When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is 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 posterior thoracic, lumbar, and sacral spine:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment
Fracture
Dislocation
Scoliosis
Kyphosis
Spinal tumor and/or
Failed previous fusion (pseudoarthrosis)

The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion.

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine. the NuVasive SpheRx Spinal System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Spinal stenosis
Spondylolisthesis
Spinal deformities
Fracture
Pseudoarthosis
Tumor resection and/or
Failed previous fusion

Device Description

The NuVasive SpheRx PPS System consists of a variety of polyaxial screws, rods, locking nuts, and transverse connectors. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient.

AI/ML Overview

Here's an analysis of the provided 510(k) premarket notification for the NuVasive SpheRx PPS System, focusing on the requested information regarding acceptance criteria and study details.

Crucial Caveat: This 510(k) submission (K090981) for the NuVasive SpheRx PPS System explicitly states in Section H: "Summary of Clinical Tests (Not Applicable)." This means that no clinical studies were performed or are being presented in this specific 510(k) for this device for regulatory approval. Therefore, many of the requested points, particularly those related to clinical performance, ground truth, sample sizes for test/training sets, and human reader studies, cannot be addressed from this document because they simply don't exist within this submission.

The path to market for this device relies on substantial equivalence to a predicate device (the SpheRx System currently distributed commercially in the U.S. by NuVasive) and non-clinical mechanical testing.

Acceptance Criteria and Study Details for NuVasive SpheRx PPS System (K090981)

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) relies on substantial equivalence and non-clinical mechanical testing, the acceptance criteria are generally related to the mechanical properties and performance being equivalent to or exceeding those of the predicate device, as well as adherence to recognized industry standards for spinal implant systems. The document doesn't provide specific quantitative acceptance criteria or detailed reported device performance values in a table format. However, the implicit acceptance criteria are that the mechanical tests demonstrate the device is safe and effective for its intended use and performs at least as well as the predicate.

Criterion Type	Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Mechanical Strength & Durability	Must meet or exceed the mechanical performance characteristics of the predicate device (SpheRx System) and relevant industry standards for spinal pedicle screw systems for all specified indications.	Testing was presented demonstrating equivalence/suitability for the intended use and indications, sufficient for FDA clearance. Specific quantitative results are not provided in this summary.
Biocompatibility	Component materials must be biocompatible as per established standards for implantable medical devices.	Not explicitly stated in the summary, but assumed to be met as part of the overall device design and substantial equivalence.
Design Equivalence	Device design (materials, screw types, rods, locking mechanisms) must be substantially equivalent to the predicate device.	Components are described as polyaxial screws, rods, locking nuts, and transverse connectors, which is consistent with the predicate's description.
Intended Use Equivalence	The stated indications for use must be identical to the predicate device.	"The subject device has indications for use identical to those of its predicate..." (P.1 Section F)

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

Test Set Sample Size: Not applicable/Provided. This submission does not include clinical data. For mechanical testing, the "sample size" would refer to the number of physical devices or components tested. This detail is not provided in the 510(k) summary.
Data Provenance: Not applicable/Provided. As no clinical studies were performed, there is no clinical data provenance (e.g., country of origin, retrospective/prospective). The data submitted for this 510(k) primarily relates to non-clinical mechanical testing.

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

Not applicable. No clinical test set with corresponding ground truth established by experts is mentioned in this 510(k). Mechanical testing results do not typically involve this type of expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This 510(k) does not include a MRMC comparative effectiveness study. As a hardware device (spinal implant), this type of study is generally not applicable, as it's typically used for imaging-based diagnostic or screening devices.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical spinal implant system, not a software algorithm or AI-based device. Therefore, a standalone algorithm performance study is irrelevant.

7. Type of Ground Truth Used

Not applicable for clinical data. For mechanical testing, the "ground truth" would be established by validated test methods and measurements conforming to industry standards (e.g., ASTM, ISO) to assess properties like fatigue life, pull-out strength, and torsional strength.

8. Sample Size for the Training Set

Not applicable. As this device is not an AI/ML algorithm or system component that requires training data, there is no "training set."

