(252 days)
No
The device description and performance studies focus on the physical properties and safety of a catheter for brachytherapy, with no mention of AI or ML capabilities.
Yes
The device is used to provide access to tumor sites for treatment with high-dose rate irradiation, indicating a therapeutic purpose.
No
The device is described as an "applicator for intraluminal Brachytherapy" that acts to "guide the radioactive source to the correct location or locations for treatment." Its intended use is for "treatment of any case where high dose rate irradiation is an accepted clinical practice," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly details physical components made of PTFE and tungsten, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice." This describes a therapeutic application, not a diagnostic one.
- Device Description: The device is described as an "applicator for intraluminal Brachytherapy" that "acts to guide the radioactive source to the correct location or locations for treatment." This further reinforces its role in delivering treatment, not performing a diagnostic test on a sample from the body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens in a diagnostic manner.
The device is clearly intended for use in a therapeutic procedure (Brachytherapy) to deliver radiation treatment.
N/A
Intended Use / Indications for Use
The Standard Catheter Set is indicated for use to provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Standard Catheter Set (AL1311XXXX) is designed as an applicator for intraluminal Brachytherapy. The Standard Catheters are 4.7 French (1.6 mm in diameter) PTFE (Polytetrafluroethalene) catheters, which are supplied in nominal lengths of 100cm and 150cm with either a metal tip or plastic tip. The catheters can be readily inserted into small lumen. The metal tip catheter is sealed at the distal end with a small tungsten pluq for easy visualization under fluoroscopy. The distal end of the plastic catheter is tightly sealed to prevent body fluids from entering the lumen or extension of the source wire beyond the tip. The catheters are shipped with a pin plug in the open end to keep the lumen clean and to keep the opening round. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
The Standard Catheter Set is 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. The Standard Catheter Set is compatible with the Varian Afterloaders: VariSource iX™ and VariSource 200™.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is supplied non-sterile and is intended for single use only. This device is used on female and male patients. The device can be steam sterilized with common parameters using pre-vacuum steam autoclave sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Small lumen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Standard Catheter Set is 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:
The biocompatibility evaluation for the subject device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993-1, '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
- Systemic Toxicity
- Subchronic Toxicity
- Genotoxicity
- Implantation
Sterilization Testing:
Sterilization testing was performed for the subject device and 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.
- Steam Sterilization Validation Reports
- Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization Cycles
Electrical Safety and Electromagnetic Compatibility (EMC):
Not applicable.
Software Verification and Validation Testing:
Not applicable.
Mechanical and Acoustic Testing:
- CT Compatibility Test and Analysis
- Rationale MR Properties
Animal Study / Clinical Tests:
No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination.
Key results: 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 device performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in a way that "FDA" is on top, followed by "U.S. FOOD & DRUG", and then "ADMINISTRATION" at the bottom.
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304
February 9, 2018
Re: K171631
Trade/Device Name: Standard Catheter Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAO Dated: December 22, 2017 Received: January 3, 2018
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Mr. Peter Coronado
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D'Hara For
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)
Device Name Standard Catheter Set
Indications for Use (Describe)
The Standard Catheter Set is indicated for use to provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice.
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
Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a blue accent mark above the "I". Below the word "VARIAN" is the phrase "medical systems" in a smaller font. To the right of the word "VARIAN" is a vertical line, followed by the phrase "A part" in a light gray font.
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 Standard Catheter Set
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).
I. SUBMITTER
| Submitter's Name: | Varian Medical Systems
3100 Hansen Way, m/s C260
Palo Alto CA 94304-1038 |
|-------------------|--------------------------------------------------------------------------------|
| Contact Name: | Peter J. Coronado |
| Position: | Director, Regulatory Affairs |
| Phone: | 1.650.424. 6320 |
| Fax: | 1.650.646.9200 |
| Email: | submissions.support@varian.com |
| Date Prepared: | May 12, 2017 |
II. DEVICE
| Name of Device: | Standard Catheter Set |
|---|---|
| Common/Usual Name: | System, Applicator, Radionuclide, Remote- |
| Controlled | |
| Regulation Name: | Remote controlled radionuclide applicator |
| system (21 CFR 892.5700) | |
| Regulatory Class: | Class II |
| Product Code: | JAQ |
In this submission, some documents may reference the Standard Catheter Set by the common name Standard Catheters (AL1311XXXX).
