SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL
Device Facts
| Record ID | K020343 |
|---|---|
| Device Name | SURGASSIST SYSTEM; WIRELESS REMOTE CONTROL (COMPONENT); WIRED REMOTE CONTROL |
| Applicant | Power Medical Interventions, Inc. |
| Product Code | GDW · General, Plastic Surgery |
| Decision Date | Apr 10, 2002 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4750 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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, and general surgical procedures for resection, transection, and creation of anastomosis.
Device Story
SurgASSIST™ Wireless Remote Control is a battery-powered, handheld accessory for the SurgASSIST™ Power Console (PC). It transmits radio frequency (RF) control commands to the console to operate surgical stapling/cutting devices. Each remote is preprogrammed with a unique identification code; the console stores this code to ensure it only responds to its paired remote. The device features buttons for 'ON', 'FIRE', 'Release', 'OPEN', 'CLOSE', and directional movement. It is used by surgeons in clinical settings to remotely control the stapler console. The wireless functionality provides an alternative to the existing wired remote control. The device is non-sterile and compatible with steam autoclave, ethylene oxide, and peracetic acid sterilization methods.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Handheld remote control; RF transmitter; battery-powered (3.8 VDC, 1.6Ah lithium AA cell). Housing: ULTEM polyether-imide. Keypad: Parylene-coated silicone rubber. Dimensions: 16 cm x 9.5 cm. Connectivity: Proprietary RF link with unique ID pairing. Sterilization: Steam autoclave, ethylene oxide, and peracetic acid compatible.
Indications for Use
Indicated for patients undergoing gastrointestinal, gynecological, or general surgical procedures requiring resection, transection, or anastomosis 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 Disposable Loading Unit (K003277)
- Skylight Imaging Systems (K000908)
- SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit (K012809)
Submission Summary (Full Text)
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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.
1) 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
- 2) Name of Device:
SurgASSIST™ System Trade Name: With Wireless Remote Control
Wireless Remote Control Unit Common Name:
Classification Name: Staple, Implantable, GDW; Stapler, GAG
3) 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.
- 4) 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).
#### 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 &<br>Description | Power Medical<br>SurgASSIST™ w/ Wireless RC100 | Predicate Power Medical<br>SurgASSIST™ w/ Wired RCW100 | Predicate ADAC Laboratories<br>SKYlight Imaging System |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | SurgASSIST™ System Wireless Remote Control<br>Unit | SurgASSIST System with Circular Stapler DLU;<br>SurgASSIST System with Right Angle Linear<br>Cutter | 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<br>(RCWW was in original K003277submission) | Unknown if this component is sold<br>separately |
| Intended use | Applications throughout the alimentary tract for<br>end to end, end to side, and side to side<br>anastomosis | Applications throughout the alimentary tract for<br>end to end, end to side, and side to side<br>anastomosis | Skylight is intended to produce images<br>depicting the anatomical distributions of<br>single photon and positron emitting<br>radioisotopes within the human body for<br>interpretation by medical personnel. |
| FDA Class | II | II | II |
| Human Factors | Handheld, wireless, pushbutton radio frequency<br>command | Handheld, pushbutton command, with 3 meter<br>silicone coated wire for connection to<br>SurgASSIST Power Console (PC) | Handheld, wireless, pushbutton<br>command |
| 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"<br>Directions "North" "South" "East" "West" | "ON" "FIRE" "Release" "OPEN" "CLOSE"<br>Directions "North" "South" "East" "West" | No details available |
| Transmitter / Receiver | RF Transmitter in hand held remote. Receiver in<br>Power Console (PC) | Contains indicators for appropriate range for<br>desired closed staple height, but can be deployed<br>out of range | Will not deploy until the anvil/cartridge<br>gap is within a certain range on a built in<br>indicator |
| Power | Battery powered. High Temperature lithium AA<br>Cell 3.8 VDC, 1.6Ah | None | Presumably battery powered. No details<br>available |
| Software Containing | Yes | No | No details available |
| Sterilization Methods | Supplied to Customer Non-Sterile<br>Steam Autoclave Compatible<br>Ethylene Oxide Compatible<br>Peracetic Acid Wash Compatible | Supplied to Customer Non-Sterile<br>Ethylene Oxide Compatible<br>Peracetic Acid Wash Compatible | No details available |
| How Supplied | Non-Sterile, plastic wrapped in single unit<br>corrugated box | Non-Sterile, plastic wrapped in single unit<br>corrugated 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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