Who is the manufacturer of ATEC IOM Accessory Instruments?

Alphatec Spine, Inc. filed the 510(k) submission for ATEC IOM Accessory Instruments (K182617).

What is the FDA product code for ATEC IOM Accessory Instruments?

PDQ. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for ATEC IOM Accessory Instruments?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ATEC IOM Accessory Instruments?

Stryker ES2 Neuromonitoring Accessory Instruments (K171807); Pioneer Surgical Nerve Monitoring Cable System (K142438); The EPAD 2 System (K182542).

Who can help prepare an FDA 510(k) submission like ATEC IOM Accessory Instruments?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ATEC IOM Accessory Instruments

K182617 · Alphatec Spine, Inc. · PDQ · May 9, 2019 · Ear, Nose, Throat

Device Facts

Record ID	K182617
Device Name	ATEC IOM Accessory Instruments
Applicant	Alphatec Spine, Inc.
Product Code	PDQ · Ear, Nose, Throat
Decision Date	May 9, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Intended Use

The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches.

Device Story

ATEC IOM Accessory Instruments are surgical tools (drills, taps, awls, probes, screwdrivers, dilators, guidewires, needles) used in spine surgery; provide electrical stimulation to body tissues to locate/identify nerves; compatible with standard neuromonitoring consoles via clips or probes; provide surgeon with nerve location, proximity, and integrity data; used in open or percutaneous minimally invasive procedures; assists surgeon in targeting, bone preparation, and implant placement; benefits patient by reducing risk of nerve injury during spinal instrumentation.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including functional performance, electrical safety, biocompatibility, and reprocessing validation.

Technological Characteristics

Instruments include drills, taps, awls, probes, screwdrivers, dilators, guidewires, and needles. Electrical stimulation principle; compatible with external neuromonitoring consoles. Biocompatible materials; limited patient contact (≤ 24 hours). Sterilization via validated steam (ANSI/AAMI/ISO 17665-1). Electrical safety per IEC 60601-1.

Indications for Use

Indicated for use in spine surgical procedures to assist in nerve location during or after preparation and placement of intervertebral fusion cages and pedicle screw fixation devices in open and percutaneous minimally invasive approaches.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

Stryker ES2 Neuromonitoring Accessory Instruments (K171807)
Pioneer Surgical Nerve Monitoring Cable System (K142438)
The EPAD 2 System (K182542)

Reference Devices

IdentiTi Porous Ti Interbody System (K183705)
Arsenal Posterior Fixation System (K161363)
Arsenal Posterior Fixation System (K133221)
Illico MIS Posterior Fixation System (K123623)
Raptor Facet Fixation System (K110170)

