(97 days)
Not Found
No
The summary describes a physical medical device (embolization coil system) and its modifications. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are bench tests of physical properties.
Yes
The device is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, which is a therapeutic intervention.
No
The device is an embolization coil system used for the treatment of existing neurovascular abnormalities, not for determining the presence or nature of a disease.
No
The device description clearly outlines physical components like platinum/tungsten coils, a composite implant delivery pusher, and a hand-held detacher, 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 for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, as well as arterial and venous embolizations in the peripheral vasculature. This is a therapeutic procedure performed within the body.
- Device Description: The device is a physical implant (a coil) delivered into the body to block blood flow.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide diagnostic information. IVDs are typically used to test blood, urine, tissue, or other samples.
Therefore, the Axium Prime Detachable Coil System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Axium Prime Detachable Coil System is indicated for the endovascular embolization of intracranial anewrysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium Prime Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
Product codes
HCG, KRD
Device Description
The Axium™ Prime Detachable Coil System consists of a platinum/tungsten embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Axium™ I.D. (Instant Detacher) which, when activated, detaches the coil from the delivery pusher tip. The Axium™ I.D. (Instant Detacher) is sold separately.
This submission expands Axium™ Detachable Coil (subject device) family by adding forty-four (44) new model numbers to the currently cleared Axium product portfolio (predicate device). These new model numbers come in the 3D configuration only and are a line extension of the currently sold predicate device, ranging in size from 3mm diameter x 6cm length to 25mm diameter x 50cm length. All forty-four (44) new SKUs fall within the currently cleared Axium size range of 1mm diameter x 1cm length to 25mm diameter x 50cm length.
The subject device was modified to change the 3D loop configuration from a 4-loop configuration to a 6-loop configuration and to slightly increase the primary wire diameter size for the 7 - 10mm and the 12 - 25mm size coils.
All other aspects of the subject device design (materials of construction of the implant coil, principles of operation, packaging, labeling and indications for use) are identical to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial, peripheral vasculature
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)
The following bench tests were performed to support the addition of new models to the Axium coil portfolio and to establish substantial equivalence to predicate Axium™ Detachable Coil System: Visual and Dimensional Inspection First loop OD post-sterilization Dimensional Inspection Deformation Force Friction in Sheath Friction in Catheter Force Transfer Stretch Resistant Polypropylene Tensile Test Coil Shell Tensile Test Fatigue and Knotting Labeling verification Physician use testing
The following testing was adopted from existing test data for currently cleared Axium™ coil sizes:
Shield Coil Weld
Coil Tensile - Assembly
Marker Radiopacity
Tip Buckling
Detachment Zone Stiffness
Detachment Reliability
Kink Resistance
Hypotube and Weld Tensile Strength
Pusher Elongation
Pusher Tensile
Positive Load Indicator Dimension
Break Indicator Dimension
Sheath wave-lock
Thrombogenicity
MRI Compatibility
Sterilization, biocompatibility, packaging and aging data were also adopted from the predicate device as there is no change to the materials or packaging for the addition of these new models.
No clinical or animal testing was performed, as the subject device has a similar safety profile and a similar effectiveness profile when compared to the predicate device. In addition, there is no change in the indications for use or the fundamental scientific technology of the device that would require any additional testing.
A summary of the non-clinical bench testing performed for the subject device is presented in the table below:
Test: Visual and Dimensional Inspection of Coil: Length, First Loop OD
Test Method: Dimensions were measured and key characteristics of the implant coil were inspected.
Conclusion: All devices met acceptance criteria.
Test: Coil Deformation Force
Test Method: The first loop is compressed to a deformation distance of 20% of the coil's loop OD. The peak force is recorded.
Conclusion: All devices met acceptance criteria.
Test: Ease of Deliverability, Friction Testing, Force Transfer, Fatigue and Knotting
Test Method: Peak delivery force was measured through a representative tortuous anatomical model. The proximal end of the device is advanced until the distal force exceeds a specified value. The force transfer is calculated. The device is placed inside the microcatheter and advanced until the coil is deployed completely inside the aneurysm model. The device is retracted and the cycle is repeated. After the required number of cycles the device is inspected.
Conclusion: All devices met acceptance criteria.
Test: Detachment Stretch Resistant Polypropylene Tensile test Coil-Coil Shell Tensile Test
Test Method: The coil is stretched until the stretch resistant member breaks. The peak force result was recorded. The primary wire of the coil is stretched until the coil-coil shell weld breaks. The peak force result was recorded.
Conclusion: All devices met acceptance criteria.
Test: Labeling Verification
Test Method: Text and format of drawings were visually compared to labeling and packaging product specifications.
Conclusion: All devices met acceptance criteria.
