(71 days)
Not Found
No
The device description and intended use focus solely on the mechanical components and surgical application of a spinal fixation system. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes.
The device is described as "intended for anterior screw fixation to the cervical spine" and "for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions." This indicates it is used for medical treatment or to alter the structure or function of the body, which aligns with the definition of a therapeutic device.
No
Explanation: The Katia System is described as a device for anterior screw fixation to the cervical spine, used for temporary stabilization and fusion development. This indicates a therapeutic or surgical purpose, not a diagnostic one.
No
The device description explicitly states that the Katia System includes implants (bone plates, screws) and associated instruments made from titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Katia System Description: The provided text clearly describes the Katia System as a surgical implant and associated instruments used for anterior screw fixation to the cervical spine. It is a physical device implanted into the body to provide structural support.
- Intended Use: The intended use is for temporary stabilization of the anterior spine during the development of cervical spinal fusions. This is a surgical procedure, not an in vitro diagnostic test.
The description focuses on the physical components, the surgical application, and the anatomical site of use, all of which are characteristic of a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 – T1). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis.
Product codes
KWO, KWQ
Device Description
The Katia System includes implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical fusion. The Katia system consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The components are made from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 – T1)
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)
Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081038, K111132, K031276, K971883
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
7 2013
| | 510(k) Summary
KATIA SYSTEM
July 22, 2013 | AUG |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Company: | Manufacturing Facility and Headquarters:
Shanghai Sanyou Medical Co, LTD
1988 Jiatang Road
Jiading District, Shanghai, 201807, China | |
| | Manufacturing Facility:
Shanghai Sanyou Medical Co, LTD
Rm 101/102/106/107
356 Renqing Rd, Building 3-1F,
Pudong New District, Shanghai 201201, China | |
| Establishment
Registration: | Registration applied; Number not assigned | |
| Primary Contact: | Kimberly Strohkirch
Phone: 901-361-2037
Fax: 902-318-5380
strohkirch@memphisregulatory.com | |
| Company Contact: | David Fan, VP, Marketing
Phone: +86 21 58389980
Fax: +86 21 38682915
david.fan@sanyou-medical.com | |
| Trade Name: | Katia System | |
| Common Name: | Appliance, Fixation, Spinal Intervertebral Body | |
| Classification: | Class II | |
| Regulation Number: | 21 CFR 888.3060 (Spinal intervertebral body fixation orthosis) | |
| Panel: | 87- Orthopedic | |
| Product Code: | KWO | |
.
1
Device Description:
The Katia System includes implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical fusion. The Katia system consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The components are made from titanium alloy.
Indications for Use:
The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 – T1). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis.
Substantial Equivalence:
K081038 - Medtronic ATLANTIS® Anterior Cervical Plate System K111132 - Genesys Spine Anterior Cervical Plate System K031276 - Synthes Anterior Cervical Locking Plate (ACLP System) K971883 – Synthes Small Stature Anterior Cervical Vertebrae Plate System
Performance Testing:
Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004.
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
August 7, 2013
Shanghai Sanyou Medical Co, Ltd % Memphis Regulatory Consulting Ms. Kimberly Strohkirch 3416 Roxee Run Cove Bartlett, Tennessee 38133
Re: K131512
Trade/Device Name: Katia System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 19, 2013 Received: June 20, 2013
Dear Ms. Strohkirch:
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 - Ms. Kimberly Strohkirch
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Traditional 510(k)
Indications for Use Statement
510(k) Number (if known): K131512
Katia System Device Name:
Indications for Use:
The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 – T1). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis.
| Prescription Use X
(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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Anton E. Dmitriev, PhD Division of Orthopedic Devices
CONFIDENTIAL