(132 days)
The ETHICON ™ Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.
The ETHICON™ Linear Stapler delivers two staggered rows of titanium staples in order to approximate internal tissues. The Subject device is sterile, single patient, disposable device used in conjunction with reloadable ETHICON™ Linear Stapler 3D Reloads to staple tissue in one firing stroke. The Subject device is a next generation Linear Stapler to be used in open procedures requiring a surgical stapler. The Subject device incorporates proven Gripping Surface Technology (GST) Reload Technology, leveraged from Ethicon Endocutters, along with a 3-D staples developed for other Ethicon Endocutters and open mechanical devices.
The ETHICON™ Linear Stapler 30 mm, 60 mm and 90 mm Staplers are sterile, single- patient-use instruments that staple tissue. There are two staggered rows of staples, on either side of the staple line. This device may be used on the general population for routine wound closure via stapling. The 30 mm reload creates a 30 mm staple line. The 60 mm reload creates a 60 mm staple line. The 90 mm reload creates a 90 mm staple line.
The 90mm device and compatible reloads have also been developed. The 90mm device can be used by surgeons who prefer to use a 90mm device when transecting wider tissue such as completing the closure of a side-to-side anastomosis or when performing a sleeve gastrectomy. The Predicate device does not currently offer a 90mm size but the principles of operation are the 30mm and 60mm devices. Design verification testing demonstrates that the 90mm device and compatible reloads do not raise new types of safety or effectiveness questions.
The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instrument may be loaded eight times for a maximum of eight firings per instrument during a single procedure. There are blue and green reload options for each device size.
The instruments' lock-out 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 does not contain information about acceptance criteria or a study proving a device meets them in the context of an AI/ML powered medical device. Instead, the document is an FDA 510(k) clearance letter and summary for a surgical stapler and its reloads.
The information in the document details the substantial equivalence of the ETHICON™ Linear Stapler to a predicate device, focusing on bench performance testing and animal testing for mechanical, functional, and biological properties of the stapler itself, NOT an AI/ML algorithm.
Therefore, I cannot provide the requested information, such as:
- Acceptance criteria and reported device performance for an AI/ML product: The document outlines engineering specifications and performance evaluations for a mechanical device.
- Sample size for the test set and data provenance: No test set for an AI/ML algorithm is mentioned.
- Number of experts used to establish ground truth and their qualifications: Ground truth for AI/ML is not relevant here.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted as it's not an AI-assisted device.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable for an AI/ML algorithms ground truth, but for the mechanical stapler, the "ground truth" would be successful stapling outcomes and tissue integrity observed in bench and animal tests.
- Sample size for the training set: No training set for an AI/ML algorithm is mentioned.
- How the ground truth for the training set was established: Not applicable.
The document focuses on:
- Bench Performance Testing:
- Formed Staple Height (FSH)
- Staple Form Quality (SFQ)
- Staple Line Integrity (SLI)
- Force to Close
- Force to Fire
- Jaw Aperture
- No Spent Reload/Lockout
- Human Factor Report/Usability Testing
- Staple line Strength Test
- Animal Testing (In-vivo):
- Acute Hemostasis evaluation study
- Tissue Healing response, Survival Study
- Biocompatibility: Based on ISO 10993-1.
All of these tests "passed the criteria for success," indicating the device met the pre-defined performance requirements for a mechanical surgical stapler.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 25, 2025
Ethicon Endo- Surgery. LLC Aysenur Huseyinoglu Erucman Senior Regulatory Affairs Specialist 475 Calle C Guaynabo, PR 00969
Re: K243276
Trade/Device Name: ECHELON LINEAR™ Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G): ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEARTM Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G) Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: October 16, 2024 Received: January 28, 2025
Dear Aysenur Huseyinoglu Erucman:
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.
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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.
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 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.
