battery-powered maternal-fetal monitoring system that non-invasively measures abdominal fetal heart rate (aFHR), abdominal uterine activity (aToco), and abdominal maternal heart rate (aHR).
The Avalon CL Fetal & Maternal (F&M) Pod & Patch is part of the Philips 'Avalon Cableless (CL) Solution' Family and consists of the following components:
- Avalon CL Fetal & Maternal (F&M) Patch (PN: 989803196341) .
- . Avalon CL Fetal & Maternal (F&M) Pod (PN: 866488)
The Avalon CL Fetal & Maternal (F&M) Patch is a single-use disposable adhesive electrode patch designed to be affixed to the maternal abdomen.
The Avalon CL Fetal & Maternal (F&M) Pod is a reusable device which, when connected to the Avalon CL Fetal & Maternal (F&M) Patch, picks up electrical signals and converts it to Short Range Radio (SRR).
The operating range is typically 'in-room', unless the subject device is used in conjunction with the Avalon CL Wide Range Pod (PN: 866487), an optional accessory.
The Avalon CL Fetal & Maternal Pod communicates the data measurement values to the Avalon CL Base Station using Short-Range Radio (SRR). The Avalon CL Base Station in turn relays the information to the connected Philips Fetal-Maternal (FM) Monitor (i.e., FM20, FM30, FM40, and FM50).
The Avalon CL Fetal & Maternal Pod's software release version is D.05.23.
The Avalon CL Fetal & Maternal Pod utilizes identical software infrastructure and radio from the cleared Philips IntelliVue CL Pods (K101600) - NiBP and SpO2 devices. The IntelliVue CL
Image /page/5/Picture/15 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and four stars, also in white. The logo is simple and recognizable, representing the brand's identity.
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Image /page/6/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
Avalon CL Fetal & Maternal (F&M) Pod & Patch
Pods have a similar purpose and are used in similar environments as the Avalon Pod.
The Avalon CL F&M Patch does not have software in a medical device (SiMD). No software resides in the Avalon CL Fetal & Maternal Patch.
5. Indications for Use as required per 21 CFR 807.92(a)(5)
The Avalon CL Fetal & Maternal (F&M) Pod & Patch is a device indicated for use by healthcare professionals in a clinical setting for non-invasive monitoring of maternal heart rate (aHR), fetal heart rate (aFHR), and uterine activity (aToco) in women who are at >36 completed weeks, in labor, with singleton pregnancy, using surface electrodes on the maternal abdomen.
| 6. Comparison of Intended Use and Technological Characteristics for the Subject and
| Predicate Devices | |||
|---|---|---|---|
| Subject Device | |||
| Avalon CL Fetal & Maternal | |||
| (F&M) Pod & Patch | Predicate Device | ||
| Monica Novii Wireless Patch | |||
| System | Comparison | ||
| K233440 | K140862 | ||
| Indications for use | The Avalon CL Fetal & Maternal | ||
| (F&M) Pod & Patch is a device | |||
| indicated for use by healthcare | |||
| professionals in a clinical setting for | |||
| non-invasive monitoring of | |||
| maternal heart rate (aHR), fetal | |||
| heart rate (aFHR), and uterine | |||
| activity (aToco) in women who are | |||
| at >36 completed weeks, in labor, | |||
| with singleton pregnancy, using | |||
| surface electrodes on the maternal | |||
| abdomen. | The Monica Novii Pod is an | ||
| intrapartum maternal-fetal monitor | |||
| that non-invasively measures and | |||
| displays fetal heart rate (FHR), | |||
| uterine activity (UA) and maternal | |||
| heart rate (MHR). The Novii Pod | |||
| acquires and displays the FHR | |||
| tracing from abdominal surface | |||
| electrodes that pick up the fetal ECG | |||
| (fECG) signal. Using the same | |||
| surface electrodes, the Pod also | |||
| acquires and displays the UA tracing | |||
| from the uterine electromyography | |||
| (EMG) signal and the MHR tracing | |||
| from the maternal ECG signal | |||
| (mECG). The Pod is indicated for | |||
| use on women who are at >36 | |||
| completed weeks, in labor, with | |||
| singleton pregnancies, using surface | |||
| electrodes on the maternal abdomen. | |||
| The Novii Patch is an accessory to | |||
| the Novii Pod that connects directly | |||
| to the Novii Pod and contains the | |||
| surface electrodes that attach to the | |||
| abdomen. The Novii Interface is an | |||
| accessory to the Novii Pod which | |||
| provides a means of interfacing the | |||
| wireless output of the Novii Pod to | Similar | ||
| the transducer inputs of a CTG Fetal | |||
| monitor. The Novii Interface enables | |||
| signals collected by the Novii Pod to | |||
| be printed and displayed on a CTG | |||
| Fetal Monitor and sent on to a central | |||
| network, if connected. The Novii Pod | |||
| maternal-fetal monitor and its | |||
| accessories are intended for use by | |||
| healthcare professionals in a clinical | |||
| setting | |||
| Anatomical site | Maternal abdomen | Maternal abdomen | Same |
| Measurement | Maternal Heart Rate | ||
| Fetal Heart Rate | |||
| Uterine Activity | Maternal Heart Rate Fetal Heart Rate Uterine Activity | Same | |
| Intended | |||
| environments | Professional healthcare | Professional healthcare | Same |
