(32 days)
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
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.
The provided text discusses the MAGIS1 and MAGIS2 devices for radiation therapy patient setup and their substantial equivalence to predicate devices, but it does not contain any performance testing results, acceptance criteria, or details of a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information from the given input.
The document only lists the following:
- Intended Use: Aid in patient target to radiation beam set-up for administration of radiation therapy, indicated for all body procedures.
- Device Description: Self-supported, added-on mobile imaging systems (one or two X-ray channels) that acquire and process stereoscopic images for deriving localization data (markers triangulation and DRR comparisons).
- Performance Testing List: A list of IEC and FDA standards the device was tested according to, but no results or specific acceptance criteria are provided. The standards listed are:
- 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)
- Substantial Equivalence: Claimed based on descriptive information and performance testing (without providing details of those tests).
To answer your request, a different document containing the actual performance study details would be needed.
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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, 2006Direx Systems Corporation437 Turnpike StreetCantonMA 02021 |
|---|---|
| Telephone:Fax:Contact Person | (339) 502-6013(339) 502-6018Larisa GershteinQA 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 Corp | MIGUE (K052212) |
|---|---|
| BrainLAB AG | ExacTrac X-Ray 6D (K040585) |
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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
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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.
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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
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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 |
| Other | 240-276-0100 |
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
§ 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.