The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, 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-S2/ilium), 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 screw and connector components and titanium alloy and cobaltchrome rod components that are assembled to create a rigid spinal construct. The components of the CapSure® PS System are attached to the non-cervical spine of skeletally mature patients to stabilize the spine during fusion of vertebral bodies and are intended to be removed after spinal fusion is achieved.

AI/ML Overview

This 510(k) premarket notification describes a medical device, the CapSure® PS System, which is a spinal fixation system. The document concerns the addition of new components (4.75 mm diameter cobalt-chrome straight rods and dual-diameter titanium rods) to a previously cleared system.

Therefore, the study described is a performance test to demonstrate that these new components do not degrade the overall device performance and are substantially equivalent to the predicate device. This is not a study involving human or image data with AI systems.

Based on the provided information, I can answer the relevant questions about the device's performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
In accordance with ASTM F1717	"The results of this testing show that the modified implants do not represent a new worst case for the system and are therefore substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact number of samples tested but refers to "worst-case samples of the modified implants."
Data Provenance: Not applicable as this is a physical device performance test rather than a data-driven study. The testing was performed by Spine Wave, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth (device performance and safety) for this type of mechanical testing is established by adherence to a recognized international standard (ASTM F1717) and engineering analysis, not by expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically associated with human decision-making or image interpretation, not physical device testing.

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:
Not applicable. This is a mechanical device performance study, not a study evaluating human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is a mechanical device performance study, not an algorithm performance study.

7. The type of ground truth used:
The ground truth used is conformance to the ASTM F1717 standard for dynamic axial compression bend testing and the determination that the modified implants "do not represent a new worst-case for the system."

8. The sample size for the training set:
Not applicable. There is no training set mentioned or implied as this is a physical device performance test, not a machine learning model.

9. How the ground truth for the training set was established:
Not applicable. There is no training set.

Summary

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

Spine Wave, Inc. Amy Noccioli Regulatory Affairs Specialist 3 Enterprise Drive. Suite 210 Shelton, Connecticut 06484

August 16, 2017

Re: K172175

Trade/Device Name: CapSure® PS System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbar Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: July 18, 2017 Received: July 19, 2017

Dear Amy Noccioli:

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

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K172175

Device Name CapSure® PS System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the words "Spine Wave" in a bold, sans-serif font. The words are arranged horizontally, with "Spine" on the left and "Wave" on the right. A blue wave design is located under the word "Wave" and extends to the left.

510(k) Summary CapSure® PS System

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise DriveSuite 210Shelton, CT 06484
Telephone:	203-712-1842
Telefax:	203-944-9493
Contact:	Amy Noccioli
Date Prepared:	August 11, 2017

2. Device Information

Trade Name:	CapSure® PS System
Common Name:	Pedicle Screw Spinal System
Classification:	Class II per 21 CFR 888.3070
Classification Name:	Thoracolumbosacral Pedicle Screw System
Product Code:	NKB

3. Purpose of Submission

The purpose of this submission is to gain clearance for the 4.75 mm diameter cobalt-chrome straight rod and dual-diameter titanium rod additions to the previously cleared CapSure® PS System.

4. Predicate Device Information

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

Predicate Device	Manufacturer	510(k) No.
CapSure® PS System	Spine Wave, Inc.	K132154

5. Device Description

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6. Indications for Use

The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) 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).

7. Comparison of Technological Characteristics

The subject CapSure® PS System has technological characteristics similar to the predicate device, including intended use and indications for use, performance, design, and material composition. The only difference between the subject device and the predicate device is the addition of 4.75 mm diameter cobalt-chrome straight rods and dual-diameter titanium rods.

8. Performance Data

Spine Wave, Inc. performed dynamic axial compression bend testing on the worst-case samples of the modified implants in accordance with ASTM F1717. The results of this testing show that the modified implants do not represent a new worst case for the system and are therefore substantially equivalent to the predicate device.

9. Conclusion

The indications for use, technological characteristics, and comparison to the predicate show that the subject CapSure® PS System is substantially equivalent to the predicate device identified in this submission, and does not present any new issues of safety or effectiveness.

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.