(149 days)
The CD HORIZON TM Spinal System with or without SEXTANT TM instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON TM Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD HORIZON TM LEGACY TM 3.5mm rods and the CD HORIZON TM Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON TM Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON TM Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON TM SPIRE TM Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON TM Spinal System rods may be connected to the VERTEXT TM Reconstruction System with the VERTEX TM rod connector. Refer to the VERTEX TM Reconstruction System Package Insert for a list of the VERTEX TM indications of use.
The CD HORIZON™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.
A subset of CD HORIZON™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK™ Plates and connecting components. Similarly, to the CD HORIZON™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this Traditional 510(k) is to modify Medtronic's CD HORIZON™ Spinal System to add additional components to the system, specifically, a sterile domino connector. The subject device is made of Titanium Alloy, Cobalt Chrome and Silicone.
Here's an analysis of the provided text regarding the acceptance criteria and study for the CD HORIZON™ Spinal System, structured according to your request.
Please note: This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not contain the detailed clinical study information often found in PMA applications or publications about AI/software as a medical device (SaMD). Therefore, many of your requested points related to AI/software performance, such as sample size for training/test sets, ground truth establishment for training, number of experts, adjudication methods, and MRMC studies, are not applicable or available from this type of regulatory submission for a spinal implant system.
The "device" in this context refers to a physical spinal implant system, not an AI/software device.
Acceptance Criteria and Device Performance for CD HORIZON™ Spinal System
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (as implied by regulatory guidelines) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials meet relevant ASTM/ISO standards for surgical implants and have a history of safe use. | Materials (Titanium Alloy, Cobalt Chrome, Silicone) are identical to predicate devices and meet standards (ASTM F136, ASTM F1537, ISO14949). Biocompatibility testing was deemed not required due to established safety. |
| Mechanical Testing | Devices must meet pre-determined acceptance criteria as per ASTM F1798 and ASTM F1717. | Non-clinical mechanical testing was performed in accordance with ASTM F1798 (Axial Grip, Axial Torsion, Flexion Extension Static) and ASTM F1717 (static compression, static torsion, compression fatigue). The subject devices met the pre-determined acceptance criteria. |
| Non-Pyrogenicity Endotoxin Testing | Endotoxin limit of < 20 EU/device for implanted medical devices as per ANSI/AAMI ST72 and USP <161>. | Testing successfully performed on worst-case subject implants, confirming they meet the 20 EU/device limit. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each mechanical or endotoxin test. However, "worst case subject implants" were used for endotoxin testing. For mechanical testing, standard sample sizes for such tests according to ASTM F1798 and F1717 would have been used, but specific numbers are not provided in this summary.
- Data Provenance: The studies were non-clinical (laboratory-based mechanical and biological testing) performed by the manufacturer, Medtronic Sofamor Danek USA, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a physical implant, not an AI/software device requiring expert ground truth for image interpretation or diagnosis. The ground truth for mechanical testing is derived from the physical properties and performance under specified loads, measured by instrumentation.
4. Adjudication method
- Not applicable for the types of non-clinical tests performed.
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 is not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
7. The type of ground truth used
- Biocompatibility: Conformance to established material standards and historical safe use.
- Mechanical Testing: Physical measurements of mechanical properties (e.g., strength, durability under load) against specified limits outlined in ASTM standards F1798 and F1717.
- Non-Pyrogenicity Endotoxin Testing: Measurement of bacterial endotoxin levels against the established limit of 20 EU/device.
8. The sample size for the training set
- Not applicable. This is a physical implant; there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering, materials science, and previous product iterations, but not "trained" in the AI sense.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for an AI/ML context. The "ground truth" for the device's design and manufacturing is derived from engineering principles, material science, and regulatory standards.
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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 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.
March 8, 2018
Medtronic Sofamor Danek USA, Inc. Mr. Ankit K. Shah Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K173249
Trade/Device Name: CD HORIZON™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: February 6, 2018 Received: February 7, 2018
Dear Mr. Shah:
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 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);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -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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| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number ( if known ) | K173249 |
|---|---|
| Device Name | CD HORIZON TM Spinal System |
| Indications for Use (Describe) | The CD HORIZON TM Spinal System with or without SEXTANT TM instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON TM Spinal System may also be used for the same indications as an adjunct to fusion. With the exception of DDD, the CD HORIZON TM LEGACY TM 3.5mm rods and the CD HORIZON TM Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON TM Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON TM Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/ spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.The CD HORIZON TM SPIRE TM Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/ attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.In order to achieve additional levels of fixation, the CD HORIZON TM Spinal System rods may be connected to the VERTEXT TM Reconstruction System with the VERTEX TM rod connector. Refer to the VERTEX TM Reconstruction System Package Insert for a list of the VERTEX TM indications of use. |
| 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 MEDTRONIC Sofamor Danek CD HORIZON™ Spinal System February 2018
| I. | Submitter | Medtronic Sofamor Danek USA, Inc. |
|---|---|---|
| 1800 Pyramid Place | ||
| Memphis, Tennessee 38132 | ||
| Telephone: (901)396-3133 | ||
| Contact: | Ankit K. Shah | |
| Sr. Regulatory Affairs Specialist | ||
| Phone: (901) 344-1272 | ||
| Date Prepared: | February 6, 2018 | |
| II. | Device | |
| Name of Device: | CD HORIZON™ Spinal System | |
| Classification Names: | Thoracolumbosacral Pedicle Screw System | |
| (21 CFR 888.3070) | ||
| Class: | Class II | |
| Product Code: | NKB, KWP, KWQ | |
| III. | Predicate Devices: | Primary Predicate: |
| • CD HORIZON Spinal System, K090390 | ||
| (S.E. 05/15/2009) | ||
| Additional Predicates: | ||
| • TSRH™ Spinal System, K030285 (S.E. 02/25/2003) | ||
| • CD HORIZON Spinal System,K062606 (S.E. 09/25/2006) | ||
| • CD HORIZON Spinal System,K042025 (S.E. 08/25/2004) |
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- CD HORIZON Spinal System, . K132639 (S.E 11/25/2013)
- . CD HORIZON Spinal System, K132328 (S.E 12/06/2013)
Reference predicates have been mentioned in certain sections. The predicates have not been subject to a design related recall.
