(129 days)
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.
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.
The provided text is a 510(k) summary for the MedChannel EasyTac Anchor, a medical device. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria through a clinical trial or performance study comparing it against a predefined set of metrics.
Therefore, the document does not contain the information requested regarding detailed acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC comparative effectiveness study results.
The 510(k) summary focuses on:
- Intended Use & Indications: For approximation of soft tissues and fixation of surgical mesh during laparoscopic surgical procedures like hernia repair.
- Description: An endoscopic/open surgical stapler with a disposable delivery instrument and resorbable fixation devices.
- Predicate Devices: Lists one predicate device, "Trannon," but no specific performance data for comparison is provided.
- Standards Achieved: Mentions compliance with FDA Quality Systems Regulation (21 CFR § 820), ISO 10993:1 (biological evaluation), AAMI 11135 (sterilization), and ISO 13485 (quality management).
The core of a 510(k) submission is to assert "substantial equivalence" to a predicate device, as explicitly stated in the 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." This means the device relies on the established safety and effectiveness of its predicate, rather than presenting a new study with explicit acceptance criteria for performance.
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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+++ | COLLECT AND LAA DIM DD OD ODLICTIONCONTIN |
|---|---|---|
| 1701911NAME A LEGE BE BRIT BE LEA LE BE LE BE LE BE | A BRACH AND START CONSULT COLLEGION COLLEGIONDECATIV | -------------------------------------------------------------------------------------------------do the Part: |
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 11135Sterilization | Medical Devices - Validation and Routine Control of Ethylene Oxide |
| ISO 13485 | Medical Devices - Quality Management Systems Requirements |
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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.
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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 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.
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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
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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
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510(k) Number K060494
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.