The SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™ (DLU) with Reloads has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Device Description

The devices described here are reloadable Right Angle Linear Cutter DLUs for single patient use. Both the 30mm RALC and the 45mm RALC can be passed through surqical tubing with an inside diameter of 3.1". The 60mm RALC can be passed through surgical tubing with an inside diameter of 4.1". They are all supplied pre-sterilized and ready for use upon removal from their packaging. The 30mm DLU can be used with only the 30mm reloadable cartridge. The 45mm DLU can be used with only the 45mm reloadable cartridge. The 60mm DLU can be used with only the 60mm reloadable cartridge. During the Design Input stage of the Right Angle Linear Cutter, it was determined that the product would evolve into a reloadable device. Features that were incorporated into the non reloadable were designed in such a fashion that the components would yield a reloadable component. These features designed into a non reloadable version that would be useful in a reloadable version include the latch that would allow the cartridge to be removed and the tongs of the cartridge cap that would secure the reload in position but be capable of being removed as well. The design that features the reloadable cartridges maintain much of the features of the non reloadable but with modest modifications. Each DLU contains a staple-forming anvil. The anvil acts with the staple cartridge to compress and position lavers 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 30mm, 45mm and 60mm DLUs are perpendicular to the FlexShaft, 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 DLU 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 assembly that contains a pair of flexible rotary drive shafts within an overall flexible shaft called the FlexShaft, hereafter referred to as the FS. The other end of the FS is connected to a Power Console (the 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 cartridges. Each Reload has an integral electronic memory module. This identifies the type and size of the Reload being used.

AI/ML Overview

This document is a 510(k) PreMarket Notification for a device modification, not a study proving the device meets acceptance criteria. As such, it does not contain the detailed information typically found in a clinical study report.

Here's a breakdown of what can be extracted and what information is missing based on your request:

1. Table of acceptance criteria and reported device performance:

The document does not specify formal acceptance criteria or present a performance study with quantitative results to demonstrate the device meets those criteria. The submission is a 510(k) for a modification (making the device reloadable) and relies on substantial equivalence to predicate devices, rather than new extensive performance testing against defined metrics.

However, we can infer some "performance characteristics" from the comparison table (though not "acceptance criteria" or measured performance against them):

Feature & Description	Subject Device (SurgASSIST™ Right Angle Linear Cutter DLU with Reloads)	Predicate Device (SurgASSIST™ Right Angle Linear Cutter DLU)	Predicate Device (Endopath EZ45 Endoscopic Linear Cutter)
Number of Staples	30mm - 22 staples; 45mm - 32 staples; 60mm - 46 staples	45mm - 32 staples	(Not specified for EZ45)
Rows of Staples	30mm - 4 rows; 45mm - 4 rows; 60mm - 4 rows	45mm - 4 rows	4 rows
Staple Crown Dimension	30mm - 3.5mm; 45mm - 3.5mm; 60mm - 3.5mm	45mm - 3.5mm	3.0mm
Staple Leg Dimension	30mm - 4.4mm; 45mm - 4.4mm; 60mm - 4.4mm	45mm - 4.4mm	4.1mm
Staple Thickness	30mm - 0.23mm; 45mm - 0.23mm; 60mm - 0.23mm	45mm - 0.23mm	0.20mm
Staple Closed Range	30mm - 1.2 / 2.0mm; 45mm - 1.2 / 2.0mm; 60mm - 1.2 / 2.0mm	45mm - 1.2 / 2.0mm	2.0mm

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

This document does not describe a test set or clinical study with a specified sample size. It's a regulatory submission based on substantial equivalence, design modifications, and likely non-clinical testing (which is not detailed here).

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):

This information is not applicable as no clinical test set requiring expert ground truth establishment is described.

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

This information is not applicable as no clinical test set requiring adjudication is described.

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:

This is not applicable. The device is a surgical stapler, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a surgical stapler, not an algorithm.

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

This is not applicable as no clinical study requiring ground truth is detailed. The "ground truth" for the device's functionality would be its ability to staple and cut tissue effectively and safely, which is assessed through design verification, validation, and historical performance of predicate devices, not typically a "ground truth" as you might see in an AI/diagnostic context.

8. The sample size for the training set:

This is not applicable as the device is not an algorithm or AI system that requires a training set.

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

This is not applicable as the device is not an algorithm or AI system that requires a training set and ground truth.

Summary of what the document does provide:

Device Type: SurgASSIST™ Right Angle Linear Cutter DLU with Reloads (30mm, 45mm, 60mm) - a surgical stapler.
Modification: The key modification is making the device reloadable.
Intended Use/Indications For Use: Applications in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, and creation of anastomoses.
Predicate Devices:
- SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit™ with Titanium Implantable Staple (K012809)
- EZ45 Endoscopic Linear Cutter/Stapler Reloads (K980815)
Substantial Equivalence: The submission argues that the modified device is substantially equivalent to these predicates.
Sterilization Method: Ethylene Oxide Gas (ETO) for both the subject device and the predicate SurgASSIST™ device. The Endopath EZ45 predicate lists Irradiation and ETO.
Power Source: The device is powered by an external Power Console (PC) via a FlexShaft, and controlled by a Remote Control Unit (RCU).
Digital Information: Each reload has an integral electronic memory module to identify its type and size.

