(242 days)
Not Found
No
The summary describes a passive interbody fusion device made of PEEK and Zeolite with tantalum markers for visualization. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are mechanical and biocompatibility tests, not related to algorithmic performance.
Yes
The device is indicated for intervertebral body fusion of the lumbar spine for the treatment of degenerative disc disease, which is a medical condition, hence classifying it as a therapeutic device.
No
The device is an interbody fusion system intended for surgical implantation to facilitate spinal fusion, not to diagnose a condition. Its function is therapeutic, not diagnostic.
No
The device is a physical implant made of PEEK and Zeolite, with tantalum markers. The description details its physical characteristics, materials, and mechanical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for intervertebral body fusion of the lumbar spine. This is a surgical procedure involving the implantation of a device to facilitate bone growth between vertebrae.
- Device Description: The device is a permanent implant made of PEEK and Zeolite, designed to be surgically placed in the spine.
- Function: The device provides structural support and facilitates bone fusion. It does not perform any diagnostic testing on samples taken from the body (like blood, urine, or tissue).
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, and equivalence to a predicate surgical implant. There are no studies related to diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a surgical implant used in the body for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The XIPHOS™ ZFUZE™ Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The XIPHOS™ ZFUZE™ Interbody Fusion System is a single use sterile- packed permanent implant identical to that of the construct in the cleared XIPHOS™ Interbody Fusion system (K100042). The DiFUSION Technologies XIPHOS™ ZFUZE™ Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The XIPHOS™ ZFUZE™ Interbody Fusion System will be offered in two (2) configurations of various sizes like its predicate XIPHOS™. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS™ ZFUZE™ PLIF, posterior lumbar approach and 2) XIPHOSTM ZFUZE™ TLIF, transforaminal lumbar approach.
XIPHOS™ ZFUZE™ Interbody Fusion System implants consist of bullet shaped (PLIF) and banana shaped (TLIF) blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft to facilitate fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.
Additionally, the device contains four (4) radiolucent tantalum markers in the PLIF configuration and five (5) radiolucent tantalum markers in TLIF configuration to assist the surgeon with proper placement of the device. The PLIF device may be implanted singularly or in pairs via a posterior approach while The TLIF device may be implanted singularly via a transforaminal approach.
The XIPHOS™ ZFUZE™ Interbody Fusion System is made of Ketaspire PEEK (KT1211FP) and Type 4A Zeolite. In addition tantalum beads are embedded in the spacers to allow radiographic visualization. These permanent implants are available for prescription use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to S1
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)
The XIPHOS™ ZFUZE™ Interbody Fusion System was tested in compliance with FDA's guidance document titled "Class II special controls Guidance Document: Intervertebral Body Fusion Device" and demonstrated substantially equivalent performance characteristics to XIPHOS™ (K100042) implants which is the predicate device.
Mechanical Testing on the final device that has been gamma irradiated and aged include:
- Static Compression (ASTM F2077)
- Dynamic Compression (ASTM F2077)
- Static Torsion (ASTM F2077)
- Dynamic Torsion (ASTM F2077)
- Wear Debris (ASTM F1877)
- Expulsion
- Subsidence (ASTM F2267)
Biocompatibility assessment for the XIPHOS™ ZFUZE™ Interbody Fusion System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and the most recent FDA-recognized International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". The battery of testing also included in vitro and in vivo material assessment.
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.
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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
November 1, 2019
DiFusion Technologies % John J. Smith, M.D., J.D. Partner Hogan Lovells 555 Thirteenth Street NW Washington, District of Columbia 20004
Re: K190544
Trade/Device Name: XIPHOSTM ZFUZE™ Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: October 28, 2019 Received: October 28, 2019
Dear Dr. Smith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
K190544
Device Name
XIPHOSTM ZFUZE™ Interbody Fusion System
Indications for Use (Describe)
The XIPHOS™ ZFUZE™ Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion.