Test: Physician Usability Testing
Test Method: The device was navigated through a tortuous benchtop model and deployed into a simulated silicone aneurysm in order to assess stability, neck coverage, conformability, softness and smoothness of delivery.
Conclusion: All test results met the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K151447, K133310, K081465, K060747
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 3, 2016
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Joyce Zhong, PhD, RAC Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
Re: K162704
Trade/Device Name: Axium™ Prime Detachable Coil System Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular Embolization Device Regulatory Class: Class II Product Code: HCG, KRD Dated: November 18, 2016 Received: November 21, 2016
Dear Dr. Zhong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
William J.
Heetderks -A
Digitally signed by William J. Heetderks
-A
DN: c=US, o=U.S. Government, ou=HHS,
ou=NIH, ou=People,
0.9.2342.19200300.100.1.1=0010149848
, cn=William J. Heetderks -A
Date: 2017.01.03 16:31:53 -05'00'
for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162704
Device Name Axium Prime Detachable Coil System
Indications for Use (Describe)
The Axium Prime Detachable Coil System is indicated for the endovascular embolization of intracranial anewrysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium Prime Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
| 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
510(k) Summary for K162704
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joyce Zhong
Regulatory Affairs Specialist
Telephone: (949) 680-1307
E-mail: joyce.zhong@medtronic.com |
| Date Summary
Prepared: | December 19, 2016 |
| Trade Name of
Device: | Axium™ Prime Detachable Coil System |
| Common Name of
Device: | Neurovascular Embolization Device |
| Classification of
Device: | 21 CFR 882.5950 – Class II |
| Product Code | HCG and KRD |
| Predicate Device: | Axium™ Detachable Coil System:
K151447, cleared July 28, 2015 K133310, cleared January 10, 2014 K081465, cleared August 19, 2008 K060747, cleared April 24, 2007 |
| Performance Data: | The following bench tests were performed to support the addition of
new models to the Axium coil portfolio and to establish substantial
equivalence to predicate Axium™ Detachable Coil System :
Visual and Dimensional Inspection First loop OD post-sterilization Dimensional Inspection Deformation Force Friction in Sheath Friction in Catheter Force Transfer Stretch Resistant Polypropylene Tensile Test Coil Shell Tensile Test Fatigue and Knotting Labeling verification Physician use testing
The following testing was adopted from existing test data for currently
cleared Axium™ coil sizes: |
- Porque Responsions .
4
- Shield Coil Weld ●
- Coil Tensile - Assembly
- Marker Radiopacity ●
- Tip Buckling
- . Detachment Zone Stiffness
- Detachment Reliability
- Kink Resistance
- Hypotube and Weld Tensile Strength ●
- Pusher Elongation
- Pusher Tensile
- Positive Load Indicator Dimension
- Break Indicator Dimension
- Sheath wave-lock .
- Thrombogenicity ●
- MRI Compatibility ●
Sterilization, biocompatibility, packaging and aging data were also adopted from the predicate device as there is no change to the materials or packaging for the addition of these new models.
No clinical or animal testing was performed, as the subject device has a similar safety profile and a similar effectiveness profile when compared to the predicate device. In addition, there is no change in the indications for use or the fundamental scientific technology of the device that would require any additional testing.
Conclusion: The forty-four (44) new Axium™ Prime Detachable Coil System models are substantially equivalent to the currently cleared AxiumTM Detachable Coil System based on the successful completion of nonclinical testing; a thorough assessment of existing test data; as well as identical materials of coil implant construction, principles of operation, packaging and indications for use. The subject device has a similar safety profile and a similar effectiveness profile when compared to the predicate device.
Device Description:
The Axium™ Prime Detachable Coil System consists of a platinum/tungsten embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Axium™ I.D. (Instant Detacher) which, when activated, detaches the coil from the delivery pusher tip. The Axium™ I.D. (Instant Detacher) is sold separately.
This submission expands Axium™ Detachable Coil (subject device) family by adding forty-four (44) new model numbers to the currently cleared Axium product portfolio (predicate device). These new model numbers come in the 3D configuration only and are a line extension of the currently sold predicate device, ranging in size from 3mm diameter x 6cm length to 25mm diameter x 50cm length. All forty-four (44) new SKUs fall within the currently cleared Axium size range of 1mm diameter x 1cm length to 25mm diameter x 50cm length.
5
The subject device was modified to change the 3D loop configuration from a 4-loop configuration to a 6-loop configuration and to slightly increase the primary wire diameter size for the 7 - 10mm and the 12 - 25mm size coils.
All other aspects of the subject device design (materials of construction of the implant coil, principles of operation, packaging, labeling and indications for use) are identical to the predicate device.