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For comprehensive regulatory information about mediation-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-regulatoryassistance/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,
Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2025.02.25 21:04:48 -05'00'
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
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Indications for Use
| Submission Number (if known) | K243276 |
|---|---|
| ------------------------------ | --------- |
| Device Name | ETHICON™ Linear Stapler 30mm Stapler (GTX30); |
|---|---|
| ETHICON™ Linear Stapler 60mm Stapler (GTX60); | |
| ETHICON™ Linear Stapler 90mm Stapler (GTX90); | |
| ETHICON™ Linear Stapler 3D Reload 30 mm Blue (GTXR30B); | |
| ETHICON™ Linear Stapler 3D Reload 30mm Green (GTXR30G); | |
| ETHICON™ Linear Stapler 3D Reload 60mm Blue (GTXR60B); | |
| ETHICON™ Linear Stapler 3D Reload 60mm Green (GTXR60G); | |
| ETHICON™ Linear Stapler 3D Reload 90mm Blue (GTXR90B); | |
| ETHICON™ Linear Stapler 3D Reload 90mm Green (GTXR90G) |
| Indications for Use (Describe) | The ETHICON ™ Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues. |
|---|---|
| -------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 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
I. SUBMITTER
Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
- Contact: Aysenur Huseyinoglu Erucman Senior Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. Phone: 201-725-4434 Email: ahuseyi1@its.jnj.com
Date Prepared: February 25, 2025
II. Subject DEVICES
Trade Names:
- ETHICON™ Linear Stapler 30mm Stapler (GTX30) ●
- ETHICON™ Linear Stapler 60mm Stapler (GTX60) ●
- ETHICON™ Linear Stapler 90mm Stapler (GTX90)
- ETHICON™ Linear Stapler 3D Reload 30 mm Blue (GTXR30B) ●
- ETHICON™ Linear Stapler 3D Reload 30mm Green (GTXR30G) .
- ETHICON™ Linear Stapler 3D Reload 60mm Blue (GTXR60B)
- ETHICON™ Linear Stapler 3D Reload 60mm Green (GTXR60G) ●
- . ETHICON™ Linear Stapler 3D Reload 90mm Blue (GTXR90B)
- ETHICON™ Linear Stapler 3D Reload 90mm Green (GTXR90G) ●
| Classification Name: | Surgical Stapler |
|---|---|
| Staple, Implantable | |
| Classification Regulation : | 21 CFR878.4750 |
| 21 CFR 878.4740 | |
| Regulatory Class: | Class 2 -Staple, Implantable |
| Product Code: | GDW,GAG |
III. Predicate DEVICES
| Predicate Device510(k) Number | Predicate Device Name | Predicate Device Model Numbers |
|---|---|---|
| K020779 | PROXIMATE® Reloadable LinearStapler and reloads | Devices: TX30B, TX30G, TX60B, TX60GReloads: XR30B, XR30G, XR60B, XR60G |
These predicates have not been subjected to a recall related to these design modifications.
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Reference Device(s):
The below reference devices were used to show equivalency to the 3D technology:
Reference Device Models
| ReferenceDevice 510(k)Number | Reference Device Name | Reference Device Model Numbers |
|---|---|---|
| K223760 | ECHELON LINEAR™ Cutter Reloads | GLCR60B,GLCR60G,GLCR80B, GLCR80G,GLCR100B,GLCR100G |
| K200420 | ECHELON CONTOUR™ CurvedCutter Reloads | GCR40B, GCR40G |
| K163523 | ECHELON CIRCULAR™ PoweredStapler | CDH23P, CDH25P, CDH29P,CDH31P |
| K070887 | ECHELON 60 Endopath Stapler,Endoscopic Linear Cutter Reload | ECR60G |
ETHICON™ Linear Staplers Product Configuration
| SubjectDeviceModelNumbers | Product CodeDescription | StapleLineLength | SubjectDeviceReloads | Predicate DeviceModel Numbers | Predicate KNumber |
|---|---|---|---|---|---|
| GTX30 | ETHICON™Linear 30mmStapler | 30mm | GTXR30BGTXR30G | TX30B; TX30GCompatibleReloads:XR30B (Blue)XR30G (Green) | K020779 |
| GTX60 | ETHICON™Linear 60mmStapler | 60mm | GLCR60BGLCR60G | TX60B; TX60GCompatibleReloads:XR60B (Blue)XR60G (Green) | K020779 |
| GTX90 | ETHICONTMLinear 90mmStapler | 90mm | GLCR90BGLCR90G | There is no 90mmPredicate device,therefore, 30mmand 60mmdevices used toshow substantialequivalence. | K020779 |
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| 30 mm Reloads Codes | 60 mm Reload Codes | 90 mm Reloads Codes | Corresponding Reload Color |
|---|---|---|---|
| GTXR30B | GTXR60B | GTXR90B | Blue |
| GTXR30G | GTXR60G | GTXR90G | Green |
Reload codes and corresponding Reload color
IV. DEVICE DESCRIPTION
The ETHICON™ Linear Stapler delivers two staggered rows of titanium staples in order to approximate internal tissues. The Subject device is sterile, single patient, disposable device used in conjunction with reloadable ETHICON™ Linear Stapler 3D Reloads to staple tissue in one firing stroke. The Subject device is a next generation Linear Stapler to be used in open procedures requiring a surgical stapler. The Subject device incorporates proven Gripping Surface Technology (GST) Reload Technology, leveraged from Ethicon Endocutters, along with a 3-D staples developed for other Ethicon Endocutters and open mechanical devices.
The ETHICON™ Linear Stapler 30 mm, 60 mm and 90 mm Staplers are sterile, single- patient-use instruments that staple tissue. There are two staggered rows of staples, on either side of the staple line. This device may be used on the general population for routine wound closure via stapling. The 30 mm reload creates a 30 mm staple line. The 60 mm reload creates a 60 mm staple line. The 90 mm reload creates a 90 mm staple line.
The 90mm device and compatible reloads have also been developed. The 90mm device can be used by surgeons who prefer to use a 90mm device when transecting wider tissue such as completing the closure of a side-to-side anastomosis or when performing a sleeve gastrectomy. The Predicate device does not currently offer a 90mm size but the principles of operation are the 30mm and 60mm devices. Design verification testing demonstrates that the 90mm device and compatible reloads do not raise new types of safety or effectiveness questions.
The instruments are shipped without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instrument may be loaded eight times for a maximum of eight firings per instrument during a single procedure. There are blue and green reload options for each device size.
The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.
INDICATIONS FOR USE V.
The ETHICON™ Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.
| Subject Device | Predicate Device | Difference |
|---|---|---|
| The ECHELON LINEAR TM Staplerhas application throughout thealimentary tract and in thoracicsurgery for transection and resectionof internal tissues. | The Proximate ® Reloadable LinearStapler has application throughoutthe alimentary tract and in thoracicsurgery for transection and resectionof internal tissues. | The indications are the same. |
Indication for Use Comparison Table
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VI. TECHNOLOGICAL COMPARISON
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| General Information | ||
| Stapler Code | GTX30, GTX60, GTX90 | TX30B, TX30GTX60B, TX60G |
| Compatible Reloads | GTXR30B, GTXR60B,GTXR90BGreen: GTXR30G,GTXR60G, GTXR90G | XR30B,XR60BGreen:XR30G, XR60G |
| How it is supplied | Provided sterile, singlepatient use | Same |
| Packaged | PETG Tray | Same |
| Sterilization Method | Gamma | Same |
| Sterility AssuranceLevel | SAL 10-6 | Same |
| Design Features | ||
| Operation of staplingand transection of tissue | The device operates bydriving staples into astaple forming anvil tostaple tissue | Same |
| Cartridge Reloadsurface | GST Reload Technologyfor cartridge deck surface | Flat cartridge deck surface |
| Number of staple rows | 2 Staggered Rows | Same |
| Staple material | Titanium Alloy -Ti3Al-2.5V Wire | Titanium Alloy (Ti-6Al-4V) |
| Formed staple geometry | 3D final staple form | 2 D shaped staple form |
| Principle of Operation | ||
| Environment of Use | Surgical facility | Same |
| Intended population | General | Same |
| Energy Type | Manual | Same |
| Maximum number ofFirings per device | 8 Firings | Same |
Subiect and Predicate Device and Reload Comparison Table
Regulatory History
The Regulatory History of the predicate device ETHICON™ Linear Stapler is provided in the Table below to help clarify the submissions associated with the predicate.
Regulatory History of the Predicate Device
| Submission Number | Description | Clearance Date |
|---|---|---|
| K020779 | PROXIMATE® TX ReloadableLinear Stapler | 05-JUN-2002 |
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VII. PERFORMANCE DATA:
The following performance data demonstrate that the Subject device is substantially equivalent to the Predicate device and the differences between the devices were found not to affect safety or performance.
Bench Performance Testing:
- Device Stapling Performance and Comparison to Predicate ●
- Formed Staple Height (FSH) O
- Staple Form Quality (SFQ) O
- Staple Line Integrity (SLI) o
- Device Functional Requirement ●
- Force to Close O
- Force to Fire o
- Jaw Aperture O
- No Spent Reload/Lockout O
- Human Factor Report/Usability Testing O
- Product Characterization ●
- Staple line Strength Test O
Animal Testing: In-vivo testing evaluations included.
- Acute Hemostasis evaluation study ●
- Tissue Healing response, Survival Study ●
All animal studies passed the criteria for success.
Clinical Studies: The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence.
Bio-compatibility: studies was performed based on ISO 10993-1 and confirmed that the
proposed device is biocompatible for the intended patient contact profile. All biocompatibility studies passed the criteria for success.
Electrical Safety and Electromagnetic Compatibility: This device is not powered and does not include software therefore this does not apply.
VII. CONCLUSIONS
The conclusions of the testing criteria demonstrate that the Subject device; ETHICON™ Linear Stapler performs substantially equivalent to the Predicate device and does not raise 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.