(289 days)
Not Found
No
The summary describes a physical implant device made of PEEK Optima for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is described as an "Intervertebral Body Fusion Device" intended for "intervertebral body fusion of the spine" in patients with "degenerative disc disease (DDD)", which falls under the definition of a therapeutic device designed to treat a medical condition.
No
The device description indicates it is a "spinal intervertebral body fusion device" used for fusion, not for diagnosing conditions.
No
The device description clearly states it is a "spinal intervertebral body fusion device" comprised of PEEK Optima®, indicating it is a physical implant, not software.
Based on the provided information, 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 Description and Intended Use: The S-LIF™ Intervertebral Body Fusion Device is a physical implant designed to be surgically placed in the spine to facilitate bone fusion. It is a medical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the S-LIF™ Intervertebral Body Fusion Device falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The S-LIF™ Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The SpineFrontier S-LIF™ Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The S-LIFTM Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of body fusion donoo intents, using autogenous bone graft to facilitate fusion. Skeletally mature pationto, asing autogenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. The system is (DDD) at one of two of two of PEEK Optima®, with a fixed width and various comprised of dovious fiace of a vide of a wide variety of patients. lengins and heights to in the analoms on the superior and inferior surfaces that will resist device movement following implant
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal levels 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)
Mechanical test comparisons were conducted per the following standard test methods:
- ASTM F2077-03, Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression
- ASTM F2267-04, Subsidence Under Static Axial Compression -
- ASTM Draft Standard F-04.25.02.02, Static Expulsion -
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
§ 888.3080 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.
0
JUN 3 0 2010
, l
510(k) Summary 5.0
1. Sponsor
SpineFrontier, Inc. 500 Cummings Center Suite 3500 Beverly, MA 01915
| Primary Contact: | John Sullivan |
|---|---|
| Telephone: | 1- 978-232-3990 |
May 29, 2009 Date Prepared:
2. Device Name and Classification:
| Proprietary Name: | S-LIF™ Intervertebral Body Fusion Device,
S-LIF™ IBC, S-LIF™ IBF |
|----------------------|--------------------------------------------------------------------------------------|
| Common/Usual Name: | Intervertebral Fusion Device With Bone Graft,
Lumbar |
| Classification Name: | Intervertebral Fusion Device With Bone Graft,
Lumbar, (21 CFR 888.3080), Class II |
| Product Code: | MAX |
3. Predicate Devices
K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K071795 - Nuvasive CoRoent System K072791 - Synthes Spine Oracle Spacer
4. Device Description
The S-LIFTM Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of body fusion donoo intents, using autogenous bone graft to facilitate fusion. Skeletally mature pationto, asing autogenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. The system is (DDD) at one of two of two of PEEK Optima®, with a fixed width and various comprised of dovious fiace of a vide of a wide variety of patients. lengins and heights to in the analoms on the superior and inferior surfaces that will resist device movement following implant
SpineFrontier, Inc. S-LIF' Intervertebral Body Fusion Device - Abbreviated 510(k) June 28, 2010
1
5. Intended Use
The S-LIFTM Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The SpineFrontier S-LIF™ Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
6. Technological Characteristics
The SpineFrontier S-LIF™ Intervertebral Body Fusion Device was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials.
7. Basis for Substantial Equivalence
The S-LIF™ Intervertebral Body Fusion Device was evaluated in accordance with FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007, and has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use, function, materials, and performance (mechanical testing). Inunical data was not required for this device. Mechanical test comparisons were conducted per the following standard test methods:
- ASTM F2077-03, Static and Dynamic Axial Compression, Static Torsion, and Static and Dynamic Shear Compression
- ASTM F2267-04, Subsidence Under Static Axial Compression -
- ASTM Draft Standard F-04.25.02.02, Static Expulsion -
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 3 0 2010
SpineFrontier, Inc. % Mr. John Sullivan 500 Cummings Center Beverly, Massachusetts 01915
Re: K092815
Trade/Device Name: S-LIF™ Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 21, 2010 Received: June 21, 2010
Dear Mr. Sullivan:
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
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Page 2 - Mr. John Sullivan
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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
sincerely yours,
Mark A. Milkeron
Mark N. Melkerson 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 Statement 4.0
510(k) Number (if Known):
Indications For Use:
The S-LIF™ Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The SpineFrontier S-LIF™ Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (Part 21 CFR 807 Subpart C)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092815