(92 days)
Not Found
No
The document describes surgical instruments for electrical stimulation and neuromonitoring, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used to locate and identify nerves through electrical stimulation during surgical procedures, not to treat a medical condition. It provides information to the surgeon but does not deliver therapy.
Yes
The device provides "spinal nerve location, proximity, and integrity information" which assists the surgeon in identifying and locating nerves; this function is diagnostic in nature as it provides information used to identify a condition or state (the location and integrity of nerves).
No
The device description explicitly states the ATEC IOM Accessory Instruments are "surgical instruments that provide electrical stimulation to the body" and are made of materials like "conductive sliver ink, aluminum alloy, and dielectric coating," indicating they are physical hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used during surgical procedures to locate nerves by providing electrical stimulation. This is a direct interaction with the patient's body for real-time information during surgery.
- Device Description: The device is described as "surgical instruments that provide electrical stimulation to the body." This clearly indicates an in-vivo (within the living body) application.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not analyze specimens taken from the body.
The device's function is to provide real-time physiological information during a surgical procedure, which falls under the category of a surgical or monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PDQ, ETN
Device Description
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). All sterile instruments are single use only and all reusable instruments are offered non-sterile to be steam sterilized by the end user.
The purpose of this submission is to gain clearance for new dilators made of conductive sliver ink, aluminum alloy, and dielectric coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Operating Room
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)
Performance testing includes IEC 60601-1 testing, and functional testing on insulation effectiveness and electrical resistance.
Test: Electrical Safety Testing and/or Evaluation; Test Method Summary: Evaluation and testing was performed on the subject devices in accordance with IEC 60601-1: 2005 (R) 2012; Results: All samples passed acceptance criteria.
Test: Functional Performance Testing and Verification Analysis; Test Method Summary: Insulation Effectiveness, Electrical Resistance; Results: All samples passed acceptance criteria.
Test: Reprocessing; Test Method Summary: Cleaning validation or adoption study based on acceptance criteria from AAMI TIR30:2011, Steam sterilization validation or adoption performed per ANSI/AAMI/ISO 17665-1:2006/(R)2013; Results: All samples passed acceptance criteria.
Biocompatibility testing evaluated per ISO 10993-1.
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
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.
K191723, K171807, K110989, K212166
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.1820 Surgical nerve stimulator/locator.
(a)
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.(b)
Classification. Class II.
0
September 23, 2022
Image /page/0/Picture/1 description: The image shows 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. Sandy Gill Sr. Regulatory Affairs Specialist 1950 Camino Vido Roble Carlsbad, CA 92008
Re: K221821
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: August 29, 2022 Received: August 30, 2022
Dear Sandy Gill:
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices 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) K221821
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) |
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Image /page/3/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the "tec" is dark blue. There is a black line underneath the logo.
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.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|----|------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Sandy Gill
Sr. Regulatory Affairs Specialist |
| | Date Summary Prepared: | August 29, 2022 |
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
Primary Predicate Device:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K191723 | ATEC IOM Accessory Instruments | October 18, 2019 |
Additional Predicate Devices:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K171807 | ES2 Neuromonitoring Accessory Instruments | July 18, 2017 |
| K110989 | Neurovision Ink Printed Endotracheal Tube | |
| Electrode | November 03, | |
| 2011 | ||
| K212166 | ISIS Headbox 5042XX and ISIS Neurostimulator | January 07, 2022 |
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Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a black line underneath the logo.
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). All sterile instruments are single use only and all reusable instruments are offered non-sterile to be steam sterilized by the end user.
The purpose of this submission is to gain clearance for new dilators made of conductive sliver ink, aluminum alloy, and dielectric coating.
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.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
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. See Table 1 below.
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| Table 1: Summary of Technological Comparison to Predicates | |||||
|---|---|---|---|---|---|
| Primary Predicate | |||||
| K191723 | Additional Predicate | ||||
| K171807 | Additional Predicate | ||||
| K110989 | Additional Predicate | ||||
| K212166 | Subject Device | ||||
| Attribute | ATEC | ||||
| IOM Instruments | Stryker ES2 | ||||
| Neuromonitoring | |||||
| Accessory | |||||
| Instruments | Neurovision Ink | ||||
| Printed Endotracheal | |||||
| Tube Electrode | ISIS Headbox 5042XX | ||||
| and ISIS | |||||
| Neurostimulator | ATEC | ||||
| IOM Instruments | |||||
| 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. | The ES2 Neuromonitoring | ||||
| instruments (Awls, Taps, | |||||
| Screwdriver and LITe Y- | |||||
| NEEDLE 200, 300 and |
- 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 Neurovision Ink
Printed Endotracheal
Tube Electrode is
intended for use during
surgery and parasurgical
care only, with any
compatible monitoring
system, for continuous
EMG monitoring and
status assessment of the
nerves supplying the
laryngeal musculature as
well as providing an
open airway for patient
ventilation. | ISIS Headbox 5042xx
products:
The products are intended for
intraoperative
neuromonitoring; for recording
of electrophysiological signals
and stimulating of nerve and
muscle tissues. The products
are intended for use in the
operating room to measure and
display the electrical signals
generated by muscle,
peripheral nerves and the
central nervous system. The
products support the clinical
application of
Electroencephalography (EEG),
Electromyography (EMG),
Somatosensory Evoked
Potentials (SEP), Motor
Evoked Potentials (MEP), and
Auditory Evoked Potentials
(AEP). The products are not
intended for monitoring life-
sustaining functions.
ISIS Neurostimulator 504180:
The ISIS Neurostimulator is
intended for provision of
neurophysiological stimulation
when used in surgical
procedures and for diagnostics.
It is suitable for continuous | 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. |
| Attribute | Primary Predicate
K191723 | Additional Predicate
K171807 | Additional Predicate
K110989 | Additional Predicate
K212166 | Subject Device |
| | ATEC
IOM Instruments | Stryker ES2
Neuromonitoring
Accessory
Instruments | Neurovision Ink
Printed Endotracheal
Tube Electrode | ISIS Headbox 5042XX
and ISIS
Neurostimulator | ATEC
IOM Instruments |
| | | | | the following fields:-
Transcranialelectrical
stimulation (TES) - Direct
cortical stimulation (DCS)-
Direct nerve stimulation
(DNS) - Transcutaneous
electrical nerve stimulation
(TNS) — Direct muscle
stimulation (DMS) | |
| Regulation
Number.
Product Code, &
Classification | 21 CFR 874.1820
PDQ, ETN
Class II | 21 CFR 874.1820
PDQ
Class II | 21 CFR 874.1820
ETN, BTR, GWF
Class II | 21 CFR 882.1870
GWF, ETN, GWE, GWJ,
GWQ, IKN | 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) | Unknown | Yes | Yes
Protected Pin Design via
compatible clip/probe
Clause 56.3(c) |
| Instrument Type
(Description) | Drills/Taps. Awls.
Probes, Screwdrivers,
Dilators (Sleeves),
Guidewires, and Needles | Awls, Taps, Screwdrivers,
Guidewires (K-wires), and
200, 300, 400 LITE Y-
Needles | ET Tube | ISIS Xpert®Plus, ISIS
Xpert®, ISIS
Xpress Accessories | Drills/Taps. Awls.
Probes, Screwdrivers,
Dilators (Sleeves).
Guidewires, and Needles |
| Biocompatibility
Patient Contact
Duration | Limited patient duration
contact
(