Who is the manufacturer of SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)?

Power Medical Interventions, Inc. filed the 510(k) submission for SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33) (K032701).

What is the FDA product code for SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)?

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

What is the regulatory pathway for SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)?

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

What are the predicate devices for SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)?

SurgASSIST™ System with Circular Stapler Digital Loading Units® (K003277); Endopath ILS Endoscopic Circular Staplers (K920752).

Who can help prepare an FDA 510(k) submission like SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)?

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.

SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)

K032701 · Power Medical Interventions, Inc. · GDW · Sep 30, 2003 · General, Plastic Surgery

Device Facts

Record ID	K032701
Device Name	SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS (CS21, CS25, CS29, CS33)
Applicant	Power Medical Interventions, Inc.
Product Code	GDW · General, Plastic Surgery
Decision Date	Sep 30, 2003
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4750
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The SurgASSIST™ Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Device Story

SurgASSIST™ Circular Stapler Digital Loading Units (DLUs) are single-patient-use surgical instruments for alimentary tract anastomoses. DLUs contain titanium staples and integral circular cutting blades. Device operates via remote electrically powered console; provides computer-mediated steering and stapling. Input: surgeon control via console. Transformation: device applies double staggered circular row of staples to secure tissue layers; simultaneously cuts excess tissue at controlled diameter. Output: stapled, anastomosed tissue. Safety feature: prevents deployment unless within appropriate range for desired closed staple height. Modification (K032701) addresses latching mechanism failure by modifying spline tube and trocar to improve latch finger engagement. Benefits: provides controlled staple closure and tissue cutting in a steerable, flexible format.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: ASTM F-67 unalloyed titanium staples, stainless steel knife, polymeric components. Energy: Electrically powered via remote console. Form factor: Flexible, steerable circular stapler (21, 25, 29, 33 mm). Connectivity: Memory module for digital data/identification. Sterilization: Ethylene Oxide (ETO). Software: Embedded, includes safety interlocks for deployment range.

Indications for Use

Indicated for patients requiring end-to-end, end-to-side, or side-to-side anastomoses throughout the alimentary tract.

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 Circular Stapler Digital Loading Units® (K003277)
Endopath ILS Endoscopic Circular Staplers (K920752)

Related Devices

K040024 — SURGASSIST CIRCULAR STAPLER DIGITAL LOADING UNITS - 29 MM, MODEL CS29 · Power Medical Interventions, Inc. · Feb 4, 2004
K061649 — POWER CIRCULAR STAPLER DIGITAL LOADING UNIT WITH AND WITHOUT SHEATH · Power Medical Interventions, Inc. · Sep 1, 2006
K022313 — SURGASSIST RIGHT ANGLE LINEAR CUTTER DLU 30MM, 45MM & 60MM - VASCULAR WITH RELOADS, MODELS RALC30V, RALC45V & RALC60V · Power Medical Interventions, Inc. · Dec 9, 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
K131303 — DISPOSABLE CIRCULAR STAPLER · Changzhou City Zhiye Medical Devices Institute Co. · Jun 11, 2013

Submission Summary (Full Text)

