The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is intended for posterical fixation in sketally mature patients as an adjunct to fusion for the following indications:

· Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

·Spondylolisthesis;

·Trauma (i.e., fracture or dislocation);

·Spinal stenosis;

·Curvatures (i.e., scoliosis, kyphosis and/or lordosis);

·Tumor and pseudarthrosis

Device Description

Auxein Brand Vertaux 5.5 mm Pedicle Screw System consists of rods, connectors and screws for implantation in the spine. The system is available in multiple rod diameters and screw sizes.

AI/ML Overview

The provided document describes the Auxein Brand Vertaux 5.5 mm Pedicle Screw System and its substantial equivalence to a predicate device (K091442, Medtronic Sofamor Danek, USA, CD HORIZON Spinal System). The acceptance criteria and the study proving the device meets these criteria are outlined primarily through a comparison with the predicate device and non-clinical testing.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly defined by the equivalence to the predicate device and compliance with established performance and material standards. The device performance is reported as meeting these standards and being "equivalent" to the predicate.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (Auxein Brand Vertaux 5.5 mm Pedicle Screw System)
Indications for Use	Similar intended use as predicate device	Similar intended use
Material	Same material as predicate device	Same material used (ASTM F 136 for implants, ASTM F 899-12 for instruments)
Performance Standards	Same performance standards as predicate device	Same performance standards used (ASTM F 1717-18 for static compression, static torsion, fatigue compression)
Sterilization	Same method of sterilization as predicate device	Same method of sterilization used (Provided in non-sterile and sterile conditions)
Dimensional Verification	Same dimensions as predicate device	Same dimensions found
Mechanical Test Performance	Compliance with ASTM F 1717-18 for spinal implant constructs in a vertebrectomy model	Tested as per ASTM F 1717-18
Material Standards Compliance	Compliance with ASTM F 136 (Implants) and ASTM F 899-12b (Instruments)	ASTM F 136 (Implants) & ASTM F899-12b (Instruments) / Same

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

The document describes non-clinical testing for the Auxein Brand Vertaux 5.5 mm Pedicle Screw System.

Sample Size for Test Set: Not explicitly stated as a number of devices or constructs. The testing refers to "Applicable standards" and "Relevant test results" for materials and "Static compression testing," "Static Torsional Testing," and "Fatigue Compression testing" as per ASTM F 1717-18 for performance. These standards typically involve specific numbers of specimens, but those numbers are not detailed in this submission.
Data Provenance: The testing was conducted for the Auxein Brand Vertaux 5.5 mm Pedicle Screw System to demonstrate compliance with ASTM standards. This is prospective testing performed for the purpose of this submission. The origin of the data is internal testing or outsourced testing to laboratories demonstrating compliance with the specified ASTM standards. No mention of country of origin for the test data specifically, beyond the company's location in India.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not applicable to this type of submission. This document describes a medical device (pedicle screw system) which is evaluated primarily through engineering and material testing standards, and comparison to existing predicate devices, rather than human expert interpretation of diagnostic images or clinical outcomes that would require ground truth establishment by experts.

The submission is a 510(k) for substantial equivalence, relying on:

Non-clinical mechanical and material testing.
Comparison of technological characteristics and intended use to a legally marketed predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable as it's not a clinical study involving human interpretation or outcome assessment requiring adjudication. The "test set" here refers to the physical devices undergoing mechanical and material testing, which are evaluated against predefined pass/fail criteria from the ASTM standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or referenced in this document. This type of study is typically used for diagnostic devices that involve human interpretation (e.g., radiology AI tools). This submission is for an implantable surgical device evaluated by engineering standards, not diagnostic interpretative tasks.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):

Not Applicable. This device is a pedicle screw system, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical testing is defined by the acceptance criteria and methodologies outlined in the referenced ASTM standards (ASTM F 136, ASTM F 899-12, ASTM F 1717-18). These standards define the parameters, test methods, and acceptable ranges or failure modes for the materials and mechanical performance of spinal implant constructs. For the comparative analysis, the "ground truth" is the characteristics of the predicate device (CD HORIZON Spinal System, K091442) to which substantial equivalence is claimed.

8. Sample Size for the Training Set:

Not Applicable. This submission is for a physical medical device (implantable pedicle screw system), not a software or AI device that requires a "training set."

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

Not Applicable. As no training set is involved for this type of medical device submission.

