(90 days)
Not Found
No
The device description and performance studies focus on mechanical function and staple performance, with no mention of AI or ML.
No.
The device is a surgical stapler used for cutting and stapling tissue, which is a surgical tool rather than a therapeutic device in the medical sense of treating a condition or disease.
No.
The device description and intended use clearly indicate that the ECHELON LINEAR™ Cutters are surgical instruments used for "transection, resection, and the creation of anastomoses" by delivering staples and dividing tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly details a physical surgical instrument with mechanical features (staples, knife, firing knob, lockouts) and mentions bench and animal testing related to its physical performance (stapling, cutting, forces). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states applications in surgical procedures (gastrointestinal, thoracic, pediatric surgery) for transection, resection, and creating anastomoses. This involves direct interaction with the patient's body during surgery.
- Device Description: The description details a surgical stapling and cutting instrument used to physically manipulate tissue.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples. It is a surgical tool used on the patient.
Therefore, the ECHELON LINEAR™ Cutter is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ECHELON LINEAR™ Cutters have application in gastrointestinal, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The ECHELON LINEAR™ Cutter delivers two, double-staggered rows of staples while simultaneously dividing the tissue between rows. The instrument has a safety lockout feature that is designed to prevent firing if either no reload or a used reload is installed. An unclamp lockout feature prevents knife exposure by allowing the instrument to open only when the Firing Knob is in the home position. A clamp lockout feature prevents closure of the jaws when the knife is not in the home position. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. This device may be used on the general population for routine wound closure via stapling. The 60 mm reload creates a 61 mm staple line and cuts tissue approximately 52 mm beyond the tissue stop. The 80 mm reload creates an 81 mm staple line and cuts tissue approximately 72 mm beyond the tissue stop. The 100 mm reload creates a 101 mm staple line and cuts tissue approximately 92 mm beyond the tissue stop. The instruments are shipped without a reload and must be loaded prior to use. The instrument may be loaded eight times for a maximum of eight firings per instrument during a single procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal, thoracic
Indicated Patient Age Range
pediatric, general population
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)
Bench Testing:
- Device Stapling Performance and Comparison to Predicate
- Formed Staple Height (FSH)
- Staple Form Quality (SFO)
- Staple Line Integrity (SLI)
- Device Functional Requirement
- Force to Close/Clamping Force
- Force to Fire
- Force to Couple/Decouple Device Halves
- Force to Press Clamp Release Button
- Human Factor Report
- Product Characterization
- Staple line Strength Test
Animal Testing:
- Staple line Strength Test
- Acute Hemostasis evaluation study
- Tissue Healing response, Survival Study using both gastrointestinal and pulmonary models.
Clinical studies: The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence.
Biocompatibility: studies were performed and confirmed that the Subject device is biocompatible for the intended patient contact profile.
Electrical Safety and Electromagnetic Compatibility: This device is not powered and therefore this does not apply.
The conclusions of the testing criteria demonstrate that the Subject device: ECHELON LINEAR™ CUTTER 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.
Not Found
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 shows the logo of the U.S. Food & 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.
