(148 days)
No
The document describes a physical implant (lumbar spacer) and its associated trials and instruments. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies are based on mechanical testing of the device.
Yes
The device is a lumbar spacer system used for spinal fusion procedures to treat degenerative disc disease, which qualifies it as a therapeutic device.
No
The AUDERE Lumbar Spacer System is an implant used in spinal fusion procedures; it is a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the system consists of "implants and trials," which are physical hardware components used in surgical procedures. The performance studies also describe testing of these physical components (static axial compression, dynamic axial compression, expulsion, subsidence).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details implants and trials used in surgery.
- Performance Studies: The performance studies focus on the mechanical strength and stability of the implant, which are relevant for a surgical device.
- No mention of in vitro testing: There is no indication that this device is used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is implanted into the body to treat a condition.
N/A
Intended Use / Indications for Use
The AUDERE Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the AUDERE Lumbar Spacer System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AUDERE Lumbar Spacer System.
The AUDERE Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The AUDERE Lumbar Spacer System consists of implants and trials that are compatible with all previously cleared AUDERE instruments. The AUDERE Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transforaminal (TLIF) approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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)
THE AUDERE Lumbar Spacer System has been tested in the following test modes:
- Static axial compression per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Expulsion per ASTM F-04.25.02.02
- Subsidence per ASTM F2267
The results of this non-clinical testing show that the strength of the AUDERE Lumbar Spacer System is sufficient for its intended use and substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AUDERE Lumbar Spacer System (Met One Technologies, LLC - K160699), PATRIOTTM Spacer (Globus Medical Inc. – K122097), Interbody System (Tyber Medical - K130573), AccuLiF® TL-PEEK Cage and AccuLiF® TL and PL (CoALign Innovation – K112095)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Met One Technologies Mr. Evan Carbonell President & CEO 513 W. San Antonio Ave, Suite C El Paso, Texas 79901
Re: K193457
Trade/Device Name: AUDERE Lumbar Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: January 24, 2020 Received: February 13, 2020
Dear Mr. Carbonell:
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
May 12, 2020
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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
Brent Showalter, Ph.D. Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193457
Device Name AUDERE Lumbar Spacer System
Indications for Use (Describe)
The AUDERE Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the AUDERE Lumbar Spacer System.
Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AUDERE Lumbar Spacer System.
The AUDERE Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.
| 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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K193457 - 510(K) Summary
| Date: | 20 April 2020 |
|---|---|
| Sponsor: | Met One Technologies, LLC |
| 513 W. San Antonio Ave Ste. C | |
| El Paso, TX 79901 | |
| Sponsor Contact | Kyle Atwood, Vice President, Engineering |
| Proposed Trade | |
| Name: | AUDERE Lumbar Spacer System |
| Common Name: | Interbody Fusion System |
| Device Classification: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Code: | Intervertebral fusion device with bone graft, lumbar, 888.3080, MAX |
| Submission Purpose: | The purpose of this submission is to address dimensional changes of the |
| AUDERE Lumbar Spacer System for the purpose of improving insertion, better | |
| radio-visibility and to expand the system to include 4° and 8° lordotic | |
| implantable devices. | |
| Device Description: | The AUDERE Lumbar Spacer System consists of implants and trials that are |
| compatible with all previously cleared AUDERE instruments. The AUDERE | |
| Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) | |
| approach, or as a single device employing a transforaminal (TLIF) approach. | |
| Indications for Use: | The AUDERE Lumbar Spacer System is indicated for spinal fusion procedures in |
| skeletally mature patients with degenerative disc disease (DDD) at one or two | |
| contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 | |
| spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as | |
| discogenic back pain with degeneration of the disc confirmed by history and | |
| radiographic studies. Patients with previous non-fusion spinal surgery at the | |
| involved level may be treated with the AUDERE Lumbar Spacer System. | |
| Patients must have undergone a regimen of at least six (6) months of non- | |
| operative treatment prior to being treated with the AUDERE Lumbar Spacer | |
| System. | |
| The AUDERE Lumbar Spacer System is designed for use with autogenous bone | |
| graft. The system is also intended to be used with supplemental fixation | |
| systems that are cleared by the FDA for use in the lumbar spine. | |
| Materials: | The AUDERE Lumbar Spacer System is comprised of a family of implants that |
| has bodies manufactured from polyetheretherketone (PEEK), in compliance | |
| with ASTM F2026, and radiographic markers manufactured from Tantalum, in | |
| compliance with ASTM F560. | |
| Primary Predicate | AUDERE Lumbar Spacer System (Met One Technologies, LLC - K160699) |
| Additional Predicates | PATRIOTTM Spacer (Globus Medical Inc. – K122097) |
| Interbody System (Tyber Medical - K130573) | |
| AccuLiF® TL-PEEK Cage and AccuLiF® TL and PL (CoALign Innovation – K112095) | |
| Performance Data: | THE AUDERE Lumbar Spacer System has been tested in the following test |
| modes: |
- Static axial compression per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Expulsion per ASTM F-04.25.02.02
- Subsidence per ASTM F2267
The results of this non-clinical testing show that the strength of the AUDERE
Lumbar Spacer System is sufficient for its intended use and substantially
equivalent to legally marketed predicate devices. |
| Technological
Characteristics: | The modified AUDERE Lumbar Spacer System possesses the same
technological characteristics as one or more of the predicate devices. These
include: - Performance (as described above),
- Basic design (machined structural interbody)
- Material (PEEK and Tantalum) and
- Size (dimensions are comparable to those offered by the cleared
devices)
Therefore, the fundamental scientific technology of the modified AUDERE
Lumbar Spacer System is the same as previously cleared devices. |
| Conclusion: | The modified AUDERE Lumbar Spacer System possesses the same intended use
and technological characteristics as the predicate devices. Therefore, the
modified AUDERE Lumbar Spacer System is substantially equivalent for its
intended use. |
4