Related Devices

K191723 — ATEC IOM Accessory Instruments · Alphatec Spine, Inc. · Oct 18, 2019
K221821 — ATEC IOM Accessory Instruments · Alphatec Spine, Inc. · Sep 23, 2022
K140400 — ES2 NEUROMONITORING ACCESSORY INSTRUMENTS · Stryker Corporation · Jul 1, 2014
K171807 — ES2 Neuromonitoring Accessory Instruments · Stryker Corporation · Jul 18, 2017
K161893 — Neuromonitoring Kit · SI-BONE, Inc. · Oct 18, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ May 9, 2019 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Alphatec Spine, Inc Jeremy Markovich Senior Manager, Regulatory and Clinical Affairs 5818 El Camino Real Carlsbad, California 92008 ## Re: K182617 Trade/Device Name: ATEC IOM Accessory Instruments Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ, ETN Dated: April 5, 2019 Received: April 8, 2019 ## Dear Jeremy Markovich: 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. 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 located 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. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 4, Subpart A) for combination products; 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 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, for Carlos L. Peña, PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182617 Device Name ATEC IOM Accessory Instruments ### Indications for Use (Describe) The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white letter "a" inside of it. To the right of the square is the word "tec" in white font. The background of the logo is a dark blue color. This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. | I. | SUBMITTER: | Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Phone: (760) 431-9286 Fax: (760) 431-0289 | |----|------------------------|-------------------------------------------------------------------------------------------------------------------| | | Contact Person: | Jeremy Markovich Senior Manager, Regulatory and Clinical Affairs Contact Phone: (760) 431-9286 | | | Date Summary Prepared: | May 8, 2019 | #### II. DEVICE | Trade or Proprietary Name: | ATEC IOM Accessory Instruments | |----------------------------|------------------------------------| | Common Name: | Surgical nerve stimulator/locator. | | Classification Name: | Neurosurgical Nerve Locator | | Regulation Number: | 21 CFR 874.1820 | | Classification: | Class II | | Product Code: | PDQ, ETN | #### III. LEGALLY MARKETED PREDICATE DEVICES | Predicate Device(s): | | |----------------------|--| | | | | 510(k) | Product Name | Clearance Date | |---------|---------------------------------------------------|-------------------| | K171807 | Stryker ES2 Neuromonitoring Accessory Instruments | July 18, 2017 | | K142438 | Pioneer Surgical Nerve Monitoring Cable System | March 5, 2015 | | K182542 | The EPAD 2 System | February 22, 2019 | ## Reference Device(s): | 510(k) | Product Name | Clearance Date | |---------|--------------------------------------|-------------------| | K183705 | IdentiTi Porous Ti Interbody System | March 1, 2019 | | K161363 | Arsenal Posterior Fixation System | June 10, 2016 | | K133221 | Arsenal Posterior Fixation System | March 13, 2014 | | K123623 | Illico MIS Posterior Fixation System | February 14, 2013 | | K110170 | Raptor Facet Fixation System | November 28, 2011 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white curved line inside, followed by the word "atec" in white. The "c" in "atec" has a trademark symbol next to it. The background of the logo is dark blue. #### DEVICE DESCRIPTION IV. The ATEC IOM Accessory Instruments are surgical instruments that provide electrical stimulation to the body to locate and identify nerves in either open, minimally invasive, or percutaneous procedures. These surgical instruments are compatible with common FDA cleared neuromonitoring platforms as they are connected via a compatible clip or probe depending on the system. The neuromonitoring capability provides the surgeon with spinal nerve location, proximity, and integrity information. This information assists the surgeon during targeting, bone preparation, and placement of orthopedic implants such as intervertebral fusion devices (e.g., interbodies) and bone screws (e.g., pedicle screws). {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the "atec" logo. The logo consists of a green square with a white stylized "a" inside it, followed by the word "tec" in white. There is a trademark symbol after the word "tec". The background is dark blue. | | Predicate Device K171807 | Predicate Device K142438 | Predicate Device K182542 | Subject Device | |------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | Stryker ES2 Neuromonitoring Accessory Instruments | Pioneer Surgical Nerve Monitoring Cable System | The EPAD 2 System | ATEC IOM Instruments | | Indications for Use | The ES2 Neuromonitoring instruments (Awls, Taps, Screwdriver and LITe Y- NEEDLE 200, 300 and 400) can be used by the surgeon to assist in location of the spinal nerves by providing proximity information before, during or after bone preparation and placement of