(115 days)
StentBoost Mobile is intended for use as a vascular x-ray interventional application. StentBoost Mobile provides high image quality visualization of stents in relation to vessels. StentBoost Mobile assists in the treatment of endovascular diseases by visualizing the placement and deployment of stents.
StentBoost Mobile is a software product (iApp) intended to provide a high-resolution visualization of stents in vessels. It supports the physician in placing and deploying stents.
Here's an analysis of the provided text regarding the acceptance criteria and study for StentBoost Mobile:
The provided text does not contain detailed acceptance criteria for specific performance metrics nor the specific study results that directly prove the device meets these criteria in a quantitative sense as might be expected for an AI/CADe device. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (StentBoost Rel. 4) through non-clinical performance testing and compliance with recognized standards.
Therefore, the table below will reflect the information that is present, noting where specific details are missing.
Acceptance Criteria and Device Performance for StentBoost Mobile
| # | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1 | Compliance with IEC 62304 Medical device software – Software life cycle processes. | "Software verification testing... has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures ... and the Privacy and Security requirements and mitigations have been implemented. Results demonstrated that all executed verification tests were passed." |
| 2 | Compliance with IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices. | "Non-clinical validation testing has been performed to validate that StentBoost Mobile conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. All these tests were used to support substantial equivalence... and demonstrate that StentBoost Mobile: complies with the aforementioned international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use." |
| 3 | Compliance with IEC 82304-1 Health software Part 1: General requirements for product safety. | "Non-clinical validation testing has been performed to validate that StentBoost Mobile conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. All these tests were used to support substantial equivalence... and demonstrate that StentBoost Mobile: complies with the aforementioned international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use." |
| 4 | Compliance with ISO 14971 Medical devices – Application of risk management to medical devices. | "Software verification testing... has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix ...have been implemented. Results demonstrated that all executed verification tests were passed." |
| 5 | Compliance with ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements. | "Non-clinical validation testing has been performed to validate that StentBoost Mobile conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. All these tests were used to support substantial equivalence... and demonstrate that StentBoost Mobile: complies with the aforementioned international and FDA-recognized consensus standards, and meets the acceptance criteria and is adequate for its intended use." |
| 6 | StentBoost Mobile conforms to its intended use, claims, user needs, effectiveness of safety measures, and instructions for use. | "Non-clinical validation testing has been performed to validate that StentBoost Mobile conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. All these tests were used to support substantial equivalence of the subject device and demonstrate that StentBoost Mobile: ...meets the acceptance criteria and is adequate for its intended use." |
| 7 | Specific quantitative performance metrics related to image quality, stent visualization, placement, and deployment accuracy (e.g., sensitivity, specificity, spatial resolution, contrast-to-noise ratio, measurement accuracy, etc.) | Not specified in the provided text. The document relies on substantial equivalence to the predicate device, StentBoost Rel. 4, stating that the fundamental scientific technology (image processing algorithm) is the same, and differences do not raise new safety or effectiveness questions. |
Additional Study Information:
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "software verification testing" and "non-clinical validation testing" but does not provide details on the number of images or cases used in these tests.
- Data Provenance: Not specified. The data types (e.g., x-ray image sequences) are implied, but their origin (country, retrospective/prospective) is not mentioned.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts & Qualifications: Not specified in the provided text. The document describes "non-clinical validation testing" and "software verification testing" but does not detail the involvement of human experts for establishing ground truth for evaluating performance. Since it's a software intended to assist physicians, the evaluation likely involves expert assessment, but the details are absent.
-
Adjudication method for the test set:
- Adjudication Method: Not specified.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The proposed StentBoost Mobile did not require clinical study since substantial equivalence to the currently marketed and predicate device StentBoost was demonstrated with the following attributes: Indication for use; Technological characteristics; Non-clinical performance testing; and Safety and effectiveness."
