The RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended for use in the non-cervical spine. When used for anterior/anteral and posterior, non-cervical pedicle and non-pedicle fixation system, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

Degenerative disc disease (DDD) (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

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.

The RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediative use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The RIPLEY SPINAL SCREW SYSTEM BY SAGICO constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and multiaxial transverse connectors and associated surgical instruments. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. RIPLEY SPINAL SCREW SYSTEM BY SAGICO is designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.

AI/ML Overview

This FDA 510(k) Premarket Notification document (K232561) for the Ripley Spinal Screw System by SAGICO describes a medical device, not an AI or software-driven diagnostic tool. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic performance, is not applicable in this context.

The document primarily focuses on demonstrating the device's substantial equivalence to existing predicate devices based on:

Indications for Use: The Ripley Spinal Screw System's intended uses are comparable to existing predicate devices.
Design and Materials: The system's design (monoaxial, uniplanar, polyaxial screws, rods, hooks, connectors) and material (Ti6A14V alloy) are similar to predicate devices.
Performance Data (Non-Clinical): Mechanical testing was performed to ensure the device's physical properties are equivalent or superior to predicate devices.

Here's a breakdown of the relevant information provided for this medical device, which differs significantly from the requested AI-specific information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific clinical acceptance criteria or human-in-the-loop diagnostic performance. Instead, it references performance data generated from mechanical testing standards:

Performance Standard	Test Type	Acceptance Criteria (Implicit)	Reported Device Performance
ASTM F1717	Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (Static & Dynamic Compression Bending Test)	Device must meet or exceed the mechanical performance (e.g., stiffness, strength, fatigue life) of the predicate devices under these conditions.	Implicitly met, as the conclusion states substantial equivalence was established. Specific values are not provided in this summary.
ASTM F1798	Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants (Axial Gripping, Axial Torsion Gripping, Flexion Extension Static Tests)	Device must demonstrate comparable mechanical integrity and stability to predicate devices for its interconnection mechanisms.	Implicitly met, as the conclusion states substantial equivalence was established. Specific values are not provided in this summary.

Explanation: For mechanical devices like spinal screws, "acceptance criteria" are typically defined by engineering specifications (e.g., maximum load, fatigue cycles without failure, deformation limits) derived from recognized standards like ASTM. The goal of the testing is to show that the new device performs at least as well as legally marketed predicate devices, thereby establishing substantial equivalence.

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

Sample Size (Test Set): Not applicable in the context of human data or AI diagnostic test sets. The "test set" here refers to the number of physical device samples used for mechanical testing according to ASTM standards. The exact number of samples tested for each ASTM standard is not specified in the provided summary, but these are typically small numbers of physical prototypes designed to represent the final product.
Data Provenance: The data is non-clinical, derived from laboratory mechanical testing of physical implants, not from patient data or clinical studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not Applicable. As this is a mechanical device, there is no "ground truth" to be established by clinical experts in the diagnostic sense. The "truth" is determined by the physical properties and performance measured in a laboratory setting against engineering standards.
Mechanical testing engineers and quality assurance personnel would be involved in performing and validating these tests, but they are not "experts" establishing clinical ground truth.

4. Adjudication Method:

Not Applicable. There is no adjudication method described for clinical interpretation or data labeling, as this is non-clinical product testing.

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

No. This type of study is relevant for evaluating the diagnostic performance of software or AI with human readers. It is not applicable to the mechanical testing of a spinal implant system.

6. Standalone (Algorithm Only) Performance:

Not Applicable. This device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used:

Engineering Specifications and Performance Standards (e.g., ASTM F1717, F1798). The "ground truth" or reference for evaluating performance is adherence to established mechanical testing standards and demonstrating comparable performance to predicate devices in those tests.

8. Sample Size for the Training Set:

Not Applicable. This is a physical device, not an AI model. There is no concept of a "training set" for physical product development in this context. Design and engineering principles guide the development, followed by verification and validation through mechanical testing.

