(65 days)
No
The document describes a computer-mediated, powered surgical stapler system but does not mention any AI or ML components, algorithms, or functionalities. The technology is described as identical to a previously cleared device.
Yes
The device is a surgical stapler/cutter used in various surgical procedures, which are considered therapeutic interventions as they are performed to treat or alleviate a medical condition.
No
The device is described as a cutter/stapler system used in surgical procedures for resection, transection, and creating anastomoses, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines multiple hardware components including a steerable FlexShaft, a hand held Remote Control Unit, and a Right Angle Linear Cutter Digital Loading Unit (DLU) containing staples and a knife blade. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures performed on the body (in vivo), not tests performed on samples taken from the body (in vitro).
- Device Description: The description details a surgical stapler and cutter used for tissue manipulation during surgery. This is a surgical instrument, not a diagnostic device.
- No mention of diagnostic testing: The text does not mention analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the SurgASSIST™ System with Right Angle Linear Cutter DLU is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SurgASSIST™ System with Right Angle Linear Cutter DLU has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
Product codes
GDW
Device Description
The SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit™ (DLU) is a cutter/stapler component addition to a Eodaing cleared device, K003277, SurgASSIST™ System with Circular Stapler Disposable Loading Unit. This Notification offers an additional style of cutting/stapling configuration, specifically, a right angle linear cutter/stapler of 45mm in length. The computer mediated, powered steering, tissue cutting and stapling of the Right Angle Linear Cutter is utilizing the identical technology and system approach which the previously cleared device currently utilizes.
The technological features of the SurgASSIST™ System with Right Angle 45mm Linear Cutter are identical to that of the predicate device, K003277.
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.
Right Angle Linear Cutter Digital Loading Unit (DLU) that . contains 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 Cutter is designed to between the center line of the FlexShaft, permitting access to tissue which may not normally be accessed via current stapling tissue whilen may re. The Right Angle Linear Cutter DLU is offered currently in a 45mm length size, in non-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)
Substantial Equivalence for this Notification also includes a preclinical study in porcine subjects to assess the SurgASSIST™ System Right Angle Linear Cutter DLU against a predicate device, Ethicon's Proximate® Linear Cutter with Safety Lock-Out (TLC55), having comparable intended use. Additional Laboratory Bench Testing of the subject device against the Proximate predicate is also defined within this Notification and summarized as equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K012809 (p. 1 of 3)
Power Medical Interventions, Inc. SurgASSIST™ Right Angle Linear Cutter DLU 510(k), August-17-01
PREMARKET NOTIFICATION 510(K SAFETY AND EFFECTIVENESS SUMMARY
SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™ (DLU)
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 St. New Hope, PA 18938 USA 215-862-4450 215-862-1009 FAX
Applicant: Laurence A. Potter
Date of Notification: August 17, 2001
- Name of Device:
Trade Name: SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™
Common Name: Linear Cutter with Implantable Staples
Classification Name: Staple, Implantable, GDW, Stapler, GAG
- Predicate Devices:
LINEAR CUTTERS / STAPLING INSTRUMENTS
A. SurgASSIST™ System, Circular Stapler Digital Loading Unit. Power Medical Interventions, Inc., New Hope, PA. REF CS21, CS25, CS29, CS33. (K003277)
1
O'2809(P.2 of 3)
Power Medical Interventions, Inc. SurgASSIST™ Right Angle Linear Cutter DLU 510(k), August-17-01
- B. Proximate® Linear Cutter and Four Row with Safety Lock-Out. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF TLC55 (K890841)
- C. United States Surgical Powered Endoscopic GIA Stapler. United States Surgical Corp., Norwalk, CT. ( K913802).
-
- Device Description:
The SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit™ (DLU) is a cutter/stapler component addition to a Eodaing cleared device, K003277, SurgASSIST™ System with Circular Stapler Disposable Loading Unit. This Notification offers an additional style of cutting/stapling configuration, specifically, a right angle linear cutter/stapler of 45mm in length. The computer mediated, powered steering, tissue cutting and stapling of the Right Angle Linear Cutter is utilizing the identical technology and system approach which the previously cleared device currently utilizes.
The technological features of the SurgASSIST™ System with Right Angle 45mm Linear Cutter are identical to that of the predicate device, K003277.
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.
Right Angle Linear Cutter Digital Loading Unit (DLU) that . contains 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 Cutter is designed to between the center line of the FlexShaft, permitting access to tissue which may not normally be accessed via current stapling tissue whilen may re. The Right Angle Linear Cutter DLU is offered currently in a 45mm length size, in non-reloadable configuration.
2
la809 (p.3 of 3)
Power Medical Interventions, Inc. SurgASSIST™ Right Angle Linear Cutter DLU 510(k), August-17-01
5) Indications For Use
The SurgASSIST™ System with Right Angle Linear Cutter DLU has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
-
- Comparison to Predicate Devices
- SurgASSIST™ System, Circular Stapler Digital Loading Unit. 1. Interventions, Inc., Inc., New Hope, PA. Medical Power (K003277)
- Proximate® Linear Cutter and Four Row with Safety Lock-2. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF Out. TLC55 (K890841)
- United States Surgical Powered Endoscopic GIA Stapler. 3. United States Surgical, Norwalk, CT. USA (K913802)
Substantial equivalence includes the predicate SurgASSIST™ System with Circular Staple Disposable Loading Unit literature including descriptions, specifications, identification of standard components, and identification of tissue contact materials.
Substantial Equivalence for this Notification also includes a preclinical study in porcine subjects to assess the SurgASSIST™ System Right Angle Linear Cutter DLU against a predicate device, Ethicon's Proximate® Linear Cutter with Safety Lock-Out (TLC55), having comparable intended use. Additional Laboratory Bench Testing of the subject device against the Proximate predicate is also defined within this Notification and summarized as equivalent.
0017
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design that resembles an abstract caduceus, a symbol often associated with medicine and healthcare.
OCT 2 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Laurence A. Potter Vice President Regulatory Affairs & Quality Assurance Power Medical Interventions, Inc. 4 B East Bridge Street New Hope, Pennsylvania 18938
Re: K012809
Trade/Device Name: SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™ Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: August 17, 2001 Received: August 22, 2001
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 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
4
Page 2 -- Mr. Laurence A. Potter
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to over maing of substantial equivalence of your device to a legally premaired 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 and If you desire specific ad 1.80 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) 274-4657. Ticalities)), list contribution at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 8th-Other general information on your responsibilities under the Act may be obtained from the Outer general miormation of your respectional 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,
Susan Walker, MD
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
SECTION D
STATEMENT OF INTENDED USE
Power Medical Interventions, Inc.
510(k) No. K O/2809
Device Name:
SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™
INDICATIONS FOR USE:
The SurgASSIST™ System with Right Angle Linear Cutter DLU has applications 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)
Prescription Use
(per 21 CFR 801.109)
Over-The-Counter Use
SK
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number LO1280 J
0013