K Number

Device Name

Sequel External Fixation Device

Manufacturer

Sequel Medical Inc.

Date Cleared

2021-01-19

(116 days)

Product Code

KTT

Regulation Number

888.3030

Intended Use

The Sequel Ring Fixation System is indicated for both adults and pediatric patients for: 1. Open and closed fracture fixation 2. Pseudoarthrosis or non-union of long bones 3. Limb lengthening by epiphyseal or metaphyseal distraction 4. Correction of bony or soft tissue deformities 5. Correction of segmental or nonsegmental bony or soft tissue defects 6. Post-Traumatic joint contracture which has resulted in loss of range of motion

Device Description

The Sequel® External Fixation System is a single-use modular external fixator consisting of implantable half pins and fixation wires and non-patient contact rings, struts, telescoping rods, threaded rods, posts, hinges, connection plates, twisted plates, threaded sockets, bolts, washers and nuts that are combined by the health care professional to construct different frame configurations based on patient anatomy and indicated use. The frame forms the support metalwork for the torsion wire used in fracture fixation and several other indications for long bone fixation procedures. The Subject device includes additional components (tabbed rings and struts) compared to the primary predicate. The tabbed rings and struts are substantially equivalent to the tabbed rings and struts in the secondary predicates. Special wrenches and accessories are included for the proper assembly of the components. The components of the frame are manufactured from titanium, stainless steel, and aluminum.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K190486, K071394, K170650

Reference Devices

K190486, K071394, K170650

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and summary of performance studies focus on mechanical components and bench testing, with no mention of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".

Therapeutic

Yes.
The device is used for treating various medical conditions such as fracture fixation, pseudoarthrosis, limb lengthening, and correction of deformities.

Diagnostic

Explanation: The device description and intended use indicate that the Sequel Ring Fixation System is an external fixator used for treating various musculoskeletal conditions like fractures, non-unions, limb lengthening, and deformity correction. Its function is to provide mechanical support and stabilization, not to diagnose medical conditions or identify the presence/absence of a disease.

SaMD (Software as a Medical Device)

The device description explicitly details numerous hardware components made of titanium, stainless steel, and aluminum, including pins, wires, rings, struts, rods, and other mechanical parts. It is a physical external fixation system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a system for fixing fractures, correcting deformities, and lengthening limbs. These are all procedures performed directly on the patient's body.
Device Description: The device is described as a modular external fixator consisting of implantable components (pins and wires) and external components (rings, struts, etc.) that are assembled by a healthcare professional to construct a frame. This is a physical device used in surgery.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside or on the body) for structural support and manipulation of bones.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Sequel Ring Fixation System is indicated for both adults and pediatric patients for:

1. Open and closed fracture fixation
1. Pseudoarthrosis or non-union of long bones
1. Limb lengthening by epiphyseal or metaphyseal distraction
1. Correction of bony or soft tissue deformities
1. Correction of segmental or nonsegmental bony or soft tissue defects
1. Post-Traumatic joint contracture which has resulted in loss of range of motion

Product codes

KTT

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Long bones

Indicated Patient Age Range

Adults and pediatric patients

Intended User / Care Setting

Health care professional (in a health care institution for sterilization)

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 Testing: The components of the Sequel® External Fixation System frame are not in direct contact with patient tissue so no testing was performed. The implantable half pins and fixation wires are manufactured from 316L stainless steel, a material routinely used in implantable medical devices. Therefore, biocompatibility testing is not required to prove substantial equivalence of the subject device.
Bench Testing: Bench testing for the characterization of the design and mechanical function of Sequel® External Fixation System was performed in accordance with ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation. The Sequel® External Fixation System conformed to the requirements and specification of this standard.
Sterilization Validation: The recommended sterilization cycle was validated in accordance with ISO 17665-1:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO/TS 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1.
Animal Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.
Clinical Testing: Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K190486, K071394, K170650

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.

Summary

January 19, 2021

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.

