(36 days)
K 100766
No
The summary describes a robotic arm for patient positioning with a focus on accuracy and repeatability, but there is no mention of AI, ML, image processing, or any data-driven learning components.
No
The device is described as a patient positioning system, a robotic arm designed to position a patient for medical procedures. It does not state that it treats, diagnoses, cures, or prevents any disease or condition, which are characteristics of a therapeutic device.
No
The device is described as a patient positioning system, a robotic arm designed for accurate and repeatable patient positioning during medical procedures. Its function is to physically manipulate the patient's position, not to diagnose a condition or disease.
No
The device description explicitly states it is a "SCARA designed robotic arm," which is a physical hardware component. The performance studies also describe testing on the "submitted device," including electromagnetic compatibility, vibration, speed, accuracy, and collision detection tests, all of which are characteristic of hardware testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to position a patient for medical procedures. This is a physical manipulation of the patient's body, not an analysis of samples taken from the body.
- Device Description: The device is a robotic arm designed for positioning. This aligns with a physical manipulation function.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device's function is to physically position a patient, which falls under the category of a medical device used in procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.
Product codes (comma separated list FDA assigned to the subject device)
JAI
Device Description
The patient positioning system is a SCARA designed robotic arm allowing six degrees of freedom.
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
oncologists and others that require a high degree of accuracy and repeatability.
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)
Nonclinical Tests:
Electromagnetic compatibility and susceptibility tests as well as surge and static tests were performed by a third party on the submitted device and all passed. Vibration tests were performed by a third party on the submitted device and passed. Speed, accuracy and collision detection tests were performed by Forte Automation and passed.
Clinical Tests:
The submitted device does not impart energies into a patient. Therefore no clinical testing was needed.
Testing Conclusions:
Forte Automation has manufactured the predicate device as well as the submitted device. All of the tests performed on the submitted device were done to the industries normal criteria and passed proving the submitted device meets or exceeds the safety and effectiveness of both of the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Passed electromagnetic compatibility and susceptibility tests, surge and static tests, vibration tests, speed, accuracy and collision detection tests.
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.
K 100766
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
§ 892.5770 Powered radiation therapy patient support assembly.
(a)
Identification. A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Forte Automation Systems. The word "FORTE" is displayed in a bold, sans-serif font at the top. Below "FORTE" is a thick, black horizontal bar with the words "AUTOMATION SYSTEMS, INC." printed in a smaller font. Underneath the bar, the word "FORTE" is repeated in a smaller, italicized font, creating a layered effect.
Forte Automation Systems, Inc.
5 510(k) Summary
1 3 2012
September 7, 2012 Submittal Date: Company Name: Forte Automation Systems, Inc. Street Address: 8155 Burden Road City, St, Zip: Machesney Park, IL 61115 Country: USA Phone: +1 (815) 633-236 00 +1 (815) 633-7131 Fax: Contact: Phil Reece Contact Title: Regulatory Manager
Device Name:
| Common Name: | Patient Positioning System |
|---|---|
| Device: | Couch, Radiation Therapy, Powered |
| Regulation Description: | Powered radiation therapy patient support assembly |
| Regulation Medical Specialty: | Radiology |
| Review Panel: | Radiology |
| Product Code: | JAI |
| Submission Type: | 510(k) |
| Regulation Number: | 892.5770 |
| Device Class: | 2 |
Device Description:
The patient positioning system is a SCARA designed robotic arm allowing six degrees of freedom.
Indications for Use:
The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.
Predicate Device:
A similar system has received Substantial Equivalence (SE) through Accuray Incorporated under number K042146 dated August 5, 2004.
1
Image /page/1/Picture/0 description: The image contains a logo for FORTE. The logo is black and white and features the word "FORTE" in large, bold letters at the top. Below "FORTE" is the text "AUTOMATION SYSTEMS INC." in smaller letters. The word "FORTE" is repeated in reverse at the bottom of the logo.
Technolgical Characteristics:
The technological differences between the predicate and the submitted devices are as follows:
| Predicate Device | Submitted Device | |
|---|---|---|
| Vertical travel | Ball screw driven | Rack and pinion driven |
| Axes 4, 5, and 6 | Belt driven | Gear driven |
| Couch top coupling | Single couch top | Multiple couch tops |
| Measuring Patient weight | N/A | Load Cell |
Figure 1 Predicate Differences
Theses changes are included in another patient positioning system device that was included as a part of different submittal K 100766 with a different intended use.
Nonclinical Tests:
Electromagnetic compatibility and susceptibility tests as well as surge and static tests were performed by a third party on the submitted device and all passed. Vibration tests were performed by a third party on the submitted device and passed. Speed, accuracy and collision detection tests were performed by Forte Automation and passed.
Clinical Tests:
The submitted device does not impart energies into a patient. Therefore no clinical testing was needed.
Testing Conclusions:
Forte Automation has manufactured the predicate device as well as the submitted device. All of the tests performed on the submitted device were done to the industries normal criteria and passed proving the submitted device meets or exceeds the safety and effectiveness of both of the predicates.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
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
SEP 13 2012
Mr. Phil Reece Regulatory Manager Forte Automation Systems. Inc. 8155 Burden Road MACHESNEY PARK IL 61115
Re: K122413
Trade/Device Name: Patient Positioning System (PPS) Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: II " 您 Product Code: JAI Dated: August 3, 2012 Received: August 8, 2012
Dear Mr. Reece:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass slavou in the extrebute) is the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1576) 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). alla Cosmette Act (1101) that ao not required to the general controls provisions of the Act. The T ou may, dicierore, market als 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 class II (Special Controls), it may be subject to such If your device is classified (see as regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Flease of advised that I Dri 3 issuance or a subscribe complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any rederal statutes and regulations and uncluding, but not limited to: registration and listing (21 Comply with an the Act 3 requirements, artical device reporting (reporting (reporting of
3
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
4 Indications for Use Statement
510(k) Number if Known:
Unknown K122413
Device Name:
Patient Positioning System (PPS)
Indications for Use:
The patient positioning system is a SCARA designed robotic arm designed to position a patient for medical procedures prescribed by oncologists and others that require a high degree of accuracy and repeatability.
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (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)
Michael D'Orten
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