(66 days)
No
The description focuses on mechanical and computer-mediated control of cutting and stapling, explicitly stating the technology is identical to a previously cleared device without mentioning AI or ML. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
No.
This device is described as a cutter/stapler used for resection, transection, and creation of anastomoses during surgical procedures, which are mechanical actions rather than therapeutic in nature.
No
The device is described as a cutter/stapler used for surgical procedures like resection, transection, and creation of anastomoses, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly details hardware components such as a steerable FlexShaft, a hand-held Remote Control Unit with pushbuttons, and a Digital Loading Unit (DLU) containing implantable staples and a steel knife blade. These are physical components, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for cutting, stapling, and creating connections in tissues during surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical device with components like a FlexShaft, Remote Control Unit, and a Digital Loading Unit containing staples and a knife blade. These are all tools for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is used to perform surgical actions directly on the body.
N/A
Intended Use / Indications for Use
The SurgASSIST™ System Straight Linear Cutter DLU has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™ (DLU), 55mm, 30mm is a cutter/stapler component addition to a previously cleared device, K012809, SuraASSIST™ System Right Angle Linear Cutter - 45mm Digital Loading Unit™. This Notification offers an additional style of cutting/stapling configuration, specifically, Straight Linear Cutters/staplers, both Blue and Green, of 55mm and 30mm in length. The computer mediated, powered steering, tissue cutting and stapling of the Straight Linear Cutters are utilizing the identical technology and system approach which the previously cleared device currently utilizes.
The technological features of the SurgASSIST™ System Straight Linear Cutters are identical to that of the predicate device, K012809.
- A steerable FlexShaft that serves as the interface between the . Digital Loading Unit™ (DLU) and the Power Console and provides the means of insertion of the DLU. The FlexShaft is steerable for surgical positioning of the DLU for access and visualization.
- . A hand held Remote Control Unit that contains pushbuttons that actuate steering, extension and retraction of the anvil, stapling, and cutting.
- Straight Linear Cutter Digital Loading Unit™ (DLU) that . contain implantable staples that form in a double staggered linear row of staples and a steel knife blade which transects the tissue between the two rows of formed staples. The Straight Linear Cutter DLU is offered currently in a 55mm and 30mm length size, in reloadable configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal, gynecological, general abdominal and thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Power Medical Interventions, Inc SurgASSIST™ Straight Linear Cutter DLUs with Blue and Green Reload Cartridges 510(k), March 1, 2002
Ko20719
PREMARKET NOTIFICATION 510(K) SAFETY AND EFFECTIVENESS SUMMARY
SurgASSIST™ Straight Linear Cutter Digital Loading Unit™ (DLU), 55mm, 30mm
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. 4 B East Bridge Street New Hope, PA 18938 USA 215-862-4450 215-862-3073 FAX
Applicant: Barbara J. Whitman
Date of Notification: 03/01/2002
-
- Name of Device:
Trade Name: SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™, 55mm, 30mm with Blue and Green Reload Cartridges
- Name of Device:
Common Name: Linear Cutter with Implantable Staples
Classification Name: Staple, Implantable, GDW; Stapler, GAG; Cutter, FZT; Endoscope, GCJ
- Predicate Devices: LINEAR CUTTERS / STAPLING INSTRUMENTS
- A. SurgASSIST™ System, Right Angle Linear Cutter Digital Loading Unit™. Power Medical Interventions, Inc., New Hope, PA. REF RALC45 (K012809).
- B. EZ45 Endoscopic Linear Cutter. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF ET45B (K980815).
000015
1
- C. Endopath® EZ45 Endoscopic Linear Cutter/Stapler Reloads. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF ZR45B ( K980815).
-
- Device Description:
The SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™ (DLU), 55mm, 30mm is a cutter/stapler component addition to a previously cleared device, K012809, SuraASSIST™ System Right Angle Linear Cutter - 45mm Digital Loading Unit™. This Notification offers an additional style of cutting/stapling configuration, specifically, Straight Linear Cutters/staplers, both Blue and Green, of 55mm and 30mm in length. The computer mediated, powered steering, tissue cutting and stapling of the Straight Linear Cutters are utilizing the identical technology and system approach which the previously cleared device currently utilizes.
The technological features of the SurgASSIST™ System Straight Linear Cutters are identical to that of the predicate device, K012809.
- A steerable FlexShaft that serves as the interface between the . Digital Loading Unit™ (DLU) and the Power Console and provides the means of insertion of the DLU. The FlexShaft is steerable for surgical positioning of the DLU for access and visualization.
- . A hand held Remote Control Unit that contains pushbuttons that actuate steering, extension and retraction of the anvil, stapling, and cutting.
- Straight Linear Cutter Digital Loading Unit™ (DLU) that . contain implantable staples that form in a double staggered linear row of staples and a steel knife blade which transects the tissue between the two rows of formed staples. The Straight Linear Cutter DLU is offered currently in a 55mm and 30mm length size, in reloadable configuration.
2
5) Indications For Use
The SurgASSIST™ System Straight Linear Cutter DLU has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
-
- Comparison to Predicate Devices
- SurgASSIST™ System, Right Angle Linear Cutter Digital 1. Loading Unit. Power Medical Interventions, Inc., New Hope, PA. REF RALC45 (K012809).
-
- EZ45 Endoscopic Linear Cutter. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF ET45B (K980815).
- Endopath® EZ45 Endoscopic Linear Cutter/Stapler Reloads. 3. Ethico0n Endo-Surgery, Inc., Cincinnati, Ohio. REF ZR45B ( K980815).
Substantial equivalence includes the predicate SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™ literature including descriptions, specifications, identification of standard components, and identification of tissue contact materials.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2002
Ms. Barbara J. Whitman Regulatory Affairs Specialist Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938
Re: K020719
SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™ (DLU), 55mm, 30mm with Blue and Green Reload Cartridges Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: March 1, 2002 Received: March 5, 2002
Dear Ms. Whitman:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your concernined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the exerces, 1976, the enactment date of the Medical Device Amendments, or to conniner of the 10 may 20, 2018 11:14 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 If your device is classinonal controls. Existing major regulations affecting your device can thay be subject to back acceral 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 or any I 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.
4
Page 2 - Ms. Barbara J. Whitman
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally premated predicated 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 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 O inter go at 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,
Muriam 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
5
Power Medical Interventions, Inc. SurgASSIST™ Straight Linear Cutter DLUs with Blue and Green Reload Cartridges 510(k), March 1, 2002
SECTION D
STATEMENT OF INTENDED USE
Power Medical Interventions, Inc.
510(k) No. K020719
Device Name:
SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™, 55mm, 30mm with Reload Cartridges
INDICATIONS FOR USE:
The SurgASSIST™ System Straight Linear Cutter DLU has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
(PLEASE DO NOT WRITE BELOW THIS LINE - (CONTINUE ON ANOTHER PAGE IF NEEDED)
Miriam C. Phovost (Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020719
Prescription Use X Over-The-Counter Use
(per 21 CFR 801.109)