PIVOTEC LUMBAR INTERBODY FUSION DEVICE (LIFD) by CAPTIVA SPINE, INC

The Pivotec LIFD implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Pivotec LIFD Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Device Description

The Pivotec LIFD is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The device is made of PEEK-Optima with Tantalum markers and is provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant within the intra-vertebral disc space.

AI/ML Overview

The provided text describes a 510(k) summary for the Pivotec Lumbar Interbody Fusion Device (LIFD). This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing, rather than a clinical study evaluating diagnostic or prognostic performance in the way an AI/ML medical device might undergo.

Therefore, many of the requested sections related to AI/ML device studies (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission. The study described is a mechanical performance study.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are based on its mechanical performance, demonstrating functionality and safety comparable to legally marketed predicate devices. The "reported device performance" refers to the results of these mechanical tests.

Acceptance Criteria Category	Specific Criteria (Implicit from ASTM standards)	Reported Device Performance
Mechanical Performance	Static compression (conforms to ASTM F2077-03)	"performed as designed"
	Dynamic compression (conforms to ASTM F2077-03)	"performed as designed"
	Static compression shear (conforms to ASTM F2077-03)	"performed as designed"
	Dynamic compression shear (conforms to ASTM F2077-03)	"performed as designed"
	Subsidence (conforms to ASTM F2267-04)	"performed as designed"
Product Specifications	All product specifications	"met, or exceeded, all product specifications"
Material Equivalence	PEEK-Optima with Tantalum markers, hollow core	Similar to predicate devices
Design Equivalence	Various configurations and heights	Similar to predicate devices
Indications for Use Equivalence	DDD (L2-S1), up to Grade 1 spondylolisthesis, autograft, supplemental fixation	Similar to predicate devices
Functional Equivalence	Intervertebral body fusion to stabilize and promote fusion	Similar to predicate devices

Key Finding on Performance: "The device performed as designed and met, or exceeded, all product specifications."

Study Details (Mechanical Testing)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for mechanical testing, but typically involves a number of device samples (e.g., n=5 or n=10 per test condition) to perform the specified ASTM tests. The focus here is on device physical properties, not patient data.
- Data Provenance: Not applicable in the sense of patient data. The "data" comes from engineering laboratory testing of the manufactured devices.
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. Mechanical testing does not involve human experts establishing ground truth in the context of diagnostic or prognostic accuracy. The "ground truth" is defined by the objective physical properties and performance benchmarks established by the ASTM standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used to resolve disagreements among human reviewers on clinical data. Mechanical testing involves objective measurements of physical properties.
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 mechanical device, not an AI/ML diagnostic or prognostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a mechanical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Standards: The "ground truth" (or benchmark for performance) is established by the relevant ASTM (American Society for Testing and Materials) standards:
  - ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices)
  - ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression)
- The device's performance is compared against the requirements and typical performance characteristics of predicate devices that have successfully met these standards.
The sample size for the training set:
- Not Applicable. This device uses mechanical testing, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. (See point 7).

Conclusion of the Study:
"The documentation provided demonstrates that the Pivotec LIFD is substantially equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in materials, design, indications for use, function and mechanical function."

Summary

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

く

510(k) Summary

心 · .

.
... ...

Submitter:	Captiva Spine, Inc.
Contact Person:	Mr. Dale Mitchell, PresidentCaptiva Spine, Inc.967 Alt. AlA #1Jupiter, FL 33477Phone: 877-772-5571Fax: 866-318-3224
	DEC - 1 2009
Date Prepared:	July 2, 2009
Trade Name:	Pivotec Lumbar Interbody Fusion Device (LIFD)
ClassificationName and Number:	Class IIIntervertebral Body Fusion Device21 CFR 888.3080
Product Code:	MAX
Predicate Device(s):	The subject device is substantially equivalent to the followingdevices:Lumbar I/F Cage (P960025)Marketed and distributed by DePuyRay Threaded Fusion Cage (TFC)TM (P950019)Marketed and distributed by Stryker (originally approved bySurgical Dynamics)AVS TL PEEK Spacer (K083661)Marketed and distributed by Stryker
Device Description:	The Pivotec LIFD is an intervertebral body fusion device for usewith autogenous bone graft in the intervertebral disc space tostabilize spinal segments and promote fusion. The device is madeof PEEK-Optima with Tantalum markers and is provided invarious configurations and heights, containing a hollow core toreceive bone autograft. Placement is achieved with an insertioninstrument that allows for manipulation of the implant within theintra-vertebral disc space.

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

Intended Use: The Pivotec LIFD implant is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Pivotec LIFD Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Mechanical testing of the subject device consisted of static and Functional and dynamic compression, static and dynamic compression shear and Safety Testing: subsidence. All testing was conducted in accordance with ASTM F2077-03 and ASTM F2267-04. The device performed as designed and met, or exceeded, all product specifications. Conclusion: The documentation provided demonstrates that the Pivotec LIFD is substantially equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in materials, design, indications for use, function and mechanical function.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, composed of three curved lines that suggest movement or flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Captiva Spine, Inc. % Sanacor, LLC Mr. Mike Ensign Director of Engineering P.O. Box 1196 Pleasant Grove, Utah 84062

DEC - 1 2009

Re: K092017

Trade/Device Name: Pivotec Lumbar Interbody Fusion Device (LIFD) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: II Product Code: MAX Dated: July 2, 2009 Received: July 6, 2009

Dear Mr. Ensign:

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.

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); 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.

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

Page 2 - Mr. Mike Ensign

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Mulkern

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

Enclosure

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

Indications for Use

510(k) Number (if known): NA

Device Name: Pivotec Lumbar Interbody Fusion Device (LIFD)

Indications for Use:

The Pivotec LIFD implant is an intervertebral body fusion deviceindicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Pivotec LIFD Implant is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Prescription Use X (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 IF NEEDED)

Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092017

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.