| Target population | Women ≥ 36 gestational weeks with | ||
| a singleton pregnancy | Women ≥ 36 gestational weeks with | ||
| a singleton pregnancy | Same | ||
| Monitor Type | Electrodes - Electrical signals are | ||
| passively monitored using five | |||
| electrodes place on the pregnant | |||
| abdomen in a fixed array. | Electrodes - Electrical signals are | ||
| passively monitored using five | |||
| electrodes place on the pregnant | |||
| abdomen in a fixed array. | Same | ||
| Data transmission | |||
| wireless technology | Short-Range-Radio (SRR), range | ||
| 16ft (5m). The Avalon Wide Range | |||
| Pod is offered as an optional | |||
| accessory to extend the Avalon CL | |||
| F&M Pod signal's range. | Bluetooth, range - 100ft (30m) | Different | |
| Power source | Battery (Li-ion battery) | Battery (Li-Po battery) | Different |
| Patch Shelf-life | 1 year | 2 year | Different |
| Use life of the | |||
| Pod | 500 cycles/4 years | 4.7 years | Different |
| Patch size | 161mm x 190mm | 160mm x 185mm | Different |
| Measurement | |||
| method | |||
| (FHR/MHR) | Abdominal electrophysiological | ||
| signal and template matching, | |||
| filtering and confidence tagging to | |||
| identify the fECG and mECG | |||
| complexes from other signals and | |||
| interference/noise. R-R interval | |||
| detection to determine FHR & | |||
| Maternal HR. | Abdominal electrophysiological | ||
| signal and template matching, | |||
| filtering and confidence tagging to | |||
| identify the fECG and mECG | |||
| complexes from other signals and | |||
| interference/noise. R-R interval | |||
| detection to determine FHR & | |||
| Maternal HR. | Same | ||
| Measurement | |||
| method (uterine | |||
| activity) | Uterine electromyography (EMG) | ||
| signals to obtain uterine | |||
| contractions (aToco) | Uterine electromyography (EMG) | ||
| signals to obtain uterine contractions | |||
| (UA) | Same | ||
| Data Interface | Avalon CL Base Station (K140535) | ||
| only captures measurements | |||
| received from the Avalon CL F&M | |||
| Pod and sends them to the Philips | |||
| Avalon Fetal Monitor (FM) for | CTG Interface - capture and display | ||
| the measurements received from the | |||
| Monica Novii Pod | Different | ||
| display. | |||
| Charging ports | One dedicated port for the charging | ||
| of the Avalon CL F&M Pod on the | |||
| Avalon CL Base Station (K140535) | Two dedicated ports for charging of | ||
| the Monica Novii Pods | Different |
Image /page/6/Picture/8 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and two four-pointed stars, also in white. The logo is simple and recognizable, representing the brand's identity.
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Image /page/7/Picture/0 description: The image contains the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. The background is plain white, which makes the blue letters stand out.
Avalon CL Fetal & Maternal (F&M) Pod & Patch
Traditional 510(k)
Image /page/7/Picture/5 description: The image shows the Philips logo. The logo is blue and white. The word "PHILIPS" is in white text at the top of the logo. Below the text is a white circle with two wavy lines and two stars inside.
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Image /page/8/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, which makes the blue letters stand out. The word is horizontally oriented and centered.
The subject and predicate devices have the same intended use, i.e., measuring FHR, MHR, and UA. The subject and predicate devices have the similar design, technology, and FHR output. They have different power sources, wireless technology, data interfaces, patch shelf-life, pod use-life and number of charging ports for pods. However, these differences do not raise different questions of safety and effectiveness.
7. Performance Data
Non-Clinical Tests - Recognized Consensus Standards
The Avalon CL F&M Pod & Patch has passed all safety tests for demonstrated compliance with the consensus standards listed below:
| Standard | FDA
Recognition # | Title # |
|------------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 10993-5 | 2-245 | Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity |
| ISO 10993-10 | 2-174 | Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization |
| ANSI AAMI
ES60601-1 | 19-4 | Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance (IEC 60601-1:2005,
MOD) |
| IEC 60601-1-2 | 19-36 | Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance - Collateral Standard:
Electromagnetic disturbances - Requirements and tests |
| IEEE ANSI
C63.27 | 19-29 | American National Standard for Evaluation of Wireless
Coexistence |
| IEC/TR 60601-4-2 | 19-19 | Medical electrical equipment - Part 4-2: Guidance and
interpretation - Electromagnetic immunity: performance of
medical electrical equipment and medical electrical systems |
Image /page/8/Picture/9 description: The image shows the Philips logo, which is a blue shield shape. Inside the shield, the word "PHILIPS" is written in white at the top. Below the text, there are two wavy lines and two four-pointed stars, also in white. The logo is simple and recognizable, representing the brand's identity.
