(250 days)
No
The 510(k) summary describes a standard intervertebral fusion device made of PEEK and metal, with no mention of AI or ML in its intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an intervertebral fusion device intended for spinal fusion procedures, which is a surgical implant rather than a therapeutic device in the sense of delivering therapy.
No
Explanation: The device is an intervertebral fusion device (implant) used for spinal fusion procedures, not for diagnosing medical conditions. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states the device is an intervertebral fusion device made of PEEK polymer, titanium, and other materials, and includes instruments. This indicates it is a physical medical device, not software only.
Based on the provided information, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Xenco Medical InterAlign Cervical Interbody System is an implantable surgical device used for spinal fusion. It is physically placed within the patient's body to provide structural support and promote bone growth.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease in the cervical spine by fusing vertebrae. This is a therapeutic intervention, not a diagnostic test performed on a specimen outside the body.
- Device Description: The description details the materials and components of an implant and surgical instruments, not reagents, analyzers, or other equipment typically associated with IVDs.
The device is a medical device, specifically an implantable surgical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used as an intervertebral fusion device with bone graft, cervical: Xenco Medical InterAlign Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).
When used as an intervertebral fixsion, cervical (interbody spacer w/ provided plate, bone screws, and locking cover): Xenco Medical InterAlign Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xeno Medical InterAlign Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical InterAlign Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.
Product codes
OVE, ODP
Device Description
Xenco Medical IntelAlign Cervical Interbody System devices are generally box shaped with surface teeth and a central channel for packing autogenous bone. These implants are available in a range of shapes and sizes to accommodate variations in patient anatomy. Spacers are manufactured from PEEK polymer (Zeniva ZA-500 per ASTM F2026) and contain titanium (per ASTM F67), titanium alloy (per ASTM F1472), or tantalum (per ASTM F560) markers to assist with radiographic visualization. Stand-alone device constructs additionally utilize a fixation plate and bone screws manufactured from titanium alloy, and a PEEK locking cover. The system also includes instruments manufactured using anodized 6061 T6 aluminum alloy per ASTM B211 / B221. All system implants and instruments are provided sterile packaged and are intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-C7)
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)
As the implants are identical to those cleared in K160313 and no changes have been made to indications or claims, no new non-clinical performance testing was required for the subject device implants. The subject device instrumentation is manufactured identically to those described in the reference device (K112913). As such, no biocompatibility testing was required to support the change. A gamma sterilization validation was performed to support the change in device material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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June 7, 2023
Xenco Medical, LLC % Linda Braddon, Ph.D. CEO Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock. Georgia 30188
Re: K223059
Trade/Device Name: Xenco Medical InterAlign Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: May 10, 2023 Received: May 12, 2023
Dear Dr. Braddon:
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
1
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 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 (QS) 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,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223059
Device Name
Xenco Medical InterAlign Cervical Interbody System
Indications for Use (Describe) When used as an intervertebral fusion device with bone graft, cervical:
Xenco Medical InterAlign Cervical Interbody System devices are intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Devices are to be implanted via an open, anterior approach and packed with autogenous bone. Patients should have had at least six weeks of nonoperative treatment prior to surgical treatment with the device is intended to be used with supplemental fixation (e.g. anterior plate system).
When used as an intervertebral fixsion, cervical (interbody spacer w/ provided plate, bone screws, and locking cover):
Xenco Medical InterAlign Cervical Interbody System constructs are stand-alone anterior cervical interbody fusion devices intended for use as an adjunct to fusion at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients should have received at least six weeks of non-operative treatment with the device. Xeno Medical InterAlign Cervical Interbody System constructs are to be packed with autogenous bone graft and implanted via an open, anterior approach. Xenco Medical InterAlign Cervical Interbody System constructs are intended to be used with the plate, bone screws, and locking cover provided and require no additional fixation.