Essentially, this is a regulatory filing asserting that a modified version of an existing device is safe and effective because its changes are minor and it is substantially equivalent to previously cleared devices. It is not a detailed clinical study report against specific acceptance criteria.

Summary

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K021701 (P.1 of 7)

Power Medical Interventions, Inc. SurgASSIS Right Angle Linear Cutter DLU with Reloads, 30mm, 45mm, 60mm Special 510(k) Device Modification PreMarket Notification May 20, 2002

JUN 2 1 200

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

SurgASSIST™ Right Angle Linear Cutter DLU with Reloads, 30mm, 45mm, 60mm

In Accordance with 21 CFR section 807.92 Power Medical Interventions, Inc., is submitting the following safety and effectiveness summary.

1. Submitter Information:
  Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 215-862-4450 Ph 215-862-1009 Fax

Applicant:

Barbara J. Whitman

Date of Notification:

May 20, 2002

1. Name of Device:
- SurgASSIST™ Trade Name: Right Angle Linear Cutter DLU with Reloads
- Linear Cutter with Implantable Staples Common Name: and Reloads

Classification Name: Staple, Implantable, GDW

1. Predicate Devices:
- a) SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit™ with Titanium Implantable Staple, Power Medical Interventions, Inc., New Hope, PA. REF RALC45. (K012809).

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021701 (P.2 an?)

b) EZ45 Endoscopic Linear Cutter/Stapler Reloads. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF ET45B (K980815).

4) Device Description:

The 30mm DLU can be used with only the 30mm reloadable cartridge.

The 45mm DLU can be used with only the 45mm reloadable cartridge.

The 60mm DLU can be used with only the 60mm reloadable cartridge.

During the Design Input stage of the Right Angle Linear Cutter, it was determined that the product would evolve into a reloadable device. Features that were incorporated into the non reloadable were designed in such a fashion that the components would yield a reloadable component.

These features designed into a non reloadable version that would be useful in a reloadable version include the latch that would allow the cartridge to be removed and the tongs of the cartridge cap that would secure the reload in position but be capable of being removed as well. The design that features the reloadable cartridges maintain much of the features of the non reloadable but with modest modifications.

Each DLU contains a staple-forming anvil. The anvil acts with the staple cartridge to compress and position lavers 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 30mm, 45mm and 60mm DLUs are perpendicular to the FlexShaft, 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 DLU 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 assembly that contains a pair of flexible rotary drive shafts within an overall flexible shaft called the FlexShaft, hereafter referred to as the FS. The other end of the FS is connected to a Power Console (the PC), which applies mechanical power to the drive shafts. DLUs

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21701 (P.3007)

Power Medical Interventions. Inc. SurgASSIST™ Right Angle Linear Cutter DLUs with Reloads, 30mm, 45mm, 60mm Special 510(k) Device Modification PreMarket Notification, May 20, 2002

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 cartridges. Each Reload has an integral electronic memory module. This identifies the type and size of the Reload being used.

1. Indications For Use The Right Angle Linear Cutter DLU with Reloads, 30mm, 45mm, 60mm will have substantially equivalent Indications For Use as the predicate device K012809.
  The SurgASSIST™ Right Angle Linear Cutter DLU with Reloads has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
1. Comparison to Predicate Devices
  The following table compares the subject Right Angle Linear Cutter DLU with Reloads to the previously cleared predicate Right Angle Linear Cutter DLU (K012809) device and the Ethicon Endopath EZ45 Endoscopic Linear Cutter with Reloads (K980815):

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സാം നിന്നും ,അമ്മരി നിന്നും പ്രവർ ക്രാപ്പി ക്വാസ് , മാന്‍ശാസ്ത്രവരി സ്വാപ്പ് സ്വാലാവും പ്രാലാവും പ്രാവാത്രമായി

