(114 days)
No
The summary describes a mechanical intervertebral body fusion device and its mechanical testing. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
Yes
Explanation: The device is indicated for interbody fusion in patients with degenerative disc disease, which involves treating a medical condition to improve health.
No
Explanation: The device described is an intervertebral body fusion device used for surgical treatment of degenerative disc disease, not for diagnosing conditions.
No
The device description clearly states the device is made from titanium and is an articulated-expanded device, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for interbody fusion in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device into the body.
- Device Description: The device is described as an implantable device made from titanium, designed to be placed between vertebrae.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples.
Therefore, the EOI FLXfit™ 15 and FLXfit™ Intervertebral body fusion device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EOI FLXfit™ 15 and 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™ 15 and FLXfit™ devices are intended to be used with supplemental spinal fixation system and with autogenous bone graft.
Important: FLXfit™ 15 must be applied in combination with posterior fusion system such as the EOI Spinal System.
Product codes
MAX
Device Description
EOI FLXfit15 Intervertebral Body Fusion Device is made from titanium (Ti6Al4V-ELI per ASTM F136). This is an articulated-expanded device with height ranges from 8mm through 13mm. The device also expands in height to provide lordosis angle correction of up to 15°.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
L2 to S1 (Spine)
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)
Expanding Orthopedics has conducted mechanical testing to demonstrate that the modifications to the FLXfit15 Lumbar Interbody Fusion System provide adequate and substantially equivalent mechanical strength for their intended use. The tests conducted were:
- Dynamic and static compression per ASTM F2077
- Dynamic and static shear compression per ASTM F2077
- Subsidence per ASTM F2267
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its design. The eagle and profiles are black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Expanding Orthopedics, Inc. % Meredith May Senior Manager Empirical Technologies Corp. 4628 Northpark Drive
Colorado Springs, Colorado 80918
September 15, 2017
Re: K171519
Trade/Device Name: FLXfit™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 15, 2017 Received: June 19, 2017
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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education (DICE) 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/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 (DICE) 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.
Mark N. Melkerson -S
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 Food and Drug Administration Indications for Use
510(k) Number (if known) K171519 Device Name
FLXfit™
Indications for Use (Describe)
The EOI FLXfit™ 15 and 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™ 15 and FLXfit™ devices are intended to be used with supplemental spinal fixation system and with autogenous bone graft.
Important: FLXfit™ 15 must be applied in combination with posterior fusion system such as the EOI Spinal System.
Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) 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."
FORM FDA 3881 (8/14)
Page 1 of 1
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| Submitter's Name: | Expanding Orthopedics |
|---|---|
| Submitter's Address: | 3379 Peachtree Road NE (Buckhead), Suite 555, Atlanta, GA |
| 30326 | |
| Submitter's Telephone: | 901.322.0332 |
| Contact Person: | Meredith L. May, MS |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was Prepared | 15 September 2017 |
| Trade or Proprietary Name: | FLXfitTM |
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Orthopedic |
| Predicate Devices | K133813 FLXfitTM by Expanding Orthopedics Inc - Primary |
| K080537 L-Varlock by Kiscomedica - Additional |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: EOI FLXfit15 Intervertebral Body Fusion Device is made from titanium (Ti6Al4V-ELI per ASTM F136). This is an articulated-expanded device with height ranges from 8mm through 13mm. The device also expands in height to provide lordosis angle correction of up to 15°.
INDICATIONS FOR USE
The EOI FLXfit™ 15 and 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™ 15 and FLXfit devices are intended to be used with supplemental spinal fixation system and with autogenous bone graft.
Important: FLXfif™ 15 must be applied in combination with posterior fusion system such as the EOI Spinal System.
TECHNOLOGICAL CHARACTERISTICS COMPARISON
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The purpose of this submission is to add the FLXfit 15 with additional lengths and lordotic angles to the FLXfit family of interbody devices. FLXfit 15 Lumbar Interbody Fusion Device is a modified FLXfit™ Lumbar Interbody Fusion Device and adds two main features compared to the current FLXfit: an additional device length option of 32mm to the already existing 40mm) and up to 15° of lordosis correction angle as opposed to the 10° of the original FLXfit™. Those features do not involve any change in the device's mechanism, technical characteristics, material or usability. As such, the differences do not adversely affect the safety and efficacy of the device.
The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for use .
- Materials of manufacture .
- Structural support mechanism .
PERFORMANCE TESTING SUMMARY
In support of this Traditional 510(k) Premarket Notification, Expanding Orthopedics has conducted mechanical testing to demonstrate that the modifications to the FLXfit15 Lumbar Interbody Fusion System provide adequate and substantially equivalent mechanical strength for their intended use. The tests conducted were:
- Dynamic and static compression per ASTM F2077 .
- . Dynamic and static shear compression per ASTM F2077
- . Subsidence per ASTM F2267
CONCLUSION
The subject modified is FLXfit15 Lumbar Interbody Fusion System is similar to the previously cleared FLXfit Lumbar Interbody Fusion System. The subject FLXfit15 Lumbar Interbody Fusion System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate device. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance data
5
lead to the conclusion that the FLXfit15 Lumbar Interbody Fusion System is substantially equivalent to the predicate device.