Summary

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Auxein Medical Private Limited Rahul Luthra Director Plot No.168,169,170 Phase-4 Kundli Industrial Area, HSIIDC, Sector-57 Sonipath. Harvana 131028 India

Re: K201457

Trade/Device Name: Auxein Brand Vertaux 5.5 mm Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: March 3, 2021 Received: March 8, 2021

Dear Rahul Luthra:

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 Mav 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

April 6, 2021

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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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 53 1 -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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Anne D. Talley -S for

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

Enclosure

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Indications for Use

510(k) Number (if known) K201457

Device Name

Auxein Brand Vertaux 5.5 mm Pedicle Screw System

Indications for Use (Describe)

The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is intended for posterical fixation in sketally mature patients as an adjunct to fusion for the following indications:

· Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);

·Spondylolisthesis;

·Trauma (i.e., fracture or dislocation);

·Spinal stenosis;

·Curvatures (i.e., scoliosis, kyphosis and/or lordosis);

·Tumor and pseudarthrosis

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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Image /page/3/Picture/0 description: The image shows a logo with the word "Auxein" next to a circle with a stylized letter A inside. To the right of the logo, there is text that reads "K201457 Page 1 of 7". The logo and text are in a clear, legible font and appear to be part of a document or presentation.

Section 5.0 - 510K Summary

Premarket Notification 510(k) Summary as required by Section 807.92

General Company Information as required by 807.92 (a)

(A.1) The submitters name, address, telephone number, a contact person, and the date the summary was prepared

Submitter's Name	Auxein Medical Private Limited.
Address:	Auxein Medical Pvt. Ltd.Plot No. 168-169-170, Phase-4,Kundli Industrial Area, HSIIDC,Sector-57, Sonepat - 131028, Haryana, India
Contact Person Name:	Mr. Rahul Luthra
Title:	Director
Phone Number:	+91-9811720999
Dated:	04.02.2021

Throughout the submission Auxein Brand Vertaux 5.5 mm Pedicle Screw System is covered under 510 (k) Submission.

A.2: The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known

Proprietary Name:

Auxein Brand Vertaux 5.5 mm Pedicle Screw System

Common or Usual Name:

Pedicle screw system .

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Classification Name:

0 Thoracolumbosacral pedicle screw system.

Product Code:

NKB

Device Class: II

Review Panel: Orthopedic

Regulation Number: 21 CFR 888.3070

Variants/Types:

Auxein Brand Vertaux 5.5 mm Pedicle Screw System consists of the following components:

S.No.	Product Description
1	VERTAUX Mono-Axial Pedicle Screw
2	VERTAUX Poly-Axial Pedicle Screw
3	VERTAUX Pedicle Screw Cap
4	VERTAUX Crosslink-l
5	VERTAUX Crosslink-II
6	VERTAUX Rod

A.3) Identification of the Predicate Device:

The identified primary predicate within this submission is as follows: K 091442, Medtronic Sofamor Danek, USA, CD HORIZON Spinal System

A.4). A description of the device that is the subject of the premarket notification submission, such as might be found in the labelling or promotional material for the device

Device Description:

Auxein Brand Vertaux 5.5 mm Pedicle Screw System consists of rods, connectors and screws for implantation in the spine. The system is available in multiple rod diameters and screw sizes.

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Image /page/5/Picture/0 description: The image shows the logo for Auxein. The logo consists of a stylized letter A inside of a circle, followed by the text "Auxein" in a sans-serif font. To the right of the logo is the text "K201457 Page 3 of 7".

VERTAUX Mono-axial Pedicle Screw

0 The screw is threaded and the head is fixed for top loading for an easy rod introduction.
It may be used in instrumentation procedures to affix rods and screws to the spine. .
25 mm to 55 mm lengths & the diameter ranges from 4.5 mm to 7.0 mm. .

VERTAUX Poly-axial Pedicle Screw

It may be used in instrumentation procedures to affix rods and screws to the spine. 25 mm to 55 mm lengths & the diameter ranges from 4.5 mm to 6.5 mm.

VERTAUX-Pedicle Screws Cap

0 These cap is used to apply the pressure to hold the Rod inside the U-Part Head.
Buttress threads reduce profile and improves cross-threading resistance. .
Internal set screw allows for placement and visualization. .

VERTAUX -Pedicle Crosslink I & II

Vertaux Crosslink I

The Vertaux Crosslink I is used for connecting two vertaux rods providing a rigid and stable spine construct.

Vertaux Crosslink II

The intended use of vertaux cross link II is the same as used for cross link I with only change in design.

The Crosslink I is a pre assembled expandable part, while cross link II has assembly parts which are assembled during Surgery.

VERTAUX-Pedicle Rod

0 Auxein pedicle screw system has a titanium rod.
Easily contours to meet individual patient anatomy. .
These rods are available from 50mm, 60mm, 90mm, 100mm, 100mm, 110mm, 0 120mm, 130mm, 140mm, 150mm, 160mm, 180mm, 200mm, 220mm, 240mm, 250mm, 260mm, 280mm, 350mm, 400mm, 450mm, 500mm and having dia. of 5.5mm.

