EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM

K060494 · Medchannel, LLC · GDW · Jul 3, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060494
• Device Name: EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM
• Applicant: Medchannel, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EasyTac Anchor and delivery system is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.

Device Story

EasyTac Anchor is an endoscopic/open surgical stapler for soft tissue approximation and mesh fixation. System comprises a disposable delivery instrument and resorbable fixation devices. Instrument features ergonomic handle, trigger, locking/unlocking mechanism, rotation knob, shaft containing 5-15 fixation devices, and retractable hollow needle. Used by surgeons in laparoscopic or open surgical settings. Device delivers resorbable anchors to secure mesh to tissue. Benefits include simplified fixation during hernia repair.

Clinical Evidence

Bench testing only.

Technological Characteristics

Resorbable fixation devices; disposable delivery instrument with ergonomic handle, trigger, and retractable hollow needle. Sterilization via ethylene oxide (AAMI 11135). Quality management per ISO 13485. Biological evaluation per ISO 10993-1.

Indications for Use

Indicated for soft tissue approximation and surgical mesh fixation during laparoscopic procedures, including hernia repair.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Submission Summary (Full Text)

{0}------------------------------------------------

K060494

1/2

# 510(k) Summary of Safety and Effectiveness MedChannel EasyTAC

#### Company Name

JUL - 3 2006

MedChannel, LLC 1241 Adams Street #603 Boston, MA 02210

#### Device Name

| Proprietary Name: | MedChannel EasyTac Anchor |
|-------------------------|---------------------------|
| Common Name: | Anchor |
| Classification Name(s): | Implantable Staple |
| Classification Code(s): | GDW |
| Classification: | Class II 878.4750 |

#### Predicate Devices used for Substantial Equivalence

| Trannon | DADICEIV<br>+++ | COLLECT AND LA<br>A DIM DD OD ODLICTION<br>CONTIN |
|---------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| 1701911<br>NAME A LEGE BE BRIT BE LEA LE BE LE BE LE BE | A BRACH AND START CONSULT COLLEGION COLLEGION<br>DECATIV | -------------------------------------------------------------------------------------------------<br>do the Part<br><br>: |

### Intended Use & Indications

The EasyTac Anchor and delivery system is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.

### Description

The EasyTac Anchor device is an endoscopic or open surgical stapler composed of a disposable delivery instrument and resorbable fixation devices. The EasyTac Anchor Delivery System consists of an ergonomic handle, trigger, locking and unlocking mechanism, totation knob, shaft containing a cartridge of five to fifteen fixation devices, and retractable hollow needle.

#### Summary of Standards Achieved

| 21 CFR § 820 | FDA Quality Systems Regulation |
|-----------------------------|----------------------------------------------------------------------------|
| ISO 10993:1 | Biological evaluation of medical devices -- Part 1: Evaluation and testing |
| AAMI 11135<br>Sterilization | Medical Devices - Validation and Routine Control of Ethylene Oxide |
| ISO 13485 | Medical Devices - Quality Management Systems Requirements |

{1}------------------------------------------------

# Summary

In summary, the MedChannel EasyTac Anchors are substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 3 2006

MedChannel LLC % Mr. Frederick Tobia Regulatory Consultant 55 Worcester Street, #3 Boston, Massachusetts 02118

Re: K060494

Trade/Device Name: MedChannel EasyTac Anchor Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: May 30, 2006 Received: June 5. 2006

Dear Mr. Tobia:

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 Mav 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

#### Page 2 - Mr. Frederick Tobia

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" (21 CFR 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 vours.

Barbay Buelup
for

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

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K060494

Device Name: MedChannel EasyTac Anchor

Indications for Use:

The EasyTac Anchor and delivery system is indicated for approximation of soft tissues and fixation of surgical mesh to tissues during laparoscopic surgical procedures such as hernia repair.

Prescription Use Over-The-Counter Use Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Comments on and consistences and consistence and consistences and consections and consections of the commender and the comments of the comments of the commentation in the com

Arabase Buckum

Division of General, Restorative, and Neurological Devices

Page _ 1_ of _ l _

510(k) Number K060494