(55 days)
No.
The device description mentions "embedded software to articulate and initiate firing of the device" and a "lockout feature" to prevent misuse. These functions are typical of embedded systems and safety mechanisms, and do not indicate the presence of an AI model. There is no mention of AI, machine learning, or deep neural networks in the provided text, nor are there descriptions of a training set, test set, or performance metrics typically associated with AI models.
No
Explanation: This device is a surgical stapler used for cutting and stapling tissues during surgical procedures. Its function is to facilitate the surgical process (transection, resection, and/or creation of anastomoses) rather than directly prevent, diagnose, or treat a disease or condition itself. While it aids in surgery that may be therapeutic, the device itself is a surgical instrument.
No
The device is described as a surgical stapler used for transection, resection, and creation of anastomoses, which are therapeutic medical procedures, not diagnostic ones.
No
The device is a stapler system with physical components (stapler, reloads, staples that are permanent implants) and includes a primary lithium Battery Pack that must be installed prior to use. While it has embedded software, it is not a software-only device as it incorporates significant hardware and mechanical functions.
No.
The device is a surgical stapler used for cutting and stapling tissues during surgical procedures, which is a therapeutic function, not an in vitro diagnostic one.
N/A
Intended Use / Indications for Use
The ETHICON™ 4000 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 instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.
Product codes
GDW, GAG
Device Description
The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses.
The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, single-patient-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 Staplers and ETHICON™ 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 60mm 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen
Indicated Patient Age Range
pediatric surgical procedures
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)
Performance test data (bench and animal) demonstrates that the subject device is substantially equivalent to the predicate device and that the device meets all requirements for the expanded indications for use to include solid organs.
The nonclinical (bench) tests that have been submitted include vessel sealing, formed staple height, staple form quality, and staple line integrity in solid organs. No additional bench testing was needed as the subject device is technologically identical to the reference device.
Pre-clinical (animal) testing includes hemostasis performance in solid organs and vessels. Hemostasis testing of liver, spleen and pancreas using porcine model was conducted to support the expansion of indications to include solid organs. Data was also collected from isolated arteries, veins and bundles/pedicles. Lung and uterine tissues along with their isolated vessels were also included in the testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
FDA 510(k) Clearance Letter - K250835
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
May 14, 2025
Ethicon Endo-Surgery, LLC
Megan Westendorf
Senior Regulatory Affairs Specialist
475 Calle C
Guaynabo, PR 00969
Re: K250835
Trade/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)
Regulation Number: 21 CFR 878.4750
Regulation Name: Implantable staple
Regulatory Class: Class II
Product Code: GDW, GAG
Dated: March 19, 2025
Received: March 20, 2025
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/cdrh/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
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K250835 - Megan Westendorf Page 2
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (QS) 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Page 3
K250835 - Megan Westendorf Page 3
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-devices/device-advice-comprehensive-regulatory-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,
TEK N. LAMICHHANE - S
Tek N. Lamichhane, Ph.D.
Assistant Director
DHT4B: Division of Plastic and
Reconstructive Surgery Devices
OHT4: Office of Surgical and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
Indications for Use
Submission Number: K250835
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:
The ETHICON™ 4000 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 instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.
Type of Use:
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
Page 5
K250835
510(k) Summary
I. SUBMITTER
Submission: K250835
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: May 14, 2025
II. Subject DEVICES
| Trade Names | Models |
|---|---|
| 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 |
Classification Name: Surgical Stapler
Staple, Implantable
Classification Regulation: 21 CFR 878.4740
21 CFR 878.4750
Device Class: II
Product Code: GDW, GAG
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K250835
III. Predicate DEVICES
| Predicate Device 510(k) Number | Predicate Device Name | Predicate Device Models |
|---|---|---|
| K241629 | ECHELON™ 3000 60mm Stapler | ECH60C, ECH60S, ECH60L |
| K183435 | ECHELON Endoscopic Linear Cutter Reload (+Gripping Surface Technology) 60mm | GST60W, GST60B, GST60G, GST60T |
Reference DEVICES
| Reference Device 510(k) Number | Reference Device Name | Reference Device Models |
|---|---|---|
| K241630 | ETHICON™ 4000 60mm Stapler | EC3D60C, EC3D60S, EC3D60L |
| K241630 | ETHICON™ 3D Reloads | ER60B, ER60G, ER60T, ER60W |
IV. Device Description
The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses.
The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, single-patient-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 Staplers and ETHICON™ 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 60mm 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
Page 7
K250835
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.
V. Intended Use/Indications for Use
This submission is to expand the indications for use to include transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.
