(232 days)
Not Found
No
The description focuses on the mechanical properties and intended use of a physical interbody fusion device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat degenerative disc disease, which is a medical condition, by enabling spinal fusion.
No
The device is an intervertebral body fusion device used for treatment, not diagnosis. It is intended to be implanted surgically to provide structural support.
No
The device description clearly describes a system of physical intervertebral body fusion devices made of structural columns with teeth and a central cavity, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to facilitate spinal fusion in patients with degenerative disc disease. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as an intervertebral body fusion device, a structural implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients of non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The SurgTech Interbody System is a system of intervertebral body fusion devices. The Posterior Lumbar device is a structural column in a generally rectangular shape having a rounded nose. Teeth are integral to the inferior and superior surfaces and there is a central cavity to be filled with autograft. The implants are available in an assortment of footprint, height and angulation combinations to accommodate a variety of anatomic requirements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
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)
Mechanical testing of the worst case SurgTech Interbody System device was performed according to ASTM F2077 and included static and dynamic compression. Subsidence testing according to ASTM F2267 was performed on the worst case SIS PL device. The mechanical test results demonstrate that the SurgTech Interbody System performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
PLIF Cage (Eisertech LLC, K113478), AVS® PL PEEK Spacers (Stryker Spine – K073470, K082014 & K093704)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2016
SurgTech Incorporated % Karen E. Warden, Ph.D. BackRoads Consulting Incorporated P.O. Box 566 Chesterland, Ohio 44026
Re: K152200
Trade/Device Name: SurgTech Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 11, 2016 Received: March 14, 2016
Dear Dr. Warden:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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 N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152200
Device Name SurgTech Interbody System
Indications for Use (Describe)
The SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients of non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbar spine.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date: | 5 August 2015 |
|---|---|
| Sponsor: | SurgTech Inc. |
| 24600 Center Ridge Road, Suite 195 | |
| Westlake, OH 44145 | |
| Phone (216) 421-2613 | |
| Sponsor Contact: | Xuegong Yu, General Manager |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Name: | SurgTech Interbody System |
| Common Name: | Interbody fusion device |
| Device Classification | Class II |
| Classification Name: | Intervertebral body fusion device |
| Regulation: | 888.3080 |
| Device Product | |
| Code: | MAX |
| Device Description: | The SurgTech Interbody System is a system of intervertebral body fusion |
| devices. The Posterior Lumbar device is a structural column in a generally | |
| rectangular shape having a rounded nose. Teeth are integral to the inferior | |
| and superior surfaces and there is a central cavity to be filled with autograft. | |
| The implants are available in an assortment of footprint, height and | |
| angulation combinations to accommodate a variety of anatomic | |
| requirements. | |
| Indications for Use: | The SurgTech Interbody System is indicated for use with autogenous bone |
| graft in skeletally mature patients with degenerative disc disease (DDD) at | |
| one or two contiguous levels from L2 to S1. DDD is defined as discogenic | |
| back pain with degeneration of the disc confirmed by history and | |
| radiographic studies. These patients should have had six months of non- | |
| operative treatment. These patients may have had a previous non-fusion | |
| spinal surgery and may also have up to Grade 1 spondylolisthesis or | |
| retrolisthesis at the involved spinal level(s). These devices are intended to | |
| be used with supplemental fixation which has been cleared for use in the | |
| lumbar spine. | |
| Materials: | The SurgTech Interbody System cages are manufactured from PEEK |
| Optima® LT1 (polyetheretherketone) per ASTM F2026 and contain tantalum | |
| radiopaque markers per ASTM F560. | |
| Primary Predicate: | PLIF Cage (Eisertech LLC, K113478) |
| Additional Predicate: | AVS® PL PEEK Spacers (Stryker Spine – K073470, K082014 & K093704) |
| Performance Data: | Mechanical testing of the worst case SurgTech Interbody System device |
| was performed according to ASTM F2077 and included static and dynamic | |
| compression. Subsidence testing according to ASTM F2267 was performed | |
| on the worst case SIS PL device. | |
| The mechanical test results demonstrate that the SurgTech Interbody | |
| System performance is substantially equivalent to the predicate devices. | |
| Technological | |
| Characteristics: | The SurgTech Interbody System implants possess similar technological |
| characteristics as one or more of the predicate devices. These include: | |
| performance (as described above), basic design (hollow structural column), implant grade materials (PEEK polymer and tantalum), and sizes (widths, lengths, heights and angulation are within the range(s) offered by the predicates). | |
| Therefore the fundamental scientific technology of the SurgTech Interbody System is similar to previously cleared devices. | |
| Conclusion: | The SurgTech Interbody System possesses similar intended use and |
| technological characteristics as the predicate devices. Therefore SurgTech | |
| Interbody System is substantially equivalent to legally marketed predicates. |
4