Z-Robot Patient Positioning System

K182683 · Chinan Biomedical Technology, Inc. · JAI · Jun 27, 2019 · Radiology

Device Facts

• Record ID: K182683
• Device Name: Z-Robot Patient Positioning System
• Applicant: Chinan Biomedical Technology, Inc.
• Product Code: JAI · Radiology
• Decision Date: Jun 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5770
• Device Class: Class 2

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.

Device Story

Z-Robot™ is an electro-mechanical robotic arm providing six degrees of freedom for patient positioning in radiotherapy and medical imaging. It enables precise translational and rotational movement of a patient couch. Operated by clinical staff, the device ensures high accuracy and repeatability during imaging or treatment procedures. It features collision detection (150 N force threshold) and emergency stop functionality. The system supports a maximum patient weight of 180 kg. By providing stable, accurate positioning, the device facilitates consistent delivery of radiotherapy and high-quality medical imaging, potentially improving treatment outcomes.

Clinical Evidence

No clinical data was used to support the decision of substantial equivalence. Evidence is based on bench testing, including reliability, software validation, electromagnetic compatibility, electrical safety (IEC 60601-1), and performance testing (speed, translational/rotational accuracy, and repeatability).

Technological Characteristics

Electro-mechanical robotic arm with 6 degrees of freedom. Rated payload: 360 kg. Accuracy: ± 0.5 mm and ± 0.2°. Collision detection: 150 N force. Compliance: IEC 60601-1. Connectivity/software details not specified beyond general software validation.

Indications for Use

Indicated for patient positioning in radiotherapy and medical imaging environments. Intended for use by clinical professionals in a prescription-only setting.

Regulatory Classification

Identification

A powered radiation therapy patient support assembly is an electrically powered adjustable couch intended to support a patient during radiation therapy.

Predicate Devices

• LEONI Orion System (K160518)

Submission Summary (Full Text)

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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

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803) 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 ([e-mail]) or phone [phone] 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

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Traditional 510(k) Section 4 - Indications for Use Statement

Section 4

# Indications for Use Statement

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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) | |
|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Section 5 - 510 (k) Summary

Section 5

# 510(k) Summary

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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,<br>Hsinchu County 302, Taiwan (R.O.C.) |
| Phone: | [phone] |
| Contact: | James Chinan Chen ([e-mail]) |

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.

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### 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.

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| Item | Subject device | Predicate device | Substantially<br>equivalence |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Proprietary Name | Z-Robot™ Patient Positioning<br>System | LEONI Orion System | - |
| Model Name | Z-KR360 | - | - |
| 510(k) No. | - | K160518 | - |
| Intended Use | The Z-Robot™ Patient<br>Positioning System is an<br>electro-mechanical robotic arm<br>for patient positioning in<br>radiotherapy and medical<br>imaging. It is designed for<br>positioning a patient with a high<br>degree of accuracy and<br>repeatability. | The LBONI Orion System is an<br>electro-mechanical robotic arm<br>for patient positioning in<br>radiotherapy and medical<br>imaging. It is designed for<br>positioning a patient with a high<br>degree of accuracy and<br>repeatability. | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| Payload | Rated payload of the robotic arm :<br>360 kg<br>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<br>speed: 10 cm/s<br>• Linear XYZ maximum<br>maintenance speed: 20 cm/s<br>• Angular Yaw Pitch Roll<br>maximum medical speed: 5 °/s<br>• Angular Yaw Pitch Roll<br>maximum maintenance speed:<br>12 °/s | • Linear XYZ maximal medical<br>speed: 10 cm/s<br>• Linear XYZ maximum<br>maintenance speed: 20 cm/s<br>• Angular Yaw Pitch Roll<br>maximum medical speed: 5 °/s<br>• Angular Yaw Pitch Roll<br>maximum maintenance speed:<br>12 °/s | Same |
| Item | Subject device | Predicate device | Substantially<br>equivalence |
| Safety | | | |
| Collision detection | Detection of a 150 N force | Detection of a 150 N force | Same |
| "Overtravel" in case of<br>emergency stop | <5 mm | <5 mm | Same |

#### 5.10. Substantial equivalence determination

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Different' : Different but does not impact safety and effectiveness of subject device

#### 5.11. Similarity and difference

The subject device has same intended use and similar performance as the predicate device. And the difference between the subject device and the predicate device is the payload. The subject device has undergone performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use and performance claims.

## 5.12. Conclusion

After analyzing bench tests, device description and intended use, it can be concluded that the Z-Robot™ Patient Positioning System is substantially equivalent to the predicate device.