MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)

K071375 · Disc-O-Tech Medical Technologies, Ltd. · NDN · Dec 21, 2007 · Orthopedic

Device Facts

• Record ID: K071375
• Device Name: MESH FENESTRATED INTRODUCER NEEDLE (MESH INTRODUCER NEEDLE)
• Applicant: Disc-O-Tech Medical Technologies, Ltd.
• Product Code: NDN · Orthopedic
• Decision Date: Dec 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

Device Story

Mesh Introducer Needle is a surgical instrument for percutaneous delivery of bone cement. System components: Bone Access Assembly (cannula, dilator-reamer, K-wire) and Mesh Assembly (fabric pouch mounted on injection cannula with blunt stylet). Used in OR by physicians during vertebroplasty or kyphoplasty. Bone access assembly creates working channel; mesh assembly introduces cement into vertebral body via fabric pouch. Pouch contains cement, preventing leakage during delivery. Benefits include controlled cement placement for fracture fixation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual orthopedic surgical instrument. Comprises a cannula, dilator-reamer, K-wire, and fabric mesh pouch. Materials include metal components and fabric. Non-powered, standalone device. Sterilization method not specified.

Indications for Use

Indicated for patients with pathological fractures of the vertebral body requiring vertebroplasty or kyphoplasty procedures, used in combination with the Confidence Bone Cement Delivery System.

Regulatory Classification

Identification

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Predicate Devices

• Confidence High Viscosity Bone Cements (K060300, K062424)
• Confidence Fenestrated Introducer Needle (K063067)
• V Super Revo® Herculine™ Suture Anchor (K041713)
• Force Fiber™ Polyethylene Nonabsorbable Surgical Suture (K033654)

Submission Summary (Full Text)

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K071375

# 510(K) Summary

### Disc-O-Tech Medical Technologies Ltd.

## Confidence Bone Cement Delivery System - Mesh Introducer Needle

#### Submitter Name

Disc-O-Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel

## Contact Person

### 1. Yael Rubin

Disc-O-Tech Medical Technologies Ltd. 11 Ha'Hoshlim St., Herzliya 46724, Israel Tel: [phone], Fax: [phone]

- 2. Jonathan S. Kahan, Esq.
Hogan & Hartson L.L.P 555 Thirteenth Street, NW, Washington, DC 20004 Tel: [phone], Fax: [phone]

### Date Prepared

May 2007

### Trade/Proprietary Name

Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)

### Common Name

Needle

DEC 2 1 2007

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#### Classification Name

Orthopedic Manual Surgical Instrument

#### Predicate Devices

- Confidence High Viscosity Bone Cements (K060300, K062424)
- Confidence Fenestrated Introducer Needle (K063067)
- V Super Revo® Herculine™ Suture Anchor, by Linvatec Corporation (K041713) (and Force Fiber™ Polyethylene Nonabsorbable Surgical Suture, by TeleFlex Medical (K033654)).

#### Intended Use

The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

#### System Description

The Mesh Introducer Needle is a combination of a Bone Access Assembly (Single Step Instrument) and a Mesh Assembly. The Bone Access Assembly comprises a cannula (acting as a working channel), a dilator-reamer, and a K-wire. The Mesh Assembly comprises a fabric-made mesh (pouch) through which the bone cement is introduced into the treatment site, mounted on a small diameter injection cannula, provided with a blunt edge stylet.

#### Substantial Equivalence

In general, the Mesh Introducer Needle intended use, design, materials, technological characteristics, and principles of operation are substantially equivalent to those of the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Public Health Service

DEC 2 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disc-O-Tech Medical Technologies, Ltd. % Mr. Yael Rubin 11 Ha'Hoshlim Street Herzliya 46724, Israel

Re: K071375

Trade/Device Name: Mesh Fenestrated Introducer Needle (Mesh Introducer Needle) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: NDN, OAR Dated: September 20, 2007 Received: September 25, 2007

Dear Mr. Rubin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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### Page 2 – Mr. Yael Rubin

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

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

Enclosure

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## Indication for Use

510(K) Number (if known):

Device Name: Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)

Indication for Use:

The Mesh Introducer Needle is indicated for use in combination with the Confidence Bone Cement Delivery System. The Confidence Bone Cement Delivery System is intended for percutaneous delivery of Confidence Bone Cements, which are indicated for fixation of pathological fractures of the vertebral body during vertebroplasty or kyphoplasty procedures.

Prescription Use 2 (Part 21 CFR 801 Subpart D) Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brienin

Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number_