(62 days)
No
The device description and performance studies focus on the mechanical and material properties of an applicator set for brachytherapy, with no mention of AI or ML capabilities.
Yes.
The device is used for "intraluminal brachytherapy treatments" which is a medical treatment, indicating it is a therapeutic device.
No
Explanation: The device is described as an "Intraluminal Applicator Set" intended for "guiding the radioactive source to the correct location for treatment" in brachytherapy. Its purpose is therapeutic, not diagnostic.
No
The device description clearly outlines physical components such as catheters, spacing tubes, and monofilament, and the performance studies include biocompatibility, cleaning/disinfection/sterilization, mechanical, and MR testing, all of which are associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intraluminal brachytherapy treatments." Brachytherapy is a form of radiation therapy, not a diagnostic test performed on samples outside the body.
- Device Description: The description focuses on guiding a radioactive source for treatment, not on analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological specimens. The device's function is purely related to delivering radiation therapy.
- Performance Studies: The performance studies focus on biocompatibility, cleaning/sterilization, human factors, mechanical/acoustic testing, MR compatibility, and EMC. These are typical tests for a therapeutic medical device, not an IVD.
In summary, the Intraluminal Applicator Set is a therapeutic medical device used in brachytherapy, not a diagnostic device used for testing samples in vitro.
N/A
Intended Use / Indications for Use
The Intraluminal Applicator Set is intended for intraluminal brachytherapy treatments including endobronchial treatments and treatments on body sites such as the bile duct using HDR brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Intraluminal Applicator Set is intended for intrapy treatments including endobronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.
The Intraluminal Applicator Set acts to guide the radioactive source to the correct location for treatment.
Key performance characteristics are as follows:
- Suitable for treating body sites allowing insertion of a catheter.
- CT compatible.
- MR Compatibility: Safe.
- Fits a 2 mm diameter bronchoscope biopsy channel allowing for easy insertion.
- Elastomer construction provides increased flexibility for easy placement and luminal rigidity to avoid kinks.
- Nylon monofil adds luminal stability during catheter insertion and manipulation.
- Comes with 2.8 mm spacing tubes, which minimize surface dose.
- Spacing tubes enable secure placement during treatment.
- The bronchial catheter and monofil are supplied sterile, and for single use.
- The guide tubes, the bronchial catheter, the bite catheters are intended for continuous use for less than 24 hours of contact with patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Endo-bronchial treatments, esophagus (using a guide tube), and the bile duct
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Brachytherapy treatment room
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)
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing:
The compatibility of the skin-contact component meets the biocompatibility requirements. The Biological Evaluation Tests are in compliance with the standards of ISO 1099-1 and its applicable parts, "Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process" Biocompatibility testing conducted included in the Hypersensitivity, Material Mediated Pyrogen, and Acute Systemic Toxicity
Cleaning, Disinfection and Sterilization Testing:
Cleaning, disinfection and sterilization testing was condonents may be sterilized effectively (as appropriate) and the device can be used and sterilized for the specified number of times.
Human factors validation study was conducted according to the standard IEC 62366 to verify that the intended for the intended users, uses, and use environments.
Mechanical and Acoustic Testing:
htraluminal Applicator Set Applicator Set has undergon formal design validation testing. Design verification and design validation testing demonstrates that the device performs as intended.
Design verification and design validation testing to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard.
Magnetic Resonance Testing (MR):
MR Compatibility testing was completed, and documentation was provided to FDA in substantial equivalence determination. The Intraluminal Applicator Set is MR Safe and complies with the following MR standard:
ASTM F2503-23 (2023 ED): Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Electromagnetic Compatibility (EMC) Testing:
The electromagnetic compatibility of the Intraluminal Applicator Set was assessed by testing the requirements of EC 60601-2-17. The results of the testing demonstrate that the subject device is compatible in an electromagnetic setting.
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
November 26, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size.
Varian Medical Systems Lynn Allman Sr. Director Regulatory Affairs 3100 Hansen Way Palo Alto, California 64304
Re: K242961
Trade/Device Name: Intraluminal Applicator Set Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: September 25, 2024 Received: September 25, 2024
Dear Lynn Allman:
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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K242961
Device Name
Intraluminal Applicator Set
Indications for Use (Describe)
The Intraluminal Applicator Set is intended for intraluminal brachytherapy treatments including endobronchial treatments and treatments on body sites such as the bile duct using HDR brachytherapy.