4
III. PREDICATE DEVICE
Name of Predicate: Standard Catheters (as part of the Applicators for Varian Varisource Remote High Dose Rate Afterloader). K952913 510k Number:
Please note that the required and optional accessories listed in Section 3.4 of the Device Description have been previously cleared under the 510(k) premarket notifications K113766, K945383, and K952913.
IV. DEVICE DESCRIPTION
The Standard Catheter Set (AL1311XXXX) is designed as an applicator for intraluminal Brachytherapy. The Standard Catheters are 4.7 French (1.6 mm in diameter) PTFE (Polytetrafluroethalene) catheters, which are supplied in nominal lengths of 100cm and 150cm with either a metal tip or plastic tip. The catheters can be readily inserted into small lumen. The metal tip catheter is sealed at the distal end with a small tungsten pluq for easy visualization under fluoroscopy. The distal end of the plastic catheter is tightly sealed to prevent body fluids from entering the lumen or extension of the source wire beyond the tip. The catheters are shipped with a pin plug in the open end to keep the lumen clean and to keep the opening round. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
The Standard Catheter Set is 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. The Standard Catheter Set is compatible with the Varian Afterloaders: VariSource iX™ and VariSource 200™.
The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is supplied non-sterile and is intended for single use only. This device is used on female and male patients. The device can be steam sterilized with common parameters using pre-vacuum steam autoclave sterilization.
5
V. INDICATIONS FOR USE
Indications for Use Statement:
The Standard Catheter Set is indicated for use to provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both the subject and predicate devices are intended for use in the treatment of cancer through intraluminal brachytherapy. The subject device is based on a subset of applicators from the predicate device, Standard Catheters (as part of the K952913 Applicators for Varian Varisource Remote High Dose Rate Afterloader).
At a high level, the subject and predicate devices are based on the following similar technological elements:
- . Biocompatible Standard Catheters
- Same design ●
- Application in intraluminal brachytherapy treatments o
- Same anatomical treatment site/application ●
The following main differences exist between the subject and predicate devices:
- . Change and clarification to Intended Use and Indications for Use to apply specifically to Standard Catheter Set instead of the applicators for Varian Varisource Remote High Dose Rate Afterloader (K952913)
- The sterilization method for the standard catheter set is changed from . ethylene oxide and plasma sterilization to steam sterilization only
- A change to the material of the plastic tipped catheter from Nylon to . PTFE.
In addition to the changes listed above, other changes since the predicate device include the following:
- Verification of CT and MR compatibility
6
| | CLEARED DEVICE
FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FEATURE
AND/OR
SPECIFICATION | PREDICATE DEVICE: | SUBJECT DEVICE: |
| | Standard Catheters | STANDARD CATHETER SET |
| | (K952913 Applicators for Varian
Varisource Remote High Dose Rate
Afterloader) | |
| Compatible
Afterloader | • VariSource 200 and ID | • VariSource 200 and iX Series |
| Intended Use | The VariSource applicators and
accessories complete the VariSource
system, and as such their intended use
is the same as the parent VariSource
device.
The Varian VariSource Remote High
Dose Rate Afterloader system,
including the applicators and
accessories, is a device intended to be
used by properly trained and licensed
medical personnel to provide radiation
brachytherapy with a high specific
activity radioisotope source to reduce
the exposure times required to achieve
a prescribed dose. Remote operation of
the afterloader eliminates the necessity
of exposing medical personnel to
radiation during hand loading or hand
placement of radioactive sources on or
within the body of a patient. The
radioactive source is Iridium-192,
encapsulated in the end of a wire stored
in the afterloader and mechanically
driven from it to a precisely described
position for a specified dwell time during
treatment. Between treatments the wire
is retracted into the afterloader and the
source end resides in a tungsten-
shielded safe to limit personnel
exposures to an acceptable, safe level.
