(116 days)
No
The summary describes a mechanical spinal implant system and its components, with performance studies focused on mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is an implantable spinal system designed to provide additional support during fusion for various spinal instabilities and deformities, which directly addresses a medical condition to restore function or alleviate symptoms.
No
The device is described as an implant system (screws, rods, hooks) intended to provide support during spinal fusion. It is a treatment device, not one that gathers or interprets data for diagnosis.
No
The device description explicitly lists physical components such as screws, rods, hooks, and surgical instruments, and describes manufacturing materials and testing of these physical components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SAGICO OSI SPINAL SYSTEM is a system of implants (screws, rods, hooks, etc.) designed to be surgically implanted into the non-cervical spine to provide structural support during fusion. It is a physical device used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, chemical reactions, or diagnostic testing.
Therefore, the SAGICO OSI SPINAL SYSTEM is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine.
When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- · Degenerative disc disease (DDD) (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:
- · Pseudoarthrosis; and
- Failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the SAGICO OSI SPINAL SYSTEM by Osimplant implants are indicated as an adjunct to treat adolescent idiopathic scoliosis.
The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP, KWO
Device Description
The SAGICO OSI SPINAL SYSTEM by Osimplant constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and muttiaxial transverse connectors and associated surgical instruments. The SACICO OSI SPINAL SYSTEM by Osimplants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. SAGICO OSI SPINAL SYSTEM by Osimplant implants are designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine
Indicated Patient Age Range
Skeletally mature patients, pediatric patients (adolescent)
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)
Non-clinical performance data testing conducted to support substantial equivalence for the SAGICO OSI SPINAL SYSTEM by Osimplant device included:
ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static Compression Bending Test
- Dynamic Compression Bending Test
ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants - Σ Axial Gripping Test
- Σ Axial Torsion Gripping Test
- Flexion Extension Static Test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K113666, K071373, K091445, K994121, K111492
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 21, 2018
Spinal Analytics & Geometrical Implant Co, LLC James J. Gibson Jr., CPA, Ph.D. SAGICO Project Manager 2189 West Busch Boulevard Tampa, Florida 33612
Re: K180220
Trade/Device Name: SAGICO OSI SPINAL SYSTEM by Osimplant Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWO Dated: February 8, 2018 Received: February 9, 2018
Dear Dr. Gibson:
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);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
Device Name
SAGICO OSI SPINAL SYSTEM by Osimplant
Indications for Use (Describe)
The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine.
When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- · Degenerative disc disease (DDD) (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:
- · Pseudoarthrosis; and
- Failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the SAGICO OSI SPINAL SYSTEM by Osimplant implants are indicated as an adjunct to treat adolescent idiopathic scoliosis.
The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended 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 shows the text 'K180220 - Page 1 of 2'. This text appears to be a document identifier and page number. The document identifier is K180220, and the page number is 1 of 2, indicating that this is the first page of a two-page document.
Image /page/3/Picture/1 description: The image shows a logo for SAGICO, which stands for Sinai Analytics & Geometrical Implant Co. The logo features a blue hexagon shape with the word "SAGICO" in bold, sans-serif font inside. Below the hexagon, the full name of the company is written in a smaller, less bold font. The logo appears to be for a company that specializes in analytics and geometrical implants.
SAGICO OSI SPINAL SYSTEM by Osimplant Traditional 510(k) Premarket Notification
510(k) Summary
Device Trade Name(s): SAGICO OSI SPINAL SYSTEM by Osimplant Classification Panel: Orthopedic Common Name: Pedicle Screw Spinal System Class and Reference: Class II Product Code(s): NKB, KWQ, KWP Thoracolumbosacral Pedicle Screw System (NKB) Classification Name(s): Class II per 21 CFR §888.3070 Appliance, Fixation, Spinal Intervertebral Body (KWQ) Class II per 21 CFR §888.3060 Appliance, Fixation, Spinal Interlaminal (KWP) Class II per 21 CFR §888.3050 Applicant/Official Contact Person: James J. Gibson, Jr., CPA, PhD SAGICO Project Manager Email: JG@Sagico.com Tel. (813) 830-3636 / Fax (813) 433-5586 Submitter /Manufacturer: Spinal Analytics & Geometrical Implant Co, LLC dba/ SAGICO 2189 West Busch Blvd Tampa, Florida 33612 Tel. (813) 830-3636 / Fax (813) 433-5586 Preparation Date: May 18th, 2018
Predicate Devices
The subject device is substantially equivalent to the primary predicate device XIA® 3 Spinal System - Stryker Spine (K113666) and additional predicate devices, USS Small Stature System - Synthes Spine Medtronic Spine (K071373), CD HORIZON - Spinal System - Sofamor Danek USA (K091445), TSRH Spinal System - Sofamor Danek USA (K994121), XIA 3 Spinal System - Stryker Spine (K111492)
Purpose:
The purpose of this submission is to request clearance for new system "SAGICO OSI SPINAL SYSTEM by Osimplant".
Device Description:
The SAGICO OSI SPINAL SYSTEM by Osimplant constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and muttiaxial transverse connectors and associated surgical instruments. The SACICO OSI SPINAL SYSTEM by Osimplants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. SAGICO OSI SPINAL SYSTEM by Osimplant implants are designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.
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Image /page/4/Picture/1 description: The image shows a logo for SAGICO, which stands for SP NGI Analytics & Geometrical Implant Co. The logo is a blue hexagon with the word "SAGICO" in white letters inside. Below the hexagon, the full name of the company is written in smaller letters. The logo is simple and professional, and it conveys a sense of precision and expertise.
SAGICO OSI SPINAL SYSTEM by Osimplant Traditional 510(k) Premarket Notification
Indications for use:
The SAGICO OSI SPINAL SYSTEM by Osimplant is intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the SAGICO OSI SPINAL SYSTEM by Osimplant is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- Degenerative disc disease (DDD) (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);
- MMMMM Spinal stenosis;
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
- Tumor;
- Pseudoarthrosis; and
- Failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the SAGICO OSI SPINAL SYSTEM by Osimplant implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The SAGICO OSI SPINAL SYSTEM by Osimplant for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Technological Characteristics:
Testing performed on SAGICO OSI SPINAL SYSTEM by Osimplant included in this submission demonstrates that the SAGICO OSI SPINAL SYSTEM by Osimplant is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States market. The SAGICO OSI SPINAL SYSTEM by Osimplant substantial equivalence determination to the predicate systems is based on comparable data drawn from design, labeling, and indications for use, function and implant materials.
Performance data:
Non-clinical performance data testing conducted to support substantial equivalence for the SAGICO OSI SPINAL SYSTEM by Osimplant device included:
ASTM F1717-04
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static Compression Bending Test
- Dynamic Compression Bending Test
ASTM F1798-13
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- Σ Axial Gripping Test
- Σ Axial Torsion Gripping Test
- Flexion Extension Static Test
Basis of Substantial Equivalence:
The SAGICO OSI SPINAL SYSTEM by Osimplant has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject and predicate devices.
Conclusion:
The SAGICO OSI SPINAL SYSTEM by Osimplant has been shown to be substantially equivalent to legally marketed predicate devices with respect to its indications for use, design, function, and materials.