(15 days)
No
The device description focuses on mechanical components for patient positioning and transport, and there is no mention of AI, ML, or image processing for analysis or decision-making.
No.
The device is described as a system for patient positioning and fixation on a treatment couch, including transportation. It does not deliver any therapy itself, but rather facilitates the patient's movement to and positioning for therapeutic treatment.
No
Explanation: The device is described as a "Patient Logistics System" for positioning and transporting patients in a radiation therapy department, including transport to diagnostic devices like CT or MR. It does not perform any diagnostic functions itself but rather facilitates the use of other diagnostic devices.
No
The device description explicitly lists multiple hardware components: Patient Table Plates, Transport Trolleys, Patient Loading Stations, and Docking Units. This indicates it is a system with significant hardware elements, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "patient positioning and fixation on the treatment couch, including transportation of the patient". This describes a device used on the patient for physical support and movement, not for testing samples from the patient (which is the core of IVD).
- Device Description: The description details components like "Patient Table Plates", "Transport Trolleys", "Patient Loading Stations", and "Docking Units". These are all physical components used for patient handling and positioning, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, assays, or any other elements typically associated with in vitro diagnostics.
- Input Imaging Modality: While it mentions input imaging modalities like CT, MR, and X-ray, these are used for guiding the positioning and treatment, not for analyzing samples in vitro.
- Predicate Devices: The predicate devices listed (PatLog 1.0, Hercules Radiation Therapy Couch, ATLAS Couch Top) are all devices related to patient positioning and treatment delivery in radiation therapy, not IVDs.
In summary, the PatLog 2.0 Patient Logistics System is a device for patient handling and positioning in a radiation therapy setting, which falls under the category of medical devices used in vivo (on the living patient), not in vitro (outside the body).
N/A
Intended Use / Indications for 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
Product codes
IYE
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified radiotherapy personnel trained in using the device.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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
i
Page: 34(46) Date: 2009-08-24
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 and | |
| ATLAS Couch Top | K950061 |
1
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 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.
2
Summary of Technological Characteristics and Intended Use
r.
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
3
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
4
Page 2 –
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
5
Indications for Use Statement
510(k) Number
Device Name
Indications for Use
PatLog 2.0.
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