SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM
Device Facts
| Record ID | K040720 |
|---|---|
| Device Name | SURGASSIST COMPUTER MEDIATED LINEAR CUTTER DIGITAL LOADING UNITS, 30 MM, 55 MM, 75 MM |
| Applicant | Power Medical Interventions, Inc. |
| Product Code | GDW · General, Plastic Surgery |
| Decision Date | Jun 3, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4750 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units® have applications for general endoscopic surgery in gastrointestinal, and gynecological, general abdominal and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
Device Story
SurgASSIST® Computer Mediated Linear Cutter (CMLC) Digital Loading Units® (DLUs) are reusable surgical stapling components used with previously cleared reloads. Device functions in general, endoscopic, gastrointestinal, gynecological, abdominal, and thoracic surgeries for tissue resection, transection, anastomosis, and left atrial appendage occlusion. DLUs are designed for multi-patient use, requiring cleaning and autoclave sterilization. Operation involves mechanical stapling and cutting; anvil clamp force increased to 100 lbs to support durability for multi-patient cycles. Surgeons operate the device during procedures to provide mechanical tissue management. Benefits include reusability and enhanced mechanical performance compared to single-use predecessors.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on technological characteristics and design modifications for reusability.
Technological Characteristics
Reusable linear stapler loading units. Materials modified to withstand multiple cleaning and autoclave sterilization cycles. Mechanical actuation with increased anvil clamp force (100 lbs). Available in 30 mm, 55 mm, and 75 mm sizes. Standalone mechanical device.
Indications for Use
Indicated for patients undergoing general, endoscopic, gastrointestinal, gynecological, abdominal, or thoracic surgical procedures requiring resection, transection, or creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
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® Straight Linear Cutter Digital Loading Units® with Reloads (K020719)
- SurgASSIST® Straight Linear Stapler Digital Loading Units® with Reloads and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads (K040398)
- USSC Auto Suture TA & GIA Staplers (K032696)
Related Devices
- 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
- K033578 — REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS · Clearmedical, Inc. · Jul 11, 2005
- K021701 — SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60 · Power Medical Interventions, Inc. · Jun 21, 2002
- K040398 — SURGASSIST STRAIGHT LINEAR 4 ROW NO KNIFE DLUS WITH RELOADS · Power Medical Interventions, Inc. · Mar 24, 2004
Submission Summary (Full Text)
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K040720 Page 1/2
Power Medical Interventions, Inc. SurgASSIST® Computer Mediated Linear Cutter DLUs Traditional 510(k) Premarket Notification · March 17, 2004
JUN 0 3 2004
#### Section E
#### Traditional 510(k) - Summary
In Accordance with 21 CFR Section 807.92 Power Medical Interventions, Inc., is submitting the following 510(k) Summary:
1) Submitter Information:
Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 267-775-8151 Ph 267-775-8123 Fax
Applicant:
Barbara J. Whitman
March 17, 2004 Date of Notification:
2) Name of Device:
| Trade Name: | SurgASSIST®<br>Computer Mediated Linear Cutter (CMLC)<br>Digital Loading Units® (DLUs)<br>30 mm, 55 mm, 75 mm |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Linear Staplers with Implantable Staples |
| Classification<br>Name: | Staple, Implantable, GDW |
- 3) Predicate Devices:
- a. SurgASSIST® Straight Linear Cutter Digital Loading Units® with Reloads, Power Medical Interventions, Inc., New Hope, PA. REF SLC55B, SLCR55B, SLC55G, SLCR55G, SLC30B, SLCR30B, SLC30G, SLCR30G (K020719).
- b. SurgASSIST® Straight Linear Stapler Digital Loading Units® with Reloads and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads, Power Medical Interventions, Inc., New Hope, PA. |REF SLS55B, SLSR55B, SLS55G, SLSR55G, SLSR55G, SLS55B4, SLSR55B4 (K040398).
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K040720 page 2/2
- c. USSC Auto Suture TA & GIA Staplers, United States Surgical, Norwalk, CT. REF TA, GIA (K032696).
- 4) Device Description:
devices described here are reusable CMLC DLUs used in The conjunction with a variety of Reloads, which were previously cleared to market under K020719 and K030653. The DLUs are designed to be cleaned and sterilized for multi-patient use.
- 5) Device Modification
The CMLC DLUs have identical technological features as the predicate devices (K020719). The CMLC DLUs underwent material changes in order for the DLUs to withstand multiple cleaning and autoclave cycles for the purpose of multi-patient use. The average anvil clamp force was increased from 50 lbs. on the predicate device to 100 lbs. on the Computer Mediated Linear Cutter DLUs.
- 6) Indications For Use
The SuraASSIST® Computer Mediated Linear Cutter Digital Loading Units® have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic suraical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
- 7) Comparison to Predicate Devices
The CMLC DLUs have the same function as the previously cleared predicate Straight Linear Cutter Digital Loading Units® with Reloads (K020719). Material changes in the DLUs allow for cleaning, sterilizing, and multi-patient use. The average anvil clamp force was increased in the CMLC DLUs. For further details, please refer to Section J for predicate comparison chart.
The CMLC DLUs Indications For Use statement is identical to that which appears in the following two predicate devices, K040398 and K032696.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HEALTH & HUMAN SERVICES - USA" are arranged around the top of the symbol. The logo is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2004
Ms. Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938
Re: K040720
Trade/Device Name: SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units® Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 18, 2004 Received: March 19, 2004
Dear Ms. Whitman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use slated in the elerosure) to 1egars atment date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuired in accessaried of a premarket approval application (PMA). and Cosmette Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, ulcrefore, market the device, books requirements for annual registration, listing of general controls provisions of all rist leveling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) and class of regulations affecting your device can may be subject to back acated as a legulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obas acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that i Dri brisoaanso o vour device complies with other requirements of the Act that I DA has made a aother regulations administered by other Federal agencies. You must of any I coclar statutes and regulations and limited to: registration and listing (21 Comply with an the rice brequirements)01); good manufacturing practice requirements as set CITY art 607), adomig (21 CFR Part 820); and if applicable, the electronic 101th in the quant) Bybellio (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) This letter will anow you to begin marketing your antial equivalence of your device to a legaliy premarket notification. The FDA Inding of substantial equilies 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 If you desire specific advice for your de 110 your ac 9. Also, please note the regulation entitled, contact the Office of Complance at (301) 597 1707 (21) Part 807.97). You may obtain " Misoranding by reference to premarked nonlineaus in the Act from the Division of Small other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance on and also and also and Manufacturers, International and Consulter Parison Parison of Carb/dsmaldsmamain.html
Sincerely yours,
Miriam C. Provost
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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### Section D
K040720
# Indications for Use
Power Medical Interventions, Inc. New Hope, PA 18938
510(k) Number (if known):
Device Name: SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units®
Indications For Use:
The SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units® have applications for general endoscopic surgery in gastrointestinal, and gynecological, general abdominal and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
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510(k) Number K0140720