Type of Use (Select one or both, as applicable)
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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K242961
Premarket Notification - 510(k) Summary
Traditional 510(k) Submission for Intraluminal Applicator Set
l. Submitter's Name
Varian Medical Systems 3100 Hansen Way Palo Alto, CA 94304
Contact Name: Lynn, Allman, PhD., Senior Director Regulatory Affairs Phone: (650) 424-5369 E-mail: submissions.support@varian.com Date Prepared: September 24, 2024
II. Device Information
Proprietary Name: Intraluminal Applicator Set Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ
III. Predicate Device
Intraluminal Applicator Set (K151022)
IV. Device Description
The Intraluminal Applicator Set is intended for intrapy treatments including endobronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.
The Intraluminal Applicator Set acts to guide the radioactive source to the correct location for treatment.
Key performance characteristics are as follows:
- . Suitable for treating body sites allowing insertion of a catheter.
- CT compatible. ●
510(k) Summary
Traditional 510(k) Application Intraluminal Applicator Set
Page 1 of 10
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- MR Compatibility: Safe. ●
- Fits a 2 mm diameter bronchoscope biopsy channel allowing for easy insertion.
- Elastomer construction provides increased flexibility for easy placement and luminal rigidity to avoid kinks. ●
- Nylon monofil adds luminal stability during catheter insertion and manipulation. ●
- Comes with 2.8 mm spacing tubes, which minimize surface dose. .
- . Spacing tubes enable secure placement during treatment.
- The bronchial catheter and monofil are supplied sterile, and for single use.
- . The guide tubes, the bronchial catheter, the bite catheters are intended for continuous use for less than 24 hours of contact with patients.
V. Intended Use
The Intraluminal Applicator Set is intended for intralities and treatments including endobronchial treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.
VI. Comparison of Technological Characteristics with the Predicate Device
Table 1: Comparison of Subject Device to Predicate Device
| Feature and/or
Specification of
new/modified device | Predicate Device:
Intraluminal Applicator Set
(K151022) | Subject Device:
Intraluminal Applicator Set | Comparison |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended use | The Intraluminal Applicator Set is
intended for intraluminal brachytherapy
treatments including endo-bronchial
treatments and treatments on body
sites such as the esophagus and the bile
duct using HDR brachytherapy. | The Intraluminal Applicator Set is
intended for intraluminal brachytherapy
treatments including endobronchial
treatments and treatments on body
sites such as the esophagus and the bile
duct using HDR brachytherapy. | No change |
510(k) Summary Traditional 510(k) Application Intraluminal Applicator Set
Page 2 of 10
6
| Feature and/or
Specification of
new/modified device | Predicate Device:
Intraluminal Applicator Set
(K151022) | Subject Device:
Intraluminal Applicator Set | Comparison |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Indications for Use | The Intraluminal Applicator Set is
indicated for use for intraluminal
brachytherapy treatments including
endo-bronchial treatments and
treatments on body sites such as the
esophagus and the bile duct using HDR
brachytherapy. | The Intraluminal Applicator Set is
indicated for use for intraluminal
brachytherapy treatments including
endobronchial treatments and
treatments on body sites such as the
esophagus and the bile duct using HDR
brachytherapy. | No change |
| Compatible
Afterloader | GammaMedplus plus | GammaMedplus Afterloader Series
BRAVOS Afterloader System (K221797) | Added compatibility to
the BRAVOS
Afterloader System for
completeness |
| Design | Components: | Components: | |
| | Bronchial catheter 5 Fr. ( Ø 1.67mm)
(material PA) | Bronchial catheter 5 Fr. ( Ø 1.67mm)
(material PA) | No change |
| | Guide tube Ø 2.8mm, length 900mm
(material FEP) | Guide tube Ø 2.8mm, length 900mm
(material FEP) | No change |
| | Monofil, Ø 0.8 mm, for bronchial
catheter, sterile
(material PA) | Monofil, Ø 0.8 mm, for bronchial
catheter, sterile
(material PA) | No change |
510(k) Summary Traditional 510(k) Application Intraluminal Applicator Set
Page 3 of 10
7
| Feature and/or
Specification of
new/modified device | Predicate Device:
Intraluminal Applicator Set
(K151022) | Subject Device:
Intraluminal Applicator Set | Comparison |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bite protector for intraluminal
applicators
(material PPSU) | Bite protector for intraluminal
applicators
(material PPSU) | No change |
| | Components Required for Afterloaders: | Components Required for Afterloaders: | |
| | 3rd party component
"GM11004210 guide wire, 0.032" x
2600 mm, sterile" | No longer included | The feature and use of
the Intraluminal
Applicator does not
