(27 days)
Not Found
No
The description focuses on mechanical and digital control features, with no mention of AI/ML terms or functionalities like image processing, data analysis for decision support, or adaptive behavior based on data.
No.
This device is an surgical instrument used for cutting and stapling tissue, not for treating a disease or condition itself.
No
The device is a surgical cutting and stapling tool used for resection, transection, and creation of anastomoses, not for diagnosing conditions.
No
The device description clearly details physical components like a rigid extension, hand piece, quick connect, and FlexShaft, indicating it is a hardware device with integrated controls, 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 (anastomoses) within the body during surgical procedures. This is a direct intervention on the patient's anatomy.
- Device Description: The description details a surgical instrument with mechanical functions (cutting, stapling, opening, closing, firing) and a power source. It does not mention any components or processes related to analyzing biological samples outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological sample in vitro (outside the living body) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device performs a surgical action directly on the patient.
N/A
Intended Use / Indications for Use
The Power Linear Cutter Reusable Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The device described here is a Power Linear Cutter Reusable Digital Loading Unit® with Reloads used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transactions and the creation of anastomoses.
The Power Linear Cutter Reusable Digital Loading Unit® cuts and staples identically to the predicate device (K040720). The Power Linear Cutter Reusable Digital Loading Unit® has a rigid extension, allowing for more surgeon control of the Digital Loading Unit®. The remote control functions have been integrated into a hand piece at the end of the rigid shaft. These functions include an open, close and fire button. The integrated remote control buttons function identically to the SurgASSIST® Remote Control Unit buttons, which enable the surgeon to open, close and fire the predicate DLUs. The hand piece on the Power Linear Cutter Reusable Digital Loading Unit® has a proximal quick connect that connects to the distal end of the FlexShaft. The non-steerable FlexShaft serves as the conduit between the DLU and the Power Console.
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, heart's left atrial appendage
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. Power Linear Cutter Reusable Digital Loading Units® with Reloads Special 510(k) Device Modification PreMarket Notification - August 31, 2005
SECTION E - Special 510(k) Summary
In Accordance with 21 CFR Section 807.92 Power Medical Interventions® is submitting the following safety and effectiveness summary.
- Submitter Information:
Power Medical Interventions, Inc. 2021 Cabot Blvd. Langhorne, PA 19047 267-775-8151 Ph 267-775-8123 Fax
Applicant:
Barbara J. Whitman
Date of Notification: August 31, 2005
-
- Name of Device:
| Trade Name: | Power Linear Cutter Reusable Digital Loading Unit® |
|---|---|
| Common Name: | Linear Staplers with Implantable Staples |
| Classification Name: | Staple, Implantable, GDW |
-
- Predicate Devices:
SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units®, Power Medical Interventions, Inc., K040720.
- Predicate Devices:
-
- Device Description
The device described here is a Power Linear Cutter Reusable Digital Loading Unit® with Reloads used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transactions and the creation of anastomoses.
- Device Description
5) Device Modification
The Power Linear Cutter Reusable Digital Loading Unit® cuts and staples identically to the predicate device (K040720). The Power Linear Cutter Reusable Digital Loading Unit® has a rigid extension, allowing for more surgeon control of the Digital Loading Unit®. The remote control functions have been integrated into a hand piece at the end of the rigid shaft. These
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Power Medical Interventions, Inc. Power Linear Cutter Reusable Digital Loading Units® with Reloads Special 510(k) Device Modification PreMarket Notification - August 31, 2005
functions include an open, close and fire button. The integrated remote control buttons function identically to the SurgASSIST® Remote Control Unit buttons, which enable the surgeon to open, close and fire the predicate DLUs. The hand piece on the Power Linear Cutter Reusable Digital Loading Unit® has a proximal quick connect that connects to the distal end of the FlexShaft. The non-steerable FlexShaft serves as the conduit between the DLU and the Power Console.
-
- Indications For Use
The Power Linear Cutter Reusable Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
- Indications For Use
-
- Comparison to Predicate Devices
The Power Linear Cutter Reusable Digital Loading Units® have the same indications for use and the same functions as the previously cleared predicate Computer Mediated Linear Cutter Digital Loading Units® (K040720). Both the Power Linear Cutter Reusable Digital Loading Units® and the Computer Mediated Linear Cutter Digital Loading Units® deliver two staggered rows of titanium staples on each side of a transection. For further details, please see the Predicate Comparison Chart in Section J of this submission.
- Comparison to Predicate Devices
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it.
Public Health Service
SEP 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions 2021 Cabot Boulevard Langhorne, Pennsylvania 19047
Re: K052415
Trade/Device Name: Power Linear Cutter Reusable Digital Loading Units® with Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 31, 2005 Received: September 2, 2005
Dear Ms. Whitman:
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 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- Ms. Barbara J. Whitman
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 marketed 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division 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,
Mark A. Mulkern
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Power Linear Cutter Reusable Digital Loading Units® with Reloads
Indications For Use:
The Power Linear Cutter Reusable Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, 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 × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliman and the following is the JSON: {"markdown": "Mark A. Milliman Page 1 of 1"}
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number