The Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdomihal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Device Description

The Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads has identical technological features as the predicate device, i45/160 (K071708). The modification made to the device was that the pivot point for the jaws was translated distally, which enables the device to open in Reverse. Both the subject device and the predicate device deliver stapling/cutting action to create anastomoses.

AI/ML Overview

The provided FDA 510(k) summary (K083527) is for a medical stapling device, the "Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads." This submission details modifications to an existing predicate device (K071708) and asserts substantial equivalence based on identical technological features except for a pivot point translation.

Based on the provided document, the typical detailed acceptance criteria and study data for a device with an AI component are not present. This is because the device described is a mechanical stapling device, not an AI/software-as-a-medical-device (SaMD) or AI-augmented device in the modern sense. The term "Intelligent" in its name likely refers to its design or features at the time of its 2008 submission, rather than AI capabilities for diagnosis, prediction, or data analysis.

Therefore, many of the requested points related to AI performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable or cannot be extracted from this document, as they are typically associated with devices that use algorithms for analytical or interpretive functions.

However, I can still extract the information relevant to a traditional medical device submission, focusing on the device's functional equivalence and indications for use.

Acceptance Criteria and Device Performance (for a Mechanical Device)

For a device like this, the "acceptance criteria" and "performance" would typically revolve around mechanical tests, bench testing, and potentially animal or cadaver studies to demonstrate:

Tissue compression force
Staple formation consistency and strength
Cutting performance
Leakage rates (if relevant to the application)
Durability and fatigue testing of components
Biocompatibility of materials

The provided 510(k) summary does not contain specific numerical acceptance criteria or detailed study results for these types of mechanical performance, as is common in a 510(k) summary which focuses on demonstrating substantial equivalence rather than providing full study reports. The summary notes that the modified device has "identical technological features as the predicate device" (K071708) and "functions the same as the predicate device."

Table of Acceptance Criteria and Reported Device Performance (Conceptual, as details are not provided in the document):

Acceptance Criteria Category	Reported Device Performance	Comments (Based on 510(k) Text)
Mechanical Equivalence	Functionally identical to predicate device (K071708)	The device's "electronics, power configuration, and internal gearing & transmission are common to both" the subject and predicate devices. The primary difference is the pivot point for reversed jaw opening.
Intended Use	Same indications for use as predicate.	Applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic procedures for resection, transection, and creation of anastomoses.
Safety and Effectiveness	Substantially equivalent to predicate device (K071708).	The FDA's substantial equivalence determination implies that the sponsor provided sufficient data (not detailed in this summary) to demonstrate that the device is as safe and effective as the predicate.

Information (Not Applicable or Not Provided for an AI Device)

2. Sample size used for the test set and the data provenance: Not applicable/provided. This device is mechanical; performance is typically demonstrated through bench testing or animal studies, not a "test set" of patient data for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI models (e.g., expert radiological reads, pathology reports) is not relevant for this mechanical stapler.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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. This is not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI device. For a mechanical device, "ground truth" might refer to physical measurements of staple line integrity or tissue compression, demonstrated through standard engineering tests.

8. The sample size for the training set: Not applicable. There is no AI model that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

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K083527

DEC 1 8 2008

Page 1/2

Section E

Special 510(k) - Summary

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

1) Submitter Information:

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: November 26, 2008

Name of Device: 2)

Trade Name:

Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads

Linear Staplers with Implantable Staples Common Name:

Staple, Implantable, GDW Classification Name:

Predicate Device:

Intelligent Articulating Endoscopic Linear Cutters with Reloads, Power Medical Interventions, Inc., Langhorne, PA. REF i45, i455, i60, i6oS (Ko71708).

Device Description:

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Device Modification 5)

0012 2

Indications For Use 6)
The Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
Comparison to Predicate Devices
The Intelligent Articulating Endoscopic Linear Cutters Reverse functions the same as the predicate device, i45/160 (K071708). The electronics, power configuration, and internal gearing & transmission are common to both the Intelligent Articulating Endoscopic Linear Cutters Reverse and 160/145. The difference is that the pivot point for the stapling jaws was translated distally in order to enable the device to open in reverse. The shafts on both the subject device, Intelligent Articulating Endoscopic Linear Cutters Reverse, and the predicate device, i45/i6o, are both rigid. Both 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 2008

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

Re: K083527

Trade/Device Name: Intelligent Articulating Endoscopic Lincar Cutter Reverse with Reloads Regulation Number: 21 CFR 878.4750

Regulatory Class: II Product Code: GDW Dated: November 26, 2008 Received: November 28, 2008

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, please 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-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Mulhern

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

Indications for Use

510(k) Number (if known): K083527

Device Name: Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

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

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number 1083527-

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.