(20 days)
i45/160 (K071708)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a mechanical modification to a predicate device.
No
The device is a surgical stapler/cutter used for creating anastomoses during surgical procedures, which is a surgical tool rather than a therapeutic device designed to treat a disease or condition.
No
Explanation: The device is described as a "Cutter" and "stapling/cutting action" to create anastomoses, which are surgical functions, not diagnostic ones.
No
The device description clearly describes a physical surgical instrument (endoscopic linear cutter) with mechanical components (jaws, pivot point) that performs a stapling/cutting action. There is no mention of software being the primary or sole component of the device.
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 anastomoses within the body during surgical procedures. This is a direct surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a surgical instrument with jaws, stapling, and cutting actions. This aligns with surgical tools, not diagnostic equipment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely surgical.
N/A
Intended Use / Indications for Use
The Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
Product codes
GDW
Device Description
The Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads has identical technological features as the predicate device, i45/160 (K071708). The modification made to the device was that the pivot point for the jaws was translated distally, which enables the device to open in Reverse. Both the subject device and the predicate device deliver stapling/cutting action to create anastomoses.
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
general and endoscopic surgery
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
DEC 1 8 2008
Page 1/2
Section E
Special 510(k) - Summary
In Accordance with 21 CFR Section 807.92 Power Medical Interventions, Inc., is submitting the following 510(k) Summary:
1) Submitter Information:
Power Medical Interventions, Inc. 2021 Cabot Blvd. Langhorne, PA 19047 Ph: 267-775-8151 Fax: 267-775-8123
Applicant: Barbara J. Whitman
Date of Notification: November 26, 2008
Name of Device: 2)
Trade Name:
Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads
Linear Staplers with Implantable Staples Common Name:
- Staple, Implantable, GDW Classification Name:
- Predicate Device:
Intelligent Articulating Endoscopic Linear Cutters with Reloads, Power Medical Interventions, Inc., Langhorne, PA. REF i45, i455, i60, i6oS (Ko71708).
Device Description:
1
Device Modification 5)
The Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads has identical technological features as the predicate device, i45/160 (K071708). The modification made to the device was that the pivot point for the jaws was translated distally, which enables the device to open in Reverse. Both the subject device and the predicate device deliver stapling/cutting action to create anastomoses.
0012 2
-
Indications For Use 6)
The Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses. -
Comparison to Predicate Devices
The Intelligent Articulating Endoscopic Linear Cutters Reverse functions the same as the predicate device, i45/160 (K071708). The electronics, power configuration, and internal gearing & transmission are common to both the Intelligent Articulating Endoscopic Linear Cutters Reverse and 160/145. The difference is that the pivot point for the stapling jaws was translated distally in order to enable the device to open in reverse. The shafts on both the subject device, Intelligent Articulating Endoscopic Linear Cutters Reverse, and the predicate device, i45/i6o, are both rigid. Both devices are powered mechanically by rotational energy. In both the predicate and the subject device, a clamp shaft drives a clamp screw, which causes the anvil to close and compress tissue. The same is true for firing:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 8 2008
Power Medical Interventions, Inc. % Ms. Barbara J. Whitman Director, Regulatory Affairs 2021 Cabot Boulevard West Langhorne, Pennsylvania 19047
Re: K083527
Trade/Device Name: Intelligent Articulating Endoscopic Lincar Cutter Reverse with Reloads Regulation Number: 21 CFR 878.4750
Regulatory Class: II Product Code: GDW Dated: November 26, 2008 Received: November 28, 2008
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark M. Mulhern
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
Indications for Use
510(k) Number (if known): K083527
Device Name: Intelligent Articulating Endoscopic Linear Cutter Reverse with Reloads
Indications For Use:
The Intelligent Articulating Endoscopic Linear Cutters Reverse with Reloads have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdomihal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
Prescription Use (Part 21 CFR 801 Subpart D)
家庭的多少家 出家
ANDIOR
ver-The-Counter-Use
(21 CFR 807 Subpart C)
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ffice of Device Evaluation (ODE) Concurrence of
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number 1083527-