(86 days)
No
The device description explicitly states that these are "mechanical surgical stapling devices" and there is no mention of AI, ML, or any computational processing in the provided text.
No
Explanation: The device is a surgical stapler used for transection and resection of tissues and creation of anastomoses, which are surgical procedures, not therapeutic treatments.
No
The device description clearly states its purpose as "deliver[ing] staples while simultaneously dividing tissue between rows" or "deliver[ing] staples, but not cut" for surgical procedures. It does not mention any function for diagnosing conditions.
No
The device description explicitly states that these are "mechanical surgical stapling devices" and describes physical components like staples, shafts, articulating heads, and safety lock-out features. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the devices as being used in vivo (within the body) for surgical procedures like transection, resection, and creating anastomoses of tissues. IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue samples to provide information about a patient's health.
- Device Description: The description details mechanical surgical stapling devices that deliver staples and/or cut tissue during surgery. This aligns with surgical instruments, not diagnostic tests performed on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The devices described are surgical instruments used directly on the patient's tissues during an operation.
N/A
Intended Use / Indications for Use
The ENDOPATH and PROXIMATE Linear Cutters and Staplers are intended for use in multiple open or minimally invasive surgical procedures for the transection and resection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures. Specific indications are provided in specific instrument product insert labeling.
The ENDOPATH ETS Endoscopic Linear Cutter and ETS FLEX Endoscopic Articulating Linear Cutter have application in general, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS Flex45 Endoscopic Articulating Linear Cutters, the ETS Compact Flex45 Articulating Linear Cutters are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ENDOPATH ETS Flex45 No-Knife Articulating Linear Staplers and the ETS Compact Flex45 No-Knife Articulating Linear Staplers are intended for transection, and /or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, resection of anastomoses, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic and other minimally invasive surgical procedures for transection, resection of anastomoses, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The PROXIMATE ACCESS 55 Articulating Linear Staplers have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection and resection of tissues.
The PROXIMATE Linear and Vascular Linear Cutters with Safety Lockout have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The PROXIMATE Linear Four Row Stapler with Safety Lockout have application in gastrointestinal and thoracic surgery for transection and can be used with staple buttressing materials, such as bovine pericardium.
The PROXIMATE Reloadable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.
The PROXIMATE Reloadable Vascular Linear Stapler has application for use on internal tissue that can easily be compressed to 1.0 mm in thickness. The staplers may also be used to ligate pulmonary vessels.
Product codes
GDW
Device Description
The ENDOPATH and PROXIMATE Linear Cutter models are sterile single use instruments that deliver staples while simultaneously dividing tissue between rows. The ENDOPATH No-Knife Stapler and PROXIMATE Stapler models are sterile single use instruments that deliver staples, but do not cut. Depending upon the particular model, they deliver 2 to 3 staggered rows of staples, 2 double-staggered rows, or 2 triple-staggered rows of staples. Staple line lengths vary between 35 mm and 100 mm. These instruments may be used in either open or endoscopic procedures, depending upon the design. Some instruments are reloadable and, if so, they may be reloaded with various reloads (i.e. vascular/thin, standard, thick) depending on the thickness of tissue that is to be transected or resected. Vascular models use specific vascular reload cartridges. The instruments may be reloaded a number of times according to product insert instructions for a maximum number of firings per instrument. Some instruments have articulating heads and flex features. The length of the shaft may vary as well. A safety lock-out feature on linear cutter instruments prevents a used reload from being fired again. The common element among all these instruments is that they are all mechanical surgical stapling devices.
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)
Animal testing demonstrated satisfactory performance of the ENDOPATH and PROXIMATE Linear Cutters and Staplers to support the revised product insert labeling. The performance data and information in this submission demonstrate that these devices, when used in accordance with directions for use with respect to tissue thickness, can be used in procedures where pulmonary vessels are encountered.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K821994, K843034, K890841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398
Reference Device(s)
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
JUN 0 5 2002
Ethicon Endo-Surgery, Inc.
510(k) Premarket Notification for ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers ™
K020779 (1.1 of 2)
ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers 510(k) Summary of Safety and Effectiveness
JUN 0 5 2002
Company:
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Ethicon Endo-Surgery, Inc.
Contact:
Name: Doug Kentz Title: Sr. Regulatory Affairs Associate
Date Prepared:
March 8, 2002
Name of Device:
Trade Name: ENDOPATH and PROXIMATE Linear Cutters and Staplers Classification Name: Endoscope and Accessories, Implantable Staples, General & Plastic Surgery
Predicate Devices:
ENDOPATH and PROXIMATE Linear Cutters and Staplers and Reloads are cleared under K821994, K843034, K890841, K843034, K892927, K932434, K935064, K961390, K970720, K980023, K980815, K002398. Auto Suture™ ENDO GIA II and ENDO GIA Universal (United States Surgical Corporation) cleared under K913802.
