(144 days)
No
The description mentions "embedded software to articulate and initiate firing," but there is no indication that this software utilizes AI or ML for decision-making, analysis, or control. The functionality described appears to be purely electromechanical control.
No
The device is described as a surgical stapler used for transection, resection, and/or creation of anastomoses, which are surgical procedures, not therapeutic treatments. It cuts and staples tissue, rather than treating a disease or condition.
No
Explanation: The device is a surgical stapler intended for "transection, resection, and/or creation of anastomoses," meaning it cuts and staples tissue. It is not used to diagnose conditions or diseases.
No
The device is a surgical stapler with embedded software for articulation and firing. It is a physical medical device with hardware components (stapler, reloads, battery pack) and is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "transection, resection, and/or creation of anastomoses" in surgical procedures. This describes a surgical tool used directly on tissue within the body.
- Device Description: The description details a surgical stapler that cuts and staples tissue. It is a mechanical device used for surgical manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is used to perform a surgical procedure directly on the body.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
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.
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
pediatric
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)
Nonclinical Tests Summary:
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.
Clinical Studies:
The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence.
Conclusion:
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.
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.
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
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.
1
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
2
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
3
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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4
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 Device
510(k) Number | Predicate Device Name | Predicate Device Product
Codes |
|-----------------------------------|-----------------------------------------------------------------------------------|-----------------------------------|
| K213633 | ECHELON TM 3000 60mm Stapler | ECH60C, ECH60S, ECH60L |
| K183435 | ECHELON Endoscopic Linear Cutter
Reload (+Gripping Surface
Technology) 60mm | GST60W, GST60B,
GST60G, GST60T |
5
| Reference Device
510(k) Number | Reference Device Name | Reference Device Product
Codes |
|-----------------------------------|-------------------------------------------|--------------------------------------------------------------|
| K223760 | ECHELON LINEAR™ Cutter
Reloads | GLCR60B, GLCR60G,
GLCR80B, GLCR80G,
GLCR100B, GLCR100G |
| K200420 | ECHELON CONTOUR™ Curved
Cutter Reloads | GCR40B, GCR40G |
| K163523 | ECHELON CIRCULAR™ Powered
Stapler | 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.
6
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, EC3D60L | |
| Reloads: ER60W, ER60B, ER60G, ER60T | Staplers: ECH60C, ECH60S, ECH60L | |
| Reloads: 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
7
| Characteristic | Subject Device
Staplers: EC3D60C, EC3D60S, EC3D60L
Reloads: ER60W, ER60B, ER60G, ER60T | Predicate Device
Staplers: ECH60C, ECH60S, ECH60L
Reloads: GST60W, GST60B, GST60G, GST60T |
|-----------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Sterile, Single
Patient Use | Yes | Same |
| Sterilization
Method | Same | Same |
| Control Mechanism | Same | Same |
| Shelf Life | Same | Same |
| Biocompatibility of
Materials | Meets ISO 10993-1 | Same |
| Packaging
Materials | Same | Same |
| Stapler Anvil &
End Effector | Compatible with ETHICON 3D
Reloads only | Compatible with ETHICON 2D
reloads |
| Staple Form | 3D staple form (first, second, fifth
and sixth rows)
2D staple form (third & fourth
rows) | 2D staple form (all rows) |
| Staple Material | Titanium Alloy | Same |
| Staple Line Length | 60 mm | Same |
| Formed Staple
Height 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.
8
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.