- Effect Size: Not applicable, as no MRMC study was performed.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: The verification and validation described are primarily focused on the software's functional and technical performance in isolation (e.g., meeting system requirements, safety measures, usability standards), rather than an explicit standalone clinical performance study in the sense of diagnostic accuracy. However, "non-clinical performance testing" refers to testing the device without human interaction, to ensure it meets technical specifications. The document implies that the device's image processing algorithm (the "fundamental scientific technology") is the same as the predicate, which had already established its standalone technical capabilities.
-
The type of ground truth used:
- Type of Ground Truth: Not explicitly stated. For the verification testing, the ground truth would be the expected output or behavior according to the System Requirements Specification and Risk Management Matrix. For the validation testing, the ground truth would be user needs, claims, and intended use as defined, which would be assessed against the software's output. Clinical-level ground truth (e.g., pathology, outcomes data, or expert consensus on stent placement accuracy in real cases) is not mentioned as part of the described studies.
-
The sample size for the training set:
- Training Set Sample Size: Not applicable. The document states that "The fundamental scientific technology provided in the subject device StentBoost Mobile and predicate device StentBoost Rel. 4 is same based on the following: Image processing algorithm." This implies that the device leverages an existing, already developed algorithm from the predicate, rather than being a newly trained AI model requiring a distinct training set. The focus is on the software's implementation on a new platform and ensuring standards compliance.
-
How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable, as there is no mention of a new training set. The device utilizes an existing algorithm.
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April 5, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Philips India Limited % Shruti Sancheti Regulatory Approbation Officer Plot No. B-79, MIDC, Phase-II, Chakan, Taluka-Khed, Village - Savardari Pune, Maharashtra 410501 INDIA
Re: K203623
Trade/Device Name: StentBoost Mobile Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, LLZ Dated: March 2, 2021 Received: March 8, 2021
Dear Shruti Sancheti:
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 Mav 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. 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
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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 (OS) 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.
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K203623
Device Name StentBoost Mobile
Indications for Use (Describe)
StentBoost Mobile is intended for use as a vascular x-ray interventional application.
StentBoost Mobile provides high image quality visualization of stents in relation to vessels.
StentBoost Mobile assists in the treatment of endovascular diseases by visualizing the placement and deployment of stents.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| For Investigative Testing/STP Validation Study | For In-Situ Testing/STP Validation Study |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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K203623 510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR $807.92.
| 21 CFR §807.92. | Date Prepared: | December 8, 2020 |
|---|---|---|
| Manufacturer: | Philips India LimitedPlot No. B-79, MIDC, Phase-II, ChakanTaluka - Khed, Village - SavardariDistrict: PuneMaharashtra 410501IndiaEstablishment Registration Number: 3010685285 | |
| Primary ContactPerson: | Shruti SanchetiRegulatory Approbation OfficerPhone: +91 9518546814E-mail: shruti.sancheti@philips.com | |
| Secondary ContactPerson: | Neena SonavaneSenior RA Manager, Q&R R&C Affairs - IGTPhone: +91 8446020023E-mail: neena.sonavane@philips.com | |
| Device: | Trade Name: | StentBoost Mobile |
| Classification Name: | Interventional fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | Radiology | |
| Regulatory Class: | Class II | |
| Product Code: | Primary Code: OWBSubsequent Codes: LLZ | |
| Predicate Device: | Trade Name: | StentBoost Rel. 4 |
| Manufacturer: | Philips Medical Systems Nederland B.V. | |
| 510(k) Clearance: | K132305 (October 30, 2013) | |
| Classification Name: | Image intensified fluoroscopic x-ray system | |
| Classification Regulation: | 21CFR §892.1650 | |
| Classification Panel: | Radiology | |
| Device Class: | Class II | |
| Product Code: | Primary Code: OWBSubsequent Code: LLZ |
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This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
