The GentleCare AR Applicator is Intended for use during brachytherapy procedures. The nultiple lumens of the GC MedTech device are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Device Description

The GentleCare AR Applicator is a specialized applicator that is temporarily inserted into the vagina or rectum to facilitate the application of radiation to the target site in the treatment of carcinoma. The GentleCare AR Applicator is provided sterile for single use and is disposable.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the GentleCare AR Applicator:

Disclaimer: The provided text is a 510(k) summary for a medical device. These summaries are intended to demonstrate substantial equivalence to an existing predicate device, not necessarily to prove the device's efficacy through a rigorous clinical trial in the same way a new drug would. Therefore, the "study" described is primarily focused on engineering and biocompatibility testing, rather than clinical performance (e.g., diagnostic accuracy or treatment outcomes).

Acceptance Criteria and Device Performance for GentleCare AR Applicator

The provided documentation describes the acceptance criteria and performance for the GentleCare AR Applicator, primarily focusing on its equivalence to a predicate device (CAPRI Applicator) through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" and "reported device performance" in a direct comparative table for clinical outcomes, as this is a 510(k) for a device demonstrating substantial equivalence, not a novel device requiring extensive clinical efficacy studies. Instead, the acceptance criteria are implicitly tied to meeting engineering and biocompatibility standards, and the performance is demonstrated by similarity to the predicate and successful completion of specified tests.

Implied Acceptance Criteria and Performance based on Non-Clinical Testing:

Category	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Meet ISO10993 standards for cytotoxicity, sensitization, irritation.	Tested per ISO10993 and found to be biocompatible.
Dimensional	Within acceptable manufacturing tolerances.	Testing completed and met all acceptance criteria.
Visual Inspection	Free from defects, proper assembly.	Testing completed and met all acceptance criteria.
Balloon Inflation	Proper inflation mechanism and integrity.	Testing completed and met all acceptance criteria.
Balloon Deflation	Proper deflation mechanism.	Testing completed and met all acceptance criteria.
Balloon Burst	Withstand specified pressure without premature burst.	Testing completed and met all acceptance criteria.
Bond Strength	Adequate bond strength for components.	Testing completed and met all acceptance criteria.
Mechanical Performance	Meet design specifications for mechanical integrity.	Testing completed and met all acceptance criteria.
Overall Performance	Function as intended for brachytherapy procedures.	Testing completed and met all acceptance criteria.
Sterilization	Maintain sterility upon delivery.	Ethylene Oxide sterilization method is well known and acceptable.
Single Use & Shelf Life	Disposable, with specific shelf life.	Designed for single use, 180 days shelf life.

Note: The "acceptance criteria" are inferred from the types of non-clinical tests performed. The document simply states that "Product testing was completed and met all of the acceptance criteria," without detailing the specific numeric or qualitative thresholds for each test.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample size for each non-clinical test (dimensional measurements, visual inspection, balloon inflation, etc.). It generally states "Product testing was completed." This implies that a sufficient number of units were tested to provide statistical confidence in the results, as per standard engineering testing protocols, but the specific numbers are not provided in this summary.
Data Provenance: The data is generated from non-clinical testing of the manufactured device. This is internal testing performed by the applicant (GC MedTech, LLC) or a contracted lab. The data is prospective in the sense that the tests were specifically conducted for this submission. The "country of origin" for the data is not specified beyond being generated by the applicant, who is based in the US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this 510(k) submission. The ground truth for engineering and biocompatibility tests is established by industry standards (e.g., ISO10993) and the device's design specifications, not by expert consensus on clinical data. No "experts" were used in the sense of clinical reviewers establishing ground truth for a test set of patient data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers interpreting clinical data, which is not the nature of the tests performed for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study assesses how AI impacts human reader performance (e.g., diagnostic accuracy, efficiency). The GentleCare AR Applicator is a physical medical device (brachytherapy applicator), not an AI algorithm. Therefore, an MRMC study is not relevant to its clearance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical brachytherapy applicator, not an algorithm. Its performance is inherent in its physical properties and function, always used with a human operator and remote afterloading equipment.

