(93 days)
Not Found
No
The document describes a mechanical spinal implant system (cages, plates, and screws) and its intended use and materials. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance studies are mechanical tests, not software validation.
Yes.
The device is used to treat diagnosed medical conditions such as degenerative disc disease, trauma, tumors, and scoliosis, by facilitating spinal fusion and providing stabilization. These applications align with the definition of a therapeutic device designed to treat a disease, injury, or medical condition.
No
This device is an implantable medical system (interbody cages, plates, and bone screws) intended for surgical use in lumbar spinal fusion and stabilization. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states that the PIVOX™ Oblique Lateral Spinal System consists of physical components: interbody cages, plates, and bone screws, made from materials like PEEK and titanium alloy. These are hardware implants, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The PIVOX™ Oblique Lateral Spinal System is a surgical implant designed to be placed within the body to facilitate spinal fusion and provide stabilization. It is used directly in a surgical procedure on the patient, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, performing laboratory tests, or providing diagnostic information based on such tests.
Therefore, the PIVOX™ Oblique Lateral Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the PIVOX® Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach.
The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.
When used together, the PIVOX™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.
Product codes
MAX, OVD, KWQ
Device Description
The PIVOX™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws.
The PIVOX™ Oblique Lateral System interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft or allograft and must be used with supplemental fixation. The cages are manufactured from medical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.
The PIVOX™ Oblique Lateral Spinal System plates and bone screws are available in a broad range of sizes intended for anterior column screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior, lateral, or oblique approach. The PIVOX™ Oblique Lateral System plate and bone screws are made from titanium alloy and are provided sterile.
The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, lumbosacral levels (L1-L5, L2-S1, L5-S1)
Indicated Patient Age Range
Skeletally mature
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)
Biocompatibility:
The biocompatibility evaluation for the subject PIVOX™ Oblique Lateral Spinal System interbody cages, plates, and bone screws was conducted in accordance with the FDA's Draft Guidance for Industry and FDA Staff, Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing, issued April 23, 2013.
The subject devices are manufactured from ASTM F2026: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
Polyetheretherketone (PEEK), titanium alloy, and tantalum have a long history of safe and effective use in predicate spinal implants. Therefore. no new biocompatibility testing was required.
The subject trials, inserters, and interbody remover are manufactured from: Silicone (Elastosil® liquid silicone rubber) and medical grade stainless steel per ASTM A564 or ASTM F899.
The silicone rubber is used to manufacture instrument handles, which are non-patient contacting. Therefore, no new biocompatibility testing was required.
Medical grade stainless steel has a long history of safe and effective use in spinal surgery and no new biocompatibility testing was required.
Mechanical Testing:
In accordance with the Guidance for Industry and FDA Staff - Spinal System 510(k)'s, and the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
Design verification testing was completed in accordance with:
- ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
- ASTM F2077, Test Methods for Intervertebral Body Fusion Devices -
- ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- ASTM F-04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices
The tests completed were:
For the Interbody Cages
- Static Compression
- Static Compression Shear
- Compression Fatigue
- Compression-Shear Fatigue
- Subsidence
- Expulsion
For the Plates and Screws
- Construct Static Compression
- Construct Compression Fatigue
- Construct Static Torsion
- -Static Push-Out
Key Results: The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K150135, K151128, K133577, K131669, K071416, K991460, K091442
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized representation of three human profiles. The profiles are stacked on top of each other, creating a sense of unity and connection. The seal is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
November 13, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Lila Joe Principle Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K152277
Trade/Device Name: PIVOX™ OBLIQUE LATERAL SPINAL SYSTEM Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD, KWQ Dated: October 9, 2015 Received: October 13, 2015
Dear Ms. Joe:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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" (21CFR 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
K152277 Page 1 of 1
510(k) Number (if known)
Device Name PIVOX™ Oblique Lateral Spinal System
Indications for Use (Describe)
The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the PIVOX® Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach.
The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.
When used together, the PIVOX™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.
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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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PIVOX® Oblique Lateral Spinal System 510(k) SUMMARY November 2015
- I. Submitter Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 (901)396-3133 Contact Lila Joe Principle Regulatory Affairs Specialist Date Prepared November 12, 2015 II. Device Name of Device PIVOX™ Oblique Lateral Spinal System Classification Name Intervertebral Body Lumbar Fusion Device with Bone Graft (CFR 888.3080) Spinal Intervertebral Body Fixation Orthosis (CFR 888.3060) Classification Class II MAX, OVD (Interbody Cages) Product Codes KWQ (Plates and Screws) Predicates There are 7 Predicates. Primary Predicate DIVERGENCE™-L™ Anterior Oblique Lumbar . Fusion System (K150135 - S.E. 06/11/2015) Additional Predicates ● CLYDESDALE® Spinal System K151128 (S.E. 08/06/2015) . CLYDESDALE® Spinal System
- K133577 (S.E. 09/26/2014)
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- PERIMETER® Interbody Fusion Device K131669 (S.E. 11/01/2013)
- PYRAMID® +4 Anterior Lumbar Plate System ● K071416 (S.E. 11/01/2007)
- ZPLATE II™ Anterior Fixation System ● K991460 (S.E. 05/19/1999).
