(211 days)
No
The summary describes a mechanical intervertebral body fusion device made of titanium with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an intervertebral body fusion device indicated for treating degenerative disc disease, which is a medical condition, making it a therapeutic device.
No
The device is an intervertebral body fusion device, which is an implant used for structural support in spinal fusion surgery, not for diagnosing medical conditions.
No
The device description clearly states it is made from Titanium and describes its physical components and mechanical properties, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The EOI FLXfit Intervertebral body fusion device is a physical implant made of titanium. It is surgically placed within the body to fuse vertebrae.
- Intended Use: The intended use is to provide structural support and facilitate bone fusion in patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
The description clearly indicates a surgical implant used for treatment, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The EOI FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The EOI FLXfit device is intended to be used with supplemental spinal fixation system and with autogenous bone graft.
Product codes
MAX
Device Description
EOI FLXfit Intervertebral Body Fusion Device is made From Titanium (Ti6A14V-ELI per ASTM norm F136). This is an articulated-expanded device with height ranges from 8mm through 14mm. The device also expands in height to provide lordosis angle correction of up to 10°.
The FLXfit components are manufactured from titanium alloy (ASTM F136). The predicate devices are manufactured from the same or similar materials. It is implanted via a Transforaminal approach and supplemented by posterior fixation. The device is made from two titanium segments that are serrated on the superior and inferior surfaces. The titanium segments are attached (linked) with titanium wedge pins that provide the means to form the implant into its final articulated shape. The device also expands in height to provide lordosis angle correction of up to 10°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to 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)
The FLXfit has been tested in the following test modes:
- Static Axial Compression (ASTM F2077) .
- Static Compression-Shear (ASTM F2077) .
- Dynamic Axial Compression (ASTM F2077) .
- Dynamic Compression-Shear (ASTM F2077) .
- . Subsidence (ASTM F2267 and ASTM F2077)
- Usability cadaveric study conducted to evaluate clinical application of the device, . including the expansion mechanism. and intra-operative subsidence
The results of this non-clinical testing show that the strength of the FLXfit is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CoAlign Innovation AccuLiF® TL-PEEK Cage and AccuLiF® TL and PL (K112095, K123281, and K123752), Synthes T-PAL Spacer (K100089), Custom Spine Pathway AVID (K090566), Kiscomedica L-Varlock (K080537)
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.
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JUL 1 5 2014
5.510(K) SUMMARY
| Submitter's Name: | Expanding Orthopedics, Inc. |
|---|---|
| Submitter's Address: | 17 West Pontotoc Avenue Suite 200 |
| Memphis, TN 38103 | |
| Submitter's Telephone: | 901-322-0332 |
| Submitter's Fax: | 901-322-0339 |
| Authorized Contact Person: | Meredith L. May, MS |
| Empirical Testing Corp. - Empirical Consulting | |
| 719.337.7579 | |
| Date Summary was | |
| Prepared: | 15-Jul-14 |
| Trade or Proprietary Name: | FLXfit Intervertebral Body Fusion Device |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | CoAlign Innovation AccuLiF® TL-PEEK Cage and |
| AccuLiF® TL and PL (K112095, K123281, and | |
| K123752) | |
| Synthes T-PAL Spacer (K100089) | |
| Custom Spine Pathway AVID (K090566) | |
| Kiscomedica L-Varlock (K080537) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
EOI FLXfit Intervertebral Body Fusion Device is made From Titanium (Ti6A14V-ELI per ASTM norm F136). This is an articulated-expanded device with height ranges from 8mm through 14mm. The device also expands in height to provide lordosis angle correction of up to 10°.
INDICATIONS FOR USE
The EOI FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The EOI FLXfit device is intended to be used
1
with supplemental spinal fixation system and with autogenous bone graft. The indication for use for the Expanding Orthopedics FLXfit is similar to those of the predicate devices.
TECHNICAL CHARACTERISTICS
The FLXfit components are manufactured from titanium alloy (ASTM F136). The predicate devices are manufactured from the same or similar materials. It is implanted via a Transforaminal approach and supplemented by posterior fixation. The device is made from two titanium segments that are serrated on the superior and inferior surfaces. The titanium segments are attached (linked) with titanium wedge pins that provide the means to form the implant into its final articulated shape. The device also expands in height to provide lordosis angle correction of up to 10°.
PERFORMANCE DATA
The FLXfit has been tested in the following test modes:
- Static Axial Compression (ASTM F2077) .
- Static Compression-Shear (ASTM F2077) .
- Dynamic Axial Compression (ASTM F2077) �
- Dynamic Compression-Shear (ASTM F2077) .
- . Subsidence (ASTM F2267 and ASTM F2077)
- Usability cadaveric study conducted to evaluate clinical application of the device, . including the expansion mechanism. and intra-operative subsidence
The results of this non-clinical testing show that the strength of the FLXfit is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the FLXfit is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2014
Expanding Orthopedics, Incorporated % Meredith L. May, MS, RAC Empirical Consulting. LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K133813
Trade/Device Name: FLXfit Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 12, 2014 Received: June 13, 2014
Dear Ms. May:
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 complics 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 - Meredith L. May, MS. RAC
forth in the quality systems (OS) 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" (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/Safetv/ReportalProblem/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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | |
|---|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 | |
| Indications for Use | See PRA Statement on last page. | |
| 510(k) Number (if known) | K133813 | |
| Device Name | FLXfit Intervertebral body fusion device | |
| Indications for Use (Describe) | ||
| The EOI FLXfit Intervertebral body fusion device is indicated for interbody fusion in patients | ||
| with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is | ||
| defined as back pain of discogenic origin with degeneration of the disc confirmed by history | ||
| and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis | ||
| or retrolisthesis at the involved level(s). These patients should be skeletally mature and have | ||
| completed six months of non-operative treatment. The EOI FLXfit device is intended to be | ||
| used with supplemental spinal fixation system and with autogenous bone graft. | ||
| 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) | |
| PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||
| FOR FDA USE ONLY | ||
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | ||
| Anton E. Dmitriev, PhD | ||
| Division of Orthopedic Devices | ||
| FORM FDA 3881 (9/13) | Page 1 of 2 | PSC Publishing Services (301) 443-6740 EF |
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FORM FDA 3881 (9/13)
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