(180 days)
Not Found
No
The description focuses on the mechanical function of the applicator and its use in guiding a radioactive source. There is no mention of AI, ML, image processing, or any software functionality that would suggest the use of these technologies. The performance studies described are verification and validation of the physical device, not algorithmic performance.
Yes
The device is used for cancer treatment by guiding a radioactive source to target tissue, which is a therapeutic intervention.
No
The device, the Aarhus Applicator Set, is described as being used for cancer treatment and to guide a radioactive source for brachytherapy. It facilitates treatment by placing a radioisotope treatment source near the target tissue. There is no indication that it is used to diagnose a medical condition.
No
The device description explicitly states it is an "applicator for intracavitary/interstitial brachytherapy" which is a physical device inserted into the patient. The summary also mentions "Verification testing was performed to demonstrate that the performance and functionality of the new Aarhus Applicator Set meets the design input requirements" and "Validation testing was performed on production equivalent devices," indicating hardware testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Aarhus Applicator Set Function: The description clearly states that the Aarhus Applicator Set is an applicator for intracavitary/interstitial brachytherapy. It is a device inserted into the patient to guide a radioactive source for cancer treatment. It is a therapeutic device, not a diagnostic test performed on a sample outside the body.
The information provided about the device's intended use, description, and function all point to it being a medical device used for treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Aarhus Applicator Set is indicated for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy within a hospital CT or MRI environment.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
Aarhus Applicator Set
The Aarhus Applicator Set is an applicator for intracavitary/interstitial brachytherapy. The Applicator is inserted into the patient and connected to an afterloader. The applicator acts to guide the radioactive source from the afterloader to the correct location or locations for treatment. This combination places the remote-controlled radioisotope treatment source (brachytherapy source) nearby the target tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MRI
Anatomical Site
vagina, cervix, and uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital
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)
Verification and validation were conducted according to QSR §820.30 and ISO 13485:2016 design control requirements. Submission documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, Format for Traditional and Abbreviated 510(k)s.
No animal studies or clinical tests have been included in this pre-market submission.
Verification testing was performed to demonstrate that the performance and functionality of the new Aarhus Applicator Set meets the design input requirements. Validation testing was performed on production equivalent devices, under clinically representative conditions and by qualified personnel.
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
§ 892.5700 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
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Varian Medical Systems, Inc % Peter Coronado Sr. Director 3100 Hansen Way, M/S/E-110 PALO ALTO CA 94304
March 13, 2023
Re: K222775
Trade/Device Name: Aarhus Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: February 6, 2023 Received: February 8, 2023
Dear Peter Coronado:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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Lora D. Weidner, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222775
Device Name Aarhus Applicator Set
Indications for Use (Describe)
The Aarhus Applicator Set is indicated for cancer treatment of the vagina, cervix, and uterus using HDR or PDR brachytherapy within a hospital CT or MRI environment.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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Varian Medical Systems
3100 Hansen Way Palo Alto, CA 94304
650.493.4000 800.544.4636
varian.com
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Premarket Notification 510(k) Summary K222775
The following information is provided according to 21 CFR 807.92.
| Submitter: | Varian Medical Systems, Inc.
