(56 days)
No
The document describes a physical medical device (PICC catheter) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a catheter designed for intravenous therapy, which involves administering fluids and medications, thus providing treatment.
No
The device is a peripherally inserted central catheter (PICC) used for intravenous therapy, blood sampling, power injection of contrast media, and central venous pressure monitoring. While it can collect information (blood samples, pressure monitoring), its primary function is not to diagnose a condition based on that information, but rather to facilitate treatment or monitoring.
No
The device description clearly indicates it is a physical catheter, a hardware component, and the performance studies involve physical testing like tensile testing and leak decay testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring." These are all procedures performed in vivo (within the living body).
- Device Description: The description reinforces the in vivo nature of the device, stating it's designed to "provide access to the patient's vascular system" and is a "peripherally inserted central catheter (PICC)."
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens outside of the body, which is the defining characteristic of an in vitro diagnostic device.
The device is a medical device used for direct patient care and intervention, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The PowerPICC Provena Catheters with SOLO² Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are sterile, single use devices designed to provide access to the patient's vascular system. The devices are intended for short- or long-term use, as clinically indicated, to sample blood and administer fluids intravenously. The catheters are capable of central venous pressure monitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters (PICC) and utilize the same placement technique as the predicate device. The SOLO2 versions of the subject devices include a silicone valve on the proximal end. The subject devices are provided sterile in basic interventional radiology (IR) as well as basic, full, and max barrier nursing PICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standard and small patient versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system, Peripheral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on a risk analysis, the performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. In addition, when technological characteristics between the subject and predicate device were found to be identical, results of the performance testing conducted on the predicate device were applied to the subject device. The following table identifies the performance tests completed on the subject device based upon the specific modification to the extension leg material, including a test description and applicable standard associated with each test.
Verification / Validation Method: Assembly Tensile Testing. Risk Acceptability Criteria: Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements.
Verification / Validation Method: Dimensional Characterization. Risk Acceptability Criteria: Test to demonstrate that the new material formulation conforms correctly to design tolerances of the extension legs. BAS internal standards and procedures.
Verification / Validation Method: Leak Decay Testing. Risk Acceptability Criteria: Testing performed to evaluate that the catheter assembly will not leak when the distal end of the catheter is occluded. BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements.
Verification / Validation Method: Hydraulic Burst Testing. Risk Acceptability Criteria: Testing performed to evaluate that the catheter burst pressure exceeds the peak use pressure at maximum flow conditions. BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters - Part 1: General requirements.
A biocompatibility evaluation was also conducted based upon the specific modification to the subject device per ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process. According to this evaluation, and the tests and references mentioned above, the subject devices met design requirements and demonstrated substantial equivalence as compared to the cited predicate devices. This biocompatibility evaluation also utilized the information from the reference device PowerPICC SOLO (K072230), which uses the same material for the extension legs as the subject devices.
Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted in accordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices.
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
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 26, 2018
C.R. Bard, Inc (Bard has joined BD) Brvan Stone Associate Manager, Regulatory Affairs 605 North 5600 West Salt Lake City, Utah 84116
Re: K180548
Trade/Device Name: PowerPICC Provena Catheters PowerPICC Provena Catheters with SOLO2 Valve Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: February 27, 2018 Received: March 1, 2018
Dear Bryan Stone:
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
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 mediation-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.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K180548
Device Name
PowerPICC Provena Catheters with SOLO2 Valve Technology
Indications for Use (Describe)
The PowerPICC Provena Catheters with SOLO² Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
| Catheter Size | Maximum Flow Rate |
|---|---|
| 3 F Single Lumen | 3 mL/sec |
| 4 F Dual Lumen | 5 mL/sec |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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."
