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

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the iDrive Intelligent Power Unit with iConsole:

Unfortunately, the provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification summary, which focuses on establishing substantial equivalence to predicate devices rather than reporting on performance studies against defined criteria.

Here's a breakdown of what is and is not available in the given input, organized according to your requested points:

Acceptance Criteria and Study for iDrive Intelligent Power Unit with iConsole

Information Type	Detail
1. Table of acceptance criteria and reported device performance	Not available. The document does not describe specific quantitative or qualitative acceptance criteria for the device's performance, nor does it report on any specific performance metrics from a study against such criteria. The focus is on demonstrating that the modified device functions identically to the predicate devices.
2. Sample size and data provenance (test set)	Not available. There is no mention of a specific test set or any associated data provenance (country of origin, retrospective/prospective). The document primarily discusses the device's design and its intended use, along with a comparison to predicate devices, but not a performance study.
3. Number/qualifications of experts (ground truth for test set)	Not available. Since no specific test set or performance evaluation against a ground truth is described, there is no mention of experts establishing ground truth or their qualifications.
4. Adjudication method (test set)	Not available. Without a described test set or performance evaluation, there is no adjudication method detailed.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study	Not available. The document describes a "device modification" to the iDrive where components become detachable from the handpiece, and states that the device "functions identically" to its predicates. It does not mention any MRMC study, human-in-the-loop performance, or AI assistance. The device appears to be a mechanical surgical stapler system, not an AI-assisted diagnostic or prognostic tool.
6. Standalone (algorithm only) performance study	Not applicable/Not available. This device is a mechanical surgical instrument, not an algorithm. Therefore, a standalone algorithm-only performance study would not be relevant, and none is described.
7. Type of ground truth used	Not available. No ground truth for performance evaluation is described, as the document focuses on substantial equivalence for a modified device rather than de novo performance testing.
8. Sample size for training set	Not applicable/Not available. As the device is a mechanical surgical instrument and not an AI/algorithmic system, there would be no "training set" in the context of machine learning. The document describes a modification to an existing device, and the evaluation relies on comparison to predicate devices.
9. How ground truth for training set was established	Not applicable/Not available. See point 8.

Summary of the Provided Document:

The provided document is a 510(k) premarket notification for the iDrive Intelligent Power Unit with iConsole. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K073001, K073148, K071708).

The "study" in this context is the comparison made to the predicate devices. The document states:

"The iDrive with iConsole, when used in conjunction with the Intelligent Delivery Systems and Intelligent Surgical Instruments, functions identically to the predicate devices..." (Page 2, Section 5 - Device Modification)
"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." (Page 3, Section 7 - Comparison to Predicate Devices)

This means the "proof" that the device meets acceptance criteria (implied to be "performs as safely and effectively as the predicate devices") is based on a technical comparison and functional assessment showing that the modifications (making the instruments detachable) do not change the fundamental operation, electronics, power configuration, or tissue manipulation mechanism that were validated in the predicate devices. This is a common approach for 510(k) submissions for device modifications.

No new clinical or performance studies with specific acceptance criteria, test sets, or ground truth establishment are detailed in this 510(k) summary.

Summary

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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: 267-775-8123

Applicant: Barbara J. Whitman

Date of Notification: April 24, 2009

1. Name of Device:

Trade Name:	Intelligent Power Unit (iDrive) with IntelligentConsole (iConsole), Intelligent Delivery Systems(iStraight, iCurve, iFlex), and Intelligent SurgicalInstruments (i45, i60, i60XXL, i45R, i60R, i45V,iNOLC 45, iNOLC60)
Common Name:	Surgical Staplers with Implantable Staples
Classification	Staple, Implantable, GDW

Predicate Device:

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).

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

K091215 Page 2/3

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

4) Device Description:

1. 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.
1. Indications For Use
  The iDrive Intelligent Power Unit with iConsole, when used with:

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.

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

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.

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

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

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

Page 2 - Ms. Barbara J. Whitman

(240) 276-0115. 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 (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

{5}------------------------------------------------

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

{6}------------------------------------------------

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

{7}------------------------------------------------

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

Regulation Number and Section

§ 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.