(356 days)
No
The device description explicitly states that the devices do not contain or consist of software/firmware, and there are no mentions of AI, DNN, or ML in the provided text. The device is a physical applicator accessory for brachytherapy.
Yes
The device is described as an accessory for brachytherapy, which is a form of radiotherapy used to treat cancer. Its intended use is for interstitial brachytherapy treatments for various cancers, directly addressing a medical condition.
No
These devices are described as "applicator accessories for Brachytherapy" for guiding radioactive sources for treatment, not for diagnosing conditions.
No
The device description explicitly states, "The devices do not contain or consist of software/firmware."
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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The Kelowna GYN and Crook Prostate Templates are described as "applicator accessories for Brachytherapy." Their function is to guide a radioactive source to specific locations within the body for cancer treatment. They are used in vivo (within the living body) during a medical procedure, not in vitro (in a test tube or laboratory setting) on a sample.
- Intended Use: The intended use is for "interstitial brachytherapy treatments for gynecological and rectal/anal cancer" and "interstitial brachytherapy treatments for prostate cancer." This is a therapeutic application, not a diagnostic one.
The device is a medical device used in a therapeutic procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / Indications for Use
The Kelowna GYN Templates are interstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy. The Crook Prostate Templates are intended for interstitial brachytherapy treatments for prostate cancer using HDR or PDR brachytherapy.
Product codes
JAQ
Device Description
The Kelowna GYN and Crook Prostate Templates are applicator accessories for Brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicators act to guide the radioactive source to the correct location or locations for treatment.
The devices do not contain or consist of software/firmware. The devices do not contain any biologics or drug components. The devices have patient-contacting materials. The devices are designed for repeated use. No parts of the system are provided sterile. The devices can be steam sterilized with common parameters using pre-vacuum sterilization. These devices are used on both female and male patients.
The Kelowna GYN and Crook Prostate Templates are compatible with the following Varian Afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.
The Kelowna GYN and Crook Prostate Templates are CT compatible.
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Compatible / CT compatible
Anatomical Site
Pelvic, vaginal, female urethral, cervical, prostatic and rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
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 Tests:
- Biocompatibility Testing: Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Tests included Cytotoxicity, Sensitization, Irritation, System Toxicity, Subacute Toxicity, and Implantation.
- Sterilization Testing: Assessed effectiveness of cleaning, disinfection, and sterilization procedures. Components subjected to sterilization cycles up to stated use life and evaluated for performance and damage.
- Electrical Safety and Electromagnetic Compatibility (EMC): Not applicable.
- Software Verification and Validation Testing: Not applicable (no software/firmware).
- Mechanical and Acoustic Testing: Included CT Compatibility Tests and Analysis, and Verification and Validation Testing for Applicator Design Specifications.
- Animal Study / Clinical Tests: No animal studies or clinical tests included.
Key Results: The non-clinical tests support the safety and effectiveness of the device under specified use conditions. The validation and verification testing demonstrates that the subject devices perform comparably to the predicate device, meeting the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
Varian Medical Systems, Inc. % Mr. Peter Coronado Director. Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
Re: K162533
Trade/Device Name: Kelowna Gyn and Crook Prostate Templates Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 14, 2017 Received: August 18, 2017
Dear Mr. Coronado:
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 comply with 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 device
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael D. O'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162533
Device Name
Kelowna GYN and Crook Prostate Templates
Indications for Use (Describe)
The Kelowna GYN Templates are interstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy. The Crook Prostate Templates are intended for interstitial brachytherapy treatments for prostate cancer using HDR or PDR brachytherapy.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
A partner for life
Varian Medical Systems, Inc. Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038
Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
510k Summary
510(k) Submission for the Kelowna GYN and Crook Prostate Templates
As required by 21 CFR 807.92, Reference: FDA's Guidance Document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" (June 2014).
SUBMITTER l.
