FIREFLY® Pedicle Screw Navigation Guide

K181399 · Mighty Oak Medical, Inc. · PQC · Jul 24, 2018 · Orthopedic

Device Facts

• Record ID: K181399
• Device Name: FIREFLY® Pedicle Screw Navigation Guide
• Applicant: Mighty Oak Medical, Inc.
• Product Code: PQC · Orthopedic
• Decision Date: Jul 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2

Intended Use

The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (TI-S2/S2Al and ilium) intended for fusion, with the additional conditions listed below: - . Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved) - . Pedicle screw's major and minor thread diameters are centered about the longitudinal axis - Pedicle screw's longitudinal axis matches the direction of insertion ● - Pedicle screw is intended to be inserted into a pilot hole ● - Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® ● - Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan - . Compatible pediale screw spinal system instruments may be used with the FIREELY® Pedicle Screw Navigation Guide - Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o - Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be O quided to tap pilot holes - All other pedicle screw spingl system components and accessories (including non-quided faps) are to be O used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use This device is intended for single use only.

Device Story

FIREFLY® Pedicle Screw Navigation Guide assists surgeons in accurate pedicle screw placement during spinal fixation. Input: patient-specific CT imaging data. Process: surgeon defines surgical trajectories presurgically; system generates patient-specific pedicle screw guides and bone models that fit patient anatomy. Operation: guides are placed on patient anatomy in the OR to direct surgical instruments (taps) for pilot hole creation along pre-planned trajectories. Output: physical guides for instrument alignment. Benefit: improved accuracy of pedicle screw placement. Used in open, posterior spinal procedures by surgeons. Device is single-use.

Clinical Evidence

No clinical data. Performance supported by cadaveric accuracy testing demonstrating that acceptance criteria were met and the device performs as intended.

Technological Characteristics

Patient-specific navigation guides. Materials: Titanium alloy (ASTM F136), stainless steel (ASTM F899), and epoxy resin (Accura ABS White SL 7810). Single-use. Mechanical guidance system based on patient-specific anatomy derived from CT data.

Indications for Use

Indicated for patients undergoing non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) requiring fusion, where pedicle screws are used. Requires adequate pedicle dimensions determined by preoperative CT scan. Contraindicated for curved pedicle screws or scenarios where screw diameter is not larger than the pilot hole.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FIREFLY® Pedicle Screw Navigation Guide (K162419)

Reference Devices

• FIREFLY® Pedicle Screw Navigation Guide (K143222)

Submission Summary (Full Text)

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July 24, 2018

Mighty Oak Medical Inc. Mr. Mark A. Wylie Vice President of Quality and Regulatory 750 West Hampden Avenue, Suite 120 Englewood, Colorado 80110

Re: K181399

Trade/Device Name: FIREFLY® Pedicle Screw Navigation Guide Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: POC Dated: May 29, 2018 Received: May 29, 2018

Dear Mr. Wylie:

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 comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] 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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# DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

# Indications for Use

510(k) Number (if known

# K181399

#### Device Name

FIREFLY® Pedicle Screw Navigation Guide

#### Indications for Use (Describe)

The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (TI-S2/S2Al and ilium) intended for fusion, with the additional conditions listed below:

- . Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
- . Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
- Pedicle screw's longitudinal axis matches the direction of insertion ●
- Pedicle screw is intended to be inserted into a pilot hole ●
- Pedicle screw's diameter is larger than the pilot hole created with FIREFLY® ●
- Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on ● preoperative scan
- . Compatible pediale screw spinal system instruments may be used with the FIREELY® Pedicle Screw Navigation Guide
- Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity o
- Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be O quided to tap pilot holes
- All other pedicle screw spingl system components and accessories (including non-quided faps) are to be O used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use

This device is intended for single use only.

