INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT

K091215 · Power Medical Interventions, Inc. · GDW · May 18, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091215
• Device Name: INTELLIGENT POWER UNIT, INTELLIGENT CONSOLE, INTELLIGENT DELIVERY SYSTEM, INTELLIGENT SURGICAL INSTRUMENT
• Applicant: Power Medical Interventions, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: May 18, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The iDrive Intelligent Power Unit with iConsole, when used with compatible Intelligent Surgical Instrument Linear Staplers , 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. The iDrive Intelligent Power Unit with iConsole, when used with compatible Intelligent Delivery Systems (iStraight, iFlex, iCurve) and Right Angle or Power Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses. The iDrive Intelligent Power Unit with iConsole, when used with compatible Intelligent Delivery Systems and Circular Stapler Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses. The iDrive Intelligent Power Unit with iConsole, when used with compatible Vascular Intelligent Surgical Instruments or Intelligent Delivery Systems with 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 buttressing material such as bovine pericardium.

Device Story

iDrive Intelligent Power Unit with iConsole is a motorized surgical handpiece; operates detachable Intelligent Delivery Systems and Surgical Instruments. Input: manual user control via integrated console. Transformation: mechanical rotational energy drives clamp shaft and screw to close/compress tissue and fire staples. Output: tissue resection, transection, and anastomosis. Used in OR by surgeons for open and minimally invasive procedures. Benefits: provides powered assistance for staple delivery and tissue manipulation. Device is a modification of previous iDrive systems allowing instrument detachment.

Clinical Evidence

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

Technological Characteristics

Handpiece with integrated controls; mechanical rotational energy source; internal gearing and transmission; detachable surgical instruments and delivery systems; compatible with staple line buttressing material (e.g., bovine pericardium).

Indications for Use

Indicated for patients undergoing general, endoscopic, gastrointestinal, gynecological, abdominal, thoracic, urologic (including radical prostatectomy), and pediatric surgical procedures requiring tissue resection, transection, or anastomosis; includes 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

• iDriveS, iDriveC, iDriveF (K073001)
• iDrive with Vascular Indications (K073148)
• Intelligent Articulating Endoscopic Linear Cutters with Reloads (K071708)

Submission Summary (Full Text)

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K091215

Page. 1/3

MAY 18 2009

## Section E - Special 510(k) - Summary (Additional Information Requested - Section E - page 1 of 3)

In Accordance with 21 CFR Section 807.92 Power Medical Interventions, Inc., is submitting the following 510(k) Summary:

Submitter Information: 1)

> Power Medical Interventions, Inc. 2021 Cabot Blvd. Langhorne, PA 19047 Ph: 267-775-8151 Fax: [phone]

Applicant: Barbara J. Whitman

Date of Notification: April 24, 2009

- 2) Name of Device:

| Trade Name: | Intelligent Power Unit (iDrive) with Intelligent<br>Console (iConsole), Intelligent Delivery Systems<br>(iStraight, iCurve, iFlex), and Intelligent Surgical<br>Instruments (i45, i60, i60XXL, i45R, i60R, i45V,<br>iNOLC 45, iNOLC60) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Surgical Staplers with Implantable Staples |
| Classification | Staple, Implantable, GDW |

Predicate Device:

3)

Name:

iDriveS, iDriveC, iDriveF, Power Medical Interventions, Inc., Langhorne, PA. REF |iDriveS, iDriveC, iDriveF (K073001).

iDrive with Vascular Indications, Power Medical Interventions, Inc., Langhorne, PA. REF iDriveS, iDriveC, iDriveF (K073148).

Intelligent Articulating Endoscopic Linear Cutters with Reloads, Power Medical Interventions, Inc., Langhorne, PA. REF145, i45S, i60, i60S (K071708).

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K091215 Page 2/3

(Additional Information Requested - Section E - page 2 of 3)

#### 4) Device Description:

The iDrive with iConsole is used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments in order to resect tissue, transect tissue and create anastomoses between structures. The iDrive was previously cleared to market via K073001 and was subsequently cleared to market with additional vascular indications via K073148. The iDrive is a handpiece with integrated controls that operate the attached Intelligent Delivery Systems and Intelligent Surgical Instruments.