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way,
Palo Alto CA 94304-1038 |
|-------------------|-----------------------------------------------------------------------|
| Contact Name: | Peter J. Coronado |
| Position: | Director, Regulatory Affairs |
| Phone: | 1.650.424.6230 |
| Fax: | 1.650.646.9200 |
| Email: | submissions.support@varian.com |
| Date Prepared: | August 25, 2016 |
II. DEVICE
| Name of Devices: | Kelowna GYN and Crook Prostate Templates |
|---|---|
| Common/Usual Name: | System, Applicator, Radionuclide, Remote-Controlled |
| Regulation Name: | Remote controlled radionuclide applicator system (21 CFR 892.5700) |
| Regulatory Class: | |
| Product Code: | Class II |
| JAQ |
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PREDICATE DEVICE lll.
GammaMed Plus High Dose Rate Remote Name of Predicate: Afterloading System
510k Number: K983436
DEVICE DESCRIPTION IV.
The Kelowna GYN and Crook Prostate Templates are applicator accessories for Brachytherapy. Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan. The treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicators act to guide the radioactive source to the correct location or locations for treatment.
The devices do not contain or consist of software/firmware. The devices do not contain any biologics or drug components. The devices have patient-contacting materials. The devices are designed for repeated use. No parts of the system are provided sterile. The devices can be steam sterilized with common parameters using pre-vacuum sterilization. These devices are used on both female and male patients.
The Kelowna GYN and Crook Prostate Templates are compatible with the following Varian Afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™.
The Kelowna GYN and Crook Prostate Templates are CT compatible.
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
5
The associated components of the Kelowna GYN and Crook Prostate Templates include:
| Product Number | Component List | Associated
510(k) | Refer ISD |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|-----------------------------|
| GM11012200 | Kelowna GYN Template for 2.0 mm needles, including
locking collets (pack of 25) and needle collet wrench | | |
| GM11012210 | Kelowna GYN Template for 16 gauge (1.65 mm) needles,
including locking collets (pack of 25) and needle collet
wrench | | |
| GM11012220 | Kelowna GYN Template for 17 gauge (1.47 mm) needles,
including locking collets (pack of 25) and needle collet
wrench | | Kelowna
GYN and
Crook |
| GM11012230 | Crook Prostate Template for 2.0 mm needles, B-K labelling,
including locking collets (pack of 25) and needle collet
wrench | This 510(k) | Prostate
Templates |
| GM11012240 | Crook Prostate Template for 17 gauge (1.47 mm) needles, B-
K labelling, including locking collets (pack of 25)
and needle collet wrench | | |
| GM11012250 | Crook Prostate Template for 2.0 mm needles, Siemens
labelling, including locking collets (pack of 25) and needle
collet wrench | | |
| GM11012260 | Crook Prostate Template for 17 gauge (1.47 mm) needles,
Siemens labelling, including locking collets (pack of 25) and
needle collet wrench | | |
INDICATIONS FOR USE V.
Indications for Use Statement: The Kelowna GYN Templates are intended for interstitial brachytherapy treatments for gynecological and rectal/anal cancer using HDR or PDR brachytherapy. The Crook Prostate Templates are intended for interstitial brachytherapy treatments for prostate cancer using HDR or PDR brachytherapy.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both subject and predicate devices are intended for use in the treatment of cancer through interstitial brachytherapy.
