The iDriveS/iDrive&/iDriveF, when used with compatible Vascular Digital Loading Units®, have 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, fransection, and/or creation of anastomoses. They can be used with staple line or buttressing material such as bovine pericardium.

Device Description

The iDrive is a reusable, hand-held medical device that is used to operate various SurgASSIST® 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.

AI/ML Overview

This PMA pertains to a powered surgical stapler (iDrive) with various attachments (DLUs). The device itself is an incremental modification of a previously cleared device. Therefore, a comprehensive standalone performance study (such as a diagnostic accuracy or clinical trial), specifically for the AI component, is not relevant in this context. The provided text does not include information about acceptance criteria or a study proving that the device meets those criteria, as it's not a diagnostic AI device.

Here's an analysis of why these aspects are absent and what information is available in relation to your questions:

No AI Component: The device described (iDrive) is a battery-powered surgical stapler handle designed to operate various Digital Loading Units (DLUs). There is no mention of any artificial intelligence, machine learning, or software algorithm for analysis, diagnosis, or prediction in the provided documentation. Therefore, questions related to AI performance, ground truth, experts, and reader studies are not applicable.
Device Modification, Not Novel Device: The submission is a "Special 510(k) Device Modification." This means the iDrive is a modification of previously cleared predicate devices (i45, i45S, i60, i60S, Power Extenders). The core function and indications for use remain largely the same, with the modification primarily enabling the firing of multiple DLUs from a battery-powered, untethered hand-held device.
Focus on Substantial Equivalence: For a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device. This typically involves comparing technological characteristics and indications for use, often supported by bench testing and sometimes limited biocompatibility or sterility data, rather than large-scale clinical performance studies as would be required for a novel, high-risk device or a diagnostic AI.

Therefore, many of the specific questions you asked are not applicable to this type of device and submission.

Here's what can be extracted from the provided text based on your request, with an explanation of why certain information is missing:

1. A table of acceptance criteria and the reported device performance

Not Applicable / Not Provided: This document does not contain acceptance criteria or performance data in the context of diagnostic accuracy or clinical outcomes, as it is a device modification for a surgical stapler handle, not a diagnostic AI device. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the performance is considered equivalent to the already cleared predicates.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: As there is no described performance study for a diagnostic algorithm, there are no test sets, data provenance, or sample sizes related to AI performance. Device modifications for surgical staplers typically undergo bench testing for functional equivalence and safety, but the details of such testing (e.g., number of staples fired, force measurements) are not typically included in the summary provided for a Special 510(k) but would be in the full submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided: There is no AI component requiring ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: No AI test set, therefore no adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable / Not Provided: There is no AI component, so no MRMC study involving human readers and AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided: No AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Provided: No AI component requiring ground truth. For a mechanical device like this, "ground truth" would relate to engineering specifications and performance metrics verified by testing, not clinical diagnostic accuracy.

8. The sample size for the training set

Not Applicable / Not Provided: No AI component, therefore no training set.

9. How the ground truth for the training set was established

Not Applicable / Not Provided: No AI component, therefore no training set or ground truth for it.

In summary, the provided FDA 510(k) summary for the iDrive surgical stapler handle is for a device modification and does not involve any artificial intelligence or sophisticated diagnostic algorithms. Therefore, the questions related to AI performance, ground truth, experts, and reader studies are not addressed in this document.

Summary

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K073148
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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. DEC 0 7 2007 2021 Cabot Blvd. Langhorne, PA 19047 267-775-8151 Ph 267-775-8123 Fax

Applicant:

Barbara J. Whitman

Date of Notification: November 7, 2007

1. Name of Device:
  Trade Name: iDriveS, iDriveC, iDriveF with Vascular Indications

Common Name: Intelligent Delivery System, Implantable Staples

Classification Name: Staple, Implantable, GDW

1. Predicate Devices:
- i45, i45S, i60, i60S, Power Medical Interventions, Inc., Langhorne, PA. . (K071708)
- . Power Extenders, Power Medical Interventions, Inc., Langhorne, PA. (K063746)
- . Right Angle Linear Cutter DLUs, 30 mm, 45 mm and 60 mm Vascular, Power Medical Interventions, Inc., Langhorne, PA. (K022313)
1. Device Description

1. 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

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Ko 73148
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Power Medical Interventions, Inc. iDrive with Vascular Indications Special 510(k) Device Modification PreMarket Notification - November 7, 2007

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, including the predicate vascular DLUs (K022313).

1. 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 vascular device are included below:

The iDriveS/iDrive&/iDriveF, when used with compatible 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.

1. Comparison to Predicate Devices
  The iDrive with Vascular Indications functions identically to the predicate devices i45, i45S, i60, i60S (K071708), the Power Extenders (K063746), and the Right Angle Linear Cutter Vascular DLUs (K022313), 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, including Vascular ones. The predicate device, Power Extender, was able to fire multiple DLUs, but was tethered to the PC100 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three human profiles facing right, representing health and human services. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 7 2007

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

Re: K073148

Trade/Device Name: iDrive with Vascular Indications Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: November 07, 2007 Received: November 08, 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, nlease contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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-frec 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. Mikkelsen

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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K073148

Power Medical Interventions, Inc. iDrive with Vascular Indications Special 510(k) Device Modification PreMarket Notification - November 7, 2007

SECTION D – Statement of Indications for Use Indications for Use

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

Device Name: iDrive with Vascular Indications

Indications for Use:

The & Larives // Driver, when used with compatible Vascular Digital Loading Units®, have 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, fransection, and/or creation of anastomoses. They can be used with staple line or buttressing material such as bovine pericardium.

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 of CDRH, Office of Device Evaluation (ODE)
Division of
and Neurological

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51	K02600015
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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.