(58 days)
No
The device description and performance studies focus on mechanical functionality and reprocessing, with no mention of AI or ML terms or concepts.
No
The device is described as an "accessory for HDR or PDR brachytherapy treatment" and is intended to "hold dedicated applicator holding devices." It does not directly provide therapy but rather assists in the application of other therapeutic devices.
No
The device is described as an "Applicator Clamping Device" used to hold applicator holding devices during cancer treatment (brachytherapy), not for diagnosis.
No
The device description clearly outlines physical components made of stainless steel and thermoplastic, 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:
- 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 outside of the body (in vitro).
- Device Function: The ASSISTO® Universal Applicator Clamping Device is a mechanical device used to physically hold brachytherapy applicators in place during a medical procedure (cancer treatment). It does not analyze biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states it's an accessory for brachytherapy treatment, not for diagnostic testing.
The device is a medical device used in a therapeutic setting, not a diagnostic one.
N/A
Intended Use / Indications for Use
The ASSISTO® Universal Applicator Clamping Device is indicated for use as an accessory for HDR or PDR brachytherapy treatment.
Specifically, it is intended to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAQ, GWG, and GCJ
Device Description
The ASSISTO® Universal Applicator Clamping Device is a self-retaining device that consists of a stainless steel tubular, articulated arm connected to a vertical stand. The arm is freely adjustable within the articulating radius. A screw clamp mounted on the distal end of the device serves to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vagina, vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy. Two accessories, a stainless steel clamp socket and a base plate manufactured of thermoplastic and stainless steel, are provided to table-mount the device during clinical use.
The ASSISTO® Universal Applicator Clamping Device and the clamp socket are reusable and provided non-sterile for cleaning and sterilization by the user before use. The non-sterile, reusable base plate is intended for cleaning and disinfection by the user before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vaginal stump, rectum, cervix, uterus and endometrium
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)
Performance Design verification and validation testing to support determination of substantial Testing: equivalence consisted of the following tests:
- Verification of the device's capacity to securely hold the Varian Medical Systems applicator holding devices.
- Validation testing of the recommended end user devicereprocessing procedures
Acceptance criteria were met for all tests performed.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Geomed Medizin-Technik GmbH & Co. KG % Ms. Angelika Scherp Regulatory Affairs Consultant Business Support International Aalsmeerweg 123-3 Amsterdam, Noord-Holland 1059AH THE NETHERLANDS
July 10, 2020
Re: K201279
Trade/Device Name: ASSISTO® Universal Applicator Clamping Device Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: Class II Product Code: JAQ, GWG, and GCJ Dated: May 12, 2020 Received: May 13, 2020
Dear Ms. Scherp:
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,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201279
Device Name
ASSISTO® Universal Applicator Clamping Device
Indications for Use (Describe)
The ASSISTO® Universal Applicator Clamping Device is indicated for use as an accessory for HDR or PDR brachytherapy treatment.
Specifically, it is intended to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy.
| Type of Use (Select one or both, as applicable) |
|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) |
| [] Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary of Safety and Effectiveness
| Date: | June 15, 2020 | |
|---|---|---|
| Submitter: | Name: | |
| Address: | Geomed Medizin-Technik GmbH & Co. KG | |
| Ludwigstaler Strasse 27 | ||
| D-78532 Tuttlingen | ||
| Germany | ||
| Contact Person: | ||
| Telephone: | Hanno Haug | |
| +49.7461.93550 | ||
| Product: | Name of Device: | |
| Common Name: | ||
| Classification Name: | ||
| Regulatory Class: | ||
| 21 CFR Section: | ASSISTO® Universal Applicator Clamping Device | |
| Holding Accessory for Applicator System | ||
| Remote Controlled Radionuclide Applicator System | ||
| II | ||
| 892.5700 | ||
| Predicate Device: | K170203 – Kobold® Prostate HDR Template(s) and Kobold® HDR Stepper Template(s) | |