Features & Description	Name	Manufacturer of Record	Contract Manufacturer	510(k) Clearance Numbers	Product Codes	Intended use	Features & Description	FDA Class (System)	Number of Staples	Rows of Staples	Staple Crown Dimension	Staple Leg Dimension	Staple Thickness	Staple Closed Range	DLU Internal Power	Digital Information	How Supplied	Features & Description	Reloads	Digital Loading Unit™	Method of Sterilization	Packaging		Features & Description	Method of Sterilization	Packaging
SurgASSISTTMRight Angle Linear Cutter DLUwith Reloads30mm, 45mm, 60mm	SurgASSISTTMRight Angle Linear Cutter DLUwith Reloads	Power Medical Interventions, Inc.	Lacey ManufacturingBridgeport, CT	Subject of this Notification	RALC30, RALC45, RALC60RALCR30, RALCR45, RALCR60	Has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.	SurgASSIST™Right Angle Linear Cutter DLUwith Reloads30mm, 45mm, 60mm	II	30mm - 22 staples45mm - 32 staples60mm - 46 staples	30mm - 4 rows45mm - 4 rows60mm - 4 rows	30mm - 3.5mm45mm - 3.5mm60mm - 3.5mm	30mm - 4.4mm45mm - 4.4mm60mm - 4.4mm	30mm - 0.23mm45mm - 0.23mm60mm - 0.23mm	30mm - 1.2 / 2.0mm45mm - 1.2 / 2.0mm60mm - 1.2 / 2.0mm	None	Memory module containingdigital data for identification,etc.	Sterile - Single Patient Use	SurgASSIST™Right Angle LinearCutter DLUwith Reloads30mm, 45mm, 60mm	Blister Traywith Tyvek Lid	Blister Traywith Tyvek Lid	Ethylene Oxide Gas (ETO)	Blister Traywith Tyvek Lid	Right Angle Linear Cutter DLU Product Features Comparison Chart continued from previous pageSurgASSIST™Right Angle Linear Cutter DLUwith Reloads30mm, 45mm, 60mm	Ethylene Oxide Gas (ETO)	Blister Tray with Tyvek Lid	Digital Loading Unit™
PredicateSurgASSISTTMRight Angle Linear Cutter DLU45mm	SurgASSISTTMRight Angle Linear Cutter DLU	Power Medical Interventions, Inc.	Lacey ManufacturingBridgeport, CT	K012809	RALC45	Has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.	PredicateSurgASSIST™Right Angle Linear Cutter DLU45mm	II	45mm - 32 staples	45mm - 4 rows	45mm - 3.5mm	45mm - 4.4mm	45mm - 0.23mm	45mm - 1.2 / 2.0mm	None	Memory module containing digital data foridentification, etc.	Sterile - Single Patient Use	PredicateSurgASSIST™Right Angle Linear Cutter DLU45mm	Blister Traywith Tyvek Lid	Blister Traywith Tyvek Lid	Ethylene Oxide Gas (ETO)	Blister Traywith Tyvek Lid	PredicateSurgASSIST™Right Angle Linear Cutter DLU45mm	Ethylene Oxide Gas (ETO)	Blister Tray with Tyvek Lid
PredicateEndopath EZ45Endoscopic Linear Cutter	Endopath EZ45Endoscopic Linear Cutter	Ethicon Endo-Surgery, Inc.	Ethicon Endo-Surgery, Inc.	K980815	EZ45	Application in gastroenterology for transection, resection, and/or creation of anastomoses and can be used in multiple open or minimally invasive surgical procedures, including radical prostatectomy, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.	PredicateEndopath EZ45Endoscopic Linear Cutter	II		4 rows	3.0	4.1	.20	2.0	None	None	Sterile - Single Patient Use	PredicateEndopath EZ45Endoscopic Linear Cutter	Blister Traywith Tyvek Lid	Blister Traywith Tyvek Lid	Irradiation	Blister Traywith Tyvek Lid	PredicateEndopath EZ45Endoscopic Linear Cutter	Ethylene Oxide Gas (ETO)	Blister Tray with Tyvek Lid
		44

ນຂອງ ແດຣເນຍປແທວວິ ຂອງແນ້ຂອ

K021701 (P.4 of 7)

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ında vəziyədə qalan ən ənga suoiyeva motif bənnin əlaqələrini

ന്നും സസ്റ്റ് ,നന്നുക ,ജാമിക്ക നിന്നും എന്നു ,ബന്ധിക്കുന്ന അവലംബം 1900-ൽ പ്രശസ്ത

(P.50P7) Koallol

000013

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021701 (P.6 of 7)

ന്നും സസ്സ് കോട്ടിക്കുന്നത് ക്രൈവിക്കുന്നു. കുറച്ചിത്രവലിന് സ്വാമക്കുന്നു. അവലംബം പ്രശസ്ത പ്രവേശവും വലിവ

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(021701 (p.7of7)

000000

Power Medical Interventions, Inc.
SurgASSIST™ Right Angle Linear Cutter DLUs with Reloads, 30mm, 45mm, 60mm
Special 510(k) Device Modification PreMarket Notification, May 20, 2002

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 1 2002

Ms. Barbara J. Whitman Regulatory Affairs Specialist Power Medical Interventions, Inc. 110 Union Square Drive New Hope. PA 18938

Re: K021701

Trade/Device Name: SurgASSISTTM

Right Angle Linear Cutter Digital Loading Unit™ with Reloads, 30mm, 45mm, 60mm Regulation Number: 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: May 20, 2002 Received: May 23, 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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.

R. Mark N. Millhurn

Celia M. Witten, Ph.D., M.D. 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. K Q21701

Device Name:

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

INDICATIONS FOR USE:

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

Prescription Use
Per 21CFR §801.109

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Mmh n Mulleum
Division Sign Off

estorative

510(k) Number K021701

000012

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.