7. Type of Ground Truth Used

The "ground truth" for this device's testing is based on:

Engineering Specifications: The design parameters and functional requirements of the device (e.g., dimensions, bond strength, balloon integrity).
Biocompatibility Standards: Adherence to established international standards like ISO10993, which define acceptable levels for cytotoxicity, sensitization, and irritation.
Predicate Device Characteristics: The characteristics of the legally marketed predicate device (Capri Applicator, K092822) serve as a benchmark for substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This device is hardware, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI algorithm, there is no ground truth related to one for this device.

Summary of the "Study" (Non-Clinical Testing):

The "study" or testing performed for the GentleCare AR Applicator was non-clinical in nature, designed to demonstrate its safety and performance equivalence to a legally marketed predicate device. This involved:

Biocompatibility Testing: According to ISO10993 standards (cytotoxicity, sensitization, irritation).
Engineering and Performance Testing: Including dimensional measurements, visual inspection, balloon inflation/deflation/burst tests, bond strength, and overall mechanical performance.

The success of these tests, along with a detailed comparison of its characteristics to the predicate device, formed the basis for the FDA's determination of substantial equivalence (K133922). The FDA letter confirms the device was found substantially equivalent for its stated indications for use.

Summary

{0}------------------------------------------------

510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

APPLICANT:	GC MedTech, LLC
TRADE NAME:	GentleCare AR Applicator
COMMON NAME:	Brachytherapy Applicator
CLASSIFICATION NAME:	Remote Controlled Radionuclide Applicator System, 21 CFR 892.5700
DEVICE CLASSIFICATION:	Class II
PRODUCT CODE:	JAQ
PREDICATE DEVICES:	Capri Applicator (K092822)
CONTACT	Colin CarpenterPresident
DATE:	December 16, 2013

Substantially Equivalent to:

The GentleCare AR Applicator is equivalent in intended use, principal of operation and technological characteristics to the CAPRI Applicator (K092822).

Description of the device subject to premarket notification

Indications for Use

The Gentle Care AR Applicator is intended for use with commercially available remote afterloading equipment used during brachytherapy procedures. The multiple lumens of the GentleCare AR Applicator are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

{1}------------------------------------------------

Materials

All materials used in the manufacture of the GentleCare AR Applicator are suitable for this use and have been used in numerous previously cleared products. The GentleCare AR Applicator was tested per ISO10993 and found to be biocompatible. Testing included the following:

Cytotoxicity .
Sensitization .
. Irritation

Non-Clinical Testing

Product testing was completed and met all of the acceptance criteria. Testing included dimensional measurements, visual inspection, balloon inflation, balloon deflation, balloon burst, bond strength, mechanical and performance.

Performance Data:

All necessary verification and validation testing has been performed for the GentleCare AR Applicator to assure substantial equivalence to the predicate devices.

Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the GentleCare AR Applicator is determined by GC MedTech, to be substantially equivalent to existing legally marketed devices.

Trade name	GC MedTech System	CAPRI Applicator	SE Discussion
Product code	JAQ	JAQ	Same product code - JAQ
510k number	K133922	K092822
Device Classification	II	II	Same - Class II
Device description	The GentleCare AR Applicator isa specialized applicator that istemporarily inserted into thevagina or rectum to facilitate theapplication of radiation to thetarget site in the treatment ofcarcinoma. The GentleCare ARApplicator is provided sterile forsingle use and is disposable.	The CAPRI Applicator is aspecialized applicator that istemporarily inserted into thevagina or rectum to facilitatethe application of radiation tothe target site in the treatmentof carcinoma. The CAPRIApplicator is provided sterilefor single use and is disposable	The device description is the same.
Intended Use	Intended for use duringbrachytherapy procedures. Themultiple lumens of the	Intended for use duringbrachytherapy procedures. Themultiple lumens of the CAPRI	Same Indications for Use

