(258 days)
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 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) 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 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 provided FDA 510(k) summary for the Philips Avalon CL Fetal & Maternal (F&M) Pod & Patch focuses heavily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics rather than a detailed clinical study report with specific acceptance criteria and performance metrics for the device's accuracy in monitoring FHR, MHR, and UA.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., accuracy, sensitivity, specificity, agreement with ground truth for FHR, MHR, and UA) is not explicitly detailed in this document. The document primarily discusses non-clinical tests for safety, electrical performance, and biocompatibility.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific clinical performance acceptance criteria (e.g., accuracy ranges for FHR) and reported device performance from an effectiveness standpoint. Instead, it details non-clinical technical acceptance criteria related to safety, electrical performance, and biocompatibility, which the device met.
| Criterion Category | Specific Criterion / Test | Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Met acceptance criteria as defined in test requirements | Met |
| Sensitization (ISO 10993-10) | Met acceptance criteria as defined in test requirements | Met | |
| Irritation (ISO 10993-10) | Met acceptance criteria as defined in test requirements | Met | |
| Electrical Safety | ANSI AAMI ES60601-1 | Compliance with standard for basic safety and essential performance | Passed |
| EMC/Wireless | IEC 60601-1-2 | Compliance with standard for electromagnetic disturbances | Passed |
| IEEE ANSI C63.27 | Compliance with standard for evaluation of wireless coexistence | Passed | |
| IEC/TR 60601-4-2 | Compliance with standard for electromagnetic immunity | Passed | |
| Alarm Systems | IEC 60601-1-8 | Compliance with standard for alarm systems | Passed |
| Battery Safety | IEC 62133-2 | Compliance with standard for lithium systems | Passed |
| Software/Firmware | FDA Guidance compliance | Compliance with "Content of Premarket Submissions for Device Software Functions" | Documentation provided and reviewed |
| Cybersecurity | FDA Guidance compliance | Compliance with "Cybersecurity in Medical Devices" guidance | Documentation provided and reviewed |
| Performance Bench | Inspection of labeling and pouch sealing | N/A (Visual inspection) | Met |
| Impedance/tensile strength/pull-off force/noise level/conductivity/offset voltage/defibrillation overload (new and aged patches) | Met acceptance criteria as defined in test requirements | Met | |
| In vivo testing: integrity, detachment/reattachment, and performance (impedance, noise level, MHR, conductivity) after shower and usage | Met acceptance criteria as defined in test requirements | Met | |
| Peel-off force of each electrode and central sticker | Met acceptance criteria as defined in test requirements | Met | |
| MHR/FHR/UA accuracy after storage at various temperatures | Met acceptance criteria as defined in test requirements | Met | |
| Signal transmission continuity | Met acceptance criteria as defined in test requirements | Met |
Regarding MHR/FHR/UA accuracy, the document states for "Performance Bench" that "MHR/FHR/UA accuracy after stored in room (23℃), high (32℃) and low (2-8℃) temperature" were conducted and "met the acceptance criteria as defined in the test requirements." However, the specific numerical acceptance criteria for accuracy (e.g., mean absolute difference, percentage agreement, etc.) and the reported numerical performance regarding MHR/FHR/UA accuracy are not provided in this summary. This suggests that these accuracy tests were likely bench tests under controlled conditions, not a clinical trial comparing device readings to a clinical ground truth.
2. Sample Size for Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical performance study with human subjects to evaluate the accuracy of FHR, MHR, and UA measurements. The in-vivo testing mentioned under "Performance Bench" refers only to "integrity, detachment/reattachment, and performance (impedance, noise level, MHR, conductivity) after shower and usage (8 hours/32 hours) for the patch (Novii Patch)." This does not sound like a large-scale clinical accuracy study.
Therefore, based on the provided text alone:
- Sample size for the test set: Not explicitly stated for clinical performance as commonly understood for device accuracy. The "in vivo testing" details are too limited to determine sample size or its direct relation to device accuracy claims.
- Data provenance: Not explicitly stated. The type of testing suggests it might be internal company testing rather than an independent clinical trial.