depend on the guide
wire. The guide wire is
used (if needed) to
place the Intraluminal
Applicator in the
patient's body. If the
customers need a guide
wire they can purchase
a suitable guide wire
locally |
| | Clamping adapter for 5 Fr bronchial
catheter, GammaMedplus
(material Stainless Steel) | Clamping adapter for 5 Fr bronchial
catheter, GammaMedplus
(material Stainless Steel) | No change |
| | No clamping adapter for BRAVOS
Afterloader system | Clamping adapter for 5 Fr bronchial
catheter, BRAVOS
(material Stainless Steel) | Added component
to support
compatibility with
the BRAVOS
Afterloader
System (K221797) |
510(k) Summary Traditional 510(k) Application Intraluminal Applicator Set
Page 4 of 10
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| Feature and/or
Specification of
new/modified device | Predicate Device:
Intraluminal Applicator Set
(K151022) | Subject Device:
Intraluminal Applicator Set | Comparison |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| | Optional Components and Accessories: | Optional Components and Accessories: | |
| | Guide tube, Ø 4.5 mm, length 700 mm
(material FEP) | Guide tube, Ø 4.5 mm, length 700 mm
(material FEP) | No change |
| | Tube catheter, Ø 2.8 mm,
GammaMedplus
(material FEP/Stainless Steel) | Tube catheter, Ø 2.8 mm,
GammaMedplus
(material FEP/Stainless Steel) | No change |
| | No tube catheter, | Tube catheter
(material FEP/Stainless Steel) | Added tube catheter to
support use with
BRAVOS Afterloader
System |
| Tube Catheter | Tube catheter included as optional
accessory | Tube catheter included as optional
accessory | No change |
| Materials | PA (Polyamide)
FEP (Fluorinated Ethylene Propylene)
Stainless Steel
PPSU (Polyphenylsulfone) | PA (Polyamide)
FEP (Fluorinated Ethylene Propylene)
Stainless Steel
PPSU (Polyphenylsulfone) | No Change |
| Packing | Individual | Individual and Pack of 5 and 10 | Added packs of 5 and 10
to expand product
offerings |
510(k) Summary Traditional 510(k) Application Intraluminal Applicator Set
Page 5 of 10
9
| Feature and/or
Specification of
new/modified device | Predicate Device:
Intraluminal Applicator Set
(K151022) | Subject Device:
Intraluminal Applicator Set | Comparison |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility
(Bronchial catheter
and Monofil) | Supplied sterile -single use only | Supplied sterile -single use only | No change |
| Biocompatibility
Contact Duration | Bronchial Catheter: 24hr to 30 days
Guide Tube: Up to 24h
Tube Catheter: 24hr to 30 days | Intraluminal Applicator Set: Up to 24
Hours | The revised contact time
was chosen based on
typical clinical use of the
product and the
biocompatibility data
included as part of this
submission. |
| Sterilization method
(Bronchial catheter
and Monofil) | Gamma sterilization (shelf-life 5 years) | EtO sterilization (shelf-life 2 years) | Updated sterilization
method to EtO for
consistency with other,
Varian applicator sets |
| Sterilization method
(Guide Tubes) | Steam sterilization -single use only | Steam sterilization -single use only | No change |
| Sterilization method
(Tube Catheter) | High level disinfection up to 20 times | High level disinfection up to 20 times | No change |
| Biocompatibility | Fully biocompatible | Fully biocompatible | No change |
| Anatomical sites | Endo-bronchial treatments, esophagus
(using a guide tube), and the bile duct | Endo-bronchial treatments, esophagus
(using a guide tube), and the bile duct | No change |
510(k) Summary
Traditional 510(k) Application
Intraluminal Applicator Set
Page 6 of 10
10
| Feature and/or
Specification of
new/modified device | Predicate Device:
Intraluminal Applicator Set
(K151022) | Subject Device:
Intraluminal Applicator Set | Comparison |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|------------|
| Human factors | Controlled through Varian afterloaders | Controlled through Varian afterloaders | No change |
| Compatibility with
the environment and
other devices | CT compatible and MR Safe
(MR Safe components as listed in
Instructions for Use are used) | CT compatible and MR Safe
(MR Safe components as listed in
Instructions for Use are used) | No change |
| Where used | Brachytherapy treatment room | Brachytherapy treatment room | No change |
VII. Summary of Performance Testing (Non-Clinical Testing)
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing:
The compatibility of the skin-contact component meets the biocompatibility requirements. The Biological Evaluation Tests are in compliance with the standards of ISO 1099-1 and its applicable parts, "Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process" Biocompatibility testing conducted included in the Hypersensitivity, Material Mediated Pyrogen, and Acute Systemic Toxicity
Cleaning, Disinfection and Sterilization Testing:
Cleaning, disinfection and sterilization testing was condonents may be sterilized effectively (as appropriate) and the device can be used and sterilized for the specified number of times.
