EARP Interbody System

K212477 · Nvision Biomedical Technologies, Inc. · MAX · Apr 28, 2022 · Orthopedic

Device Facts

• Record ID: K212477
• Device Name: EARP Interbody System
• Applicant: Nvision Biomedical Technologies, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.

Device Story

EARP Interbody System consists of PEEK intervertebral body fusion implants used in lumbar spine following discectomy. Implants feature hollow centers for autograft, multiple footprints/heights for anatomical fit, and anti-migration surface features. Tantalum markers provide radiographic visualization. Device implanted by surgeons via posterolateral approach; requires supplemental fixation. System provides structural support to facilitate fusion in DDD patients. Benefits include stabilization of vertebral segments and promotion of spinal fusion.

Clinical Evidence

Bench testing only. Engineering analysis performed for mechanical performance including compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), and expulsion.

Technological Characteristics

Materials: PEEK Optima LT1 (ASTM F2026) and tantalum markers (ASTM F560). Form factor: Intervertebral cage with hollow center, multiple footprints/heights, and anti-migration surface features. Principle: Mechanical stabilization for spinal fusion. No software or energy source.

Indications for Use

Indicated for skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with or without Grade 1 spondylolisthesis, who have failed six months of non-operative treatment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Nvision Biomedical's nva, nvp, and nvt system (K193645)

Submission Summary (Full Text)

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April 28, 2022

Nvision Biomedical Technologies, Inc. % Jeffrey Brittan Vice President of Product Realization Watershed Idea Foundry 1815 Aston Ave., Suite 106 Carlsbad, California 92008

Re: K212477

Trade/Device Name: EARP Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 30, 2022 Received: April 1, 2022

Dear Jeffrey Brittan:

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Brent L. 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) K212477

Device Name EARP Interbody System

#### Indications for Use (Describe)

The EARP Interbody System is intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. These patients should have had six months of non-operative treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

## DATE PREPARED

April 27, 2022

## MANUFACTURER

Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: [phone] Fax: [phone] Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance

## REPRESENTATIVE/CONSULTANT

Jeffrev Brittan Vice President of Product Realization Watershed Idea Foundry Telephone: [phone] Email: [e-mail]

## PROPRIETARY NAME OF SUBJECT DEVICE

EARP Interbody System

## COMMON NAME Intervertebral Fusion Device with Bone Graft, Lumbar

## DEVICE CLASSIFICATION

Intervertebral Body Fusion Device (Classification Regulations: 21 CFR 888.3080, Product Codes: MAX, Class: II)

## PREMARKET REVIEW

Orthopedic Devices, Spine Devices

## INDICATIONS FOR USE

The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with decenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.

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## DEVICE DESCRIPTION

EARP implants are intervertebral body fusion devices used in the lumbar spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization. The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

## PREDICATE DEVICE IDENTIFICATION

The subject EARP Interbody System is substantially equivalent to the following predicates:

| 510(k) Number | Manufacturer & Predicate Device Name | Primary<br>Predicate |
|---------------|-----------------------------------------------|----------------------|
| K193645 | Nvision Biomedical's nva, nvp, and nvt system | ✓ |

## SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the EARP Interbody System. The following was performed to demonstrate equivalence of mechanical safety:

- Engineering analysis of mechanical performance in compression and compression-shear ● (ASTM F2077), subsidence (ASTM F2267), and expulsion.
The results of the engineering analysis demonstrated that the EARP Interbody System is substantially equivalent to the tested predicate devices.

## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The EARP Interbody System is substantially equivalent to the predicate devices. The subject implants maintain the same materials and features as the previously cleared devices but add a wider range of footprint sizes. These modifications do not change the intended use or performance of the device and do not raise additional questions of substantial equivalence. These technological characteristics have undergone engineering analysis to ensure the device would have equivalent performance as the predicates.

#### CONCLUSION

Based on the engineering analysis of device characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The equivalent indications for use, technological characteristics, and performance characteristics for the proposed EARP Interbody System are assessed to be substantially equivalent to the predicate devices.