(36 days)
Not Found
No
The document does not mention AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses on the mechanical function of stapling.
No
The device is a surgical stapler used for closing tissues and creating anastomoses, but it does not inherently treat or cure a disease or condition, which is a characteristic of a therapeutic device.
No
The device is described as placing staples to close openings and create anastomoses in various tissues, which are surgical and treatment-oriented functions, not diagnostic ones.
No
The device description clearly states it is a reloadable Straight Linear 4 Row No Knife Digital Loading Unit® (DLU) with Reloads, which are physical devices designed to place staples in tissue. This indicates a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a surgical stapler used for "resection, transection, creation of anastomoses, for open occlusion of the heart's left atrial appendage." It physically manipulates and joins tissues within the body.
- Lack of In Vitro Testing: There is no mention of the device being used to analyze samples outside of the body. Its function is entirely surgical and in vivo.
Therefore, the SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SurgASSIST® Straight Linear 4 Row No Knife 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, for open occlusion of the heart's left atrial appendage.
Product codes
GDW
Device Description
The devices described here are reloadable Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) with Reloads for single patient use. The SLS55B4 DLUs are designed to place two, double-staggered rows of titanium staples in various types of tissues. The SLS55B4 DLUs are used to close otomies and other common and uncommon openings by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together.
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)
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
Pi/2
Section E
MAR 2 4 2004
Traditional 510(k) - Summary
In Accordance with 21 CFR Section 807.92 Power Medical Interventions, Inc., is submitting the following 510(k) Summary:
- 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
February 13, 2004 Date of Notification:
-
- Name of Device:
| Trade Name: | SurgASSIST®
Straight Linear 4 Row No Knife DLUs
with Reloads |
|-------------------------|--------------------------------------------------------------------|
| Common Name: | Linear Staplers with Implantable Staples
and Reloads |
| Classification
Name: | Staple, Implantable, GDW |
-
- Predicate Devices:
- a. 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, SLS55B4 and SLSR55B4 (K030653).
1
4) Device Description:
The devices described here are reloadable Straight Linear 4 Row No Knife Digital Loading Units® (DLUs) with Reloads for single patient use. The SLS55B4 DLUs are designed to place two, double-staggered rows of titanium staples in various types of tissues. The SLS55B4 DLUs are used to close otomies and other common and uncommon openings by applying staples through the tissue and forming the staples to a controlled closed condition to secure the layers of tissue together.
-
- Device Modification
The Straight Linear 4 Row No Knife Digital Loading Units® are identical to the predicate devices (K030653). The only changes are in the "Indications For Use" statement. The specific change is to include the application of the device for open occlusion of the heart's left atrial appendage.
- Device Modification
-
- Indications For Use
The SurgASSIST® Straight Linear 4 Row No Knife 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, for open occlusion of the heart's left atrial appendage.
- Indications For Use
-
- Comparison to Predicate Devices
The Straight Linear 4 Row No Knife Digital Loading Units® with Reloads are identical to the previously cleared predicate Straight Linear 4 Row No Knife Digital Loading Units® with Reloads (K030653). We have expanded the Indications For Use, but the fundamental scientific technology is identical. Please refer to Section J for predicate comparison chart.
- Comparison to Predicate Devices
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling three curved lines, possibly representing a stylized bird or a flame.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4, 2004
Ms. Barbara Whitman Regulatory Affairs Manager Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938-1364
Re: K040398
Trade/Device Name: SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: February 13, 2004 Received: February 17, 2004
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.
3
Page 2 - Ms. Barbara 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 (301) 594-4659. 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,
Miriam 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
4
K04032f
Power Medical Intervantions. Inc. SurgASSIST® Straight Linear 4 Row No Knife DLUs with Reloads
Traditional 510(k) – Expanded Indications • February 13, 2004
Section D
Indications for Use
Power Medical Interventions, Inc. New Hope, PA 18938
510(k) Number (if known):
Device Name: SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads
Indications For Use:
The SurgASSIST® Straight Linear 4 Row No Knife Digital Loading Units® with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures tor resection, transection, creation of anastomases, for open occlusion of the heart's left atrial appendage.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Muriam C. Lawrent
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K040398