The Zavation eZspand™ PLIF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand PLIF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of nonoperative treatment.

The Zavation eZspand™ PLIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.

Device Description

The Zavation eZspand™ Interbody System devices are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The implants are provided in a shape that accommodates a posterior or transforaminal approach to the lumbar spine. After insertion, the implant can be continuously expanded, within in the limitations of the design, to the desired height to suit the individual anatomical conditions of the patient. The devices are available in various footprints and geometric options to fit the anatomical needs of a wide variety of patients. The implants include an opening through the superior and inferior endplates of the device to facilitate fusion. The posterior opening of the device allows for the packing of autogenous bone graft material post expansion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called the "Zavation eZspand™ Interbody System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials. As such, it does not typically involve the type of detailed acceptance criteria and clinical study data that would be used for a new medical AI device.

Therefore, many of the requested categories for AI device evaluation (such as sample sizes for test and training sets, expert qualifications, ground truth establishment for AI, MRMC studies, or standalone algorithm performance) are not applicable or detailed in this document.

However, I can extract the information that is available about the device's performance evaluation against established standards.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Biomechanical Testing	ASTM F2077:	Demonstrated substantial equivalence to predicate devices.
	- Static Axial Compression
	- Dynamic Axial Compression
	- Static Compression Shear
	- Dynamic Compression Shear
	ASTM F2267:	Demonstrated substantial equivalence to predicate devices.
	- Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
	Static Pushout Test	Demonstrated substantial equivalence to predicate devices.
	- Test Method for Intervertebral Body Fusion Devices
Technological Characteristics	- Basic Design	Similar to predicate devices
	- Sizes (length, width, min/max height)	Similar to predicate devices
	- Material (titanium alloy)	Similar to predicate devices
	- Mechanical Safety and Performance	Similar to predicate devices
	- Intended Use	Similar to predicate devices

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria is a biomechanical testing study conducted in accordance with the listed ASTM standards. The conclusion is that the "Zavation eZspand™ Interbody System devices are similar to the predicate systems with respect to technical characteristics, performance and intended use." This demonstrates substantial equivalence to previously cleared devices.

Additional Information (where applicable from the provided text):

Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. Biomechanical testing generally uses a specified number of physical samples of the device and predicate devices.
- Data Provenance: The testing was "in accordance with" ASTM standards. The location of the testing facility or specific data origin is not provided. It's not clinical data, so country of origin for patients isn't relevant here. This is a retrospective comparison against established standards and predicate device data, not a prospective clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI device relying on expert-annotated ground truth. The "ground truth" here is the performance metrics defined by the ASTM standards and the performance of the predicate devices.
Adjudication method for the test set: Not applicable. This is not an AI device with human review of outputs. Performance is measured objectively according to test methods.
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: Not applicable. This is a physical medical device, not an AI diagnostic/interpretive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used:
- For biomechanical performance: Established ASTM standards for intervertebral body fusion devices, and the performance characteristics of the predicate devices.
- For technological characteristics: Specifications and design features of the predicate devices.
The sample size for the training set: Not applicable. This is a physical device, not an AI device requiring a "training set."
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Zavation Medical Products, LLC Mr. Matt Jones Design Engineer 220 Lakeland Parkway Flowood, Mississippi 39232

Re: K191339

Trade/Device Name: Zavation eZspand™ Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: July 19, 2019 Received: July 24, 2019

Dear Mr. Jones:

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

August 19, 2019

{1}------------------------------------------------

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 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 Melissa Hall Assistant Director 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) K191339

Device Name Zavation eZspand™ Interbody System

Indications for Use (Describe)

The Zavation eZspand™ PLIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Spinal System.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K191339 - 510K Summary

Date:	July 19, 2019
Submitter:	Zavation Medical Products LLC220 Lakeland PkwyFlowood, MS 39232Phone: 601-919-1119Fax: 800-447-1302
Contact Person:	Matt Jones
Type of 510(k) submission:	Traditional
Trade name:	Zavation eZspand™ Interbody System
Common name:	Intervertebral Body Fusion Device
Classification regulation:	Intervertebral body fusion device(21 CFR 888.3080)
Device classification:	Class II
Classification Panel:	Orthopedic
Product code:	MAX
Basis for submission:	New device

Device Description:

K191339 510k Summary Page 1 of 3

{4}------------------------------------------------

Intended Use:

The Zavation eZspand™ PLIF implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The Zavation eZspand™ PLF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended to be used in patients who have had six months of non-operative treatment.

The Zavation eZspand™ PLIF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including the Zavation Spinal System.

Materials:

The Zavation eZspand™ Interbody System components are manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.

Primary Predicate Device:

K172696 Forza XP Expandable Spacer System [Orthofix]

Additional Predicate Devices:

K181246 Zavation IBF System [Zavation] K142271 Zavation Z-Link Lumbar [Zavation]

Technological Characteristics:

The Zavation eZspand™ Interbody System possesses the same technological characteristics as the predicate devices, including: basic design (posterior lumbar interbody fusion device of various footprints and lordosis with an expansion mechanism that allows for continuous height adjustment within the design limitations of the device), sizes (length, width and minimum/maximum height), material (titanium alloy), mechanical safety and performances, and intended use.

Performance Data:

Biomechanical test results demonstrated that the Zavation eZspand™ PLIF is substantially equivalent to the predicate devices. Testing was performed in accordance with:

ASTM F2077, Test Methods for Intervertebral Body Fusion ● Devices
- o Static Axial Compression
- Dynamic Axial Compression O
- Static Compression Shear O
- O Dynamic Compression Shear

K191339 510k Summary Page 2 of 3

{5}------------------------------------------------

. ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression
. Static Pushout Test Method for Intervertebral Body Fusion Devices.

Conclusion:

The Zavation eZspand™ Interbody System devices are similar to the predicate systems with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate devices.

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.