(112 days)
Not Found
No
The summary describes a physical implant (cervical cage) and its mechanical testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as an intervertebral body fusion orthosis intended for cervical spinal fusion surgery, providing mechanical support and protecting bone graft for healing, which aligns with the definition of a therapeutic device.
No.
The device is an implant for spinal fusion and provides mechanical support, it does not diagnose a condition.
No
The device description clearly states it is an "intervertebral body fusion orthosis" and a "Cervical Cage," which are physical implants, not software. The performance studies also describe mechanical testing of a physical device.
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 about a person's health.
- Device Description: The provided text clearly describes the Cervical Cage as an "intervertebral body fusion orthosis" intended for surgical implantation in the spine. It provides mechanical support and protects bone graft.
- Intended Use: The intended use is for spinal fusion procedures, which is a surgical intervention, not an in vitro test.
The information provided describes a surgically implanted medical device, not a device used to test samples outside the body.
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 Caqe is an intervertebral body fusion orthosis intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and protects the bone graft from excessive loads so that bone healing can occur.
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 Cervical Cage was tested by the methods described in ASTM F2077, including static axial compression, dynamic axial compression, static torsion, and dynamic torsion. Testing per ASTM F2267 to quantify the potential for device subsidence was also conducted. The resistance to expulsion was evaluated by performing expulsion testing against grade 15 polyurethane foam with 100 N axial preload.
The Cervical Cage performs at least as safely and effectively as a legally marketed predicate device.
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.
K083311, K073351, K082848, K081611, K081730
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.
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K110915 Page 1/2
JUL 222 2011
| Company: | Eisertech, LLC
San Diego, California 92103 |
|--------------------------|------------------------------------------------------------|
| Contact: | Lukas Eisermann
lukas@eisertech.com
888-262-2817x101 |
| Trade Name: | Cervical Cage |
| Common Name:
Cervical | Intervertebral FusionDevice with Bone Graft |
| Classification Name: | Orthosis, spinal intervertebral fusion |
| Regulation Number: | 888.3080 |
| Product Code: | ODP |
Substantial Equivalence
510(k) Summary:
Eisertech, LLC believes that the Eisertech, LLC Cervical Cage is substantially equivalent to the Aesculap CeSpace PEEK Spinal Implant System (K083311), the Spinal Elements Crystal Cervical Interbody System (K073351), the Signus Medical, LLC Rabea implant (K082848), the Nuvasive CoRoent-S (K081611), and the Alphatec Spine, Inc. Novel Cervical Spine System (K081730).
Description of device and its 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.
Description of device design requirements
The Cervical Cage design must maintain the spacing between two vertebral bones following cervical discectomy until fusion occurs.
ldentification of the risk analysis method
Risks were qualitatively summarized and addressed by quantitatively analyzing specific in-vivo device performance requirements. The biomechanical loads that the device is expected to be subjected to were described and used as design input criteria. Test results relative to those loading conditions (e.g. design output data) were compared to the design input criteria. The device output data showed
1
performance meeting or exceeding the design input requirements for all conditions.
Discussion of the device characteristics
The Cervical Caqe is an intervertebral body fusion orthosis intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and protects the bone graft from excessive loads so that bone healing can occur.
Description of the performance aspects
The Cervical Cage was tested by the methods described in ASTM F2077, including static axial compression, dynamic axial compression, static torsion, and dynamic torsion. Testing per ASTM F2267 to quantify the potential for device subsidence was also conducted. The resistance to expulsion was evaluated by performing expulsion testing against grade 15 polyurethane foam with 100 N axial preload.
The Cervical Cage performs at least as safely and effectively as a legally marketed predicate device.
Reliance on standards
Standards relevant to the methods in which the testing was conducted were relied upon. These include ASTM F2077 and ASTM F2267. However, no performance standard exists for intervertebral body fusion orthoses.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Eisertech, LLC % Mr. Lukas Eisermann 2555 Front Street San Diego, California 92103
ງປະ 2-2-2011
Re: K110915
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: June 29, 2011 Received: June 30, 2011
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
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Page 2 - Mr. Lukas Eisermann
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 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 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/ReportalProblem/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 yours,
yours,
Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Cervical Cage Device Name:
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.
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 _________________________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
KI10915 510(k) Number_