bone screws in open and percutaneous minimally invasive posterior surgical approaches of the non- cervical spine. | The Nerve Monitoring Cable in conjunction with dilators, pedicle probes, taps, awls or screw drivers, are intended for tissue dilation/dissection and stimulation of peripheral nerves including spinal nerve roots for location and identification during spinal surgery. The dilators are also intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site to allow passage of current from a point on the proximal end to an uninsulated portion of the distal tip. The purpose of this is to allow controlled monitoring of neural elements near and around the point of access. The dilators are offered sterile/single use. | The EPAD 2 system is intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEP), electromyography (EMG), or assessing the neuromuscular junction (NMJ). Neuromonitoring procedures include intracranial, extracranial, intratemporal, extratemporal, neck dissections, upper and lower extremities, spinal degenerative treatments, pedicle screw fixation, intervertebral fusion cages, rhizotomy, orthopedic surgery, open or percutaneous, lumbar, thoracic, and cervical surgical procedures. | The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches. | | Regulation, Product Code, & Class | 21 CFR 874.1820 PDQ Class II | 21 CFR 874.1820 21 CFR 882.1350 PDQ, ETN, GXZ Class II | 21 CFR 882.1870 21 CFR 874.1820 21 CFR 882.1350 21 CFR 882.1320 GWF, ETN, PDQ, GXY, GXZ Class II | 21 CFR 874.1820 PDQ, ETN Class II | | IEC 60601 Compliant | Yes Protected Pin Design via compatible clip/probe Clause 56.3(c) | Yes Protected Pin Design via compatible clip/probe Clause 56.3(c) | Yes Protected Pin Design via compatible clip/probe Clause 56.3(c) | Yes Protected Pin Design via compatible clip/probe Clause 56.3(c) | | Instrument Type (Description) | Awls, Taps, Screwdrivers, Guidewires (K-wires), and 200, 300, 400 LITE Y-Needles | Dilators, Pedicle Probes, Taps, Awls and Screwdrivers | Probes, Dilators, Electrodes | Drills, Taps, Awls, Probes, Screwdrivers, Dilators (Sleeves), Guidewires, and Needles | | Biocompatibility Patient Contact Duration | Limited patient duration contact (≤ 24 hours) | Limited patient duration contact (≤ 24 hours) | Limited patient duration contact (≤ 24 hours) | Limited patient duration contact (≤ 24 hours) | | Biocompatible | Yes (Characterizatio | Yes | Yes | Yes | | Surgical Approach | Open or Percutaneous/ Minimally Invasive | Open or Percutaneous/ Minimally Invasive | Open or Percutaneous/ Minimally Invasive | Open or Percutaneous/ Minimally Invasive | | Sterility | Sterile and Non-sterile Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of $10^{-6}$ | Sterile and Non-sterile Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of $10^{-6}$ | Sterile and Non-sterile | Non-sterile Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of $10^{-6}$ | | Reusable/ Single Use | 200, 300, and 400 LITE Y Needles – Single Use Awls, Taps, and Screwdrivers - Reusable | Dilators – Single Use Pedicle probes, taps, awls and screw drivers - Reusable | Single Use | Guidewires, Targeting Needles and Dilators – Single Use Awls, Drills/Taps, Probes, Dilators (Sleeves), and Screwdrivers - Reusable | | Compatible with Common Neuromonitoring Consoles & Software | Yes | Yes | Yes | Yes | | Connection to Neuromonitoring Unit | Clip or probe (based on Neuromonitoring system) | Clip or probe (based on Neuromonitoring system) | Clip or probe (based on Neuromonitoring system) | Clip or probe (based on Neuromonitoring system) | | Minimum exposed surface area during tissue stimulation | 0.53 mm² | 12.9032 mm² (0.02 in²) | Unknown | 8.6 mm² | # Table 1: Comparison for Substantial Equivalence {6}------------------------------------------------ Image /page/6/Picture/0 description: The image is a logo for a company called "atec". The logo consists of a green square with a white "a" inside of it, followed by the word "tec" in white. The background of the logo is a dark blue color. There is a trademark symbol after the word "tec". {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Atec. The logo features a green square with a white letter "a" inside of it. To the right of the square is the word "tec" in white font with a trademark symbol. | Table 2: Comparison for Substantial Equivalence for Reference Device(s) | | | | | | |-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | Reference Device K183705 | Reference Device K110170 | Reference Device K123623 | Reference Device K133221 K161363 | Subject Device | | Regulation, Product Code, & Class | IdentiTi Porous Ti Interbody System 21 CFR 888.3080 MAX Class II | Raptor Facet Fixation System 21 CFR 888.4540 LXH Class I | Illico MIS Posterior Fixation System 21 CFR 888.4540 LXH Class I | Arsenal Posterior Fixation System 21 CFR 888.4540 LXH Class I | ATEC IOM Instruments 21 CFR 874.1820 PDQ, ETN Class II | | Instrument Type (Description) | Inserter | Screwdrivers, Guidewires | Guidewires, Dilators (Sleeves) | Screwdrivers | Drills, Taps, Awls, Probes, Screwdrivers, Dilators (Sleeves), Guidewires, and