(100 days)
The Overwatch Spine System is intended for non-cervical fixation (T1-S2/Ilium) in skeletally mature patients as an adjunct to following instabilities/deformities in the thoracolumbar and sacral spine: a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) b) spondylolisthesis, c) trauma (i.e., fracture or dislocation), d) spinal stenosis, e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis). f) tumor, g) pseudoarthrosis, and h) failed previous fusion The Overwatch Spine System is intended for the following indications when used in a posterior percutaneous approach for non-cervical pedicle and non-pedical fixation: Degenerative disc disease; spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion When used for posterior non-cervical pedicle screw fixation in pediatric patients the Overwatch Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Overwatch Spine System consists of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, screws, transverse crosslinks, rod connectors, and hooks. The Overwatch screws are self-tapping and are available with either a cancellous or a dualfix thread design. They are available in cannulated and noncannulated configurations, in a variety of diameters and lengths. The system implants are manufactured from Ti-6Al-4V (ASTM F136).
The provided document is a 510(k) premarket notification for a medical device called the "Overwatch Spine System." It describes the device, its intended use, and a summary of performance testing to demonstrate substantial equivalence to legally marketed predicate devices.
However, the document does not describe acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered device. The "Summary of Performance Testing" section refers to mechanical testing of the spinal fixation system, not a clinical study involving data provenance, expert ground truth, sample sizes for training/test sets, or comparative effectiveness studies with human readers.
Therefore, I cannot provide the requested information for an AI/ML context based on this document. The document focuses on the mechanical and material equivalence of a physical medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2016
Amendia, Inc. Ms. Chelsea Proffitt Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062
Re: K161842
Trade/Device Name: Overwatch Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWP Dated: September 9, 2016 Received: September 12, 2016
Dear Ms. Proffitt:
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
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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,
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Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K161842
Device Name Overwatch Spine System
Indications for Use (Describe)
The Overwatch Spine System is intended for non-cervical fixation (T1-S2/Ilium) in skeletally mature patients as an adjunct to following instabilities/deformities in the thoracolumbar and sacral spine:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion
The Overwatch Spine System is intended for the following indications when used in a posterior percutaneous approach for non-cervical pedicle and non-pedical fixation: Degenerative disc disease; spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scolosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients the Overwatch Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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 is a logo for AMENDIA. The logo is blue and features the word "AMENDIA" in a sans-serif font. The "A" in "AMENDIA" is inside of a blue square. Below the word "AMENDIA" is the phrase "creating balanced solutions" in a smaller, lighter blue font.
510(k) Summary
Overwatch Spine System
| Submitter: | Amendia, Inc.1755 W. Oak ParkwayMarietta, GA 30062 |
|---|---|
| Contact Person: | Chelsea ProffittRegulatory Affairs Specialist770-575-5181 (W), 877-420-1213 (F)cproffitt@amendia.com (e-mail) |
| Date Prepared: | September 9, 2016 |
| Trade Name: | Overwatch Spine System |
| Common Name: | Spinal Fixation System |
| Device Product Codeand Classification: | Regulation Numbers: 21 CFR 888.307021 CFR 888.3050NKB, Class III, Pedicle Screw Spinal System, ForDegenerative Disc DiseaseCGH, Class II, Pedicle Screw Spinal System, AdolescentIdiopathic ScoliosisMN<, Class II, Spondylolisthesis Spinal Fixation DeviceAB=, Class II, Pedicle Screw Spinal System?KD, Class II, Spinal Interlaminal Fixation Orthosis |
| Primary Predicate Device: | Firebird Spinal Fixation System/Phoenix MIS SpinalFixation System (K151488) |
| Additional Predicate Devices: | CD HORIZON Spinal System (K153589)Savannah-T Pedicle Screw System (K132925) |
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Image /page/4/Picture/0 description: The image is a logo for AMENDIA. The logo features the word "AMENDIA" in a sans-serif font, with the "A" in a blue square. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller font. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
Device Description:
The Overwatch Spine System consists of spinal implants for fixation of the thoracolumbar and/or sacral spine. The system includes rods, screws, transverse crosslinks, rod connectors, and hooks. The Overwatch screws are self-tapping and are available with either a cancellous or a dualfix thread design. They are available in cannulated and noncannulated configurations, in a variety of diameters and lengths. The system implants are manufactured from Ti-6Al-4V (ASTM F136).
Indications and Intended use:
The Overwatch Spine System is intended for non-cervical pedicle and non-pedical fixation (T1-S2/llium) in skeletally mature patients as an adjunct to fusion for the following instabilities/deformities in the thoracolumbar and sacral spine:
- a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- b) spondylolisthesis,
- c) trauma (i.e., fracture or dislocation),
- d) spinal stenosis,
- e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- f) tumor,
- g) pseudoarthrosis, and
- h) failed previous fusion
The Overwatch Spine System is intended for the following indications when used in a posterior percutaneous approach for non-cervical pedicle and non-pedical fixation: Degenerative disc disease; spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients the Overwatch Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Summary of Technological Characteristics:
The subject device is substantially equivalent to the predicate devices as well as other similar devices cleared by FDA for commercial distribution in the United States. The Subject Device is equivalent to the predicates in regards to technological characteristics including design, intended use, material composition, and function.
Summary of Performance Testing:
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Mechanical testing for the Overwatch Spine System was performed on the worst-case subject device in accordance with ASTM standards.
| Test | Standard |
|---|---|
| Static Axial Compression Bending | ASTM F1717-15 |
| Static Torsion | ASTM F1717-15 |
| Dynamic Axial Compression Bending | ASTM F1717-15 |
| Axial Pullout | ASTM F543-13 |
| Static Cantilever Screw Bending | ASTM F2193-14 |
For all test methods, the subject devices met or exceeded the requirements as established by the test protocol and applicable ASTM standards.
Performance testing of the Subject Device was compared to similar legally marketed Predicate and Reference Devices.
Conclusion:
Based on the comparison to predicate devices, the Subject Device has been shown to be substantially equivalent to legally marketed predicate devices.
§ 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.