(199 days)
Yes
The device description explicitly states that "Precise position adopts the AI algorithm (Convolution Neural Network)".
No
The device is described as an optional feature to assist users in positioning patients for CT scans, specifically mentioning that it reduces patient position time and improves positioning accuracy and consistency. It does not exert any direct therapeutic effect on the patient.
No
The device is described as an "optional feature to assist user for position the patient before the body examination such as CT scan" and its purpose is "to reduce the patient position time". It provides visual images and assists with patient orientation, surview range recommendation, and automatic centering of patient anatomy, but it does not diagnose medical conditions.
No
The device description explicitly states that Precise Position includes a camera with both color and depth function, which is a hardware component.
Based on the provided information, the Precise Position device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Precise Position's Function: The Precise Position device's intended use and description clearly state its purpose is to assist in the physical positioning of the patient on a CT scanner table before the scan takes place. It uses a camera and AI to identify patient orientation, recommend scan ranges, and center the patient anatomy.
- No Specimen Analysis: The device does not interact with or analyze any biological specimens from the patient. It works externally to the patient's body to facilitate the imaging process.
Therefore, while it is a medical device used in a clinical setting, its function falls outside the scope of In Vitro Diagnostics.
No
The document states "Not Found" for "Control Plan Authorized (PCCP) and relevant text," indicating no explicit clearance or approval of a PCCP.
Intended Use / Indications for Use
The Precise Position is intended for use with Philips Incisive CT systems. The following guided workflow.
- Patient orientation identification
- · Surview range recommendation
- · Automatic centering the patient anatomy
- · Provide visual images of patient on the table
Precise position is indicated for use for CT imaging of the head, chest, abdomen, pelvis, and combination of those anatomies.
Patient population limitation: Patient younger than 16 years are not supported.
Product codes
JAK
Device Description
Precise Position is an optional feature to assist user for position the patient before the body examination such as CT scan. The purpose of this feature is to reduce the patient position time via the camera detection and calculation result. It includes automatic detect patient orientation, patient anatomy scan range and center of patient anatomy.
Precise Position including a camera with both color and depth function is installed in the ceiling of the scan room, in such a way to cover the entire patient on the patient table. The camera control and image data transmit via the high speed fiber and copper hybrid USB cable. The power supply of the camera is from the gantry.
Precise position adopts the AI algorithm (Convolution Neural Network) to detect the joints of the patient body, and then identify surview start/end position and patient orientation. The algorithm can also support detect center of patient anatomy.
Limitation for Precise Position
There is no limitation for Precise Position except below items:
• Patients below the age of 16 are not supported.
• Decubitus orientations are not supported.
The Precise Position display results may get affected by the following conditions:
• When the patient is covered by sheet, blanket etc.,
• When the patient is not completely covered by the ceiling camera view, e.g. blocked by the gantry or out of camera's FOV etc.
• When the patient is wearing clothes that reflects light, e.g. plastic-like clothes.
• When the patient is wearing black clothes.
• When the patient is wearing thick clothes.
• When there are other people around the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Precise position adopts the AI algorithm (Convolution Neural Network) to detect the joints of the patient body, and then identify surview start/end position and patient orientation. The algorithm can also support detect center of patient anatomy.
Precise position adopt the AI algorithm (Convolution Neural Network) to detect the joints of the patient body automatically, and then automatic detect surview start/end position, center of patient anatomy and patient orientation.
Input Imaging Modality
Not Found
Anatomical Site
head, chest, abdomen, pelvis, and combination of those anatomies
Indicated Patient Age Range
Patient younger than 16 years are not supported.
More than 16 years old.
Intended User / Care Setting
Hospitals, outpatient clinics, research institutions, and other clinical facilities.
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
Precise Position is evaluation covered total 80 clinical scan positions in which 40 cases used with Precise Position and another 40 cases without the usage of Precise Position in order to meet the sample size calculation of 40 cases performed average on a CT scanner per day.
The thorough clinical evaluation of this feature is done by 5 Clinical experts.