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

Not applicable. See point 8.

Summary of Device Approval Basis:

The NuVasive SpheRx PPS System received 510(k) clearance based on substantial equivalence to an already legally marketed predicate device (the SpheRx System by NuVasive). The submission included:

Identical Indications for Use: The new device shares the exact same indications for use as the predicate.
Same Principles of Operation: The device functions on the same core mechanical and physiological principles as the predicate.
Non-Clinical Mechanical Testing: This testing was presented to demonstrate that the new device meets or exceeds the performance characteristics of the predicate, ensuring its safety and effectiveness for its intended use. The specific details of these tests and their results are not provided in this public summary, but they were sufficient for FDA to determine substantial equivalence.

The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This confirms that no clinical studies were deemed necessary for this clearance.

Summary

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K090981

Image /page/0/Picture/2 description: The image shows a logo with the word "NUVA" in bold, sans-serif font. Below the word "NUVA" is the text "Creative Spirit" in a smaller, italicized font. To the left of the word "NUVA" is a stylized graphic element that appears to be a leaf or abstract shape.

Special 510(k) Premarket Notification SpheRx® PPS System

VII. 510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92, the following summary of information is provided:

A. Submitted by:

Ms. Han Fan Regulatory Affairs Associate NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-3338 Fax: (858) 909-3438

B. Device Name

Trade or Proprietary Name: NuVasive SpheRx PPS System Common or Usual Name: Pedicle Screw System Classification Name: Spinal Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis, Spinal Intervertebral Body Fixation orthosis. Device Class: Class III Classification: 888.3050, §888.3060, §888.3070 Product Code: NKB, KWP, MNI, MNH, KWQ

C. Predicate Devices

The subject SpheRx PPS System is substantially equivalent to the SpheRx System currently distributed commercially in the U.S. by NuVasive.

D. Device Description

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Image /page/1/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of the word "NUVASIVE" in bold, sans-serif font. Below the word "NUVASIVE" is the phrase "Creative Spine Technology" in a smaller font. To the left of the word "NUVASIVE" is a stylized graphic.

E. Intended Use

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.
1. Fracture
1. Dislocation
1. Scoliosis

Kyphosis

1. Spinal tumor and/or
1. Failed previous fusion (pseudoarthrosis)

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine. the NuVasive SpheRx Spinal System is also intended for the following indications:

1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
1. Spinal stenosis
1. Spondylolisthesis
1. Spinal deformities
1. Fracture
1. Pseudoarthosis
1. Tumor resection and/or
1. Failed previous fusion

F. Comparison to Predicate Devices

The subject device has indications for use identical to those of its predicate, and employs the same principles of operation.

Summary of Non-Clinical Tests G. Mechanical testing was presented.
H. Summary of Clinical Tests (Not Applicable).

Page - 35 -

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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 features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2009

NuVasive, Inc. c/o Ms. Han Fan Regulatory Affairs Associate 7475 Lusk Blvd. San Diego, CA 92121

Re: K090981

Trade/Device Name: NuVasive SpheRx PPS System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, KWP, KWQ, MNH, MNI Dated: May 27, 2009 Received: June 2, 2009

Dear Ms. Fan:

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 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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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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buehr

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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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:___SpheRx® PPS System

Indications For Use:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc 1. confirmed by patient history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment 2.

Fracture 3.

Dislocation র্য :

Scoliosis

ତ. Kyphosis

Spinal tumor and/or 7.

Failed previous fusion (pseudoarthrosis) ಕ

When used as an anterolateral non-pedicle screw system in the thoracic and lumbar spine, the NuVasive SpheRx Spinal System is also intended for the following indications:

Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc 1. confirmed by patient history and radiographic studies)
Spinal stenosis 2.

Spondylolisthesis 3.

Spinal deformities 4.

Fracture
Pseudoarthosis

Tumor resection and/or 7.

Failed previous fusion

Prescription Use (Part 21 CFR 801 Subpart D)

510(k) Number_

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)

(EXT For MXM)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K090981
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Page 1 of 1

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.