- CD HORIZON® Spinal System ● K091442 (S.E. 07/15/2009)
III. Product Description
The PIVOX™ Oblique Lateral Spinal System consists of interbody cages, plates, and bone screws.
The PIVOX™ Oblique Lateral System interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft or allograft and must be used with supplemental fixation. The cages are manufactured from medical grade polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.
The PIVOX™ Oblique Lateral Spinal System plates and bone screws are available in a broad range of sizes intended for anterior column screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior, lateral, or oblique approach. The PIVOX™ Oblique Lateral System plate and bone screws are made from titanium alloy and are provided sterile.
The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 - Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
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The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation.
Indications for Use: IV.
The PIVOX™ Oblique Lateral Spinal System Interbody Cage is designed to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The PIVOX™ Oblique Lateral Spinal System interbody cage is used for patients diagnosed with DDD at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the PIVOX® Oblique Lateral Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of non- operative treatment. These implants may be implanted via a minimally invasive or open lateral or oblique approach.
The PIVOX™ Oblique Lateral Spinal System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral levels, anterior below the bifurcation (L5-S1) of the vascular structures, and oblique or lateral above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) degenerative disc disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.
When used together, the PIVOX™ Oblique Lateral Spinal System components can be used to treat patients with DDD at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels.
V. Comparison of Technological Characteristics
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The primary predicate for the PIVOX™ Oblique Lateral Spinal System is the CLYDESDALE® Spinal System (K151128, S.E. 08/06/2015)
The subject PIVOX™ Oblique Lateral Spinal System interbody cages have the same or similar indications, intended use, fundamental scientific technology, and similar materials as the following FDA cleared predicates K151128 (S.E. 08/06/2015) and K131669 (S.E. 11/01/2013).
The subject PIVOX™ Oblique Lateral Spinal System plates and bone screws have the same intended use, fundamental scientific technology, material, and similar indications as the following FDA cleared predicates K071416 (S.E. 11/01/2007), K991460 (S.E. 05/19/1999). K091442 (S.E. 07/15/2009), and K150135 (S.E. 06/11/2015).
VI. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility
The biocompatibility evaluation for the subject PIVOX™ Oblique Lateral Spinal System interbody cages, plates, and bone screws was conducted in accordance with the FDA's Draft Guidance for Industry and FDA Staff, Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing, issued April 23, 2013.
The subject devices are manufactured from ASTM F2026: Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136: Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
The subject plates, bone screws, and interbody cages are permanent implants and will be classified as "Implant Devices - Tissue/bone - C Permanent (>30 days)" according to FDA's Draft Guidance for Industry and FDA Staff, Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing, issued April 23, 2013.
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Polyetheretherketone (PEEK), titanium alloy, and tantalum have a long history of safe and effective use in predicate spinal implants. Therefore. no new biocompatibility testing was required.
The subject trials, inserters, and interbody remover are manufactured from:
- Silicone (Elastosil® liquid silicone rubber) .
- medical grade stainless steel per ●
- ASTM A564, Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes, or
- ASTM F899, Standard Specification for Wrought Stainless Steel for । Surgical Instruments
The subject instruments are classified as limited, up to 24 hours of body contact according to FDA's Draft Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, issued April 23, 2013.
The silicone rubber is used to manufacture instrument handles, which are non-patient contacting. Therefore, no new biocompatibility testing was required according to FDA's Draft Guidance for Industry and FDA Staff: Use of International Standard ISO-10993, Biological Evaluation Method Devices Part 1: Evaluation and Testing, issued April 23, 2013.
Medical grade stainless steel has a long history of safe and effective use in spinal surgery and no new biocompatibility testing was required.
Mechanical Testing
In accordance with the Guidance for Industry and FDA Staff - Spinal System 510(k)'s, and the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
Design verification testing was completed in accordance with
- ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.
- ASTM F2077, Test Methods for Intervertebral Body Fusion Devices -
- ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence । of Intervertebral Body Fusion Device Under Static Axial Compression
8
- ASTM F-04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices
The tests completed were: For the Interbody Cages
- Static Compression -
- Static Compression Shear -
- Compression Fatigue -
- Compression-Shear Fatigue -
- Subsidence -
- Expulsion -
For the Plates and Screws
- Construct Static Compression -
- Construct Compression Fatigue -
- Construct Static Torsion -
- -Static Push-Out
The subject devices with pre-determined acceptance criteria met the acceptance criteria for all tests.
VII. Conclusions
Design verification testing was completed in accordance with ASTM F1717, ASTM F2077, ASTM F2267, and ASTM F-04.25.02.02. Based on the test results and additional supporting information provided in this pre-market notification, Medtronic believes the subject devices demonstrated substantial equivalence to the legally marketed predicate devices.