(73 days)
Not Found
Not Found
No
The summary describes a mechanical implant system (plates and screws) for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is intended for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with various spinal conditions, indicating its use in treating medical conditions.
No
This device is described as an "anterior screw fixation system" for the cervical spine, used for temporary stabilization and fusion. It is an implantable device used for treatment, not for diagnosing conditions.
No
The device description explicitly states that the system includes titanium alloy plates and screws, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior screw fixation to the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spinal fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues in the spine.
- Device Description: The description confirms it's an "anterior screw fixation system for the cervical spine" including "titanium alloy plates and screws." These are physical implants, not reagents or instruments used to test biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The description and intended use do not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on the analysis of these samples
- Using reagents or assays
This device is a surgical implant used for structural support and stabilization within the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Altiva Classic ACP System is intended for anterior screw fixation to the cervical spine (C2 to C7). The system is intended for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- degenerative disc disease (as defined by neck pain of discogenic . origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, ●
- trauma (i.e. fractures or dislocations), .
- tumors, .
- deformity (defined by kyphosis, lordosis, or scoliosis), .
- pseudoarthrosis, and .
- failed previous fusion. .
Product codes
KWQ
Device Description
The Altiva Classic ACP System is an anterior screw fixation system for the cervical spine. It includes titanium alloy plates and screws which are provided clean and non-sterile. Various sizes of the implants are provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 Altiva Classic ACP System.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
JUN 1 1 2007
PREMARKET NOTIFICATION 510(K) SUMMARY
| Company: | Altiva Corporation
9800 Suite i, Southern Pines Blvd
Charlotte, NC 28273
Telephone: 704/409-1754
Fax: 704/409-1771 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | John Kapitan
Vice President, Product Development and RA/QA |
| Date: | March 27, 2007 |
| Trade Name: | Altiva® Classic ACP System |
| Common Name | Spinal Intervertebral Fixation Orthosis |
| Classification: | Orthopedics, 888.3060, Class II |
| FDA Product Code : | KWQ |
| Device Description: | The Altiva Classic ACP System is an anterior screw
fixation system for the cervical spine. It includes
titanium alloy plates and screws which are provided
clean and non-sterile. Various sizes of the implants are
provided. |
| Intended Use: | The Altiva Classic ACP System is intended for anterior
screw fixation to the cervical spine (C2 to C7). The
system is intended for use in the temporary stabilization
of the anterior spine during the development of cervical
spinal fusion in patients with degenerative disc disease
(as defined by neck pain of discogenic origin with
degeneration of the disc confirmed by patient history
and radiographic studies), spondylolisthesis, trauma
(i.e. fractures or dislocations), tumors, deformity
(defined by kyphosis, lordosis, or scoliosis),
pseudoarthrosis, and failed previous fusion. |
| Predicate Device: | Predicate device information is included. |
| Performance Data: | Performance data were submitted to characterize the
Altiva Classic ACP System. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing left. The eagle is composed of three curved lines that form the body, wings, and tail feathers. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Altiva Corporation % Mr. John Kapitan VP, Product Development, RA/QA 9800 Southern Pines Boulevard Charlotte, North Carolina 28273
JUN 1 1 2007
Re: K070891
Trade/Device Name: Altiva® Classic ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 26, 2007 Received: March 30, 2007
Dear Mr. Kapitan:
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 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); 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.
2
Page 2 – Mr. John Kapitan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
for
Mark N. Melkerson
Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 3 – Mr. John Kapitan
cc: HFZ-401 DMC IIFZ-401 DMC
HFZ-404 510(k) Staff HFZ- Division D.O. f/t:SJB:afb:6/4/07
OC Numbers:
| Division of Enforcement A | 240-276-0115 |
|---|---|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |
.
:
and the comments of the comments of
4
Indication for Use Statement
510(k) Number (if known): 长070891
Device Name: Altiva® Classic ACP System
Indications for Use:
The Altiva Classic ACP System is intended for anterior screw fixation to the cervical spine (C2 to C7). The system is intended for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:
- degenerative disc disease (as defined by neck pain of discogenic . origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, ●
- trauma (i.e. fractures or dislocations), .
- tumors, .
- deformity (defined by kyphosis, lordosis, or scoliosis), .
- pseudoarthrosis, and .
- failed previous fusion. .
Prescription Use × or
Over-The-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mok
Division of General, Restorative, and Neurological Devices
510(k) Number.