(340 days)
Not Found
No
The summary describes a mechanical patient positioning system with 6 degrees of freedom and mentions standard software verification and performance testing, but there is no mention of AI, ML, or related concepts like image processing for automated positioning or treatment planning.
No
The device is a patient positioning subsystem for external beam radiation delivery, not the therapy delivery device itself. Its function is to facilitate the delivery of therapy by a separate device.
No
The device is described as a patient positioning subsystem for external beam radiation therapy, facilitating precise patient positioning for treatment delivery rather than diagnosing a medical condition.
No
The device description explicitly details a physical "Patient Positioning Subsystem" with 6 degrees of freedom, indicating it is a hardware device designed for physical manipulation of a patient. While it likely includes software for control, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a "Patient Positioning Subsystem" used to "facilitate delivery of external beam radiation" by "precise positioning of human patients." It physically moves and holds the patient.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples or performing any tests on bodily fluids or tissues.
- Intended Use: The intended use is focused on patient positioning for radiation therapy, not on diagnosing or monitoring a condition through sample analysis.
Therefore, the Leo Cancer Care Patient Positioning Subsystem falls under the category of a medical device used for treatment delivery support, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.
Product codes (comma separated list FDA assigned to the subject device)
JAI
Device Description
The Leo Cancer Care (LCC) Patient Positioning Subsystem (EVE) is designed to deliver precise positioning of a patient when combined with an external Beam Therapy device, to provide the intended treatment therapy prescribed for patients requiring radiation treatments.
The Patient Positioning System has 6 degrees of freedom to provide full alignment capability for a patient treatment session, with the patient being located in an upright position. The Eve Patient Positioning Subsystem is held in a static position for the duration of the external Beam Therapy System radiation exposure. After the beam delivery has been completed, the patient positiong subsystem is then aligned to the next patient position required by the treatment system and the process repeated for the required series of different beam placements to achieve the full prescribed treatment delivery for the patient.
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
Prescription Use
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)
Design verification and performance testing were carried out in accordance with design controls of FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 risk management requirements, IEC 62304 requirements for software life-cycle processes, and FDA guidance.
Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system and system levels. Software verification testing was conducted and documented in accordance with FDA guidance for devices that pose a major level of concern (Class C per IEC 62304).
Basic safety and essential performance have been satisfied through conformance with recognized consensus standards for medical devices listed below.
No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that EVE Patient Positioner System is as safe and effective and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy:
X: ±0.3mm
Y: ±0.3mm
Z: ±0.7mm
Iso-rotation: ±0.1deg.
Pitch & Roll: ±0.5deg
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
§ 892.5770 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
May 7, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
Leo Cancer Care % Graham Lukey Regulatory Affairs Management Contractor 7921 UW Health Court MIDDLETON, WI 53562
Re: K231612
Trade/Device Name: Eve Patient Positioner System Regulation Number: 21 CFR 892.5770 Regulation Name: Powered Radiation Therapy Patient Support Assembly Regulatory Class: Class II Product Code: JAI Dated: March 29, 2024 Received: March 29, 2024
Dear Graham Lukey:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming
1
product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231612
Device Name
EVE Patient Positioner System
Indications for Use (Describe)
The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K231612
Traditional 510(k) SUMMARY Leo Cancer Care Eve Patient Positioning Subsystem
| I. | SUBMITTER | Leo Cancer Care Inc
7921 UW Health Court
Middleton WI 53562
USA |
|-----|------------------------------|------------------------------------------------------------------------------|
| | Contact: | Graham Lukey
Graham@leocancercare.com |
| | Establishment Registration # | 3017500061 |
| | 510(k) Number: | K231612 |
| | Date: | 8 September 2023 |
| II. | DEVICE | |
| | Trade Name: | Leo Cancer Care Eve Patient Positioning Subsystem |
| | Product Classification: | Class II |
| | Common Name: | Patient Positioner (for use with external Beam
Treatment delivery system) |
| | Regulation Number: | 21 CFR 892.5770 |
| | Regulation Description: | Couch, radiation therapy, powered |
III. PREDICATE
Predicate device: LEONI Orion System K160518
IV. INTENDED USE
The Leo Cancer Care Patient Positioning Subsystem is indicated for precise positioning of human patients to facilitate delivery of external beam radiation when integrated with a separate beam therapy treatment delivery device.
4
V. DEVICE DESCRIPTION
The Leo Cancer Care (LCC) Patient Positioning Subsystem (EVE) is designed to deliver precise positioning of a patient when combined with an external Beam Therapy device, to provide the intended treatment therapy prescribed for patients requiring radiation treatments.
