(367 days)
K081730, P980048
Not Found
No
The summary describes a passive implant device for spinal fusion and does not mention any AI/ML components or functionalities.
No.
The Transcorp ACIF System is an intervertebral body fusion device used to facilitate fusion, not directly treat a disease or condition.
No
The Transcorp ACIF System is a surgical implant designed to facilitate fusion in the cervical spine. It is used to treat degenerative disc disease and is not involved in diagnosing the condition.
No
The device description explicitly states the device is manufactured from implant grade PEEK and is a physical implant for spinal fusion, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate fusion in the cervical spine in skeletally mature patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The device is an implant made of PEEK, designed to be placed in the cervical spine.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are typically used to test blood, urine, tissue, etc.
- Performance Studies: The performance studies described are related to the mechanical properties and wear of the implant, not diagnostic accuracy or performance on biological samples.
Therefore, the Transcorp ACIF System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
Product codes
ODP
Device Description
The Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 to C7 disc levels
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)
Performance testing was performed on the Transcorp ACIF System. Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion testing per ASTM F2077-03, and subsidence testing per ASTM F2267-04. A wear testing analysis was performed to determine particulate generation during dynamic axial compression and dynamic torsion testing. The wear debris was collected and analyzed per ASTM F1877-05. No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K081730, P980048
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
Ko92794
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510(k) Summary Pursuant to 21 CFR 807.92c
SEP 1 8 2010
Submitted By:
Andrew Rodenhouse Transcorp, Inc. 1000 100th St. SW Suite F Byron Center, MI 49315 Ph: 616-877-4177 Fax: 616-877-4522
Date:
September 10, 2010
Device Information:
| Trade Name: | Transcorp ACIF System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | 21 CFR Section 888.3080, Product Code ODP, |
| Class II |
Predicate Devices:
K081730 Alphatec Novel Spinal Spacer System P980048 BAK/C Vista Cervical Interbody Fusion Device
Device Description:
The Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided nonsterile.
Intended Use:
The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with
Page 1 of 2
1
the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
Performance Data:
Performance testing was performed on the Transcorp ACIF System. Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion testing per ASTM F2077-03, and subsidence testing per ASTM F2267-04. A wear testing analysis was performed to determine particulate generation during dynamic axial compression and dynamic torsion testing. The wear debris was collected and analyzed per ASTM F1877-05. No clinical testing was performed.
Substantial Equivalence:
The Transcorp ACIF System is equivalent to the predicate devices in design, function, intended use, and indications for use. The results of non-clinical performance testing and analysis have demonstrated that the Transcorp ACIF System is substantially equivalent to the predicate devices.
Pay 2.f2
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 stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Transcorp, Inc. % Mr. Andrew Rodenhouse 1000 100th Street, SW - Suite F Byron Center, Michigan 49315
Re: K092794
SEP 1 3 2010
Trade/Device Name: Transcorp ACIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 02, 2010 Received: September 02, 2010
Dear Mr. Rodenhouse:
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
3
Page 2 - Mr. Andrew Rodenhouse
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/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.
Barbara Buettner
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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Indications for Use Statement
510(k) Number: Ko92794
Device Name: Transcorp ACIF System i;
SEP 1 3 2010
Indications for Use:
The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
Prescription Use X Over-the-counter use or (per CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KO92794 510(k) Number_