(305 days)
Yes
The document explicitly states that the device uses "Artificial Intelligence powered reconstruction" and "a Convolutional Neural Networks (CNN)".
No
The device is a reconstruction software for a CT system, intended for diagnostic imaging and not for direct therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states, "These scanners are intended to be used for diagnostic imaging," referring to the CT system with Precise Image.
No
The device is described as a "reconstruction software application for a Computed Tomography X-Ray System" and is intended to be used "on a Philips whole-body computed tomography (CT) X-Ray System." While it is software, it is explicitly designed to function as a component of a larger hardware system (the CT scanner) and its performance is evaluated in the context of that system. It is not a standalone software application that operates independently of a specific hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "reconstruction software application for a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes." This describes an imaging device used for diagnostic imaging of the body, not for testing samples in vitro (outside of the body).
- Device Description: The description reinforces that it's a "reconstruction software application that may be used on a Philips whole-body computed tomography (CT) X-Ray System." Again, this is related to medical imaging of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
The device is a software application that processes data from a CT scanner to create images for diagnostic purposes. This falls under the category of medical imaging devices, not in vitro diagnostics.
No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked 'Not Found'.
Intended Use / Indications for Use
The Precise Image is a reconstruction software application for a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment supports, components and accessories. Precise Image has been evaluated and available on preselected reference protocols for adult subjects. Precise Image is not indicated for use in pediatric subjects.
The CT system with Precise Image is indicated for head, whole body and vascular X-ray Computed Tomography applications. These scanners are intended to be used for diagnostic imaging.
Precise Image uses an Artificial Intelligence powered reconstruction that is designed for low radiation dose, provides lower noise, and improves low contrast detectability.
Product codes
JAK
Device Description
The proposed Precise Image is a reconstruction software application that may be used on a Philips whole-body computed tomography (CT) X-Ray System. Precise Image is a robust reconstruction software application, utilizing technological advancements in Artificial Intelligence and a Convolutional Neural Networks (CNN), When used, Precise Image generates CT images that provides an image appearance similar to traditional FBP images while reducing dose and improving image quality.
The implemented algorithm includes 5 user-adjustable settings to match the Radiologist's preference for dose reduction and image quality.
The proposed Precise Image reconstruction has been trained on and may be used on the currently marketed predicate device Philips Incisive CT System (K180015).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Precise Image uses an Artificial Intelligence powered reconstruction that is designed for low radiation dose, provides lower noise, and improves low contrast detectability.
Precise Image is an Artificial Intelligence powered reconstruction algorithm that is designed for low radiation dose, provides low noise, and improves low contrast detectability as compared to iDose, as well as improve image appearance that more closely resembles Filtered Back Projection (FBP) at higher doses.
The proposed Precise Image is a reconstruction software application, utilizing technological advancements in Artificial Intelligence and a Convolutional Neural Networks (CNN)
Input Imaging Modality
Computed Tomography X-Ray System
Anatomical Site
head and body
head, whole body and vascular
Indicated Patient Age Range
adult subjects. Precise Image is not indicated for use in pediatric subjects.
Intended User / Care Setting
Not Found
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)
The proposed Precise Image reconstruction software application for CT Systems did not require any external clinical study. A comparative image evaluation study was performed on 55 image set pairs from Precise Image and the predicate Incisive CT and Brilliance iCT by 6 board certified radiologists to evaluate Diagnostic Confidence. Sharpness, Noise level. Image texture and Artifacts on a five point Likert scale.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
January 14, 2022
Image /page/0/Picture/1 description: The image shows 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.
Philips Medical Systems Nederland, B.V. % Michael Chilbert Regulatory Affairs Engineer Veenpluis 4-6 Best Noord-Brabant, 5684 PC NETHERLANDS
Re: K210760
Trade/Device Name: Precise Image Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: December 10, 2021 Received: December 13, 2021
Dear Mr. Michael Chilbert:
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. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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
2
Indications for Use
510(k) Number (if known) K210760
Device Name Precise Image
Indications for Use (Describe)
The Precise Image is a reconstruction software application for a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment supports, components and accessories. Precise Image has been evaluated and available on preselected reference protocols for adult subjects. Precise Image is not indicated for use in pediatric subjects.
