(65 days)
Not Found
No
The summary describes a mechanical intervertebral body fusion device and its associated instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is used for intervertebral body fusion to treat degenerative disc disease, which is a therapeutic intervention.
No
The device is an expandable interbody fusion cage used for spinal fusion, not for diagnosing medical conditions. Its purpose is therapeutic, not diagnostic.
No
The device description clearly outlines a physical implant (cage) made of titanium alloy, stainless steel, and silicone rubber, along with associated physical instruments for insertion and expansion. There is no mention of software as the primary or sole component of the device.
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, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the AccuLIF TL and PL Cage is an implantable device used for intervertebral body fusion in patients with degenerative disc disease. It is a physical device inserted into the body during surgery.
- Lack of Diagnostic Function: The device's function is structural support and promoting bone fusion, not analyzing biological samples for diagnostic purposes.
- No Mention of Samples or Testing: The description does not mention any interaction with biological samples or performing any kind of diagnostic test.
Therefore, the AccuLIF TL and PL Cage is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intervertebral Body Fusion Device: The 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 AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autogenous bone graft.
Product codes
MAX
Device Description
The AccuLIF® TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6AI4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F 138-08, 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 l 1mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x 22mm and 11mm x 25mm for the straight shape. Also the TL crescent shape comes in an 8 degree lordotic model as well as a 0 degree model for a total of 18 TL and PL 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.
The AccuLIF TL and PL Cage system comprises a packaged sterile AccuLIF implant, an instrument tray, and a packaged sterile Unlock Tubing Assembly. Within the TL or PL instrument trays are an inserter, pressure syringe, slap hammer, graft insertion cannula, graft insertion pusher, bone graft block, and TL or PL distractor trials. Additional instruments supplement the instrument trays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (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)
Design verification testing was conducted to assess the instrument modifications. Specifically, the AccuLIF Pressure Syringe was tested after 20 cycles of simulated cleaning, sterilization and insertion/withdrawal impact, to verify that the modifications to the instrument did not adversely affect the intended function of the device. Specifically, the instrument and o-rings were observed for damage and the pressure delivered by the instrument was examined to ensure the appropriate pressure continues to be delivered to the AccuLIF TL or PL Cage. Modifications to the AccuLIF Pressure Syringe have been verified to meet the design input requirements and showed no signs of deterioration or malfunction after 20 simulated cleanings, sterilizations and uses. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicate device.
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.
AccuLIF TL and PL Cage (K132505)
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: AccuLIF® TL and PL Cage | ||
|---|---|---|
| Stryker Spine | ||
| Submitter: | 2 Pearl Court | |
| Allendale, New Jersey 07401 | ||
| Kristen Meany, MS, CQA, RAC | ||
| Project Manager, Regulatory Affairs | ||
| Contact Person | Phone: 201-760-8070 | |
| Fax: 201-962-4070 | ||
| Email: kristen.meany@stryker.com | ||
| Date Prepared | June 18, 2014 | |
| Trade Name | AccuLIF® TL and PL Cage | |
| Common Name | Lumbar Interbody Device | |
| Proposed Class | Class II | |
| Classification Name | Intervertebral body fixation device | |
| and Number | 21 CFR § 888.3080 | |
| Product Code | MAX | |
| Predicate Devices | AccuLIF TL and PL Cage (K132505) | |
| Device Description | The AccuLIF® TL and PL Cage device is an expandable interbody | |
| fusion cage manufactured from implant grade Titanium alloy (TI6AI4V | ||
| ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM | ||
| F 138-08, 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 | ||
| l 1mm x 25mm and 13mm x 25mm for the crescent shape and 11mm x | ||
| 22mm and 11mm x 25mm for the straight shape. Also the TL crescent | ||
| shape comes in an 8 degree lordotic model as well as a 0 degree model | ||
| for a total of 18 TL and PL 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. | ||
| The AccuLIF TL and PL Cage system comprises a packaged sterile | ||
| AccuLIF implant, an instrument tray, and a packaged sterile Unlock | ||
| Tubing Assembly. Within the TL or PL instrument trays are an inserter, | ||
| pressure syringe, slap hammer, graft insertion cannula, graft insertion | ||
| pusher, bone graft block, and TL or PL distractor trials. Additional |
:
1
.
| 510(k) Summary: AccuLIF® TL and PL Cage
| instruments supplement the instrument trays. | |
|---|---|
| Intended Use | Intervertebral Body Fusion Device: The 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 AccuLIF TL and PL Cages are always to be | |
| used with supplemental internal spinal fixation. Additionally, the | |
| AccuLIF TL and PL Cages are to be used with autogenous bone graft. | |
| Summary of the | |
| Technological | |
| Characteristics | The purpose of this 510(k) is to introduce modifications to the |
| AccuLIF Pressure Syringe. There have been no changes to the | |
| AccuLIF TL and PL Cage implants as a result of the proposed | |
| modifications to the AccuLIF Pressure Syringe. The AccuLIF TL and | |
| PL Cage and the predicate device are both expandable, have similar | |
| design features, are both used in the anterior column of the spine, and | |
| both use Titanium alloy as the main device material. | |
| The modified AccuLIF Pressure Syringe continues to function as the | |
| predicate AccuLIF Pressure Syringe - to pressure saline in order to | |
| expand the AccuLIF TL and PL Cage implants. Although there are | |
| minor differences between the modified device and its predicate | |
| device, namely the changes being made to the AccuLIF Pressure | |
| Syringe, those differences do not raise new questions of safety or | |
| efficacy. | |
| Summary of the | |
| Performance Data | Design verification testing was conducted to assess the instrument |
| modifications. Specifically, the AccuLIF Pressure Syringe was tested | |
| after 20 cycles of simulated cleaning, sterilization and | |
| insertion/withdrawal impact, to verify that the modifications to the | |
| instrument did not adversely affect the intended function of the device. | |
| Specifically, the instrument and o-rings were observed for damage and | |
| the pressure delivered by the instrument was examined to ensure the | |
| appropriate pressure continues to be delivered to the AccuLIF TL or PL | |
| Cage. Modifications to the AccuLIF Pressure Syringe have been verified | |
| to meet the design input requirements and showed no signs of | |
| deterioration or malfunction after 20 simulated cleanings, sterilizations | |
| and uses. The non-clinical test results demonstrate that any minor | |
| differences do not impact device performance as compared to the | |
| predicate device. | |
| 510(k) Summary: AccuLIF® TL and PL Cage | |
| Conclusions | The modified accessory to the AccuLIF TL and PL Cage has identical |
| indications, technological characteristics, and principles of operation as | |
| its predicate. The non-clinical test results demonstrate that any minor | |
| differences do not impact device performance as compared to the | |
| predicate. Thus, the modified device was shown to be substantially | |
| equivalent to the AccuLIF TL and PL Cage (K132505). |
. . . . .
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2
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 16, 2014
Stryker Spine Kristen Meany, MS, CQA, RAC Project Manager, Regulatory Affairs 2 Pearl Court Allendale, New Jersey 07401
Re: K141217
Trade/Device Name: AccuLIF® TL and PL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 18, 2014 Received: June 19, 2014
Dear Ms. Meany:
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 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.
4
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" (21 CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141217
Device Name AccuLIF(R) TL and PL Cage
Indications for Use (Describe)
Intervertebral Body Fusion Device: The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at onc level or two continuous 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 spondvlolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
The AccuLIF TL and PL Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF TL and PL Cages are to be used with autogenous bone graft.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 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)
Anton E. Dmitriev, PhD
Division of Orthopedic Devices
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