Akesis Galaxy

K190844 · Akesis, Inc. · IWB · Sep 4, 2019 · Radiology

Device Facts

• Record ID: K190844
• Device Name: Akesis Galaxy
• Applicant: Akesis, Inc.
• Product Code: IWB · Radiology
• Decision Date: Sep 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Galaxy Rotating Gamma System is a teletherapy device intended for the stereotactic irradiation of human head structures

Device Story

Akesis Galaxy is a teletherapy device for stereotactic irradiation of human head structures. System utilizes 30 Cobalt-60 sources housed in a hemispheric carrier within a shielded unit. Features a secondary collimator with 4 sizes and a block position (radiation shutter). Operation involves aligning sources to a selected collimator size; source unit and collimator rotate as a single assembly. Produces 30 non-overlapping 360° arcs to achieve high focal dose uniformity and small penumbra. System includes a y-ray treatment unit and a stereotactic localization system. Operated by clinical staff in a medical facility. Treatment bed supports 3D automated motion for patient positioning. Output is ionizing radiation for therapeutic purposes; clinical decision-making relies on precise dose delivery to target head structures. Benefits include high-precision stereotactic radiotherapy.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including biocompatibility, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and hardware/software verification and validation in accordance with FDA recognized consensus standards (ISO 13485, ISO 14971, IEC 61217, IEC 62274, IEC 62366).

Technological Characteristics

Teletherapy system using 30 Cobalt-60 sources. Hemispheric source carrier and shield. Secondary collimator with 4 sizes and block position. 3D automated patient positioning bed. Connectivity/Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 61217, IEC 62274, IEC 62366. Software level of concern: Major.

Indications for Use

Indicated for stereotactic irradiation of human head structures.

Regulatory Classification

Identification

A radionuclide radiation therapy system is a device intended to permit an operator to administer gamma radiation therapy, with the radiation source located at a distance from the patient's body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts (including beam-limiting devices), and accessories.

Predicate Devices

• OUR Rotating Gamma System (K970647)

Submission Summary (Full Text)

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September 4, 2019

Akesis Inc % Christopher Brown Director Quality Assurance and Regulatory Affairs 5129 Commercial Circle CONCORD CA 94520

Re: K190844

Trade/Device Name: Akesis Galaxy Regulation Number: 21 CFR 892.5750 Regulation Name: Radionuclide Radiation Therapy System Regulatory Class: Class II Product Code: IWB Dated: July 17, 2019 Received: July 19, 2019

Dear Christopher Brown:

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

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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 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia M. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190844

Device Name Akesis Galaxy

Indications for Use (Describe)

The Akesis Galaxy Rotating Gamma System, is a teletherapy device intended for the stereotactic irradiation of human head structures

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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# Premarket Notification [510(k)] Summary Akesis Galaxy Rotating Gamma System

The following information is provided following the format of 21 CFR 807.92.

## I. GENERAL INFORMATION

| Submitter's Name: | Akesis Inc.<br>5129 Commercial Circle<br>Concord, CA 94520 |
|-------------------|---------------------------------------------------------------------|
| Contact Name: | Christopher Brown<br>Phone: [phone]<br>Fax: [phone] |

### II. DEVICE INFORMATION

Date Prepared:

| Proprietary Name: | Akesis Galaxy |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Name: | Radionuclide radiation therapy system |
| Device Classification: | 21 CFR 892.5750 |
| Device Class: | Class II |
| Product Code: | IWB |
| Common/Usual Name: | Radionuclide radiation therapy system |
| III. PREDICATE DEVICE | OUR Rotating Gamma System (K970647) |
| IV. DEVICE DESCRIPTION | The Galaxy Rotating Gamma System is a teletherapy device which contains 30 cobalt - 60 sources distributed on a hemispheric source carrier, which is inside a hemispheric shield. Inside the source unit is the "built in" secondary collimator, which has 4 sizes of collimators and 1 block position. When not treating a patient, all sources are aligned with the block position of the secondary collimator, which in this case acts as a radiation shutter Treatment starts by aligning the sources to the desired collimator size, then both the source unit and the secondary collimator rotates as one unit. By rotating the cobalt -60 y-ray beams during treatment, 30 non overlapping full 360° arcs are formed, resulting in high focal dose uniformity and small focal spot penumbra. The entire system consists of a) The v-ray treatment unit, and b) the stereotactic localization system. |

March, 29, 2019

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| V. INTENTDED USE | The Galaxy Rotating Gamma System is a teletherapy device intended for<br>the stereotactic irradiation of human head structures |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| VI. INDICATIONS FOR USE | The Galaxy Rotating Gamma System is a teletherapy device intended for<br>the stereotactic irradiation of human head structures |

## VII. COMPARISION OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Akesis Galaxy has the same intended use, uses the same radioisotope, applies the same operating principle, has the same technical characteristics and meets the same performance specifications. Both the predicate and the Akesis Galaxy meet the same set of regulations and standards.

The following technological differences exists between the subject and the predicate device:

- -The treatment planning software has been removed
- The treatment bed / table now supports three dimensional automated motions. Previously only one- dimensional automated motions were possible.
- -Patient position accuracy is improved in the new device from 0.30mm to 0.25mm

#### VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence:

#### Biocompatibility Testing

In conformance with FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process'", there was no change biocompatibility compared to the predicate device due to the patient-contact materials used in this medical device.

#### Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and electromagnetic compatibility (EMC) testing was conducted on this medical device. The system complies with the IEC 60601-1 standards for safety and the IEC 60601-1-2 standard for EMC. Successful testing was performed in accordance with IEC standards 60601-1, 60601-1-2, 61217, 62274 and 62366.

#### Hardware and Software Verification and Validation Testing

Hardware and software verification and validation testing was conducted according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System standard, ISO 14971 Risk Management Standard and the other FDA recognized consensus standards. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.

#### Animal and Clinical Studies

Animal and clinical testing was not required.

## Summary

These tests have demonstrated that the Akesis Galaxy has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use.

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## IX. CONCLUSIONS

The Akesis Galaxy has the same intended use, fundamental scientific technology and principles of operation as the predicate device.

Use of the Akesis Galaxy does not raise any new or different issues of safety or effectiveness when compared with the predicate device.

Performance tests have demonstrated that the Akesis Galaxy has met its specifications, demonstrated substantially equivalent performance to the predicate device and is suitable for its intended use.