| | CLEARED DEVICE
FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE | NEW / MODIFIED DEVICE |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE AND/OR
SPECIFICATION | 510(K) K983436 GAMMAMED
PLUS HIGH DOSE RATE
REMOTE AFTERLOADING
SYSTEM
(GM11004650 PROSTATE AND
PERINEAL IMPLANT
TEMPLATED
SET IS LISTED IN
ATTACHMENT B, PAGE 11) | KELOWNA GYN TEMPLATES | CROOK PROSTATE TEMPLATES |
| Intended use | The intended use of the
GammaMed Plus transportable
high-dose-rate remotely
controlled afterloading
brachytherapy device is for the
treatment of cancer by
intracavitary, interstitial,
intralumenal and intraoperative
irradiation. | The Kelowna GYN Templates
are intended for interstitial
brachytherapy treatments for
gynecological and rectal/anal
cancer using HDR an PDR
brachytherapy. | The Crook Prostate Templates
are intended for interstitial
prostate cancer using HDR or
PDR brachytherapy. |
| Indication for
use | The intended use of the
GammaMed Plus transportable
high-dose-rate remotely
controlled afterloading
brachytherapy device is for the
treatment of cancer by
intracavitary, interstitial,
intralumenal and intraoperative
irradiation. | The Kelowna GYN
Templates are intended for
interstitial brachytherapy
treatments for gynecological
and rectal/anal cancer using
HDR and PDR brachytherapy. | The Crook Prostate Templates
are intended for interstitial
prostate cancer using HDR or
PDR brachytherapy. |
| Applicator
Design | Various Plates (Templates) with
10 x 10mm hole geometry
pattern;
Cylinder, length 130mm, Ø
24.9mm;
Needle: length 200mm,
Ø1.65mm;
Needle stopper/holder for
1.65mm needles;
Pipe screw driver | Kelowna GYN Templates for
16 gauge, 17 gauge and Ø 2
mm needles
Dosimetry based hole
geometry pattern;
Locking collets for fixation of
needles;
Needle collet wrench to
securely affix the needles | Crook Prostate Templates
for 17 gauge and Ø 2 mm
needles
5 x 5 mm hole geometry pattern;
Locking collets for fixation of
needles;
Needle collet wrench to securely
affix the needles |
| Compatible
Afterloader | GammaMed Plus Afterloader
Series | GammaMed Plus Afterloader
Series | GammaMed Plus Afterloader
Series |
| | GammaMed 12i(t) | VariSource Afterloader Series | VariSource Afterloader Series |
| Component List | Base plate for 1.65mm steel needles Cover plate II without cylinder hole, with fixation screws Cover plate III with centered cylinder hole with fixation screws Cover plate IV with de-centered cylinder hole, with fixation screws Cylinder, length 130mm, 24.9mm diameter Base plate filling piece for needles Cover plate filling piece for cylinder with fixation screws Needle stopper for 1.56mm needles Pipe screwdriver Stainless Steel needle, 200mm, 1.65mm diameter Sterilization plugs (pack of 25) Cleaning caps, white (pack of 20) | Kelowna GYN Template for Ø 2.0 mm needles, including locking collets (pack of 25) and needle collet wrench Kelowna GYN Template for 16 gauge (1.65 mm) needles, including locking collets (pack of 25) and needle collet wrench Kelowna GYN Template for 17 gauge (1.47 mm) needles, including locking collets (pack of 25) and needle collet wrench | Crook Prostate Template for Ø 2.0 mm needles, B-K labelling, including locking collets (pack of 25) and needle collet wrench Crook Prostate Template for 17 gauge (1.47 mm) needles, B-K labelling, including locking collets (pack of 25) and needle collet wrench Crook Prostate Template for 2.0 mm needles, Siemens labelling, including locking collets (pack of 25) and needle collet wrench |
| | Channel marker clips, code 1-12 Channel marker clips, coded 13-24 Leak stop buttons, non-sterile, pack of 50 | | |
| Materials | Template: PPSU
Needle stopper: Stainless Steel
Screw Driver: Stainless Steel | Template: PEEK
Locking collets: Titanium
Needle collet wrench: Stainless Steel | Template: PEEK
Locking collets: Titanium
Needle collet wrench: Stainless Steel |
| Packing | Individual | Individual | Individual |
| Sterility | Provided in non-sterile condition
Sterilized by user prior to use | Provided in non-sterile condition
Sterilized by user prior to use | Provided in non-sterile condition
Sterilized by user prior to use |
| Cleaning
Method | Manual cleaning | Manual cleaning
Machine cleaning | Manual cleaning