Device Description:
The ENDOPATH and PROXIMATE Linear Cutter models are sterile single use instruments that deliver staples while simultaneously dividing tissue between rows. The ENDOPATH No-Knife Stapler and PROXIMATE Stapler models are sterile single use instruments that deliver staples, but do not cut. Depending upon the particular model, they deliver 2 to 3 staggered rows of staples, 2 double-staggered rows, or 2 triplestaggered rows of staples. Staple line lengths vary between 35 mm and 100 mm. These instruments may be used in either open or endoscopic procedures, depending upon the design. Some instruments are reloadable and, if so, they may be reloaded with various reloads (i.e. vascular/thin, standard, thick) depending on the thickness of tissue that is to be transected or resected. Vascular models use specific vascular reload cartridges. The instruments may be reloaded a number of times according to product insert instructions for a maximum number of firings per instrument. Some instruments have articulating heads and flex features. The length of the shaft may vary as well. A safety lock-out
1
feature on linear cutter instruments prevents a used reload from being fired again. The common element among all these instruments is that they are all mechanical surgical stapling devices.
Intended Use:
The ENDOPATH and PROXIMATE Linear Cutters and Staplers are intended for use in multiple open or minimally invasive surgical procedures for the transection and resection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures. Specific indications are provided in specific instrument product insert labeling.
Technological Characteristics:
The ENDOPATH and PROXIMATE Linear Cutters and Staplers are similar to the predicate devices in that they have the same intended use and are single-use sterile devices.
Performance Data
Animal testing demonstrated satisfactory performance of the ENDOPATH and PROXIMATE Linear Cutters and Staplers to support the revised product insert labeling. The performance data and information in this submission demonstrate that these devices, when used in accordance with directions for use with respect to tissue thickness, can be used in procedures where pulmonary vessels are encountered.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized eagle-like emblem. The emblem consists of three angled lines above three curved lines, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.
Public Health Service
JUN 0 5 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Doug Kentz, RAC Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242-2839
Re: K020779
Trade/Device Name: ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers Regulation Number: 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 8, 2002 Received: March 11, 2002
Dear Mr. Kentz:
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 – Mr. Doug Kentz, RAC
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.
to Mark N. Milken
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
Page | of |
510(k) Number (if known):
Device Name: ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers
Indications for Use:
The ENDOPATH ETS Endoscopic Linear Cutter and ETS FLEX Endoscopic Articulating Linear Cutter have application in general, gynecologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
The ENDOPATH ETS45 Endoscopic Linear Cutters, the ETS Flex45 Endoscopic Articulating Linear Cutters , the ETS Compact Flex45 Articulating Linear Cutters are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ENDOPATH ETS Flex45 No-Knife Articulating Linear Staplers and the ETS Compact Flex45 No-Knife Articulating Linear Staplers are intended for transection, and /or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ENDOPATH EZ45 Endoscopic Linear Cutter has application in multiple open and other minimally invasive surgical procedures for transection, resection of anastomoses, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The ENDOPATH EZ45 No-Knife Endoscopic Linear Stapler has application in multiple open or other minimally invasive surgical procedures for transection, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The ENDOPATH EZ45 Thoracic Endoscopic Linear Cutter has application in thoracic and other minimally invasive surgical procedures for transection, resection of anastomoses, and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The PROXIMATE ACCESS 55 Articulating Linear Staplers have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection and resection of tissues.
The PROXIMATE Linear and Vascular Linear Cutters with Safety Lockout have application in gastrointestinal, gynecologic, thoracic, and pediatric surgery for transection, and/or creation of anastomoses and can be used with staple line or tissue buttressing materials, such as bovine pericardium.
The PROXIMATE Linear Four Row Stapler with Safety Lockout have application in gastrointestinal and thoracic surgery for transection and can be used with staple buttressing materials, such as bovine pericardium.
The PROXIMATE Reloadable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.
The PROXIMATE Reloadable Vascular Linear Stapler has application for use on internal tissue that can easily be compressed to 1.0 mm in thickness. The staplers may also be used to ligate pulmonary vessels.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of ODRH, Office of Device Evaluation (ODE) | (Optional Fo |
|---|---|
| Division Sign-Off |
n o: General. Pestorative
510(k) Number K0207
Optional Format 3-10-98)