K Number
K061713
Device Name
MAGIS1;MAGIS2
Date Cleared
2006-07-21

(32 days)

Product Code
Regulation Number
892.5050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MAGIS1 / MAGIS2 is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures
Device Description
MAGIS1 and MAGIS21 are self-supported, added-on mobile imaging systems incorporating one or two X-ray channels respectively. MAGIS is mechanically coupled to the Linac Gantry and the couch, and is capable of rotating with both. MAGIS acquires and processes stereoscopic images for deriving localization data, in the form of discrepancy between planned and actual object position. Localization methods include markers trianqulation and DRR comparisons to acquired images. MAGIS incorporates X-ray production and detection modules mounted on extension arms attached to a Ring. The ring has a bore large enough to accommodate a patient and is operable to rotate about a horizontal axis, whereas said axis is parallel to couch direction and intersecting the isocenter. MAGIS also incorporates a Console for user interface and for accommodation of the image acquisition, processing, display and user interface equipment.
More Information

Not Found

No
The summary describes image processing for localization but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.

No
The device is used to aid in patient target to radiation beam set-up for administration of radiation therapy, which is a supportive role in delivering therapeutic agents rather than being therapeutic itself.

No

The device is intended to aid in patient target to radiation beam set-up for administration of radiation therapy by acquiring and processing stereoscopic images for deriving localization data. It does not diagnose medical conditions.

No

The device description explicitly states that MAGIS is a "self-supported, added-on mobile imaging system incorporating one or two X-ray channels" and includes "X-ray production and detection modules mounted on extension arms attached to a Ring." This indicates significant hardware components beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description clearly states that MAGIS is an imaging system that uses X-rays to aid in patient positioning for radiation therapy. It acquires and processes images of the patient's body to determine their position relative to the radiation beam.
  • No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is purely based on external imaging.

Therefore, MAGIS falls under the category of a medical imaging device used for treatment planning and delivery, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

MAGIS1 / MAGIS2 intended use and indications for use are: MAGIS1 / MAGIS2 is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures

Product codes

IYE

Device Description

MAGIS1 and MAGIS21 are self-supported, added-on mobile imaging systems incorporating one or two X-ray channels respectively. MAGIS is mechanically coupled to the Linac Gantry and the couch, and is capable of rotating with both. MAGIS acquires and processes stereoscopic images for deriving localization data, in the form of discrepancy between planned and actual object position. Localization methods include markers trianqulation and DRR comparisons to acquired images.

MAGIS incorporates X-ray production and detection modules mounted on extension arms attached to a Ring. The ring has a bore large enough to accommodate a patient and is operable to rotate about a horizontal axis, whereas said axis is parallel to couch direction and intersecting the isocenter.

MAGIS also incorporates a Console for user interface and for accommodation of the image acquisition, processing, display and user interface equipment.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

all body procedures

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

MAGIS was tested according to the following standards:

  • IEC 60601-1 (1988) + A1(1991) + A2 (1995) .
  • IEC 60601-1-1 (2000) .
  • IEC 60601-1-2 (2001)+A1(2004) .
  • IEC 60601-1-3 (1994) .
  • IEC 60601-2-7 (1998) .
  • FDA CDRH 21CFR 1020.30 .
  • FDA CDRH 21CFR 1020.32 .
  • IEC 60601-1-4 (1996) + A1(1999) .

Key Metrics

Not Found

Predicate Device(s)

K052212, K040585

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

0

SECTION 5 - 510(k) SUMMARY

[Submitted pursuant to 21 CFR 807.92(a). All data included in this document are accurate and complete to the best of DSC's knowledge.]

