(164 days)
The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure.
The AVS® ARIA Neuromonitoring Probe (NM Probe) and AVS® ARIA Probe Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The NM Probe and probe dilators are available in monopolar configuration. These are made from stainless steel (NM Probe) insulated with either polytetrafluoroethylene or polyphenylsulfone (dilator tubes). The NM probe has a male 1.5mm DIN connector. The components are provided clean to users for sterilization prior to use. The components are not intended for cleaning, reprocessing, or reuse.
The provided text is a 510(k) summary for a medical device called the AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to performance standards rather than presenting a study with specific performance metrics against acceptance criteria in the way a diagnostic AI device might.
Therefore, many of the requested fields (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not mentioned in this type of regulatory submission for this particular device.
However, I can extract the available information related to performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety/Compatibility | Compliance with IEC 60601-1-2: 2007 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests) | The device was tested in accordance with IEC 60601-1-2: 2007, and "the test results indicate that the AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are substantially equivalent to predicate devices." |
| Material Standards (Stainless Steel) | Compliance with ASTM F899 (Standard Specification for Wrought Stainless Steels for Surgical Instruments) | "All stainless steel components, comply with ASTM F899." |
| Material Standards (PTFE) | Compliance with ASTM D4895 (Standard Specification for Polytetrafluoroethylene (PTFE) Resins Produced From Granular Molding Powders) | "all PTFE components comply with ASTM D4895." |
| Sterilization Assurance Level (SAL) | SAL of 10^-6 for both gravity and prevacuum steam sterilization, validated according to AAMI ST79:2010, AAMI A1:2010, AAMI TIR12:2010, and ISO 17665-1:2006. | "All devices have been validated... for a Sterility Assurance Level (SAL) of 10^-6 according to AAMI ST 79: 2010, AAMI A1:2010, AAMI TIR 12:2010, and ISO 17665-1: 2006." |
| Recommended Sterilization Parameters (Prevacuum) | Temperature: 132°C (270°F), Exposure Time: 4 Minutes, Dry Time: 20 Minutes | These parameters were validated to achieve the required SAL. |
| Recommended Sterilization Parameters (Gravity) | Temperature: 132°C (270°F), Exposure Time: 15 Minutes, Dry Time: 30 Minutes | These parameters were validated to achieve the required SAL. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not mentioned. This submission focuses on engineering and sterilization validation against established standards and substantial equivalence to predicate devices, not on clinical performance metrics derived from a "test set" of patient data in the context of diagnostic algorithms. The testing relates to the device's physical and functional properties, and its ability to be sterilized.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not mentioned. Ground truth in the context of this device's submission refers to compliance with engineering and material standards, and validated sterilization efficacy, which are established through laboratory testing and published standards, not through expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. This concept applies to clinical outcome or diagnostic accuracy studies, which are not detailed here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a MRMC study was not done. This type of study is relevant for AI-powered diagnostic aids, not for a neuromonitoring probe, which is a surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical surgical probe and dilators; there is no "algorithm only" performance to evaluate. Its function is to deliver an electrical stimulus under direct human control during surgery.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance claims in this submission is established engineering and material standards (IEC 60601-1-2, ASTM F899, ASTM D4895) and sterilization validation protocols (AAMI ST79, AAMI A1, AAMI TIR 12, ISO 17665-1). The device's performance is measured against these objective, verifiable standards.
8. The sample size for the training set
- Not applicable/Not mentioned. This device does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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K 110419
P.1 of 2
510(k) Summary
Contact:
Date Prepared:
Device Trade Name:
Submitter:
Manufacturer:
Common Name:
Classification:
Class:
Product Code:
Kimberly Lane
Sr. Regulatory Affairs Specialist
Stryker Spine
2 Pearl Court
Allendale, NJ 07401
July 22, 2011
AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe
Dilators
Stryker Spine
2 Pearl Court
Allendale, NJ 07430
Stryker Spine
ZI de Marticot, 33610
Cestas - FRANCE
Electrode needle
21 CFR § 882.1350
II
GXZ
JUL 28 2011
Indications For Use:
The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure.
Device Description:
The AVS® ARIA Neuromonitoring Probe (NM Probe) and AVS® ARIA Probe Dilators are used as instruments to deliver electrical stimulation to tissue during intraoperative neurological monitoring. The NM Probe and probe dilators are available in monopolar configuration. These are made from stainless steel (NM Probe) insulated with either polytetrafluoroethylene or polyphenylsulfone (dilator tubes). The NM probe has a male 1.5mm DIN connector. The components are provided clean to users for sterilization prior to use. The components are not intended for cleaning, reprocessing, or reuse.
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110419 p.2 of 2
| Reference Number | Device Name |
|---|---|
| 48755006 | NM Probe/Guide Wire |
| 48755001 | Dilator 1 - 6.4mm |
| 48755002 | Probe Dilator 2, NM - 14.4mm |
| 48755003 | Probe Dilator 3, NM - 22.5mm |
The NM Probe and probe dilators are provided by Stryker Spine non-sterily and must be sterilized by the end user prior to use and subsequently disposed of after use in a single case. These devices are not labeled non-pyrogenic.
Predicate Device(s):
The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators were shown to be substantially equivalent to the below previously cleared devices and have the same indications for use, design, function, and materials used.
| 510(k) | Company Name | Device Name |
|---|---|---|
| K090838 | Axon Systems, Inc. | XPAK & XPAK II |
| K062996 | Axon Systems, Inc. | Disposable Stimulator Probes |
| K850107 | Carefusion (Nicolet) | Probes |
Performance Standards:
The device was tested in accordance with IEC 60601-1-2: 2007 and the test results indicate that the AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are substantially equivalent to predicate devices. All stainless steel components, comply with ASTM F899 and all PTFE components comply with ASTM D4895. All devices have been validated, in both gravity and pre-vacuum, in their surgical case set for a Sterility Assurance Level (SAL) of 10 according to AAM ST 79: 2010, AAMI A1:2010, AAMI TIR 12:2010, and ISO 17665-1: 2006. The steam sterilization parameters are:
Prevacuum (Porous Load) steam sterilization autoclave:
- Temperature: 132°C (270°F) .
- Exposure Time: ◆ 4 Minutes
- Dry Time: 20 Minutes .
Gravity Displacement steam sterilization autoclave:
- Temperature: 132°C (270°F) .
- Exposure Time: . 15 Minutes
- Dry time: 30min. .
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in a simple, bold line drawing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Stryker Spine c/o Ms. Tiffani Rogers Regulatory Affairs Manager 2 Pearl Court Allendale, NJ 07401
JUL 28 2011
Re: K110419
Trade/Device Name: AVS ARIA Neuromonitoring Probe and AVS ARIA Probe Dilators Regulation Number: 21 CFR 882.1350 Regulation Name: Electrode Needle Regulatory Class: Class II Product Code: GXZ Dated: July 14, 2011 Received: July 15, 2011
Dear Ms. Rogers:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Keria Alexander
Malvina B. Eydelman, M.D. Director
Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K110419
Device Name: AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators
The AVS® ARIA Neuromonitoring Probe and AVS® ARIA Probe Dilators are indicated for use during surgery of the spine to deliver an electrical stimulus to the tissues and nerves at the operative site to assist in locating those nerves at risk during the surgical procedure.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
John Doucet
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Division of Ophthalmic, Neurological and Ear,
Levices of Ophthalmic, Neurological and Ear,
Levices LTbroat (Division Sign-Off)
(Division Sign-Off) Division of Opinal Devices
Nose and Throat Devices
Nose and
510(k) Number K110419
Prescription Use
(Per 21 CFR 801.109)
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).