(255 days)
No
The description focuses on an electromagnetic positioning system for real-time tracking of a transmitter, with no mention of AI or ML algorithms for analysis or decision-making.
No.
The device is used for patient positioning and monitoring during radiation therapy, not for treating a disease or condition itself.
No
The device is described as an "adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator." It provides "localization of a treatment isocenter" and "localization of a treatment target." This indicates a role in guiding or assisting therapy, rather than diagnosing a condition.
No
The device description explicitly mentions hardware components like a "transmitter located within one lumen of a urinary catheter" and describes the system as an "electromagnetic positioning system" that "detects the transmitter." It also mentions performance testing including "packaging, sterility, electromagnetic compatibility" and "biocompatibility," which are typically associated with hardware devices.
Based on the provided information, the RayPilot® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- RayPilot® System's Intended Use: The RayPilot® System's intended use is clearly stated as an adjunct in treatment planning and radiation therapy to align and monitor the patient's position relative to the linear accelerator. It uses a transmitter placed within the body (in a urinary catheter) to track the prostate's position in vivo.
- No Specimen Examination: The device does not involve the collection, preparation, or examination of any biological specimens from the patient. It directly interacts with the patient's body to determine the location of an internal structure.
Therefore, the RayPilot® System falls under the category of a medical device used for treatment guidance and monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RayPilot® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The RayPilot® System provides accurate, precise. and continuous localization of a treatment isocenter by using RayPilot@ HypoCath®, a transmitter located within one lumen of a urinary catheter, for prostate localization and tracking, and for automatic patient identification.
The device is limited for use to patients who both have prostate cancer and that would also be reasonably expected to require a urinary catheter for the radiation treatment, for example due to bladder outlet obstruction or patients who require a chronic indwelling Foley catheter.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The RayPilot system is designed to provide accurate, objective and continuous localization of a treatment target for patient setup before treatment and target position monitoring during radiation therapy. The RayPilot system is an electromagnetic positioning system, which detects the transmitter in the RayPilot HypoCath, placed in the prostate. The RayPilot HypoCath is removed after finalized treatment.
The RayPilot system provides objective information about the location of the treatment target in real-time in 3 dimensions. The system operator uses the information to setup the patient for treatment and to monitor the position during radiation delivery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Prostate
Indicated Patient Age Range
Not Found
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 RayPilot system have been the subject of performance testing, including design verification and validation, packaging, sterility, electromagnetic compatibility as well as other assessments to demonstrate that the system meets its intended use, is safe and effective and performs comparably to legally marketed devices. Other types of testing, such as biocompatibility and software verification and validation are performed as well.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Calypso 4D Localization system (K060906)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Silicone Foley Catheter 3-way (K063442)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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September 2, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Micropos Medical AB % Hanna Syren Director QA, Regulatory and Clinical Affairs Adolf Edelsvärds gata 11 Gothenburg, SE414 51 SWEDEN
Re: K203722
Trade/Device Name: RayPilot System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: August 2, 2021 Received: August 2, 2021
Dear Hanna Syren:
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
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
Indications for Use
510(k) Number (if known) K203722
Device Name RayPilot® System
Indications for Use (Describe)
The RayPilot® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The RayPilot® System provides accurate, precise. and continuous localization of a treatment isocenter by using RayPilot@ HypoCath®, a transmitter located within one lumen of a urinary catheter, for prostate localization and tracking, and for automatic patient identification.
The device is limited for use to patients who both have prostate cancer and that would also be reasonably expected to require a urinary catheter for the radiation treatment, for example due to bladder outlet obstruction or patients who require a chronic indwelling Foley catheter.
| 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 & Effectiveness
This 510 (k) Summary of safety and effectiveness is provided in accordance with 21 CFR 807.92.
| Date of preparation: | August 25, 2021 |
|---|---|
| Submitter information: | Micropos Medical AB |
| Adolf Edelsvärds gata 11 | |
| SE - 414 51 Gothenburg | |
| Sweden | |
| Phone: +46 31 760 80 05 | |
| Contact: | Hanna Syrén |
| Phone: +46 709 40 42 54 | |
| Device trade name: | RayPilot® system |
| Common name | Patient Localization System |
| Classification name: | Accelerator, Linear, Medical |
| Classification: | 21 CFR 892.5050 |
| Class II | |
| Product code - IYE | |
| Predicate device: | |
| Reference Device: | Calypso 4D Localization system (K060906) |
| Silicone Foley Catheter 3-way (K063442) |
Indications for use:
The RayPilot® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The RayPilot System provides accurate, precise, and continuous localization of a treatment isocenter by using RayPilot HypoCath, a transmitter located within one lumen of a urinary catheter, for prostate localization and tracking, and for automatic patient identification.