Indications for Use:
The Axium Prime Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium Prime Detachable Coils are also indicated for arterial and venous embolizations in the peripheral vasculature.
Device Comparison:
The table below provides a comparison of the technological characteristics of the subject device and the currently cleared predicate Axium device line.
| | Predicate Device | Subject Device | Rationale for
Difference (if
applicable) |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Characteristics | Axium™ Detachable Coil
System (K133310, K081465,
K060747, K151447) | Axium™ Prime Detachable
Coil System (K162704) | |
| Indication for
Use | The Axium Detachable Coil
System is indicated for the
endovascular embolization of
intracranial aneurysms and other
neurovascular abnormalities, such
as arteriovenous malformations
and arteriovenous fistulae. The
Axium Detachable Coils are also
indicated for arterial and venous
embolizations in the peripheral
vasculature. | Same* | N/A |
| Method of
Supply | Stored within dispenser coil,
Tyvek pouch, & shipping carton | Same | N/A |
| Sterilization
Method | Ethylene Oxide | Same | N/A |
| Device Size
Range
(Coil Diameter x
Coil Length) | 1mm x 1cm - 25mm x 50cm | 3mm x 6cm - 25mm x 50cm | Subject device size
range falls within
the currently
cleared predicate
device size range |
| 3D Loop
Configuration | 4 loops | 6 loops | Additional loops
provide improved
stability |
| Primary wire
diameter | 0.0015" for 3-3.5 mm size coils
0.0020" for 4-6 mm size coils
0.00225" for 7-10mm size coils | same
same
0.0025" for 7-10mm size coils | Larger wire
diameter provide
improved stability |
| | 0.00275" for 12-25mm size coils | 0.0030" for 12-25mm size coils | |
| Materials
(Implant Coil) | | | |
| Characteristics | Predicate Device | Subject Device | Rationale for Difference (if applicable) |
| | Axium™ Detachable Coil System
(K133310, K081465, K060747,
K151447) | Axium™ Prime
Detachable Coil
System (K162704) | |
| Implant Coil
Wire | Pt (92%)/ W (8%) | Same | N/A |
| Stretch
Resistant
Member | Polypropylene | Same | N/A |
| Coil Shell | Pt (92%)/ W (8%) | Same | N/A |
| Detach
Subassembly | SS 316LVM | Same | N/A |
| Materials
(Implant Delivery Pusher) | | | |
| Characteristics | Predicate Device | Subject Device | Rationale for Difference (if applicable) |
| | Axium™ Detachable Coil System
(K133310, K081465, K060747,
K151447) | Axium™ Prime
Detachable Coil
System (K162704) | |
| Unibody | SS 304 | Same | N/A |
| Outer Jacket | PTFE | Same | N/A |
| Marker Coil | Pt (92%)/ W (8%) | Same | N/A |
| Lumen Stop | SS 304 | Same | N/A |
| Inner Liner | PTFE | Same | N/A |
| Coupler Tube | SS 304 | Same | N/A |
| Actuator
Interface | SS 304 | Same | N/A |
| Release Wire | SS 304 | Same | N/A |
| Retainer Ring | SS 304 | Same | N/A |
| Break Indicator | PET shrink tubing or Laser mark | PET shrink tubing | N/A |
| Positive Load
Indicator | PET shrink tubing or Laser mark | PET shrink tubing | N/A |
| Materials
(Introducer sheath) | | | |
| Introducer
sheath | Polypropylene/HDPE | Same | N/A |
6
*product name has been rebranded to Axium™ Prime, otherwise identical.
7
Sterilization and Shelf Life
The subject device was adopted into the EO sterilization cycle originally cleared under K060747 for the predicate device. The materials of construction of the subject device, packaging and overall manufacturing process are the same to the predicate device. EO residual, bioburden and pyrogen testing were adopted as well for these reasons.
Aging and packaging studies for the predicate device have established the product and packaging remain functional and maintain sterility for 3 years. Aging studies for packaging integrity (per ASTM F2096-11) and conditioning (ASTM-4169, ISTA-2A) and device functionality were adopted from the predicate device and met all acceptance criteria. The materials of implant coil construction, manufacturing process, and packaging of the new line extension models of the subject device are identical to the predicate device.
