SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V

Q: Who is the manufacturer of SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V?

Power Medical Interventions, Inc. filed the 510(k) submission for SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V (K022313).

Q: What is the FDA product code for SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V?

GDW. It is classified under 21 CFR 878.4750 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K022313 · Power Medical Interventions, Inc. · GDW · Dec 9, 2002 · General, Plastic Surgery

Device Facts

Record ID	K022313
Device Name	SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V
Applicant	Power Medical Interventions, Inc.
Product Code	GDW · General, Plastic Surgery
Decision Date	Dec 9, 2002
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4750
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended 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.

Device Story

SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™ (DLU) is a single-patient-use surgical stapler component. It attaches to a flexible shaft (FS) connected to a power console (PC). The DLU features a staple-forming anvil and a cutting blade. During operation, the PC provides mechanical power to drive the stapling and cutting mechanism. The surgeon controls the device via a handheld electronic Remote Control Unit (RCU). The DLU compresses tissue, sequentially forms staples, and simultaneously severs the tissue. Each DLU includes an integral electronic memory module for identification of reload type and size. The device is used in OR settings by surgeons to facilitate tissue anastomosis and resection. It benefits patients by providing a powered, steerable, and precise method for tissue transection and stapling in both open and endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Single-patient-use DLU with staple-forming anvil and cutting blade. Powered by external console via flexible shaft. Includes electronic memory module for reload identification. Sterilized via Ethylene Oxide (ETO). Dimensions: 30mm, 45mm, 60mm variants. Staple configuration: 6 rows, 2.4mm crown, 2.3mm leg, 0.20mm thickness.

Indications for Use

Indicated for patients undergoing general, gynecological, urologic (including radical prostatectomy), thoracic, or pediatric surgical procedures requiring transection, resection, or creation of anastomoses via open or minimally invasive techniques.

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™ Right Angle Linear Cutter Digital Loading Unit™, 30 mm, 45 mm and 60 mm with Titanium Implantable Staples and Reloads (K021701)
ETS Compact-Flex45 Articulating Endoscopic Linear Cutter, Vascular/Thin (K002398)

