The RadiaPak™ Brachytherapy Applicator Balloon Device is a single use, non-sterile, disposable, inflatable, non-powered positioning device, manufactured without the use of latex, intended to be used on a daily treatment basis to position and stabilize the brachytherapy radiation delivery applicator within the vagina or rectum during brachytherapy radiation therapy procedures, x-ray, or computed tomography (CT) exam. The placement of the balloon device requires a physician directed healthcare professional.

Device Description

The RadiaPak™ Device is designed to position and stabilize the brachytherapy applicator and to space the applicator surface from the targeted vaginal or rectal mucosa during computed tomography and brachytherapy procedures. The proposed device is a latex free balloon and can be inflated with either air or saline, is provided non-sterile, and is intended for single use.

AI/ML Overview

The provided text describes a 510(k) submission for the RadiaPak™ Brachytherapy Applicator Balloon Device. This document does not include detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.

Instead, this is a traditional medical device submission based on substantial equivalence to predicate devices. For such devices, the "acceptance criteria" are primarily related to general safety and effectiveness characteristics, and the "study" is a comparison to legally marketed predicate devices, along with performance testing and biocompatibility testing.

Here's an attempt to answer your questions based on the provided text, recognizing that it's not a SaMD-style submission with AI performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a physical medical device cleared via substantial equivalence), the "acceptance criteria" are implied by the characteristics of the predicate devices and general regulatory requirements for safety and effectiveness. The "reported device performance" demonstrates that the new device meets these implied criteria.

Acceptance Criteria (Implied by Predicate Devices & Regulatory Standards)	Reported Device Performance (RadiaPak™)
Intended Use: Position and stabilize brachytherapy radiation delivery applicator within vagina or rectum during brachytherapy, x-ray, or CT.	Meets this exact intended use.
Material Biocompatibility: Non-toxic, non-irritating, non-sensitizing for mucosal membrane contact.	Biocompatibility testing performed in accordance with ISO 10993-1.
Mechanical Performance: - Inflatable and Deflatable - Balloon Fill Volume and Pressure - Flexible - Expands	- Inflatable: Yes - Deflatable: Yes - Performance testing to determine balloon fill volume and fill pressure completed. - Flexible: Yes - Expands: Yes
Treatment Area: Vaginal or rectal mucosa compatibility.	Vaginal or rectal mucosa compatibility.
Body Contact Area: Mucosal Membrane.	Mucosal Membrane.
Procedure Time: Approx. ≤ 90 minutes.	Approx. ≤ 90 minutes.
Single Use: Designed for single use.	Yes, single use.
Inflation Medium: Compatibility with air, saline, or water.	Pressurized with air, saline, water.
Connection Type: Functioning connection mechanism.	Stopcock valve.
Sterility: Whether supplied sterile or non-sterile is a characteristic, not an acceptance value.	Supplied non-sterile.
Latex-free: If aiming for latex-free status.	Manufactured without the use of latex.
No new questions of safety or effectiveness.	Differences to predicates do not raise new questions of safety/effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. This submission relies on non-clinical testing (biocompatibility and performance) and comparison to predicate devices, not clinical data from a test set of patients in the way an AI/SaMD product would.
Data Provenance: Not applicable for a clinical test set. The data provenance for biocompatibility and performance testing would be from in vitro or in vivo (animal) lab studies, but the document does not specify the country or whether it was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no clinical test set requiring expert ground truth in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical test set.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is a physical medical device, not an AI/SaMD. No MRMC study was performed.

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

No. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable for a clinical ground truth. For the non-clinical performance and biocompatibility testing, the "ground truth" would be established by validated test methods and passing criteria defined by relevant industry standards (e.g., ISO 10993 for biocompatibility) and engineering specifications.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

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

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

Summary

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Image /page/0/Picture/0 description: The image shows the logo for "RADIADYNE". Above the company name is a stylized atom symbol. Below the company name is the phrase "REDEFINING RADIATION THERAPY".

120344
MAY - 3, 2012

5. 510(K) Summary

Submission Correspondent

Company Name:

Company Address:

Company Contact:

Country:

Phone:

Fax:

Submission Date:

Website:

Submission Sponsor

Company Name:

Company Address:

Country:

Phone:

Fax:

Website:

Device Classification

Device Trade Name:

Product Classification Name:

Product Code:

Emergo Group, Inc.

