(144 days)
The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.
The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, singlepatient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 60 mm Staplers and ETHICONTM 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.
ETHICON™ 4000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.
The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.
The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.
The Subject stapler and reloads will not be compatible with previous ECHELON™ staplers and reloads. This is a new platform that will work with 3D reloads only.
This 510(k) summary is for the ETHICON™ 4000 60mm Staplers and ETHICON™ 3D 60mm Reloads. It focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list a table of acceptance criteria with corresponding performance metrics for the reasons stated below. Instead, it indicates that the devices either met or improved upon the predicate devices' performance, or passed functional requirements.
| Test Type | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Staple Performance Bench Testing | Equivalent to or improved compared to predicate devices | Performed staple performance equivalence bench testing compared to the predicate, and performed at least equivalently or showed improved performance. |
| Device Functional Performance | Met functional requirements of the subject device features | Performed device functional performance bench testing and passed the functional requirements. |
| Staple Line Strength | Demonstrated characteristics comparable to predicate devices | Performed staple line strength product characterization of Subject and Predicate devices, implying comparable strength or meeting specified criteria, though specific metrics are not provided. |
| Biocompatibility | Compliant with ISO 10993-1 | Biocompatibility evaluation was performed according to ISO 10993-1. |
| Hemostasis Performance | Acceptable hemostasis performance in pre-clinical models (details not provided) | Pre-clinical data including hemostasis performance was collected in abdominal and thoracic procedures. Result deemed acceptable to demonstrate substantial equivalence, though specific metrics and acceptance levels are not given. |
| Tissue Healing Response | Acceptable tissue healing response in pre-clinical models (details not provided) | Pre-clinical data including tissue healing response was collected in abdominal and thoracic procedures. Result deemed acceptable to demonstrate substantial equivalence, though specific metrics and acceptance levels are not given. |
| Human Factors | Met human factors engineering requirements (details not provided) | Human Factors testing report was included. |
| 3D Staple Design Safety/Efficacy | Safe and effective staple formation with the 3D staple design, as demonstrated by testing vs. reference devices and meeting acceptance criteria. | The same stapling performance tests were conducted on the Subject and reference devices (with 3D staple design), and all met their respective acceptance criteria. This demonstrates safe and effective staple formation with the 3D staple design. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes for the test sets used in the non-clinical studies (e.g., staple performance, functional performance, staple line strength, hemostasis, tissue healing).
The data provenance is from non-clinical studies, which implies laboratory or animal testing rather than human subject data. Pre-clinical data for hemostasis and tissue healing response were conducted in "Abdominal and Thoracic procedures," indicating animal models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation relies on non-clinical (bench and pre-clinical animal) testing and not on expert interpretation of human clinical data or images. Ground truth, in this context, would be established by objective measurements and scientific protocols.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on non-clinical testing, not subjective assessments that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This device is a surgical stapler and reload system, not an AI-assisted diagnostic or interpretive device that would involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a surgical stapler, which is a physical medical instrument, not an algorithm or software-only device.
7. The type of ground truth used
The ground truth for the non-clinical tests would be established through:
- Objective Measurements: For staple performance, functional performance, and staple line strength, measurements of physical properties (e.g., staple formation, closure force, staple line integrity, burst pressure) would serve as ground truth, compared against pre-defined engineering specifications or predicate performance.
- Histopathology/Pathology and Physiological Measurements: For hemostasis and tissue healing response in pre-clinical animal studies, ground truth would be established through direct observation, macroscopic assessment, histological examination (pathology), and physiological measurements relevant to bleeding control and tissue repair.
- Compliance with Standards: For biocompatibility, ground truth is compliance with the requirements of ISO 10993-1.
8. The sample size for the training set
This information is not applicable. The device is a physical surgical instrument, not an AI/ML algorithm that requires a "training set." The development process would involve extensive engineering design, prototyping, and iterative testing, but not a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 28, 2024
Ethicon Endo-Surgery, LLC Megan Westendorf Regulatory Affairs Specialist 475 Calle C Guaynabo. PR 00969
Re: K241630
Trade/Device Name: ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Stapler (EC3D60L); ECHELON 3D 60mm White Reload (ER60W); ECHELON 3D 60mm Blue Reload (ER60B); ECHELON 3D 60mm Green Reload (ER60G); ECHELON 3D 60mm Black Reload (ER60T)
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: September 24, 2024 Received: September 24, 2024
Dear Megan Westendorf:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/2/Picture/3 description: The image shows a digitally signed document by Tek N. Lamichhane. The signature includes the date and time of 2024-10-28 17:24:10. The document also lists Tek N. Lamichhane's title as Assistant Director at DHT4B: Division of Plastic and Reconstructive Surgery Devices and OHT4: Office of Surgical and Infection Control Devices, as well as the Office of Product Evaluation and Quality Center for Devices and Radiological Health.
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)
Indications for Use (Describe)
The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.