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 instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.
There is no change to the intended use: The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses.
VI. Technological Comparison
This table provides an overview of the characteristics of the subject device compared to the predicate device. The subject and predicate device share the same Indications for Use.
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Indication 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. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. | The ECHELON FLEX™, ECHELON™ 3000, and ECHELON ENDOPATH™ 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. |
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K250835
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Intended Use | Transection, resection, and/or creation of anastomoses. | Same |
| Contraindications | - Do not use the instruments on ischemic or necrotic tissue |
- Do not use the instruments on the aorta.
- Do not use any endocutter on major vessels without making provision for proximal and distal control.
- Tissue thickness should be carefully evaluated before firing any stapler.
- Refer to the Reload Product Codes Table below for tissue compression requirement (closed staple height) for each staple size.
- If tissue cannot comfortably compress to the closed staple height listed in the table, or easily compresses to less than the closed staple height listed in the table, the tissue is contraindicated as it may be too thick or too thin for the selected staple size.
- These instruments are not intended for use when surgical stapling is contraindicated. | Same |
| Sterile, Single Patient Use | Yes | Same |
| Staple Rows | 6 | Same |
| Staple Form | 3D Staple form (first, second, fifth & sixth rows)
2D Staple form (third & fourth rows) | 2D Staple form |
| Staple Line Length | 60 mm | Same |
| Sterilization Method | Stapler: EO Sterilization
Reload: Gamma Irradiation | Same |
| Shelf Life | 3 Years | Same |
| Biocompatibility of Materials | Meets ISO 10993-1 | Same |
| Packaging Materials | Stapler: PETG Tray with Tyvek Lid
Reload: Flexible C-Film Blister with Tyvek Lid | Same |
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K250835
This table provides an overview of the characteristics of the subject device compared to the reference device. The technological characteristics of the subject device are identical to that of the reference device; the only change is the expansion of the indications for use.
| Characteristic | Subject Device | Reference Device |
|---|---|---|
| Indication 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. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. | 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. |
| Intended Use | Transection, resection, and/or creation of anastomoses. | Same |
| Contraindications | - Do not use the instruments on ischemic or necrotic tissue |
- Do not use the instruments on the aorta.
- Do not use any endocutter on major vessels without making provision for proximal and distal control.
- Tissue thickness should be carefully evaluated before firing any stapler.
- Refer to the Reload Product Codes Table below for tissue compression requirement (closed staple height) for each staple size.
- If tissue cannot comfortably compress to the closed staple height listed in the table, or easily compresses to less than the closed staple height listed in the table, the tissue is contraindicated as it may be too thick or too thin for the selected staple size.
- These instruments are not intended for use when surgical stapling is contraindicated. | Same |
| Sterile, Single Patient Use | Yes | Same |
| Staple Rows | 6 | Same |
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K250835
| Characteristic | Subject Device | Reference Device |
|---|---|---|
| Staple Form | 3D Staple form (first, second, fifth & sixth rows) | |
| 2D Staple form (third & fourth rows) | Same | |
| Staple Line Length | 60 mm | Same |
| Sterilization Method | Stapler: EO Sterilization | |
| Reload: Gamma Irradiation | Same | |
| Shelf Life | 3 Years | Same |
| Biocompatibility of Materials | Meets ISO 10993-1 | Same |
| Packaging Materials | Stapler: PETG Tray with Tyvek Lid | |
| Reload: Flexible C-Film Blister with Tyvek Lid | Same |
VII. Non-Clinical and/or Clinical Tests
Performance test data (bench and animal) demonstrates that the subject device is substantially equivalent to the predicate device and that the device meets all requirements for the expanded indications for use to include solid organs.
The nonclinical (bench) tests that have been submitted include vessel sealing, formed staple height, staple form quality, and staple line integrity in solid organs. No additional bench testing was needed as the subject device is technologically identical to the reference device.
Pre-clinical (animal) testing includes hemostasis performance in solid organs and vessels. Hemostasis testing of liver, spleen and pancreas using porcine model was conducted to support the expansion of indications to include solid organs. Data was also collected from isolated arteries, veins and bundles/pedicles. Lung and uterine tissues along with their isolated vessels were also included in the testing.
Clinical Tests
This premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence.
VIII. Conclusion
In all cases the subject devices passed the functional requirements of the device features. The ETHICON™ 4000 and ETHICON™ 3D Reloads have been demonstrated to be safe and effective for the expanded indications for use.
In conclusion, the performance testing demonstrates that the Subject device performs substantially equivalent to the Predicate device and does not raise any new questions of safety and effectiveness.