The CD HORIZON® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The CD HORIZON® Growth Rod Conversion Set may be used with any cleared traditional CD HORIZON® Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods. SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

Device Description

The CD HORIZON® Growth Rod Conversion Set consists of a variety of connectors designed to convert a traditional fusion construct into a non-fusion growth enabling construct which can be surgically lengthened on a periodic basis as the patient grows. The CD HORIZON® Growth Rod Conversion Set components are manufactured from stainless steel and titanium alloy and are designed to interact with rod-based pedicle screw/hook constructs in which the rods range in diameter from 3.5mm to 5.5mm. The CD HORIZON® Growth Rod Conversion Set is specifically to be used with any traditional CD HORIZON® Spinal System (3.5mm to 5.5mm) fusion construct cleared for pediatric usage. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods, SPIRE® Spinous Process Plates and/or Shape Memory Alloy (SMA) Staples. The CD HORIZON® Growth Rod Conversion Set is limited to a posterior approach.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the "CD HORIZON® Growth Rod Conversion Set." It primarily addresses the substantial equivalence of the device to a predicate device, rather than providing a detailed study proving performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not available in the provided text.

However, I can extract the following information based on the document's content:

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

This information is not provided in the document. The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device, not necessarily on specific performance metrics or acceptance criteria for the new device as would be found in a clinical trial report.

Instead, the document states:

Technological Characteristics: "The subject CD HORIZON® Growth Rod Conversion Set Spinal System has the same fundamental scientific technology as the predicate Harrington Spinal Rod System for the treatment of spinal deformities in a nonfusion manner. Additionally, the subject CD HORIZON® Growth Rod Conversion Set connectors are substantially equivalent to similar connectors previously cleared in the CD HORIZON® Spinal System (K121764, SE 08/21/12)."
Conclusion: "The design features, materials used, manufacturing and sterilization methods are equivalent to the pre-amendment Harrington Spinal Rod System device used to treat early onset deformities including early-onset scoliosis in a non-fusion manner and to previously cleared connectors which are contained within the CD HORIZON® Spinal System (K121764)."

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

This information is not provided. The document mentions "non-clinical testing" and "comparisons were made to Harrington Rod System," but does not specify sample sizes, data provenance, or study design (retrospective/prospective) related to a test set for performance evaluation.

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 information is not provided. The document does not describe the establishment of ground truth by experts for a test set.

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

This information is not provided. There is no mention of a test set or associated adjudication method.

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 to this device. The device is a "Growth Rod Conversion Set" for spinal surgery, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study with AI assistance is not relevant.

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

This is not applicable to this device. The device is a surgical implant, not a standalone algorithm.

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

This information is not provided. The document focuses on performance testing to support fusion applications and comparisons to a predicate device, rather than establishing a ground truth for a diagnostic or predictive algorithm.

8. The sample size for the training set

This information is not provided. Given that this is a surgical implant device undergoing 510(k) clearance by demonstrating substantial equivalence, there would typically not be a "training set" in the context of machine learning or AI models.

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

This information is not provided and is not applicable for the reasons mentioned in point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 29, 2022

Medtronic Sofamor Danek USA Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132

Re: K133904

Trade/Device Name: CD Horizon® Growth Rod Conversion Set Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGM

Dear Mr. Grant:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 25, 2014. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 21 CFR 888.3070.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ronald Jean, OHT6: Office of Orthopedic Devices, (301)796-5650, Ronald.Jean@fda.hhs.gov

Sincerely,

Ronald P. Jean -S

Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 25, 2014

Medtronic Sofamor Danek USA Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132

Re: K133904

Trade/Device Name: CD HORIZON® Growth Rod Conversion Set Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: PGM Dated: January 17, 2014 Received: January 22, 2014

Dear Mr. Grant:

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 - Mr. Lee Grant

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 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/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 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,

Vincent Ji Devlin -S

for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133904

Device Name

CD HORIZON® Growth Rod Conversion Set

Indications for Use (Describe)

The CD HORIZON® Growth Rod Conversion Set is indicated in patients with potential for additional spinal growth under 10 years of age who require surgical treatment to obtain and maintain correction of severe, progressive, lifethreatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis. The CD HORIZON® Growth Rod Conversion Set may be used with any cleared traditional CD HORIZON® Spinal System rod construct ranging in diameter from 3.5mm, with the exception of PEEK Rod constructs. The CD HORUZON® Growth Rod Conversion Set may not be used with PEEK rods, SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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CD HORIZON® Growth Rod Conversion Set 510(k) Summary - K133904

FEB 2 5 2014

February 2014

Company:	Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact:	Lee GrantDistinguished Regulatory Affairs Advisor
Proprietary Trade Name:	CD HORIZON® Growth Rod Conversion Set
Product Code:	PGM
Regulation:	Pre-Amendment Unclassified
Classification:	Unclassified

Description:

Indications for Use:

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CD HORIZON® Growth Rod Conversion Set may be used with any cleared traditional CD HORIZON® Spinal System rod construct ranging in diameter from 3.5mm to 5.5mm, with the exception of PEEK Rod constructs. The CD HORIZON® Growth Rod Conversion Set may not be used with PEEK Rods. SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.

Summary of the Technological Characteristics: The subject CD HORIZON® Growth Rod Conversion Set Spinal System has the same fundamental scientific technology as the predicate Harrington Spinal Rod System for the treatment of spinal deformities in a nonfusion manner. Additionally, the subject CD HORIZON® Growth Rod Conversion Set connectors are substantially equivalent to similar connectors previously cleared in the CD HORIZON® Spinal System (K121764, SE 08/21/12). No new implant materials, instruments or sterilization methods are being added to the system through this application.

Identification of Legally Marketed Devices: The CD HORIZON® Growth Rod Conversion Set is substantially equivalent to the Harrington Spinal Rod System. The Harrington Spinal Rod System has been designated as a pre-amendment non-fusion spinal construct designed to treat pediatric patients who require surgical intervention prior to age 10 for severe, progressive, life-threatening early-onset deformities.

Discussion of Supporting Information and Non-Clinical Testing: Testing previously performed on the CD HORIZON® Growth Rod Conversion Set to support fusion applications was provided to support usage for the aforementioned non-fusion indication. Additionally, comparisons were made to Harrington Rod System which FDA designated (09/11/13) as a pre-amendment device for non-fusion surgical correction of this treatment population.

Conclusion: The design features, materials used, manufacturing and sterilization methods are equivalent to the pre-amendment Harrington Spinal Rod System device used to treat early onset deformities including early-onset scoliosis in a non-fusion manner and to previously cleared connectors which are contained within the CD HORIZON® Spinal System (K121764).

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.