Related Devices

K021701 — SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 · Power Medical Interventions, Inc. · Jun 21, 2002
K030653 — SURGASSIST STRAIGHT LINEAR STAPLER AND STRAIGHT LINEAR 4 ROW NO KNIFE DIGITAL LOADING UNITS WITH RELOADS · Power Medical Interventions, Inc. · Mar 31, 2003
K012809 — SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU - 45MM, MODEL RALC45 · Power Medical Interventions, Inc. · Oct 26, 2001
K020719 — SURGASSIST SYSTEM STRAIGHT LINEAR CUTTER DIGITAL LOADING UNIT, 55MM, 30MM WITH BLUE AND GREEN RELOAD CARTRIDGES · Power Medical Interventions, Inc. · May 10, 2002
K052910 — POWER RIGHT ANGLE LINEAR CUTTER DIGITAL LOADING UNIT WITH RELOADS · Power Medical Interventions, Inc. · Nov 7, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ 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. 1) 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: - 2) Name of Device: | Trade Name: | SurgASSIST™ Right Angle Linear Cutter DLU 30 mm, 45 mm and 60 mm - Vascular with Reloads | |--------------|---------------------------------------------------------------------------------------------------| | Common Name: | Linear Cutter with Implantable Staples and Reloads | Classification Name: Staple, Implantable, GDW {1}------------------------------------------------ 3) 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). - 4) 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 {2}------------------------------------------------ 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. 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. - 5) 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. - 6) 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. {3}------------------------------------------------ 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 | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------------------|---------------------------------------|------------------------------|-----------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SurgASSISTTM Right Angle Linear Cutter DLU 30mm, 45mm, 60mm - Vascular with Reloads | SurgASSISTTM Right Angle Linear Cutter DLU Vascular with Reloads | Power Medical Interventions, Inc. | Lacey Manufacturing Bridgeport, CT | Subject of this Notification | RALC30V, RALC45V, RALC60V RALCR30V, RALCR45V, RALCR60V | Ethicon ETS Compact-Flex45 Articulating Endoscopic Linear Cutter, Vascular/Thin | 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 | | SurgASSISTTM Right Angle Linear Cutter DLU 30mm, 45mm, 60mm with Reloads | SurgASSISTTM Right Angle Linear Cutter DLU with Reloads | Power Medical Interventions, Inc. | Lacey Manufacturing Bridgeport, CT | K021701 | RALC30, RALC45, RALC60 RALCR30, RALCR45, RALCR60 | ETS Compact-Flex45 Articulating Endoscopic Linear Cutter, Vascular/Thin | Has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses. | | | | | | K002398 | | Ethicon Endo-Surgery, Inc. | 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. | | | | | | | | Ethicon Endo-Surgery, Inc. | | | | | | | | | SCW45 TR45W | | K022313 page 4/6 {4}------------------------------------------------ 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 | |------------------------------------------------------------------------------------------------|--------------------|--|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | SurgASSISTTM Right Angle Linear Cutter DLU 30 mm, 45 mm, 60mm - Vascular with Reloads | II | | | Ethicon ETS Compact- Flex45 Articulating Endoscopic Linear Cutter, Vascular/Thin | | SurgASSISTTM Right Angle Linear Cutter DLU with Reloads 30 mm, 45 mm, 60 mm | II | | | II | | | | | 30mm Vascular- 46 staples 45mm Vascular - 69 staples 60mm Vascular - 92 staples | 30mm - 22 staples | | | | | Number of Staples | 45mm - 32 staples | | | | | | 60mm - 46 staples | | | | | 30mm Vascular -6 rows 45mm Vascular - 6 rows 60mm Vascular - 6 rows | 30mm- 4 rows | | | | | Rows of Staples | 45mm- 4 rows | | | | | | 60mm- 4 rows | | | | | 30mm Vascular - 2.4 mm 45mm Vascular - 2.4 mm 60mm Vascular - 2.4 mm | 30mm- 4.0 mm | | | | | Staple Crown Dimension | 45mm- 4.0 mm | | | | | | 60mm- 4.0 mm | | | | | 30mm Vascular - 2.3 mm 45mm Vascular - 2.3 mm 60mm Vascular - 2.3 mm | 30mm- 4.4 mm | | | | | Staple Leg Dimension | 45mm- 4.4 mm | | | | | | 60mm- 4.4 mm | | | | | 30mm Vascular - 0.20 mm 45mm Vascular - 0.20 mm 60mm Vascular - 0.20 mm | 30mm- 0.23mm | | | | | Staple Thickness | 45mm- 0.23mm | | | | | | 60mm- 0.23mm | | | | | 30mm Vascular - 1.0 mm 45mm Vascular - 1.0 mm 60mm 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 data for identification, etc. | Memory module containing digital data for identification, 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 | {5}------------------------------------------------ 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 | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | . | | | | | | | | | | | | | | Features & Description | Method of Sterilization | Packaging | | |--------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------|-----------------------------| | SurgASSIST™ Right Angle Linear Cutter DLU 30 mm, 45 mm, 60 mm – Vascular with Reloads | Ethylene Oxide Gas (ETO) | Blister Tray with Tyvek Lid | Blister Tray with Tyvek Lid | | SurgASSIST™ Right Angle Linear Cutter DLU with Reloads 30 mm, 45 mm, 60 mm | Ethylene Oxide Gas (ETO) | Blister Tray with Tyvek Lid | Blister Tray with Tyvek Lid | | Predicate Ethicon ETS Compact- Flex45 Articulating Endoscopic Linear Cutter, Vascular/Thin | Irradiation | Blister Tray with Tyvek Lid | Blister Tray with Tyvek Lid | 000000 {6}------------------------------------------------ # 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 {7}------------------------------------------------ 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 {8}------------------------------------------------ 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: 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. # (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