When used as a pedicle screw fixation system of the noncervical spine in skeletally mature patients, the CapSure™ PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The CapSure™ PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

Device Description

The CapSure™ PS System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw components of the CapSure™ PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.

AI/ML Overview

The provided document is a 510(k) summary for the CapSure™ PS System, a pedicle screw spinal system. It compares the device to legally marketed predicate devices to demonstrate substantial equivalence, but it does not contain information about acceptance criteria, device performance, or any studies involving human readers, training sets, or ground truth establishment based on clinical data or expert consensus for AI/ML devices.

The study mentioned is a mechanical test according to ASTM F1717, which assesses the mechanical properties of the device. This is a bench-top study, not a clinical study involving patients or human readers.

Therefore, I cannot provide the requested information from the given document as it pertains to AI/ML device studies.

Summary

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[on letterhead]

510(k) Summary CapSure™ PS System

1. Submitter Information

Spine Wave, Inc. Two Enterprise Drive Suite 302 Shelton, CT 06484 203-944-9494 Telephone: 203-944-9493 Telefax:

Contact:	Ronald K. Smith
Date Prepared:	January 24, 2007

2. Device Information

Trade Name:	CapSure™ PS System
Common Name:	Pedicle Screw Spinal System
Classification:	Class II per 21 CFR 888.3070
Classification Name:	Pedicle Screw Spinal System
Product Code:	MNH, MNI

3. Device Information

4. Intended Use

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are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.

5. Substantial equivalence

The CapSure™ PS System is substantially equivalent to the Moss Miami Spinal System (K030383), the Issys Pedicle Screw System (K043522), and the ST360™ Spinal Fixation System (K041925). Mechanical testing according to ASTM F1717 demonstrated that the CapSure™ PS System has substantially equivalent mechanical properties to the predicate Moss Miami Spinal System. Since the CapSure™ PS System is substantially equivalent in intended use, design, materials, and construction to the predicate devices, the CapSure™ PS System does not raise any new issues of safety and efficacy when compared to these legally marketed devices.

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" Use of the terms "substantially equivalence" in this application is intended only to denote a comparison of the subject device to predicate devices for the purpose of an FDA review of the safety and effectiveness of the subject device in accordance with 21 CFR 807. Statements comparing the subject device to predicate devices, including statements regarding "substantial equivalence", contained in any way to relate to patentability, patent infringement, or any analysis of the subject device under foreign or United States patent laws including 35 U.S.C. paragraph 100 et seq. or related judicial doctrines

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be a scanned or printed image.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 5 = 2007

Spine Wave, Inc. % Mr. Ronald K. Smith Director, Quality and Regulatory Affairs Two Enterprise Drive, Suite 302 Shelton, Connecticut 06484

K070245 Trade/Device Name: Capsure™ PS System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: March 23, 2007 Received: March 26, 2007

Dear Mr. Smith:

Re:

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 - Mr. Ronald K. Smith

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dan Dave Buchup
Mark N. Melkerson

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

Enclosure

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	Indications for Use

510(k) Number (if known): 长670245

Device Name:

CapSure™ PS System

Indications for Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Valbare buelum

al. Restorative. Division of Gene and Neurological Devices

510(k) Number K070245
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Regulation Number and Section

N/A