Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes

The device is an intervertebral body fusion device used to treat degenerative disc disease and provide mechanical support, indicating a therapeutic purpose to treat a medical condition.

Diagnostic

No

The device is an implantable intervertebral body fusion device designed for mechanical support, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a titanium alloy implant, which is a physical hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is an intervertebral body fusion device used in surgery to provide mechanical support and facilitate bone fusion in the lumbar spine. This is a surgical implant, not a diagnostic test performed on biological samples in vitro (outside the body).
Device Description: The description details a titanium alloy implant designed for surgical insertion and expansion within the body. This aligns with a surgical device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.

Therefore, the ELITE™ L Expandable Lumbar Fusion System is a surgical implant, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in skeletally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-L5. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.

Product codes

MAX

Device Description

The Elite™ L is a titanium alloy (Ti6Al4V-ELI) implant that is designed to provide mechanical support of the intradiscal space while biologic fusion occurs. The device is available in a variety of footprints, all of which are inserted in the unexpanded state and are expanded in situ. There are various heights to accommodate varied patients' anatomy. The implants are available in parallel and lordotic angles, with the implant end plates being bi-convex to optimize contact with the vertebral body end plates. All implants are made from medical grade titanium alloy. Implants have a locking mechanism to hold the implant in the expanded position once deployed.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar spine from L2-L5

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 Primary Predicate Device, the Elite Expandable Interbody Fusion Device was tested according to ASTM F2077 and ASTM F2267. Testing included static and dynamic axial compression, subsidence and expulsion. The Elite™ L device was compared to the Primary Predicate using FEA and demonstrated greater strength and durability to static and dynamic forces compared to the Primary Predicate. A complete analysis is provided.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K133459, K100175, K081611

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Innova Spinal Technologies, LLC % Rich Jansen, Pharm.D. President Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905

May 7, 2015

Re: K150954

Trade/Device Name: ELITE™ L Expandable Lumbar Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 7, 2015 Received: April 9, 2015

Dear Dr. Jansen:

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, 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

1

Page 2 - Rich Jansen, Pharm.D.

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K150954

Device Name

ELITE™ L Expandable Lumbar Fusion System

Indications for Use (Describe)

The ELITE™ L Expandable Lumbar Fusion System is indicated for use as intervertebral body fusion devices in sketetally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-L5. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) SUMMARY

Elite L Expandable Lumbar Fusion System

Date:	April 7, 2015
Submitter:	Armando Varela
Innova Spinal Technologies, Inc.
22324 Boyaca Ave
Boca Raton, FL 33433
Telephone: 561-504-5431
Regulatory Contact:	Rich Jansen, Pharm. D.
Silver Pine Consulting, LLC
612-281-5505
Product
Trade Name:	Elite TM L Expandable Lumbar Fusion System
Common Name:	Intervertebral Body Fusion Device
Product Class:	Class II
Classification:	21 CFR 888.3080
Product Code:	MAX
Panel Code:	87

Purpose:

The purpose of this submission is to add devices to be implanted from the lateral surgical approach.

Device Description

The Elite™ L is a titanium alloy (Ti6Al4V-ELI) implant that is designed to provide mechanical support of the intradiscal space while biologic fusion occurs. The device is available in a variety of footprints, all of which are inserted in the unexpanded state and are expanded in situ. There are various heights to accommodate varied patients' anatomy. The implants are available in parallel and lordotic angles, with the implant end plates being bi-convex to optimize contact with the vertebral body end plates. All implants are made from medical grade titanium alloy. Implants have a locking mechanism to hold the implant in the expanded position once deployed.

Predicate Device

The predicate devices include the Primary Predicate which is the Elite IBF by Innova Spine (K133459). Additional predicates include the Clydesdale Spinal System from Medtronic (K100175) and the Coroent XL Keeled System by Nuvasive (K081611).