(62 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GammaMedplus iX Series HDR Brachytherapy Afterloader:
Based on the provided S10(k) summary, the device is an HDR Brachytherapy Afterloader, which is a medical device used to deliver radiation therapy. The submission is for a medical device that delivers treatment, not one that diagnoses or predicts. Therefore, the typical "acceptance criteria" related to diagnostic performance metrics like sensitivity, specificity, or AUC based on a test set and ground truth are not applicable in this context.
Instead, for a device like an afterloader, acceptance criteria would typically revolve around functional performance, safety, and equivalence to predicate devices. The provided document focuses on demonstrating substantial equivalence to previously cleared devices (GammaMedplus K983436 and GammaMedplus 3/24 K031524).
The document does not contain information about a study that involves human readers, AI assistance, or diagnostic performance metrics. It's a regulatory submission for a therapeutic device, not a diagnostic AI system.
Here's a breakdown based on your requested categories, highlighting what is (and isn't) present in the text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a therapeutic device (an afterloader) and not a diagnostic AI/image processing system, the acceptance criteria are focused on functional equivalence and safety rather than diagnostic accuracy. The document implicitly relies on demonstrating substantial equivalence to predicate devices. Explicit acceptance criteria in terms of quantitative performance metrics for a diagnostic task are not detailed in this submission.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence to Predicate Devices | The device is described as "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." This functional description aligns with the predicate devices. |
| Similar Intended 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." This mirrors the intended use of prior approved afterloaders. |
| Similar 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." (The charts themselves are not provided in the extract, but their existence is stated as the basis for claiming equivalence). |
| Safety and Control Mechanisms | "The console control application runs on validated PCs under a Microsoft® 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." This describes the control systems in place for safe operation. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable and not provided in the document. The device is not a diagnostic tool evaluated on a "test set" of patient data in the typical sense. Its performance is related to its mechanical and software operation in delivering radiation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. "Ground truth" in the context of diagnostic accuracy is not relevant for this type of medical device submission.
4. Adjudication Method for the Test Set
This information is not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done, as this is not a diagnostic or AI-assisted interpretation device. The concept of human readers improving with AI assistance does not apply here.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is an electro-mechanical system controlled by software and hardware, not a standalone AI algorithm for medical image interpretation or diagnosis. Its "performance" would be evaluated through engineering testing and validation (e.g., accuracy of source positioning, dose delivery, safety interlocks) rather than standalone algorithmic diagnostic performance.
7. The Type of Ground Truth Used
This information is not applicable and not provided. The "ground truth" for an afterloader would relate to its engineering specifications and successful delivery of radiation according to a treatment plan, confirmed through physical measurements and calibration, not pathology or outcomes data in the sense of a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This is not an AI/machine learning device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided.
In summary: The provided document is an S10(k) premarket notification for a therapeutic device (an HDR brachytherapy afterloader), not a diagnostic device or an AI/machine learning system. Therefore, the questions related to diagnostic performance, ground truth, test sets, training sets, and human reader studies are not applicable to the content presented in this filing abstract. The "study" referenced would be the demonstration of substantial equivalence through comparison of technological characteristics to predicate devices, and likely internal validation and verification testing of the device's functional and safety aspects, which are not detailed in this summary.
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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
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- 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
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- 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
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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.
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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
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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.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
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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
§ 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.