(20 days)
Not Found
No
The summary describes a physical implant (Cervical Cage) made of PEEK with tantalum pins for radiographic visualization. There is no mention of software, algorithms, or any functionality related to data processing, analysis, or decision-making that would typically involve AI/ML. The performance study focuses on material change, not algorithmic performance.
No.
The device's sole purpose is spinal fusion and stabilization, not the treatment or diagnosis of a condition.
No
Explanation: The device, a cervical cage, is an implant used for spinal fusion procedures. Its purpose is to treat degenerative disc disease by providing structural support and facilitating fusion, rather than to diagnose medical conditions.
No
The device description explicitly states the device is manufactured from PEEK and contains Tantalum pins, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Cervical Cage is an implantable device made of PEEK and Tantalum, intended for spinal fusion procedures. It is surgically placed within the body.
- Intended Use: The intended use is for spinal fusion in patients with degenerative disc disease, which is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The device uses radiographic studies as input, but this is for assessing the patient's condition and the placement of the implant, not for performing a diagnostic test on a biological sample.
N/A
Intended Use / Indications for Use
The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Cervical Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK). Tantalum pins are embedded in the implants to help allow for radiographic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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)
The change in marker pin material does not affect the performance of the product. No additional testing or analysis is provided.
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.
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:
Date:
August 29, 2012
AUG 30 2012
Company:
Eisertech, LLC 1133 Columbia Street Suite 107 San Diego, California 92101
Contact:
Lukas Eisermann lukas@eisertech.com 888-262-2817x101
Type of 510(k) submission: Special
| Trade Name: | Cervical Cage |
|---|---|
| Common Name: | Intervertebral FusionDevice with Bone Graft, |
| Cervical | |
| Classification Name: | Orthosis, spinal intervertebral fusion |
| Regulation Number: | 888.3080 |
| Device Classification: | Class II |
| Product Code: | ODP |
Purpose of the Submission
The purpose of this special 510(k) is to change the material of the marker pins from titanium to tantalum, per ASTM F560.
Description of device
The Cervical Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK). Tantalum pins are embedded in the implants to help allow for radiographic visualization.
Intended use
The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.
1
K122444 page 2 of 2
Materials
The devices are manufactured from medical grade PEEK (ASTM F2026) with tantalum radiographic markers (ASTM F560)
Predicate Devices
Eisertech, LLC Cervical Cage (K110915) Nexxt Spine Honour Spacer System (K120345)
Technological Characteristics
The Cervical Cage geometry is unchanged from that approved in K110915. The main material of construction, PEEK is unchanged from that approved in K110915. The marker pin material is identical to that used in K120345.
Performance Data
The change in marker pin material does not affect the performance of the product. No additional testing or analysis is provided.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, which is a common symbol associated with the department.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 30 2012
Eisertech, LLC % Mr. Lukas Eisermann Chief Executive Officer 1133 Columbia Street San Diego, California 92101
Re: K122444
Trade/Device Name: Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: August 08, 2012 Received: August 10, 2012
Dear Mr. Eisermann:
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
3
Page 2 -- Mr. Lukas Eisermann
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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Einl Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Cervical Cage
Indications for Use:
. .
The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T10 Our hour bage to a patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page
Carl R.
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122444