(143 days)
Not Found
No
The summary describes a standard intervertebral body fusion system with various material and size options, along with associated instruments. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities. The performance studies are standard mechanical and material tests for spinal implants.
Yes.
The device is indicated for spinal fusion procedures to treat degenerative disc disease, which involves a medical intervention to address a pathological condition.
No
The device, the Battalion System, is an intervertebral body fusion system used in spinal fusion procedures. Its description clearly defines it as an implantable device to aid in fusion, not to diagnose a condition. While it treats degenerative disc disease (DDD) which is confirmed by "patient history and radiographic studies," the device itself is a treatment, not a diagnostic tool.
No
The device description explicitly details physical implants made of various materials (PEEK, titanium, tantalum) and surgical instruments made of stainless steel. This indicates a hardware-based medical device, not a software-only one.
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 Battalion System is an implantable device used in spinal fusion surgery. It is surgically placed within the body to provide structural support and facilitate bone growth. Its intended use is for treating degenerative disc disease in the lumbar spine.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens taken from the patient.
Therefore, the Battalion System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Battalion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as discogenic spinal pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have had at least six months of non-operative treatment. Lumbar DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The Battalion System is to be used with autogenous bone graft and supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are available in three material varieties: Polyetheretherketone with tantalum markers, commercially pure titanium coated polyetheretherketone with tantalum markers, and titanium alloy. All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580, and the titanium alloy (Ti-6Al-4V ELI) conforms to ASTM F136. All implants are provided sterile.
As an accessory, this system includes inserter instruments used to set the implants between the vertebrae. The patient contacting portions of all of these instruments are made of surgical grade stainless steel (17Cr-4Ni ) per ASTM A564/A564M. These instruments are provided non-sterile and are intended to be cleaned and steam sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical tests support the substantial equivalence determination as discussed in Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.
Static and dynamic axial compression per ASTM F2077-11
Static and dynamic torsion per ASTM F2077-11
Static and dynamic Shear per ASTM 2077-11
Subsidence Analysis per ASTM F2267-04
Coating Characterization testing was performed using coupons
Static Shear per ASTM F1044-05
Dynamic Shear per ASTM F1160-05
Static Tension per ASTM F1147-05
Abrasion per ASTM F1978-00
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 22, 2015
Alphatec Spine, Incorporated Ms. Nadine Smith Senior Specialist, Regulatory Affairs 5818 El Camino Real Carlsbad, California 92008
Re: K143740
Trade/Device Name: Battalion Universal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 24, 2015 Received: April 27, 2015
Dear Ms. Smith:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Nadine Smith
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 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/Resourcesfor You/Industry/default.htm. 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 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 vours.
Lori A. Wiggins -S
for
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
510(k) Number (if known) K143740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
| K143740 |
|---|
| --------- |
| Page | 1 of 2 |
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| ------ | -------- |
Device Name
Battalion Universal Spacer System
Indications for Use (Describe)
The Battalion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as discogenic spinal pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients should have had at least six months of non-operative treatment. Lumbar DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The Battalion System is to be used with autogenous bone graft and supplemental fixation.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 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)
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K143740 Page 2 of 2
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/0 description: The image shows the logo for Alphatec Spine. The word "Alphatec" is written in a dark blue, sans-serif font, with the "alpha" symbol in place of the letter "A". The word "Spine" is written in a light gray, sans-serif font. The logo is simple and modern, and it conveys a sense of professionalism and expertise.
510(k) Summary
I. SUBMITTER
Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 Phone: (760) 494-6951 Fax: (760) 431-0289
| Contact Person: | Nadine Smith |
|---|---|
| Date Prepared: | April 22, 2015 |
II. DEVICE
| Name of Device: | Battalion Universal Spacer System |
|---|---|
| Common or Usual Name: | Spinal Spacer System |
| Classification Name: | Intervertebral body fusion device (21 CFR 888.3080) |
| Regulatory Class: | II |
| Product Code: | MAX |
III. PREDICATE DEVICE(S)
Novel® Spinal Spacer System, K080699 (primary predicate) Lucent® and Lucent Magnum®, K110632 (additional predicate)
IV. DEVICE DESCRIPTION
The Battalion Universal Spacer System is an intervertebral body fusion system. The implants consist of various lengths, widths, heights and degrees of lordosis to accommodate individual patient anatomy. These implants are available in three material varieties: Polyetheretherketone with tantalum markers, commercially pure titanium coated polyetheretherketone with tantalum markers, and titanium alloy. All materials are of surgical grade; polyetheretherketone (PEEK Optima LT1) conforms to ASTM F2026, tantalum conforms to ASTM F560, titanium coating conforms to ASTM F1580, and the titanium alloy (Ti-6Al-4V ELI) conforms to ASTM F136. All implants are provided sterile.
As an accessory, this system includes inserter instruments used to set the implants between the vertebrae. The patient contacting portions of all of these instruments are made of surgical grade stainless steel (17Cr-4Ni ) per ASTM A564/A564M. These instruments are provided non-sterile and are intended to be cleaned and steam sterilized before use.
5
Image /page/5/Picture/0 description: The image shows the logo for Alphatec Spine. The word "Alphatec" is written in a stylized font, with the "Alpha" portion in blue and the "tec" portion in gray. The word "Spine" is written in gray to the right of "Alphatec". The logo is simple and modern, and it is likely used to represent the company's brand.
INDICATIONS FOR USE V.
The Battalion System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as discogenic spinal pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients should have had at least six months of non-operative treatment. Lumbar DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Battalion System is to be used with autogenous bone graft and supplemental fixation.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISICS VI.
The technological characteristics of the Battalion implants are substantially equivalent to both predicates in that they are hollow rectangular boxes intended for spinal fixation. Testing demonstrated that the performance capabilities of the Battalion System are substantially equivalent to that of the previously cleared Novel System in K080699. Additionally, the material composition of the PEEK and the Titanium Alloy is substantially equivalent to the Novel System. The material compositions of the Titanium coated PEEK is substantially equivalent to the Lucent and Lucent Magnum in K110632.
VII. PERFORMANCE DATA
The following non-clinical tests support the substantial equivalence determination as discussed in Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.
Static and dynamic axial compression per ASTM F2077-11 Static and dynamic torsion per ASTM F2077-11 Static and dynamic Shear per ASTM 2077-11 Subsidence Analysis per ASTM F2267-04
Coating Characterization testing was performed using coupons
Static Shear per ASTM F1044-05 Dynamic Shear per ASTM F1160-05 Static Tension per ASTM F1147-05 Abrasion per ASTM F1978-00
VIII. CONCLUSION
The above characteristics and non-clinical tests support the substantial equivalence of the Battalion System to the legally marketed predicates.