(27 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on a surgical cutting device and its intended uses.
No.
The device is a surgical cutting and stapling device used for resection, transection, and creation of anastomoses, which are surgical procedures rather than therapeutic treatments themselves.
No
The device is described as a surgical tool used for "resection, transection, creation of anastomoses," and "open occlusion," which are all therapeutic or interventional procedures, not diagnostic ones.
No
The device description explicitly states it is a "Natural Orifice Linear Cutter Digital Loading Unit®," which is a surgical instrument and therefore a hardware device. The term "Digital Loading Unit" likely refers to a component of the hardware, not a standalone software product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is used for surgical procedures (resection, transection, creation of anastomoses, occlusion of the left atrial appendage). These are all in vivo procedures performed directly on a living patient.
- Device Description: The description reinforces its use in surgical settings for physical manipulation of tissues.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide information about a patient's health status, which is the core definition of an IVD.
Therefore, this device is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Natural Orifice Linear Cutter 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
GDW
Device Description
The device described here is a Natural Orifice Linear Cutter Digital Loading Unit ® used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transections and the creation of anastomoses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal, gynecological, anoneral abdominal, 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
Not Found
Key Metrics
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
K063075
page 1 of 2
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:
NOV - 2 2006
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: October 4, 2006
-
- Name of Device:
Trade Name: Natural Orifice Linear Cutter Digital Loading Units ®
- Name of Device:
Common Name: Linear Staplers with Implantable Staples
Classification Name: Staple, Implantable, GDW
-
- Predicate Devices:
SurgASSIST® Power Linear Cutter Reusable Digital Loading Unit®, Power Medical Interventions, Inc., K052415.
- Predicate Devices:
-
- Device Description
The device described here is a Natural Orifice Linear Cutter Digital Loading Unit ® used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transections and the creation of anastomoses.
- Device Description
-
- Device Modification
The Natural Orifice Linear Cutter Digital Loading Unit® cuts and staples identically to the predicate device Power Linear Cutter Digital Loading Unit® (K052415). The modifications include the following: 2-button handle instead of 3-button handle; autoclavable flexible shaft replaces the rigid stainless steel shaft; and anvil matterial changed from tungsten to stainless steel.
- Device Modification
1
6) Indications For Use
63075
page 292
The Natural Orifice Linear Cutter Digital Loading Units® have applications for general and endoscopic surgery in gastrointestinal, gynecological, anoneral abdominal, and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage,
-
- Comparison to Predicate Devices
The Natural Orifice Linear Cutter Digital Loading Unist® have the same indications for use and the same functions as the previously cheared predicate Power Linear Cutter Reusable Digital Loading Units® with Reloads (K052415), Both the Natural Orifice Linear Cutter Digital Loading Units® and the Power Linear Cutter Reusable Digital Loading Units® with Reloads deliver two staggered rows of titanium staples on each side of a transection. Fw further details, please see the Predicate Comparison Chart in Section J of this submission.
- Comparison to Predicate Devices
2
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 circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 2006
Power Medical Interventions % Ms. Barbara J. Whitman Regulatory Affairs Manager 2021 Cabot Boulevard West Langhorne, Pennsylvania 19047
Re: K063075
Trade/Device Name: Natural Orifice Linear Cutter Digital Loading Units 6 Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: October 4, 2006 Received: October 6, 2006
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 Fedcral 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 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 promance noticated device results in a classification for your device and thus, permits your device to proceed to the market.
ff 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION D -- Statement of Indications for Use
Indications for Use
510(k) Number (if known): Subject of this notification
Device Name: Natural Orifice Linear Cutter Digital Loading Units®
Indications for Use:
The Natural Orifice Linear Cutter 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.
Note: The Indications For Use for the Natural Orifice Linear Cutter Digital Loading Units® are identical to that of the predicate device, Power Linear Cutter Digital Loading Units®, which were cleared to market via K052415.
Prescription Use AND/OR X Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)
Division of General, Restorative, and Neurological I
Page 1 of 1
Neurological Devices
510(k) Number Ld63605
000013