(62 days)
No
The summary describes a computer-controlled electromechanical system for brachytherapy and does not mention AI or ML capabilities. While it mentions "Radiological Image Processing System," this alone does not confirm AI/ML use.
Yes
The device is used for high dose rate brachytherapy, which is a treatment for both benign and malignant diseases, indicating its therapeutic purpose.
No
The device is described as a high dose rate afterloader system used for delivering brachytherapy treatment, not for diagnosing conditions. Its purpose is to place an irradiated seed for treatment, not to identify or characterize disease.
No
The device description explicitly states it is a "computer controlled remote electro/mechanical system" used for placing a cable with an iridium seed, indicating it includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for delivering radiation therapy (brachytherapy) directly to a tumor or tumor bed within the body. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a system for placing a radioactive source internally or close to a tumor. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The focus is on delivering treatment.
- Radiological Image Processing: While image processing is mentioned, it's likely used for treatment planning and guidance, which is common for therapeutic devices, not for in vitro diagnosis.
In summary, the device's function is to treat disease by delivering radiation, which falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GammaMedplus iX Series is computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specified clinical purpose in a patient.
The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes ) from the Afterloader into needles or applicators within or on the patient.
The length of time and position that the High Dose Rate source spends within the needle or applicator is controlled in accordance with an Irradiation Treatment Prescription.
Both the GammaMedplus iX and GammaMedplus 3/24 iX are indicated, in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote controlled high dose rate brachytherapy for conditions anywhere in the body when brachytherapy treatment is indicated.
Product codes
JAQ
Device Description
The GammaMedplus iX Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 24 channels.
Hardware Platform and Operating System
The console control application runs on validated PCs under a Microsoft®1 windows operating system. The firmware controlling the High Dose Rate Afterloader runs on an embedded Intel 8085 processor. In addition, embedded processors, both based on the Intel 8051, control the afterloaders control desk and its junction interface box.
Peripherals and Accessories
The iX Series control console provides real time information of wire position and system status and interfaces with a printer in order to provide a hard copy of a treatment prescriptions and delivery records. In addition the iX Series control console can receive treatment plans from a treatment planning application (not part of this submission), this information is transferred either manually using a USB2 drive, or via a network interface.
Mentions image processing
Radiological Image Processing System
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anywhere in the body
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
K07/381
JUL 1 8 2007
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the GammaMedplus iX Series HDR Brachytherapy Afterloader.
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- Submitter: Varian Medical Systems
3100 Hansen Way M/S E-110 Palo Alto, CA 94304-1129 Contact Name: Vy Tran Phone: (650) 424-5731 Fax: (650) 842-5040 Email: vy.tran@varian.com Date summary was prepared: May 9, 2007
- Submitter: Varian Medical Systems
-
- Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:
GammaMedplus iX Series HDR Afterloader;
- Name of the Device: Trade/Proprietary Name: Common or Usual Name: Classification Name:
GammaMedplus iX Series HDR Afterloader
Radiological Image Processing System 21 CFR 8892.5700 Class II Product Code: JAQ
-
- Description of the Device: The GammaMedplus iX Series High Dose Rate Afterloader system is a computer controlled remote electro/mechanical system used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by, a malignant tumor or tumor bed in a practice known as brachytherapy. The device has up to 24 channels.
Hardware Platform and Operating System
The console control application runs on validated PCs under a Microsoft®1 windows operating system. The firmware controlling the High Dose Rate Afterloader runs on an embedded Intel 8085 processor. In addition, embedded processors, both based on the Intel 8051, control the afterloaders control desk and its junction interface box.
Peripherals and Accessories
The iX Series control console provides real time information of wire position and system status and interfaces with a printer in order to provide a hard copy of a treatment prescriptions and delivery records. In addition the iX Series control
1 Registered Trade Mark of Microsoft Corporation
1
console can receive treatment plans from a treatment planning application (not part of this submission), this information is transferred either manually using a USB2 drive, or via a network interface.
- Intended Use Statement: The GammaMedplus iX Series is computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specified clinical purpose in a patient.
The radioactive source (enclosed within the wire/cable) is driven via coupling catheters (Transfer Guide Tubes ) from the Afterloader into needles or applicators within or on the patient.
The length of time and position that the High Dose Rate source spends within the needle or applicator is controlled in accordance with an Irradiation Treatment Prescription.
- Summary of the Technological Characteristics: The Substantial Equivalence Comparison Charts provide a comparison of the technological characteristics to those of the predicate devices. These charts are located in Tab 9 of the submission.
2
Image /page/2/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three wavy lines representing the human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the emblem in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 1 8 2007
Ms. Vy Tran Corporate Director, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way, M/S E-110 PALO ALTO CA 94304-1038
Re: K071381
Trade/Device Name: GammaMed iX Series HDR Brachytherapy Afterloader Regulation Number: 21 CFR §892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: May 16, 2007 Received: Mav 17, 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 commence 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 Comence Act (Act) that do not require approval of a premarket approval application (PMA). Your cost. 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 adultervation.
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 at (riving 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/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is the acronym "FDA" in a stylized font. The word "Centennial" is written below the acronym. Three stars are arranged in a horizontal line below the word "Centennial". The text "Protecting and Promoting" is written along the bottom edge of the circle.
Protecting and Promoting Public Health
3
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.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxx . Other
(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology) 240-276-0120 240-276-0100
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K07/381
Device Name: GammaMed iX Series HDR Brachytherapy Afterloader
Indications For Use:
Both the GammaMedplus iX and GammaMedplus 3/24 iX are indicated, in the treatment of both benign and malignant disease, for both curative and palliative intent, in the delivery of remote controlled high dose rate brachytherapy for conditions anywhere in the body when brachytherapy treatment is indicated.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Helu Peuse
(Division Sign-Off)
Division of Reproductive, Abdominal Radiological Devices 510(k) Number