3100 Hansen Way Palo Alto, CA 94304 |
|------------|-----------------------------------------------------------------------------------------------------------------------|
| | Contact Name: Peter J. Coronado
Phone: 650.424.6320
Fax: 650.646.9200
E-mail: submissions.support@varian.com |
| | Date Prepared: September 8, 2022 |
| Trade/
Proprietary
| Names: | Aarhus Applicator Set | |
|---|---|---|
| Aarhus Applicator Set | ||
| Classification Name: | ||
| Remote controlled radionuclide | ||
| applicator system, 21 CFR §892.5700 | Predicate Device: | |
| Common/Usual Name: | 3D Interstitial Ring Applicator Set 60 & Set 90; | |
| Ring Applicator Set 45, Set 60, Set 90 | ||
| (K150839) | ||
| Afterloader System | ||
| Source Guide Tubes | ||
| Brachytherapy Accessory | ||
| Regulatory Class: | ||
| Class II | ||
| Product Code: | ||
| JAQ | ||
| Device | ||
| Description: | Aarhus Applicator Set | |
| The Aarhus Applicator Set is an applicator for intracavitary/interstitial brachytherapy. | ||
| The Applicator is inserted into the patient and connected to an afterloader. The | ||
| applicator acts to guide the radioactive source from the afterloader to the correct | ||
| location or locations for treatment. This combination places the remote-controlled | ||
| radioisotope treatment source (brachytherapy source) nearby the target tissue. |
4
| Intended/
Indications
For Use
| Statement: | Aarhus Applicator Set | |
|---|---|---|
| Intended Use | Indications for Use | |
| The Aarhus Applicator Set is intended for use | ||
| when performing HDR or PDR brachytherapy | ||
| within a CT and MRI environment. | The Aarhus Applicator Set is indicated for | |
| cancer treatment of the vagina, cervix, and | ||
| uterus using HDR or PDR brachytherapy | ||
| within a hospital CT or MRI environment. |
The purpose of this Traditional 510(k) submission is to provide details on how the new Aarhus Applicator Set is similar to Varian's 3D Interstitial Ring Applicator Set 60 & Set 90; Ring Applicator Set 45, Set 60, Set 90 (K150839) for which we are claiming substantial equivalence.
The subject device Indications for Use is similar to the predicate device and Intended Use is similar to the predicate device.
Comparison of Technological Characteristics with the Predicate Device
At a high level, the subject and predicate devices are based on the following similar technological elements:
Aarhus Applicator Set:
- . Similar Design and Technology as Predicate device
Significant Difference
Aarhus Applicator Set: The significant differences compared to the predicate device are
- The subject device Intended Use now includes a CT or MRI environment. ●
- The compatible afterloaders have been expanded to include the VariSource iX, 200 and BRAVOS models.
- The device material has been changed to PEEK-only. .
Performance Data
Verification and validation were conducted according to QSR §820.30 and ISO 13485:2016 design control requirements. Submission documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, Format for Traditional and Abbreviated 510(k)s.
Varian Medical's Aarhus Applicator Set is substantially equivalent to the predicate device (K150839). Compared to the predicate device, the basic operation and technological characteristics are substantially the same.
No animal studies or clinical tests have been included in this pre-market submission.
Verification testing was performed to demonstrate that the performance and functionality of the new Aarhus Applicator Set meets the design input requirements. Validation testing was performed on production equivalent devices, under clinically representative conditions and by qualified personnel.
5
varian
Standards Conformance
The subject device conforms in whole or in part with the following standards:
- ISO 14971:2019
- IEC 62366-1:2015 +A1:2020
- ISO 10993-1:2018 .
- ISO 10993-2:2006 ●
- . ISO 10993-5:2009
- ISO 10993-6:2016
- ISO 10993-10:2010 ●
- ISO 10993-11:2017 ●
- ISO 10993-12:2021
- ISO 10993-17:2002
- ISO 10993-18:2020
- ANSI AAMI ST79:2017 & 2020 ● Amendments A1, A2, A3, A4 (Consolidated Text)
- IEC 60601-2-17:2013 ●
- AAMI TIR-12:2010
- AAMI TIR-30: 2011 .
- . ISO 15223-1:2021
- ISO 11607-1:2020 ●
- ISO 11737-2:2019 .
- ISO 17664-1:2021 ●
- ISO 17665-1:2006/(R)2013 ●
- ISO/TS 17665-2:2009 .
- ASTM F2503-20 ●
- ASTM F2052-15 .
- ASTM F2213-17 ●
- ASTM F2182-19e2
- ASTM F2119-07
- . ANSI / AAMI ES60601-1:2005 (IEC 60601-1:2005, MOD) + A1 2012
- . ASTM D4332-13
- ASTM D4332-14 ●
- . ISTA 3A 2018
The subject device also complies with the following non-FDA recognized standards:
- ISO 13485:2016
- . ISO 11138-3:2017
- ASTM D4332-13
- . BS EN 1041:2008 +A1:2013
Conclusion
The non-clinical data for the new Aarhus Applicator Set supports the safety of the device and the verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. Varian considers the new Aarhus Applicator Set to be as safe and effective, and substantially equivalent to the predicate device.