System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit

Device Description

The PatLog 2.0 Patient Logistics System is a combination of separate products that together form a complete patient logistics system for a radiation therapy department. The Loading Station facilitates loading and initial setup of the patient Table Plate, the Transport Trolley provides transport from the Loading Station to diagnostic devices like CT or MR, further to the Radiation therapy treatment room and back to the Loading Station for unloading after the treatment. The Patient Table Plate is docked on the patient table bases at each unit, CT, MR or Proton Gantry, and undocked for the transport between stations with the Transport Trolley. The system has the following components: Patient Table Plates, Transport Trolleys, Patient Loading Stations, Docking Units.

AI/ML Overview

This document, a 510(k) summary for the PatLog 2.0 device, focuses on substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner typically seen for performance or diagnostic accuracy claims.

Therefore, much of the requested information regarding acceptance criteria and performance studies (e.g., sample size, data provenance, expert consensus, MRMC studies, standalone performance, training set details) is not available in the provided text. The document describes a medical device, a patient logistics system for radiotherapy, and its intended use, but it does not include a clinical performance study with specific acceptance criteria related to numerical performance metrics (like sensitivity, specificity, or accuracy) that would usually be associated with AI or diagnostic imaging devices.

The information provided primarily relates to the device's technical characteristics and its substantial equivalence to previous versions and similar devices.

Device Acceptance Criteria and Performance (Based on available information)

Since a traditional performance study comparing numerical metrics is not available, the "acceptance criteria" here refer to the substantial equivalence determination by the FDA based on the device's technological characteristics and intended use being similar to legally marketed predicate devices.

Acceptance Criteria (Implied by 510(k))	Reported Device Performance (Summary)
Technological Characteristics: Substantially similar to predicate devices.	"The technological characteristics and the intended use are substantially the same for the new PatLog 2.0 Patient Logistics System as for PatLog 1.0 and Hercules."
Intended Use: Substantially similar to predicate devices.	"System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit." (Similar to predicates).
Safety and Effectiveness: No new questions of safety or effectiveness raised compared to predicate devices.	The FDA granted 510(k) clearance, indicating a determination of substantial equivalence, which implies no new questions of safety or effectiveness.

Study Details (Based on available information)

Due to the nature of the 510(k) summary, specific details about a performance study with numerical acceptance criteria are not presented. The "study" here is essentially the 510(k) premarket notification process itself, where the manufacturer demonstrates substantial equivalence.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable/Not Provided. The document does not describe a test set or clinical study with an explicit sample size for performance evaluation. The 510(k) process relies on demonstrating equivalence to predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable/Not Provided. Ground truth establishment for a test set is not described as part of this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided. No test set or expert adjudication process is described.
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:
- No. This device is a patient logistics system, not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies for comparative effectiveness with AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable/Not Provided. The concept of "ground truth" for performance metrics in a clinical study is not detailed for this device within this document. The ground truth for regulatory clearance is the established performance and safety of the predicate devices.
The sample size for the training set:
- Not Applicable/Not Provided. The device is not an AI/ML algorithm that requires a training set in the conventional sense.
How the ground truth for the training set was established:
- Not Applicable/Not Provided. As above, no training set for an algorithm is discussed.

In summary, the provided text is a regulatory submission (510(k) summary) focused on demonstrating substantial equivalence to predicate devices, rather than a detailed report of a clinical performance study with specific numerical acceptance criteria and associated methodological details.

Summary

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ONCOlog Medical QA AB

Image /page/0/Picture/1 description: The image contains a logo with the word "ONCOlog" in a sans-serif font, with the word "MEDICAL" underneath in a smaller font. Above the word "ONCOlog" is a circular symbol divided into four equal quadrants by a cross shape. The symbol is positioned directly above the text, creating a visual association between the symbol and the company name.

