(227 days)
No
The summary describes a device that provides electrical stimulation for nerve location and is compatible with neuromonitoring platforms. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies focus on electrical safety, biocompatibility, and reprocessing, not algorithmic performance.
No
The device is described as an accessory instrument used to locate and identify nerves during surgical procedures, not to treat a disease or condition. Its purpose is to assist in the placement of implants by providing nerve location, proximity, and integrity information.
Yes
The device is described as providing "spinal nerve location, proximity, and integrity information," which assists the surgeon in identifying and locating nerves during surgery. This process of identifying and gathering information about a physiological state (nerve location and integrity) classifies it as a diagnostic device, assisting in informing surgical decisions.
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 that interact directly with the patient's body, not just software. The performance studies also focus on physical properties like insulation effectiveness, electrical resistance, and biocompatibility, further supporting that it is a hardware device.
Based on the provided information, the ATEC IOM Accessory Instruments are not an In Vitro Diagnostic (IVD) device.
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 description explicitly states that the instruments "provide electrical stimulation to the body to locate and identify nerves." This is an in-vivo function (within the living body).
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, urine, etc.) outside of the body. IVDs are designed to perform tests on these types of samples in a laboratory or clinical setting.
The device is clearly designed for use on the patient during surgery to provide real-time feedback about nerve location and integrity. This falls under the category of a surgical instrument with a neuromonitoring function, 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
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerves (in spine surgical procedures)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / 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)
Functional performance testing and verification analysis
- Study type: Functional performance testing and verification analysis
- Test Method Summary: Insulation Effectiveness Electrical Resistance Current Density
- Results: All functional performance testing passed. Substantial equivalence has been shown via analysis and testing.
Electrical safety testing and/or evaluation
- Study type: 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: Subject devices passed electrical safety testing and/or evaluation, demonstrating that the devices meet the requirements.
Biocompatibility testing
- Study type: Biocompatibility testing
- Test Method Summary: Biocompatibility testing conducted per ISO 10993. Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Material Mediated Pyrogenicity Hemocompatibility
- Results: 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
- Study type: Reprocessing
- Test Method Summary: Cleaning validation study based on acceptance criteria from AAMI TIR30:2011 Steam sterilization validation performed per ANSI/AAMI/ISO 17665-1:2006/(R)2013.
- Results: The subject devices can be adequately cleaned and steam sterilized prior to use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K183705, K161363, K133221, K123623, K110170
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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) |
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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 |
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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).
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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
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| 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)
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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. |
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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.