3
Indications for Use
510(k) Number (if known)
K180548
Device Name PowerPICC Provena Catheters
Indications for Use (Describe)
The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.
| Catheter Size | Maximum Flow Rate |
|---|---|
| 3 F Single Lumen | 3 mL/sec |
| 4 F Dual Lumen | 5 mL/sec |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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
510(k) Summary K180548
21 CFR 807.92(a)
| Submitter Name: | Bard Access Systems, Inc. (Bard has joined BD) | |
|---|---|---|
| Submitter Address: | 605 North 5600 West | |
| Salt Lake City, UT 84116 | ||
| General | ||
| Provisions | Contact Person: | Bryan Stone |
| Associate Manager, Regulatory Affairs | ||
| Telephone Number: | (801) 522-5876 | |
| Fax Number: | (801) 522-5425 | |
| Date of Preparation: | April 19, 2018 | |
| Trade Name(s): | PowerPICC Provena Catheters | |
| PowerPICC Provena Catheters with SOLO2 Valve Technology | ||
| Subject Devices | Common Name: | Catheter, Intravascular, Therapeutic, Long-term Greater than 30 days |
| Classification Name: | Percutaneous, Implanted, Long-term intravascular catheter | |
| Product Code/Regulation: | LJS/21 CFR §880.5970 | |
| Class | 2 | |
| Classification Panel | General Hospital | |
| Predicate Trade Name: | ||
| Predicate Devices | Classification Name: | Percutaneous, Implanted, Long-term intravascular catheter |
| Product Code/Regulation: | LJS/21 CFR §880.5970 | |
| Premarket Notification #: | K162443 (PowerPICC Provena) | |
| K162441 (PowerPICC Provena Catheters with SOLO2 Valve Technology) | ||
| Manufacturer: | Bard Access Systems, Inc. | |
| Reference Device | Reference Trade Name: | PowerPICC SOLO Catheter |
| Classification Name: | Percutaneous, Implanted, Long-term intravascular catheter | |
| Product Code/Regulation: | LJS/21 CFR §880.5970 | |
| Premarket Notification: | K072230 | |
| Manufacturer: | Bard Access Systems, Inc. |
5
| Device
Description | The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are sterile, single use
devices designed to provide access to the patient's vascular system. The devices are intended for short- or long-term use, as
clinically indicated, to sample blood and administer fluids intravenously. The catheters are capable of central venous pressure
monitoring, and can withstand power injection of contrast media. The catheters are peripherally inserted central catheters
(PICC) and utilize the same placement technique as the predicate device. The SOLO2 versions of the subject devices include
a silicone valve on the proximal end.
The subject devices are provided sterile in basic interventional radiology (IR) as well as basic, full, and max barrier nursing
PICC kits with legally marketed components to assist in the placement procedure. These kits are available in both standard
and small patient versions. | | | | | | | | | | | |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|-------------------------------------------------------------------------------------|--|--|--|--|
| Intended Use | The PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO2 Valve Technology are intended for
short- or long-term peripheral access to the central venous system for intravenous therapy and blood sampling. | | | | | | | | | | | |
| Indications For
Use | The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for
intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring.
For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. | | | | | | | | | | | |
| | Catheter Size Maximum Flow Rate 3F Single Lumen 3 mL/sec 4F Dual Lumen 5 mL/sec | | | | | | | Catheter Size Maximum Flow Rate 3F Single Lumen 3 mL/sec 4F Dual Lumen 5 mL/sec | | | | |
| | The PowerPICC Provena Catheters with SOLO2 Valve Technology are indicated for short or long-term peripheral access to
the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central
venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge
or larger be used. | | | | | | | | | | | |
6
| Technological
Characteristics | Technological characteristics of the subject PowerPICC Provena Catheters and PowerPICC Provena Catheters with SOLO²
Valve Technology are substantially equivalent with respect to basic design, function and fundamental scientific technology to
those of the cited primary predicate devices.
Key modifications made to the subject devices when compared to the predicate devices are as follows:
• The material formulation of the extension leg has been changed from Polycarbonate Polyurethane to Polyether
Polyurethane.
