(2 days)
Not Found
No
The summary describes a brachytherapy source assembly and its use with remote afterloaders, with no mention of AI or ML technologies.
Yes
The device is used for "treatment of cancerous tumors," indicating a therapeutic purpose.
No
Explanation: The device is described as a brachytherapy source used for the "treatment of cancerous tumors," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly states it is a "source assembly" and a "brachytherapy source," which are physical components used in conjunction with remote afterloaders, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of cancerous tumors" and is used in "hospitals and medical facilities." This describes a therapeutic device used directly on a patient, not a device used to examine specimens (like blood, tissue, etc.) outside the body to diagnose or monitor a condition.
- Device Description: The description identifies the device as "brachytherapy sources" used with "remote afterloaders." Brachytherapy is a form of radiation therapy where a radioactive source is placed inside or next to the area requiring treatment. This is a therapeutic procedure, not a diagnostic one.
- Lack of IVD Indicators: The document does not mention any activities typically associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the Gammamed Model 212 and 232 source assembly is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Gammamed Model 212 and 232 source assembly is designed to be used in conditions typically associated with hospitals and medical facilities for the treatment of cancerous tumors.
Product codes (comma separated list FDA assigned to the subject device)
90 KXK
Device Description
The Gammamed 212 and 232 Source Assemblies are brachytherapy sources that are used in conjunction with Gammamed remote afterloaders. The Gammamed 212 Source Assembly is used in conjunction with the Gammamed 12i or 12it temote afterloader. The Gammamed 232 Source Assembly is used with either the Gammamed Plus or Gammamed 3/24 afterloader.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and medical facilities
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.
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
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a bold, sans-serif font, with a stylized "I" that has a dot above it. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and clean, and it conveys a sense of professionalism and innovation.
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 IISA tel +1 650 493 4000 www.varian.com
The following information is provided following the format of 21 CFR 807.92 for the Gammamed 212 and 232 Source Assembly
MAR 1 2 2003
| 1. Submitter: | Varian Medical Systems |
|---|---|
| 3100 Hansen Way M/S H055 | |
| Palo Alto, CA 94304-1129 | |
| Contact Name: Vy Tran | |
| Phone: (650) 424-5731 | |
| Fax: (650) 842-5040 | |
| Email: vy.tran@varian.com | |
| Date: March 7, 2003 |
- Device Name: Gammamed 212 and 232 Source Assembly
| Classification Name: | Radionuclide brachytherapy source |
|---|---|
| Common/Usual Name: | Gammamed 212 and 232 Source Assembly |
| Proprietary Name: | Gammamed 212 and 232 Source Assembly |
-
Equivalent Device: Gammamed 12i, K891131
-
Device Description: The Gammamed 212 and 232 Source Assemblies are brachytherapy sources that are used in conjunction with Gammamed remote afterloaders. The Gammamed 212 Source Assembly is used in conjunction with the Gammamed 12i or 12it temote afterloader. The Gammamed 232 Source Assembly is used with either the Gammamed Plus or Gammamed 3/24 afterloader.
-
Statement of Intended Use: The Gammamed Model 212 and 232 source assemblies are designed for use in medical brachytherapy applications.
-
Comparison to substantially equivalent devices:
| Features / Products | GAMMAMED 12i | GAMMAMED 212 | GAMMAMED 232 | |
|---|---|---|---|---|
| Device | FDA approval | K891131 | Pending | Pending |
| Isotope | Ir-192 | Ir-192 | Ir-192 | |
| Nominal Activity | 370 GBq (10 Ci) | 370 GBq (10 Ci) | 370 GBq (10 Ci) | |
| Active dimensions Ø x length | 0.6 x 4.0 mm | 0.6 x 3.5 mm | 0.6 x 3.5 mm | |
| cable length | 2100 mm | 2100 mm | 2100 mm | |
| cable diameter | 1.1 mm | 1.1 mm | 0.9 mm | |
| manufacturing process | electron beam | laser welding | laser welding |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2003
Ms. Vy Tran Manager, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K030745
Trade/Device Name: Gammamed 212 and 232 Source Assembly Regulation Number: 21 CFR $892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: March 7, 2003 Received: March 10, 2003
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 (PMA), it may be subject to 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.
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.
2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
3
Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "I" that resembles a person. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font. The logo is simple and professional, and it conveys a sense of innovation and technology.
Varian Medical Systems, Inc. 3100 Hanson Way Palo Alto, CA 94304-1038 USA tel +1 650 493 4000 www.varian.com
Statement of Indications for Use
510(k) Number (if known):
Device Name:
The Gammamed Model 212 and 232 source assembly
Indications For Use:
The Gammamed Model 212 and 232 source assembly is designed to be used in conditions typically associated with hospitals and medical facilities for the treatment of cancerous tumors.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
David R. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K030745