(28 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical stapling functionality.
No.
The device is a surgical stapler used for cutting and sealing tissue during surgery, which is a tool for performing a procedure rather than for treating a disease or condition itself.
No
The device is a surgical stapler used for cutting, resecting, and creating anastomoses, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a "reusable, articulating and non-articulating, handheld vascular surgical staplers" which are physical hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a surgical stapler used for cutting and stapling tissue during surgical procedures. It is used directly on the patient's body, not on samples taken from the body.
The information provided focuses on the surgical application of the device, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Intelligent Articulating and Straight Endoscopic Linear Cutters – Vascular with Reloads have applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy) thoracic, and pediatric surgical procedures for transaction, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The Intelligent Articulating and Straight Endoscopic Linear Cutters - Vascular with Reloads are reusable, articulating and non-articulating, handheld vascular surgical staplers. The devices are supplied non-sterile and must be cleaned and sterilized prior to use. The device creates a linear transection with three staggered rows of titanium staples on each side of the cutting blade.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Konstzic
JUL 2 5 2008
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: June 26, 2008
-
- Name of Device:
| Trade Name: | i30V, i45V, i60V, iR30V, iR45V, iR60V, i30SV, i45SV, i60SV |
|---|---|
| Common Name: | Intelligent Articulating and Straight Endoscopic Linear Cutters - |
| Vascular with Reloads | |
| Regulation Name: | Staple, Implantable |
| Product Code: | GDW |
-
- Predicate Devices:
- i45, i45S, i60, i60S, Power Medical Interventions, Inc., Langhorne, PA. (K071708) .
- Right Angle Linear Cutter DLUs, 30 mm, 45 mm and 60 mm Vascular with Reloads, . Power Medical Interventions, Inc., Langhorne, PA. (K022313)
-
- Device Description:
The Intelligent Articulating and Straight Endoscopic Linear Cutters - Vascular with Reloads are reusable, articulating and non-articulating, handheld vascular surgical staplers. The devices are supplied non-sterile and must be cleaned and sterilized prior to use. The device creates a linear transection with three staggered rows of titanium staples on each side of the cutting blade.
Image /page/0/Picture/16 description: The image shows the number "00064" in bold, black font. The numbers are slightly distorted, with the top of the first zero being cut off and some smudging around the edges of the numbers. The background is white.
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-
- Device Modification:
Intelligent Articulating and Straight Endoscopic Linear Cutters - Vascular with Reloads are identical in function as the predicate device i45, i45S, i60, i60S previously cleared under (K071708), except that an additional row of staggered staple pockets have been added to the anvil. This modification along with the Vascular Reloads creates a linear transection with three staggered rows of formed titanium staples on each side of the cutting blade. This is identical to the predicate Right Angle Linear Cutter DLU 30 mm, 45 mm, & 60 mm Vascular with Reloads previously cleared under (K022313). The software has been modified to properly operate the modified devices with the Reloads.
- Device Modification:
-
- Indications For Use:
The Intelligent Articulating and Straight Endoscopic Linear Cutters – Vascular with Reloads have applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy) thoracic, and pediatric surgical procedures for transaction, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.
- Indications For Use:
-
7} Comparison to Predicated Devices:
The Intelligent Articulating Endoscopic Linear Cutters - Vascular with Reloads i30V, i45V, i60V (subject of this notification) and the predicate device i45/i60 (K071708) are reusable articulating handheld endoscopic linear cutters. The Intelligent Straight Endoscopic Linear Cutters - Vascular with Reloads i30SV, i45SV, i60SV and the predicate device i45S/i60S (K071708) are reusable, non-articulating handheid endoscopic linear cutters. The modified devices and the predicate devices are all battery powered with the control switches and rocker switches in the handle
The Intelligent Articulating and Straight Endoscopic Linear Cutters – Vascular with Reloads have the exact Indications For Use as the predicate device, Right Angle Linear Cutter Digital Loading Unit 30mm, 45mm 60mm with Vascular with Reloads (K022313).
: ---
Please see the Predicate Device Comparison Chart in section H of this submission.
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird-like figure with three curved lines forming its body and wings. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2008
Power Medical Intervention, Inc. % Ms. Barbara J. Whitman Director Regulatory Affairs 2021 Cabot Boulevard West Langhorne, Pennsylvania 19047
Re: K081826
Trade/Device Name: i30V, i45V, i60V, iR30V, iR45V, iR60V, i30SV, i45SV, i60SV Regulation Number: 21 CFR 878.4750 Device Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: June 26, 2008 Received: June 27, 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 yours.
Mark M. Wilkerson
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: i30V, i45V, i60V, iR30V, iR45V, iR60V, i30SV, i45SV, i60SV
Indications for Use:
The Intelligent Articulating and Straight Endoscopic Linear Cutters -- Vascular with Reloads have applications for general and endoscopic surgery including multiple open or minimally invasive general, gynecological, urologic (including radical prostatectomy) thoracic, and pediatric surgical procedures for transaction, resection, and/or creation of anastomoses. They can be used with staple line or tissue buttressing material such as bovine pericardium.
| Prescription Use | x |
|---|---|
| (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)
(Division Sign-Off)rence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | ILOHAI |
|---|---|
| --------------- | -------- |
000063
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