| 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) |
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| 510(k) SUMMARY: |
|---|
| Xenco Medical IntelAlign Cervical Interbody System |
| Date Prepared | May 31, 2023 |
|---|---|
| Sponsor | Xenco Medical, LLC |
| Jason Haider, Founder and CEO | |
| 9930 Mesa Rim Rd | |
| San Diego, CA 92121 | |
| 858-202-1522 ext. 202 | |
| jhaider@xencomedical.com | |
| 510(k) Contact(s) | Secure BioMed Evaluations |
| Linda Braddon, Ph.D. | |
| Justin Gracyalny, MSE | |
| 7828 Hickory Flat Highway | |
| Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 | |
| Regulatory@SecureBME.com | |
| Trade Name | Xenco Medical IntelAlign Cervical Interbody System |
| Code – | |
| Classification | Classification Name: Intervertebral body fusion device (21 CFR 888.3080) |
| Regulatory Class: Class II | |
| Product Code: OVE, ODP | |
| Primary Predicate | |
| Device | K160313 Xenco Medical Cervical Interbody System |
| Additional Predicate | |
| Device | K140786 Xenco Medical Cervical Interbody System |
| Reference Device | K112913 DePuy Spine, Inc. Spotlight Access System |
| Device Description | Xenco Medical IntelAlign Cervical Interbody System devices are generally |
| box shaped with surface teeth and a central channel for packing autogenous | |
| bone. These implants are available in a range of shapes and sizes to | |
| accommodate variations in patient anatomy. Spacers are manufactured from | |
| PEEK polymer (Zeniva ZA-500 per ASTM F2026) and contain titanium (per | |
| ASTM F67), titanium alloy (per ASTM F1472), or tantalum (per ASTM F560) | |
| markers to assist with radiographic visualization. Stand-alone device | |
| constructs additionally utilize a fixation plate and bone screws manufactured | |
| from titanium alloy, and a PEEK locking cover. The system also includes | |
| instruments manufactured using anodized 6061 T6 aluminum alloy per ASTM | |
| B211 / B221. All system implants and instruments are provided sterile | |
| packaged and are intended for single use. | |
| Indications for Use | |
| Statement | When used as an intervertebral fusion device with bone graft, cervical: |
| Xenco Medical IntelAlign Cervical Interbody System devices are intended for | |
| spinal fusion procedures at one level (C3-C7) in skeletally mature patients | |
| with degenerative disc disease (defined as neck pain of discogenic origin with | |
| degeneration of the disc confirmed by history and radiographic studies) of the | |
| cervical spine. Devices are to be implanted via an open, anterior approach and | |
| packed with autogenous bone. Patients should have had at least six weeks of | |
| non-operative treatment prior to surgical treatment with the device. The device | |
| is intended to be used with supplemental fixation (e.g. anterior plate system). |
When used as an intervertebral fusion device w/ integrated fixation, cervical
(interbody spacer w/ provided plate, bone screws, and locking cover):
Xenco Medical IntelAlign Cervical Interbody System constructs are stand-
alone anterior cervical interbody fusion devices intended for use as an adjunct
to fusion at one level (C3-C7) in skeletally mature patients with degenerative
disc disease (defined as discogenic neck pain with degeneration of the disc
confirmed by history and radiographic studies). Patients should have received
at least six weeks of non-operative treatment prior to treatment with the
device. Xenco Medical IntelAlign Interbody System constructs are to be
packed with autogenous bone graft and implanted via an open, anterior
approach. Xenco Medical IntelAlign Cervical Interbody System constructs are
intended to be used with the plate, bone screws, and locking cover provided
and require no additional fixation. |
| Technological
Characteristics | There are no significant technological differences between the subject and
predicate device. The subject device implants are identical to those of the
primary predicate (K160313). The only difference between the subject and
predicate device is the material of manufacture for the instrumentation which
is identical to the reference device (K112913). As supported by the non-
clinical performance testing, this difference does not raise new concerns for
safety or effectiveness. |
| Performance
Testing | As the implants are identical to those cleared in K160313 and no changes have
been made to indications or claims, no new non-clinical performance testing
was required for the subject device implants. The subject device
instrumentation is manufactured identically to those described in the reference
device (K112913). As such, no biocompatibility testing was required to
support the change. A gamma sterilization validation was performed to
support the change in device material. |
| Conclusion | Based on the similarities of the intended use/indications for use, technological
and functional characteristic, and the results of the non-clinical performance
testing, the subject device is substantially equivalent to the legally marketed
predicate device. |
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