Sequel Medical Inc. Valentina Kamysheva CEO 12550 Biscayne Blvd Ste 110 North Miami, Florida 33181-2536

Re: K202833

Trade/Device Name: Sequel External Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT Dated: October 23, 2020 Received: November 20, 2020

Dear Valentina Kamysheva:

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-reportingcombination-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 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,

Ting Song, Ph.D., R.A.C. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K202833

Device Name

Sequel External Fixation Device

Indications for Use (Describe)

The Sequel Ring Fixation System is indicated for both adults and pediatric patients for:

1. Open and closed fracture fixation
1. Pseudoarthrosis or non-union of long bones
1. Limb lengthening by epiphyseal or metaphyseal distraction
1. Correction of bony or soft tissue deformities
1. Correction of segmental or nonsegmental bony or soft tissue defects
1. Post-Traumatic joint contracture which has resulted in loss of range of motion

Type of Use (Select one or both, as applicable)
-------------------------------------------------

☑ Residential Use (A.R.S. §33-181 Sets Limits)	☐ For The Operation of A.R.S. §33-181 Sets Limits)
------------------------------------------------	----------------------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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K202833 - 510(K) SUMMARY

In accordance with 21 CFR 807.92 the following information is provided for the Sequel External Fixation System 5110(k) premarket notification.

1. SUBMITTER

| Applicant: | Sequel Medical
12550 Biscayne Blvd.
Suite 110
Miami, Fl 33181 |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Valentina Kamysheva
CEO
Sequel Medical
12550 Biscayne Blvd.
Suite 110
Miami, Fl 33181
Phone: 1-305-814-8299
Email: Valentina@sequelmd.com |
| Date Prepared: | August 19, 2020 |

2. DEVICE

Name of Device:	Sequel External Fixation System
Common or Usual Name:	Multilateral Fixator Components
Regulatory Class:	II
Product Code:	KTT- Single/multiple component metallic bone
fixation appliances and accessories (21 CFR 888.3030)
FDA Panel:	Division of Orthopedic Devices

Page 1 of 6

3. PREDICATE DEVICES

| Predicate Device: | K190486
Pitkar External Fixation System
S H Pitkar Orthotools Pvt Ltd.
Plot No. EL 32, J Block, MIDC Bhosari
Pune, IN 411026 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Predicate Devices: | K071394
SBi RingFIXTM System
Small Bone Innovations Inc.
505 Park Ave., 14th Floor
New York, NY 10022

K170650
Orthofix TrueLok Hexapod System (TL-HEX) V2.0
Orthofix Srl
Via Delle Nazioni 9
Bussolengo, IT 37012 |

4. GENERAL DESCRIPTION

K202833 Page 3 of 6

5. INDICATION FOR USE STATEMENT

The Sequel® External Fixation System is indicated for both adult and pediatric patients for:

1. Open and closed fracture fixation
1. Pseudoarthrosis or non-union of long bones
1. Limb lengthening by epiphyseal or metaphyseal distraction
1. Correction of bony or soft tissue deformities
1. Correction of segmental or nonsegmental bony or soft tissue defects
1. Post-Traumatic joint contracture which has resulted in loss of range of motion

6. SUBSTANTIAL EQUIVALENCE

Comparison of Intended Use:

The intended use of the Sequel® External Fixation System is equivalent to the intended use for the primary predicate. The system is intended used to provide stabilization of open and/or closed unstable fractures and other indicated corrective procedures.

Indications for Use:

The indications for use of the Sequel® External Fixation System are equivalent to the indications for use cleared for the primary predicate. Like the primary predicate, the Sequel® External Fixation System indicated for both adult and pediatric patients for open and closed fracture fixation, pseudoarthrosis or non-union of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, correction of segmental or nonsegmental bony or soft tissue defects, and post-traumatic joint contracture which has resulted in loss of range of motion.

Technology Comparisons:

Table 1 below compares the key technological feature of the subject devices to the predicate devices.

