(14 days)
No
The provided text does not mention AI, ML, deep learning, or any related terms, nor does it describe features typically associated with AI/ML in medical imaging or planning software.
No.
The document describes "VariSeed 7.0" as a software application used for planning and evaluation of brachytherapy procedures, not as a device that delivers therapy itself.
No
The device is described as a software application for planning and evaluating permanent implant brachytherapy procedures for prostate cancer. This indicates a role in treatment planning and assessment, not in diagnosing a medical condition.
Yes
The device is explicitly described as a "software application" and the description refers to a "Software Description of the Device". There is no mention of any accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that VariSeed 7.0 is a software application for planning and evaluating permanent implant brachytherapy procedures for the treatment of prostate cancer. This involves treatment planning and evaluation based on medical imaging and patient data, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Lack of IVD Characteristics: The description does not mention any activities typically associated with IVDs, such as analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
- Focus on Treatment Planning: The core function of the software is to facilitate pre-operative and intra-operative planning and evaluation for a specific medical treatment (brachytherapy).
Therefore, VariSeed 7.0 falls under the category of medical device software used for treatment planning and evaluation, not as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
VariSeed 7.0 is a software application used for planning and evaluation of permanent implant brachytherapy procedures.
Product codes
90 MUJ
Device Description
See the Software Description of the Device, Tab E
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
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)
MMS TherapacPLUS B3DTUI, K982821, Brachyvision, K992762
Reference Device(s)
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
§ 892.5050 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.
0
JUL 1 2 2001
KO12017
VARI
medical sy
Oncology Systems 100 Hansen Way alo Alto, CA 94304-1038 tel +1 650 493 4000 ww.varian.com
Premarket Notification [510K] Summary as required by 21 CFR 807.92
Date Summary was prepared:
June 7, 2001
Submitter's Name:
Varian Medical Systems 3140 Hansen Way F-055 Palo Alto, CA 94304
Contact Person:
Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance (650) 424-6990 Phone (650) 842-5051 FAX E-Mail linda.nash(@os.varian.com
Device Name:
VariSeed 7.0
Classification Name:
Source, Brachytherapy, Radionuclide
Predicate Device:
MMS TherapacPLUS B3DTUI, K982821 and Brachyvision, K992762
1
Product Description:
See the Software Description of the Device, Tab E
Intended Use:
VariSeed 7.0 is a software application used for planning and evaluation of permanent implant brachytherapy procedures.
Technological Characteristics:
See the "Substantial Equivalence Comparison Chart", Tab F.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
JUL 1 2 2001
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings or feathers. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Linda Nash Director, Regulatory Affairs and Quality Assurance Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K012017
VARISEED 7.0 (Brachytherapy Treatment Planning System) Dated: June 25, 2001 Received: June 28, 2001 Regulatory Class: II 21 CFR 892.5730/Procode: 90 MUJ
Dear Ms. Nash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We have is substantially equivalent (for the intications 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). 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 th your device is classimos (so aco regulations affecting your device can be found in the Code of Federal Regulations, to such additional controls. Internally equivalent determination assumes compliance with the Current Good Manufacturing Fride 21, 1 at 5 00 to 099. 11 backed to 1941. System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 1 rache requirements, is set tour in the Quand Drug Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to comply war the Federal Register. Please note: this response to your premarket notification submission does not offect 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 I his lotter while no 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 If you distic devices), please contact the Office of Compliance at (301) 594-4639. 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" (21CFR 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) 1638-2041 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 (s)
3
Page | of |
510(k) Number (if known): K012017
Device Name: Vari Seed 7.0_
Indications For Use:
VariSeed 7.0 is a software application for planning and evaluating permanent implant Vanoood 7.0 lo a connate application of prostate cancer with permanent implants braonythorapy procount of to AAPM TG-43. It facilitates pre-operative planning and that our be models a socialing in the operative planning and evaluation.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices, | |
| 510(k) Number | K012017 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |