The SuraASSIST™ Right Angle Linear Cutter Digital Loading Unit™, 30 mm, 45 mm and 60 mm, Vascular with Reloads has applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for transection, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.

Device Description

The devices described here are Right Angle Linear Cutter Digital Loading Units™(DLUs), 30 mm, 45 mm and 60 mm, Vascular, with Reloads for single patient use. All have a maximum diameter of 3.1". Both DLUs and Reloads are supplied pre-sterilized and ready for use upon removal from their packaging.

The 30 mm Vascular DLU can only be used with the 30 mm Vascular Reload.

The 45 mm Vascular DLU can only be used with the 45 mm Vascular Reload.

The 60 mm Vascular DLU can only be used with the 60 mm Vascular Reload.

The DLU contains a staple-forming anvil. The anvil acts with the staple cartridge to compress and position layers of tissue in readiness for stapling and cutting. At the same time, the anvil provides support and a means for correctly forming staples while they are closed sequentially along the tissue, followed by the cutting blade. The Right Angle Linear Cutter Vascular DLU is perpendicular to the Flex Shaft, forming an extension to the Flex Shaft, to which they are connected.

A loaded DLU is used to anastomose tubular structures by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together. It also severs the tubular structure.

Right Angle Linear Cutter Vascular Reloads contain staples, a cutting blade. and the means to simultaneously force staples toward the anvil. The cutting blade is advanced in conjunction with the staple pushers so that tissue is simultaneously stapled and cut.

The DLUs are attached to the end of the FlexShaft (FS), which contains a pair of flexible rotary drive shafts within an overall flexible shaft. The other end of the FS is connected to the Power Console (PC), which applies mechanical power to the drive shafts. DLUs have all functions powered by the PC. The FS has a short steerable section at the distal end (near the attached DLU) so that the angle of attack (attitude) of the DLU can be adjusted by the surgeon to optimize patient accessibility.

The surgeon operates a DLU via a hand held electronic Remote Control Unit (RCU).

The DLUs have quick attach and release means for coupling to the FS. No tools are required. DLUs are pushed onto the FS end, snapping and locking into place. To remove a DLU from the FS, a sleeve on the DLU at the junction with the FS is rotated by hand.

DLU designs shall allow for attachment of their corresponding Reloads, but shall inhibit attachment of incompatible Reloads. Each Reload has an integral electronic memory module. This identifies the type and size of the Reload being used.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™ 30mm, 45mm, 60mm - Vascular with Reloads." This document is focused on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and device performance as typically found in clinical trials for new technologies like AI.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics, acceptance criteria, or a study designed to prove the device meets such criteria. It focuses on comparing features to a predicate device.
Sample sizes used for the test set and data provenance: No test set or data provenance is mentioned as this is not a study reporting clinical performance.
Number of experts used to establish the ground truth for the test set and their qualifications: Ground truth establishment is not relevant in this type of submission.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: This is not a comparative effectiveness study.
Standalone (algorithm only without human-in-the-loop performance) study: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Explanation Based on Document Type:

This document is a "Special 510(k) Device Modification Premarket Notification". A 510(k) submission primarily aims to demonstrate substantial equivalence to a legally marketed predicate device, meaning the new device is as safe and effective as the predicate. It does this by comparing device features, intended use, technological characteristics, and safety/performance data (if necessary, though often bench testing or existing data for the predicate is sufficient). It is not a clinical trial report where specific acceptance criteria for performance would be rigorously tested against a defined ground truth.

The "study" in this context is the comparison of the modified device to the predicate device, focusing on demonstrating that the modifications do not raise new questions of safety or effectiveness. The key element presented is a table comparing the features of the subject device to its predicate devices.

Summary of Relevant Information from the Provided Text:

Device Name: SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™ 30mm, 45mm, 60mm - Vascular with Reloads
Predicate Devices:
- SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™, 30 mm. 45 mm and 60 mm with Titanium Implantable Staples and Reloads, Power Medical Interventions, Inc. (K021701)
- ETS Compact-Flex45 Articulating Endoscopic Linear Cutter, Vascular/Thin. Ethicon Endo-Surgery, Inc. (K002398)
Basis for "Acceptance": The FDA's determination of substantial equivalence to the predicate devices. The letter from the FDA (page 6-7) states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This is the "acceptance" in the context of a 510(k) submission.

