(147 days)
Not Found
No
The summary describes a mechanical intervertebral body fusion device and its materials, without any mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for spinal fusion procedures to treat degenerative disc disease, which falls under therapeutic intervention.
No
The device is an intervertebral body fusion device used to stabilize spinal segments and promote fusion, not for diagnosing conditions.
No
The device description explicitly states the system consists of an implant manufactured from PEEK-Optima and insertion tools, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for spinal fusion procedures in skeletally mature patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device to stabilize the spine.
- Device Description: The device is an intervertebral body fusion device made of PEEK-Optima and titanium. It is designed to be implanted in the disc space.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the human body, or provide information about a physiological state.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Atlas Spine Pivoting System is a therapeutic device used in a surgical procedure.
N/A
Intended Use / Indications for Use
The Atlas Spine Pivoting System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Atlas Spine Pivoting System is to be used with a supplemental fixation system and autogenous bone graft.
Product codes
MAX
Device Description
The Atlas Spine Pivoting System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion.
The Atlas Spine Pivoting System consists of an implant manufactured from PEEK-Optima and insertion tools. The PEEK-Optima implant is crescent-shaped and radiolucent. The implant design includes three (3) radiopaque, tantalum markers, which allow postoperative radiographic confirmation of the device position and orientation. The design also includes two (2) titanium alloy pins which secure the implant to an insertion tool for placement and deployment. The Atlas Spine Pivoting System is provided in various configurations and heights; containing hollow core to receive bone autograft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal segments, L2-S1
Indicated Patient Age Range
skeletally mature patients
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)
Pre-clinical, mechanical testing was performed on the Atlas Spine Pivoting System. Testing consisted of static testing in a load to failure mode in axial compression; static testing in expulsion; static testing in subsidence; and dynamic axial compression testing to estimate the maximum run out load. Testing was performed in accordance with ASTM F-2077 and ASTM F-2267. Data have been submitted to characterize the performance of the Atlas Spine Pivoting System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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AUG 1 0 2010
1 1.1
510(k) SUMMARY
| Manufacturer:
Address: | Atlas Spine, Inc.
1555 Jupiter Park Drive, Suite # 4
Jupiter, FL 33458 |
|-----------------------------------|-----------------------------------------------------------------------------------------|
| Telephone:
Fax: | 561-741-1108
561-741-1870 |
| Official Correspondent:
Title: | Jeannette G. Dailey
Vice President Regulatory Affairs &
Quality Assurance |
| Telephone: | 561-354-4319 |
| Date Prepared: | June 4, 2010 |
| Device Classification: | Intervertebral body fusion device
Class II per 21 CFR §888.3080
Product Code: MAX |
| Trade/Proprietary Name: | Atlas Spine Pivoting System |
| Common Names: | Intervertebral Body Fusion Device [IBFD] |
| Predicate Device: | Novel® Spinal Spacer System
Alphatec Spinal, Inc.
K080699 |
| | Atlas Spine Spacer
Atlas Spine, Inc.
K091406 |
| | Pivotec Lumbar Interbody Fusion Device
Captiva Spine, Inc.
K092017 |
Device Description:
The Atlas Spine Pivoting System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion.
The Atlas Spine Pivoting System consists of an implant manufactured from PEEK-Optima and insertion tools. The PEEK-Optima implant is crescent-shaped and radiolucent. The implant design includes three (3) radiopaque, tantalum markers, which allow postoperative radiographic confirmation of the device position and orientation. The design also includes two (2) titanium alloy pins which secure the implant to an
1
insertion tool for placement and deployment. The Atlas Spine Pivoting System is provided in various configurations and heights; containing hollow core to receive bone autograft.
Intended Use:
The Atlas Spine Pivoting System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Atlas Spine Pivoting System is to be used with a supplemental fixation system and autogenous bone graft.
Performance Data
Pre-clinical, mechanical testing was performed on the Atlas Spine Pivoting System. Testing consisted of static testing in a load to failure mode in axial compression; static testing in expulsion; static testing in subsidence; and dynamic axial compression testing to estimate the maximum run out load. Testing was performed in accordance with ASTM F-2077 and ASTM F-2267. Data have been submitted to characterize the performance of the Atlas Spine Pivoting System.
Discussion of the Technological Characteristics
The intended use, design, materials and functional characteristics of the Atlas Spine Pivoting System and the predicate devices are substantially the same. The height, width, length and lordotic angles of the Atlas Spine Pivoting implant are within the ranges available for the predicate devices. The Atlas Spine Pivoting implant and the predicate devices consist of a single piece that is made from implantable PEEK polymer. The Atlas Spine Pivoting implant, the Novel Spinal Spacer and the Pivotec implant are similarly "crescent" shaped. Each system is intended to restore the biomechanical integrity of the anterior, middle and posterior spinal column. The Atlas Spine Pivoting implant and the predicate devices are placed within the area of removed or resected spine and are functionally complemented by supplemental fixation. Manipulation of the Atlas Spine Pivoting implant, the Novel Spinal Spacer and the Pivotec implant is achieved by a unique tool. The Atlas Spine Pivoting implant and the predicate devices are intended to be used with bone graft.
Conclusion
Provided documentation demonstrates that the Atlas Spine Pivoting System is substantially equivalent to the aforementioned predicate devices. This conclusion is g based on the devices' similarities in indications for use, design, function, materials and mechanical function.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Atlas Spine, Inc. % Ms. Jeannette G. Dailey Vice President Regulatory Affairs & Quality Assurance 1555 Jupiter Park Drive, Suite #4 Jupiter, Florida 33458
AUG1 0 2010
Re: K100743
Trade/Device Name: Atlas Spine Pivoting System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 26, 2010 Received: July 27, 2010
Dear Ms. Dailey:
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 misleding,
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 of edus in 1111111711 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 Ri gister.
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Page 2 - Ms. Jeannette G. Dailey
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Clarence Buekins
Mark N. Mel kerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
AUG 1 0 2010
Device Name: Atlas Spine Pivoting System
Indications for Use:
The Atlas Spine Pivoting System is indicated for spinial fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Atlas Spine Pivoting System is to be used with a supplemental fixation system and autogenous bone graft.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K100743 510(k) Number_
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(Posted November 13, 2003)