The Raphael Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Raphael Pedicle Screw 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 thoracic lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The Raphael Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Raphael Hook System can be used in conjunction with Raphael Pedicle Screw System.

Device Description

The Raphael Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system that consists of pedicle screws, rods, hooks, set screws, connectors, and a transverse (cross) linking mechanism. The Raphael Pedicle Screw System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

AI/ML Overview

This document is a 510(k) premarket notification for the Raphael Pedicle Screw System. It seeks to demonstrate substantial equivalence to a predicate device, the Dio Medical Rexious Spinal Fixation System.

Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in terms of performance derived from non-clinical or clinical testing.

Instead, the submission relies entirely on a claim of substantial equivalence to a previously cleared predicate device.

Here's an analysis based on the information provided and what is explicitly missing in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria are defined in the document for the Raphael Pedicle Screw System related to its performance.

The document states:
"Non-clinical testing was not performed as part of this submission."
"The subject device is identical to the predicate device in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling..."

Therefore, a table of reported device performance for the Raphael Pedicle Screw System cannot be generated from this document, as no performance testing was conducted or reported for this specific submission. The acceptance criteria, by extension, are implicitly met if the device is indeed "identical" to the predicate, whose performance would have been established through prior clearance.

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

Not applicable. No test set was used for this submission because no new performance testing (non-clinical or clinical) was performed. The clearance is based on substantial equivalence to a predicate device.

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

Not applicable. No test set was used, and therefore no ground truth establishment by experts was required for this submission.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

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 device is a pedicle screw system, not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.

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

Not applicable. This device is a pedicle screw system, not an algorithm or AI device. No standalone performance study was conducted.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new performance data requiring ground truth was generated for this submission. The "ground truth" for clearance in this case is the previously established performance and substantial equivalence of the predicate device.

8. The Sample Size for the Training Set

Not applicable. No training set was used as this is not an AI/ML device.

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

Not applicable. No training set was used.

In summary: The clearance for the Raphael Pedicle Screw System is based on a "Special 510(k)" pathway, where the manufacturer asserts that the device is identical to a previously cleared predicate device (Dio Medical Rexious Spinal Fixation System K113324, K111362, K100765) in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process, and labeling. Therefore, no new performance testing or clinical studies were conducted or reported in this specific document.

Summary

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510(k) Summary Raphael Pedicle Screw System

SUBMITTED BY	Accel Spine14901 Quorum Dr. Ste. 125Dallas, TX 75254
ESTABLISHMENTREGISTRATION NUMBER	3009051471
OWNER/OPERATORNUMBER	10035914
CONTACT PERSON	Aekta PatelGeneral CounselAccel SpinePhone: 214-545-5833Fax: 888-831-4892
SUBMISSION PREPARED BY	Lisa PetersonKaedon Consulting, LLCEmail: Ipeterson@kaedonconsulting.comPhone: 512-507-0746
DATE PREPARED	July 24, 2013
CLASSIFICATION NAME	Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation
DEVICE CLASS	Class II
REGULATION NUMBER	888.3070 (Product Code MNH, KWP, MNI)
COMMON NAME	Pedicle Screw Spinal Fixation System
PROPRIETARY NAME	Raphael Pedicle Screw System
IDENTIFICATION OF PREDICATEDEVICE(S)	Dio Medical Rexious Spinal Fixation System (K113324,K111362, K100765)

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DEVICE DESCRIPTION

INDICATIONS

The Raphael Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Raphael Hook System can be used in conjunction with Raphael Pedicle Screw System.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this Special 510(k) is to obtain clearance to market the subject device as the Raphael Pedicle Screw System. The subject device was previously cleared as the Dio Medical Rexious Spinal Fixation System (K113324, K111362, K100765). Documentation demonstrating the legal right to distribute the Raphael Pedicle Screw System is maintained at Accel Spine.

The subject device is identical to the previously cleared Rexious System in terms of indications for use. device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling. The System implant components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

DISCUSSION OF NON-CLINICAL TESTING

Non-clinical testing was not performed as part of this submission.

CONCLUSIONS

The subject device is identical to the predicate device in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling, Documentation was provided as part of this Special 510(k) to demonstrate that the Raphael Pedicle Screw System is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. To the left of the bird-like figure, there is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20093-0002

August 20, 2013

Ms. Aekta Patel General Counsel Accel Spine 14901 Ouorum Drive, Suite 125 Dallas, Texas 75254

Re: K132365

・

Trade/Device Name: Raphael Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI, KWP Dated: July 24, 2013 Received: July 30, 2013

Dear Ms. Patel:

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 10 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 (sec above) into cither 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Aekta Patel

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/default.htm1 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

K132365 510(k) Number (if known):

Raphael Pedicle Screw System Device Name:

Indications for Use:

Prescription Use × (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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132365

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.