(86 days)
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.
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.
The provided text describes a 510(k) premarket notification for "ENDOPATH™ and PROXIMATE™ Linear Cutters and Staplers". Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Implied Criteria: Demonstrated safety and effectiveness for intended use, substantial equivalence to predicate devices. | Demonstrated Performance: "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." |
| New Indication: Use in procedures where pulmonary vessels are encountered (implies a specific performance standard for vessel transection/ligation). | Adequately demonstrated for this use. |
Important Note: The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and specific numerical performance data against those criteria. The acceptance criteria for a 510(k) are generally implicit: the device must be as safe and effective as a legally marketed predicate device. The performance data described is a summary to support this claim, particularly for a revised indication (pulmonary vessels).
Beyond the provided text, specific numerical acceptance criteria (e.g., staple line integrity, burst pressure, or tissue thickness range) would typically be found in the full 510(k) submission, internal design verification and validation documents, or industry standards applied to surgical staplers.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document only mentions "Animal testing."
- Data Provenance: Animal testing. The country of origin is not specified, but the submission is to the U.S. FDA. The testing would be prospective in nature as it's designed to evaluate the device's performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. For animal testing, the "ground truth" would likely be established by the observed physiological outcomes, successful stapling, and lack of adverse events, assessed by veterinary or surgical experts involved in the study.
4. Adjudication Method for the Test Set
- This information is not provided in the document. In animal studies, adjudication would typically involve veterinary pathologists or surgeons evaluating the results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices, rather than a mechanical surgical stapler. The evaluation here is based on physical performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, this is not applicable. The device is a mechanical surgical stapler, not an algorithm. Its performance is inherent to its design and how it's used by a human surgeon.
7. Type of Ground Truth Used
- The ground truth used was based on physiological outcomes and direct observation of device performance during animal testing (e.g., successful transection, anastomoses creation, hemostasis, and absence of leaks or defects in the stapled tissue). The specific details of what was considered "satisfactory performance" are not elaborated upon.
8. Sample Size for the Training Set
- This concept is not applicable to a traditional mechanical surgical device like a stapler. There is no "training set" in the context of machine learning. The device's design and manufacturing processes are refined through engineering, material science, and prior testing, not through a data-driven training set in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable for the reasons stated above.
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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
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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.
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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.
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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
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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)
§ 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.