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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Xenco Medical InterAlign Cervical Interbody System. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance data as might be seen for novel devices or those requiring PMA.

Therefore, the document does not contain information on acceptance criteria for device performance in a clinical study, nor does it detail a study that proves the device meets such criteria in terms of clinical outcomes. Instead, it demonstrates equivalence to existing devices primarily through technological characteristics and non-clinical performance testing.

Here's a breakdown based on the provided text, addressing the points where information is available or relevant to a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not applicable in the context of a 510(k) summary for a cervical interbody system. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific clinical performance acceptance criteria in a study. The "Performance Testing" section states: "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."

This indicates that equivalence was established through material, design, and manufacturing comparisons, along with sterilization validation. There are no clinical performance metrics or acceptance criteria presented.

2. Sample Size Used for the Test Set and the Data Provenance:

This information is not applicable as there was no clinical "test set" in the context of device performance testing for this 510(k). The evaluation was based on design and material comparisons to predicate devices and non-clinical testing for material changes (sterilization validation).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable. Ground truth establishment for a clinical test set is not part of this 510(k) submission.

4. Adjudication Method for the Test Set:

This information is not applicable. No clinical test set adjudication method is mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

This information is not applicable. An MRMC comparative effectiveness study is a clinical study involving human readers (e.g., radiologists interpreting images affected by an AI device) and is not relevant to this 510(k) for an interbody fusion device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. This device is a physical implant, not an algorithm, and therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

This information is not applicable for clinical performance. The "ground truth" in this 510(k) context relates to the established safety and effectiveness of the predicate devices based on their prior clearances and the technical specifications/materials of the subject device matching or being equivalent to those predicates.

8. The Sample Size for the Training Set:

This information is not applicable, as there is no "training set" in the context of an algorithm or AI.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no "training set" for this device.

In summary, for the Xenco Medical InterAlign Cervical Interbody System as described in this 510(k) submission (K223059):

The device gained clearance by demonstrating substantial equivalence to previously cleared predicate devices (K160313, K140786) and a reference device (K112913). The primary arguments for equivalence are:

Identical Implants: The implants of the subject device are identical to those cleared in K160313.
No Change in Indications/Claims: The indications for use and claims are unchanged from the predicate.
Material Equivalence: The instrumentation material is identical to the reference device (K112913).
Non-clinical Performance Testing: A gamma sterilization validation was performed to support the change in instrument material. No new non-clinical performance testing was required for the implants because they are identical to the predicate. No biocompatibility testing was required for the instrument material change due to its similarity to the reference device.

The 510(k) process explicitly relies on the premise that if a new device is substantially equivalent to a legally marketed predicate device (in terms of intended use, technological characteristics, and safety/effectiveness), then it does not raise new questions of safety and effectiveness and does not require a full clinical trial to establish performance criteria.

Summary

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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

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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:

When used as an intervertebral fixsion, cervical (interbody spacer w/ provided plate, bone screws, and locking cover):

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 HighwaySuite 120Woodstock, GA 30188770-837-2681Regulatory@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 IIProduct Code: OVE, ODP
Primary PredicateDevice	K160313 Xenco Medical Cervical Interbody System
Additional PredicateDevice	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 generallybox shaped with surface teeth and a central channel for packing autogenousbone. These implants are available in a range of shapes and sizes toaccommodate variations in patient anatomy. Spacers are manufactured fromPEEK polymer (Zeniva ZA-500 per ASTM F2026) and contain titanium (perASTM F67), titanium alloy (per ASTM F1472), or tantalum (per ASTM F560)markers to assist with radiographic visualization. Stand-alone deviceconstructs additionally utilize a fixation plate and bone screws manufacturedfrom titanium alloy, and a PEEK locking cover. The system also includesinstruments manufactured using anodized 6061 T6 aluminum alloy per ASTMB211 / B221. All system implants and instruments are provided sterilepackaged and are intended for single use.
Indications for UseStatement	When used as an intervertebral fusion device with bone graft, cervical:Xenco Medical IntelAlign Cervical Interbody System devices are intended forspinal fusion procedures at one level (C3-C7) in skeletally mature patientswith degenerative disc disease (defined as neck pain of discogenic origin withdegeneration of the disc confirmed by history and radiographic studies) of thecervical spine. Devices are to be implanted via an open, anterior approach andpacked with autogenous bone. Patients should have had at least six weeks ofnon-operative treatment prior to surgical treatment with the device. The deviceis 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 adjunctto fusion at one level (C3-C7) in skeletally mature patients with degenerativedisc disease (defined as discogenic neck pain with degeneration of the discconfirmed by history and radiographic studies). Patients should have receivedat least six weeks of non-operative treatment prior to treatment with thedevice. Xenco Medical IntelAlign Interbody System constructs are to bepacked with autogenous bone graft and implanted via an open, anteriorapproach. Xenco Medical IntelAlign Cervical Interbody System constructs areintended to be used with the plate, bone screws, and locking cover providedand require no additional fixation.
TechnologicalCharacteristics	There are no significant technological differences between the subject andpredicate device. The subject device implants are identical to those of theprimary predicate (K160313). The only difference between the subject andpredicate device is the material of manufacture for the instrumentation whichis identical to the reference device (K112913). As supported by the non-clinical performance testing, this difference does not raise new concerns forsafety or effectiveness.
PerformanceTesting	As the implants are identical to those cleared in K160313 and no changes havebeen made to indications or claims, no new non-clinical performance testingwas required for the subject device implants. The subject deviceinstrumentation is manufactured identically to those described in the referencedevice (K112913). As such, no biocompatibility testing was required tosupport the change. A gamma sterilization validation was performed tosupport the change in device material.
Conclusion	Based on the similarities of the intended use/indications for use, technologicaland functional characteristic, and the results of the non-clinical performancetesting, the subject device is substantially equivalent to the legally marketedpredicate device.

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Regulation Number and Section

§ 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.