(225 days)
Not Found
No
The document describes a physical spinal implant and surgical system, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an intervertebral body fusion device intended for spinal fusion procedures in patients with degenerative disc disease, which falls under the definition of a therapeutic device designed to treat a medical condition.
No.
This device is an intervertebral body fusion device intended for spinal fusion procedures, used with autogenous bone graft and screws to anchor the implant to adjacent vertebrae. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is comprised of physical implants made from PEEK and titanium alloy, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion procedures. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The description details a physical implant made of PEEK and titanium, designed to be surgically placed between vertebrae.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is a therapeutic implant used to treat a structural problem in the spine.
N/A
Intended Use / Indications for Use
The Life Spine Stand-Alone Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft.
The Life Spine Stand-Alone Spacer System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.
Product codes
MAX, OVD
Device Description
The Life Spine Stand-Alone Spacer System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. The spacers are hollow to permit packing with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/or migration. Additionally, the implants incorporate a titanium alloy (6AL-4V-ELI per ASTM F-136) anterior fixation plate which has integrated screw holes to allow for placement of four titanium alloy screws that anchor the implant to the adjacent vertebrae. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomicial conditions of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K080411, K081849, K072253, K081395, K073109
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.
0
Image /page/0/Picture/0 description: The image shows the logo for Life Spine. The text is in a bold, sans-serif font and is black. There is a curved line underneath the word "Spine".
lifespine.com
510(k) Summary * LIFE SPINE® Stand-Alone Spacer System
Submitted By:
Life Spine, Inc. 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118
510(k) Contact:
Michael S. Butler Life Spine, Inc. 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118
LIFE SPINE® Stand-Alone Spacer System
Intervertebral Body Fusion Device
DEC 1 5 2009
Date Prepared:
May 1, 2009
Trade Name:
Common Name:
Class II
Product Code:
Classification:
MAX - Intervertebral Fusion Device with Bone Graft, Lumbar 21 CFR 888.3080 - Intervertebral Body Fusion Device
Predicate Devices:
Life Spine Plateau® Spacer System (K080411) Blackstone PILLAR™ SA PEEK Spacer System (K081849) Synthes SynFix "-LR (K072253) Biomet Solitaire™ PEEK-Optima® (K081395) Surgicraft STALIF™ TT (K073109)
Device Description:
The Life Spine Stand-Alone Spacer System implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Polyetheretherketone (PEEK-OPTIMA LT1) with tantalum markers. The spacers are hollow to permit packing with bone graft to help promote intervertebral body fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/or migration. Additionally, the implants incorporate a titanium alloy (6AL-4V-ELI per ASTM F-136) anterior fixation plate which has integrated screw holes to allow for placement of four titanium alloy screws that anchor the implant to the adjacent vertebrae. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomicial conditions of the patient.
1
Image /page/1/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. There is a curved line underneath the words, which may represent a spine. The logo is simple and modern.
Page 2 KO91301 401 W. Hassell Boad fran Estates, IL 60169 0847.884.6117 847.884.6118 ww.lifespine.com
Intended Use of the Device:
The Life Spine Stand-Alone Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft.
The Life Spine Stand-Alone Spacer System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.
Substantial Equivalence:
The Life Spine Stand-Alone Spacer System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 2 2011
Life Spine, Inc. % Mr. Michael S. Butler President & CEO 2401 West Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169
- Re: K091301
Trade/Device Name: Life Spine Stand-Alone Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: November 24, 2009 Received: November 25, 2009
Dear Mr. Butler:
This letter corrects our substantially equivalent letter of December 15, 2009.
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 (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.
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
3
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/CDRHQffices/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.
Sincerely yours,
Mule A. Mulkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the words "Life Spine" in a stylized font. The letters are black and have a textured appearance. A small registered trademark symbol is located to the upper right of the word "Spine".
2401 W. Hassell Road Suite 1535 Hoffman Estates, IL 60169 p 847.884.6117 f 847.884.6118 www.lifespine.com
Indications for Use
510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: LIFE SPINE® Stand-Alone Spacer System
The Life Spine Stand-Alone Spacer System System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autogenous bone graft.
The Life Spine Stand-Alone Spacer System is intended for use with four titanium alloy screws which are provided with the system. If the physician chooses to use fewer than four of the provided screws, then a supplemental internal spinal fixation system that is cleared for use in the lumbosacral spine must be used.
Prescription Use x-(Part 21 CFR 801 Subpart D) And/Or
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
and a series and the control of the 2012 and 11:50 personal program and on the program and on
(Divisigh Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KO91301 510(k) Number_