Device Performance (as described in comparison to predicate): The document provides a detailed comparison of physical characteristics between the subject device and the predicate (Ethicon ETS Compact-Flex45). This comparison serves as the "proof" that the device is equivalent for its intended purpose.

Features & Description	SurgASSIST™ (Subject Device)	Predicate (Ethicon ETS Compact-Flex45)
Number of Staples	30mm Vascular - 46 staples45mm Vascular - 69 staples60mm Vascular - 92 staples	30mm - 22 staples45mm - 32 staples60mm - 46 staples
Rows of Staples	30mm Vascular - 6 rows45mm Vascular - 6 rows60mm Vascular - 6 rows	30mm- 4 rows45mm- 4 rows60mm- 4 rows
Staple Crown Dimension	30mm Vascular - 2.4 mm45mm Vascular - 2.4 mm60mm Vascular - 2.4 mm	30mm- 4.0 mm45mm- 4.0 mm60mm- 4.0 mm
Staple Leg Dimension	30mm Vascular - 2.3 mm45mm Vascular - 2.3 mm60mm Vascular - 2.3 mm	30mm- 4.4 mm45mm- 4.4 mm60mm- 4.4 mm
Staple Thickness	30mm Vascular - 0.20 mm45mm Vascular - 0.20 mm60mm Vascular - 0.20 mm	30mm- 0.23mm45mm- 0.23mm60mm- 0.23mm
Staple Closed Range	30mm Vascular - 1.0 mm45mm Vascular - 1.0 mm60mm Vascular - 1.0 mm	30mm- 1.2 / 2.0mm45mm- 1.2 / 2.0mm60mm- 1.2 / 2.0mm
DLU Internal Power	None	None
Digital Information	Memory module containing digital data for identification, etc.	Memory module containing digital data for identification, etc.
How Supplied	Sterile - Single Patient Use	Sterile - Single Patient Use
Method of Sterilization	Ethylene Oxide Gas (ETO)	Irradiation
Packaging	Blister Tray with Tyvek Lid	Blister Tray with Tyvek Lid

Intended Use: The subject device has applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for transection, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.
Regulatory Class: Class II

In essence, the "study" referred to here is the documentation provided in the 510(k) submission itself, demonstrating that the subject device is similar enough to an already approved device to be considered safe and effective without requiring entirely new clinical performance data against explicit acceptance criteria.

Summary

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KO22313 page

Power Medical Interventions, Inc. Fower Medical Interventions, Inc.
SurgASSIST™ Right Angle Linear Cutter DLUs with Reloads, 30 mm, 45 mm, 60 mm Vascular Special 510(k) Device Modification PreMarket Notification, July 16, 2002

DEC 0 9 2002

Special 510(k) Device Modification PREMARKET NOTIFICATION SAFETY AND EFFECTIVENESS SUMMARY

SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™ 30mm, 45mm, 60mm - Vascular with Reloads

In Accordance with 21 CFR Section 807.92 Power Medical Interventions, Inc., is submitting the following Safety and Effectiveness summary.

Submitter Information:

Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 267-775-8100 Ph 267-775-8123 Fax

Applicant:

Barbara J. Whitman

July 12, 2002 Date of Notification:

1. Name of Device:

Trade Name:	SurgASSIST™Right Angle Linear Cutter DLU30 mm, 45 mm and 60 mm - Vascularwith Reloads
Common Name:	Linear Cutter with Implantable Staplesand Reloads

Classification Name: Staple, Implantable, GDW

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Predicate Devices:

a) SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™, 30 mm. 45 mm and 60 mm with Titanium Implantable Staples and Reloads, Power Medical Interventions, Inc., New Hope, PA. REF RALC30, RALC45, RALC60, RALCR30, RALCR45, RALCR60 (K021701).
b) ETS Compact-Flex45 Articulating Endoscopic Linear Cutter, Vascular/Thin. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF SCW45 (K002398).
1. Device Description:

The 30 mm Vascular DLU can only be used with the 30 mm Vascular Reload.