3. Number of Experts and Qualifications for Ground Truth
Given the lack of a detailed clinical performance study report, there is no information provided regarding the number or qualifications of experts used to establish ground truth for a clinical test set for FHR, MHR, or UA.
4. Adjudication Method
Again, due to the absence of a detailed clinical performance study, there is no information provided on any adjudication method (e.g., 2+1, 3+1) for a clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance in this context. This device appears to be a monitoring system for physiological parameters, not an AI-assisted diagnostic imaging or interpretation tool.
6. Standalone Performance
The device itself is a "standalone" monitoring system in the sense that it performs its measurements (aHR, aFHR, aToco) via its electrodes and pod, then relays this data to a Philips Fetal-Maternal (FM) Monitor for display. The performance tests ("Performance Bench") assess the device's ability to measure these parameters. However, the exact "standalone" clinical accuracy metrics (e.g., sensitivity, specificity, accuracy vs. a gold standard) are not provided. The phrase "standalone performance" is generally associated with diagnostic algorithms, which doesn't seem to be the primary claim here.
7. Type of Ground Truth Used
For the non-clinical performance "MHR/FHR/UA accuracy after stored in room (23℃), high (32℃) and low (2-8℃) temperature," the type of ground truth used is not specified. It likely refers to controlled laboratory measurements against calibrated reference standards, rather than clinical ground truth like pathology, expert consensus, or outcomes data. For clinical performance data (which is not detailed), common ground truths for FHR, MHR, and UA would be internal fetal monitoring (IUPC for UA, fetal scalp electrode for FHR) or expert interpretation of existing monitoring tracings (though this isn't mentioned).
8. Sample Size for the Training Set
No information is provided about a "training set." This term is typically associated with machine learning or AI algorithm development. While the device uses signal processing (template matching, filtering, confidence tagging) to identify fECG and mECG complexes, the document does not describe the development or training of such algorithms or any associated data sets used for this purpose.
9. How Ground Truth for the Training Set Was Established
As no training set is discussed, there is no information provided on how ground truth for a training set was established.
In summary, the provided FDA summary focuses on demonstrating substantial equivalence through technical and non-clinical performance and safety testing. It lacks detailed clinical performance data (e.g., accuracy, sensitivity, specificity) against a clinical ground truth, specific sample sizes for clinical evaluations, or information about expert consensus or adjudication methods for such clinical data, which are typically found in clinical study reports for devices claiming diagnostic or interpretative capabilities.
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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
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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
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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, GmbHHewlett-Packard-Strasse 2Böblingen, 71034 GermanyPhone: +49 7031 4630Fax: 07031-463 -2202FDA Registration: FDA #9610816 |
| Key Contact: | Trang AdamsRegulatory Affairs Manager (CAD MCS/OBS)trang.adams@philips.com |
| Official Correspondent: | Peng CuiPrinciple 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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| 3. Predicate Device | |||
|---|---|---|---|
| 510(k) No. | Company Name & Device Name | Product Code | |
| PredicateDevice: | K140862 | Company: GE HealthcareDevice Name: Monica Novii Wireless PatchSystem | 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 andPredicate Devices | |||
|---|---|---|---|
| Subject DeviceAvalon CL Fetal & Maternal(F&M) Pod & Patch | Predicate DeviceMonica Novii Wireless PatchSystem | Comparison | |
| K233440 | K140862 | ||
| Indications for use | The Avalon CL Fetal & Maternal(F&M) Pod & Patch is a deviceindicated for use by healthcareprofessionals in a clinical setting fornon-invasive monitoring ofmaternal heart rate (aHR), fetalheart rate (aFHR), and uterineactivity (aToco) in women who areat >36 completed weeks, in labor,with singleton pregnancy, usingsurface electrodes on the maternalabdomen. | The Monica Novii Pod is anintrapartum maternal-fetal monitorthat non-invasively measures anddisplays fetal heart rate (FHR),uterine activity (UA) and maternalheart rate (MHR). The Novii Podacquires and displays the FHRtracing from abdominal surfaceelectrodes that pick up the fetal ECG(fECG) signal. Using the samesurface electrodes, the Pod alsoacquires and displays the UA tracingfrom the uterine electromyography(EMG) signal and the MHR tracingfrom the maternal ECG signal(mECG). The Pod is indicated foruse on women who are at >36completed weeks, in labor, withsingleton pregnancies, using surfaceelectrodes on the maternal abdomen.The Novii Patch is an accessory tothe Novii Pod that connects directlyto the Novii Pod and contains thesurface electrodes that attach to theabdomen. The Novii Interface is anaccessory to the Novii Pod whichprovides a means of interfacing thewireless output of the Novii Pod to | Similar |
