The coflex-F Implant System is a posterior, non-pedicle supplemental fixation device intended for use with an interbody cage as an adjunct to fusion at a single level in the lumbar spine (L1-S1). It is intended for attachment to the spinous processes for the purpose of achieving stabilization to promote fusion in patients with degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies - with up to Grade 1 spondylolisthesis.

Device Description

The coflex-F Implant System is a spinous process fixation device that stabilizes the spinous processes and spine to act as an adjunct to fusion. It consists of a single, Ushaped component, fabricated from medical grade titanium alloy (Ti6Al4V). A set of two wings extends vertically from the superior long arm of the device, with a second set of wings extending below the inferior long arm. A screw and sleeve are inserted through a prepared hole and fixes the crimped wings to the superior and inferior spinous processes.

The purpose of this Special 510(k) is to add small- and medium-sized coflex-F Short devices to the coflex-F Implant System. The modifications are intended to allow the operating surgeon to better accommodate various patient anatomies. The modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the changes introduced by the modified coflex-F Short implant system.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Performance	No new worst-case scenario introduced by new components.	Finite element analysis and engineering rationale demonstrated that the addition of new components did not introduce a new worst case.
Biocompatibility	Meet acceptance criteria defined in the Design Control Activities Summary for irritation and sensitization (per ISO 10993).	Biocompatibility tests per ISO 10993 (irritation and sensitization) were conducted on materials for device-specific instruments. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met.
Substantial Equivalence	Be substantially equivalent to the predicate coflex-F Implant (K093438) in terms of indications, design, function, and materials.	The modified coflex-F Short is substantially equivalent to the predicate coflex-F Implant (K093438) with respect to indications, design, function, and materials.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes an engineering and biocompatibility study for a medical device modification, not a clinical trial with a test set of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) in the context of clinical data are not applicable to this submission.

The "test set" here refers to the new small- and medium-sized coflex-F Short devices themselves, which were subjected to:

Finite Element Analysis: This is a computational simulation, not a test on a physical sample size in the traditional sense. The "sample" is the digital model of the device.
Biocompatibility Tests: These tests would have used samples of the materials of the device-specific instruments. The exact number of material samples isn't specified, but it would be according to ISO 10993 standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the described study is a non-clinical evaluation of device modification (mechanical and biocompatibility), not a study involving human interpretation of clinical data where expert ground truth would be established. The "ground truth" for the engineering analysis would be the established principles of mechanics, and for biocompatibility, it would be the ISO 10993 standards themselves.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as #3. There was no human interpretation of data requiring adjudication.

5. 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

This is not applicable. The device described is a spinal implant, and the study focuses on its mechanical integrity and biocompatibility, not on an AI-based diagnostic tool that would involve human readers or comparative effectiveness studies with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Mechanical Performance: The ground truth for the finite element analysis is the established principles of mechanical engineering and physics as applied to the finite element models, and comparison of the results against the predicate device's established performance parameters.
Biocompatibility: The ground truth for biocompatibility is conformance to ISO 10993 standards for irritation and sensitization.
Substantial Equivalence: The ground truth for substantial equivalence is the predicate device's (K093438) cleared specifications regarding indications, design, function, and materials.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device modification study. The study involves engineering analysis and biocompatibility testing of physical materials, not machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8.

Summary

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FEB 1 3 2012

5. 510(k) Summary

Device Trade Name:	coflex-F Implant System
Manufacturer:	Paradigm Spine, LLC505 Park Avenue, 14th FloorNew York, NY 10022
Contact:	Ms. Michelle McDonoughMusculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	February 10, 2012
Classification:	21 CFR 888.3050, Spinal interlaminal fixation orthosis
Class:	II
Product Code:	KWP

Indications For Use:

Device Description:

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Predicate Device(s):

The modified coflex-F Short is substantially equivalent to the predicate coflex-F Implant (Paradigm Interspinous Fusion Plate) previously cleared in K093438 with respect to indications, design, function, and materials.

Substantial Equivalence:

Finite element analysis and engineering rationale demonstrated that the addition of new components did not introduce a new worst case. Additionally, biocompatibility tests per ISO 10993 (i.e., irritation and sensitization) were conducted on materials used for devicespecific instruments. The results demonstrate that the acceptance criteria defined in the Design Control Activities Summary were met and the coflex-F Short is substantially equivalent to the predicate device(s).

Conclusion:

The coflex-F Short is substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract human form or symbol, composed of three curved, flowing lines.

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

FEB 1 3 2012

Paradigm Spine, LLC % Musculoskeletal Clinical Regulatory Advisers, LLC Ms. Michelle McDonough 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K112595

Trade/Device Name: coflex-F Implant System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 20, 2011 Received: December 21, 2011

Dear Ms. McDonough: .

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.

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Page 2 - Ms. Michelle McDonough

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 (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.

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/ucm11.5809.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/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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. McMullen

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

Enclosure

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4. Indications for Use

510(k) Number (if known): K112595

Device Name: coflex-F Implant System

Prescription Use V (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

KII2595 510(k) Number_

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.