(274 days)
Not Found
No
The description focuses on the electro-mechanical nature and precise positioning capabilities of the robotic arm, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The Z-Robot™ is described as a patient positioning system for radiotherapy and medical imaging, designed to accurately and repeatably position a patient. It is not directly involved in treating or diagnosing a disease, but rather assists in the therapeutic or diagnostic process by accurately positioning the patient.
No
The device is described as an "electro-mechanical robotic arm for patient positioning" and focuses on "accurately position patient in radiotherapy and medical imaging." There is no indication that it analyzes or interprets patient data for diagnostic purposes.
No
The device is described as an "electro-mechanical robotic arm" and the description details its physical motion capabilities and axes, indicating it is a hardware device with integrated software for control.
Based on the provided information, the Z-Robot™ Patient Positioning System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "patient positioning in radiotherapy and medical imaging." This involves physically manipulating the patient's position, not analyzing biological samples or providing diagnostic information based on in vitro tests.
- Device Description: The description focuses on the electro-mechanical nature of the robotic arm and its ability to move and position a patient. There is no mention of analyzing samples or performing any kind of diagnostic test.
- Lack of IVD Characteristics: The document 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 diagnostic information based on laboratory tests
The Z-Robot™ is clearly a device used in conjunction with medical imaging and radiotherapy procedures, but it does not perform the diagnostic or therapeutic function itself. Its role is to facilitate these procedures by accurately positioning the patient.
N/A
Intended Use / Indications for Use
The Z-Robot™ Patient Positioning System is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
Product codes
JAI
Device Description
The Z-Robot™ Patient Positioning System (hereinafter referred to as Z-Robot™) is an electro-mechanical robotic arm with the motion capability in six degrees of freedom. These axes allow the couch to be precisely positioned translationally and rotationally within the specified movement limits. Therefore, Z-Robot™ could be used to accurately position patient in radiotherapy and medical imaging.
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
Not Found
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
A series of safety and performance tests were conducted on the subject device, Z-Robot™ Patient Positioning System.
- Reliability test
- Software Validation test
- Electromagnetic compatibility and electrical safety test
- Performance test
To ensure proper performance in this application, the design input requirements direct that the final products must demonstrate the following properties: - Speed Accuracy
- Translational Accuracy
- Rotational Accuracy
- Repeatability
All test results were acceptable per the acceptance criteria detailed in the corresponding protocol and test report. No clinical test data was used to support the decision of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Chinan Biomedical Technology, Inc. % Mr. James Chinan Chen CEO 6F., No.16, Sec.2 ,Shengyi Rd., Zhubei City Hsinchu County, 302 TAIWAN (R.O.C)
June 27, 2019
Re: K182683
Trade/Device Name: Z-Robot™ Patient Positioning System Regulation Number: 21 CFR 892.5770 Regulation Name: Powered radiation therapy patient support assembly Regulatory Class: Class II Product Code: JAI Dated: May 10, 2019 Received: May 20, 2019
Dear Mr. Chen:
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. 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 located 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.
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Traditional 510(k) Section 4 - Indications for Use Statement
Section 4
Indications for Use Statement
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Z-Robot™ Patient Positioning System
Indications for Use (Describe)
The Z-Robot™ Patient Positioning System is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
| 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) |
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4
Section 5 - 510 (k) Summary
Section 5
510(k) Summary
5
Traditional 510(k) Section 5 - 510 (k) Summary K182683
510(k) SUMMARY
| 5.1. Type of Submission: | Traditional |
|---|---|
| 5.2. Date of Summary: | Sep. 25, 2018 |
| 5.3. Submitter: | Chinan Biomedical Technology, Inc. |
| Address: | 6F., No.16, Sec. 2, Shengyi Rd., Zhubei City, |
| Hsinchu County 302, Taiwan (R.O.C.) | |
| Phone: | +886-3-5509118 |
| Contact: | James Chinan Chen (chinan777@gmail.com) |
5.4. Identification of the Device: Z-Robot™ Patient Positioning System Proprietary/Trade name: Model Name: Z-KR360 Classification Product Code: JAI Regulation Number: 892.5770 Regulation Description: Powered radiation therapy patient support assembly Review Panel: Radiology II Device Class:
ર.ડ. Identification of the Predicate Device:
| Predicate Device Name: | LEONI Orion System |
|---|---|
| Manufacturer: | LEONI CIA Cable Systems SAS |
| Classification Product Code: | JAI |
| Regulation number: | 892.5770 |
| Device Class: | II |
| 510(k) Number: | K160518 |
5.6. Intended use
The Z-Robot™ Patient Positioning System is an electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging. It is designed for positioning a patient with a high degree of accuracy and repeatability.
6
5.7. Device description
The Z-Robot™ Patient Positioning System (hereinafter referred to as Z-Robot™) is an electro-mechanical robotic arm with the motion capability in six degrees of freedom. These axes allow the couch to be precisely positioned translationally and rotationally within the specified movement limits. Therefore, Z-Robot™ could be used to accurately position patient in radiotherapy and medical imaging.
5.8. Non-clinical testing
A series of safety and performance tests were conducted on the subject device, Z-Robot™ Patient Positioning System.
- Reliability test
- · Software Validation test
- · Electromagnetic compatibility and electrical safety test The Z-Robot™ Patient Positioning System complies with IEC 60601-1 standard
- for safety.
- · Performance test
To ensure proper performance in this application, the design input requirements direct that the final products must demonstrate the following properties:
- Speed Accuracy
- Translational Accuracy -
- Rotational Accuracy
- -Repeatability
All test results were acceptable per the acceptance criteria detailed in the corresponding protocol and test report.
5.9. Clinical testing
No clinical test data was used to support the decision of substantial equivalence.
7
| Item | Subject device | Predicate device | Substantially
equivalence |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Proprietary Name | Z-Robot™ Patient Positioning
System | LEONI Orion System | - |
| Model Name | Z-KR360 | - | - |
| 510(k) No. | - | K160518 | - |
| Intended Use | The Z-Robot™ Patient
Positioning System is an
electro-mechanical robotic arm
for patient positioning in
radiotherapy and medical
imaging. It is designed for
positioning a patient with a high
degree of accuracy and
repeatability. | The LBONI Orion System is an
electro-mechanical robotic arm
for patient positioning in
radiotherapy and medical
imaging. It is designed for
positioning a patient with a high
degree of accuracy and
repeatability. | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| Payload | Rated payload of the robotic arm :
360 kg
Maximum patient weight: 180 kg | 375 kg | Differen1 |
| Accurate treatment volume | 400×1,000×500 mm | 400×1,000×500 mm | Same |
| Accuracy | ± 0.5 mm and ± 0.2° | ± 0.5 mm and ± 0.2° | Same |
| Speed | • Linear XYZ maximal medical
speed: 10 cm/s
• Linear XYZ maximum
maintenance speed: 20 cm/s
• Angular Yaw Pitch Roll
maximum medical speed: 5 °/s
• Angular Yaw Pitch Roll
maximum maintenance speed:
12 °/s | • Linear XYZ maximal medical
speed: 10 cm/s
• Linear XYZ maximum
maintenance speed: 20 cm/s
• Angular Yaw Pitch Roll
maximum medical speed: 5 °/s
• Angular Yaw Pitch Roll
maximum maintenance speed:
12 °/s | Same |
| Item | Subject device | Predicate device | Substantially
equivalence |
| Safety | | | |
| Collision detection | Detection of a 150 N force | Detection of a 150 N force | Same |
| "Overtravel" in case of
emergency stop |