(132 days)
No
The device description and performance studies focus on mechanical function, staple formation, and tissue interaction. There is no mention of software, data processing, or any features that would suggest the use of AI or ML. The "Electrical Safety and Electromagnetic Compatibility" section explicitly states the device is not powered and does not include software.
No.
Explanation: The device is a surgical stapler used for closing wounds and rejoining tissues, which is a surgical tool rather than a therapeutic treatment in itself.
No
This device is a surgical stapler used for transecting and resecting internal tissues, approximating tissues by delivering staples, and wound closure. It is not designed to diagnose a condition or disease.
No
The device is a mechanical surgical stapler, which is a hardware device. The summary explicitly states that the device is not powered and does not include software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "transection and resection of internal tissues" during surgery. This is a surgical tool used directly on the patient's body.
- Device Description: The device is a surgical stapler that delivers staples to approximate tissues. It is used in open surgical procedures.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a surgical instrument used for mechanical tissue manipulation during a procedure.
N/A
Intended Use / Indications for Use
The ETHICON ™ Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transection and resection of internal tissues.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical facility
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)
Bench Performance Testing:
- Device Stapling Performance and Comparison to Predicate
- Formed Staple Height (FSH)
- Staple Form Quality (SFQ)
- Staple Line Integrity (SLI)
- Device Functional Requirement
- Force to Close
- Force to Fire
- Jaw Aperture
- No Spent Reload/Lockout
- Human Factor Report/Usability Testing
- Product Characterization
- Staple line Strength Test
Animal Testing:
- 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.
Key results: 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.
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.
K223760, K200420, K163523, K070887
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
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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.
1
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.
2
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
3
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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4
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 Device
| 510(k) Number | Predicate Device Name | Predicate Device Model Numbers |
|---|---|---|
| K020779 | PROXIMATE® Reloadable Linear | |
| Stapler and reloads | Devices: TX30B, TX30G, TX60B, TX60G | |
| Reloads: XR30B, XR30G, XR60B, XR60G |
These predicates have not been subjected to a recall related to these design modifications.
5
Reference Device(s):
The below reference devices were used to show equivalency to the 3D technology:
Reference Device Models
| Reference
Device 510(k)
| Number | Reference Device Name | Reference Device Model Numbers |
|---|---|---|
| K223760 | ECHELON LINEAR™ Cutter Reloads | GLCR60B,GLCR60G,GLCR80B, GL |
| CR80G, | ||
| GLCR100B,GLCR100G | ||
| K200420 | ECHELON CONTOUR™ Curved | |
| Cutter Reloads | GCR40B, GCR40G | |
| K163523 | ECHELON CIRCULAR™ Powered | |
| Stapler | CDH23P, CDH25P, CDH29P, | |
| CDH31P | ||
| K070887 | ECHELON 60 Endopath Stapler, | |
| Endoscopic Linear Cutter Reload | ECR60G |
ETHICON™ Linear Staplers Product Configuration
| Subject
Device
Model
Numbers | Product Code
Description | Staple
Line
Length | Subject
Device
Reloads | Predicate Device
Model Numbers | Predicate K
Number |
|---------------------------------------|-------------------------------------|--------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------|
| GTX30 | ETHICON™
Linear 30mm
Stapler | 30mm | GTXR30B
GTXR30G | TX30B; TX30G
Compatible
Reloads:
XR30B (Blue)
XR30G (Green) | K020779 |
| GTX60 | ETHICON™
Linear 60mm
Stapler | 60mm | GLCR60B
GLCR60G | TX60B; TX60G
Compatible
Reloads:
XR60B (Blue)
XR60G (Green) | K020779 |
| GTX90 | ETHICONTM
Linear 90mm
Stapler | 90mm | GLCR90B
GLCR90G | There is no 90mm
Predicate device,
therefore, 30mm
and 60mm
devices used to
show substantial
equivalence. | K020779 |
6
| 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 Stapler | ||
| has application throughout the | ||
| alimentary tract and in thoracic | ||
| surgery for transection and resection | ||
| of internal tissues. | The Proximate ® Reloadable Linear | |
| Stapler has application throughout | ||
| the alimentary tract and in thoracic | ||
| surgery for transection and resection | ||
| of internal tissues. | The indications are the same. |
Indication for Use Comparison Table
7
VI. TECHNOLOGICAL COMPARISON
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| General Information | ||
| Stapler Code | GTX30, GTX60, GTX90 | TX30B, TX30G |
| TX60B, TX60G | ||
| Compatible Reloads | GTXR30B, GTXR60B, | |
| GTXR90B | ||
| Green: GTXR30G, | ||
| GTXR60G, GTXR90G | XR30B, | |
| XR60B | ||
| Green: | ||
| XR30G, XR60G | ||
| How it is supplied | Provided sterile, single | |
| patient use | Same | |
| Packaged | PETG Tray | Same |
| Sterilization Method | Gamma | Same |
| Sterility Assurance | ||
| Level | SAL 10-6 | Same |
| Design Features | ||
| Operation of stapling | ||
| and transection of tissue | The device operates by | |
| driving staples into a | ||
| staple forming anvil to | ||
| staple tissue | Same | |
| Cartridge Reload | ||
| surface | GST Reload Technology | |
| for 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 of | ||
| Firings 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 Reloadable | |
| Linear Stapler | 05-JUN-2002 |
8
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.