- 5) Device Modification
The iDrive with iConsole, when used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments, functions identically to the predicate devices iDriveS, iDriveC, iDriveF (Ko73001), iDrive with Vascular indications (K073148), and Intelligent Articulating Endoscopic Linear Cutters with Reloads (Ko71708). The iDrive was modified so that the Intelligent Surgical Instruments and the Intelligent Surgical Instruments are detachable from the handpiece.

- 6) Indications For Use
The iDrive Intelligent Power Unit with iConsole, when used with:

a) compatible Intelligent Surgical Instrument Linear Staplers , 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.

b) compatible Intelligent Delivery Systems (iStraight, iFlex, iCurve) and Right Angle or Power Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surqical procedures for resection, transection, and creation of anastomoses.

c) compatible Intelligent Delivery Systems and Circular Stapler Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

d) compatible Vascular Intelligent Surgical Instruments or Intelligent Delivery Systems with 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

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K091215

Page 3/3

### (Additional Information Requested - Section E - page 3 of 3)

resection, transection, and/or creation of anastomoses. They can be used with staple line buttressing material such as bovine pericardium.

### 7) Comparison to Predicate Devices

The iDrive with iConsole is used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments and functions identically to the predicate devices. The electronics, power configuration, and internal gearing & transmission are common to both predicate and subject devices. Both the predicate and subject devices are powered mechanically by rotational energy. In both the predicate and the subject device, a clamp shaft drives a clamp screw, which causes the anvil to close and compress tissue. The same is true for firing.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".

#### Public Health Service

MAY 18 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K091215

Trade/Device Name: iDrive Intelligent Power Unit with iConsole Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: April 24, 2009 Received: April 27, 2009

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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

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Page 2 - Ms. Barbara J. Whitman

[phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Section D - Indications for Use (Additional Information Requested - Sectio D - paqe 1 of 4)

510(k) Number (if known): Kog1215

Device Name: iDrive Intelligent Power Unit with iConsole

Indications For Use

The iDrive Intelligent Power Unit with iConsole, when used with compatible Intelligent Surgical Instrument Linear Staplers , 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 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 4

Daniel Krane for mxm

gical, Orthopedic.

510(k) Number K091215

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# Section D - Indications for Use

(Additional Information Requested -Section D - page 2 of 4)

510(k) Number (if known): Kog1215

Device Name: iDrive Intelligent Power Unit with iConsole

Indications For Use

The iDrive Intelligent Power Unit with iConsole, when used with compatible Intelligent Delivery Systems (iStraight, iFlex, iCurve) and Right Angle or Power Linear Cutter Digital Loading Units®, has applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 4

Daniel Krone fu mxim

(Division Sign-C Division of Surgical, Orthopedic,

510(k) Number K091215

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## Section D - Indications for Use

(Additional Information Requested -Section D - page 3 of 4)

510(k) Number (if known): Ko91215

Device Name: iDrive Intelligent Power Unit with iConsole

Indications For Use

The iDrive Intelligent Power Unit with iConsole, when used with compatible Intelligent Delivery Systems and Circular Stapler Digital Loading Units®, has applications for use throughout the alimentary tract for end-to-end, end-toside, and side-to-side anastomoses.

· Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 4

Daniel Kiane for MXM
(Division Sign-Off)

(Division Sien. Division of Surgical. Orthopedic, and Restorative Devices

510(k) Number K091215

{8}------------------------------------------------

# Section D - Indications for Use (Additional Information Requested -Section D - page 4 of 4)

510(k) Number (if known): Kog1215

Device Name: iDrive Intelligent Power Unit with iConsole

Indications For Use

The iDrive Intelligent Power Unit with iConsole, when used with compatible Vascular Intelligent Surqical Instruments or Intelligent Delivery Systems with 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.buttressing material such as bovine pericardium.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of 4

Daniel Keane for MXM

I. Orthovedic.

510(k) Number K091215