The SurgASSIST™ System with Right Angle Cutter Digital Loading Unit has applications in gastrointestinal, gynecological, surgical procedures for resection, transection, and creation of anastomosis.

Device Description

The SurgASSIST™ Wireless Remote Control Unit is a battery powered, hand held device that transmits control commands to the SurgASSIST™ System Power Console (PC).

The existing wired Remote control version will remain as a component of the SurgASSIST System. The wireless version of the Remote Control will be commercialized in addition to the existing wired version, and sold as an accessory to the System.

A battery capable of supplying power throughout the predictive life of the Remote Control Unit is permanently installed inside the hermetically sealed case or housing. All Wireless Remote Control Units share identical transmittance frequencies, however each Unit is preprogrammed with a unique identification code. When the Wireless Remote Control Unit is used to poweron the SurgASSIST™ Power Console (PC), this unique identification code is read and stored by the Console. The Power Console, with the stored identification code will then only respond to commands sent by its corresponding Remote Control Unit.

The radio frequency commands sent via the hand-held Remote Control Unit are Not considered Wireless Medical Telemetry, as defined by FCC. The frequencies assigned to the transmitter will not be in Medical Telemetry MHz bands set aside by the Wireless Medical Telemetry Service (WMTS).

AI/ML Overview

The provided text does not contain information regarding quantitative acceptance criteria or a study that proves the device meets such criteria for the SurgASSIST™ System with Wireless Remote Control.

The document is a Special 510(k) Device Modification PreMarket Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a clinical or bench study with acceptance criteria.

The information primarily discusses:

Device Description: The SurgASSIST™ Wireless Remote Control Unit is a battery-powered, handheld device that transmits control commands to the SurgASSIST™ System Power Console.
Predicate Devices: It lists existing wired SurgASSIST™ systems (K003277, K012809) and a Skylight Imaging System (K000908) for comparison.
Indications for Use: The system is intended for use throughout the alimentary tract for anastomosis and in gastrointestinal, gynecological, and thoracic surgical procedures for resection, transection, and creation of anastomosis. The indications for use are stated to be substantially identical to the predicate devices.
Comparison to Predicate Devices: A table compares features like intended use, FDA class, human factors, size, materials, command buttons, transmitter/receiver, power, software, and sterilization methods. The primary modification highlighted is the wireless capability.
FDA Clearance: The letter from the FDA confirms substantial equivalence based on the provided information.

Therefore, I cannot provide the requested details because the document does not include:

A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., latency, signal range, battery life duration targets) are mentioned, nor are results of tests against such criteria.
Sample size, data provenance: No test set or study is described.
Number of experts, qualifications, adjudication method: No expert review or ground truth establishment relevant to performance testing is mentioned.
MRMC comparative effectiveness study: This type of study is not mentioned as the device is a control unit for a surgical stapling system, not an imaging AI.
Standalone performance: No standalone performance metrics are provided beyond the device description of its function.
Type of ground truth used: Not applicable as no study with ground truth is described.
Sample size for training set: Not applicable; the document describes a hardware modification, not an AI or software device that would typically have a training set in this context.
How ground truth for training set was established: Not applicable.

Summary

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K020343(P.1 of 3)

Power Medical Interventions, Inc. SurgASSIST™ System with Wireless Remote Control Special 510(k) Device Modification PreMarket Notification January 30, 2002

APR 1 0 2002

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

SurgASSIST™ System with Wireless Remote Control

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 215-862-4450 PH 215-862-1009 Fax

Applicant:

Laurence A. Potter

Date of Notification:

January 30, 2002

1. Name of Device:
  SurgASSIST™ System Trade Name: With Wireless Remote Control

Wireless Remote Control Unit Common Name:

Classification Name: Staple, Implantable, GDW; Stapler, GAG

Predicate Devices:

a) SurgASSIST™ System with Circular Stapler Disposable Loading Unit with Titanium Implantable Staple, Power Medical Interventions, Inc., K003277.

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K020343(112055/

Power Medical Interventions, Inc. SurgASSIST™ System with Wireless Remote Control Unit Special 510(k) Device Modification PreMarket Notification January 30, 2002

b) Skylight Imaging Systems, K000908, ADAC Laboratories, Milpitas, CA 95035
c) SuraASSIST™ System with Right Angle Linear Cutter Digital Loading Unit, Power Medical Interventions, Inc., K012809.
1. Device Description:

The SurgASSIST™ Wireless Remote Control Unit is a battery powered, hand held device that transmits control commands to the SurgASSIST™ System Power Console (PC).

5) Indications For Use

The SurgASSIST™ System with Circular Stapler DLU, has applications throughout the alimentary tract for end-to-end and side-to-side anastomosis.

