(107 days)
Not Found
No
The device description explicitly states, "The device does not contain or consist of software/firmware." Additionally, there are no mentions of AI, DNN, ML, image processing, or data sets for training or testing, which are typical indicators of AI/ML technology in medical devices. The device is a physical applicator for guiding a radioactive source.
Yes
The device is indicated for treating endometrial cancer using HDR or PDR brachytherapy, which is a therapeutic intervention.
No
This device is an applicator used to guide radioactive sources for brachytherapy treatment of endometrial cancer, as described in the "Intended Use / Indications for Use" and "Device Description" sections. It facilitates treatment delivery rather than diagnosing a condition.
No
The device description explicitly states, "The device does not contain or consist of software/firmware."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating endometrial cancer using brachytherapy. This is a therapeutic procedure, not a diagnostic one.
- Device Description: The description clearly states the device is an "applicator for intracavitary Brachytherapy" and its function is to "guide the radioactive source to the correct location or locations for treatment." This is a delivery mechanism for a therapeutic agent (radiation), not a device used to diagnose a condition by examining samples from the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on delivering treatment.
N/A
Intended Use / Indications for Use
The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.
Product codes (comma separated list FDA assigned to the subject device)
JAQ
Device Description
The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes.
The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets).
The Heyman Packing Applicator Set is an applicator for intracavitary 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 defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
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 designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.
The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
The key performance characteristics of this applicator set are as follows:
- Simulates the classic Heyman packing technique ●
- 4 mm, 6 mm, and 8 mm diameter capsules for optimal packing of the uterine cavity
- . Mandrins stabilize the applicators during insertion
- CT Compatible
- . MR Safe-without mandrins inserted
- Material is biocompatible for intracavitary use
- . Leak stop channel markers allow for channel number coding
- Reusable and steam sterilizable
- Compatibility with all Varian afterloader systems
- Suitable for patient contact for a period of less than 30 days
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Endometrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
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)
Biocompatibility Testing:
The compatibility of the skin-contact component material in the finished product meets the biocompatibility requirements. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, "Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process".
Magnetic Resonance Testing (MR):
MR Compatibility testing was completed, and documentation was provided to FDA in support of the substantial equivalence determination. The Heyman Packing Applicator Set is MR Safe and comply 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
Cleaning, Disinfection and Sterilization Testing:
Cleaning, disinfection and sterilization testing was conducted to demonstrate the device components may be sterilized effectively (as appropriate) and the device can be used and sterilized for the specified number of times.
Human Factors Validation Study:
A human factors validation study was conducted according to the standard IEC 62366 to verify that the device performs well as intended for the intended users, uses, and use environments.
Mechanical and Acoustic Testing:
The Heyman Packing Applicator Set has undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the device performs as intended.
Design verification and design validation testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard.
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.
Not Found
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
August 30, 2024
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Varian Medical Systems, Inc. Lynn Allman Sr. Director, Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304
Re: K241386
Trade/Device Name: Heyman Packing Applicator Set (GM11004580) Regulation Number: 21 CFR 892.5700 Regulation Name: Remote Controlled Radionuclide Applicator System Regulatory Class: Class II Product Code: JAQ Dated: July 29, 2024 Received: July 30, 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 (the 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" (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
1
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 (QS) 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.
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-regulatoryassistance/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.
Lora Werner
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K241386
Device Name
Heyman Packing Applicator Set (GM11004580)
Indications for Use (Describe)
The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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/1 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is in black and white.
Premarket Notification - 510(k) Summary
Traditional 510(k) Submission for Heyman Packing Applicator Set (GM11004580)
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: May 15th, 2024
II. Device Information
Proprietary Name: Heyman Packing Applicator Set (GM11004580) Classification Name: Remote Controlled Radionucleotide Applicator System Regulation Number: §892.5700 Product Code: JAQ
III. Predicate Device
Heyman Packing Applicator Set (K160045)
IV. Device Description
The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes.
The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets).
The Heyman Packing Applicator Set is an applicator for intracavitary 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 defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment.
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 designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization.