Human factors validation study was conducted according to the standard IEC 62366 to verify that the intended for the intended users, uses, and use environments.
510(k) Summary
Traditional 510(k) Application Intraluminal Applicator Set
Page 7 of 10
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Mechanical and Acoustic Testing:
htraluminal Applicator Set Applicator Set has undergon formal design validation testing. Design verification and design validation testing demonstrates that the device performs as intended.
Design verification and design validation testing to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard.
Magnetic Resonance Testing (MR):
MR Compatibility testing was completed, and documentation was provided to FDA in substantial equivalence determination. The Intraluminal Applicator Set is MR Safe and complies with the following MR standard:
- . ASTM F2503-23 (2023 ED): Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Electromagnetic Compatibility (EMC) Testing:
The electromagnetic compatibility of the Intraluminal Applicator Set was assessed by testing the requirements of EC 60601-2-17. The results of the testing demonstrate that the subject device is compatible in an electromagnetic setting.
Use of Consensus Standards:
The following list of FDA-recognized, voluntary consensus standards of the subject device's safety and efficacy.
| ANSI/AAMI/ISO
| 14971:2019 | Medical devices – Applications of risk management to medical devices |
|---|---|
| EN ISO 15223-1:2021 | Medical devices – Symbols to be used with the information to be supplied by the manufacturer – Part 1: General requirements |
| EN ISO 20417: 2021 | Information supplied by the manufacturer of medical devices |
| IEC 62366-1:2015+A1:2020 | Application of Usability Engineering to Medical Devices |
| ANSI/AAMI ST98:2022 | Cleaning Validation of health care products –cleaning process for medical devices |
| ANSI / AAMI | |
| ST79:2017(R)2022 | Comprehensive guide to steam sterilization and sterility assurance in health care facilities |
510(k) Summary Traditional 510(k) Application Intraluminal Applicator Set
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12
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the medical device
manufacturer for the processing of medical devices -Part 1: Critical and semi-critical
medical devices |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| EN ISO 11607-1:2020 | Packaging for terminally sterilized medical devices -Part 1: Requirements for materials,
sterile barrier systems and packaging systems |
| EN ISO 17665-1:2006 | Sterilization of health care products - Moist heat - Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices |
| ISTA 3A (2018) | General Simulation Performance Tests for packaged-products weighing 150 lb. (70 kg) or
less (standard, small, flat or elongated) |
| EN ISO 10993-1:2020 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk
management process. |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| EN ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin
sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices - Part 11: Tests for systemic toxicity |
| EN ISO 10993-12:2021 | Biological evaluation of medical devices -Part 12: Sample preparation and reference
materials |
| ISO 10993-18:2020/
AMD 1:2022 | Biological evaluation of medical devices -- Part 18: Chemical characterization of medical
device materials within a risk management process |
| EN ISO 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation |
| IEC 60601-2-17:2013 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and
essential performance of automatically-controlled brachytherapy after loading
equipment |
| ASTM F2503 -23 | Standard Practice for Marking Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment |
| ASTM D4332-22 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for
Testing |
| EN ISO 10993-2:2022 | Biological evaluation of medical devices. - Part 2: Animal welfare requirements |
| EN ISO 10993-17:2023 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for
leachable substances |
VIII. Determination of Substantial Equivalence to the Predicate
The Intraluminal Applicator Set was previously marketed under K151022. There are no changes in the devices.
510(k) Summary Traditional 510(k) Application Intraluminal Applicator Set
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Varian believes the major technological characteristics are substant to the predicate device and the differences do not raise new questions of safety and effectiveness compared to the predicate.
The results of verification as well as conformance to relevant safety standards demonstrate that the safety and performance criteria.
Varian considers the Intraluminal Applicator Set to be as safe and therefore substantially equivalent to the predicate device.
510(k) Summary Traditional 510(k) Application Intraluminal Applicator Set
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