The testing did not deliver radiation to volunteers as Precise Position is only for supporting the positioning of the patient for the localization radiograph and therefore “radiation" was not required for those volunteers.
The clinical evaluation was done with 3 major objectives as follows,
To calculate the time saved per surview planning with and without Precise Position.
To calculate the accuracy of vertical (iso)center positioning and Surview (horizontal) start /end position with and without Precise Position
Intra operator consistency in positioning the patient and surview scan range
The summary of clinical evaluation testing was clearly demonstrating the objectives in terms of user benefits as shown below
Average Time taken to position without Precise Position and with Precise Position is recorded. Time at user select the patient from Gantry Panel, to time when user pressed Go button from Gantry Panel is measured and concluded that up to 23% time reduction in patient positioning achieved with “Precise Positioning workflow”.
The average offset in mm for vertical (iso) center position among 5 operators without Precise Position and with Precise Position is recorded and results shown that with "Precise Position" the vertical position accuracy is increased up to 50%.
Standard deviation in mm for vertical (iso)center positioning & Surview (horizontal) start position among 5 operators without Precise Position and with Precise Position is recorded and results shown up to 70% increase in Vertical and horizontal position consistency with Precise Position.
Overall, the Precise Position Clinical Review Report. (Appendix_007) concluded that Philips Incisive CT systems with Precise Position, under normal condition of use, perform as intended, are safe for its intended use and have a favorable benefit-risk ratio. Further clinical investigations are not necessary, as sufficient evidence exists to support these conclusions.
Key Metrics
Time reduction in patient positioning: up to 23%
Vertical position accuracy: increased up to 50%
Vertical and horizontal position consistency (Standard deviation): increased up to 70%
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
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Philips Healthcare (Suzhou) Co., Ltd. % Shiguang An Advanced Regulatory Engineer No. 258, Zhong Yuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 CHINA
Re: K203514
Trade/Device Name: Precise Position Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 19, 2021 Received: May 19, 2021
Dear Shiguang An:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
June 17, 2021
1
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.
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K203514
Device Name
Precise Position
Indications for Use (Describe)
The Precise Position is intended for use with Philips Incisive CT systems. The following guided workflow.
- Patient orientation identification
- · Surview range recommendation
- · Automatic centering the patient anatomy
- · Provide visual images of patient on the table
Precise position is indicated for use for CT imaging of the head, chest, abdomen, pelvis, and combination of those anatomies.
Patient population limitation: Patient younger than 16 years are not supported.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.
| Date Prepared: | November 18, 2020 |
|---|---|
| Manufacturer: | Philips Healthcare (Suzhou) Co., Ltd. |
| No. 258, ZhongYuan Road, Suzhou Industrial Park, 215024 | |
| Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA | |
| Establishment Registration Number: 3009529630 | |
| Primary Contact | |
| Person: | Shiguang An |
| Advanced Regulatory Engineer | |
| Phone: +86-13940106467 | |
| E-mail: shiguang.an@philips.com | |
| Secondary Contact | |
| Person: | Erhong Wang |
| Senior Regulatory Affairs Manager | |
| Phone: +86-13021019589 | |
| E-mail: erhong.wang@philips.com | |
| Device Name: | Precise position |
| Classification: | Classification Name |
| Computed tomography x-ray system | |
| Classification Regulation: | |
| 21CFR §892.1750 | |
| Classification Panel: | |
| Radiology | |
| Device Class: | |
| Class II | |
| Primary product code: | |
| JAK | |
| Predicate Device: | Trade Name: |
| Philips Incisive CT | |
| Manufacturer: | |
| Philips Healthcare (Suzhou) Co., Ltd. | |
| 510(k) Clearance: | |
| K180015-March 20, 2018 | |
| Classification Regulation: | |
| 21 CFR, Part 892.1750 | |
| Classification Name: | |
| Computed tomography x-ray system | |
| Classification Panel: | |
| Radiology | |
| Device Class: | |
| Class II | |
| Product Code | |
| JAK | |
| Reference Device: | Manufacturer: |
| Auto Positioning | |
| GE Hangwei Medical System | |
| Co., Ltd. | |
| 510(k) Clearance: | K192956 (January 16, 2020) |
| Classification Regulation: | 21 CFR, Part 892.1750 |
| Classification Name: | Computed tomography x-ray |
| system | |
| Classification Panel: | Radiology |
| Device Class: | Class II |
| Product Code | JAK |
4
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 and takes up most of the frame. The background is white.