The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
4
Image /page/4/Picture/0 description: The image shows the Varian logo, with the word "Varian" in bold, sans-serif font. Below the logo, in a smaller font size, is the text "A Siemens Healthineers Company". The logo is simple and modern, with a focus on the company name and its affiliation with Siemens Healthineers.
The key performance characteristics of this applicator set are as follows:
- Simulates the classic Heyman packing technique ●
- 4 mm, 6 mm, and 8 mm diameter capsules for optimal packing of the uterine cavity
- . Mandrins stabilize the applicators during insertion
- CT Compatible
- . MR Safe-without mandrins inserted
- Material is biocompatible for intracavitary use
- . Leak stop channel markers allow for channel number coding
- Reusable and steam sterilizable
- Compatibility with all Varian afterloader systems
- Suitable for patient contact for a period of less than 30 days
V. Intended Use
The Heyman Packing Applicator Set is intended for use when performing HDR or PDR brachytherapy.
VI. Indications for Use
The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.
VII. 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 | CLEARED DEVICE
FEATURE/SPECIFICATION
510(k) ID # K160045
HEYMAN PACKING APPLICATOR SET | NEW / MODIFIED DEVICE NAME
HEYMAN PACKING APPLICATOR
SET (GM11004580) | COMPARISON |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatible
Afterloader | GammaMedplus Afterloader
series
VariSource Afterloader series | GammaMedplus
Afterloader series
VariSource Afterloader
Series
BRAVOS Afterloader System | Device is compatible with
the BRAVOS Afterloader
System, it is just now being
included in the labelling for
completeness. |
| Intended use | The Heyman Packing
Applicator Set is intended for
cancer treatment of the
endometrium. | The Heyman Packing
Applicator Set is intended
for use when performing
HDR or PDR brachytherapy. | The intended use was
amended to accurately
reflect the use of the
packing applicator set for
general HDR or PDR
brachytherapy procedures.
The indications for use
remain the same which
ensures that the device is
being used appropriately
for the therapeutic
indication for which it is
intended The indication for |
| | | | use statement has not
changed and limits the
clinical use of the set to
endometrial cancer using
HDR or PDR brachytherapy.
Furthermore, the risk
review for the Heyman
Packing Applicator Set did
not identify any new risks as
a result of this change; |
| Indications for Use | The Heyman Packing
Applicator Set is indicated for
use for treating endometrial
cancer using HDR or PDR
brachytherapy. | No change | Same |
| Design | Heyman capsules:
- 320 mm length
- various capsule
- diameters of 4mm,
6mm and 8mm and
length of 17.5 mm
Mandrin: - 320 mm length | No change | Same |
| Materials | Heyman capsules: PEEK,
Titanium
Mandrin: Stainless Steel | Heyman capsules: PEEK
Mandrin: Stainless Steel | This change has not
identified any new or
increased biocompatibility
or safety concerns and does
not impact the performance
specifications of the subject
device. |
| Packing | Individual | No change | Same |
| Sterility | Provided non-sterile | No change | Same |
| Sterilization
method | Manual and Machine
Cleaning, Disinfection, and
Steam Sterilization | Manual or machine cleaning
and disinfection.
Steam sterilization with
common parameters using
Pre-vacuum sterilization. | These changes were
cumulatively made as part
of a process improvement
initiative and is used to
emphasize proper
sterilization of the subject
device. This does not
impact the risk profile of
the subject device. |
| Biocompatibility | Fully biocompatible | No change | Same |
| Anatomical sites | Endometrium | No change | Same |
| Compatibility with
the environment
and other devices | CT compatible
MR-Conditional | CT compatible
MR-Safe | This change was made to
enhance the usability and
flexibility of use in the
intended population |
| Where used | Brachytherapy treatment
room | No change | Same |
5
Image /page/5/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the logo is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern, and the text clearly identifies Varian as part of the Siemens Healthineers group.
6
Image /page/6/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "varian" is written in a bold, sans-serif font. Below the word "varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern.
VIII. 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 material in the finished product meets the biocompatibility requirements. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1 and its applicable parts, "Biological Evaluation of Medical Device – Part 1: Evaluation and Testing Within a Risk Management Process".