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Image /page/6/Picture/0 description: The image shows the logo for Auxein, which is a blue circle with a white letter A inside. To the right of the logo is the word "Auxein" in blue, and above that is the text "K201457 Page 4 of 7". The logo and text are all aligned horizontally.

These implants are sold in both non-sterile and sterile conditions. Note-Non sterile products have to be sterilized beforeuse.

A5). Indications for Use:

The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to fusion for the following indications:

0 Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
0 Spondylolisthesis;
Trauma (i.e., fracture or dislocation); 0
0 Spinal stenosis;
. Curvatures (i.e., scoliosis, kyphosis and/orlordosis);
. Tumor and pseudarthrosis

A.6). Summary of Technological Characteristics as compared to the predicate devices: Substantial equivalence including comparison with predicate devices

A comparison between the Auxein Brand Vertaux 5.5 mm Pedicle Screw System and predicate devices has been performed which has resulted in demonstration of similarities in dimensional and performance criteria.

Following is the summary of parameters in which the comparison has been verified:

S.No.	Characteristics	Predicate Device Versus New Device (Auxein Brand)	Remarks
1	Indications for use	Similar intended use in New Device and Predicate device	Equivalent
2	Material	Same material used in New Device and Predicate device	Equivalent
3	Performance Standards	Same performance standards used in both New Device as well as predicate device	Equivalent
4	Sterilization	Same method of sterilization used in both	Equivalent

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		New Device as well as
		Predicate device
5	Dimensional Verification	Same dimensions found inboth New Device as well asPredicate device	Equivalent

B.1). Discussion on the non-clinical testing performed

Following are the applicable product standards considered for non-clinical standards:

A: Material Standards
B: Performance Standards

A: Material Standards:

The material standards are the essential part to be complied with first, as it is the basis of manufacturing metallic surgical implants.

We have complied with the following material standards

ASTM F 136: Standard specification for wrought Titanium-6Aluminium-4Vanadium ELI (Extra low interstitial) Alloy for surgical implant applications.
ASTM F 899-12: Standard Specification for Wrought Stainless Steels for surgical instruments

We have verified the purchased material compliance to these standards and copies of the Relevant test results are attached herewith.

B: Performance Standards:

The device performance of Auxein Brand Vertaux 5.5 mm Pedicle Screw System has been demonstrated against following applicable standards-

0 Static compression testing as per ASTM F 1717-18
Static Torsional Testing of as per ASTM F 1717-18 0
Fatigue Compression testing as per ASTM F 1717-18 0

B.2). Discussion on the clinical evaluation referenced and relied upon:

Auxein Brand of devices is of similar design and pattern as well as similar intended use. Under

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Image /page/8/Picture/0 description: The image shows the logo for Auxein, which includes a blue circle with a white "A" inside, followed by the word "Auxein" in blue. To the right of the logo, the text "K201457 Page 6 of 7" is displayed. The text appears to be a document identifier and page number.

such situation we have also considered the meddev guidance document MEDDEV 2.7 1 REV. 04: 2016 and as per that clinical evaluation/clinical equivalence has been documented in section 11.

CONCLUSION:

General, Safety and Performance conclusion:

S.No.	Parameter ofConclusion	Proposed Device	PredicateDevice
1	Product Code	Auxein Brand Vertaux 5.5 mm PedicleScrew System.	Same
2	Regulation Number	21CFR 888.3070	Same
3	Regulatory Class	Class II	Same
4	Intended Use	Auxein Brand Vertaux 5.5 mm PedicleScrew System is intended for posterior,non-cervical fixation in skeletally maturepatients as an adjunct to fusion for thefollowing indications:• Degenerative Disc Disease (Definedas back pain of discogenic originwith degeneration of the discconfirmed by history andradiographic studies)• Spondylolisthesis• Trauma (i.e. fracture or dislocation)• Spinal Stenosis• Curvatures (i.e. Scoliosis, kyphosis,and/or lordosis)• Tumor and pseudarthrosis	Same
5	Sterilization	Provided both in Non-Sterile and SterileConditions.	Same
6	Mechanical TestPerformance	Auxein Brand Vertaux 5.5 mm PedicleScrew System tested -• As per ASTM F 1717-18Standard Test Methods for SpinalImplant Constructs in a VertebrectomyModel	Same
7	Material Standards	ASTM F 136 (Implants) & ASTMF899-12b (Instruments) / Same

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Image /page/9/Picture/0 description: The image shows the logo for Auxein, which is a blue circle with a stylized "A" inside of it, followed by the word "Auxein" in blue. To the right of the logo, the text "K201457 Page 7 of 7" is displayed. The text is in black and appears to be a document identifier and page number.

From the data available we can justify that the Auxein Brand Vertaux 5.5 mm Pedicle Screw System has the same intended use and similar technological characteristics as the already marketed predicate device identified in A.3. of the 510(k) summary. Hence our device can be considered substantially equivalent to the predicate.

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.