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Image /page/9/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is plain white, which makes the blue letters stand out.
Avalon CL Fetal & Maternal (F&M) Pod & Patch
| IEC 60601-1-8 | 5-76 | Medical electrical equipment - Part 1-8: General requirements for
basic safety and essential performance - Collateral Standard:
General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems |
|---------------|-------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 62133-2 | 19-33 | Secondary cells and batteries containing alkaline or other non-
acid electrolytes - Safety requirements for portable sealed
secondary cells, and for batteries made from them, for use in
portable applications - Part 2: Lithium systems |
Non-Clinical Tests
-
- Sterilization and Shelf Life
Sterilization is not applicable to the Avalon CL F&M Pod &Patch. The subject device is not designed to be sterilized or sterilizable.
- Sterilization and Shelf Life
The Avalon CL F&M Patch is a single-use, single-patient device and is disposed of upon removal or completion of treatment. The Avalon CL F&M Pod is a reusable device that has been verified and validated (V&V) for cleaning and disinfection.
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- Biocompatibility
The patient contacting components of the subject device met the acceptance criteria as defined in the test requirements. Tests were conducted based on contact and duration, as outlined in ISO 10993-1.
- Biocompatibility
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. Cytotoxicity (ISO 10993-5)
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Sensitization (ISO 10993-10) ●
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Irritation (ISO 10993-10) ●
3. Software/Firmware & Cybersecurity/Interoperability
The GE proprietary algorithm converts the Avalon CL Fetal & Maternal (F&M) Patch's electrical signals and converts it to usable signals to the Avalon CL F&M Pod. The pod relays the numerical results (aFHR, aHR, and aToco) to the cleared Avalon CL Base Station (K140535) using the SRR Radio Transceiver & Antenna. The IEEE 802.15.4 SRR interface board contains an on-board, integrated transceiver and antenna.
The Avalon CL Fetal & Maternal Pod utilizes identical software infrastructure and radio from the cleared Intelli Vue CL Pods (K101600) - NiBP and SpO2 devices. The Intelli Vue CL Pods have a similar purpose and are used in similar environments. Additionally, the SRR technology is cleared under Philips Avalon CTS Cordless Fetal Transducer System (K023931) and Avalon CL Base Station (K140535).
Verification and Validation (V&V) testing has been conducted to ensure the safety, performance, interoperability, and effectiveness of the subject device.
Image /page/9/Picture/17 description: The image shows the Philips logo, which is a blue shield shape with the word "PHILIPS" in white at the top. Inside the shield, there are two wavy lines and two four-pointed stars. The logo is simple and recognizable, representing the brand's identity.
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Image /page/10/Picture/0 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The background is white, providing a strong contrast that makes the word stand out.
Software documentation was provided in accordance with FDA guidance document "Content of Premarket Submissions for Device Software Functions (fda.gov)" issued June, 2023.
The sponsor also provided cybersecurity documentation for the subject device per the 2023 FDA guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov)".
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- EMC, Wireless, Electrical, Mechanical and Thermal Safety
The subject devices met the acceptance criteria as defined in the test requirements per the standards listed above and 2022 FDA guidance "Electromagnetic Compatibility (EMC) of Medical Devices (fda.gov)".
- EMC, Wireless, Electrical, Mechanical and Thermal Safety
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- Performance Bench
The subject devices met the acceptance criteria as defined in the test requirements. The following performance tests were conducted for the subject device:
- Performance Bench
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Inspection of the labelling and pouch sealing (Novii Patch) ●
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Impedance/tensile strength/pull-off force/noise level/conductivity/offset ● voltage/defibrillation overload for newly manufactured and aged (12 month) patches. (Novii Patch and Avalon Patch)
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. In vivo testing: integrity, detachment/reattachment, and performance (impedance, noise level, MHR, conductivity) after shower and usage (8 hours/32 hours) for the patch (Novii Patch).
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Peel-off force of each electrode and central sticker (Novii Patch and Avalon patch).
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MHR/FHR/UA accuracy after stored in room (23℃), high (32℃) and low (2-8℃) ● temperature (Novii Patch).
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Signal transmission continuity (Avalon Pod and patch).
8. Conclusions
The non-clinical testing discussed above demonstrates that the Avalon CL Fetal & Maternal (F&M) Pod and Avalon Fetal & Maternal (F&M) Patch (Subject Device) is as safe and effective as the predicate device.
Image /page/10/Picture/17 description: The image shows the Philips logo, which is a blue shield with the word "PHILIPS" at the top. Inside the shield, there are two wavy lines and two four-pointed stars. The logo is simple and recognizable, and it is often used on Philips products and in their advertising.