SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60

K021701 · Power Medical Interventions, Inc. · GDW · Jun 21, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021701
• Device Name: SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
• Applicant: Power Medical Interventions, Inc.
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Jun 21, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

SurgASSIST Right Angle Linear Cutter DLU is a reloadable, single-patient-use surgical stapler. Device attaches to a FlexShaft assembly connected to a Power Console, which provides mechanical power for operation. Surgeon controls device via handheld electronic Remote Control Unit (RCU). DLU features a staple-forming anvil and cartridge; device compresses tissue, applies staples, and severs tissue simultaneously. Steerable distal section of FlexShaft allows adjustment of DLU attitude for accessibility. Each reloadable cartridge contains an integral electronic memory module for identification of type and size. Device is used in OR settings by surgeons to secure tissue layers during resection or anastomosis. Benefits include optimized accessibility via steerable shaft and automated, powered staple application.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reloadable linear cutter stapler; 30mm, 45mm, 60mm sizes. Powered by external Power Console via flexible rotary drive shafts. Features electronic memory module in reloads for identification. Sterilized via Ethylene Oxide (ETO). Components include staple-forming anvil, cutting blade, and staple pushers. Designed for single-patient use.

Indications for Use

Indicated for patients undergoing gastrointestinal, gynecological, general abdominal, or thoracic surgical procedures requiring resection, transection, or creation of anastomoses.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• SurgASSIST System with Right Angle Linear Cutter Digital Loading Unit with Titanium Implantable Staple (K012809)
• EZ45 Endoscopic Linear Cutter/Stapler Reloads (K980815)

Submission Summary (Full Text)

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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

- 2) 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

- 3) 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 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

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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.

- 5) 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.

- 6) 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) | Physical Characteristics | 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 | Reloads |
|-----------------------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------|---------------------------------------|------------------------------|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------|--------------------------|-------------------------------------------------------------|-------------------------------------------------|----------------------------------------------|----------------------------------------------|-------------------------------------------------|----------------------------------------------------------------|--------------------|----------------------------------------------------------------------|------------------------------|-------------------------------------------------------------------------------------|--------------------------------|--------------------------------|--------------------------|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------|-----------------------|---------|
| SurgASSISTTM<br>Right Angle Linear Cutter DLU<br>with Reloads<br>30mm, 45mm, 60mm | SurgASSISTTM<br>Right Angle Linear Cutter DLU<br>with Reloads | Power Medical Interventions, Inc. | Lacey Manufacturing<br>Bridgeport, CT | Subject of this Notification | RALC30, RALC45, RALC60<br>RALCR30, RALCR45, RALCR60 | Has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses. | SurgASSIST™<br>Right Angle Linear Cutter DLU<br>with Reloads<br>30mm, 45mm, 60mm | II | | 30mm - 22 staples<br>45mm - 32 staples<br>60mm - 46 staples | 30mm - 4 rows<br>45mm - 4 rows<br>60mm - 4 rows | 30mm - 3.5mm<br>45mm - 3.5mm<br>60mm - 3.5mm | 30mm - 4.4mm<br>45mm - 4.4mm<br>60mm - 4.4mm | 30mm - 0.23mm<br>45mm - 0.23mm<br>60mm - 0.23mm | 30mm - 1.2 / 2.0mm<br>45mm - 1.2 / 2.0mm<br>60mm - 1.2 / 2.0mm | None | Memory module containing<br>digital data for identification,<br>etc. | Sterile - Single Patient Use | SurgASSIST™<br>Right Angle Linear<br>Cutter DLU<br>with Reloads<br>30mm, 45mm, 60mm | Blister Tray<br>with Tyvek Lid | Blister Tray<br>with Tyvek Lid | Ethylene Oxide Gas (ETO) | Blister Tray<br>with Tyvek Lid | Right Angle Linear Cutter DLU Product Features Comparison Chart continued from previous page<br>SurgASSIST™<br>Right Angle Linear Cutter DLU<br>with Reloads<br>30mm, 45mm, 60mm | Ethylene Oxide Gas (ETO) | Blister Tray with Tyvek Lid | Digital Loading Unit™ | |
| Predicate<br>SurgASSISTTM<br>Right Angle Linear Cutter DLU<br>45mm | SurgASSISTTM<br>Right Angle Linear Cutter DLU | Power Medical Interventions, Inc. | Lacey Manufacturing<br>Bridgeport, CT | K012809 | RALC45 | Has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses. | Predicate<br>SurgASSIST™<br>Right Angle Linear Cutter DLU<br>45mm | 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 for<br>identification, etc. | Sterile - Single Patient Use | Predicate<br>SurgASSIST™<br>Right Angle Linear Cutter DLU<br>45mm | Blister Tray<br>with Tyvek Lid | Blister Tray<br>with Tyvek Lid | Ethylene Oxide Gas (ETO) | Blister Tray<br>with Tyvek Lid | Predicate<br>SurgASSIST™<br>Right Angle Linear Cutter DLU<br>45mm | Ethylene Oxide Gas (ETO) | Blister Tray with Tyvek Lid | | |
| Predicate<br>Endopath EZ45<br>Endoscopic Linear Cutter | Endopath EZ45<br>Endoscopic 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. | Predicate<br>Endopath EZ45<br>Endoscopic Linear Cutter | II | | | 4 rows | 3.0 | 4.1 | .20 | 2.0 | None | None | Sterile - Single Patient Use | Predicate<br>Endopath EZ45<br>Endoscopic Linear Cutter | Blister Tray<br>with Tyvek Lid | Blister Tray<br>with Tyvek Lid | Irradiation | Blister Tray<br>with Tyvek Lid | Predicate<br>Endopath EZ45<br>Endoscopic Linear Cutter | Ethylene Oxide Gas (ETO) | Blister Tray with Tyvek Lid | | |
| | | 44 | | | | | | | | | | | | | | | | | | | | | | | | | | |

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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

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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)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

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

OR

Prescription Use
Per 21CFR §801.109

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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estorative

510(k) Number K021701

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