(108 days)
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for intervertebral body fusion in patients with degenerative disc disease, which involves treating a medical condition.
No
Explanation: The device is an implantable system (Lateral Cage System) for intervertebral body fusion, used to treat degenerative disc disease. Its purpose is therapeutic intervention, not diagnosis. The "Indications for Use" section mentions confirmation of DDD by "history and radiographic studies," but this refers to the diagnostic process performed on the patient prior to the device's use, not a function of the device itself.
No
The device description explicitly states that the Lateral Cage System consists of implants and manual surgical instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Lateral Cage System is an implantable device used for intervertebral body fusion. It is a physical device surgically placed within the body.
- Intended Use: The intended use describes a surgical procedure to treat degenerative disc disease, not a diagnostic test performed on a sample.
The information provided clearly indicates this is a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Lateral Cage System is indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach. The Lateral Cage System is intended for use with DePuy Spine supplemental fixation.
Product codes
MAX
Device Description
The Lateral Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft materials. The Lateral Cage System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
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)
Performance data were submitted to characterize the Lateral Cage System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
LUMBAR I/F CAGE System, NuVasive CoRoent System (K071795)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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KCS 2128
Page 1 of 1
510(k) Summary
| 510(k) Summary | |
|---|---|
| SUBMITTER: | DePuy Spine, Inc. |
| 325 Paramount Drive | |
| Raynham, MA 02780 | |
| NOV 14 2008 | |
| CONTACT PERSON: | Hande Tufan |
| DATE PREPARED: | June 1, 2008 |
| CLASSIFICATION NAME: | Intervertebral Fusion Device with Bone Graft - |
| 87MAX - 888.3080 - Class II | |
| PROPRIETARY NAME: | Lateral Cage System |
| PREDICATE DEVICES: | LUMBAR I/F CAGE System (P960025) |
| NuVasive CoRoent System (K071795) | |
| DEVICE DESCRIPTION: | The Lateral Cage System consists of implants |
| available in various heights and lordotic configurations | |
| with an open architecture to accept packing of bone | |
| graft materials. | |
| The Lateral Cage System also contains Class 1 | |
| manual surgical instruments and cases that are | |
| considered exempt from premarket notification. | |
| INTENDED USE: | The Lateral Cage System is indicated for intervertebral body |
| fusion with autogenous bone graft in patients with | |
| degenerative disc disease (DDD) at one or two contiguous | |
| levels from L2 to S1. These DDD patients may also have up | |
| to Grade 1 Spondylolisthesis or retrolisthesis at the involved | |
| levels. DDD is defined as discogenic back pain with | |
| degeneration of the disc confirmed by history and | |
| radiographic studies. These patients should be skeletally | |
| mature and have had six months of non-operative treatment. | |
| These implants may be implanted via an open or a minimally | |
| invasive lateral approach. The Lateral Cage System is | |
| intended for use with DePuy Spine supplemental fixation. | |
| MATERIALS: | Manufactured from Carbon Fiber Reinforced Polymer. |
| PERFORMANCE | |
| DATA: | Performance data were submitted to characterize the Lateral |
| Cage System. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuv Spine % Ms. Handc Tufanyazici Senior Regulatory Affairs Associate 325 Paramount Drive Raynham Massachusetts 02767
NOV 1 4 2008
Re: K082128 Trade/Device Name: Lateral Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: November 07, 2008 Received: November 12, 2008
Dear Ms. Tufanyazici:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or other to be 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 or uny I edual states and see and see and see and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in all qualis) by over is on the end of the Act); 21 CFR 1000-1050.
2
Pagc 2 - Ms. Hande Tufanyazici
This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter witification. The FDA finding of substantial equivalence of your device to a legally marketed predicated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you acon Copter for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to (210) 216 0167. alion's (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use IV.
510(k) Number (if known): K082128
Device Name: Lateral Cage System
Indications For Use:
The Lateral Cage System is indicated for intervertebral body fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive lateral approach.
The Lateral Cage System is intended for use with DePuy Spine supplemental fixation.
X Prescription Use: (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ision Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K082464