(21 days)
The Power Right Angle Linear Cutter Digital Loading Units® have applications in gastrointestinal, gynecological, and general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
The device described here is a Power Right Angle Linear Cutter Digital Loading Unit® used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transactions and the creation of anastomoses. The Power Right Angle Linear Cutter Digital Loading Unit® cuts and staples identically to the predicate devices (K021701 and K012809). The Power Right Angle Linear Cutter Digital Loading Unit® was modified to enhance ease of use. This new design enables the anvil to swivel 90 degrees once the DLU is opened beyond 16 mm, allowing the user to work in confined anatomical areas.
This document describes a Special 510(k) Device Modification for the Power Right Angle Linear Cutter Digital Loading Unit®. The modification enhances ease of use by enabling the anvil to swivel 90 degrees once opened beyond 16mm, allowing for work in confined anatomical areas. The device's indications for use and functions remain the same as its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document is a Special 510(k) summary for a device modification. For this type of submission, extensive new clinical studies with defined acceptance criteria are often not required if the modification does not change the fundamental operating principle, safety, or effectiveness, and substantial equivalence can be demonstrated through non-clinical testing.
The document states: "The Power Right Angle Linear Cutter Digital Loading Unit® cuts and staples identically to the predicate devices (K021701 and K012809)." This is the primary performance claim, implying that the modified device's core function (cutting and stapling) meets the same performance as the already cleared predicate devices.
The acceptance criteria for a "Special 510(k)" typically involve demonstrating that the design modification does not adversely affect the safety and effectiveness of the device as previously cleared. This is often done through engineering analysis, verification, and validation testing (e.g., mechanical testing, materials testing, functional testing) to show that the modified device still performs within specified parameters and meets the same safety and performance requirements as the predicate device.
No specific quantitative acceptance criteria or reported device performance metrics (e.g., staple height, cutting force, anastomotic integrity) are explicitly detailed in this summary. The implicit acceptance criterion is that the modified device performs identically to the predicate devices in its primary function of cutting and stapling. The modification is primarily focused on usability ("ease of use") by allowing the anvil to swivel, which is a design change to enhance maneuverability without altering the fundamental stapling mechanism.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Device cuts and staples identically to predicate devices | "The Power Right Angle Linear Cutter Digital Loading Unit® cuts and staples identically to the predicate devices (K021701 and K012809)." |
| Enhanced ease of use (swiveling anvil functionality) | "This new design enables the anvil to swivel 90 degrees once the DLU is opened beyond 16 mm, allowing the user to work in confined anatomical areas." |
| Maintained Indications For Use | "The Power Right Angle Linear Cutter Digital Loading Units® have the same indications for use and the same functions as the previously cleared predicate Right Angle Linear Cutter Digital Loading Units® (K012089 and K021701)." |
| Maintained safety and effectiveness as predicate devices | Implied by the substantial equivalence determination for a modification not impacting core performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly mention sample sizes for specific test sets or the provenance of data for any testing done. For a Special 510(k) focusing on a design modification for usability, non-clinical bench testing or engineering analysis is typically used instead of clinical trials. Such testing would involve a sufficient number of samples to ensure statistical validity for mechanical and functional performance, but these details are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. As this is a medical device for surgical procedures, "ground truth" as typically defined in diagnostic AI/imaging studies (e.g., expert consensus on image interpretation) is not directly applicable. Performance is usually assessed via engineering specifications and functional testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for clinical studies involving human interpretation or subjective endpoints, which are not detailed here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the effectiveness of AI assistance on human reader performance, which is not relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable. The device is a mechanical surgical stapler, not an AI algorithm. Its performance is inherent in its design and operation, not through an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device modification, "ground truth" would be established through objective engineering specifications and functional testing. For instance, the ability for the anvil to swivel 90 degrees beyond 16mm would be verified through direct measurement. The identical cutting and stapling performance would be verified through bench testing (e.g., staple formation, tissue compression, cut line integrity) against established engineering specifications matched to the predicate device. The document does not detail the specific ground truth types for these tests.
8. The sample size for the training set
This information is not applicable. The device is a mechanical surgical instrument, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a mechanical surgical device.
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NOV -- 7 2005
Power Medical Interventions, Inc. Power Right Anale Linear Cutter Diaital Loadina Units® Special 510(k) Device Modification PreMarket Notification - October 14, 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: October 14, 2005
-
- Name of Device:
| Trade Name: | Power Right Angle Linear Cutter Digital Loading Unit® |
|---|---|
| Common Name: | Linear Staplers with Implantable Staples |
| Classification Name: | Staple, Implantable, GDW |
-
- Predicate Devices:
SurgASSIST® Right Angle Linear Cutter Digital Loading Units®, Power Medical Interventions, Inc., K012809.
- Predicate Devices:
SurgASSIST® Right Angle Linear Cutter Digital Loading Units® with Reloads, Power Medical Interventions, Inc., K021701.
-
- Device Description
The device described here is a Power Right Angle Linear Cutter Digital Loading Unit® used in gastrointestinal, gynecological, thoracic, bariatric and other surgeries for resections, transactions and the creation of anastomoses.
- Device Description
00000
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K052910 page 2/2
Power Medical Interventions, Inc. Power Right Angle Linear Cutter Digital Loading Units® Special 510(k) Device Modification PreMarket Notification - October 14, 2005
use. This new design enables the anvil to swivel 90 degrees once the DLU is opened beyond 16 mm, allowing the user to work in confined anatomical areas.
-
- Indications For Use
The Power Right Angle Linear Cutter Digital Loading Units® have applications in gastrointestinal, gynecological, and general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
- Indications For Use
-
- Comparison to Predicate Devices
The Power Right Angle Linear Cutter Digital Loading Units® have the same indications for use and the same functions as the previously cleared predicate Right Angle Linear Cutter Digital Loading Units® (K012089 and K021701). Both the Power Right Angle Linear Cutter Digital Loading Units® and the Right Anale Linear Cutter Digital Loading Units® deliver two staggered rows of fitanium 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2005
Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions 2021 Cabot Boulevard Langhorne, Pennsylvania 19047
Re: K052910
Trade/Device Name: Power Right Angle Linear Cutter Digital Loading Units® Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: October 14, 2005 Received: October 17, 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 Codc 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 niean 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- 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/industry/support/index.html
Sincerely vours.
Sincerely, yours,
Jentare Buend
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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Power Medical Interventions, Inc. Power Right Angle Linear Cutter Digital Loading Units® Special 510(k) Device Modification PreMarket Notification - October 14, 2005
SECTION D -- Statement of Indications for Use
Indications for Use
052910 510(k) Number (if known):
Device Name: Power Right Angle Linear Cutter Digital Loading Units®
Indications For Use:
The Power Right Angle Linear Cutter Digital Loading Units® have applications in
gastrointestinal, gynecological, and general abdominal and thoracic surgical
procedures for resection, transection, and creation of anastomoses.
X 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)
KOS 2910 Souberofmelup
(Division Division of Gener and Neurological Devices
510(k) Number K052910
000013
§ 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.