(396 days)
No
The description focuses on patient-specific guides based on pre-operative surgeon planning using CT images, without mentioning any AI/ML algorithms for image analysis, planning, or guidance. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".
No.
The device is a navigation guide and surgical aid, intended to assist in the accurate placement of pedicle screws by guiding drilling and tapping, rather than directly treating a disease or condition. Its function is to facilitate a surgical procedure, not to provide therapy itself.
No
The device is described as a "patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws" and "intended to assist in the accurate placement of pedicle screws." Its purpose is to guide surgical instruments post-planning, not to diagnose a condition or provide diagnostic information.
No
The device description explicitly states it consists of "single-use components designed for treatment of a specific patient as well as reusable non-patient-specific components," and mentions "Patient-Specific Pedicle Screw Guides" and "Patient-Specific Bone Models," which are physical components, not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The FIREFLY™ Pedicle Screw Navigation Guide is a surgical planning and guidance system used during surgery to assist in the placement of pedicle screws. It uses pre-operative imaging and patient-specific guides to direct surgical instruments.
- No Biological Samples: The device does not analyze any biological samples from the patient. Its function is entirely related to surgical planning and physical guidance during the procedure.
Therefore, the FIREFLY™ Pedicle Screw Navigation Guide falls under the category of a surgical navigation or guidance system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use.
Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided 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.
Product codes (comma separated list FDA assigned to the subject device)
MNI
Device Description
The FIREFLY ™ Pedicle Screw Navigation Guide is a patient-specific system 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT radiological images
Anatomical Site
T1-S1/Ilium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cadaveric accuracy and sterilization stability 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 performance is adequate to perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 11, 2015
Mighty Oak Medical, Incorporated Mr. Mark A. Wylie Director of Quality 750 West Hampden Avenue, Suite 120 Englewood, Colorado 80110
Re: K143222
Trade/Device Name: FIREFLY™ Pedicle Screw Navigation Guide Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI Dated: November 6, 2015 Received: November 9, 2015
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143222
Device Name FIREFLYTM Pedicle Screw Navigation Guide
Indications for Use (Describe)
The FIREFLY™ Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use.
Use of the FIREFLY™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of anatomical landmarks. Only compatible OEM taps that are supplied with the pedicle screw spinal systems specified in the instructions for use may be used through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All other pedicle screw spinal system components and accessories (including non-guided 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.
| 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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Section 8 – 510(k) Summary
| Date: | December 8, 2015 |
|---|---|
| Sponsor: | Mighty Oak Medical, Inc. |
| 750 W. Hampden Ave., Suite 120 | |
| Englewood, CO 80110 | |
| (720) 398-9703 | |
| Contact Person: | Mark A. Wylie, Director of Quality |
| Trade Name: | FIREFLY ™ Pedicle Screw Navigation Guide |
| Common Name: | Pedicle Screw Placement Guide |
| Device Classification: | Class II |
| Regulation, Name: | 888.3070, Pedicle screw spinal system |
| Device Product Code: | MNI |
| Device Description: | The FIREFLY ™ Pedicle Screw Navigation Guide is a patient-specific system 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. | |
| Intended Use: | The FIREFLY Pedicle Screw Navigation Guide is a patient-specific system intended to guide the drilling and tapping of pilot holes for placement of pedicle screws according to surgeon-prescribed pre-operatively planned trajectories during open, posterior, instrumented spinal surgery (T1-S1/Ilium). The FIREFLY ™ Pedicle Screw Navigation Guide is intended for use with the pedicle screw spinal systems specified in the instructions for use and in patients consistent with the selected system's cleared indications for use. |
| Use of the FIREFLY ™ Pedicle Screw Navigation Guide involves surgical planning software used pre-operatively to plan the surgical placement of the pilot holes on the basis of patient CT radiological images with identifiable placement of |
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| | anatomical landmarks. Only compatible OEM taps that are supplied with the
pedicle screw spinal systems specified in the instructions for use may be used
through the FIREFLY™ Pedicle Screw Navigation Guide to tap pilot holes. All
other pedicle screw spinal system components and accessories (including non-
guided 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). |
| Predicate Devices: | Primary:
MySpine Pedicle Screw Placement Guides (Medacta International SA: K132788) |
| | Reference:
VSP® System (3D Systems [formerly Medical Modeling Inc.]: K120956 and
K133907),
TRUMATCH Personalized Solutions (DePuy Synthes: K110397) |
| Performance Data: | Cadaveric accuracy and sterilization stability 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
performance is adequate to perform as intended. |
| Technological
Characteristics: | The FIREFLY Pedicle Screw Navigation Guide possesses the same technological
characteristics as the predicate devices. These include: |
| | • performance, |
| | • manufacturing process, |
| | • biocompatible materials, and |
| | • basic design. |
| | Technological characteristics which are different have been supported with
descriptive information and/or performance data. Therefore the fundamental
scientific technology of the System devices is the same as previously cleared
devices. |
| Conclusion: | The FIREFLY Pedicle Screw Navigation Guide possesses the same intended use
and technological characteristics as the predicate devices. Therefore the FIREFLY
Pedicle Screw Navigation Guide is substantially equivalent for its intended use. |