Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical applicator for brachytherapy and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The device is used to deliver a prescribed radiation dose for the treatment of carcinoma, which is a therapeutic purpose.

Diagnostic

No
The device is described as an applicator for delivering radiation during brachytherapy, which is a treatment procedure, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "specialized applicator" that is "temporarily inserted into the vagina or rectum," indicating a physical, hardware-based medical device. The performance studies also focus on physical characteristics like dimensional measurements, bond strength, and balloon performance.

IVD (In Vitro Diagnostic)

Based on the provided information, the GentleCare AR Applicator is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
GentleCare AR Applicator's Function: The GentleCare AR Applicator is a device that is inserted into the body (vagina or rectum) to deliver radiation for treatment. It does not analyze specimens taken from the body.

Therefore, the GentleCare AR Applicator falls under the category of a therapeutic device used for delivering treatment, not an in vitro diagnostic device used for analyzing samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

JAQ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Vagina or rectum

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)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Capri Applicator (K092822)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 Carpenter
President
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

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.

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 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.	The CAPRI 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 CAPRI
Applicator is provided sterile
for single use and is disposable	The device description is the same.
Intended Use	Intended for use during
brachytherapy procedures. The
multiple lumens of the	Intended for use during
brachytherapy procedures. The
multiple lumens of the CAPRI	Same Indications for Use

	GentleCare AR Applicator are
intended to provide pathways
from which a prescribed radiation
dose is delivered to the treatment
area.	applicator are intended to
provide pathways from which a
prescribed radiation dose is
delivered to the treatment area.
Length	Balloon: 10cm; Device: 20cm	Balloon: 8.5cm; Device: 15cm	The small differences in the balloon
length does not affect the safety or
efficacy of the device's ability to
interface with the Afterloader or the
delivery of physician controlled
therapy
Diameter	6cm	Balloon: 4cm when inflated	The diameter difference does not
affect the safety of the device as the
inflation of both devices is controlled
by the physician with the diameter
based on the individual patient's
anatomy
Deflated insertion
diameter	2cm	3.3cm	The diameters are equivalent for the
insertion of the device to the target
area
Number of treatment
lumens	8: 8 evenly spaced in a single
concentric ring	13: 12 evenly spaced in two
concentric rings (with six
lumens each) surrounding 1
central lumen.	During the treatment planning, the
number of lumens are considered in
the determination of the treatment
plan. The main issue is the
concentricity of the treatment lumens
which allow the physician to develop
an appropriate treatment plan.
Number of
expandable baffles	2	2	Same
Location of lumens	Inner baffle	Inner baffle	Same
Inner expandable
baffle	Air	Foam	Both inner baffles serve the same
purpose - to space the treatment
lumens in a circumferential array
Outer expandable
baffle	Air	Air	Same
Method of
visualization	X-ray	X-ray	Same
Conforming
treatment length	10cm	8.5cm	The treatment length is slightly longer
for the subject device. As stated
previously, the treatment plan is pre-
determined by the physician based on
the device itself. Therefore, the safety
profile of both devices is equivalent.

2

·

י

3

| Compatible
Afterloaders | VariSource 200- AL13301000
(channels 1-10)
VariSource 200-AL13301001
(channels 11-20)
VariSource 200-AL07356001
(channel X)
Varian GammaMedplus
Nucletron microSelectron
Digital microSelectron-HDR | VariSource 200- AL13301000
(channels 1-10)
VariSource 200-AL13301001
(channels 11-20)
VariSource 200-AL07356001
(channel X)
Varian GammaMedplus
Nucletron microSelectron
Digital microSelectron-HDR | All Afterloaders connect to 6 Fr
catheters. The connection interface is
also the same. |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Method of
sterilization | Ethylene Oxide | E-beam | Both devices are supplied sterile.
Both methods for sterilization are well
known and acceptable for medical
devices |
| 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 placed
inside outer box | Paperboard insert in sterile
pouch; IFU on 8"x11" paper;
both placed inside outer box | Same |
| Materials | Biocompatible | Biocompatible | The GC MedTech device was tested to
the ISO10993 standard and found to
be biocompatible. As the CAPRI
device was reviewed and cleared by
FDA, we assume the materials of
construction for the CAPRI are
biocompatible 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

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