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, screw, and cross connector components that are assembled to create a rigid spinal construct. The 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.

This purpose of this submission is to gain clearance for the addition of the LP Cross Connector component to the CapSure® PS System. The LP Cross Connector is a non-sterile, single use, titanium allow device which can be used with the CapSure® PS System for added stability. The LP Cross Connector is available in lengths ranging from 38mm to 81mm.

AI/ML Overview

This document is a 510(k) summary for the CapSure® PS System, a pedicle screw spinal system. It does not describe an AI/ML device or present a study comparing AI performance against acceptance criteria. Therefore, most of the requested information cannot be extracted.

However, I can provide what is available regarding the device and its equivalence.

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical study comparing the device to a predicate. Instead, the "acceptance criteria" here refers to demonstrating substantial equivalence to existing legally marketed predicate devices through mechanical testing.

Acceptance Criteria Type	Acceptance Criteria (Implicit)	Reported Device Performance
Substantial Equivalence	The device (CapSure® PS System with LP Cross Connector) must demonstrate substantial equivalence to its predicate devices (CapSure® PS System K083743, K083353) in terms of intended use, technological characteristics, and safety/effectiveness, particularly through mechanical testing.	"mechanical testing demonstrated that the CapSure® PS System is equivalent to the predicate CapSure® PS System. The differences between the CapSure® PS System and the predicate device do not raise any new questions of safety or effectiveness. Thus, the CapSure® PS System is substantially equivalent to its predicate device." The FDA concurred with this assessment, stating "We have reviewed your Section 510(k) premarket notification...and have determined the device is substantially equivalent...to legally marketed predicate devices." This implies that the device met the implicit acceptance criteria for mechanical performance that allowed it to be considered equivalent to its predicates.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a 510(k) summary for a physical medical device (pedicle screw system), not an AI/ML device requiring a test set of data. The "study" mentioned is mechanical testing. Details about the sample size (number of constructs tested) and data provenance for this mechanical testing are not provided in this summary.

3. 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)

This is not applicable. For mechanical testing of a physical device, ground truth is established by engineering standards and measurements, not by expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no test set in the context of clinical data requiring expert 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. This document pertains to a physical spinal implant device, not an AI system that assists human readers.

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

This is not applicable as this is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the mechanical testing, the "ground truth" would be the established engineering standards, material properties, and biomechanical parameters against which the device's performance was measured. No clinical ground truth from patient data (expert consensus, pathology, or outcomes) is mentioned in the context of this 510(k) summary for the equivalence determination.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established

This is not applicable as this is a physical medical device, not an AI/ML system.

Summary

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FEB 1 2 2010

510(k) Summary CapSure® PS System

Submitter Information

Spine Wave, Inc. Three Enterprise Drive Suite 210 Shelton, CT 06484 203-712-1839 Telephone: Telefax: 203-944-9493

Contact: Date Prepared: Roaida Rizkallah January 13, 2010

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:	MNI, MNH

Device Description

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Intended Use

Substantial equivalence

・、

The CapSure® PS System described in this submission is substantially equivalent to the following devices:

Predicate Device	Manufacturer	510(k) No.
CapSure® PS System	Spine Wave, Inc.	K083743,K083353

In addition, mechanical testing demonstrated that the CapSure® PS System is equivalent to the predicate CapSure® PS System. The differences between the CapSure® PS System and the predicate device do not raise any new questions of safety or effectiveness. Thus, the CapSure® PS System is substantially equivalent to its predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

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

Spine Wave, Inc. % Ms. Roaida Rizkallah Senior Regulatory Affairs Specialist Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

FEB 1 2 2010

Re: K100122

Trade/Device Name: CapSure® PS System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: January 13, 2010 Received: January 15, 2010

Dear Ms. Rizkallah:

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.

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

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Page 2- Ms. Roaida Rizkallah

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/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/ReportaProblem/def[ault.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,

Barbara Buchup

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

Enclosure

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510(k) Number (if known): _ K10012 2

CapSure® PS System_ __________________________________________________________________________________________________________________________________________________________ Device Name: _________

Indications for Use:

The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the LS-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.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device · Evaluation (ODE)

__, and I am not going to add any more to this.

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

K100122 510(k) Number

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Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.