| Reference Device: | K052745 - ASSISTO® Arm Systems | |
| Device Description: | The ASSISTO® Universal Applicator Clamping Device is a self-retaining device that consists of a stainless steel tubular, articulated arm connected to a vertical stand. The arm is freely adjustable within the articulating radius. A screw clamp mounted on the distal end of the device serves to hold dedicated applicator holding devices by Varian Medical Systems in place during cancer treatment of the vagina, vaginal stump, rectum, cervix, uterus and endometrium using HDR or PDR brachytherapy. Two accessories, a stainless steel clamp socket and a base plate manufactured of thermoplastic and stainless steel, are provided to table-mount the device during clinical use. |
The ASSISTO® Universal Applicator Clamping Device and the clamp socket are reusable and provided non-sterile for cleaning and sterilization by the user before use. The non-sterile, reusable base plate is intended for cleaning and disinfection by the user before use. | |
| Indications for Use: | The ASSISTO® Universal Applicator Clamping Device is indicated for use as an accessory for HDR or PDR brachytherapy treatment. | |
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Trade Name | ASSISTO® Universal | ||
| Applicator Clamping | |||
| Device | Kobold® Prostate | ||
| HDR Template(s) and | |||
| Kobold® HDR | |||
| Stepper Template(s) | ASSISTO® Arm Systems | ||
| Model No. CA 235-30-01 | |||
| 510(k) | |||
| Number | K201279 | K170203 | K052745 |
| Manufacturer | Geomed Medizin- | ||
| Technik | Kobold, LLC | Geomed Medizin-Technik | |
| GmbH & Co. | |||
| Indications | |||
| for Use | The ASSISTO® | ||
| Universal Applicator | |||
| Clamping Device is | |||
| indicated for use as an | |||
| accessory for HDR or | |||
| PDR brachytherapy | |||
| treatment. | |||
| Specifically, it is | |||
| intended to hold | |||
| dedicated applicator | |||
| holding devices by | |||
| Varian Medical Systems | |||
| in place during cancer | |||
| treatment of the vagina, | |||
| vaginal stump, rectum, | |||
| cervix, uterus and | |||
| endometrium using HDR | |||
| or PDR brachytherapy. | The Kobold® | ||
| Prostate HDR | |||
| Template(s) and | |||
| Kobold® HDR | |||
| Stepper Template(s) | |||
| are indicated for use | |||
| as an accessory for | |||
| high dose rate | |||
| brachytherapy | |||
| treatment of the | |||
| prostate. | ASSISTO® Arm Systems | ||
| consist of a table-mounted | |||
| endoscope holder system | |||
| intended for use by surgeons | |||
| to hold endoscopes and | |||
| arthroscopes with a diameter | |||
| of 2.7mm to 10mm during | |||
| general diagnostic and | |||
| therapeutic procedures. The | |||
| device is also intended for | |||
| use by qualified surgeons for | |||
| holding endoscopes during | |||
| diagnostic and therapeutic | |||
| neurologic procedures. | |||
| Design | Tubular, articulated arm | ||
| connected to a vertical, | |||
| table-mounted stand and | |||
| provided with a screw- | |||
| clamp holding | |||
| component. The position | |||
| of the articulated arm is | |||
| freely adjustable within | |||
| the articulating radius. | Template provided | ||
| with holes in a grid | |||
| array and a locking | |||
| mechanism to lock | |||
| needles in place. The | |||
| template is equipped | |||
| with four suture holes | |||
| to secure it to the | |||
| perineum during use. | Tubular, articulated arm | ||
| connected to a vertical, | |||
| table-mounted stand and | |||
| provided with a selection of | |||
| screw clamp holding | |||
| components. The position of | |||
| the articulated arms is freely | |||
| adjustable within the | |||
| articulating radius. | |||
| Working | |||
| Length | 310 mm | N/A | 310 mm |
| Materials | Stainless steel and | ||
| thermoplast polyamid | N/A | Stainless steel and | |
| thermoplast polyamid | |||
| Patient | |||
| Contact | No patient contact | Intact skin | No patient contact |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Reusable | Yes | No | Yes |
Comparison Table:
4
Performance Design verification and validation testing to support determination of substantial Testing: equivalence consisted of the following tests:
- Verification of the device's capacity to securely hold the Varian ● Medical Systems applicator holding devices.
- Validation testing of the recommended end user devicereprocessing ● procedures
Acceptance criteria were met for all tests performed.
The information provided in this 510(k) submission, including results of Conclusion: nonclinical testing, indicates that the ASSISTO® Universal Applicator Clamping Device is substantially equivalent to the predicate device.