(129 days)
The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 Row) reloads are sterile, single patient use devices that simultaneously cut and staple tissue. There are four staggered rows of staples, two on either side of the cut line. The Echelon Flex Powered Vascular Stapler with Advanced Placement Tip and reloads have a staple line that is approximately 35 mm long and a cut line that is approximately 30 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate access to the operative site. The instrument is packaged with a primary lithium battery pack that must be installed prior to use. The instrument is packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping, transporting, and installing the reload. The instrument's lockout feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.
The provided text describes the Ethicon Endo-Surgery, LLC's K141952 submission for the Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip, and Endopath Echelon™ Vascular White Reloads for Advanced Placement Tip.
However, the document is a 510(k) summary for a medical device and does not contain the specific acceptance criteria or a study with detailed performance outcomes in a table format as requested. It outlines the types of testing performed to demonstrate substantial equivalence to predicate devices, but it does not provide the quantitative acceptance criteria or detailed results required to complete the requested table.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study details
- Standalone (algorithm only) performance details
- Type of ground truth used (beyond general 'bench testing,' 'animal testing')
- Sample size for the training set
- How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence to existing predicate devices, which is the primary requirement for a 510(k) submission. It lists the types of testing conducted, such as:
- Bench testing for force-to-close evaluation
- Staple height, staple form, and staple line integrity evaluation
- Animal testing for hemostasis evaluation (in acute and survival models)
- Electrical safety and electromagnetic compatibility testing
- MR compatibility testing
- Aggregate device biocompatibility testing for patient contacting materials
These tests are performed to show that the new device performs as intended and is as safe and effective as the predicate devices, but the specific acceptance criteria (e.g., "force-to-close must be X to Y range") and the quantitative results are not included in this summary document. Similarly, details regarding ground truth establishment, expert involvement, or AI-specific studies (MRMC, standalone algorithm performance) are not present, as this is a mechanical surgical stapler, not an AI/software as a medical device (SaMD).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2014
Ethicon Endo-Surgery, LLC. % Ms. Linda Hill Ethicon Endo-Surgery Incorporated 4545 Creek Road Cincinnati Ohio 45242
Re: K141952
Trade/Device Name: Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip, and Endopath Echelon™ Vascular White Reloads for Advanced Placement Tip Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: October 25, 2014 Received: October 27, 2014
Dear Ms. Hill:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Ms. Linda Hill
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) To be assigned
↑
Device Name
Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip, and Endopath Vascular White Reloads for Advanced Placement Tip
Indications for Use (Describe)
The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
| Company | Ethicon Endo-Surgery, LLC475 Calle CGuaynabo, PR 00969 |
|---|---|
| Contact | Linda HillEthicon Endo-Surgery, Inc.Portfolio Leader, Regulatory AffairsTelephone (513) 337-7623Fax (513) 337-2623Email LHILL3@its.jnj.com |
Date Prepared July 17, 2014
Device Name
Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip, Trade Name: and ENDOPATH Echelon™ Vascular White Reloads for Advanced Placement Tip
Common or Usual Name: Surgical Stapler with Implantable Staples
Classification Name: Staple, Implantable
Predicate Devices
Echelon Flex Powered Articulating Endoscopic Linear Cutters, 45mm, 60mm (K110385, K081146)
ENDOPATH ETS Flex Articulating Linear Cutter. 35mm (K111111. K070887. K020779) Echelon Endoscopic Linear Cutter Reload, White (K121600, K081146, K070887) ENDOPATH ETS Endoscopic Reload, White (K11111, K 070887, K020779)
Device Description
The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 Row) reloads are sterile, single patient use devices that simultaneously cut and staple tissue. There are four staggered rows of staples, two on either side of the cut line. The Echelon Flex Powered Vascular Stapler with Advanced Placement Tip and reloads have a staple line that is approximately 35 mm long and a cut line that is approximately 30 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate access to the operative site.
The instrument is packaged with a primary lithium battery pack that must be installed prior to use. The instrument is packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping, transporting, and installing the reload. The instrument's lockout feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.
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Indications for Use
The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
Technological Characteristics
The subject Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip instrument is similar to the predicate Echelon Flex Powered Articulating Endoscopic Linear Cutters with respect to the powered handle, and closure and firing design for minimal tip movement. The subject instrument is similar to the predicate ENDOPATH ETS Flex 35mm Articulating Linear Cutter and Reloads with respect to the active articulation feature and to the tissue compression aspects of the end effector, with similar jaw length and staple line length. As compared with the predicate devices, the subject Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip instrument incorporates several design enhancements - including a narrower diameter shaft, narrower end effector tip, curved anvil tip, introducer-like cartridge body tip, and active articulation with higher maximum articulation angles - which facilitate access in surgical procedures with smaller surgical spaces or difficult-to-reach vessels.
The subject reload, the ENDOPATH Echelon™ Vascular White Reloads for Advanced Placement Tip, is similar to the predicate ENDOPATH ETS Endoscopic Reload, White, 35mm with regard to staple material (titanium alloy), reload color (white), intended tissue type (thin/vascular), and closed staple height (1.0mm). The principal difference between the subject reload and predicate reloads is that the subject reload, which features a narrower design, delivers 2 sides of double staggered staple lines, rather than 2 sides of triple staggered staple lines as in the predicate device.
Performance Data
Testing conducted to demonstrate that the subject device will perform equivalently to the identified predicate devices for the intended use included: bench testing for force-to-close evaluation; staple height, staple form, and staple line integrity evaluation; animal testing for hemostasis evaluation (in acute and survival models); electrical safety and electromagnetic compatibility testing; MR compatibility testing; and aggregate device biocompatibility testing for patient contacting materials.
§ 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.