	GentleCare AR Applicator areintended to provide pathwaysfrom which a prescribed radiationdose is delivered to the treatmentarea.	applicator are intended toprovide pathways from which aprescribed radiation dose isdelivered to the treatment area.
Length	Balloon: 10cm; Device: 20cm	Balloon: 8.5cm; Device: 15cm	The small differences in the balloonlength does not affect the safety orefficacy of the device's ability tointerface with the Afterloader or thedelivery of physician controlledtherapy
Diameter	6cm	Balloon: 4cm when inflated	The diameter difference does notaffect the safety of the device as theinflation of both devices is controlledby the physician with the diameterbased on the individual patient'sanatomy
Deflated insertiondiameter	2cm	3.3cm	The diameters are equivalent for theinsertion of the device to the targetarea
Number of treatmentlumens	8: 8 evenly spaced in a singleconcentric ring	13: 12 evenly spaced in twoconcentric rings (with sixlumens each) surrounding 1central lumen.	During the treatment planning, thenumber of lumens are considered inthe determination of the treatmentplan. The main issue is theconcentricity of the treatment lumenswhich allow the physician to developan appropriate treatment plan.
Number ofexpandable baffles	2	2	Same
Location of lumens	Inner baffle	Inner baffle	Same
Inner expandablebaffle	Air	Foam	Both inner baffles serve the samepurpose - to space the treatmentlumens in a circumferential array
Outer expandablebaffle	Air	Air	Same
Method ofvisualization	X-ray	X-ray	Same
Conformingtreatment length	10cm	8.5cm	The treatment length is slightly longerfor the subject device. As statedpreviously, the treatment plan is pre-determined by the physician based onthe device itself. Therefore, the safetyprofile of both devices is equivalent.

{2}------------------------------------------------

{3}------------------------------------------------

CompatibleAfterloaders	VariSource 200- AL13301000(channels 1-10)VariSource 200-AL13301001(channels 11-20)VariSource 200-AL07356001(channel X)Varian GammaMedplusNucletron microSelectronDigital microSelectron-HDR	VariSource 200- AL13301000(channels 1-10)VariSource 200-AL13301001(channels 11-20)VariSource 200-AL07356001(channel X)Varian GammaMedplusNucletron microSelectronDigital microSelectron-HDR	All Afterloaders connect to 6 Frcatheters. The connection interface isalso the same.
Method ofsterilization	Ethylene Oxide	E-beam	Both devices are supplied sterile.Both methods for sterilization are wellknown and acceptable for medicaldevices
Single use	Y	Y	Same
Shelf life	180 days after production	360 days after production	This will be on the product label
Packaging	Paperboard insert in sterile pouch;IFU on 8"x11" paper; both placedinside outer box	Paperboard insert in sterilepouch; IFU on 8"x11" paper;both placed inside outer box	Same
Materials	Biocompatible	Biocompatible	The GC MedTech device was tested tothe ISO10993 standard and found tobe biocompatible. As the CAPRIdevice was reviewed and cleared byFDA, we assume the materials ofconstruction for the CAPRI arebiocompatible as well.

Conclusion

The substantial equivalence was determined based on the similarity of materials, design, indications for use, packaging and clinical application.

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

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

April 18, 2014

GC Medtech, LLC. % Gregory Mathison President Regulatory Strategies, INC. 3924 Cascade Beach Road LUTSEN MN 25612

Re: K133922

Trade/Device Name: Gentlecare AR Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: March 17, 2014 Received: March 25, 2014

Dear Mr. Mathison:

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. 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 or my 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Crice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{5}------------------------------------------------

Page 2-Mr. Mathison

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known): K133922

Device Name: GentleCare AR Applicator Indications For Use:

The GentleCare AR Applicator is Intended for use during brachytherapy procedures. The nultiple lumens of the GC MedTech device are intended to provide pathways from which a prescribed radiation dose is delivered to the treatment area.

Prescription Use _ S (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Mecha D'Hara

Page 1 of _ 1 __

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.