	Subject Device	Primary Predicate	Secondary Predicate	Secondary Predicate
510(k) Number	K202833	K190486	K071394	K170650
Device Name	Sequel® External
Fixation System	Pitkar External
Fixation System	SBi RingFIXTM System	Orthofix TrueLok
Hexapod System (TL-
HEX) V2.0
Classification
Regulation	Class II	Class II	Class II	Class II
Classification Product
Code	KTT: Appliance,
Fixation,
Nail/Blade/Plate
Combination, Multiple
Component	KTT: Appliance,
Fixation,
Nail/Blade/Plate
Combination, Multiple
Component	KTT: Appliance,
Fixation,
Nail/Blade/Plate
Combination, Multiple
Component	KTT: Appliance,
Fixation,
Nail/Blade/Plate
Combination, Multiple
Component
Subsequent Product
Code	Not Applicable	JDW - Pin, Fixation,
Threaded	Not Applicable	OSN: Software for
Diagnosis/Treatment
Operating Principle	Ilizarov Apparatus
Method - Distraction -
Osteogenesis	Ilizarov Apparatus
Method - Distraction
Osteogenesis	Ilizarov Apparatus
Method - Distraction
Osteogenesis	Ilizarov Apparatus
Method - Distraction
Osteogenesis
Components	External Fixator Frame
Components.
Tabbed rings
Tabbed Struts	External fixator
components.
NA
NA	External fixator
components.
Tabbed rings
NA	External fixator
components.
NA
Tabbed Struts
May be used with a
web-based software
component that is
designed
to be used to assist
the physician in
creating a patient
adjustment
schedule that assists
in adjusting the six
struts
Materials of
Construction	Titanium
Stainless Steel
Aluminum	Titanium
Stainless Steel
Aluminum	Aluminum	Aluminum
Sterilization	Supplied non-sterile in
a sterilization tray to
be sterilized by moist
heat (autoclave) prior
to use.	Supplied non-sterile in
a sterilization tray to
be sterilized by moist
heat (autoclave) prior
to use.	Supplied non-sterile in
a sterilization tray to
be sterilized by moist
heat (autoclave) prior
to use.	Supplied non-sterile in
a sterilization tray to
be sterilized by moist
heat (autoclave) prior
to use.

Table 1: Technological Comparison

7. PERFORMANCE TESTING

Biocompatibility Testing:

The components of the Sequel® External Fixation System frame are not in direct contact with patient tissue. The frame components are not within the scope of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The frame components are manufactured from the same material, by an equivalent manufacturing process, and to the same dimensional specifications as the primary predicate. The tabbed rings and struts are manufactured from the same material, by an equivalent manufacturing process and to the same dimensional specifications as secondary predicates. Therefore, biocompatibility testing is not required to prove substantial equivalence of the subject device. Refer to Table 2.

The implantable half pins and fixation wires are manufactured from 316L stainless steel a material routinely used in implantable medical devices. The components are made by an equivalent manufacturing process and to the same dimensional specifications as the predicate devices. Therefore, biocompatibility testing is not required to prove substantial equivalence of the subject device. Refer to Table 2.

| | Patient
Contact | Material of
Construction | Manufacturing
Process | Dimensional
Specifications | Sterilization
Method |
|-----------------------------------|-----------------------------------------|-----------------------------|--------------------------|-------------------------------|-------------------------|
| Frame
Components | Same
No Direct
Patient
Contact | Same | Equivalent | Same | Same
(Moist Heat) |
| Tabbed Rings and
Tabbed Struts | Same
No Direct
Patient
Contact | Same | Equivalent | Same | Same
(Moist Heat) |
| Half Pins | Same
Implantable | Same | Equivalent | Same | Same
(Moist Heat) |
| Fixation Wires | Same
Implantable | Same | Equivalent | Same | Same
(Moist Heat) |

Table 2 - Biocompatibility Evaluation Subject Device vs Predicates

K202833 Page 6 of 6

Bench Testing

Bench testing for the characterization of the design and mechanical function of Sequel® External Fixation System was performed in accordance with ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation. The Sequel® External Fixation System conformed to the requirements and specification of this standard.

Sterilization Validation

The Sequel® External Fixation System is provided non-sterile in a sterilization tray. The Instructions for Use Manual specifies moist heat (autoclave) sterilization cycle parameters for the health care institution to sterilize the device prior to use. The recommended sterilization cycle was validated in accordance with ISO 17665-1:2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices and ISO/TS 17665-2:2009 Sterilization of health care products -- Moist heat -- Part 2: Guidance on the application of ISO 17665-1

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

8. CONCLUSION

The substantial equivalence information provided in this submission demonstrates that the subject device is substantially equivalent to the predicate devices in both indications for use and technological characteristics. The additional components compared to the primary predicate are substantially equivalent to the components in the secondary predicates. The addition of the new components does not raise new questions of safety or effectiveness. The performance test results demonstrate that the device continues to meet all the specifications and requirements that were met by the predicate devices. Therefore, the subject device can be found substantially equivalent to the predicate devices