(69 days)
No
The summary describes a passive implantable device (interbody fusion spacer) made of polymer and metal markers. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML.
No.
The device is an interbody fusion device that provides structural stability and is to be filled with bone graft material; it does not explicitly state it provides therapeutic effects like pain relief or healing.
No
This device is an interbody fusion device intended for surgical implantation to provide structural stability, not to diagnose a condition.
No
The device description clearly states that the PATRIOT® TransContinental™ Spacers are physical implants made from radiolucent polymer with titanium alloy or tantalum markers, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PATRIOT® TransContinental™ Spacers are implantable medical devices used in surgical procedures to provide structural support and facilitate bone fusion in the spine. They are not used to analyze biological samples.
- Intended Use: The intended use clearly describes a surgical intervention for degenerative disc disease, not a diagnostic test.
The device description and intended use focus on the physical properties and surgical application of the spacers within the body, which is characteristic of a non-IVD medical device.
N/A
Intended Use / Indications for Use
PATRIOT® TransContinental® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The PATRIOT® TransContinental® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.
Product codes
MAX
Device Description
The PATRIOT® TransContinental® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
PATRIOT® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-S1)
Indicated Patient Age Range
skeletally mature
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) SUMMARY: PATRIOT® TransContinental® Spacer
| Company: | Globus Medical Inc.
2560 General Armistead Ave.
Audubon, PA 19403
(610) 415-9000 | DEC 2 3 200 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Kelly J. Baker, Ph.D
Director, Clinical Affairs & Regulatory | |
| Device Name: | PATRIOT® TransContinental® Spacer | |
| Classification: | Per 21 CFR as follows:
§888.3080 Intervertebral Body Fusion device.
Product Code MAX.
Regulatory Class II, Panel Code 87 | |
| Predicate(s): | PATRIOT® Lumbar Spacers K072970
SE date January 18, 2008
DePuy Lateral Cage System K090899
SE date May 19, 2009
NuVasive CoRoent System K071795
SE date December 4. 2007 | |
Device Description:
The PATRIOT® TransContinental® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
PATRIOT® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.
Indications for Use:
PATRIOT® TransContinental® Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
1
The PATRIOT® TransContinental® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.
Basis for Substantial Equivalence:
The PATRIOT® TransContinental® Spacers are similar to the predicate systems with respect to technical characteristics, performance and intended use. The devices have been evaluated in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device", June 12, 2007.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or other bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 2 3 2009
Globus Medical Inc. % Ms. Kelly J. Baker, Ph.D. Director, Clinical Affairs & Regulatory 2560 General Armistead Avenue Audubon, Pennsylvania 19403
Re: K093242
Trade/Device Name: PATRIOT® TransContinental® Spacer Regulation Number: 21 CFR 888-3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: November 25, 2009 Received: November 27, 2009
Dear Dr. Baker:
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 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 - Ms. Kelly J. Baker, Ph.D.
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
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: | K093242 |
|---|---|
| ---------------- | --------- |
PATRIOT® TransContinental® Spacer Device Name:
Indications:
PATRIOT® TransContinental™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The PATRIOT® TransContinental® Spacers are to be filled with autogenous These devices are intended to be used with bone graft material. supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.
OR Over-The-Counter Use Prescription Use > (Per 21 CFR §801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093242