(83 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
This device is a therapeutic device because its intended use is to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities, and it functions as a non-fusion, growth-enabling construct that can be surgically lengthened, indicating direct treatment and management of a medical condition.
No
The device is described as a surgical implant (growth rod conversion set) used to obtain and maintain correction of spinal deformities. It is a therapeutic device, not one that identifies or diagnoses a condition.
No
The device description clearly states it consists of physical implants manufactured from titanium alloy, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical device used to treat spinal deformities in young patients. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a non-cervical spinal device consisting of implants made from titanium alloy. This is consistent with a surgical implant, not an in vitro diagnostic device.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a surgical implant intended for direct use within the patient's body to correct a physical condition.
N/A
Intended Use / Indications for Use
The Daytona® Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth 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 extended axial connectors may be used with any cleared Daytona® Small Stature Spinal System rod construct. The Daytona® Small Stature Growth Rod Conversion Set is not intended to be used in coniunction with staples.
Product codes
PGM
Device Description
The Daytona® Small Stature Growth Rod Conversion Set is a non-cervical spinal device intended to convert a traditional fusion construct into a non-fusion, growth- enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The system consists of single-use extended axial connectors designed to interact with constructs consisting of hooks, screws, connectors, and rods. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical 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
Non-Clinical Testing: The Daytona® Small Stature Growth Rod Conversion Set demonstrated similar mechanical performance to the predicate system based on mechanical testing per ASTM F1798.
Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2022
SeaSpine Orthopedics Corporation Alicia McArthur Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K193224
Trade/Device Name: Daytona® Small Stature Growth Rod Conversion Set Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGM
Dear Alicia McArthur:
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 13, 2020. 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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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
February 13, 2020
SeaSpine® Orthopedics Corporation Alicia McArthur Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K193224
Trade/Device Name: Daytona® Small Stature Growth Rod Conversion Set Regulatory Class: Unclassified Product Code: PGM Dated: January 31, 2020 Received: February 4, 2020
Dear Ms. McArthur:
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. 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 located 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.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
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combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Colin O'neill -S for
Ronald P. Jean, Ph.D. Director (Acting) 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) K193224
Device Name
Daytona® Small Stature Growth Rod Conversion Set
Indications for Use (Describe)
The Daytona® Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth 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 extended axial connectors may be used with any cleared Daytona® Small Stature Spinal System rod construct. The Daytona® Small Stature Growth Rod Conversion Set is not intended to be used in conjunction with 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) |
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510(k) Summary
Contact Details
| Applicant Name: | SeaSpine® Orthopedics Corporation | |
|---|---|---|
| Address: | ||
| Phone number: | ||
| Fax number: | 5770 Armada Drive, Carlsbad CA | |
| (760) 216-5117 | ||
| (760) 683-6874 | ||
| Primary Contact: | ||
| Secondary Contact: | Jesse Albright, Regulatory Affairs Specialist | |
| Alicia McArthur, Regulatory Affairs Specialist | ||
| Date Prepared: | January 31, 2020 | |
| Device Name | ||
| Trade Name: | Daytona® Small Stature Growth Rod Conversion Set | |
| Common Name: | Growing Rod System | |
| Classification Name: | Growing Rod System (Unclassified) | |
| Class: | Unclassified | |
| Product Code: | PGM |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K142114 | PGM | Xia® Growth Rod | |
| Conversion Set | Stryker Corporation |
Device Description
The Daytona® Small Stature Growth Rod Conversion Set is a non-cervical spinal device intended to convert a traditional fusion construct into a non-fusion, growth- enabling construct that can be surgically lengthened on a periodic basis as the patient grows. The system consists of single-use extended axial connectors designed to interact with constructs consisting of hooks, screws, connectors, and rods. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
5
Intended Use/Indications for Use
The Daytona® Small Stature Growth Rod Conversion Set is indicated in patients under 10 years of age with potential for additional spinal growth 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 extended axial connectors may be used with any cleared Daytona® Small Stature Spinal System rod construct. The Daytona® Small Stature Growth Rod Conversion Set is not intended to be used in coniunction with staples.
Summary of Technological Characteristics
The Daytona® Small Stature Growth Rod Conversion Set is identical or similar to the cited predicate device in regard to intended use/indications for use, device description, technological characteristics (i.e., operating principle, design, components, manufacturing, labeling, etc.), and non-clinical performance (i.e., mechanical testing).
All implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.
Non-Clinical Testing
The Daytona® Small Stature Growth Rod Conversion Set demonstrated similar mechanical performance to the predicate system based on mechanical testing per ASTM F1798.
Clinical Testing
Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrates that the Daytona® Small Stature Growth Rod Conversion Set is substantially equivalent to the cited legally marketed predicate device for its intended use.