IDRIVES, IDRIVEC, IDRIVEF

K073001 · Power Medical Interventions, Inc. · GDW · Dec 18, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K073001
• Device Name: IDRIVES, IDRIVEC, IDRIVEF
• Applicant: Power Medical Interventions, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Dec 18, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The iDriveS/iDriveC/iDriveF, when used with compatible Linear Digital Loading Units®, has 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. The iDriveS/iDriveC/iDriveF, when used with compatible Right Angle Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses. The iDriveS/iDriveC/iDriveF, when used with compatible Circular Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Device Story

iDrive is a reusable, battery-powered, hand-held surgical device; operates various previously cleared SuraASSIST® Digital Loading Units® (DLUs). Device functions as an intelligent delivery system for implantable staples. User controls firing of DLUs via integrated buttons and rocker switches on handpiece. Unlike tethered predicate (Power Extender), iDrive is untethered; provides mobility for surgeon during open or minimally invasive procedures. Enables resection, transection, and anastomosis creation across multiple surgical specialties. Benefits include improved ergonomics and flexibility in surgical workflow by eliminating need for external power tether while maintaining compatibility with existing DLU staple delivery components.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and functional comparison to predicate devices.

Technological Characteristics

Reusable, hand-held, battery-powered electromechanical device. Features integrated controls (buttons/rocker switches) and distal connector for DLU attachment. Standalone operation. Class II device.

Indications for Use

Indicated for patients undergoing general, endoscopic, gastrointestinal, gynecological, abdominal, thoracic, urologic (including radical prostatectomy), and pediatric surgical procedures requiring resection, transection, creation of anastomoses, or open occlusion of the heart's 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

• i45, i45S, i60, i60S (K071708)
• Power Extenders (K063746)

Submission Summary (Full Text)

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K073001

# 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

DEC 1 8 2007

Applicant:

Barbara J. Whitman

Date of Notification: October 23, 2007

- 2) Name of Device:
Trade Name: iDriveS, iDriveC, iDriveF

Common Name: Intelligent Delivery System, Implantable Staples

Classification Name: Staple, Implantable, GDW

- 3) Predicate Devices:
i45, i45S, i60, i60S, Power Medical Interventions, Inc., Langhorne, PA. (K071708) Power Extenders, Power Medical Interventions, Inc., Langhorne, PA. (K063746)

- 4) Device Description
The iDrive is a reusable, hand-held medical device that is used to operate various SuraASSIST® Digital Loading Units® (DLUs), all of which were previously cleared to market. The iDrive consists of a handpiece with integrated controls that operate the DLUs.

- 5) Device Modification
The iDrive functions identically to the predicate devices i45, i45S, i60, i60S (K071708) and the Power Extenders (K063746). The i45, i45S, i60, i60S was modified in order to enable the firing of multiple DLUs from the battery powered, hand-held device. The distal connector on the iDrive is identical to that found on the predicate device, Power Extender. It is this connector, which enables the iDrive to be compatible with multiple DLUs.

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#### 6) Indications For Use

The iDrive is capable of firing multiple DLUs, which were previously cleared to market. The DLUs are fired by the iDrive, but function as the component of the device responsible for delivering the implantable staple. As such, the Indications for Use of each device is included below:

The illrives / Driver, when used with compatible Linear Digital Loading Units®, has 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.

The iDriveS/iDrivel, when used with compatible Right Angle Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The illines / Drives/ iDriveF, when used with compatible Right Angle Linear Cutter Vascular Digital Loading Units®, has applications for general and endoscopic surgery including multiple open and minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for resection, transection, and/or creation of anastomoses. They can be used with staple line or buttressing material such as bovine pericardium.

The illusives / aller, when used with compatible Circular Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end- fo-side, and side-to-side anastomoses.

### 7) Comparison to Predicate Devices

The iDrive functions identically to the predicate devices i45, i45S, i60, i60S (K071708) and the Power Extenders (K063746), as it enables the user to control the battery powered, hand-held device with buttons and rocker switches, which are then able to fire multiple DLUs. The predicate device, Power Extender, was able to fire multiple DLUs, but was tethered to the PC 100 via a FlexShaft. The iDrive is capable of firing the same DLUs, which were fired by the Power Extender. However, the iDrive, is also similar

- · to the i45, i45S, i60, i60S, as it is also an untethered, battery powered, hand-held device, capable of firing multiple DLUs. Please see the Predicate Comparison Chart in Section J of this submission.

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Image /page/2/Picture/13 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### DEC 1 8 2007

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

Re: K073001

Trade/Device Name: iDrive Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: November 20, 2007 Received: November 23, 2007

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 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 N 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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# SECTION D - Statement of Indications for Use

# Indications for Use

#### 510(k) Number (if known): Subject of this notification

Device Name: iDrive

Indications for Use:

The illifies/20tives/20tiveF, when used with compatible Linear Digital Loading Units®, has 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.

The annives/iDrivell/iDriveF, when used with compatible Right Angle Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.

The illifies/40riveF/ infore, when used with compatible Circular Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end- to-side, and side-to-side anastomoses.

| Prescription Use | x | AND/OR | Over-The-Counter Use | |
|-----------------------------|---|--------|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) | |

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

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation, Division of General, Restorative, and Neurological Devices page 1 of 1

510(k) Number L07300

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