The Afterloader contains a radiation
detector which signals whenever the
source is not in the safe. | The Standard Catheter Set is
intended to provide access to
tumor sites for treatment of
any case where high dose rate
irradiation is an accepted
clinical practice. |
| | CLEARED DEVICE
FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE |
| | PREDICATE DEVICE: | SUBJECT DEVICE: |
| FEATURE
AND/OR
SPECIFICATION | Standard Catheters | STANDARD CATHETER SET |
| | (K952913 Applicators for Varian
Varisource Remote High Dose Rate
Afterloader) | |
| Indications for
Use | The VariSource applicators and
accessories complete the VariSource
system, and as such their intended use
is the same as the parent VariSource
device. The statement of Indications for
Use is the same as above.
The applicator, Standard Catheters,
from the predicate device states the
following indications in the Instruction
Manual:
The Standard Catheters are used to
provide access to tumor sites for
treatment of any case where high dose
rate irradiation is an accepted clinical
practice. | The Standard Catheter Set is indicated
for use to provide access to tumor sites
for treatment of any case where high
dose rate irradiation is an accepted
clinical practice. |
| Design | Catheters:
Diameter:
• 1.6 mm | Catheters:
Diameter:
• 1.6 mm |
| | Length: | Length: |
| | • 100 cm | • 100 cm |
| | • 150 cm | • 150 cm |
| Material | • Catheter Material :
• PTFE | • Catheter Material :
• PTFE |
| | • Plastic Tipped Catheter : Nylon | • Plastic Tipped Catheter : PTFE |
| | • Metal Tipped Catheter :
• Tungsten coated with PTFE | • Metal Tipped Catheter :
• Tungsten coated with PTFE |
| | • Metal Tipped Catheter Plug
• (distal end): Tungsten | • Metal Tipped Catheter Plug
• (distal end): Tungsten |
| | • Plastic and Metal Tipped Catheter
• Pin Plug (open end):
Delrin and stainless steel | • Plastic and Metal Tipped Catheter
• Pin Plug (open end)::
Delrin and stainless steel |
| | CLEARED DEVICE
FEATURE/SPECIFICATION | NEW / MODIFIED DEVICE |
| FEATURE
AND/OR
SPECIFICATION | PREDICATE DEVICE:
Standard Catheters
(K952913 Applicators for Varian
Varisource Remote High Dose Rate
Afterloader) | SUBJECT DEVICE:
STANDARD CATHETER SET |
| Packing | • Individual | • Individual |
| Sterility | • Provided non-sterile | • Provided non-sterile |
| Sterilization
method | • Ethylene Oxide
• Plasma | • Steam autoclave |
| Biocompatibility | • Full biocompatibility | • Full biocompatibility |
| Anatomical
sites | • Small lumen | • Small lumen |
| Compatibility
with the
environment
and other
devices | NA | • CT compatible & MR conditional
(for plastic-tipped catheter only)
• CT compatible & MR unsafe
(for metal-tipped catheter) |
| Where used | • Brachytherapy treatment room | • Brachytherapy treatment room |
7
8
VII. 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 device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993-1, '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
9
a Risk Management Process," as recognized by FDA. This included the following tests:
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Systemic Toxicity ●
- Subchronic Toxicity
- Genotoxicity
- Implantation ●
The Standard Catheters are intended for continuous use for less than 30 days of contact with patients. According to ISO 10993-1 the standard catheters are categorized as a medical device, external communicating device, Tissue/Bone communicating and prolonged contact duration (B).
Sterilization Testing:
Sterilization testing was performed for the subject device and 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.
- o Steam Sterilization Validation Reports
- Validation/Efficacy Testing of Cleaning, Disinfection, Sterilization Cycles .
Electrical Safety and Electromagnetic Compatibility (EMC):
This item is not applicable to the subject device. No electrical safety and electromaqnetic 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 device; the device does not contain or consist of software/firmware. No software verification and validation testing has been included in this submission in support of the substantial equivalence determination.
10
Mechanical and Acoustic Testing:
- CT Compatibility Test and Analysis
- Rationale MR Properties ●
Animal Study / Clinical Tests:
No animal studies or clinical tests have been included in this submission in support of the substantial equivalence determination.
VIII. 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 device performs as well as or better than the predicate device.