(443 days)
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.
The proposed modified Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade Solvay Zeniva ZA-500 PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.
This 510(k) summary describes a medical device, the Transcorp ACIF System, and its modifications. It does not contain information about an AI/ML device or the results of a study designed to evaluate its performance against acceptance criteria using a test set, ground truth, or expert readers.
The document describes the performance testing for a physical implantable device, not an algorithm. The relevant section states:
"Performance testing was performed on the proposed modified IBFD. Static and dynamic axial compression, static and dynamic compression shear, and static torsion testing per ASTM F2077-11 were performed. Expulsion testing was also performed on the proposed modified IBFD. Engineering analyses were conducted to evaluate the Subsidence and Wear of the proposed modified implant. No clinical testing was performed."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML algorithm.
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JUL 0 5 2013
Section 5.0
510(k) Summary
Image /page/0/Picture/4 description: The image contains the text "TransCor" in a large, bold font. Below "TransCor" is the word "spine" in a smaller font. To the right of the word "Cor" is a small graphic of a human head in profile.
le Back in Motion Transcorp ACIF System
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K121178 page 2 of 3
510(k) Summary Pursuant to 21 CFR 807.92c
| Submitted By: | Thanh Truong |
|---|---|
| Transcorp, Inc. | |
| 1000 100th St. SW Suite F | |
| Byron Center, MI 49315 | |
| Ph: 616-855-5375 | |
| Fax: 616-877-4522 |
6/26/13 Date:
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:
| K092794: | Transcorp ACIF System |
|---|---|
| K081730: | Alphatec Novel Spinal Spacer System |
| K090064: | Eminent Spine Interbody Fusion System |
Device Description:
The proposed modified Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade Solvay Zeniva ZA-500 PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.
Image /page/1/Picture/10 description: The image shows the words "TransCor" on the top line and "spine" on the second line. The word "TransCor" is in a larger font than the word "spine". The word "spine" is located directly below the "sCor" portion of the word "TransCor".
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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 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.
Proposed Modification:
The subject of this submission includes modification to the geometry of the Intervertebral Body Fusion Devices (IBFDs) and the instruments of the Transcorp ACIF System.
Performance Data:
Performance testing was performed on the proposed modified IBFD. Static and dynamic axial compression, static and dynamic compression shear, and static torsion testing per ASTM F2077-11 were performed. Expulsion testing was also performed on the proposed modified IBFD. Engineering analyses were conducted to evaluate the Subsidence and Wear of the proposed modified implant. No clinical testing was performed.
Substantial Equivalence:
The results of non-clinical testing demonstrates that the design, function, intended use, and indications for use of the proposed modified Transcorp ACIF System is substantially equivalent to the predicate device.
Image /page/2/Picture/9 description: The image shows the logo for TransCorp Spine. Below the logo, it says "Life Back in Motion. Transcorp ACIF System". The image also states "Special 510(k): Device Modification".
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Transcorp, Incorporated % Mr. Thanh Truong Engineer 1000 100th Street South West Suite F Byron Center, Michigan 49315
July 5, 2013
Re: K121178
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: June 19, 2013 Received: June 19, 2013
Dear Mr. Truong:
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
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Page 2 - Mr. Thanh Truong
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 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/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: KI21178
Device Name: Transcorp ACIF System
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 nonoperative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
| Prescription Use | X |
|---|---|
| (per CFR 801.109) | |
| or | |
| Over-the-counter use |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices
lal 510(k): Device Modlfication
§ 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.