Type of Use (Select one or both, as applicable)
X 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
3
510(k) SUMMARY
DIFUSION TECHNOLOGIES XIPHOS™ ZFUZE™ INTERBODY FUSION SYSTEM
Submitter:
DiFusion Technologies 1624 Headway Circle Austin, Texas- 78754 Phone: 512-284-3338 Contact Person: Derrick W. Johns
Date Prepared:
October 30, 2019
Name of Device:
XIPHOS™ ZFUZE™ Interbody Fusion System
Common or Usual Name:
Intervertebral body fusion device
Classification Name:
Intervertebral Body Fusion Device, 21 CFR 888.3080
Regulatory Class:
Class II
Product Code:
MAX
Primary Predicate Device:
XIPHOS™ Interbody Fusion System (K100042): The XIPHOS™ Interbody Fusion System is a Class II device regulated under 21 CFR 888.3080.
DEVICE DESCRIPTION
The XIPHOS™ ZFUZE™ Interbody Fusion System is a single use sterile- packed permanent implant identical to that of the construct in the cleared XIPHOS™ Interbody Fusion system (K100042). The DiFUSION Technologies XIPHOS™ ZFUZE™ Interbody Fusion System is comprised of various sizes and configurations to accommodate individual patient anatomy. The configurations are designed to provide the surgeon with different surgical approach options. The XIPHOS™ ZFUZE™ Interbody Fusion System will be offered in two (2) configurations of various sizes like its predicate
4
XIPHOS™. The configurations are designed based on indicated spinal implant level and surgical approach, and consist of: 1) XIPHOS™ ZFUZE™ PLIF, posterior lumbar approach and 2) XIPHOSTM ZFUZE™ TLIF, transforaminal lumbar approach.
XIPHOS™ ZFUZE™ Interbody Fusion System implants consist of bullet shaped (PLIF) and banana shaped (TLIF) blocks in a parallel configuration of various heights. Large bone graft windows are located through the body of the device to allow for placement of bone graft to facilitate fusion. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and inhibit movement of the implants.
Additionally, the device contains four (4) radiolucent tantalum markers in the PLIF configuration and five (5) radiolucent tantalum markers in TLIF configuration to assist the surgeon with proper placement of the device. The PLIF device may be implanted singularly or in pairs via a posterior approach while The TLIF device may be implanted singularly via a transforaminal approach.
The XIPHOS™ ZFUZE™ Interbody Fusion System is made of Ketaspire PEEK (KT1211FP) and Type 4A Zeolite. In addition tantalum beads are embedded in the spacers to allow radiographic visualization. These permanent implants are available for prescription use only.
INDICATIONS FOR USE
The XIPHOS™ ZFUZE™ Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with supplemental fixation and with autograft to facilitate fusion.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Intervertebral body fusion through Posterior or Transforminal approach is the technological principle for both the subject and predicate device. Appropriate surgical instrumentation is used to insert the implants into the intervertebral space in order to assist in fusion. At a high level the subject and predicate XIPHOS™ Interbody fusion devices are based on the following common technological elements:
- Implant Design - PLIF & TLIF
- Indications for Use
- Intended Use
- . Surgical Technique
The technological difference that exists between the subject (XIPHOS™ ZFUZE™) and predicate device is in the material composition. XIPHOS™ ZFUZE™ Interbody device is composed of PEEK and Type 4A Zeolite while the predicate XIPHOS™ implants contains PEEK exclusively. This difference in material composition does not raise a concern as it is shown to be substantially equivalent to the predicate.
5
PERFORMANCE DATA
The XIPHOS™ ZFUZE™ Interbody Fusion System was tested in compliance with FDA's guidance document titled "Class II special controls Guidance Document: Intervertebral Body Fusion Device" and demonstrated substantially equivalent performance characteristics to XIPHOS™ (K100042) implants which is the predicate device.
Mechanical Testing on the final device that has been gamma irradiated and aged include:
- Static Compression (ASTM F2077) .
- Dynamic Compression (ASTM F2077) .
- . Static Torsion (ASTM F2077)
- . Dynamic Torsion (ASTM F2077)
- Wear Debris (ASTM F1877)
- Expulsion ●
- Subsidence (ASTM F2267) ●
Biocompatibility assessment for the XIPHOS™ ZFUZE™ Interbody Fusion System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 and the most recent FDA-recognized International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". The battery of testing also included in vitro and in vivo material assessment.
CONCLUSIONS
The overall intended use and indication, technological characteristics and performance data conclude that the XIPHOS™ ZFUZE™ Interbody Fusion System is shown to be substantially equivalent to the predicate XIPHOS™ Interbody Fusion System (K100042).