(71 days)
Not Found
None
No
The provided 510(k) summary describes a spinal implant (intervertebral body fusion device) and its intended use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the physical device and its surgical application.
Yes
The device is indicated for intervertebral body fusion procedures to treat degenerative disc disease, which is a medical condition. It is used in conjunction with autogenous bone and supplemental FDA cleared fixation, suggesting it is part of a therapeutic intervention.
No
The device is described as an intervertebral body fusion device used for treating degenerative disc disease, not for diagnosing it. The "Indications for Use" section clearly states its purpose is for "procedures" and "treatment," and mentions that diagnosis (degeneration of the disc confirmed by patient history and radiographic studies) happens prior to the use of this device.
No
The device description is not found, but the intended use clearly describes a physical implant (EndoLIF® On-Cage) used in surgical procedures, which is a hardware device.
Based on the provided information, the EndoLIF® On-Cage is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information about a person's health. The intended use of the EndoLIF® On-Cage is for intervertebral body fusion procedures, which is a surgical intervention performed directly on the patient's spine.
- The description focuses on a surgical implant and its application in treating a specific spinal condition. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the EndoLIF® On-Cage falls under the category of a surgical implant or device used in a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoLIF® On-Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). EndoLIF® On-Cage are to be used with autogenous bone and implanted via a posterior or posterolateral approach. The EndoLIF® On-Cage is to be used with a supplemental FDA cleared fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an EndoLIF® On-Cage.
Product codes
MAX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine at one or two contiguous levels from L2-S1
Indicated Patient Age Range
skeletally mature patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 9, 2015
joimax® GmbH % Mr. Gary Mocnik Official Correspondent Gary S. Mocnik and Associates 49 Coastal Oak Aliso Viejo, California 92656
Re: K151143
Trade/Device Name: EndoLIF On-Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 28, 2015 Received: April 29, 2015
Dear Mr. Mocnik:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Gary Mocnik
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.
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K151143 |
|---|---|
| Device Name | EndoLIF On-Cage |
| Indications for Use (Describe) | The EndoLIF® On-Cage is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients may have had previous non-fusion spinal surgery at the involved spinal level(s). EndoLIF® On-Cage are to be used with autogenous bone and implanted via a posterior or posterolateral approach. The EndoLIF® On-Cage is to be used with a supplemental FDA cleared fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an EndoLIF® On-Cage. |
| 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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