(15 days)
Not Found
No
The description focuses on mechanical components for patient handling and transport, with no mention of AI/ML terms or functions.
No
The device is described as a "System for patient positioning and fixation on the treatment couch, including transportation of the patient," and its components are a "Patient table plate", "Docking unit", and "Transport trolley." These functions support therapy but do not directly administer or perform a therapeutic action. One of the predicate devices is also a "Radiation Therapy Couch and ATLAS Couch Top," which is a support device, not a therapeutic one itself.
No
The device is described as a "Patient Handling System" used for "patient positioning and fixation" and "transport to diagnostic devices, and/or to the treatment room." It facilitates the physical handling and movement of patients, not the diagnosis of medical conditions.
No
The device description explicitly lists hardware components: Patient table plate, Docking unit, and Transport trolley.
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.
- Device Description: The description details components like a "Patient table plate", "Docking unit", and "Transport trolley". These are all physical components for handling and positioning a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
Therefore, the PatLog Patient Handling System falls under the category of a medical device used for patient support and positioning, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
IYE
Device Description
The PatLog 1 0 Pattent Handling System is a combination of separate components that facılıtates setup of the patient on a Patıent Table Plate, transport to diagnostic devices, and/or to the treatment room and back after the treatment The Pattent Table Plate 1s docked on the patient table bases at each unt and undocked for the transport between stations with the Transport Trolley
The system consists of the following components
- Patient table plate
- Docking unit
- Transport trolley
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The PatLog Pattent Handling System is intended to be used by 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): 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.
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.
Not Found
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.
0
ંગ્રિક્ષુર્ડ
Image /page/0/Picture/3 description: The image shows a logo for a medical oncology practice. The logo consists of a stylized cross shape formed by four quadrants within a circle. Below the symbol, the word "ONCOlog" is printed in a simple, sans-serif font, with the word "MEDICAL" appearing in a smaller font size directly beneath it.
178
ONCOlog Medical QA AB Vallvägen 4B SF-756 51 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) 4618300685 Hans Dahlin and Jan Törnqvist
New Device Name:
| Trade/Proprietary Name: | PatLog 1.0. |
|---|---|
| Common/Usual Name: | Radiotherapy Patient Handling System |
| Classification Name: | Medical charged-particle radiation therapy system |
| Classification: | 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) # |
|---|---|---|
| Precision Therapy International/ | ||
| Precitron AB Sweden | Hercules Radiation Therapy Couch and | |
| ATLAS Couch Top | K950061 | |
| Philips Medical Systems North Amer- | ||
| ica Co | Intera 1.5 T MRI | K030520 |
JAN 22 2009
1
ONCOlog Medical QA AB
ן יי
14.1. Device description
The PatLog 1 0 Pattent Handling System is a combination of separate components that facılıtates setup of the patient on a Patıent Table Plate, transport to diagnostic devices, and/or to the treatment room and back after the treatment The Pattent Table Plate 1s docked on the patient table bases at each unt and undocked for the transport between stations with the Transport Trolley
The system consists of the following components
- � Patient table plate
- . Docking unit
- . Transport trolley
14.2. 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 Pattent Handling System is intended to be used by qualified radiotherapy personnel trained in using the device
14.3. Technological characteristics of the Predicate Devices
The Philips Intera MRI have a table top suitable for MR examinations - as the PatLog table top
The Hercules Radiation Therapy Couch is an electrically powered adjustable couch intended to support patients during radiation therapy The Hercules main frame consists of a T-shaped base with two vertical lifting columns The frame rests on three wheel pars, one in each comer Each wheel par consists of two driving wheels with one motor each The wheel pairs can turn freely around a vertical axis between the wheels
The Atlas couch top consists of a base section that is bolted to the consols at the lifting columns, and a top section connected to the base section with two C-arms that can be turned 270 degrees The C-arms provide a 650 mm long free opening for irradiation from any angle and have brakes for locking in the selected position
The ends of the couch have rollers for the polyester belt that supports the patient across the free ovening The roller at the base section is fixed and contains the belt drive motor The roller at the top section adjusts the tension of the belt
There are 8 automatic, 1 e computer controlled modes for Hercules The lift and the Atlas belt motions do not require computer assistance for proper function
The Hercules couch has a backup system that permits local control of the couch without use of the computer A separate battery charger transformer isolates the couch from the mans supply and provides ±18V DC to the regulators in the couch for charging the batteries The couch is powered by four 12V lead-acid batteries
2
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14.4. Summary of Technological Characteristics and Intended Use
The technological characteristics and the intended use are substantially the same for Pat-Log Pattent Handling system as for Hercules Radiation Therapy Couch and ATLAS Couch Top
Name Hans Dahlın Title CEO ONCOlog Medical QA AB Uppsala, Sweden
Date
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
: ****
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2009
ONCOlog Medical QA AB % Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc 1285 Walt Whitman Rd MELVILLE NY 11747
ಳ್ಳಿ
Re K090044
Trade/Device Name PatLog 1 0 Regulation Number 21 CFR 892 5050 Regulation Name Medical charged-particle radiation therapy system Regulatory Class II Product Code IYE Dated December 31, 2008 Received January 7, 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 regustration, 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 such 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 conceming your device in the Federal Register
4
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; 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
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter
| 21 CFR 876 xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884 xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892 xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket nottfication" (21 CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html
Sincerely yours,
Janine M. Morris
anine M. N 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 1 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 D) AND/OR Over-The-Counter Use_
(Part 21 CFR 801 subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON AÑOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tom May
(Division Sign-Off)
· vision of Reproductive, Abdominal a Radiological Devices
10(k) Number K09004
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