IV. Description:
The CD HORIZON™ Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK™ Plates, staples, and connecting components, as well as implant components from other Medtronic spinal systems which can be rigidly locked into a variety of configurations with each construct being tailor-made for the individual case.
A subset of CD HORIZON™ Spinal System components may be used for posterior pedicle screw fixation in pediatric cases. These constructs may be comprised of a variety of shapes and sizes of rods (ranging in diameter from 3.5mm to 6.35mm), hooks, screws, CROSSLINK™ Plates and connecting components. Similarly, to the CD HORIZON™ implants used in adult cases, these components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
The purpose of this Traditional 510(k) is to modify Medtronic's CD HORIZON™ Spinal System to add additional components to the system, specifically, a sterile domino connector. The subject device is made of Titanium Alloy, Cobalt Chrome and Silicone.
V. Indications for Use:
The CD HORIZON™ Spinal System with or without SEXTANT™ instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (DDD - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
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spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON™ Spinal System may also be used for the same indications as an adjunct to fusion.
With the exception of DDD, the CD HORIZON™ LEGACY™ 3.5mm rods and the CD HORIZON™ Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON™ Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON™ Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON™ SPIRE™ Plate is a posterior, single-level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation in the following conditions: DDD (as previously defined), spondylolisthesis, trauma, and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON™ Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.
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VI. Comparison of Technological Characteristics with the Predicate Devices:
The subject CD HORIZON™ Spinal System has the same indications, intended use, fundamental scientific technology, materials, and sterilization method as the previously FDA cleared predicates. The indications and the fundamental technology is identical to the FDA cleared CD HORIZON™ Spinal System, 510(k) K090390 (S.E. 05/15/2009). Other features and materials of the device within subject CD HORIZON Spinal System submission are identical to the following predicates:
- TSRH Spinal System, K030285 (S.E. 02/25/2003) .
- CD HORIZON™ Spinal System, K062606 (S.E. 09/25/2006) .
- CD HORIZON Spinal System, K042025 (S.E. 08/25/2004) .
- CD HORIZON Spinal System K132639 (S.E 11/25/2013) ●
- CD HORIZON Spinal System, K132328 (S.E 12/06/2013) ●
VII. Performance Data:
The following information is provided in support of substantial equivalence. Biocompatibility
The subject CD HORIZON™ Spinal System implants are permanent implants (> 30 days) and will be classified as body contacting devices according to FDA's Draft Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". The subject implants and instruments are manufactured from identical materials as the predicate devices, in accordance with the following standards:
- . ASTM F136: Standard Specification for Wrought Ti-6A1-4V ELI Alloy for Surgical Implant
- ASTM F1537: Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants
- . ISO14949: Implants for surgery -- Two-part addition-cure silicone elastomers
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The materials used for manufacturing the subject device have a long history of safe and effective use in predicate spinal implants, and biocompatibility testing is not required.
Mechanical Testing
Non-clinical mechanical testing was performed in accordance with ASTM F1798 including Axial Grip, Axial Torsion and Flexion Extension Static and ASTM F1717 static compression, static torsion and compression fatigue. The subject devices met the pre-determined acceptance criteria.
Medtronic believes that the subject implants do not introduce a new worst case scenario and are substantially equivalent to the predicate device.
Non-Pyrogenicity Endotoxin Testing
The bacterial endotoxin test, also known as Limulus amebocyte lysate (LAL) test, was performed utilizing worst case subject implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed, and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP <161>, Medical Devices – Bacterial Endotoxin and Pyrogen Tests.
VIII. Conclusion:
A risk analysis was completed, and non-clinical testing was performed in accordance with ASTM F1798 and ASTM F1717. Based on the test results and additional supporting information provided in this pre-market notification, the subject CD HORIZON™ Spinal System is substantially equivalent to the following predicates:
Primary Predicate:
-
· CD HORIZON™ Spinal System, K090390 (S.E. 05/15/2009)
Additional Predicates: -
· TSRH™ Spinal System, K030285 (S.E. 02/25/2003)
-
· CD HORIZON™ Spinal System, K062606 (S.E. 09/25/2006)
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§ 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.