(39 days)
Not Found
No
The device description focuses on mechanical components and hydraulic expansion, with no mention of AI or ML. The performance studies are based on mechanical testing standards.
Yes
The device is indicated for intervertebral body fusion to treat degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
The device is an intervertebral body fusion cage, which is a therapeutic device designed to fuse vertebrae, not to diagnose a condition.
No
The device description clearly details a physical implantable device made of titanium alloy, stainless steel, and silicone rubber, along with a hydraulic expansion system. This is a hardware device, not software only.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is an "Intervertebral Body Fusion Device" and its intended use is for "intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease." This involves surgically implanting a device into the spine.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition through testing of bodily fluids or tissues.
This device is a surgical implant used for structural support and fusion in the spine, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL and PL Cage are indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1, DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
The CoAlign Innovations AccuLIF TL and PL Cage are always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL and PL Cage are to be used with autogenous bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The CoAlign Innovations AccuLIF® TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6A14V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with a delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands.
The AccuLIF TL and PL Cage comes in three sizes which are expandable from 6mm to 9mm, from 8mm to 12mm, and from 10mm to 16mm in 1mm increments . As well each size comes in two shapes, crescent and straight and each shape comes in two different footprints 11mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x 22mm and 11mm x 25mm for the straight shape or a total of 12 models. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1
Indicated Patient Age Range
Skeletally mature
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)
The following non-clinical tests were conducted:
- Dynamic compression testing, conducted in accordance with ASTM F2077-03
- Dynamic shear testing, conducted in accordance with ASTM F2077-03
- Static compression testing, conducted in accordance with ASTM F2077-03
- Static shear testing, conducted in accordance with ASTM F2077-03
- Static Subsidence testing, conducted in accordance with -ASTM F2267-04
- Static Expulsion testing, conducted in accordance with -ASTM Draft Standard F-04.25.02.02
- Surgical technique validation, conducted in the same manner as the predicate surgical technique validation.
The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The AccuLIF TL and PL Cages were shown to be substantially equivalent to the AccuLIF TL Cage (K121683, K113465) and SEC IBF Cage (K093669).
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
510(k) Summary
| Submitted By: | CoAlign Innovations
150 North Hill Drive, Suite 1
Brisbane, CA 94005 | JAN 1 4 2013 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Establishment
Registration Number: | 10030843 | |
| Contact Person:
(Submission Prepared by) | Justin Eggleton
Musculoskeletal Clinical & Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800 | |
| Date Prepared: | December 3, 2012 | |
| Device Trade Name: | AccuLIF® TL and PL Cage | |
| Manufacturer: | CoAlign Innovations, Inc.
150 North Hill Drive, Suite 1
Brisbane, CA 94005 | |
| Common Name: | Spinal intervertebral body fixation orthosis | |
| Classification: | 21 CFR §888.3080 | |
| Class: | II | |
| Product Code: | MAX | |
Device Description:
The CoAlign Innovations AccuLIF® TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6A14V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with a delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands.
The AccuLIF TL and PL Cage comes in three sizes which are expandable from 6mm to 9mm, from 8mm to 12mm, and from 10mm to 16mm in 1mm increments . As well each size comes in two shapes, crescent and straight and each shape comes in two different
1
footprints 11mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x 22mm and 11mm x 25mm for the straight shape or a total of 12 models. The device has fixation ridges on the top and bottom surface. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid.
Indications For Use:
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL and PL Cage are indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to $1, DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
The CoAlign Innovations AccuLIF TL and PL Cage are always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL and PL Cage are to be used with autogenous bone graft.
Identification of Predicates
AccuLIF TL Cage (K121683) -
AccuLIF TL Cage (K113465)
SEC IBF Cage (K093669) -
Summary of Technological Characteristics
AccuLIF TL and PL Cages are expandable spacers made from Titanium-6AL-4V ELI alloy that conforms to ASTM F136. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- Indications for Use -
- -Materials of manufacture
- Expansion mechanism -
- -Structural support mechanism
Discussion of Testing:
The following non-clinical tests were conducted:
- Dynamic compression testing, conducted in accordance with ASTM F2077-03
- -Dynamic shear testing, conducted in accordance with ASTM F2077-03
- Static compression testing, conducted in accordance with ASTM F2077-03
- Static shear testing, conducted in accordance with -ASTM F2077-03
2
- Static Subsidence testing, conducted in accordance with -ASTM F2267-04
- Static Expulsion testing, conducted in accordance with -ASTM Draft Standard F-04.25.02.02
- Surgical technique validation, conducted in the same manner as the predicate surgical technique validation.
Conclusions:
The subject and predicate devices share the same indications for use, design, function, and materials of manufacture. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The AccuLIF TL and PL Cages were shown to be substantially equivalent to the AccuLIF TL Cage (K121683, K113465) and SEC IBF Cage (K093669).
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Letter dated: January 14, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Coalign Innovations, Incorporated % Musculoskeletal Clinical Regulatory Advisors, LLC Mr. Justin Eggleton 1331 H Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K123752
Trade/Device Name: Acculif TL and PL cage Regulation Number: 21 CFR 888.3080 Regulation Name: Spinal intervertebral fusion cages Regulatory Class: Class II Product Code: MAX Dated: December 3, 2012 Received: December 6, 2012
Dear Mr. Eggleton:
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
4
Page 2 - Mr. Justin Eggleton
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.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
CoAlign Innovations AccuLIF TL Cage Special 510(k)
Indications for Use
510(k) Number (if known): K123752
Device Name: AccuLIF TL and PL Cage
Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
The CoAlign Innovations AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF TL and PL Cages are to be used with autogenous bone graft.
Prescription Use (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)
Colin Owleill
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123752