The CT system with Precise Image is indicated for head, whole body and vascular X-ray Computed Tomography applications. These scanners are intended to be used for diagnostic imaging.
Precise Image uses an Artificial Intelligence powered reconstruction that is designed for low radiation dose, provides lower noise, and improves low contrast detectability.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
SECTION 5 510(K) SUMMARY
HA300-006-05 Revision: 01 Status: Approved Page: 1 of 5
CT/AMI
SECTION 5 510(K) SUMMARY
510(k) Summary for K210760
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared:
Manufacturer: | January 13, 2022
Philips Medical Systems Nederland B.V.
Veenpluis 6,
5684 PC BEST
The Netherlands
Establishment Registration Number: 3015777306 | |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Primary Contact
Person: | Michael Chilbert, Ph.D., P.E.
Regulatory Affairs Engineer
Phone: 440-869-4576
E-mail: Michael.chilbert@philips.com | |
| Secondary
Contact Person: | Douglas Kentz
Director of Regulatory Affairs
Phone: (262) 389-7369
E-mail: douglas.kentz@philips.com | |
| Device: | Trade Name: | Precise Image |
| | Common name: | Computed Tomography x-Ray System |
| | Classification Name: | Computed Tomography x-Ray System |
| | Classification Regulation: | 21CFR 892.1750 |
| | Classification Panel: | Radiology |
| | Device Class: | II |
| | Primary Product Code: | JAK |
| | Secondary Product Code: | Not Applicable |
| Predicate
Device: | Trade Name: | Incisive CT |
| | Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. |
| | 510(k) Clearance: | K180015 |
| | Classification Name: | Computed Tomography X-Ray System |
| | Classification Regulation: | 21CFR §892.1750 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code: | JAK |
| Reference
Device: | Trade Name: | Brilliance iCT |
| | Manufacturer: | Philips Medical Systems Nederland B.V. |
| | 510(k) Clearance: | K162838 |
| | Classification Name: | Computed Tomography X-Ray System |
| | Classification Regulation: | 21CFR §892.1750 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code: | JAK |
4
| PHILIPS
BG Diagnostic Imaging | SECTION 5
510(K) SUMMARY | HA300-006-05
Revision: 01
Status: Approved
Page: 2 of 5 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Device
Description: | The proposed Precise Image is a reconstruction software application that may be used
on a Philips whole-body computed tomography (CT) X-Ray System. Precise Image is a
robust reconstruction software application, utilizing technological advancements in
Artificial Intelligence and a Convolutional Neural Networks (CNN), When used, Precise
Image generates CT images that provides an image appearance similar to traditional
FBP images while reducing dose and improving image quality.
The implemented algorithm includes 5 user-adjustable settings to match the Radiologist's
preference for dose reduction and image quality. | |
| | The proposed Precise Image reconstruction has been trained on and may be used on the
currently marketed predicate device Philips Incisive CT System (K180015). | |
| Indications for
Use / Intended
Use: | The Precise Image is a reconstruction software application for a Computed Tomography
X-Ray System intended to produce images of the head and body by computer
reconstruction of x-ray transmission data taken at different angles and planes. These
devices may include signal analysis and display equipment, patient and equipment
supports, components and accessories. Precise Image has been evaluated and available
on preselected reference protocols for adult subjects. Precise Image is not indicated for
use in pediatric subjects. | |
| | The CT system with Precise Image is indicated for head, whole body and vascular X-ray
Computed Tomography applications. These scanners are intended to be used for
diagnostic imaging. | |
| | Precise Image uses an Artificial Intelligence powered reconstruction algorithm that is
designed for low radiation dose, provides low noise, and improves low contrast
detectability. | |
| Technological
