CONFIDENCE FENESTRATED INTRODUCER NEEDLE

K063067 · Disc-O-Tech Medical Technologies, Ltd. · NDN · Nov 3, 2006 · Orthopedic

Device Facts

• Record ID: K063067
• Device Name: CONFIDENCE FENESTRATED INTRODUCER NEEDLE
• Applicant: Disc-O-Tech Medical Technologies, Ltd.
• Product Code: NDN · Orthopedic
• Decision Date: Nov 3, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Confidence Bone Cement Delivery System is intended for percutaneous delivery of bone cement, during vertebroplasty/kyphoplasty procedures

Device Story

Confidence Fenestrated Introducer Needle is a component of the Confidence Cement Delivery System used in percutaneous vertebroplasty or kyphoplasty procedures. The device consists of a cannula with a diamond-shaped closed distal tip and multiple fenestrations (holes) along the distal section, paired with a stylet. It is operated by a physician in a clinical setting to facilitate the delivery of bone cement into the vertebral body. The fenestrated design allows for controlled cement distribution. The device functions as a manual surgical instrument to stabilize vertebral fractures, thereby addressing pain associated with osteoporotic or neoplastic lesions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and technological characteristics.

Technological Characteristics

Manual orthopedic surgical instrument. Consists of a cannula and stylet. Features a diamond-shaped closed distal tip and multiple distal fenestrations for cement delivery. Non-powered, mechanical device.

Indications for Use

Indicated for fixation of pathological fractures of the vertebral body via vertebroplasty or kyphoplasty. Patient population includes individuals with painful vertebral compression fractures resulting from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancer, myeloma).

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)
• Confidence High Viscosity Bone Cements (K062424)

Submission Summary (Full Text)

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K063067 p. 1/2

# 510(K) Summary

Nov - 3 2006

## Disc-O-Tech Medical Technologies Ltd.

#### Confidence Bone Cement Delivery System - Fenestrated 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

October 2006

## Trade/Proprietary Name

Confidence Fenestrated Introducer Needle

### Common Name

Needle

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KC63067 p 2/2

Disc-O-Tech Medical Technologies Ltd. Confidence Fenestrated Introducer Needle Special 510(k)

#### Classification Name

Orthopedic Manual Surgical Instrument

## Predicate Devices

Confidence High Viscosity Bone Cements (K060300, K062424)

#### Intended Use

The Confidence Bone Cement Delivery System is intended for percutaneous delivery of bone cement, during vertebroplasty/kyphoplasty procedures

#### System Description

The Confidence Fenestrated Introducer Needle, a part of the Confidence Cement Delivery System, is combined of a cannula and a stylet. The cannula has a diamond-shape closed distal tip, and has numerous holes located around its distal section.

#### Substantial Equivalence

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Disco-O-Tech Medical Technologies, Ltd. % Hogan & Hartson, L.L.P Mr. Jonathan S. Kahan, Esq. 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

- 3 2006

Rc: K063067

Trade/Device Name: Confidence Cement Delivery System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: October 4, 2006 Received: October 6, 2006

Dear Mr. Kahan:

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 adultcration.

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. Jonathan S. Kahan, Esq.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 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): KOG3067

Device Name: Confidence Cement Delivery System

Indication for Use:

The Confidence Cement Delivery System is intended for percutaneous delivery of Confidence bone cement, which is indicated for fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebrai compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancer, myeloma).

Prescription Use (Part 21 CFR 801 Subpart D)

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

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AND/OR

CDRH, Office of Device Evaluation (ODE) Concurrence o

Styts Klude
Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________