| Device
description: | Precise Position is an optional feature to assist user for position the
patient before the body examination such as CT scan. The purpose
of this feature is to reduce the patient position time via the camera
detection and calculation result. It includes automatic detect patient
orientation, patient anatomy scan range and center of patient
anatomy. |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Precise Position including a camera with both color and depth
function is installed in the ceiling of the scan room, in such a way
to cover the entire patient on the patient table. The camera control
and image data transmit via the high speed fiber and copper hybrid
USB cable. The power supply of the camera is from the gantry.
Precise position adopts the AI algorithm (Convolution Neural
Network) to detect the joints of the patient body, and then identify
surview start/end position and patient orientation. The algorithm
can also support detect center of patient anatomy. |
| | Limitation for Precise Position
There is no limitation for Precise Position except below items:
• Patients below the age of 16 are not supported.
• Decubitus orientations are not supported. |
| | The Precise Position display results may get affected by the
following conditions:
• When the patient is covered by sheet, blanket etc.,
• When the patient is not completely covered by the ceiling camera
view, e.g. blocked by the gantry or out of camera's FOV etc.
• When the patient is wearing clothes that reflects light, e.g. plastic-
like clothes.
• When the patient is wearing black clothes.
• When the patient is wearing thick clothes.
• When there are other people around the patient. |
5
Image /page/5/Picture/0 description: The image contains the words "Traditional 510(k)". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Traditional" appearing first, followed by "510(k)".
Image /page/5/Picture/1 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.
| Indications for Use: | The Precise Position is intended for use with Philips Incisive CT systems. The device provides the following guided workflow.
Patient orientation identification Surview range recommendation Automatic centering the patient anatomy Provide visual images of patient on the table Precise position is indicated for use for CT imaging of the head, chest, abdomen, pelvis, and combination of those anatomies.
Patient population limitation: Patient younger than 16 years are not supported. |
| ---------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
6
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| Fundamental
scientific
technology: | Based on the information provided above, the precise position is
considered substantially equivalent to the primary currently
marketed and predicate device Philips Incisive CT (K180015,
20/March/2018) in terms of fundamental scientific technology. | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Attribute | Predicate Device
Philips Incisive CT
(K180015) | Proposed Device Precise
Position |
| | Patient
positioning
workflow | Manually position
the patient via the
couch motion button
and laser. Normally,
need several round
adjustments by user. | Precise position provides
the auto workflow to set
the surview start/end
position, center of patient
anatomy, and patient
orientation. |
| | Detection
algorithm | The manual
workflow does not
need special
algorithm. | Precise position adopt the
AI algorithm (Convolution
Neural Network) to detect
the joints of the patient
body automatically, and
then automatic detect
surview start/end position,
center of patient anatomy
and patient orientation. |
| | Hardware
need to
support the
patient
positioning | Manual patient
positioning does not
need any unique
hardware except
traditional exiting
hardware on the CT
or other system.
Exiting hardware
includes table
motion button
(in/out, up/down) on
gantry panel or
CTBOX, lasers and
etc. | Precision position feature
need color and depth
camera, high speed USB
transmission cable, and
power cable, and relative
the enhanced workflow.
