(106 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the intervertebral body fusion device, with no mention of AI or ML technologies.
Yes.
The device is an intervertebral body fusion device indicated for use in patients with degenerative disc disease, which is a medical condition requiring treatment.
No
This device is an intervertebral body fusion device (an implant) used for treatment, not for diagnosis.
No
The device description clearly details a physical implant made of PEEK and titanium, intended for surgical implantation. It also describes mechanical testing of the physical device.
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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Stryker Spine Aero™-LL is an implantable medical device designed for intervertebral body fusion in the spine. It is surgically placed within the body to treat degenerative disc disease.
- Lack of Specimen Analysis: The description and intended use do not involve the analysis of any biological specimens taken from the patient.
Therefore, the Stryker Spine Aero™-LL falls under the category of a surgical implant rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker Spine Aero™-LL is an intervertebral body fusion device indicated for use with autogenous bone graft 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The Aero™-LL Lumbar Cage System is to be implanted via a lateral approach.
The Aero™-LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX
Device Description
The AeroTM-LL Cage is a hollow, bullet-shaped PEEK Optima cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The PEEK Optima cage portion consists of two closed pockets for graft containment and has serrations on the superior and inferior surfaces of the cage. The implant is designed to be used either with or without the internal supplemental fixation provided (AeroTM-LL Fixation Anchors) in addition to supplemental fixation systems cleared for use in the lumbosacral spine. The AeroTM-LL Fixation Anchors are constructed from titanium alloy (Ti 6Al-4V) and feature rails that mate with dovetail channels located within the AeroTM-LL PEEK cage. Once fully seated into the channels, the anchors are designed to lock into the titanium jacket.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar and sacral spine)
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)
Testing in compliance with FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the AeroTM-LL Lateral Lumbar Cage System and demonstrated substantially equivalent performance to the identified predicate device systems. The following mechanical tests were performed:
• Static Compression (per ASTM F2077)
• Dynamic Compression (per ASTM F2077)
• Static Compression Shear (per ASTM F2077)
• Dynamic Compression Shear (per ASTM F2077)
• Static Torsion (per ASTM F2077)
• Dynamic Torsion (per ASTM F2077)
• Expulsion (per ASTM F04-25-02-02 Draft)
• Subsidence (per ASTM F2267)
• Wear Debris Assessment
• Dynamic Cadaver Testing involving the implantation of the AeroTM-LL device into multiple functional spinal units and subsequent evaluation of fatigue performance under multiple loading modes.
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.
K082014, K133328, K120869, K113285, K131276
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2014
Stryker Spine Mr. Alan Traettino Senior Director, Regulatory and Clinical Affairs 2 Pearl Court Allendale, New Jersey 07401
Re: K142066
Trade/Device Name: Aero™-LL Lumbar Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: October 20, 2014 Received: October 21, 2014
Dear Mr. Traettino:
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 - Mr. Alan Traettino
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" (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/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
2
Indications for Use
510(k) Number (if known) K142066
Device Name Aero™-LL Lumbar Cage System
Indications for Use (Describe)
The Stryker Spine Aero™-LL is an intervertebral body fusion device indicated for use with autogenous bone graff 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. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.
The Aero™-LL Lumbar Cage System is to be implanted via a lateral approach.
The Aero™-LL Lumbar Cage System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g., posterior pedicle screw and rod systems). In addition, the device may be used with or without the included fixation anchors.