The 45 mm Vascular DLU can only be used with the 45 mm Vascular Reload.

The 60 mm Vascular DLU can only be used with the 60 mm Vascular Reload.

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K022313 page
3/6

FS has a short steerable section at the distal end (near the attached DLU) so that the angle of attack (attitude) of the DLU can be adjusted by the surgeon to optimize patient accessibility.

The surgeon operates a DLU via a hand held electronic Remote Control Unit (RCU).

The DLUs have quick attach and release means for coupling to the FS. No tools are required. DLUs are pushed onto the FS end, snapping and locking into place. To remove a DLU from the FS, a sleeve on the DLU at the junction with the FS is rotated by hand.

1. Indications For Use -
  The SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™, 30 mm, 45 mm and 60 mm, Vascular with Reloads has applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures for transection, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.
1. Comparison to Predicate Devices
  The following table compares the subject Right Angle Linear Cutter DLU, 30 mm. 45 mm and 60mm, Vascular, with Reloads to the previously cleared predicate Right Angle Linear Cutter DLU (K012809) device and the Ethicon ETS Compact-Flex45 Articulating Endoscopic Linear Cutter, Vascular/Thin.

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Power Medical Interventions, Inc.
SurgASSIST™ Right Angle Linear Cutter DLUs with Reloads, 30 mm, 45 mm, 60 mm Vascal
Special 510(k) Device Modification PreMarket Notificatio

ight Angle Linear Cutter DLU Product Features Comparison Ch

Features & Description	Name	Manufacturer of Record	Contract Manufacturer	510(k) Clearance Numbers	Product Codes	Predicate	Intended use
SurgASSISTTMRight Angle Linear Cutter DLU30mm, 45mm, 60mm - Vascularwith Reloads	SurgASSISTTMRight Angle Linear Cutter DLUVascularwith Reloads	Power Medical Interventions, Inc.	Lacey ManufacturingBridgeport, CT	Subject of this Notification	RALC30V, RALC45V, RALC60VRALCR30V, RALCR45V, RALCR60V	Ethicon ETS Compact-Flex45Articulating Endoscopic LinearCutter, Vascular/Thin	Has applications for general andendoscopic surgery includingmultiple open or minimally invasivegeneral, gynecological, urologic(including radical prostatectomy),thoracic and pediatric surgicalprocedures for transection,resection, and/or creation ofanastomoses. They can be usedwith staple line or tissue buttressingmaterial such as bovinepericardium
SurgASSISTTMRight Angle Linear Cutter DLU30mm, 45mm, 60mmwith Reloads	SurgASSISTTMRight Angle Linear Cutter DLUwith Reloads	Power Medical Interventions, Inc.	Lacey ManufacturingBridgeport, CT	K021701	RALC30, RALC45, RALC60RALCR30, RALCR45, RALCR60	ETS Compact-Flex45 ArticulatingEndoscopic Linear Cutter, Vascular/Thin	Has applications in gastrointestinal,gynecological, general abdominaland thoracic surgical procedures forresection, transection, and creationof anastomoses.
				K002398		Ethicon Endo-Surgery, Inc.	Application in gastroenterology fortransection, resection, and/orcreation of anastomoses and canbe used in multiple open orminimally invasive surgicalprocedures, including radicalprostatectomy, and can be usedwith staple line or tissue buttressingmaterials, such as bovinepericardium.
						Ethicon Endo-Surgery, Inc.
						SCW45TR45W