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

X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY

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FIREFLY® Pedicle Screw Navigation Guide

# Submitter:

Mighty Oak Medical Inc. 750 W. Hampden Ave., Suite 120 Englewood, CO 80110 [phone] Contact: Mark A. Wylie, VP of Quality and Requlatory Date Prepared: 01June 2018 Device Trade Name: FIREFLY® Pedicle Screw Navigation Guide Common Name: Pedicle Screw Placement Guide Device Classification: Class II

Regulation, Name: 221 CFR 888.3070, Thoracolumbosacral pedicle screw system

Device Product Code: POC

# Predicate Device(s):

FIREFLY® Pedicle Screw Navigation Guide

Primary Predicate:

K162419 (S.E. 10/28/2016)

## Description

The FIREFLY® Pedicle Screw Navigation Guide is intended to assist in the accurate placement of pedicle screws. It consists of single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components.

The FIREFLY® Pedicle Screw Navigation Guide uses Patient-Specific Pedicle Screw Guides that fit on the patient's anatomy to guide surgical instruments in line with trajectories chosen presurgically, by the surgeon, based on the patient's CT imaging data. Navigation guides are intended to guide instruments to create pilot holes in the pedicles for placing pedicle screws following the Approved Patient-Specific Surgical Plan.

Patient-Specific Bone Models may also be provided.

The purpose of this traditional 510(k) is to expand the FIREFLY® indications for use to allow use at an additional spinal level. The FIREFLY® design is the same as was originally cleared in K143222 and K162419.

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# Indications for Use

The FIREFLY® Pedicle Screw Navigation Guide can be used with any 510(k) cleared, legally marketed, pedicle screw spinal system (for its cleared indications for use) and its respective compatible components for non-cervical open, posterior spinal fixation procedures (T1-S2/S2AI and ilium) intended for fusion, with the additional conditions listed below:

- · Pedicle screw's shank is straight along its longitudinal axis (i.e. not curved)
- Pedicle screw's major and minor thread diameters are centered about the longitudinal axis
- Pedicle screw's longitudinal axis matches the direction of insertion
- · Pedicle screw is intended to be inserted into a pilot hole
- Pedicle screw's diameter is larger than the pilot hole created with FIREFLY®
- Patient's pedicle must be dimensionally adequate to accommodate a pedicle screw, as determined on preoperative scan
- Compatible pedicle screw spinal system instruments may be used with the FIREFLY® Pedicle Screw Navigation Guide
- o Pedicle sounding probes (a.k.a. feeler/ball-tip probes) may be used to confirm pedicle integrity
- o Only OEM pedicle screw spinal system taps specified in the Approved Patient-Specific Surgical Plan may be quided to tap pilot holes
- o All other pedicle screw spinal system components and accessories (including non-quided taps) are to be used, after removal of the FIREFLY® Pedicle Screw Navigation Guide, as directed by the pedicle screw spinal system's instructions for use

This device is intended for single use only.

# Materials

The patient-contacting components of the FIREFLY® Pedicle Screw Navigation Guide are manufactured from titanium alloy (ASTM F136), various stainless steels (ASTM F899), and epoxy resin (Accura ABS White SL 7810).

## Performance Data

Additional cadaveric accuracy testing of the FIREFLY® Pedicle Screw Navigation Guide was performed. The results demonstrated that the acceptance criteria were met and that the FIREFLY® Pedicle Screw Navigation Guide's performance is adequate to perform as intended.

## Technological Characteristics

The subject FIREFLY® Pedicle Screw Navigation Guide possesses the same technological characteristics as the predicate device. These include:

- Performance
- Manufacturing process ●
- Sterilization ●
- Biocompatible materials
- Basic design .

Technological characteristics which are different have been supported with descriptive information and/or performance data. Therefore the fundamental scientific technology of FIREFLY® is the same as the previously cleared device.

## Conclusion

The FIREFLY® Pedicle Screw Navigation Guide possesses the same intended use and technological characteristics as the predicate device. Therefore the FIREFLY® Pedicle Screw Navigation Guide is substantially equivalent for its intended use.