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.

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.

AI/ML Overview

The provided text describes the RayPilot System, its indications for use, and a comparison to a predicate device. However, it does NOT contain the specific details about acceptance criteria, a study that proves the device meets those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results.

The document mainly includes:

A 510(k) clearance letter from the FDA.
Indications for Use for the RayPilot System.
A 510(k) Summary of Safety & Effectiveness.
A predicate comparison table between the RayPilot System and the Calypso 4D Localization System.
A brief mention of "Performance testing" which refers to design verification and validation, packaging, sterility, electromagnetic compatibility, biocompatibility, and software verification and validation, but no detailed results or methodology for these tests are provided.

Therefore, I cannot provide the requested information from the given text. The text explicitly states: "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." However, it does not provide the specifics of these tests or their results in relation to acceptance criteria.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K203722

Device Name RayPilot® System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 ABAdolf Edelsvärds gata 11SE - 414 51 GothenburgSwedenPhone: +46 31 760 80 05
Contact:	Hanna SyrénPhone: +46 709 40 42 54
Device trade name:	RayPilot® system
Common name	Patient Localization System
Classification name:	Accelerator, Linear, Medical
Classification:	21 CFR 892.5050Class IIProduct 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.

Device description:

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Predicate Comparison Table:

FEATURE AND/ORSPECIFICATION OFDEVICE	Varian Medical Systems Calypso 4DLocalization System (K060906)	Micropos MedicalRayPilot System
Intended use/Indications for Use	The Calypso® 4D Localization Systemis intended for use as an adjunct intreatment planning and radiationtherapy, to align and monitor thepatient's position relative to theisocenter of a linear accelerator.The Calypso System provides accurate.precise, and continuous localization ofa treatment isocenter by using two ormore Beacon® transponders.Beacon transponders are indicated forpermanent implantation in the prostateonly.	The RayPilot® System withRayPilot® HypoCath® is intended foruse as an adjunct in treatment planningand radiation therapy, to align andmonitor the patient's position relativeto the isocenter of a linear accelerator.The RayPilot System providesaccurate, precise, and continuouslocalization of a treatment isocenter byusing RayPilot HypoCath, atransmitter located within one lumenof a urinary catheter, for prostatelocalization and tracking, and forautomatic patient identification.The device is limited for use topatients who both have prostate cancerand that also require a urinary catheter,for example due to bladder outletobstruction or patients who require achronic indwelling Foley catheter.
Compatibility withradiation therapyenvironment	YES	YES
Compatibility withstandard carbon fibercouch top	NO	YES
Used during patient set-up	YES	YES
Real-time targetmonitoring duringtreatment	YES	YES
TransmitterTechnology	Nonionizing electromagnetic RF-localization of two or more (normallythree) transponder beacons in relationto isocenter.	Nonionizing electromagnetic (EMF)RF-localization of one transmitter inrelation to isocenter.
Receiver Technology	Relation to isocenter performed with a4D electromagnetic array locatedbetween patient and gantry andsuspended from a movable console onwheels	Relation to isocenter performed with aReceiver placed under the patient andon top of the treatment couch.
Receiver placement	Receiver placed between patient andgantry	Receiver placed on the treatmentcouch, underneath the patient.
Ceiling mountedcamera localizationsystem required	YES	NO
Localization updatefrequency	25 Hz	30 Hz
Degrees of freedom(measurement)	3D	3D
Accuracy and precisionin X, Y and Zrespectively	Sub-mm	Sub-mm
Patient ID	NO	YES, automatic patient ID usingtransmitter ID
Preparations andinvasiveness	Permanent surgical implantation of twoor more Beacons before treatment	One non-permanent RayPilotHypoCath with a transmitter within acatheter is inserted in the urethrabefore treatment, and can be used fortreatment planning without MR.One non-permanent RayPilotViewCath with a radio opaque markeris inserted in urethra at treatmentplanning and used solely for planning.
Permanent	YES, the Beacons are implantedpermanently.	NO, the RayPilot HypoCath isremoved at completion of radiationtreatment. The RayPilot ViewCath isremoved after treatment planningimaging.
Shelf life	2 years for the Beacons, unknown forthe Calypso detector	3 years for the RayPilot HypoCath andRayPilot ViewCath, 5 years for the restof the system.
Sterilisation Method	Gamma radiation	EtO
Patient size limitation	YESPatient size limitation due to trackingdepth cannot exceed 16 cm.	NOPatient is lying on the Receiver, thetracking distance (from back toprostate) does not vary significantlywith size.
Patient weightlimitation	Patient with weight < 100 kg, BMI <30 and waist/hip circumference < 100cm are eligible	Patients with weight < 135 kg areeligible
MRI Safety aftertreatment	MR conditional	MR Safe
MR Safety duringtreatment	MR conditional	RayPilot HypoCath is MR UnsafeRayPilot ViewCath is MR Safe

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Performance testing:

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

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performs comparably to legally marketed devices. Other types of testing, such as biocompatibility and software verification and validation are performed as well.

Summary of non-clinical testing:

Non-clinical testing demonstrates that the RayPilot system is safe and effective and performs comparably to legally marketed devices.

Conclusion:

The device is substantially equivalent to the predicate device listed above.

Regulation Number and Section

N/A