K022313 page 4/6

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ower Medical Interventions, Inc.
urgASSIST™ Right Angle Linear Cutter DLUs with Reloads, 30 mm, 45 mm, 60 mm Vasca
pesial 510(K) Device Modification PreMarket Notification, J

ight Angle Linear Cutter DLU Product Features Comparison Chris

Features & Description	FDA Class (System)	Physical Characteristics	Predicate
SurgASSISTTMRight Angle Linear Cutter DLU30 mm, 45 mm, 60mm - Vascularwith Reloads	II		Ethicon ETS Compact-Flex45 ArticulatingEndoscopic Linear Cutter,Vascular/Thin
SurgASSISTTMRight Angle Linear Cutter DLUwith Reloads30 mm, 45 mm, 60 mm	II		II
		30mm Vascular- 46 staples45mm Vascular - 69 staples60mm Vascular - 92 staples	30mm - 22 staples
		Number of Staples	45mm - 32 staples
			60mm - 46 staples
		30mm Vascular -6 rows45mm Vascular - 6 rows60mm Vascular - 6 rows	30mm- 4 rows
		Rows of Staples	45mm- 4 rows
			60mm- 4 rows
		30mm Vascular - 2.4 mm45mm Vascular - 2.4 mm60mm Vascular - 2.4 mm	30mm- 4.0 mm
		Staple Crown Dimension	45mm- 4.0 mm
			60mm- 4.0 mm
		30mm Vascular - 2.3 mm45mm Vascular - 2.3 mm60mm Vascular - 2.3 mm	30mm- 4.4 mm
		Staple Leg Dimension	45mm- 4.4 mm
			60mm- 4.4 mm
		30mm Vascular - 0.20 mm45mm Vascular - 0.20 mm60mm Vascular - 0.20 mm	30mm- 0.23mm
		Staple Thickness	45mm- 0.23mm
			60mm- 0.23mm
		30mm Vascular - 1.0 mm45mm Vascular - 1.0 mm60mm Vascular - 1.0 mm	30mm- 1.2 / 2.0mm
		Staple Closed Range	45mm- 1.2 / 2.0mm
			60mm- 1.2 / 2.0mm
		None	None
		DLU Internal Power
		Memory module containing digital datafor identification, etc.	Memory module containing digital data foridentification, etc.
		Digital Information
		Sterile - Single Patient Use	Sterile - Single Patient Use
		How Supplied
			66
			6 rows
			2.7 mm
			2.5 mm
			0.20 mm
			1.0 mm
			None
			Sterile - Single Patient Use

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Power Medical Interventions, Inc.
SurgASSIST™ Right Angle Linear Cutter DLUs with Reloads, 30 mm, 45 mm, 60 mm Vascul
Special 510(k) Device Modification PreMarket Notificatio

ght Angle Linear Cutter DLU Product Features Comparison Cha

	AND AND & BLAND













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	.

Features & Description	Method of Sterilization	Packaging
SurgASSIST™Right Angle Linear Cutter DLU30 mm, 45 mm, 60 mm – Vascularwith Reloads	Ethylene Oxide Gas (ETO)	Blister Tray with Tyvek Lid	Blister Tray with Tyvek Lid
SurgASSIST™Right Angle Linear Cutter DLUwith Reloads30 mm, 45 mm, 60 mm	Ethylene Oxide Gas (ETO)	Blister Tray with Tyvek Lid	Blister Tray with Tyvek Lid
PredicateEthicon ETS Compact-Flex45 ArticulatingEndoscopic Linear Cutter,Vascular/Thin	Irradiation	Blister Tray with Tyvek Lid	Blister Tray with Tyvek Lid

000000

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three curved lines that resemble a human figure.

Public Health Service

DEC 0 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Power Medical Interventions, Inc. Barbara J. Whitman Regulatory Affairs Manager 110 Union Square Drive New Hope, Pennsylvania 18938-1364

Re: K022313

Trade/Device Name: SurgASSIST™ Right Angle Linear Cutter DLU™ 30mm, 45mm & 60mm- Vascular with Reloads

Regulation Number: 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: October 30, 2002 Received: October 31, 2002

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

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Page 2 - Ms. Barbara J. Whitman

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.

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 Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

برار Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Power Medical Interventions, Inc. New Hope, PA 18938

510(k) No. K022313

Device Name:

SuraASSIST™ Right Angle Linear Cutter Digital Loading Unit™ 30mm, 45mm, 60mm - Vascular with Reloads

INDICATIONS FOR USE:

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

Prescription Use Per 21CFR §801.109

OR Over-The-Counter Use

Miriam C. Provost

vision of General, Restorative Jeurological Devices

Ko 22313

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.