(52 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and materials of the implant, with no mention of AI, ML, image processing, or data analysis.
Yes
The device is described as an implant system for spinal fusion to treat various medical conditions, indicating its use in restoring health or alleviating disease.
No
This device is described as an "implant device" for "noncervical pedicle fixation" and is used as an "adjunct to fusion." It is a treatment device, not one that diagnoses conditions.
No
The device description explicitly states it is an "implant device made from a titanium alloy and Cobalt-Chrome" and describes various hardware components like screws, rods, hooks, and connectors. This is a physical implant system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Hubble I System is described as an implant device made of titanium and cobalt-chrome alloys. It is surgically implanted into the spine for fixation.
- Intended Use: The intended use is for noncervical pedicle fixation as an adjunct to fusion for various spinal conditions. This is a surgical procedure involving the implantation of a device, not a diagnostic test performed on a sample.
The description clearly indicates a surgically implanted device used for structural support and stabilization within the body, which is the opposite of an in vitro diagnostic test performed outside the body on a sample.
N/A
Intended Use / Indications for Use
The Hubble I System is indicated for use for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP
Device Description
The Orbbo Hubble I System is an implant device made from a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The titanium alloy implants are provided sterile. The cobalt-chrome implants are provided non-sterile. It is to be implanted from the posterior approach. The screws are available as monobloc reduction (traction) screws and polyaxial and polyaxial reduction (traction) screws in diameters from 4.0 - 8.0 mm and in lengths from 25 - 55 mm and polyaxial illac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40 - 500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1 to S1 vertebrae
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Orbbo, LLC. Hubble I System was evaluated to demonstrate equivalence to the predicate devices. Mechanical testing was performed for the predicate devices, which characterized the mechanical performance and fatigue endurance to show the original performance requirements for Static Compression Bend, Static Torsion and Dynamic Compression Bend per ASTM F1717-13. As there are no changes in design or materials or manufacturing processes, no new performance testing was required. No clinical or animal studies were performed.
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.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2017
Orbbo Surgical, LLC. % Ms. Tamala J. Wampler Regulatory and Quality Consultant Novus Management Group, LLC. 6686 Dimmick Road West Chester, Ohio 45069
Re: K163566
Trade/Device Name: Hubble I System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: December 14, 2016 Received: December 19, 2016
Dear Ms. Wampler:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
Mark N. Melkerson -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K163566
Device Name Hubble I System
Indications for Use (Describe)
The Hubble I System is indicated for use for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and failed previous fusion.
| 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) |
| PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| FOR FDA USE ONLY |
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
Page 1 of 1
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5.510(k) Summary
| Submitter's Name: | Orbbo, LLC. (Orbbo Surgical, LLC.) |
|---|---|
| Submitter's Address: | 555 W. 5th Street, 35th Floor |
| Los Angeles, CA 90013 | |
| Submitter's Telephone: | (800) 942-1880 |
| Company Contact Person: | Eric Garofano |
| CEO | |
| Contact Person: | Tamala J. Wampler |
| Novus Management Group, LLC. | |
| 513-593-4944 | |
| Date Summary was | |
| Prepared: | 12/13/2016 |
| Trade or Proprietary Name: | Hubble I System |
| Common or Usual Name: | Thoracolumbosacral Pedicle Screw System |
| Classification: | Class II per 21 CFR §888.3070 |
| Product Code: | NKB, KWP |
| Classification Panel: | Division of Orthopedic Devices |
| Panel Code: | 87 |
Description of the Device Subject to Premarket Notification:
The Orbbo Hubble I System is an implant device made from a titanium alloy Ti 6Al-4V ELI per ISO 5832-3 and Cobalt-Chrome per ISO 5832-12. The titanium alloy implants are provided sterile. The cobalt-chrome implants are provided non-sterile. It is to be implanted from the posterior approach. The screws are available as monobloc reduction (traction) screws and polyaxial and polyaxial reduction (traction) screws in diameters from 4.0 - 8.0 mm and in lengths from 25 - 55 mm and polyaxial illac screws of 7 and 8mm diameters with lengths from 55mm to 110mm. Rods are available in 5.5mm diameter in lengths from 40 - 500 mm. Hooks are available in various sizes to attach to the thoracic and lumbar spine. Transverse connectors are available in various sizes to attach to the two parallel rods. Associated instrumentation to complete the procedure is provided non-sterile.
Indications for Use
The Hubble I System is indicated for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (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, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.
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PREDICATES
Hubble I System is substantially equivalent to the Mont Blanc Spinal System (K150185) and is provided sterile as was cleared in Mont Blanc Spinal System (K161387). The Hubble I System also includes bullet shaped rods, pre-bent rods and cobalt-chrome rods cleared in Mont Blanc Spinal System (K161387). The subject and predicate devices have identical technological characteristics. Specifically, the following characteristics are identical between the subject and predicates:
- . Indications for Use (identical to Primary)
- Materials of manufacture (identical to Primary and Additional)
- . Structural support mechanism (identical to Primary and Additional)
| 510k
| Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K150185 | Mont Blanc Spinal System | Spineway | Primary |
| K161387 | Mont Blanc Spinal System | Spineway | Additional |
Table 5-1 Predicate Devices
PERFORMANCE TESTING
Orbbo, LLC. Hubble I System was evaluated to demonstrate equivalence to the predicate devices. Mechanical testing was performed for the predicate devices, which characterized the mechanical performance and fatigue endurance to show the original performance requirements for Static Compression Bend, Static Torsion and Dynamic Compression Bend per ASTM F1717-13. As there are no changes in design or materials or manufacturing processes, no new performance testing was required. No clinical or animal studies were performed.
Conclusion
Orbbo concludes that the Hubble I System is substantially equivalent to the predicates in regard to indications for use, materials, function, sizes and mechanical test results and raises no new questions of safety or effectiveness.