The device is limited for use to patients who both have prostate cancer and that would also be reasonably expected to require a urinary catheter for the radiation treatment, for example due to bladder outlet obstruction or patients who require a chronic indwelling Foley catheter.
Device description:
The RayPilot system is designed to provide accurate, objective and continuous localization of a treatment target for patient setup before treatment and target position monitoring during radiation therapy. The RayPilot system is an electromagnetic positioning system, which detects the transmitter in the RayPilot HypoCath, placed in the prostate. The RayPilot HypoCath is removed after finalized treatment.
4
The RayPilot system provides objective information about the location of the treatment target in real-time in 3 dimensions. The system operator uses the information to setup the patient for treatment and to monitor the position during radiation delivery.
Predicate Comparison Table:
| FEATURE AND/OR
SPECIFICATION OF
DEVICE | Varian Medical Systems Calypso 4D
Localization System (K060906) | Micropos Medical
RayPilot System |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use/
Indications for Use | The Calypso® 4D Localization System
is intended for use as an adjunct in
treatment planning and radiation
therapy, to align and monitor the
patient's position relative to the
isocenter of a linear accelerator.
The Calypso System provides accurate.
precise, and continuous localization of
a treatment isocenter by using two or
more Beacon® transponders.
Beacon transponders are indicated for
permanent implantation in the prostate
only. | The RayPilot® System with
RayPilot® HypoCath® is intended for
use as an adjunct in treatment planning
and radiation therapy, to align and
monitor the patient's position relative
to the isocenter of a linear accelerator.
The RayPilot System provides
accurate, precise, and continuous
localization of a treatment isocenter by
using RayPilot HypoCath, a
transmitter located within one lumen
of a urinary catheter, for prostate
localization and tracking, and for
automatic patient identification.
The device is limited for use to
patients who both have prostate cancer
and that also require a urinary catheter,
for example due to bladder outlet
obstruction or patients who require a
chronic indwelling Foley catheter. |
| Compatibility with
radiation therapy
environment | YES | YES |
| Compatibility with
standard carbon fiber
couch top | NO | YES |
| Used during patient set-
up | YES | YES |
| Real-time target
monitoring during
treatment | YES | YES |
| Transmitter
Technology | Nonionizing electromagnetic RF-
localization of two or more (normally
three) transponder beacons in relation
to isocenter. | Nonionizing electromagnetic (EMF)
RF-localization of one transmitter in
relation to isocenter. |
| Receiver Technology | Relation to isocenter performed with a
4D electromagnetic array located
between patient and gantry and
suspended from a movable console on
wheels | Relation to isocenter performed with a
Receiver placed under the patient and
on top of the treatment couch. |
| Receiver placement | Receiver placed between patient and
gantry | Receiver placed on the treatment
couch, underneath the patient. |
| Ceiling mounted
camera localization
system required | YES | NO |
| Localization update
frequency | 25 Hz | 30 Hz |
| Degrees of freedom
(measurement) | 3D | 3D |
| Accuracy and precision
in X, Y and Z
respectively | Sub-mm | Sub-mm |
| Patient ID | NO | YES, automatic patient ID using
transmitter ID |
| Preparations and
invasiveness | Permanent surgical implantation of two
or more Beacons before treatment | One non-permanent RayPilot
HypoCath with a transmitter within a
catheter is inserted in the urethra
before treatment, and can be used for
treatment planning without MR.
One non-permanent RayPilot
ViewCath with a radio opaque marker
is inserted in urethra at treatment
planning and used solely for planning. |
| Permanent | YES, the Beacons are implanted
permanently. | NO, the RayPilot HypoCath is
removed at completion of radiation
treatment. The RayPilot ViewCath is
removed after treatment planning
imaging. |
| Shelf life | 2 years for the Beacons, unknown for
the Calypso detector | 3 years for the RayPilot HypoCath and
RayPilot ViewCath, 5 years for the rest
of the system. |
| Sterilisation Method | Gamma radiation | EtO |
| Patient size limitation | YES
Patient size limitation due to tracking
depth cannot exceed 16 cm. | NO
Patient is lying on the Receiver, the
tracking distance (from back to
prostate) does not vary significantly
with size. |
| Patient weight
limitation | Patient with weight