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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ASSISTO® Universal Applicator Clamping Device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of diagnostic accuracy or clinical effectiveness with human subjects.

Therefore, many of the requested points regarding diagnostic performance studies (sample size, expert qualifications, ground truth, MRMC studies, standalone performance) are not applicable to this submission, as the device is an accessory for brachytherapy and its performance is evaluated based on engineering and functional testing.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Securely hold Varian Medical Systems applicator holding devices.	Verification of the device's capacity to securely hold the Varian Medical Systems applicator holding devices. (Stated that "Acceptance criteria were met for all tests performed.")
Device reprocessing procedures (e.g., cleaning, sterilization) are effective and validated.	Validation testing of the recommended end user device reprocessing procedures. (Stated that "Acceptance criteria were met for all tests performed.") The device is non-sterile and reusable, requiring cleaning and sterilization by the user. The base plate is non-sterile, reusable, and intended for cleaning and disinfection by the user. The validation testing would confirm the adequacy of the instructions for these processes.

Acceptance Criteria

Reported Device Performance

Securely hold Varian Medical Systems applicator holding devices.

Verification of the device's capacity to securely hold the Varian Medical Systems applicator holding devices. (Stated that "Acceptance criteria were met for all tests performed.")

Device reprocessing procedures (e.g., cleaning, sterilization) are effective and validated.

Validation testing of the recommended end user device reprocessing procedures. (Stated that "Acceptance criteria were met for all tests performed.") The device is non-sterile and reusable, requiring cleaning and sterilization by the user. The base plate is non-sterile, reusable, and intended for cleaning and disinfection by the user. The validation testing would confirm the adequacy of the instructions for these processes.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as this is not a clinical study involving human cases or diagnostic imaging. The "test set" here refers to the number of Varian Medical Systems applicator holding devices used for verification, and potentially the number of reprocessing cycles for validation. These numbers are not provided in the summary.
Data Provenance: Not applicable in the context of clinical data. The tests are engineering verification and validation tests, likely performed in a lab setting by the manufacturer, Geomed Medizin-Technik GmbH & Co. KG, located in Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for engineering performance measures (like securely holding an object or effective reprocessing) is established through technical specifications, engineering principles, and validated testing protocols, not by expert medical opinion on clinical cases.

4. Adjudication method for the test set

Not applicable. There's no clinical "ground truth" to adjudicate. Test results are likely objectively measured against predefined engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The ASSISTO® is a physical accessory for brachytherapy.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done

Not applicable. The device is a physical mechanical accessory, not an AI algorithm. Its function is to physically hold other devices.

7. The type of ground truth used

The "ground truth" for this device's performance is based on engineering specifications and functional requirements. For example, the ability to physically secure an applicator holding device without slippage or failure, and the effectiveness of specified cleaning/sterilization protocols.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI algorithm.

Summary

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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

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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

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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)

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510(K) Summary of Safety and Effectiveness

Date:	June 15, 2020
Submitter:	Name:Address:	Geomed Medizin-Technik GmbH & Co. KGLudwigstaler Strasse 27D-78532 TuttlingenGermany
	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 DeviceHolding Accessory for Applicator SystemRemote Controlled Radionuclide Applicator SystemII892.5700
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® UniversalApplicator ClampingDevice	Kobold® ProstateHDR Template(s) andKobold® HDRStepper Template(s)	ASSISTO® Arm SystemsModel No. CA 235-30-01
510(k)Number	K201279	K170203	K052745
Manufacturer	Geomed Medizin-Technik	Kobold, LLC	Geomed Medizin-TechnikGmbH & Co.
Indicationsfor Use	The ASSISTO®Universal ApplicatorClamping Device isindicated for use as anaccessory for HDR orPDR brachytherapytreatment.Specifically, it isintended to holddedicated applicatorholding devices byVarian Medical Systemsin place during cancertreatment of the vagina,vaginal stump, rectum,cervix, uterus andendometrium using HDRor PDR brachytherapy.	The Kobold®Prostate HDRTemplate(s) andKobold® HDRStepper Template(s)are indicated for useas an accessory forhigh dose ratebrachytherapytreatment of theprostate.	ASSISTO® Arm Systemsconsist of a table-mountedendoscope holder systemintended for use by surgeonsto hold endoscopes andarthroscopes with a diameterof 2.7mm to 10mm duringgeneral diagnostic andtherapeutic procedures. Thedevice is also intended foruse by qualified surgeons forholding endoscopes duringdiagnostic and therapeuticneurologic procedures.
Design	Tubular, articulated armconnected to a vertical,table-mounted stand andprovided with a screw-clamp holdingcomponent. The positionof the articulated arm isfreely adjustable withinthe articulating radius.	Template providedwith holes in a gridarray and a lockingmechanism to lockneedles in place. Thetemplate is equippedwith four suture holesto secure it to theperineum during use.	Tubular, articulated armconnected to a vertical,table-mounted stand andprovided with a selection ofscrew clamp holdingcomponents. The position ofthe articulated arms is freelyadjustable within thearticulating radius.
WorkingLength	310 mm	N/A	310 mm
Materials	Stainless steel andthermoplast polyamid	N/A	Stainless steel andthermoplast polyamid
PatientContact	No patient contact	Intact skin	No patient contact
Sterility	Non-sterile	Non-sterile	Non-sterile
Reusable	Yes	No	Yes

Comparison Table:

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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.

Regulation Number and Section

§ 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.