StentBoost Mobile is a software product (iApp) intended to provide a high-Device description: resolution visualization of stents in vessels. It supports the physician in placing and deploying stents. Indications for Use: StentBoost Mobile is intended for use as a vascular x-ray interventional application. StentBoost Mobile provides high image quality visualization of stents in relation to vessels. StentBoost Mobile assists in the treatment of endovascular diseases by visualizing the placement and deployment of stents. The indications for use of StentBoost Mobile is a subset of StentBoost Rel. 4, as StentBoost Mobile is intended for use as a vascular application only, and, StentBoost Rel. 4 is used for vascular or cardiovascular applications. Based on the information provided above. StentBoost Mobile is considered substantially equivalent to the currently marketed and predicate device StentBoost Rel. 4 in terms of Indications for Use. Comparison of The fundamental scientific technology provided in the subject device StentBoost Technological Mobile and predicate device StentBoost Rel. 4 is same based on the following: characteristics with . Image processing algorithm: the Predicate Device: . Execution on and connection to a software hosting platform/ workstation; Transmission of 2D image sequence from a digital X-ray imaging system . to the software hosting platform; Display of image series on reference monitor screen. ● The differences between StentBoost Mobile and the predicate device are as follows: . Predicate device StentBoost Rel. 4 runs on the independent hosting software functionality platform of the currently marketed Philips Interventional Workspot (K121296), whereas, the subject device StentBoost Mobile runs on compatible platform, which is available on Philips Zenition series mobile surgery interventional X-ray systems (K183101, K183040). Change in the user interface and visualization components between the . predicate and the subject device. StentBoost Rel. 4 can be controlled from both the control room and exam . room. In the exam room. StentBoost Rel. 4 can be operated via the touchscreen module of the Allura X-ray system. On the contrary, StentBoost Mobile can be controlled only from the compatible Zenition series mobile surgery systems, via the Mobile view station, Stand user interface and/or Touch screen module (option).
The differences between the proposed StentBoost Mobile and the predicate device StentBoost rel. 4 do not raise any new questions regarding safety or
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effectiveness. Based on the information provided in this 510(k) submission, the proposed StentBoost Mobile is considered substantially equivalent to the currently marketed predicate StentBoost rel. 4 in terms of fundamental scientific technology.
Performance Data: The non-clinical performance testing has been performed on StentBoost Mobile and demonstrates compliance with the following FDA recognized consensus standards:
- . IEC 62304 Medical device software – Software life cycle processes (Edition 1.1, 2015-06). FDA/CDRH recognition number 13-79.
- . IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices (Edition 1.0, 2015-02). FDA/CDRH recognition number 5-114.
- IEC 82304-1 Health software Part 1: General requirements for product . safety (Edition 1.0 2016-10), FDA/CDRH recognition number 13-97.
- . ISO 14971 Medical devices – Application of risk management to medical devices (Edition 2.0, corrected 2007). FDA/CDRH recognition number 5-40.
- . ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Third Edition, 2016-11-01). FDA/CDRH recognition number 5-117.
Software verification testing of the functional requirements as well as performance and safety has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements and mitigations have been implemented. Results demonstrated that all executed verification tests were passed.
Non-clinical validation testing has been performed to validate that StentBoost Mobile conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use. All these tests were used to support substantial equivalence of the subject device and demonstrate that StentBoost Mobile:
- . complies with the aforementioned international and FDA-recognized consensus standards, and
- . meets the acceptance criteria and is adequate for its intended use.
Therefore, StentBoost Mobile is substantially equivalent to the predicate device StentBoost Rel. 4 in terms of safety and effectiveness.
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The proposed StentBoost Mobile did not require clinical study since substantial Clinical Performance Data: equivalence to the currently marketed and predicate device StentBoost was demonstrated with the following attributes:
- Indication for use; ●
- . Technological characteristics;
- Non-clinical performance testing; and ●
- Safety and effectiveness. .
StentBoost Mobile is substantially equivalent to the currently marketed predicate Conclusion: device StentBoost Rel. 4 (K132305) in terms of indications for use, fundamental scientific technology (image processing algorithm), and safety and effectiveness. Additionally, substantial equivalence was demonstrated by non-clinical performance tests provided in this 510(k) premarket notification. These tests demonstrate that StentBoost Mobile complies with the requirements specified in the international and FDA-recognized consensus standards and is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.