(30 days)
K912555/A
Not Found
No
The summary describes a mechanical and software-controlled radiation delivery system, with no mention of AI or ML in the device description, intended use, or specific sections for AI/ML details.
Yes
The device is described as being used for "treatment of cancer" and "to provide a predetermined dose of radiation to tissues and organs," which directly relates to therapy.
No
The device is described as a brachytherapy device used for the treatment of cancer by delivering radiation. It is not mentioned anywhere that it is used for diagnosing any condition.
No
The device description explicitly states it is a "transportable high-dose-rate remotely controlled afterloading brachytherapy device" and lists hardware components like the "Treatment device including computer and control software" and "Applicators and accessories." This indicates it is a physical device with integrated software, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation." This describes a therapeutic device that delivers radiation directly to the patient's body.
- Device Description: The description details a system that manipulates a radioactive source to deliver radiation to tissues and organs within or on a patient. This is a direct treatment method.
- Definition of IVD: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such examinations on specimens.
The GammaMed Plus is a therapeutic medical device used for brachytherapy, a type of radiation therapy.
N/A
Intended Use / Indications for Use
The intended use of the GammaMed Plus transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
The GammaMed Plus is a transportable high-dose-rate remotely controlled afterloading brachytherapy device. The unit is designed to provide a predetermined dose of radiation to tissues and organs by means of manipulating a radioactive source from a shielded position within the device into an applicator, which has been previously placed within or on a patient. The GammaMed plus system is based on a further development of the existing GammaMed 12it system.
The GammaMed plus system consists of the following components:
- Treatment device including computer and control software
- Applicators and accessories .
- . Treatment planning system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tissues and organs (for cancer treatment through intracavitary, interstitial, intralumenal and intraoperative irradiation)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K912555/A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 2 9 1998
25 September 1998
Section 807.92(a)
GAMMA Med USA
2464 E. Stadium Blvd., Ann Arbor, Michigan 48104
Tel: 734-975-4500; Fax: 734-975-4300
510(k) Summary
| (1) Submitter: | GammaMed USA
2464 E. Stadium Blvd.
Ann Arbor, MI 48104 |
| ---------------- | -------------------------------------------------------------- |
|---|
| Tel: | 743-975-4500 |
|---|---|
| Fax: | 734-975-4300 |
| Establishment Registration Number: | 9023144 |
|---|---|
| ------------------------------------ | --------- |
| Contact Person: | John J. Munro III, CEO |
|---|---|
| ----------------- | ------------------------ |
| (2) Device Name: | |
|---|---|
| ------------------ | -- |
| Classification Name: | Remote Controlled Radionuclide Applicator System (892.5700) |
|---|---|
| Common or Usual Name: | High Dose Rate Remote Afterloading System |
| Proprietary Name: | GammaMed Plus High Dose Rate Remote Afterloading System |
| (3) Legally Marketed Predicate Device: | GammaMed 12it (K912555/A dated 17 July 1991)
Substantial equivalence determined through premarket
notification process |
| ---------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------ |
|---|
Description of GammaMed Plus: (4)
The GammaMed Plus is a transportable high-dose-rate remotely controlled afterloading brachytherapy device. The unit is designed to provide a predetermined dose of radiation to tissues and organs by means of manipulating a radioactive source from a shielded position within the device into an applicator, which has been previously placed within or on a patient. The GammaMed plus system is based on a further development of the existing GammaMed 12it system.
The GammaMed plus system consists of the following components:
- Treatment device including computer and control software
- Applicators and accessories .
- . Treatment planning system
- (5) Intended use of the GammaMed Plus
The intended use of the GammaMed Plus transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.
1
Image /page/1/Picture/0 description: The image shows the logo for GammaMed USA. The logo consists of a black square with a white, stylized "S" shape inside. To the right of the square is the text "GAMMAMED USA" in black, with the "MED" portion slightly smaller than the rest of the text.
(6) Technological Characteristics
The GammaMed Plus is a modification of the GammaMed 12it High Dose Rate Remote Afterloading System, which was cleared under 510(k) Number K912555/A, dated 17 July 1991. The changes made to the GammaMed plus represent routine engineering changes. These modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. There are no differences between the GammaMed Plus and the GammaMed 12it that adversely affects the safety or effectiveness of the device.
The changes are:
Industrial Design: The style and appearance of the GammaMed Plus has been changed from the GammaMed 12it to be more compatible with the modern hospital equipment. Change in the housing results in a smaller device.
Several electronic circuit boards have been combined to one single Electronics: board. Consequently, the electronics can be housed in a smaller volume, which makes it possible to decrease the size of the housing.
Source: The materials and construction of the new source will be the same as that used in the GammaMed 12it. The diameter of the source has been reduced from 1.1 mm to 0.9 mm.
Operator Console: The operator console has been reduced in size to reduce the space required for operation of the device.
The control software, GammaWin, is a modification and Operating Software: refinement of the GammaMed control software, which has been used with the GammaMed 12it and GammaMed 12i afterloading devices. The GammaWin control software operates under the Windows operating system. The previous GammaMed control software operates under DOS. The GammaWin control software is also compatible with the GammaMed 12it and GammaMed 12i.
Treatment Planning Software: The treatment planning software, ABACUS, is a modification and refinement of the GammaDot treatment planning software, which has been used with the GammaMed 12it and GammaMed 12i afterloading devices. The ABACUS treatment planning software operates under the Windows operating system. The previous GammaDot treatment planning software operates under DOS. The ABACUS treatment planning software is also compatible with the GammaMed 12it and GammaMed 12i.
ﺮﺍ 1200
John J. Munro III Chief Executive Officer
25 September 1998
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 9 1998
John J. Munro, III Chief. Executive Officer Gamma Med USA 2464 E. Stadium Blvd. Ann Arbor, Michigan 48104 Re: K983436
GammaMed Plus HDR Afterloading System Dated: September 25, 1998 Received: September 29, 1998 Regulatory class: II 21 CFR 892.5730/Procode: 90 MUJ
Dear Mr. Munro:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrivdsmaldsmamain.html".
Sincerely yours,
Lillian Yih, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for GammaMed USA, along with their address and contact information. The address is 2464 E. Stadium Blvd., Ann Arbor, Michigan 48104. The phone number is 734-975-4500, and the fax number is 734-975-4300.
Page 1 of 1
510(k) Number 983436
Device Name: GammaMed Plus High Dose Rate Remote Afterloading System
Indications for Use:
The intended use of the GammaMed Plus transportable high-dose-rate remotely controlled afterloading brachytherapy device is for the treatment of cancer by intracavitary, interstitial, intralumenal and intraoperative irradiation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Liliauip
(Division Sign-Off)
(Division Sign-Off) Division of Reproductive, Andominal, EN and Radiological De 510(k) Number
Over-The-Counter Use (Optional Format 1-2-96)