The SurgASSIST™ System with Right Angle Cutter Digital Loading Unit has applications in gastrointestinal, gynecological,

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K020343(P.3 of 3)

Power Medical Interventions, Inc. SurgASSIST™ System with Wireless Remote Control Unit Special 510(k) Device Modification PreMarket Notification January 29, 2002

6) Comparison to Predicate Devices

The flowing table compares the subject device to previously cleared predicate devices:

REMOTE CONTROL PRODUCT FEATURES COMPARISON CHART

Features &Description	Power MedicalSurgASSIST™ w/ Wireless RC100	Predicate Power MedicalSurgASSIST™ w/ Wired RCW100	Predicate ADAC LaboratoriesSKYlight Imaging System
Name	SurgASSIST™ System Wireless Remote ControlUnit	SurgASSIST System with Circular Stapler DLU;SurgASSIST System with Right Angle LinearCutter	Skylight Imaging System
Manufacturer	Power Medical Interventions, Inc.	Power Medical Interventions, Inc.	ADAC Laboratories
510(k) Clearance Numbers	N/A	K003277; K012809	K000908
Product Code	RC100	RCW100(RCWW was in original K003277submission)	Unknown if this component is soldseparately
Intended use	Applications throughout the alimentary tract forend to end, end to side, and side to sideanastomosis	Applications throughout the alimentary tract forend to end, end to side, and side to sideanastomosis	Skylight is intended to produce imagesdepicting the anatomical distributions ofsingle photon and positron emittingradioisotopes within the human body forinterpretation by medical personnel.
FDA Class	II	II	II
Human Factors	Handheld, wireless, pushbutton radio frequencycommand	Handheld, pushbutton command, with 3 metersilicone coated wire for connection toSurgASSIST Power Console (PC)	Handheld, wireless, pushbuttoncommand
Size	16 cm x 9.5cm	16 cm x 9.5 cm with 3 meter attached cord	No details available
Housing Material	ULTEM polyether-imide	polycarbonate	Plastic
Keypad Material	Parylene coated Silicone Rubber	Parylene coated Silicone Rubber	No details available
Command Buttons	"ON" "FIRE" "Release" "OPEN" "CLOSE"Directions "North" "South" "East" "West"	"ON" "FIRE" "Release" "OPEN" "CLOSE"Directions "North" "South" "East" "West"	No details available
Transmitter / Receiver	RF Transmitter in hand held remote. Receiver inPower Console (PC)	Contains indicators for appropriate range fordesired closed staple height, but can be deployedout of range	Will not deploy until the anvil/cartridgegap is within a certain range on a built inindicator
Power	Battery powered. High Temperature lithium AACell 3.8 VDC, 1.6Ah	None	Presumably battery powered. No detailsavailable
Software Containing	Yes	No	No details available
Sterilization Methods	Supplied to Customer Non-SterileSteam Autoclave CompatibleEthylene Oxide CompatiblePeracetic Acid Wash Compatible	Supplied to Customer Non-SterileEthylene Oxide CompatiblePeracetic Acid Wash Compatible	No details available
How Supplied	Non-Sterile, plastic wrapped in single unitcorrugated box	Non-Sterile, plastic wrapped in single unitcorrugated box	No details available

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2002

Mr. Laurence A. Potter Vice President, Regulatory Affairs and Quality Assurance Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938

Re: K020343

Trade/Device Name: SurgASSIST™ System with Wireless Remote Control Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: March 8, 2002 Received: March 11, 2002

Dear Mr. Potter:

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 10 mos based of 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 he 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 -- Mr. Laurence A. Potter

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 promative noticated 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 Compliance at (301) 594-4639 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 O inision 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,

iriam C. Provost

For 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. SurgASSIST™ System with Witeless Remote Control United r ower Medical Interroritions, Inc. Bargers - January 30, 2002

Power Medical Interventions, Inc. New Hope, PA 18938

510(k) No. K 020343

Device Name:

SurgASSIST™ System with Wireless Remote Control

INDICATIONS FOR USE: (Note: The intended use for this product modification will be substantially INDIOA HONO I OTC OOL. (Noto: This Interventions, Inc. immediate 510(K) Notification's, K003277 & K012809).

The SurgASSIST™ System with Circular Stapler DLU, has The Gurghout the alimentary tract for end-to-end and side-to-side anastomosis.

The SurgASSIST™ System with Right Angle Cutter Digital Loading Unit has applications in gastrointestinal, gynecological, Eoading "Only has applitiation surgical procedures for resection, transection, and creation of anastomosis.

(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

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020343

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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.