The tradition exiting
patient positioning
hardware still be available
for user all the time, it is
convenient to switch
between the camera
automatically detecting
mode and manual mode. |
| | Patient
population | All ages | More than 16 years old. |
| | Environment
of use | Hospitals, outpatient
clinics, research
institutions, and
other clinical
facilities. | Hospitals, outpatient
clinics, research
institutions, and other
clinical facilities. |
| Summary of Non-
Clinical | The Precise Position complies with the following international and
FDA-recognized consensus standards: | | |
7
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| Performance data: | • AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012
(Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements. For Basic Safety and Essential Performance (IEC 60601-1:2012, MOD).
FDA/CDRH recognition number 19-4
• IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance -- Collateral standard: Electromagnetic disturbances - Requirements and tests.
FDA/CDRH recognition number 19-8
• ISO 14971 Medical devices – Application of risk management to medical devices. FDA/CDRH recognition number 5-40.
• IEC 62304:2015, Medical device software -- Software life cycle processes
FDA/CDRH recognition number 13-79
There are no risks identified in risk management documentation that require clinical data for the purpose of clinical evaluation; Risk Management Plan as Appendix 001, Risk Management Report as Appendix 002, and Risk Management Matrix as Appendix 003 of Precise Position.
There are no clinical risks identified by the evaluated clinical data.
Sufficient evidence is available to demonstrate the ability of Precise Position achieve the intended performances during normal condition of use.
Full consistency exists between the state-of-the-art, the evaluated data, the risk management documentation and the information materials supplied.
Therefore, the Precise Position is substantially equivalent to the primary currently marketed and predicate device (K180015, 20/March/2018) in terms of safety and effectiveness. |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Clinical Data: | Precise Position is evaluation covered total 80 clinical scan positions in which 40 cases used with Precise Position and another 40 cases without the usage of Precise Position in order to meet the sample size calculation of 40 cases performed average on a CT scanner per day.
The thorough clinical evaluation of this feature is done by 5 Clinical experts.
The testing did not deliver radiation to volunteers as Precise Position is only for supporting the positioning of the patient for the localization radiograph and therefore “radiation" was not required for those volunteers. |
| | |
| | The clinical evaluation was done with 3 major objectives as follows, |
| | To calculate the time saved per surview planning with and without |
| | Precise Position. |
| | To calculate the accuracy of vertical (iso)center positioning and |
| | Surview (horizontal) start /end position with and without Precise
Position |
| | Intra operator consistency in positioning the patient and surview scan
range |
| | The summary of clinical evaluation testing was clearly demonstrating
the objectives in terms of user benefits as shown below
Average Time taken to position without Precise Position and with
Precise Position is recorded. Time at user select the patient from
Gantry Panel, to time when user pressed Go button from Gantry Panel
is measured and concluded that up to 23% time reduction in patient
positioning achieved with “Precise Positioning workflow”. |
| | The average offset in mm for vertical (iso) center position among 5
operators without Precise Position and with Precise Position is
recorded and results shown that with "Precise Position" the vertical
position accuracy is increased up to 50%. |
| | Standard deviation in mm for vertical (iso)center positioning &
Surview (horizontal) start position among 5 operators without Precise
Position and with Precise Position is recorded and results shown up to
70% increase in Vertical and horizontal position consistency with
Precise Position. |
| | Overall, the Precise Position Clinical Review Report. (Appendix_007)
concluded that Philips Incisive CT systems with Precise Position,
under normal condition of use, perform as intended, are safe for its
intended use and have a favorable benefit-risk ratio. Further clinical
investigations are not necessary, as sufficient evidence exists to
support these conclusions. |
| Substantial | The Precise Position is substantially equivalent to the primary |
| Equivalence | currently marketed and predicate device (K180015, 20/March/2018) in |
| Conclusion: | terms of design features, fundamental scientific technology, |
| | indications for use, and safety and effectiveness. Additionally, |
| | substantial equivalence was demonstrated with non-clinical |
| | performance tests, which complied with the requirements specified in |
| | the international and FDA-recognized consensus standards, IEC 62304 |
| | and ISO 14971. The results of these tests demonstrate that Precise |
| | Position met the acceptance criteria and is adequate for this intended |
| | use. |
8
Traditional 510(k)
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