The Patient Positioning System has 6 degrees of freedom to provide full alignment capability for a patient treatment session, with the patient being located in an upright position. The Eve Patient Positioning Subsystem is held in a static position for the duration of the external Beam Therapy System radiation exposure. After the beam delivery has been completed, the patient positiong subsystem is then aligned to the next patient position required by the treatment system and the process repeated for the required series of different beam placements to achieve the full prescribed treatment delivery for the patient.
| Characteristic | Leo Cancer Care Eve system | LEONI Orion System - K160518 |
|---|---|---|
| Intended Use | The Leo Cancer Care Patient | |
| Positioning Sub-system is | ||
| indicated for precise positioning | ||
| of human patients to facilitate | ||
| delivery of external beam | ||
| radiation when integrated with a | ||
| separate beam therapy | ||
| treatment delivery device. | The LEONI ORION System is an | |
| electro-mechanical robotic arm | ||
| for patient positioning in | ||
| radiotherapy, radiology and | ||
| other medical applications. It is | ||
| designed for positioning a | ||
| patient with a high degree of | ||
| accuracy and repeatability. | ||
| Indications for Use | The Leo Cancer Care Patient | |
| Positioning Sub-system is | ||
| indicated for precise positioning | ||
| of human patients to facilitate | ||
| delivery of external beam | ||
| radiation when integrated with a | ||
| separate beam therapy | ||
| treatment delivery device. | The LEONI ORION System is an | |
| electro-mechanical robotic arm | ||
| for patient positioning in | ||
| radiotherapy, radiology and | ||
| other medical applications. It is | ||
| designed for positioning a | ||
| patient with a high degree of | ||
| accuracy and repeatability. | ||
| Patient load (maximum) | 150 kg | 375 kg |
| Motion axis | 6 degrees of freedom | 6 degrees of freedom |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
5
| Motion drives | Computer controlled, servo
motor based multi axis motion
system. | Robotic positioning system
(Computer controlled, servo
motor system) |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Patient orientation | Chair based patient support | Patient table couch or other
approved patient support device |
| Speed | X: 0 – 50mm/sec
Y: 0 – 50mm/sec
Z: 0 – 25mm/sec
Pitch & Roll: 2 degrees per sec
360 rotation: 6 degrees per sec | 0.1 m/s and 6 degrees per sec |
| Accuracy | X: ±0.3mm
Y: ±0.3mm
Z: ±0.7mm
Iso-rotation: ±0.1deg.
Pitch & Roll: ±0.5deg | +/-0.5mm and +/- 0.2 degrees |
| Rotation | Full 360-degree rotation | Full 360-degree rotation |
| Patient support range of pitch | The backrest has 30-degrees of tilt motion in 5-degree increments | Support table has +/- 15 degrees
of pitch |
| Alignment geometry | Chair coordinate system configured relative to treatment system coordinate system requirement | Chair coordinate system configured relative to treatment system coordinate system requirement |
VII. SUMMAY OF PERFORMANCE TESTING (NON-CLINICAL)
Design verification and performance testing were carried out in accordance with design controls of FDA's Quality System Regulation (21 CFR §820.30), applicable ISO 13485 Quality Management System requirements, ISO 14971 risk management requirements, IEC 62304 requirements for software life-cycle processes, and FDA guidance1.
Non-clinical testing was performed to evaluate device performance and functionality against design and risk management requirements at sub-system and system levels. Software verification testing was conducted and documented in accordance with FDA guidance for devices that pose a major level of concern (Class C per IEC 62304).
6
Basic safety and essential performance have been satisfied through conformance with
recognized consensus standards for medical devices listed below.
| Standard | Title |
|---|---|
| ISO 14971:2019 Third | |
| Edition 2019-12 | Medical Devices - Application of risk management to medical |
| devices | |
| IEC 60601-1: Edition 3.2, | |
| 2020 | Medical electrical equipment - Part 1: General requirements |
| for basic safety and essential performance | |
| IEC 60601-1-2 | |
| Edition 4.1 (2020-09) | Medical electrical equipment - Part 1-2: General requirements |
| for basic safety and essential performance - Collateral | |
| Standard: Electromagnetic disturbances -- Requirements and | |
| tests | |
| IEC 62304:2019 | Software life-cycle processes |
| IEC 60601-1-6:2020 | |
| Edition 3.2 | Medical electrical equipment - Part 1-6: General requirements |
| for basic safety and essential performance - Collateral | |
| standard: Usability | |
| ANSI AAMI IEC 62366- | |
| 1:2020 Edition 1.1 | Medical Devices – Part 1: Application of Usability Engineering |
| to Medical Devices |
VIII. SUMMARY OF PERFORMACE TESTING (CLINICAL)
No animal or clinical tests were performed to establish substantial equivalence with the predicate device. The performance data demonstrate that EVE Patient Positioner System is as safe and effective and performs as well as the predicate device.
IX. SUBSTANTIAL EQUIVALENCE CONCLUSION
The Eve Patient Positioning System is substantially equivalent to the predicate devices in terms of intended use and technological characteristics. The devices safety and performance have been addressed by non-clinical testing in conformance with pre-determined performance criteria, FDA guidance, and recognized consensus standards.
The differences between the Eve Patient Positioning System and the predicate device raise no new efficacy or safety concerns.