1. Submitter Information

| Date:
Submitter: | June 8, 2006
Direx Systems Corporation
437 Turnpike Street
Canton
MA 02021 |
|--------------------------------------|----------------------------------------------------------------------------------------|
| Telephone:
Fax:
Contact Person | (339) 502-6013
(339) 502-6018
Larisa Gershtein
QA Manager |
| Contact Person e-mail address: | lgershtein@direxusa.com |
| 2. Device | |
| Trade/Proprietary Name: | MAGIS1, MAGIS2 |
| Classification Name: | Accelerator, Linear, Medical |
| Regulation Number: | 21 CFR 892.5050 |
| Regulatory Class: | Class II (special controls) |
| Product code: | 90 IYE |
| Panel: | Radiology Devices |

3. Predicate Devices

Direx Systems CorpMIGUE (K052212)
BrainLAB AGExacTrac X-Ray 6D (K040585)

1

4. Intended Use:

MAGIS1 / MAGIS2 intended use and indications for use are: MAGIS1 / MAGIS2 is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures

Kob1713

Device Description

MAGIS1 and MAGIS21 are self-supported, added-on mobile imaging systems incorporating one or two X-ray channels respectively. MAGIS is mechanically coupled to the Linac Gantry and the couch, and is capable of rotating with both. MAGIS acquires and processes stereoscopic images for deriving localization data, in the form of discrepancy between planned and actual object position. Localization methods include markers trianqulation and DRR comparisons to acquired images.

MAGIS incorporates X-ray production and detection modules mounted on extension arms attached to a Ring. The ring has a bore large enough to accommodate a patient and is operable to rotate about a horizontal axis, whereas said axis is parallel to couch direction and intersecting the isocenter.

MAGIS also incorporates a Console for user interface and for accommodation of the image acquisition, processing, display and user interface equipment.

5. Performance Testing

MAGIS was tested according to the following standards:

  • IEC 60601-1 (1988) + A1(1991) + A2 (1995) .
  • IEC 60601-1-1 (2000) .
  • IEC 60601-1-2 (2001)+A1(2004) .
  • IEC 60601-1-3 (1994) .

4 Collectively referred to as MAGIS

2

Ko61713

  • IEC 60601-2-7 (1998) .
  • FDA CDRH 21CFR 1020.30 .
  • FDA CDRH 21CFR 1020.32 .
  • IEC 60601-1-4 (1996) + A1(1999) .

6. Substantial Equivalence

MAGIS is a modification of its main predicate MIGUE (K052212). SE to BrainLAB's ExacTrac X-Ray 6D (K040585) is used for localization using DRR comparisons to acquired images.

MAGIS differences relative to its predicated devices do not raise additional safety or effectiveness issue as evidenced by performance validation.

Based on the descriptive information and the performance testing we believe that MAGIS is substantially equivalent to its predicate devices.

3

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes and two wave-like shapes at the bottom.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 1 2006

Ms. Larisa Gershtein Quality Assurance Manager Direx Systems Corporation 437 Tumpike Street CANTON MA 02021

Re: K061713

Trade/Device Name: MAGIS1 and MAGIS2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 8. 2006 Received: June 19. 2006

Dear Ms. Gershtein:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo has the letters "FDA" in a stylized font in the center. Above the letters, the numbers "1906 - 2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a dotted border with stars.

Protecting and Promoting Public Health

4

Page 2 -

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx(Gastroenterology/Renal/Urology)240-276-0115
21 CFR 884.xxx(Obstetrics/Gynecology)240-276-0115
21 CFR 894.xxx(Radiology)240-276-0120
Other240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Direx Systems Corp. The word "Direx" is in large, bold, black letters. Below "Direx" is a horizontal black line, and below that is the text "SYSTEMS CORP." in smaller, black letters. The logo is simple and professional.

SECTION 4: INDICATIONS FOR USE STATEMENT

Indications for Use Statement

510(k) Number (if known): K061713

Model Names:

MAGIS1; MAGIS2

Indications for Use:

MAGIS1; MAGIS2 is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use
(Per 21 CFR § 801.109)

OR

Over the Counter Use_ ________________________________________________________________________________________________________________________________________________________

Voucher Number

(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

437 Turnpike Street ♦ Canton, MA 02021 Phone: (339) 502-6013 ♦ Fax: (339) 502-6018 e - mailpromo@direxusa.com