Targeting Needles | | Biocompatibility Patient Contact Duration | Limited patient duration contact (≤ 24 hours) | Limited patient duration contact (≤ 24 hours) | Limited patient duration contact (≤ 24 hours) | Limited patient duration contact (≤ 24 hours) | Limited patient duration contact (≤ 24 hours) | | Biocompatible | Yes (Data provided to characterize materials) Non-sterile | Yes (Data provided to characterize materials) Non-sterile | Yes (Data provided to characterize materials) Non-sterile | Yes (Data provided to characterize materials) Non-sterile | Yes Non-sterile | | Sterility | Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of 10-6 | Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of 10-6 | Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of 10-6 | Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of 10-6 | Non-sterile devices are provided with validated steam sterilization parameters to assure an SAL of 10-6 | | Reusable/ Single Use | Inserter - Reusable | Guidewires - Single Use Screwdrivers - Reusable | Guidewires - Single Use Dilator - Reusable | Screwdrivers - Reusable | Guidewires, Targeting Needles and Dilators - Single Use Awls, Drills/Taps, Probes, Dilators (Sleeves), and Screwdrivers - Reusable | | Compatible with Common Neuromonitoring Consoles & Software | No | No | No | No | Yes | | Connection to Neuromonitoring Unit | Not applicable | Not applicable | Not applicable | Not applicable | Clip or probe (based on Neuromonitoring system) | # Table 2: Comparison for Substantial Equivalence for Reference Device(s) {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the "atec" logo. The logo consists of a green square with a white design inside, followed by the word "atec" in white font. The background is a dark blue color. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for a company called "atec". The logo consists of a green square with a white stylized "a" inside of it, followed by the white text "tec" with a trademark symbol. The background of the logo is a dark blue color. The logo is simple and modern, and the colors are eye-catching. #### V. INDICATIONS FOR USE The ATEC IOM Accessory Instruments are utilized in spine surgical procedures to assist in location of the nerves during or after preparation and placement of implants (intervertebral fusion cages and pedicle screw fixation devices) in open and percutaneous minimally invasive approaches. #### TECHNOLOGICAL COMPARISON TO PREDICATES VI. The technological design features of the subject implants were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent. #### VII. PERFORMANCE DATA Performance testing demonstrates the subject ATEC IOM Accessory Instruments are appropriate for neuromonitoring applications and do not introduce a new worst case for minimum exposed surface area during tissue stimulation compared to other legally marketed devices cleared by FDA. The table below summarizes the testing which was performed on the subject devices to show substantial equivalence to the predicate devices. | Test | Test Method Summary | Results | |-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Functional performance testing and verification analysis | Insulation Effectiveness Electrical Resistance Current Density | All functional performance testing passed. Substantial equivalence has been shown via analysis and testing. | | Electrical safety testing and/or evaluation | Evaluation and testing was performed on the subject devices in accordance with IEC 60601-1: 2005. | Subject devices passed electrical safety testing and/or evaluation, demonstrating that the devices meet the requirements. | | Biocompatibility testing | Biocompatibility testing conducted per ISO 10993. Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Material Mediated Pyrogenicity Hemocompatibility | A risk analysis was performed taking into account nature of body contact and duration to categorization the use of existing data, end-specific testing, and endpoint assessment to cover the identified test methods. Additionally, data was leveraged by other means (e.g., authorized use of Master File, predicate and reference devices, well known and characterized materials) to support the biocompatibility of the subject devices. | | Reprocessing | Cleaning validation study based on acceptance criteria from AAMI TIR30:2011 Steam sterilization validation performed per ANSI/AAMI/ISO 17665-1:2006/(R)2013. | The subject devices can be adequately cleaned and steam sterilized prior to use. | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the "atec" logo. The logo consists of a green square with a white stylized "a" inside, followed by the white text "tec" with a trademark symbol. The background is a dark blue color. ## Clinical Information Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data. #### CONCLUSION VIII. Based upon the information provided in this 510(k) submission, it has been determined that the subject devices are substantially equivalent to legally marketed devices in regards to indications for use, intended use, design, technology, and performance.