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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510(k) Summary K246130
I. SUBMITTER
| Company: | Ethicon Endo-Surgery, LLC |
|---|---|
| 475 Calle C | |
| Guaynabo, PR 00969 |
- Contact: Megan Westendorf Senior Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. Phone: 513-479-6951 Email: mwestend(@its.jnj.com
Date Prepared: October 25, 2024
II. Subject DEVICES
Trade Names:
Product Codes:
ETHICON™ 4000 60mm Compact Stapler ETHICON™ 4000 60mm Standard Stapler ETHICON™ 4000 60mm Long Stapler ETHICON™ 3D 60mm White Reload ETHICON™ 3D 60mm Blue Reload ETHICON™ 3D 60mm Green Reload ETHICON™ 3D 60mm Black Reload
| EC3D60C |
|---|
| EC3D60S |
| EC3D60L |
| ER60W |
| ER60B |
| ER60G |
| ER60T |
| Classification Name: | Surgical Stapler |
|---|---|
| Staple, Implantable | |
| Classification Regulation: | 21 CFR 878.4740 |
| 21 CFR 878.4750 | |
| Device Class: | II |
| Product Code: | GDW, GAG |
III. Predicate DEVICES
| Predicate Device510(k) Number | Predicate Device Name | Predicate Device ProductCodes |
|---|---|---|
| K213633 | ECHELON TM 3000 60mm Stapler | ECH60C, ECH60S, ECH60L |
| K183435 | ECHELON Endoscopic Linear CutterReload (+Gripping SurfaceTechnology) 60mm | GST60W, GST60B,GST60G, GST60T |
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| Reference Device510(k) Number | Reference Device Name | Reference Device ProductCodes |
|---|---|---|
| K223760 | ECHELON LINEAR™ CutterReloads | GLCR60B, GLCR60G,GLCR80B, GLCR80G,GLCR100B, GLCR100G |
| K200420 | ECHELON CONTOUR™ CurvedCutter Reloads | GCR40B, GCR40G |
| K163523 | ECHELON CIRCULAR™ PoweredStapler | CDH23P, CDH25P, CDH29P,CDH31P |
Reference DEVICES
IV. Device Description
The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.
The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, singlepatient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 60 mm Staplers and ETHICONTM 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.
ETHICON™ 4000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.
The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.
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The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.
The Subject stapler and reloads will not be compatible with previous ECHELON™ staplers and reloads. This is a new platform that will work with 3D reloads only.
V. Intended Use/Indications for Use
The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Indication for Use | Staplers: EC3D60C, EC3D60S, EC3D60LReloads: ER60W, ER60B, ER60G, ER60T | Staplers: ECH60C, ECH60S, ECH60LReloads: GST60W, GST60B, GST60G, GST60T |
| The ETHICONTM 4000 Staplers and ETHICONTM 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. | The ECHELON FLEXTM and ECHELONTM 3000 families of staplers and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. | |
| Intended Use | Same | Same |
| Contraindications | Same | Same |
VI. Technological Comparison
Confidential
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| Characteristic | Subject DeviceStaplers: EC3D60C, EC3D60S, EC3D60LReloads: ER60W, ER60B, ER60G, ER60T | Predicate DeviceStaplers: ECH60C, ECH60S, ECH60LReloads: GST60W, GST60B, GST60G, GST60T |
|---|---|---|
| Sterile, SinglePatient Use | Yes | Same |
| SterilizationMethod | Same | Same |
| Control Mechanism | Same | Same |
| Shelf Life | Same | Same |
| Biocompatibility ofMaterials | Meets ISO 10993-1 | Same |
| PackagingMaterials | Same | Same |
| Stapler Anvil &End Effector | Compatible with ETHICON 3DReloads only | Compatible with ETHICON 2Dreloads |
| Staple Form | 3D staple form (first, second, fifthand sixth rows)2D staple form (third & fourthrows) | 2D staple form (all rows) |
| Staple Material | Titanium Alloy | Same |
| Staple Line Length | 60 mm | Same |
| Formed StapleHeight in Tissue | Same | Same |
| Staple Rows | 6 | Same |
The reference devices demonstrate the same 3D staple design as the Subject device and similar intended use. The same stapling performance tests were conducted on the Subject and reference devices, and all met their respective acceptance criteria. The equivalent staple design characteristics and successful completion of the same stapling performance tests demonstrate safe and effective staple formation with the 3D staple design.
VII. Non-Clinical and/or Clinical Tests Summary
Non-Clinical Studies
The nonclinical tests that have been submitted include staple performance equivalence bench testing compared to the predicate; device functional performance bench testing; staple line strength product characterization of Subject and Predicate devices; and the Human Factors testing report. Biocompatibility evaluation was performed according to ISO 10993-1. Pre-clinical data including Hemostasis Performance and Tissue healing response in Abdominal and Thoracic procedures.
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Clinical Studies
The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence.
Conclusion VIII.
In all cases the subject devices demonstrated either equivalent or improved performance to the predicate devices or passed the functional requirements of the subject device features. The ETHICON™ 4000 and ETHICON™ 3D Reloads therefore meet the acceptance criteria for bench testing and have been demonstrated to be safe and effective.
In conclusion, the performance testing demonstrates that the Subject device performs substantially equivalent to the Predicate devices and does not raise any new questions of safety and effectiveness.
§ 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.