Characteristics | The proposed Precise Image reconstruction software application, has the same
fundamental design characteristics and are based on comparable technologies found in
the currently marketed predicate device Philips Incisive CT (K180015) | |
| | This 510(k) submission addresses the following: | |
| | Precise Image is an Artificial Intelligence powered reconstruction algorithm that is
designed for low radiation dose, provides low noise, and improves low contrast
detectability as compared to iDose, as well as improve image appearance that
more closely resembles Filtered Back Projection (FBP) at higher doses.The currently marketed predicate Philips Incisive CT (K180015) is being used for
diagnostic imaging in radiology, interventional radiology and cardiology and in
oncology as part of treatment preparation and radiation therapy planning. The
fundamental scientific technology and design of the proposed Precise Image
reconstruction software application is equivalent to the currently marketed
predicate device Philips Incisive CT (K180015). | |
5
PHILIPS BG Diagnostic Imaging
SECTION 5 510(K) SUMMARY
HA300-006-05 Revision: 01 Status: Approved Page: 3 of 5
CT/AMI
| Technological Characteristics Comparison
| Design and Fundamental Scientific Technology | |||
|---|---|---|---|
| Device | Predicate Device: | ||
| Incisive CT System | |||
| (K180015) | Proposed Device: | ||
| Precise Image software | |||
| application | Conclusion | ||
| Application | Head, Body, Vascular | ||
| and Cardiac | Head, Body and Vascular | Proposed device has scan | |
| types found in the | |||
| predicate, | |||
| Scan Regime | Continuous Rotation | Continuous Rotation | Scan data used for |
| reconstruction - Identical, | |||
| Scan Field of | |||
| View | Up to 500 mm | Up to 500 mm | Identical |
| Scan modes | Surview | ||
| Axial-after-Axial | |||
| Dynamic Scan | |||
| Helical Scan | Axial-after-Axial | ||
| Helical Scan | Proposed device has scan | ||
| types found in the | |||
| predicate | |||
| Low Contrast | |||
| Resolution (20 cm | |||
| Catphan | |||
| phantom) | 4 mm @ 0.3% @ 22 mGy | ||
| CTDIvol | 5 mm @ 0.3% @ 5.5 | ||
| mGy CTDIvol | Improved, better low | ||
| contrast resolution at lower | |||
| dose levels. | |||
| Minimum Scan | |||
| Time | 0.35 sec for 360° rotation | 0.35 sec for 360° rotation | Identical |
| Noise in Standard | |||
| Mode (as | |||
| measured on | |||
| 21.6 cm water- | |||
| equivalent) | 0.27% at 27 mGY | 0.27% at 27 mGY | Identical |
| Noise Reduction | |||
| and Low Contrast | |||
| Detectability | N/A - Standard mode | ||
| (baseline for claim) | achieving up to 85% lower | ||
| noise at 80% lower dose | |||
| and 60% better low | |||
| contrast detectability | Improved, better noise | ||
| reduction and low contrast | |||
| detectability | |||
| Noise Power | |||
| Spectrum | N/A - Standard mode | ||
| (baseline for claim) | Where noise is reduced | ||
| by at least 50%, the | |||
| system shall shift the | |||
| noise power spectrum of | |||
| images by no more than | |||
| 6% as compared to the | |||
| same data reconstructed | |||
| without Precise Image | Will not shift NPS more | ||
| than 6% | |||
| Application | Head, Body, Vascular | ||
| and Cardiac | Head, Body and Vascular | Proposed device has scan | |
| types found in the | |||
| predicate. | |||
| Scan Regime | Continuous Rotation | Continuous Rotation | Scan data used for |
| reconstruction - Identical. |
Based on the information provided above, the proposed Precise Image reconstruction software application for Philips CT Systems is considered substantially equivalent to the currently marketed predicate device Philips Incisive CT (K180015), in terms of fundamental scientific technology.
6
CT/AMI
SECTION 5 510(K) SUMMARY
| Summary of
Non-Clinical
Performance
Data: | Non-clinical performance testing has been performed on the proposed Precise Image
reconstruction software application for CT Systems.
Philips CT Systems, comply with the following International and FDA recognized
consensus standards and FDA guidance document(s).
IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012
(or IEC 60601-1: 2012 reprint) (FDA Recognition Number: 19-4) IEC 60601-1-2:2014: (FDA Recognition Number :19-8) IEC 60601-1-3:2008+A1:2013 (FDA Recognition Number: 12-269) IEC 60601-1-6:2010 +A1: 2013 (FDA Recognition Number: 5-89) IEC 60601-2-44:2009/AMD2:2016 (FDA Recognition Number: 12-302) IEC 62304:2006 + A1: 2015 (FDA Recognition Number: 13-79) ISO 10993-1:2009/Cor.1:2010 (FDA Recognition Number: 2-220) ISO 14971 2nd Edition. (FDA Recognition Number: 5-40) |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device Specific Guidance Document:
Guidance for Industry and FDA Staff – Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices" (issued May 11, 2005) International and FDA-recognized consensus IEC 62304 "Medical device software
-
Software life cycle processes" (Edition 1.1, 2006). FDA/CDRH recognition
number 13-79. Proposed Regulatory Framework for Modifications to Artificial
Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device
(SaMD) Discussion Paper. (April 2, 2019) |
| | Design Verification planning and testing was conducted at the sub-system and at the
system level. The sub-systems are tested against the sub-system requirements
specifications (SSRS) and the system level verification is conducted against the system
requirement specifications (SRS). System and sub-system verification activities
demonstrate the system or sub-systems meet the established system and sub-system
level design input requirements. System and sub-system level requirements may be
verified by manual test, automated test, inspection/analysis, or any combination of the
three. Design verification also includes Image Quality verification and risk analysis/risk
mitigation testing. |
| | The traceability between the requirements, the hazard mitigations and the test protocols
are described in the Traceability Matrix. The Traceability Matrix also shows the overall test
results per requirement and per hazard mitigation. The summary and conclusion of
results are provided in the System Verification Test Report. |
| | Non-Clinical design validation testing covered the intended use and commercial claims
Validation testing included clinical image evaluation and workflow validation. |
| | All these tests were used to support substantial equivalence of the proposed Precise
Image reconstruction software application and demonstrate that the proposed Precise
Image reconstruction software application for CT Systems. | -
ç Maintains compliance with the aforementioned international and FDA-recognized consensus standards and/or FDA device specific guidance document, and;
-
. Meets the acceptance criteria and is adequate for its intended use.
7
SECTION 5 510(K) SUMMARY
Therefore, the proposed Precise Image reconstruction software application for Philips CT Systems is considered substantially equivalent to the currently marketed predicate device Philips Incisive CT (K180015) in terms of safety and effectiveness.
Summary of Clinical Performance Data:
The proposed Precise Image reconstruction software application for CT Systems did not require any external clinical study. A comparative image evaluation study was performed on 55 image set pairs from Precise Image and the predicate Incisive CT and Brilliance iCT by 6 board certified radiologists to evaluate Diagnostic Confidence. Sharpness, Noise level. lmage texture and Artifacts on a five point Likert scale. The substantial equivalence to the currently marketed predicate device Philips Incisive CT (K180015) was demonstrated with the following attributes:
- Indication for use; .
- Technological characteristics; ●
- Non-clinical and clinical performance testing; and .
- . Safety and effectiveness.
Sample clinical images are provided with this submission, which were reviewed and evaluated by certified radiologists. All images were evaluated to have good image quality.
Substantial The proposed Precise Image reconstruction software application for Philips CT Systems is substantially equivalent to the currently marketed predicate device Philips Incisive CT Equivalence (K180015) in terms of design. features and fundamental scientific technology. The Precise Conclusion: Image reconstruction software application for Philips CT Systems does not introduce any new risk nor impact safety and effectiveness.
Additionally, substantial equivalence was demonstrated by non-clinical and clinical (verification and validation) performance tests provided in this 510(k) premarket notification. These tests demonstrate that the proposed Precise Image reconstruction software application for CT Systems complies with the requirements specified by Philips Medical Systems Nederland B.V. and the international and FDA-recognized consensus standards and is as safe and effective as its currently marketed predicate device Philips Incisive CT (K180015) without raising any new safety and/or effectiveness concerns.
CT/AMI