(56 days)
No
The 510(k) summary describes a physical intervertebral body fusion device (a cage) and its intended use. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts in the device description, intended use, or performance studies summary. The focus is on the mechanical properties and design of the implant.
Yes
The device is an intervertebral body fusion device indicated for treating degenerative disc disease, which involves implanting it into the body to restore function and relieve symptoms.
No
The device is an intervertebral body fusion device (a cage system) intended to facilitate spinal fusion by holding bone graft material, not to diagnose a condition.
No
The device description clearly describes a physical implantable device made of ceramic, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Phantom Plus Ceramic Cages are described as intervertebral body fusion devices. Their intended use is to facilitate fusion between vertebrae in the spine by holding bone graft material. They are implanted directly into the body.
- Lack of Diagnostic Function: The device does not perform any tests on bodily samples to diagnose a condition or provide information about a patient's health status through analysis of those samples. It is a therapeutic device used for structural support and fusion.
Therefore, the Phantom Plus Ceramic Cage System falls under the category of an implantable surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Phantom Plus Ceramic Cages-Lumbar are intervertebral body fusion devices 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 (6) months of nonoperative therapy.
The Phantom Plus Ceramic Cage System-Lumbar is to be filled with autogenous bone graft material. The Phantom Plus Ceramic Cages-Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.
The Phantom Plus Ceramic Cages-Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Phantom Plus Ceramic Cages-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone.
The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Product codes
MAX, ODP
Device Description
The Phantom Plus Ceramic Cage System consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 22mm in height and 14mm to 45mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2 to S1), Cervical spine (C3 to C7)
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
Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices. ASTM F2077, ASTM F1839, ASTM F1839, ASTM F1877, ASTM F04.25.02.02, and AAMI TIR 33 performance standards were adhered to and all applicable requirements were met.
Key Metrics
Not Found
Predicate Device(s)
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
1121892
510(k) Summary
AUG 2 4 2012
| Contact: | Robert M. Wolfarth, CQA
Amedica Corp.
1885 West 2100 South
Salt Lake City, UT 84119
(801) 839-3500 |
|------------------------|----------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | Phantom Plus® Ceramic Cage System |
| Manufacturer: | Amedica Corp.
1885 West 2100 South
Salt Lake City, UT 84119 |
| Common Name: | Intervertebral body fusion device |
| Classification: | 21 CFR §888.3080 |
| Device Class: | II |
| Product Codes: | MAX, ODP |
| Date Summary Prepared: | June 28, 2012 |
Indications For Use:
The Phantom Plus Ceramic Cages-Lumbar are intervertebral body fusion devices 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 (6) months of nonoperative therapy.
The Phantom Plus Ceramic Cage System-Lumbar is to be filled with autogenous bone graft material. The Phantom Plus Ceramic Cages-Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.
The Phantom Plus Ceramic Cages-Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Phantom Plus Ceramic Cages-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone.
The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
1|2
1
Device Description:
The Phantom Plus Ceramic Cage System consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 22mm in height and 14mm to 45mm in length.
22
Predicate Device(s):
The Phantom Plus Ceramic Cage System was shown to be substantially equivalent to previously cleared devices, including itself (K082801) and the Valeo® Spacer System (K091278), and has the same or equivalent indications for use, design, function, and materials used.
Performance Standards:
Testing and engineering analyses on this device indicate that the Phantom Plus Cage System is substantially equivalent to predicate devices. ASTM F2077, ASTM F1839, ASTM F1839, ASTM F1877, ASTM F04.25.02.02, and AAMI TIR 33 performance standards were adhered to and all applicable requirements were met.
2
Image /page/2/Picture/1 description: The image is a black and white 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 eagle is composed of three curved lines that suggest the shape of the bird's body and wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 4 2012
Amedica Corporation % Mr. Robert M. Wolfarth Director of Regulatory Affairs 1885 West 2100 South Salt Lake City, Utah 84119
Re: K121892
Trade/Device Name: Phantom Plus® Ceramic Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 3, 2012 Received: August 8, 2012
Dear Mr. Wolfarth:
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
3
Page 2 - Mr. Robert M. Wolfarth
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,
Mark A. Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K121892
Device Name: Phantom Plus® Ceramic Cage System
The Phantom Plus Ceramic Cages-Lumbar are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to $1.
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 (6) months of nonoperative therapy.
The Phantom Plus Ceramic Cage System-Lumbar is to be filled with autogenous bone graft material. The Phantom Plus Ceramic Cages-Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System.
The Phantom Plus Ceramic Cages-Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level.
DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Phantom Plus Ceramic Cages-Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone.
The Phantom Plus Ceramic Cages-Cervical are to used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
イ Prescription Use (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (29 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K121892 510(k) Number_