(27 days)
K133904 (SE 2/25/2014) CD HORIZON® Growth Rod Conversion Set – Primary Predicate
Not Found
No
The description focuses on mechanical components for spinal growth rods and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, which is a therapeutic purpose.
No
This device is a surgical implant designed to correct spinal deformities and allow for growth in pediatric patients; it does not diagnose medical conditions.
No
The device description explicitly states that the device consists of physical components manufactured from stainless steel or titanium alloy, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the CD HORIZON® Growth Rod Conversion Set is a surgical implant designed to convert a spinal fusion construct into a non-fusion growth enabling construct. It is used in the patient's body to treat spinal deformities.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely mechanical and therapeutic.
Therefore, the CD HORIZON® Growth Rod Conversion Set is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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, with the exception of PEEK Rod constructs. The CD HORLZON® Growth Rod Conversion Set may not be used with PEEK rods, SPIRE™ Spinous Process Plates, or Shape Memory Alloy (SMA) Staples.
Product codes (comma separated list FDA assigned to the subject device)
PGM
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 or 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) 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. The CD HORIZON® Growth Rod Conversion Set connectors are provided in both sterile and non-sterile form. The sterile implants are sterilized via gamma irradiation.
The purpose of this 510(k) submission is to add sterile connectors and set screws to the CD HORIZON® Growth Rod Conversion Set utilizing gamma irradiation and sterile packaging. The subject components are manufactured out of medical grade titanium alloy per ASTM F136 or medical grade stainless steel per ASTM F138.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
under 10 years of age
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: The subject CD HORIZON® Growth Rod Conversion Set implants are permanent implants and are manufactured from stainless steel in accordance with ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants, or from titanium alloy in accordance with ASTM F136: Standard Specification for Wrought Ti-6A1-4V ELI Alloy for Surgical Implants. These materials are identical to the materials used to manufacture the predicate CD HORIZON® Growth Rod Conversion Set implants cleared in K133904. According to the aforementioned standards, all of the materials used to manufacture the subject devices have a well characterized level of local biological response and a long history of clinical use in medical devices; therefore, no additional biocompatibility testing is required.
Mechanical Testing: No mechanical testing was performed on the subject connectors and set screws as no design changes were made to the implants. In accordance with, Guidance for Industry and FDA Staff -Spinal System 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to predicate device. It was determined that subject devices do not represent a new worst case. Packaging and sterilization assessment/rationales were used to demonstrate substantial equivalence in accordance with the following standards:
ANSI/AAMI/ISO 11137-1:2006/ A1:2013, Sterilization of health care products - Radiation -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing a sterilization dose.
ASTM F88/F88M-09: 2009 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM D4169-09 - 2009: Standard Practice for Performance Testing of Shipping Containers and Systems (Sterility).
ASTM F1929-98: 2004 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
As a new worst case has not been indicated, the sterilization and packaging rationales were deemed adequate to prove equivalence to the predicate device and no additional mechanical testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K133904 (SE 2/25/2014) CD HORIZON® Growth Rod Conversion Set – Primary Predicate
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
July 29, 2022
Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132
Re: K150200
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, 2015. 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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and have a flowing, abstract design. Encircling the profile graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
February 25, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132
Re: K150200
Trade/Device Name: CD HORIZON® Growth Rod Conversion Set Regulatory Class: Unclassified Product Code: PGM Dated: January 20, 2015 Received: January 29, 2015
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 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.
2
Page 2 - Mr. Lee Grant
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/Resourcesfor You/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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)
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 HORLZON® 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
4
| CD HORIZON® Growth Rod Conversion Set | ||
|---|---|---|
| 510(k) Summary – K150200 | ||
| February 2015 | ||
| I. | Submitter: | Medtronic Sofamor Danek USA, Inc. |
| 1800 Pyramid Place | ||
| Memphis, TN 38132 | ||
| Telephone: (901)396-3133 | ||
| Fax: (901) 346-9738 | ||
| Contact: | Lee Grant | |
| Distinguished Regulatory Affairs Advisor | ||
| Date Prepared: | January 16, 2015 | |
| II. | Device | |
| Name of Device: | CD HORIZON® Growth Rod Conversion Set | |
| Common Name: | Spinal Fixation Appliance | |
| Classification Name: | Growing Rod System | |
| Regulatory Class: | Unclassified | |
| Product Codes: | PGM | |
| III. | Predicate Device | K133904 (SE 2/25/2014) CD HORIZON® |
| Growth Rod Conversion Set – Primary Predicate | ||
| The predicate device has not been subject |
to a design related recall.
IV. 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 or 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) 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. The CD HORIZON® Growth Rod Conversion Set connectors are provided in both sterile and non-sterile form. The sterile implants are sterilized via gamma irradiation.
5
The purpose of this 510(k) submission is to add sterile connectors and set screws to the CD HORIZON® Growth Rod Conversion Set utilizing gamma irradiation and sterile packaging. The subject components are manufactured out of medical grade titanium alloy per ASTM F136 or medical grade stainless steel per ASTM F138.
V. Indications for Use:
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.
VI. Comparison of Technological Characteristics with Predicate Device
The subject CD HORIZON® Growth Rod Conversion Set implants have the same fundamental scientific technology as the predicate CD HORIZON® Growth Rod Conversion Set implants for the treatment of an identical patient population for the same indications of use. All of the implants included in this application were previously cleared in K133904 (SE 02/25/14), the only differences being that the subject implants will now be offered as pre-packaged sterile implants and the connectors will come with pre-loaded set screws. The subject connectors and set screws are identical in design, materials used to manufacture the implants, size, method of implantation and intended use. As stated previously the subject implants will be provided to the end user in a sterile state with sterilization performed via gamma irradiation.
VII. Performance Data
The following performance data are provided in support of the substantial equivalence determination.
Biocompatibilitv
The subject CD HORIZON® Growth Rod Conversion Set implants are permanent implants and are manufactured from stainless steel in accordance with ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel- 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants, or from titanium alloy in accordance with ASTM F136: Standard Specification for Wrought Ti-6A1-4V ELI Alloy for Surgical Implants. These materials are identical to the
6
materials used to manufacture the predicate CD HORIZON® Growth Rod Conversion Set implants cleared in K133904. According to the aforementioned standards, all of the materials used to manufacture the subject devices have a well characterized level of local biological response and a long history of clinical use in medical devices; therefore, no additional biocompatibility testing is required.
Mechanical Testing
No mechanical testing was performed on the subject connectors and set screws as no design changes were made to the implants. In accordance with, Guidance for Industry and FDA Staff -Spinal System 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to predicate device. It was determined that subject devices do not represent a new worst case. Packaging and sterilization assessment/rationales were used to demonstrate substantial equivalence in accordance with the following standards:
ANSI/AAMI/ISO 11137-1:2006/ A1:2013, Sterilization of health care products - Radiation -Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing a sterilization dose.
ASTM F88/F88M-09: 2009 Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM D4169-09 - 2009: Standard Practice for Performance Testing of Shipping Containers and Systems (Sterility).
ASTM F1929-98: 2004 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
As a new worst case has not been indicated, the sterilization and packaging rationales were deemed adequate to prove equivalence to the predicate device and no additional mechanical testing is required.
VIII. Conclusion
Based on a risk analysis, packaging and sterilization rationales, and additional supporting documentation provided in the pre-market notification, the subject CD HORIZON® Growth Rod Conversion Set components are substantially equivalent to the predicate devices found in K133904 (SE 02/25/14).