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)
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| 510(k) Summary: AeroTM-LL Lumbar Cage System | |
|---|---|
| Submitter: | Stryker Spine |
| 2 Pearl Court | |
| Allendale, New Jersey 07401 | |
| Contact Person | Alan Traettino |
| Senior Director, Regulatory and Clinical Affairs | |
| Phone: 201-760-8109 | |
| Fax: 201-962-4109 | |
| Email: alan.traettino@stryker.com | |
| Date Prepared | October 20, 2014 |
| Trade Name | AeroTM-LL Lumbar Cage System |
| Proposed Class | Class II |
| Classification Name | |
| and Number | Intervertebral body fusion device, 21 CFR 888.3080 |
| Product Code | OVD, MAX |
| Predicate Devices | The AeroTM-LL Lumbar Cage System was shown to be |
| substantially equivalent to the devices listed below: | |
| Primary Predicate Device: | |
| Stryker Spine AVS PL (K082014) | |
| Additional Predicate Devices: | |
| Stryker Spine AeroTM-AL Lumbar Cage System (K133328) | |
| Stryker Spine AVS Anchor-L (K120869) | |
| LDR Spine Avenue L (K113285) | |
| Depuy Synthes SYNFIX Lateral Spacer (K131276) | |
| Device Description | The AeroTM-LL Cage is a hollow, bullet-shaped PEEK Optima |
| cage surrounded by a titanium alloy (Ti-6Al-4V) jacket. The | |
| PEEK Optima cage portion consists of two closed pockets for | |
| graft containment and has serrations on the superior and inferior | |
| surfaces of the cage. The implant is designed to be used either | |
| with or without the internal supplemental fixation provided | |
| (AeroTM-LL Fixation Anchors) in addition to supplemental | |
| fixation systems cleared for use in the lumbosacral spine. The | |
| AeroTM-LL Fixation Anchors are constructed from titanium alloy | |
| (Ti 6Al-4V) and feature rails that mate with dovetail channels | |
| located within the AeroTM-LL PEEK cage. Once fully seated | |
| into the channels, the anchors are designed to lock into the | |
| titanium jacket. | |
| Intended Use and | |
| Indications for Use | The Stryker Spine AeroTM-LL is an intervertebral body fusion |
| device indicated for use with autogenous bone graft 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. The DDD patients may also have up to Grade I
spondylolisthesis at the involved level(s). These patients should |
| 510(k) Summary: AeroTM-LL Lumbar Cage System | |
| | be skeletally mature and have six months of nonoperative
therapy. |
| | The AeroTM-LL Lumbar Cage System is to be implanted via a
lateral approach. |
| | The AeroTM-LL Lumbar Cage System is intended to be used
with supplemental spinal fixation systems that have been cleared
for use in the lumbosacral spine (e.g., posterior pedicle screw
and rod systems). In addition, the device may be used with or
without the included fixation anchors. |
| Summary of the
Technological
Characteristics | The subject AeroTM-LL Lumbar Cage System and the predicates
share similar design features:
• Graft windows for packing autogenous bone
• Serrations on the superior and inferior surfaces
• Comparable heights, widths, depths, and lordotic angles |
| Summary of
Non-Clinical Testing | Testing in compliance with FDA's June 12, 2007 "Class II
Special Controls Guidance Document: Intervertebral Body
Fusion Device" was performed for the AeroTM-LL Lateral
Lumbar Cage System and demonstrated substantially equivalent
performance to the identified predicate device systems.
The following mechanical tests were performed:
• Static Compression (per ASTM F2077)
• Dynamic Compression (per ASTM F2077)
• Static Compression Shear (per ASTM F2077)
• Dynamic Compression Shear (per ASTM F2077)
• Static Torsion (per ASTM F2077)
• Dynamic Torsion (per ASTM F2077)
• Expulsion (per ASTM F04-25-02-02 Draft)
• Subsidence (per ASTM F2267)
• Wear Debris Assessment
• Dynamic Cadaver Testing involving the implantation of the
AeroTM-LL device into multiple functional spinal units and
subsequent evaluation of fatigue performance under multiple
loading modes. |
| Conclusion | Based upon a comparison of intended use, technological
characteristics, and device performance in the non-clinical
testing listed above, the AeroTM-LL Lateral Lumbar Cage
System has demonstrated substantial equivalence to the
identified predicate device systems. |
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