ESPIN

K130057 · Nlt Spine, Ltd. · HRX · Feb 7, 2013 · Orthopedic

Device Facts

• Record ID: K130057
• Device Name: ESPIN
• Applicant: Nlt Spine, Ltd.
• Product Code: HRX · Orthopedic
• Decision Date: Feb 7, 2013
• Decision: SESE
• Submission Type: Special
• 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, hand-held surgical instrument for percutaneous or open discectomy. System comprises a manipulator unit, disposable tips, and motor adaptor; connects to external electrical motor/drill. Device features articulating tip, straight during insertion and curved during rotation, for cutting and grinding intervertebral disc material. Modified version includes integrated suction and irrigation. Used in operating rooms by physicians. Output is mechanical excision of disc tissue; irrigation/suction manages debris. Benefits include targeted disc material removal during spinal fusion procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing (bending mechanism durability, tip angle verification, cleaning limits, motor parameters, tip attachment strength, bristle/tip durability) and cadaver studies to evaluate annulus breach and tip radiopacity. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Hand-held manipulator unit with disposable tips; connects to external electrical motor/drill. Features articulating tip (straight/curved). Includes suction and irrigation system. Biocompatible materials per ISO 10993. Mechanical energy source (external motor).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) requiring discectomy for fusion in L2-S1 spinal segments. Includes patients with Grade I Spondylolisthesis or retrolisthesis. Used with 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

• NLT SPINE's eSPIN (K120553)

Submission Summary (Full Text)

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K130057

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FEB 0 7 2013

# 510(k) SUMMARY NLT SPINE's eSPIN

#### Sponsor:

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

## Contact Person:

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

February 6, 2013 Date Prepared:

Name of Device: eSPIN

Common or Usual Name: Arthroscope and Accessories

Classification Name: Arthroscope and Accessories 21 CFR §880.1100 Product Code: HRX

# Predicate Devices:

NLT SPINE's eSPIN (K120553)

# Purpose of the Special 510(k) notice:

The eSPIN is a modification to previously cleared K120553 eSPIN and can be compared to the cleared device as follows:

| Feature | Predicate<br>NLT SPINE eSPIN Discectomy<br>System (K120553) | Modified<br>NLT SPINE eSPIN Discectomy<br>System |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Intended Use and<br>Indication | The eSPIN is intended for use in<br>cutting and grinding intervertebral disc<br>material during discectomy for fusion<br>procedures in L2-S1 spinal segments<br>in skeletally mature patients with | Same |
| Feature | Predicate<br>NLT SPINE eSPIN Discectomy<br>System (K120553) | Modified<br>NLT SPINE eSPIN Discectomy<br>System |
| | degenerative disc disease (DDD).<br>DDD is defined as back pain of<br>discogenic origin with degeneration of<br>the disc confirmed by the history and<br>radiographic studies. DDD patients<br>may also have up to Grade I<br>Spondylolisthesis or retrolisthesis at<br>the involved levels. The device is<br>intended to be used with<br>supplemental spinal fixation systems<br>that have been cleared for use in the<br>lumbosacral spine (i.e. posterior<br>pedicle screw and rod systems | |
| Product Code | HRX Arthroscope, 21 CFR 888.1100,<br>Class II | Same |
| Principal Operator | Physician | Same |
| Use Location | Operating room or Medical Suite | Same |
| Operating Principal | Percutaneous or open surgical<br>Discectomy system with standard<br>surgical accessories | Same |
| Functions of Included<br>Devices | Dilatation<br>Access<br>Excision | Dilatation<br>Access<br>Excision<br>Irrigation<br>Suction |
| Mechanics of Action | Percutaneous or open surgical<br>Discectomy system with standard<br>surgical accessories | Same |
| Target Anatomy | Intervertebral procedure for L2-S1<br>spinal segments | Same |
| Biocompatibility for<br>Intended Use | Yes | Yes |
| Single Use | Yes (Tips) | Yes (Tips) |
| Configuration | Straight during insertion, and curved<br>during rotation by its articulation | Straight during insertion, and curved<br>during rotation by its articulation |

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K130057

#### 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.

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K130057

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#### Technological Characteristics

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

The primary changes from the cleared eSPIN are:

- Addition of Suction tube and irrigation system .
- . Minor modifications to the device design

## Performance Data

The following testing demonstrated that the eSPIN is substantially equivalent to its predicate:

- . Bending mechanism durability of manipulator unit
- Verification of tip bending angle .
- Verification of discectomy cleaning work limits ●
- Verification of motor parameters .
- . Tip attachment strength under tensile force
- . Durability of tip bristle and tip under rotational and tensile loading
- Biocompatibility evaluation in accordance with ISO 10993 .
- Cadaver studies to evaluate whether the device breaches annulus and confirm radiopacity of . tip under X-ray

#### Substantial Equivalence

.

The eSPIN has the same intended use and indications, principles of operation, and technological characteristics as the predicate. The minor differences in the eSPIN technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the eSPIN is as safe and effective as the predicate. Thus, the eSPIN is substantially equivalent to its predicate device.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 7, 2013

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

Re: K130057

Trade/Device Name: eSPIN Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: January 09, 2013 Received: January 09, 2013

Dear Dr. 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. Iisting 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. John Smith

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Peter D.R. Rimm -S

Mark N. Melkerson Acting Director Division of Surgical 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):_____________________________________________________________________________________________________________________________________________________

Device Name: eSPIN

Indications for Use:

The eSPIN is intended for use in cutting and grinding intervertebral disc material during discectorny 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 1 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 (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -S 1300 700 1 1=1 300369056

(Division Sign-Off) Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K130057