611 West 5th Street Third Floor Austin, TX 78701

Stuart R. Goldman Senior Consultant project.management@emergogroup.com

USA

512.327.9997

512.327.9998

January 16, 2012

www.emergogroup.com

RadiaDyne, LLC (Specification Developer)

11931 Wickchester Lane Suite 360 Houston, TX 77043

USA

281.759.9600

281.759.9609

www.radiadyne.com

RadiaPak™ Brachytherapy Applicator Balloon Device System, Applicator, Radionuclide, Remote-Controlled

JAQ

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Image /page/1/Picture/0 description: The image shows the logo for "RADIADYNE REDEFINING RADIATION THERAPY". Above the text is a symbol that looks like three intersecting circles. The text is in all caps and is a sans-serif font.

Image /page/1/Picture/1 description: The image shows the logo for Emergo Group. The logo consists of the words "EMERGO" and "GROUP" in a simple, sans-serif font, with a stylized circular graphic between them. The graphic is black and white and appears to be an abstract representation of a globe or a spiral.

Regulation Number:	892.5700
Classification Panel:	Radiology
Regulatory Class:	Class 2

Predicate Devices

Capri™ Applicator (K092822)
Alatus® Vaginal Balloon Packing System (K092534)

Indications for Use

Device Description

Predicate Device Comparison

Comparison OfRadiaPak™ vs. Alatus® vs. Capri™ Devices
Device Information	RadiaPak™	Alatus®(K092534)	Capri™(K092822)
Product Code	JAQ	JAQ	JAQ
Regulation Number	892.5700	892.5700	892.5700
Classification Name	System, applicator,radionuclide, remote-controlled	System, applicator,radionuclide, remote-controlled	System, applicator,radionuclide, remote-controlled
Device Material	Polyurethane(balloon/shaft)	Polyurethane(balloon/shaft)	PVC(bulb/lumens)

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Image /page/2/Picture/0 description: The image shows the logo for Radiadyne, a company that specializes in radiation therapy. The logo features a stylized atom symbol above the company name, which is written in a modern, sans-serif font. Below the company name is the tagline "Redefining Radiation Therapy," which highlights the company's mission and focus.

Flexible	Yes	Yes	Yes
Treatment Area	Vaginal or rectal mucosa	Vaginal mucosa	Vaginal or rectal mucosa
Body Contact Area	Mucosal Membrane	Mucosal Membrane	Mucosal Membrane
Procedure Time	$≈≤$ 90 minutes	$≈≤$ 90 minutes	$≈≤$ 90 minutes
Single Use	Yes	Yes	Yes
Supplied Sterile	No	No	Yes
Inflatable	Yes	Yes	Yes
Pressurized With	Air, saline, water	Air, saline, water	Air or saline
Connection Type	Stopcock valve	Stopcock valve	Not applicable
Expands	Yes	Yes	Yes
Deflates	Yes	Yes	Yes

Non-Clinical Data - Biocompatibility & Performance Testing

As part of demonstrating the safety and effectiveness of the RadiaPak™ Device and in showing substantial equivalence to the predicate devices. RadiaDyne performed biocompatibility testing in accordance with ISO 10993-1, as well as performance testing to determine balloon fill volume and fill pressure.

Clinical Data

RadiaDyne's is not submitting any clinical data in support of its 510(k) submission to the FDA for the RadiaPak™ Device as no such clinical data was submitted by VivaRay for its Capri™ Applicator or by RadiaDyne for its Alatus® Vaginal Balloon Packing System.

Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness compared to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for "RADIADYNE REDEFINING RADIATION THERAPY". Above the word RADIADYNE is a symbol that looks like an atom with three rings around it. The words "REDEFINING RADIATION THERAPY" are in smaller font below the word RADIADYNE.

Image /page/3/Picture/1 description: The image shows the logo for EMERGO GROUP. The logo consists of the words "EMERGO" and "GROUP" in a sans-serif font, with a stylized globe symbol in between. The globe symbol is black and white and appears to be made up of curved lines.

lt has been shown in this 510(k) submission that the differences between the RadiaPak™ Brachytherapy Applicator Balloon Device and both the Capri™ Applicator and the Alatus® Vaginal Balloon Packing System do not raise any questions regarding its safety and effectiveness. RadiaDyne's RadiaPak™ Device, as designed and manufactured, is therefore determined to be substantially equivalent to the Capri™ and Alatus® devices previously cleared under K092822 and K092534, respectively.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, abstract design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

RadiaDyne, LLC % Mr. Stuart R. Goldman Senior Consultant Emergo Group, Inc. 611 West 5th Street, Third Floor AUSTIN TX 78701

MAY - 3 2012

Re: K120344

Trade/Device Name: RadiaPak™ Brachytherapy Applicator Balloon Device Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ and IYE Dated: January 16, 2012 Received: February 3, 2012

Dear Mr. Goldman:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or any 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours, Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number (if known):

Prescription Use 区

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Muht DDK
(Division Sign-Off)

Division of Radiological De Office of In Vitro Diag tion and Selety

K120344

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.