nva, nvp, nvt

K142594 · Nvision Biomedical Technologies, LLC · MAX · Nov 28, 2014 · Orthopedic

Device Facts

• Record ID: K142594
• Device Name: nva, nvp, nvt
• Applicant: Nvision Biomedical Technologies, LLC
• Product Code: MAX · Orthopedic
• Decision Date: Nov 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The nva, nvP, and nvt are 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 or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.

Device Story

Intervertebral body fusion devices (nva, nvP, nvt) designed for lumbar spine stabilization following discectomy; manufactured from PEEK Optima LT1 with tantalum markers for radiographic visualization; feature hollow centers for bone graft and anti-migration surface geometries; implanted by surgeons via anterior, posterior, or transforaminal approaches; used in conjunction with supplemental fixation to facilitate fusion; provide structural support to vertebral endplates; intended to alleviate pain associated with degenerative disc disease.

Clinical Evidence

Bench testing only. Performance testing conducted per ASTM F2077 (static and dynamic axial compression) and ASTM F2267 (subsidence), plus expulsion testing. No clinical data provided.

Technological Characteristics

Materials: PEEK Optima LT1 (ASTM F2026) and tantalum markers (ASTM F560). Design: Intervertebral cage with hollow center for bone graft, anti-migration surface features, and varying footprints/heights. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD defined as discogenic back pain with degeneration confirmed by history/radiography. Patients must have failed six months of non-operative treatment. May include Grade 1 spondylolisthesis or retrolisthesis. Must be used with supplemental fixation and autograft.

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

• Genesys Spine ApacheTM System (K103034)
• SeaSpine Spacer System – PacificaTM (K082310)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 28, 2014

Nvision Biomedical Technologies, LLC % Ms. Jennifer Palinchik JALEX Medical, LLC 27881 Clemens Road. Suite 2 Westlake, Ohio 44145

Re: K142594

Trade/Device Name: nvª, nvP and nv* Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 5, 2014 Received: September 15, 2014

Dear Ms. Palinchik:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 at its toll-free number [phone] or [phone] 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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K142594

Device Name nva, nvP, and nvt

#### Indications for Use (Describe)

The nvª, nvº, and nv are 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 with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) Summary

| Submitted By: | Nvision Biomedical Technologies, LLC<br>18618 Tuscany Stone, Suite 120 |
|-----------------------------|------------------------------------------------------------------------|
| | San Antonio, TX 78258 |
| Date: | November 24, 2014 |
| Contact Person: | Jennifer Palinchik |
| | Regulatory Consultant |
| Contact Telephone: | [phone] |
| Device Trade Name: | nva, nvp, and nvt |
| Device Classification Name: | Intervertebral Body Fusion Device with Bone Graft, |
| | Lumbar (21 CFR 888.3080) |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | MAX |
| Predicate Device: | Primary Predicate: Genesys Spine ApacheTM System |
| | (ALIF and TLIF) (K103034) |
| | Other Predicate: SeaSpine Spacer System – PacificaTM |
| | (K082310). |
| | These predicates have not been subject to a design-related<br>recall. |

### Device Description:

The nv4, nv9, and nvb 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 nv4 and nv2 devices have multiple footprints to adapt to the general shape of the vertebral endplates. The nv , nv , and nv are available in multiple heights to accommodate patient variability and have a hollow centre to accommodate bone graft. The devices are implanted via a variety of surgical approaches which include anterior, and transforaminal. There are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

### Intended Use:

The nv4, nv2, and nv are 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

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may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device systems must be used with supplemental fixation and autograft to facilitate fusion and are implanted via an anterior, posterior, or transforaminal approach.

## Substantial Equivalence Information:

The nv , nv , and nv are substantially equivalent to the predicate devices in intended use, materials, design features, technological characteristics, mechanical safety and performances. The comparison of information provided in this Premarket Notification supports the substantial equivalence, material information, and analysis of data.

## Summary of Technological Characteristics:

The nv4, nv8, and nv are substantially equivalent to the predicates as shown by the similarity of the intended use, materials, labeling, and performance. Functionally, footprint sizes, heights, and anti-migration features are substantially equivalent as supported by this Premarket Notification.

## Mechanical Testing:

Performance testing was conducted in accordance with the following standardized tests:

- . Static and Dynamic Axial Compression per ASTM F2077
- Subsidence per ASTM F2267 ●
- Expulsion

The results of the performance testing demonstrate substantial equivalence of the nv , and nv to the predicate devices.