(24 days)
Varian Medical System's Optical Guidance Platform (OGP) is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
The Optical Guidance Platform provides a method of positioning the patient for either radiosurgery or radiotherapy by using high precision infrared camera to detect the location of the stereotactic localization device comprised of infrared markers (either LED's or reflective markers) attached to the patient or stereotactic immobilization device. It is designed to provide patient positioning for intracranial and extracranial targets. It also provides an option for ultrasound tracking of soft tissue to more accurately define the target in extracranial radiosurgery and radiotherapy.
The provided text describes a 510(k) premarket notification for the Optical Guidance Platform and does not contain specific details about acceptance criteria, device performance results, or a study design. The document is primarily a formal notification of market clearance from the FDA, confirming substantial equivalence to predicate devices based on the indications for use.
Therefore, I cannot provide the requested information from the given text.
The text focuses on:
- Device Name: Optical Guidance Platform
- Manufacturer: Varian Medical Systems, Inc.
- Classification: Medical charged-particle radiation therapy system, Class II (21 CFR 892.5050)
- Indications for Use: Precise positioning of treatment targets for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions, used with a charged particle accelerator.
- Predicate Devices: Several SNT and other positioning systems.
- FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.
To answer your specific questions, I would need a different type of document, such as a summary of safety and effectiveness data (SSE) or the actual study report submitted to the FDA, which would detail performance testing and acceptance criteria.
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K07/360
Premarket Notification 510(k) Summary
| Submitter's Name: | Varian Medical Systems, Inc.3100 Hansen Way E-110Palo Alto, CA 94304Contact Name: Vy TranPhone: (650) 424-5731Fax: (650) 424-5040Date: May 11, 2007 | JUN - 8 2007 |
|---|---|---|
| Proprietary Name: | Optical Guidance Platform | |
| Classification Name: | Medical charged-particle radiation therapy system,21 CFR 892.5050, 90 IYE, Class II | |
| Common/Usual Name: | Optical Guidance Platform | |
| Predicate Devices: | SNT Stereotactic Localization System, K971675SNT Linac Accessories, K971893Patient Positioning System, K980750Biteblock Localization and Positioning System, K981346Head/Neck Application, K994355RadioCameras Extracranial System, K000246 | |
| Device Description: | The Optical Guidance Platform provides a method of positioning thepatient for either radiosurgery or radiotherapy by using high precisioninfrared camera to detect the location of the stereotactic localizationdevice comprised of infrared markers (either LED's or reflectivemarkers) attached to the patient or stereotactic immobilization device.It is designed to provide patient positioning for intracranial andextracranial targets. It also provides an option for ultrasound trackingof soft tissue to more accurately define the target in extracranialradiosurgery and radiotherapy. | |
| Statement ofIndications for Use: | Varian Medical System's Optical Guidance Platform (OGP) is for usewith a charged particle accelerator to perform precise positioning oftreatment target for stereotactic radiosurgery or radiotherapy treatmentson cranial or extracranial lesions. | |
| TechnologicalCharacteristics: | Refer to the Substantial Equivalence Comparison Chart. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 8 2007
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K071360
Trade/Device Name: Optical Guidance Platform Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 11, 2007 Received: May 15, 2007
Dear Ms. Tran:
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.
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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" (21CFR 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 Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K07 | 36 0
Device Name:
Indications for Use:
Varian Medical System's Optical Guidance Platform (OGP) is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices VD71360
5 1 O(k) Number
Page of
(Posted November 13, 2003)
§ 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.