Magnetic Resonance Testing (MR):
MR Compatibility testing was completed, and documentation was provided to FDA in support of the substantial equivalence determination. The Heyman Packing Applicator Set is MR Safe and comply 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
Cleaning, Disinfection and Sterilization Testing:
Cleaning, disinfection and sterilization testing was conducted to demonstrate the device components may be sterilized effectively (as appropriate) and the device can be used and sterilized for the specified number of times.
A human factors validation study was conducted according to the standard IEC 62366 to verify that the device performs well as intended for the intended users, uses, and use environments.
Mechanical and Acoustic Testing:
The Heyman Packing Applicator Set has undergone formal design verification and design validation testing. Design verification and design validation testing demonstrates that the device performs as intended.
Design verification and design validation testing was performed according to the FDA Quality System Regulation (21 CFR §820), ISO 13485 Quality Management System Standard, and ISO 14971 Risk Management Standard.
Use of Consensus Standards:
The following list of FDA-recognized, voluntary consensus standards were utilized in the design and evaluation of the subject device's safety and efficacy.
510(k) Summary
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Image /page/7/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller font. The logo is simple and modern.
| Standard / CS | Standard / CS Title |
|---|---|
| EN ISO 13485:2016 | Quality management systems. Requirements for regulatory purposes |
| EN ISO | |
| 14971:2019+A11:2021 | Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
| EN ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device labels, labelling and |
| information to be supplied - Part 1: General requirements | |
| EN ISO 20417:2021 | Information supplied by the manufacturer of medical devices |
| EN 62366-1:2015+A1:2020 | Application of Usability Engineering to Medical Devices |
| EN ISO 17664-1:2021 | Processing of health care products-Information to be provided by the medical device |
| manufacturer for the processing of medical devices | |
| 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 | |
| EN ISO 10993-1:2020 | Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk |
| management process. | |
| EN ISO 10993-2:2022 | Biological evaluation of medical devices. - Part 2: Animal welfare requirements |
| EN ISO 10993-3:2014 | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity |
| and reproductive toxicity | |
| EN ISO 10993-5:2009 | Biological evaluation of medical devices - part 5: Tests for in vitro cytotoxicity |
| EN ISO 10993-10:2023 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin |
| sensitization | |
| EN ISO 10993-11:2018 | 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 | |
| EN ISO 10993-17:2009 | Biological evaluation of medical devices - Part 17: Establishment of allowable limits for |
| leachable substances | |
| EN ISO 10993- | |
| 18:2020+A1:2023 | 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 |
| EN 60601-1:2006/A1:2013 | Medical Electrical Equipment Part 1- General Requirements For Safety and essential |
| performance | |
| EN 60601-2-17:2015 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and |
| essential performance of automatically-controlled brachytherapy after loading | |
| equipment |
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Image /page/8/Picture/0 description: The image shows the logo for Varian, a Siemens Healthineers Company. The word "Varian" is written in a bold, sans-serif font. Below the word "Varian" is the text "A Siemens Healthineers Company" in a smaller, sans-serif font. The logo is black and white.
IX. Determination of Substantial Equivalence to the Predicate
The Heyman Packing Applicator Set was originally marketed as MR Conditional, but has now completed the testing to be classified as MR Safe.
The intended use was amended to accurately reflect the use of the packing applicator set for general HDR or PDR brachytherapy procedures. The indications for use remain the same which ensures that the device is being used appropriately for the therapeutic indication for which it is intended. The indication for use statement has not changed and limits the clinical use of the set to endometrial cancer using HDR or PDR brachytherapy. Furthermore, the risk review for the Heyman Packing Applicator Set did not identify any new risks as a result of this change.
There are no changes in the design or principle of operation of the devices.
Varian believes the major technological characteristics are substantially equivalent to the predicate device.
The results of verification and validation as well as conformance to relevant safety standards demonstrate that the device meets the safety and performance criteria. Varian considers the Heyman Packing Applicator Set to be substantially equivalent to the predicate device.