ESPIN

K120553 · Nlt Spine, Ltd. · HRX · Aug 9, 2012 · Orthopedic

Device Facts

• Record ID: K120553
• Device Name: ESPIN
• Applicant: Nlt Spine, Ltd.
• Product Code: HRX · Orthopedic
• Decision Date: Aug 9, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

Device Story

eSpin is a powered surgical instrument for cutting and grinding intervertebral disc material during discectomy. System comprises a hand-held manipulator unit, disposable tips, and a motor adaptor; requires connection to an external electrical motor. Used by surgeons in clinical settings to facilitate spinal fusion procedures. Device enables mechanical removal of disc tissue; intended for use alongside supplemental posterior pedicle screw and rod fixation systems. Benefits include efficient disc material removal during fusion surgery.

Clinical Evidence

Bench and cadaver testing performed. No clinical data provided.

Technological Characteristics

Powered hand-held manipulator unit with disposable tips and motor adaptor. Requires external electrical motor. Mechanical cutting/grinding principle. Non-implantable surgical instrument.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) requiring discectomy for fusion in L2-S1 spinal segments. DDD defined as discogenic back pain with radiographic confirmation; includes patients with up to Grade I Spondylolisthesis or retrolisthesis. Used with cleared supplemental spinal fixation systems.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Spine View enSpire Discectomy System (K110992)

Submission Summary (Full Text)

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K120553.

NLT SPINE eSpin Traditional 510(k) Premarket Notification

#### 510(k) SUMMARY

As required by 21 C.F.R. § 807.92

Sponsor:

NLT SPINE Ltd. 6 Yad Harutzim St. Kfar-Saba lsrael 44641

Contact Person:

Eti Zinger Regulatory Affairs Director NLT SPINE Ltd. Tel: [phone] Fax: [phone] [e-mail]

Date Prepared: August 10, 2012 - .

Name of Device: eSpin

Common or Usual Name: Arthroscope and Accessories

Classification Name: Arthroscope and Accessories 21 CFR §888.1100 Product Code HRX

### Predicate Devices

- . Spine View enSpire Discectomy System (K110992)
# Intended Use / Indications for Use

The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

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Image /page/0/Picture/19 description: The image shows the logo for NLT Spine. The logo consists of a stylized spine graphic on the left, followed by the text "NLTSPINE" in a bold, sans-serif font. Below "NLTSPINE" is the text "NonLinear Technologies" in a smaller, sans-serif font.

AUG 9 2012

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## Technological Characteristics

The eSpin powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and a motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator for discectomy. The eSpin needs to be connected to an Electrical Motor. The required motor specifications are provided in the eSpin User Manual.

## Performance Data

Performance testing in bench and cadaver models demonstrated that the eSpin is substantially equivalent to its predicate.

### Substantial Equivalence

The eSpin is as safe and effective as its predicate device. The eSpin has substantially similar indications for use and technological characteristics as compared to the predicate device. Any minor differences between the device and the predicate do not raise new questions of safety and effectiveness. The company's bench and cadaver testing demonstrate that the eSpin is as safe and effective as its predicate.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.

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

> 9 2012 AUG

NLT Spine Limited % Hogan & Lovells US, LLP Mr. John J. Smith 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K120553

Trade/Device Name: eSpin Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope and Accessories Regulatory Class: II Product Code: HRX Dated: August 09, 2012 Received: August 09, 2012

Dear Mr. 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. 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

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## Page 2 - Mr. John J. Smith

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours

Mark N. Malkerson

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

Enclosure

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Indications for Use Statement

510(k) Number (if known):__ K120553

Device Name: eSpin

Indications for Use:

The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

| Concurrence of (Division Sign-Off) | |
|-----------------------------------------------------------|-------------|
| (ODRH, Office of Device Evaluation (ODE)) | |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| Page | _ of _ |
| 510(k) Number | 14120533 |
| Page | Page 1 of 1 |