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

Not Applicable. No training set exists for this type of device.

Summary

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October 23, 2023

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Sagico VA USA, LLC James Gibson, PhD President 2189 West Busch Blvd. Tampa, Florida 33612

Re: K232561

Trade/Device Name: Ripley Spinal Screw System by SAGICO Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: August 18, 2023 Received: August 24, 2023

Dear Dr. Gibson:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K232561

Device Name

Ripley Spinal Screw System by SAGICO

Indications for Use (Describe)

Degenerative disc disease (DDD) (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 RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediative use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

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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SAGICO VA USA SPINAL SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION

510(k) Summary

Device Trade Name(s):	Ripley Spinal Screw System by SAGICO
Classification Panel:	Orthopedic
Common Name:	Pedicle Screw Spinal System
Class and Reference:	Class II
Product Code(s):	NKB, KWQ, KWP
Classification Name(s):	Thoracolumbosacral Pedicle Screw System (NKB)Class II per 21 CFR §888.3070Appliance, Fixation, Spinal Intervertebral Body (KWQ)Class II per 21 CFR §888.3060Appliance, Fixation, Spinal Interlaminal (KWP)Class II per 21 CFR §888.3050
Applicant/Official Contact Person:	James J. Gibson, Jr., PhD, CPA,SAGICO VA USA, LLC, Project ManagerEmail: JG@SAGICOUSA.comTel. (813) 815-0613
Submitter /Manufacturer:	SAGICO VA USA, LLC2189 West Busch BlvdTampa, Florida 33612Tel. (813) 815-0613
Preparation Date:	August 18, 2023

Predicate Devices :

The subject device is substantially equivalent to the primary predicate device: SAGICO OSI SPINAL SYSTEM by Osimplant (K180220), the XIA® 3 Spinal System - Stryker Spine (K113666) and additional predicate devices, USS Small Stature System - Synthes Spine (K071373), CD HORIZON Spinal System - Sofamor Danek USA (K091445), TSRH Spinal System - Sofamor Danek USA (K994121), XIA 3 Spinal System - Stryker Spine (K111492)

Purpose:

The purpose of this submission is to request clearance for the system known as the "RIPLEY SPINAL SCREW SYSTEM BY SAGICO".

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SAGICO VA USA SPINAL SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION

Device Description:

Indications for use:

The RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

Degenerative disc disease (DDD) (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 RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Technological Characteristics:

Testing performed on RIPLEY SPINAL SCREW SYSTEM BY SAGICO included in this submission demonstrates that the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States market. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO substantial equivalence determination to the predicate systems is based on comparable data drawn from design, labeling, and indications for use, function and implant materials.

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Image /page/5/Picture/1 description: The image is a logo for SAGICO UNITED STATES OF AMERICA GOVERNMENT AFFAIRS. The logo is a hexagon shape with the top half of the hexagon being blue and white stars and the bottom half being red and white stripes. The text "SAGICO" is in large, bold letters in the center of the hexagon, with the words "UNITED STATES OF AMERICA" below it in smaller letters. The words "GOVERNMENT AFFAIRS" are written along the bottom of the hexagon.

SAGICO VA USA SPINAL SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION

Performance data:

Non-clinical performance data testing conducted to support substantial equivalence for the RIPLEY SPINAL SCREW SYSTEM BY SAGICO device included:

ASTM F1717

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Static Compression Bending Test
Dynamic Compression Bending Test ●

ASTM F1798

Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

Axial Gripping Test ●
Axial Torsion Gripping Test ●
Flexion Extension Static Test ●

Basis of Substantial Equivalence:

The RIPLEY SPINAL SCREW SYSTEM BY SAGICO has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject and predicate devices.

Conclusion:

The RIPLEY SPINAL SCREW SYSTEM BY SAGICO has been shown to be substantially equivalent to legally marketed predicate devices with respect to its indications for use, design, function, and materials.

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.