The Graft Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. The device is not intended for load bearing indications.

Device Description

The Graft Containment Device consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. The devices are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

Bone screws intended for anchoring the graft containment device to bone, and made from PEEK, carbon-fiber reinforced PEEK, or titanium are also available.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "Graft Containment Device." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, many of the requested sections about acceptance criteria, study details, and expert involvement are not applicable or not present in the provided document.

Here's a breakdown of the information that can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in document	Substantial equivalence to predicate devices in terms of design, materials, indications for use, and manufacturing characteristics.
Specific mechanical performance metrics (e.g., tensile strength, fatigue life, containment effectiveness)	"Mechanical testing was presented." (No specific results or acceptance criteria for mechanical tests are detailed).

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

Sample Size for Test Set: Not applicable / Not specified. The submission relied on mechanical testing and comparison to predicate devices, not a clinical test set with human subjects.
Data Provenance: Not applicable for a clinical test set. The data presented was from "Mechanical testing."

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

Not applicable. No clinical test set requiring ground truth established by experts was described.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set was described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC study was not done. This device is a physical implant, not an AI-assisted diagnostic tool, so such a study is irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant; there is no "algorithm only" performance to be evaluated.

7. The Type of Ground Truth Used

Not applicable for a clinical test set. The basis for the 510(k) clearance was "substantial equivalence" demonstrated through engineering drawings, labeling, and mechanical testing, comparing the device to already-cleared predicate devices. The "ground truth" here would be the established performance and safety profiles of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. No machine learning or AI training set was involved in the evaluation of this device.

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

Not applicable. No machine learning or AI training set was involved.

Summary of the Study Proving Device Meets Acceptance Criteria (based on provided text):

The submission for the Graft Containment Device (K070148) sought to demonstrate substantial equivalence to existing legally marketed predicate devices. The "study" or evidence provided to meet this regulatory requirement included:

Non-Clinical Tests: "Mechanical testing was presented." While the specific acceptance criteria and results are not detailed, the implication is that these tests demonstrated performance comparable to the predicate devices.
Comparison to Predicate Devices: The submission included "Engineering drawings, labeling, and mechanical testing" to show that the subject device is "substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device."

Key Takeaway: This 510(k) relies on a demonstration of substantial equivalence, which is a comparison to a legally marketed device, rather than a clinical study proving specific performance metrics against pre-defined acceptance criteria for a novel device. The document explicitly states "Summary of Clinical Tests: (Not Applicable)."

Summary

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K070148

ડ. 510(K) SUMMARY

JUL 3 1 2007

In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:

A. Submitted by

Laetitia Cousin Director of Regulatory Affairs and Ouality Assurance NuVasive, Incorporated 4545 Towne Centre Court San Diego, CA 92121 Telephone: (858) 909-1868 Date Prepared: January 12, 2007.

B. Device Name

Trade or Proprietary Name: Common or Usual Name: Classification Name:

Graft Containment Device Graft Containment Device Appliance, Fixation, Spinal Intervertebral body, code KWQ.

C. Predicate Devices

The subject device is substantially equivalent to similar previously cleared devices.

D. Device Description

Bone screws intended for anchoring the graft containment device to bone, and made from PEEK, carbon-fiber reinforced PEEK, or titanium are also available.

E. Intended Use

The Graft Containment Device, in conjunction with traditional rigid fixation, is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts. The device is not intended for load bearing indications.

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F. Comparison to Predicate Devices

As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.

Engineering drawings, labeling, and mechanical testing have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.

G. Summary of Non-Clinical Tests

Mechanical testing was presented.

H. Summary of Clinical Tests

(Not Applicable).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NuVasive, Incorporated % Ms. Lactitia Cousin Director of Regulatory Affairs and Quality Assurance 4545 Towne Centre Court San Diego, California 92121

JUL 3 1 2007

Re: K070148

Trade/Device Name: Graft Containment Device Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 14, 2007 Received: June 15, 2007

Dear Ms. Cousin:

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 such 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); 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.

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Page 2 - Ms. Laetitia Cousin

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Burchard

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE

K070148 510(k) Number (if known):

Device Name: Graft Containment Device

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Berbare Meehup
Division Sign Off

Division of General. Restorative. and Neurological Devices

510(k) Number_KO

Roger Ms.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.