(76 days)
The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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 at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
The AccuLIF TL and PL Cage device is an expandable interbody fusion cage manufactured from implant grade Titanium alloy (TI6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, and Silicone Rubber (MED-4870). As with the predicate expandable AccuLIF TL and PL Cage devices, 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 arrangements using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device automatically locks at 1mm increments as it expands. The AccuLIF TL and PL Cage come in a variety of sizes, shapes, and lordotic angles to accommodate patient anatomy.
The AccuLIF TL and PL Cage system comprises a packaged sterile AccuLIF implant, an instrument tray, and a packaged sterile 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.
The provided text is a 510(k) summary for the Stryker AccuLIF® TL and PL Cage, an intervertebral body fusion device. This type of regulatory document focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a detailed clinical study demonstrating device performance against specific acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for studies of the device itself.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
Instead, the document highlights that:
- The device is substantially equivalent to predicate devices (Stryker Spine, ACCULIF® TL and PL Cage K143163, and Medtronic, Capstone Spinal System, K123027) based on material, design, mechanical performance, and indications.
- The primary change in this submission is the expansion of indications to include degenerative scoliosis.
- Published clinical data for lumbar interbody fusion devices similar to the Stryker Spine AccuLIF TL and PL devices was provided in support of this application. This is the closest the document comes to mentioning performance data. It states that "The published clinical outcomes demonstrated that the use of the lumbar interbody fusion procedures to treat patients diagnosed with degenerative scoliosis above does not adversely affect performance of the system and does not represent a new worst case scenario."
- No changes were made to the existing devices, and therefore no additional implant testing was required or performed for this specific 510(k) submission.
In summary, the provided text describes a regulatory submission establishing substantial equivalence, not a study designed to prove the device meets specific acceptance criteria with detailed performance metrics.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2015
Stryker Corporation Mr. Aakash Jain Regulatory Affairs Specialist 2 Pearl Court Allendale, New Jersey 07401
Re: K143616
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: December 18, 2014 Received: December 19, 2014
Dear Mr. Jain:
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
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Page 2 - Mr. Aakash Jain
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.
Mark N. Melkerson -S
Mark N. Melkerson Director, Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K143616
Device Name AccuLIF® TL and PL Cage
Indications for Use (Describe)
The AccuLIF TL and PL Cages are indicated for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion 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 at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the AccuLIF TL and PL Cages can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Stryker Spine AccuLIF® TL and PL Cage 510(k) Summary | |
|---|---|
| Submitter | Stryker Spine2 Pearl CourtAllendale, NJ 07401 |
| Contact Person | Aakash JainRegulatory Affairs SpecialistPhone: 201-760-8074Fax: 201-962-4074E-mail: aakash.jain@stryker.com |
| Date Prepared | March 3, 2015 |
| Trade Name | AccuLIF® TL and PL Cage |
| Common Name | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Proposed Class | Class II |
| Additional Classification | |
| Codification | 21 CFR § 888.3080 |
| Name | Intervertebral body fusion device |
| Product Codes | MAX |
| Predicate Devices | The AccuLIF® TL and PL Cage was shown to be substantially equivalentto the device listed below:• Primary Predicate: Stryker Spine, ACCULIF® TL and PL Cage K143163• Additional Predicate: Medtronic, Capstone Spinal System, K123027 |
| Device Description | The AccuLIF TL and PL Cage device is an expandable interbody fusioncage manufactured from implant grade Titanium alloy (TI6Al4V ELI) asper ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, andSilicone Rubber (MED-4870). As with the predicate expandable AccuLIFTL and PL Cage devices, the device is inserted in unexpanded statewith a delivery handle and expanded in-situ to the required height via 2hydraulic cylinder and piston arrangements using a hydraulic systemcomprising disposable flexible expansion tubing set and inflationsyringe. The device automatically locks at 1mm increments as itexpands. The AccuLIF TL and PL Cage come in a variety of sizes, shapes,and lordotic angles to accommodate patient anatomy.The AccuLIF TL and PL Cage system comprises a packaged sterileAccuLIF implant, an instrument tray, and a packaged sterile TubingAssembly. Within the TL or PL instrument trays are an inserter, pressuresyringe, slap hammer, graft insertion cannula, graft insertion pusher,bone graft block, and TL or PL distractor trials. Additional instrumentssupplement the instrument trays. |
| Indications for Use | The AccuLIF TL and PL Cages are indicated for intervertebral bodyfusion with autograft and/or allogenic bone graft comprised ofcancellous and/or corticocancellous bone graft when the subject |
| device is used as an adjunct to fusion in patients with degenerative discdisease (DDD) at one level or two contiguous levels from L2 to $1. DDD isdefined as back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies. These DDD patients mayalso have up to Grade I spondylolisthesis or retrolisthesis at the involvedlevel(s). These patients should be skeletally mature and havecompleted six months of non-operative treatment.Additionally, the AccuLIF TL and PL Cages can be used as an adjunctto fusion in patients diagnosed with degenerative scoliosis. | |
| The AccuLIF TL and PL Cages are always to be used with supplementalinternal spinal fixation. Additionally, the AccuLIF TL and PL Cages are tobe used with autograft and/or allogenic bone graft comprised ofcancellous and/or corticocancellous bone graft when the subjectdevice is used as an adjunct to fusion. | |
| Summary of | The subject AccuLIF® TL and PL Cage and the predicate devices were |
| Technological | shown to be substantially equivalent based on material, design, and |
| Characteristics | mechanical performance and indications. |
| Summary of thePerformance Data | Published clinical data for lumbar interbody fusion devices similar to theStryker Spine AccuLIF TL and PL devices that are the subject of thissubmission was provided in support of this application. The publishedclinical outcomes demonstrated that the use of the lumbar interbodyfusion procedures to treat patients diagnosed with degenerativescoliosis above does not adversely affect performance of the systemand does not represent a new worst case scenario. No changes weremade to the existing devices; therefore, no additional implant testingwas required or performed. |
| Conclusion | The design features, materials used, manufacturing, and sterilizationmethods are identical to the previously cleared ACCULIF® TL and PLCage with the exception of expanding the indications to include thedegenerative scoliosis. The additional indication is identical toMedtronic Capstone Spinal System. Based on information provided, thesubject device has been determined to be substantially equivalent tothe predicate devices. |
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§ 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.