Machine cleaning |
| Sterilization
method | Steam Sterilization | Steam Sterilization | Steam Sterilization |
| Biocompatibility | Fully biocompatible | Fully biocompatible | Fully biocompatible |
| Anatomical sites | Pelvic, vaginal, female urethral,
cervical, prostatic and rectal | Pelvic | Pelvic |
| Compatibility
with Imaging
Environment | CT Compatible | CT compatible | CT compatible |
| Supporting
Accessories | Required:
interstitial accessory kit
Optional:
screws for cover platesource guide tube support16G stainless steel
needle, 113mm trocar | Required:
Ø 2.0 mm Plastic Interstitial Needles (K141624) 17G (1.47mm) Titanium and Stainless Steel Interstitial Needles (K160815) 16G (1.65mm) Titanium and Stainless Steel Interstitial Needles (K160815) Optional: 25mm diameter cylinders of the Universal | Required:
Ø 2.0 mm Plastic Interstitial Needles (K141624) 17 gauge (1.47mm) Titanium and Stainless Steel Interstitial Needles (K160815) Optional: Bard (Amertek) adapter Blue locking collets for Ø 2.0 mm needles |
| | point | Segmented Cylinder Applicator Set and Universal Stump Applicator Set | |
| | Source guide tube with locking mechanism for 180mm needles | Blue locking collets for Ø 2.0 mm needles Locking collets for 16 G and 17 G needles Needle collet wrench | Locking collets for 16 G and 17 G needles Needle collet wrench |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room | Brachytherapy treatment room |
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8
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VI. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Non-Clinical Tests:
Biocompatibility Testing:
The biocompatibility evaluation for the subject devices was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. This included the following tests:
- Cytotoxicity ●
- . Sensitization
- Irritation ●
- System Toxicity ●
- Subacute Toxicity ●
- Implantation
According to ISO 10993-1 the components of the Kelowna GYN and Crook Prostate Templates are categorized as a medical device, surface device in contact with breached or compromised surfaces and prolonged contact duration (>24h to 30d). (B).
10
Sterilization Testing:
Sterilization testing for the subiect devices were conducted to assess the effectiveness of the provided cleaning, disinfection, and sterilization procedures for the device. Furthermore, the components of the subject set were subjected to sterilization cycles up to the stated use life and evaluated for performance and any damage that might affect safety or effectiveness.
- . Validation/Efficacy Testing of Cleaning, Disinfection, and Sterilization Cycles
- Verification of the Suitability of Applicator Design and Material for the Stated Use Life and Reprocessing Cycles
Electrical Safety and Electromagnetic Compatibility (EMC):
This item is not applicable to the subject devices. No electrical safety and electromagnetic compatibility tests have been included in this submission in support of the substantial equivalence determination.
Software Verification and Validation Testing:
This item is not applicable to the subject devices; the devices do not contain or consist of software/firmware. No software verification and validation testing have been included in this submission in support of the substantial equivalence determination.
Mechanical and Acoustic Testing:
- . CT Compatibility Tests and Analysis
- Verification and Validation Testing for Applicator Design Specifications .
Declaration of Conformity:
The following list are standards to which the subject devices conformity:
- . AAMI TIR-12:2010
- AAMI TIR-30:2011
- ANSI/AAMI ST-79:2010/A2:2011/A3:2012/A4:2013 (R 2014) ●
- ANSI/AAMI ST-81:2004/(R)2010
- IEC 62366 ●
- ISO 10993-1:2009 ●
11
- ISO 10993-5:2009 ●
- ISO 10993-10:2009
- ISO 17664:2004
- ISO 17665-1: 2006
- ISO 14937:2009/(R)2013 .
Animal Study / Clinical Tests:
No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination.
VII. CONCLUSIONS
The results of the non-clinical tests support the safety and effectiveness of the device under the specified use conditions. Varian believes that the validation and verification testing demonstrates that the subject devices perform comparably to the predicate device, meeting the intended use.