POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS

K052415 · Power Medical Interventions, Inc. · GDW · Sep 29, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052415
• Device Name: POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS
• Applicant: Power Medical Interventions, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Sep 29, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Power Linear Cutter Reusable Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

Device Story

Device is a reusable linear stapler loading unit for surgical resection, transection, and anastomosis. Input: manual surgeon control via integrated hand piece buttons (open, close, fire). Transformation: mechanical actuation of titanium staples; device delivers two staggered rows of staples on each side of a transection. Output: stapled tissue. Used in OR by surgeons. Modification from predicate includes rigid extension for improved control and integrated remote control buttons on hand piece. Connects to non-steerable FlexShaft and Power Console. Benefits: provides surgeon control for tissue manipulation and stapling during minimally invasive or open procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: titanium staples. Sensing/Actuation: mechanical stapling via remote control interface. Form factor: rigid extension with integrated hand piece and proximal quick connect. Connectivity: connects to non-steerable FlexShaft and Power Console. Sterilization: not specified.

Indications for Use

Indicated for patients undergoing general, endoscopic, gastrointestinal, gynecological, abdominal, or thoracic surgery requiring resection, transection, or anastomosis, and for open occlusion of the left atrial appendage.

Regulatory Classification

Identification

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

Predicate Devices

• SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units® (K040720)

Submission Summary (Full Text)

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Power Medical Interventions, Inc. Power Linear Cutter Reusable Digital Loading Units® with Reloads Special 510(k) Device Modification PreMarket Notification - August 31, 2005

K052415

## SECTION E - Special 510(k) Summary

In Accordance with 21 CFR Section 807.92 Power Medical Interventions® is submitting the following safety and effectiveness summary.

1) Submitter Information:

Power Medical Interventions, Inc. 2021 Cabot Blvd. Langhorne, PA 19047 267-775-8151 Ph 267-775-8123 Fax

Applicant:

Barbara J. Whitman

Date of Notification: August 31, 2005

- 2) Name of Device:

| Trade Name: | Power Linear Cutter Reusable Digital Loading Unit® |
|----------------------|----------------------------------------------------|
| Common Name: | Linear Staplers with Implantable Staples |
| Classification Name: | Staple, Implantable, GDW |

- 3) Predicate Devices:
SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units®, Power Medical Interventions, Inc., K040720.

- 4) Device Description
The device described here is a Power Linear Cutter Reusable Digital Loading Unit® with Reloads used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transactions and the creation of anastomoses.

## 5) Device Modification

The Power Linear Cutter Reusable Digital Loading Unit® cuts and staples identically to the predicate device (K040720). The Power Linear Cutter Reusable Digital Loading Unit® has a rigid extension, allowing for more surgeon control of the Digital Loading Unit®. The remote control functions have been integrated into a hand piece at the end of the rigid shaft. These

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Power Medical Interventions, Inc. Power Linear Cutter Reusable Digital Loading Units® with Reloads Special 510(k) Device Modification PreMarket Notification - August 31, 2005

> functions include an open, close and fire button. The integrated remote control buttons function identically to the SurgASSIST® Remote Control Unit buttons, which enable the surgeon to open, close and fire the predicate DLUs. The hand piece on the Power Linear Cutter Reusable Digital Loading Unit® has a proximal quick connect that connects to the distal end of the FlexShaft. The non-steerable FlexShaft serves as the conduit between the DLU and the Power Console.

- 6) Indications For Use
The Power Linear Cutter Reusable Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

- 7) Comparison to Predicate Devices
The Power Linear Cutter Reusable Digital Loading Units® have the same indications for use and the same functions as the previously cleared predicate Computer Mediated Linear Cutter Digital Loading Units® (K040720). Both the Power Linear Cutter Reusable Digital Loading Units® and the Computer Mediated Linear Cutter Digital Loading Units® deliver two staggered rows of titanium staples on each side of a transection. For further details, please see the Predicate Comparison Chart in Section J of this submission.

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Public Health Service

SEP 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions 2021 Cabot Boulevard Langhorne, Pennsylvania 19047

Re: K052415

Trade/Device Name: Power Linear Cutter Reusable Digital Loading Units® with Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 31, 2005 Received: September 2, 2005

Dear Ms. Whitman:

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- Ms. Barbara J. Whitman

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/dsma/dsmamain.html

Sincerely yours,

Mark A. Mulkern

Mark N. Melkerson Acting 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):

Device Name: Power Linear Cutter Reusable Digital Loading Units® with Reloads

Indications For Use:

The Power Linear Cutter Reusable Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliman and the following is the JSON:  {"markdown": "Mark A. Milliman Page 1 of 1"}

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number