'ડે TO(k) Application PatLog 2.0

Page: 34(46) Date: 2009-08-24

K092939

OCT - 9 2009

ONCOlog Medical QA AB Vallvägen 4B SE-756 $1 Uppsala Sweden TEL +46 (0) 18-19 45 65 FAX +46 (0)18-30 06 85 www.oncologmedical.com

Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Traditional 510(k) section

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMA-TION

as required by section 807.92(c)

Submitter of 510(k):

Company name: Registration number: Address:

Phone: Fax: Correspondent ONCOlog Medical QA AB 10026961 Vallvägen 4B 756 51 Uppsala Sweden (011) 4618194565 (011) 461830685 Hans Dahlin and Jan Törnqvist

New Device Name:

Trade/Proprietary Name: Common/Usual Name: Classification Name: Classification:

PatLog 2.0. Radiotherapy Patient Logistics System Medical charged-particle radiation therapy system 21 CFR 892.5050, Product Code IYE Class II

Legally Marketed Device(s)

Our new device is based on the legally marketed device cited in the table below:

Manufacturer	Device	510(k) #
ONCOlog medical QA AB	PatLog 1.0	K090044
Precision Therapy International,Precitron AB/Sweden	Hercules Radiation Therapy Couch andATLAS Couch Top	K950061

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Device description

The Patient Table Plate is docked on the patient table bases at each unit, CT, MR or Proton Gantry, and undocked for the transport between stations with the Transport Trolley.

The system has the following components:

Patient Table Plates are manufactured from radiotranslucent, non-magnetic and non-. conductive composite material to be suitable both for CT, MR, X-ray and Proton therapy. They are extremely stiff and rigid and provide very precise patient positioning and reliable support during all the procedures. They have a docking mechanism for secure and precise connection to the Docking Units on all the table bases at the diagnostic and therapy units. They also have indexing features for accurate positioning and repositioning of patient immobilization devices.
. Transport Trolleys provide easy transport between the Patient Loading Station and the different patient table bases. The trolleys are designed to hold the Patient Table Plate securely during transport and easily disconnect and reconnect at Docking Stations. The Transport Trolleys are motorized and have a steering support system to make the transport safe and easy without twitches and jerks e.g. through narrow passages.
. Patient Loading Stations speed up the patient loading process and provides a reproducible transfer of the patient from standing up to horizontal position.
. Docking Units are mounted on each of the patient table bases at CT, MR, Simulator and Proton Therapy Units. They have features for quick and secure connection of the Patient Table Plates to each one of the patient table bases. The Docking Units are custom designed for each type of device, the Patient Positioning System (PPS) on the Proton Therapy Unit and the different table bases at the CT and MR units.

Intended use

System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit

Intended User: The PatLog Patient Handling System is intended to be used by qualified radiotherapy personnel trained in using the device.

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Summary of Technological Characteristics and Intended Use

The technological characteristics and the intended use are substantially the same for the new PatLog 2.0 Patient Logistics System as for PatLog 1.0 and Hercules.

Name: Hans Dahlin Title: CEO ONCOlog Medical QA AB Uppsala, Sweden

Date

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing-like shapes, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

OCT - 9 2009

Oncolog Medical OA AB % Mr. Casev Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747

Re: K092939

Trade/Device Name: PatLog 2.0 Regulation Number: 21 CFR 892,5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 18, 2009 Received: September 24, 2009

Dear Mr. Conry:

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. 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.

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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number

Device Name

Indications for Use

PatLog 2.0.

K092939

System for patient positioning and fixation on the treatment couch, including transportation of the patient from preparation site and/or diagnostic surveys to the treatment unit

Intended User

The PatLog Patient Handling System is intended to be used by qualified radiotherapy personnel trained in using the device.

Prescription Use _ X (Part 21 CFR 801 subpart ID)

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hestelmann

(Division Sign-Off) (Division Sign-Oil)
Division of Reproductive, Abdominal, Divisioningical Devices

510(k) Number.

Page 1 of 1

Regulation Number and Section

§ 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.