The following table provides a comparison between the subject and predicate devices. | | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| | Attribute | Subject Devices – PowerPICC Provena
Catheters and PowerPICC Provena Catheters
With SOLO² Valve Technology | | |
| | Owner | Same | | |
| | Classification | Same | | |
| 510(k) Status | Subjects of this Premarket Notification | K162443 – Concurrence date October 25, 2016
K162441 – Concurrence date April 24, 2017 | | |
| | | | | |
| Indications for Use | Same | The PowerPICC Provena Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. | | |
| | | Catheter Size | Maximum Flow Rate | |
| | | 3F Single Lumen | 3 mL/sec | |
| | | 4F Dual Lumen | 5 mL/sec | |
| | | The PowerPICC Provena Catheters with SOLO2 Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allows for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used. | | |
| | | Catheter Size | Maximum Flow Rate | |
| | | 3F Single Lumen | 3 mL/sec | |
| | | 4F Dual Lumen | 5 mL/sec | |
| Commercial Name | Same | PowerPICC Provena Catheters
PowerPICC Provena Catheters with SOLO2 Valve Technology | | |
| Catheter | Same | 3F Single Lumen x 55 cm | | |
| Duration of Use | Same | Short (30 days) | | |
| Means of
Insertion | Same | Percutaneous using a peel-away sheath
Introducer | | |
| Insertion Site | Same | Peripheral | | |
| Primary Device
Materials | Catheter Base Materials | Catheter Base Materials | | |
| | Shaft Tubing: | Shaft Tubing: | | |
| | Same | Polycarbonate Polyurethane | | |
| | Luer Connector: | Luer Connector: | | |
| | Same | Polyurethane | | |
| | Extension Legs: | Extension Legs: | | |
| | Polyether Polyurethane | Polycarbonate Polyurethane | | |
| | Junction: | Junction: | | |
| | Same | Polycarbonate Polyurethane (inner)
Polyether Polyurethane (outer) | | |
| | Valve (SOLO2 Only): | Valve (SOLO2 Only): | | |
| | Same | Silicone | | |
| Catheter
Proximal
Configuration | Same | Luer Connection
Luer Connection with Valve (SOLO2) | | |
| Catheter Distal
Configuration | Same | Open Ended | | |
| Number of
Lumens | Same | Single Lumen
Dual Lumen | | |
| | Power Injection
Maximum Flow Rate | Same | Catheter Size
3F Single Lumen | Maximum Flow Rate
3 mL/sec |
| | | | 4F Dual Lumen | 5 mL/sec |
| | Sterility | Same | Provided Sterile | |
| | Packaging
Configurations | Same | Both Standard and Small Patient versions of the following configurations: Basic Configuration Full Configuration Max Barrier Configuration IR Configuration | |
| | The technological differences listed above were evaluated using the same test requirements as the predicate devices, as defined in the Risk Assessment. Therefore, these differences in technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness. | | | |
| Performance
Tests | Based on a risk analysis, the performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. In addition, when technological characteristics between the subject and predicate device were found to be identical, results of the performance testing conducted on the predicate device were applied to the subject device. The following table identifies the performance tests completed on the subject device based upon the specific modification to the extension leg material, including a test description and applicable standard associated with each test. | | | |
| | Verification /
Validation Method | Risk Acceptability Criteria (Acceptance Criteria of Test) | | |
| | Assembly Tensile
Testing | Test to demonstrate the peak tensile force of each test piece exceeds the minimum peak tensile force. ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements | | |
7
8
9
10
| | Dimensional
Characterization | Test to demonstrate that the new material formulation conforms correctly to design tolerances of the extension
legs.
BAS internal standards and procedures |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Leak Decay
Testing | Testing performed to evaluate that the catheter assembly will not leak when the distal end of the catheter is
occluded.
BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular
Catheters - Part 1: General requirements |
| | Hydraulic Burst
Testing | Testing performed to evaluate that the catheter burst pressure exceeds the peak use pressure at maximum
flow conditions.
BAS internal standards and procedures and ISO 10555-1:2013 – Sterile Single-Use Intravascular
Catheters - Part 1: General requirements |
| | A biocompatibility evaluation was also conducted based upon the specific modification to the subject device per ISO 10993-
1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process.
According to this evaluation, and the tests and references mentioned above, the subject devices met design requirements
and demonstrated substantial equivalence as compared to the cited predicate devices. This biocompatibility evaluation also
utilized the information from the reference device PowerPICC SOLO (K072230), which uses the same material for the
extension legs as the subject devices.
Risk management, including a failure modes and effects analysis (FMEA), of the subject devices was conducted in
accordance with BS EN ISO 14971:2012, Medical Devices – Application of Risk Management to Medical Devices. | |
| Summary of
Substantial
Equivalence | Based on the risk management activities, the subject PowerPICC Provena Catheters and PowerPICC Provena Catheters
with SOLO2 Valve Technology have been demonstrated to be substantially equivalent to the cited predicate devices. | |