(113 days)
Not Found
No
The description focuses on electrical stimulation and compatibility with neuromonitoring platforms, with no mention of AI or ML.
No
The device is used to assist in locating nerves during surgery, providing information to the surgeon. It does not directly treat a disease or condition.
No
The device is described as an accessory instrument used to assist in locating nerves during surgical procedures by providing electrical stimulation. It works in conjunction with neuromonitoring platforms to provide information about nerve location, proximity, and integrity, which aids the surgeon. While it provides "information," its primary function is not to diagnose a medical condition but rather to guide surgical intervention.
No
The device description explicitly states the ATEC IOM Accessory Instruments are "surgical instruments that provide electrical stimulation to the body" and are "connected via a compatible clip or probe". This indicates the device includes physical hardware components for electrical stimulation and connection, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in locating nerves during or after surgical procedures by providing electrical stimulation to the body. 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. It's used in conjunction with neuromonitoring platforms, but the device itself is the stimulator applied to the patient.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any analysis on patient specimens.
The device is clearly an active medical device used for intraoperative neuromonitoring, which is a type of surgical assistance, not an in vitro diagnostic test.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerves (in spine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, spine surgical procedures
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, reliability 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.; Results: All samples passed acceptance criteria.
Test: Reliability Testing; Test Method Summary: Testing was performed to verify that there is no adverse effect on the safety or effectiveness of the subject devices based on the intended environment and storage conditions.; 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.
Testing results demonstrated the subject ATEC IOM Accessory Instruments are appropriate for neuromonitoring applications and do not introduce a new worst case compared to other legally marketed devices cleared by FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
October 18, 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. Ms. Ruby Zheng Regulatory Affairs Specialist 5818 El Camino Real Carlsbad, California 92008
Re: K191723
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: September 16, 2019 Received: September 17, 2019
Dear Ms. Ruby Zheng:
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
1
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 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 medical devices and radiation-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) K191723
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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3
Image /page/3/Picture/0 description: The image shows the logo for Atec. The logo consists of a green square with a white stylized "a" inside of it. To the right of the square is the word "tec" in white font, with a trademark symbol in the upper right corner.
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: | Ruby Zheng
Regulatory Affairs Specialist |
| | Date Summary Prepared: | September 16, 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 |
|---|---|---|
| K182617 | ATEC IOM Accessory Instruments | May 9, 2019 |
| K132138 | Rhythmlink Disposable Concentric Stimulating Probe | April 11, 2014 |
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Image /page/4/Picture/0 description: The image shows the Atec logo. The logo consists of a green square with rounded corners and a white letter "a" inside. To the right of the square is the word "tec" in white font, with a trademark symbol in the upper right corner. The background is a dark blue color.
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.
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. See Table 1 below.
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| | Primary Predicate
K182617 | Additional Predicate
K132138 | Subject Device |
|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | ATEC
IOM Instruments | Rhythmlink Disposable
Concentric Stimulating Probe | 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 Rhythmlink Disposable
Concentric Stimulating Probe is
used to perform Intended Use(s)
localized stimulation of neural
tissue and to locate, identify and
monitor cranial motor nerves,
peripheral nerve and spinal nerve
roots during surgery.
The Rhythmlink Disposable
Concentric Stimulating Probe is a
single patient use device | 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 Number.
Product Code, & | 21 CFR 874.1820
PDQ, ETN | 21 CFR 874.1820
ETN | 21 CFR 874.1820
PDQ, ETN |
| Classification | Class II | Class II | Class II |
| IEC 60601 Compliant | Yes
Protected Pin Design via
compatible clip/probe
Clause 56.3(c) | Yes
DIN 42 802 touch proof connectors
Clause 56.3(c) | 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 | Probes | 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) |
| Biocompatible | Yes | Yes | Yes |
| Surgical approach | Open or Percutaneous/Minimally
Invasive | Not specified | Open or Percutaneous/Minimally
Invasive |
| | Primary Predicate
K182617 | Additional Predicate
K132138 | Subject Device |
| Attribute | ATEC
IOM Instruments | Rhythmlink Disposable
Concentric Stimulating Probe | ATEC
IOM Instruments |
| Sterility | Non-sterile
Non-sterile devices are provided
with validated steam sterilization
parameters to assure an SAL of 10-6 | Sterile via EtO | Sterile via EtO and non-sterile
Non-sterile devices are provided
with validated steam sterilization
parameters to assure an SAL of 10-6 |
| Reusable/Single Use | Guidewires, Targeting Needles and
Dilators - Single Use
Awls, Drills/Taps, Probes, Dilators
(Sleeves), and Screwdrivers -
Reusable | Single Use | Guidewires, Targeting Needles and
Dilators - Single Use
SafeOp Ball Tip Probe - Single
Use
Awls, Drills/Taps, Probes, Dilators
(Sleeves), and Screwdrivers -
Reusable |
| Compatible with Common
Neuromonitoring Consoles
& Software | Yes | Yes | Yes |
| Minimum exposed surface
area | 8.6 mm2 | 14.6 mm2 | 8.6 mm2 |
Table 1: Summary of Technological Comparison to Predicates
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VII. PERFORMANCE DATA
Performance testing includes IEC 60601-1 testing, reliability testing, and functional testing on insulation effectiveness and electrical resistance. Table 2 below summarizes the testing which was performed on the Subject Devices to show substantial equivalence to the Testing results demonstrated the subject ATEC IOM Accessory predicate device. Instruments are appropriate for neuromonitoring applications and do not introduce a new worst case compared to other legally marketed devices cleared by FDA.
| Test | Test Method Summary | Results |
|---|---|---|
| Electrical Safety Testing | ||
| and/or Evaluation | Evaluation and testing was performed on | |
| the subject devices in accordance with IEC | ||
| 60601-1: 2005. | All samples passed | |
| acceptance criteria | ||
| Reliability Testing | Testing was performed to verify that there | |
| is no adverse effect on the safety or | ||
| effectiveness of the subject devices based | ||
| on the intended environment and storage | ||
| conditions. | All samples passed | |
| acceptance criteria | ||
| Functional Performance | ||
| Testing and Verification | ||
| Analysis | Insulation Effectiveness Electrical Resistance | All samples passed |
| acceptance criteria |
Table 2: Summary of Performance Testing
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
BIOCOMPATIBILITY DATA VIII.
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.
Biocompatibility testing conducted per ISO 10993-1.
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous
- Reactivity ●
- Acute Systemic Toxicity ●
- Material Mediated Pyrogenicity ●
- . Hemocompatibility
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In conclusion, the ATEC IOM Accessory Instruments are manufactured from the same materials as other legally US-marketed devices.
CONCLUSION IX.
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.