Biocompatibility
Biocompatibility data for the subject device has been adopted from the predicate device. A summary of adopted biocompatibility tests is provided in the table below.
| Test | Test method | Results | Conclusion |
|---|---|---|---|
| Cytotoxicity | MEM Elution Using L-929 Mouse | ||
| Fibroblast Cells | Pass | Non-cytotoxic | |
| Sensitization | Guinea Pig Maximization | ||
| Sensitization | Pass | A Grade I sensitization | |
| rate is not significant | |||
| Irritation | Intracutaneous Irritation Test | Pass | Negligible irritant |
| Acute Systemic | |||
| Toxicity | Acute Systemic Injection Test | Pass | No significant |
| difference comparing | |||
| to the control | |||
| Genotoxicity | Materials Mediated Rabbit Pyrogen | Pass | Non-pyrogenic |
| Bacterial Mutagenicity Test (Ames | |||
| Assay) | Pass | Not mutagenic | |
| In Vitro Mouse Lymphoma Assay | Pass | Not mutagenic | |
| Chromosomal Aberration Assay | Pass | Non-clastogenic | |
| Hemo- | |||
| compatibility | Thrombosis (In Vivo) - Dog (4hr) | Pass | Insignificant |
| thrombosis | |||
| Lee & White Clotting | |||
| Time/Coagulation | Pass | Not significant | |
| different comparing to | |||
| controls | |||
| Unactivated Partial Thromboplastin | |||
| Time (UPTT) | Pass | No significant | |
| difference comparing | |||
| to controls | |||
| In Vitro Hemocompatibility | |||
| (includes Platelet count) | Pass | No adverse effects | |
| Hemolysis (Direct Contact) | Pass | Non-hemolytic | |
| Hemolysis (Extract) | Pass | Non-hemolytic | |
| Complement Activation C3a and | Pass | No difference from |
8
| SC5b-9 Assay | controls | ||
|---|---|---|---|
| In Vivo Animal | |||
| Study (systemic | |||
| effects – SubAcute | |||
| /SubChronic) | SubChronic (14-day) Intravenous | ||
| Toxicity Study in Rats or Mice, | |||
| with Histopathology | Pass | Non-toxic | |
| In Vivo Animal | |||
| Study (localized | |||
| effects) | |||
| Implantation | Intramuscular Implantation Test | ||
| (Rabbits) with Histopathology - 1 | |||
| wk | Pass | No significant | |
| difference comparing | |||
| to the control | |||
| Intramuscular Implantation Test | |||
| (Rabbits) with Histopathology - | |||
| 4wk | Pass | No significant | |
| difference comparing | |||
| to the control | |||
| Intramuscular Implantation Test | |||
| (Rabbits) with Histopathology - | |||
| 13wk | Pass | No significant | |
| difference comparing | |||
| to the control |
Performance Data – Bench
A summary of the non-clinical bench testing performed for the subject device is presented in the table below:
| Test | Test Method | Conclusion |
|---|---|---|
| Visual and Dimensional | ||
| Inspection of Coil: | ||
| • Length | ||
| • First Loop OD | Dimensions were measured and key | |
| characteristics of the implant coil were | ||
| inspected. | All devices met acceptance | |
| criteria. | ||
| Coil Deformation Force | The first loop is compressed to a | |
| deformation distance of 20% of the | ||
| coil's loop OD. The peak force is | ||
| recorded. | All devices met acceptance | |
| criteria. | ||
| Ease of Deliverability | ||
| • Friction Testing | ||
| • Force Transfer | ||
| • Fatigue and | ||
| Knotting | • Peak delivery force was measured | |
| through a representative tortuous | ||
| anatomical model. | ||
| • The proximal end of the device is | ||
| advanced until the distal force | ||
| exceeds a specified value. The force | ||
| transfer is calculated. | ||
| • The device is placed inside the | ||
| microcatheter and advanced until | ||
| the coil is deployed completely | ||
| inside the aneurysm model. The | ||
| device is retracted and the cycle is | ||
| repeated. After the required | ||
| number of cycles the device is | ||
| inspected. | All devices met acceptance | |
| criteria. |
9
| Test | Test Method | Conclusion |
|---|---|---|
| Detachment | ||
| Stretch Resistant Polypropylene Tensile test Coil-Coil Shell Tensile Test | The coil is stretched until the stretch resistant member breaks. The peak force result was recorded The primary wire of the coil is stretched until the coil-coil shell weld breaks. The peak force result was recorded | All devices met acceptance criteria. |
| Labeling Verification | Text and format of drawings were visually compared to labeling and packaging product specifications. | All devices met acceptance criteria. |
| Physician Usability Testing | The device was navigated through a tortuous benchtop model and deployed into a simulated silicone aneurysm in order to assess stability, neck coverage, conformability, softness and smoothness of delivery. | All test results met the acceptance criteria. |
Performance Data – Animal
No animal study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model numbers. Substantial equivalence of the subject device has been established to the predicate device through the results of the bench testing that was performed as well as the testing that was adopted from the predicate device.
Performance Testing - Clinical
No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new model numbers. Substantial equivalence of the subject device has been established to the predicate device through the results of the bench testing that was performed as well as the testing that was adopted from the predicate device.