| the transducer inputs of a CTG Fetalmonitor. The Novii Interface enablessignals collected by the Novii Pod tobe printed and displayed on a CTGFetal Monitor and sent on to a centralnetwork, if connected. The Novii Podmaternal-fetal monitor and itsaccessories are intended for use byhealthcare professionals in a clinicalsetting | |||
| Anatomical site | Maternal abdomen | Maternal abdomen | Same |
| Measurement | Maternal Heart RateFetal Heart RateUterine Activity | Maternal Heart Rate Fetal Heart Rate Uterine Activity | Same |
| Intendedenvironments | Professional healthcare | Professional healthcare | Same |
| Target population | Women ≥ 36 gestational weeks witha singleton pregnancy | Women ≥ 36 gestational weeks witha singleton pregnancy | Same |
| Monitor Type | Electrodes - Electrical signals arepassively monitored using fiveelectrodes place on the pregnantabdomen in a fixed array. | Electrodes - Electrical signals arepassively monitored using fiveelectrodes place on the pregnantabdomen in a fixed array. | Same |
| Data transmissionwireless technology | Short-Range-Radio (SRR), range16ft (5m). The Avalon Wide RangePod is offered as an optionalaccessory to extend the Avalon CLF&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 thePod | 500 cycles/4 years | 4.7 years | Different |
| Patch size | 161mm x 190mm | 160mm x 185mm | Different |
| Measurementmethod(FHR/MHR) | Abdominal electrophysiologicalsignal and template matching,filtering and confidence tagging toidentify the fECG and mECGcomplexes from other signals andinterference/noise. R-R intervaldetection to determine FHR &Maternal HR. | Abdominal electrophysiologicalsignal and template matching,filtering and confidence tagging toidentify the fECG and mECGcomplexes from other signals andinterference/noise. R-R intervaldetection to determine FHR &Maternal HR. | Same |
| Measurementmethod (uterineactivity) | Uterine electromyography (EMG)signals to obtain uterinecontractions (aToco) | Uterine electromyography (EMG)signals to obtain uterine contractions(UA) | Same |
| Data Interface | Avalon CL Base Station (K140535)only captures measurementsreceived from the Avalon CL F&MPod and sends them to the PhilipsAvalon Fetal Monitor (FM) for | CTG Interface - capture and displaythe measurements received from theMonica Novii Pod | Different |
| display. | |||
| Charging ports | One dedicated port for the chargingof the Avalon CL F&M Pod on theAvalon CL Base Station (K140535) | Two dedicated ports for charging ofthe 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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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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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 | FDARecognition # | Title # |
|---|---|---|
| ISO 10993-5 | 2-245 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10 | 2-174 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
| ANSI AAMIES60601-1 | 19-4 | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance (IEC 60601-1:2005,MOD) |
| IEC 60601-1-2 | 19-36 | Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests |
| IEEE ANSIC63.27 | 19-29 | American National Standard for Evaluation of WirelessCoexistence |
| IEC/TR 60601-4-2 | 19-19 | Medical electrical equipment - Part 4-2: Guidance andinterpretation - Electromagnetic immunity: performance ofmedical 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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Avalon CL Fetal & Maternal (F&M) Pod & Patch
| IEC 60601-1-8 | 5-76 | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard:General requirements, tests and guidance for alarm systems inmedical 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 sealedsecondary cells, and for batteries made from them, for use inportable 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.
-
- 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
-
. Cytotoxicity (ISO 10993-5)
-
Sensitization (ISO 10993-10) ●
-
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.
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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.
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§ 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).