{0}------------------------------------------------ Power Medical Interventions, Inc SurgASSIST™ Circular Stapler DLUs Special 510(k) Corrective Action Being Effected - August 29, 2003 ψ32701 (P.1.AS) ### Special 510(k) CORRECTIVE ACTION BEING EFFECTED SAFETY AND EFFECTIVENESS SUMMARY ## SurgASSIST Circular Stapler Digital Loading Units® 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 267-775-8151 Ph 267-775-8123 Fax Barbara J. Whitman Applicant: August 29, 2003 Date of Notification: - 2) Name of Device: | Trade Name: | SurgASSIST™ | |-------------|----------------------------| | | Circular Stapler DLUs | | | 21 mm, 25 mm, 29 mm, 33 mm | Circular Stapler with Implantable Staples Common Name: Classification Name: Staple, Implantable, GDW - 3) Predicate Devices: - A. SurqASSIST™ System with Circular Stapler Digital Loading Units®, (21 mm, 25 mm, 29 mm, 33 mm), with Titanium Implantable Staple, Power Medical Interventions, Inc., New Hope, PA. REF CS21, CS25, CS29, CS33 (K003277). - B. Endopath ILS Endoscopic Circular Staplers, 21 mm, 25 mm, 29 mm, 33 mm, Ethicon Endo-Surgery, Cincinnati, OH. (K920752). {1}------------------------------------------------ ## 4) Device Description: The SurqASSIST™ System with Circular Stapler Digital Loading Units® (DLUs) offers computer mediated steering and stapling. The DLUs contain implantable, titanium staples and integral cutting blades. The DLUs are used to anastomose tubular structures by applying a double staggered circular row of staples through the tissue. The staples form to controlled closed conditions to secure the lavers of tissue together. The DLUs also cut away the excess tissue at a controlled diameter inside the ring of staples. The Circular Stapler DLUs are available in the following four sizes: 21 mm, 25 mm, 29 mm, and 33 mm. The DLU is supplied sterilized and ready for use upon removal from its packaging. - 5) Device Modification Modifications were made to the predicate SurgASSIST™ Circular Stapler Digital Loading Units® (originally cleared under K003277) to address the root cause of the voluntary recall, which was a potential for latching mechanism failure, which could result in staple line failure and/or anvil jam. In order to further minimize the already low risk of latching mechanism failure, the spline tube and trocar were modified to improve engagement of the latch fingers. Further details of this modification can be found in Section H of this submission, under the "Device Modification" heading. - 6) Indications For Use The SurqASSIST™ Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-toside, and side-to-side anastomoses. - 7) Comparison to Predicate Devices The following table compares the subject Circular Stapler to the previously cleared predicates, Circular Stapler Cutter Digital Loading Units® (K003277) and Endopath ILS Endoscopic Circular Staplers (K920752). {2}------------------------------------------------ | Features & Description | SurgASSIST™ Circular Stapler Digital Loading Units® (DLUs) 21 mm, 25 mm, 29 mm, 33 mm REF: CS21, CS25, CS29, CS33 | Predicate SurgASSIST™ Circular Stapler Digital Loading Units® (DLUs) 21 mm, 25 mm, 29 mm, 33 mm | Predicate Ethicon Endo-Surgery, Inc. Endopath ILS Endoscopic Circular Stapler 21 mm, 25 mm, 29 mm, 33 mm | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Name | Circular Stapler Digital Loading Units® 21 mm, 25 mm, 29 mm, 33 mm | Circular Stapler Digital Loading Units® 21 mm, 25 mm, 29 mm, 33 mm | Ethicon Endo-Surgery, Inc. Endopath ILS Endoscopic Circular Stapler 21 mm, 25 mm, 29 mm, 33 mm | | Manufacturer of Record | Power Medical Interventions, Inc. | Power Medical Interventions, Inc. | Ethicon Endo-Surgery, Inc | | Contract Manufacturer | Lacey Manufacturing Bridgeport, CT | Lacey Manufacturing Bridgeport, CT | Ethicon Endo-Surgery, Inc | | 510(k) Clearance Numbers | Subject of this Notification | K003277 | K920752 | | Intended use | Applications throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses. | Applications throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses. | Applications throughout the alimentary tract for end-to-end, end-to-side and side-to-side anastomoses. | | Contraindications | Same, refer to labeling | Same, refer to labeling | Same, refer to labeling | | FDA Class (System) | II | II | II | | Sizes | 21 mm, 25 mm, 29 mm, 33 mm Circular Staplers | 21 mm, 25 mm, 29 mm, 33 mm Circular Staplers | 21 mm, 25 mm, 29 mm, 33 mm Circular Staplers | | Staple Shape | B-Shaped | B-Shaped | B-Shaped | | Features & Description | SurgASSIST™ Circular Stapler Digital Loading Units® (DLUs) 21 mm, 25 mm, 29 mm, 33 mm REF: CS21, CS25, CS29, CS33 | Predicate SurgASSIST™ Circular Stapler Digital Loading Units® (DLUs) 21 mm, 25 mm, 29 mm, 33 mm | Predicate Ethicon Endo-Surgery, Inc. Endopath ILS Endoscopic Circular Stapler 21 mm, 25 mm, 29 mm, 33 mm | | Closed Staple Height | Approximately 1.5 mm - 2.3 mm | Approximately 1.5 mm - 2.3 mm | 1.0 mm - 2.5 mm | | Staple Material | ASTM F-67 Unalloyed Titanium | ASTM F-67 Unalloyed Titanium | ASTM F-67 Unalloyed Titanium | | Knife Material | Stainless steel | Stainless steel | Stainless steel | | DLU Materials | Polymeric materials, surgical grade stainless steels, adhesives, and lubricants | Polymeric materials, surgical grade stainless steels, adhesives, and lubricants | Polymeric materials, surgical grade stainless steels, adhesives, and lubricants | | Cutting Mechanism | Circular Knife | Circular Knife | Circular Knife | | DLU Internal Power | None | None | None | | Power | Electrically powered via a remote Power Console | Electrically powered via a remote Power Console | Manually powered | | Software containing | Yes | Yes | No | | Digital Information | Memory module containing digital data for identification, etc. | Memory module containing digital data for identification, etc. | None | | How Supplied | Sterile - Single Patient Use | Sterile - Single Patient Use | Sterile - Single Patient Use | | Features & Description | SurgASSIST™ Circular Stapler Digital Loading Units® (DLUs) 21 mm, 25 mm, 29 mm, 33 mm REF: CS21, CS25, CS29, CS33 | Predicate SurgASSIST™ Circular Stapler Digital Loading Units® (DLUs) 21 mm, 25 mm, 29 mm, 33 mm | Predicate Ethicon Endo-Surgery, Inc. Endopath ILS Endoscopic Circular Stapler 21 mm, 25 mm, 29 mm, 33 mm | | Safety Mechanism | Will not deploy until within an appropriate range for desired closed staple height | Will not deploy until within an appropriate range for desired closed staple height | Contains indicators for appropriate range for desired closed staple height, but can be deployed out of range | | Insertion Mechanism | Flexible, steerable | Flexible, steerable | Rigid | | Method of Sterilization | Ethylene Oxide Gas (ETO) | Ethylene Oxide Gas (ETO) | Irradiation | | Packaging | Blister Tray with Tyvek Lid | Blister Tray with Tyvek Lid | Blister Tray with Tyvek Lid | # Circular Stapler DLU Product Features Comparison Chart {3}------------------------------------------------ # Circular Stapler DLU Product Features Comparison Chart (continued from previous page) {4}------------------------------------------------ ## Circular Stapler DLU Product Features Comparison Chart (continued from previous page) {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol. SEP 3 0 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938 Re: K032701 Trade/Device Name: SurgASSIST™ Circular Stapler Digital Loading Units® 21mm, 25mm, 29mm, 33mm Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 29, 2003 Received: September 2, 2003 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {6}------------------------------------------------ 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Miriam C. Provost fed 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 {7}------------------------------------------------ Power Medical Interventions, Inc. New Hope, PA 18938 510(k) No. K \$32741 Device Name: SurgASSIST™ Circular Stapler Digital Loading Units® 21 mm, 25 mm, 29 mm, 33 mm #### INDICATIONS FOR USE: The SurgASSIST™ Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-toside, and side-to-side anastomoses. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Prescription Use Per 21CFR §801.109 Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Miriam C. Provost OR (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K03270/