March 15, 2023
Ethicon Endo-Surgery Alicia Butler Senior Regulatory Affairs Specialist 475 Calle C Guaynabo, PR 00969
Re: K223760
Trade/Device Name: ECHELON LINEAR™ 60 mm Cutter (GLC60):ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™ 100 mm Cutter (GLC100);ECHELON LINEAR™ Cutters 60mm Blue Reload (GLCR60B);ECHELON LINEAR™ Cutters 60mm Green Reload (GLCR60G):ECHELON LINEARTM Cutters 80mm Blue Reload (GLCR80B):ECHELON LINEAR™ Cutters 80mm Green Reload (GLCR80G);ECHELON LINEAR™ Cutters 100mm Blue Reload (GLCR100B);ECHELON LINEAR™ Cutters 100mm Green Reload (GLCR100G) Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: December 15, 2022 Received: December 15, 2022
Dear Alicia Butler:
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 (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 located 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-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 | |
|---|---|
| Mark | Mark Trumbore -S |
| Trumbore -S Date: 2023.03.15 08:05:38 -04'00' |
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
| ECHELON LINEARTM 60 mm Cutter (GLC60); |
|---|
| ECHELON LINEARTM 80mm Cutter (GLC80); |
| ECHELON LINEARTM 100 mm Cutter (GLC100); |
| ECHELON LINEARTM Cutters 60mm Blue Reload (GLCR60B); |
| ECHELON LINEARTM Cutters 60mm Green Reload (GLCR60G); |
| ECHELON LINEARTM Cutters 80mm Blue Reload (GLCR80B); |
| ECHELON LINEARTM Cutters 80mm Green Reload (GLCR80G); |
| ECHELON LINEARTM Cutters 100mm Blue Reload (GLCR100B); |
| ECHELON LINEARTM Cutters 100mm Green Reload (GLCR100G) |
| Indications for Use (Describe) |
| The ECHELON LINEARTM Cutters have application in gastrointestinal, thoracic, and pediatric |
| surgery for transection, resection, and the creation of anastomoses. |
| 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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3
510(k) Summary
I. SUBMITTER
Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Contact: Alicia Butler Senior Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. Phone: 513-337-1633 Email: abutler9@its.jnj.com
Date Prepared: December 15, 2022
II. SUBJECT DEVICES
Trade Names:
- ECHELON LINEAR™ 60mm Cutter and Reloads ●
- ECHELON LINEAR™ 80mm Cutter and Reloads ●
- ECHELON LINEAR™ 100mm Cutter and Reloads .
| Common or Usual Name: | Surgical Stapler with Implantable Staples | Classification Name: | Implantable staple (21 CFR 878.4750) |
|---|---|---|---|
| Regulatory Class: | Class 2 -Staple, Implantable | Product Code: | GDW |
| Common or Usual Name: | Surgical Stapler with Implantable Staples | Classification Name: | Surgical Stapler (21 CFR 878.4740) |
| Regulatory Class: | Class 2 - Stapler, Surgical | Product Code: | GAG |
III. PREDICATE DEVICES
| Predicate Device
| 510(k) Number | Predicate Device Name | Predicate Device Product Codes |
|---|---|---|
| K020779 | PROXIMATE® Linear Cutters with Safety | |
| Lockout and Reloads | Devices: TLC55, TLC75, TLC10 | |
| Reloads: TCR55, TCT55, TCR75, | ||
| TCT75, TCR10, TCT10 |
These predicates have not been Subjected to a recall related to these design modifications.
4
| Subject
Device
Product
Code | Product Code
Description | Staple
Line
Length | Cut
Line
Length | Subject
Device
Reloads | Predicate Device
Product Code | Predicate K
number |
|--------------------------------------|------------------------------------|--------------------------|-----------------------|------------------------------|------------------------------------------------------------------|-----------------------|
| GLC60 | ECHELON
LINEAR™ 60mm
Cutter | 61mm | 55mm | GLCR60B
GLCR60G | TLC55
Compatible
Reloads:
TCR55 (Blue)
TRT55 (Green) | K020779 |
| GLC80 | ECHELON
LINEAR™ 80mm
Cutter | 81mm | 75mm | GLCR80B
GLCR80G | TLC75
Compatible
Reloads:
TCR75 (Blue)
TRT75 (Green) | K020779 |
| GLC100 | ECHELON
LINEAR™ 100mm
Cutter | 101mm | 95mm | GLCR100B
GLCR100G | TLC10
Compatible
Reloads:
TCR10
TRT10 | K020779 |
Table 5-1: ECHELON LINEAR™ Cutters Product Configuration
Table 5-2: Reload codes and corresponding reload color
| Reloads Codes
for
60mm | Reload Codes for
80mm | Reload Codes for
100mm | Corresponding Reload
Color |
|------------------------------|--------------------------|---------------------------|-------------------------------|
| GLCR60B | GLCR80B | GLCR100B | Blue |
| GLCR60G | GLCR80G | GLCR100G | Green |
5
DEVICE DESCRIPTION
The ECHELON LINEAR™ Cutter delivers two, double-staggered rows of staples while simultaneously dividing the tissue between rows. The instrument has a safety lockout feature that is designed to prevent firing if either no reload or a used reload is installed. An unclamp lockout feature prevents knife exposure by allowing the instrument to open only when the Firing Knob is in the home position. A clamp lockout feature prevents closure of the jaws when the knife is not in the home position. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation.
This device may be used on the general population for routine wound closure via stapling.
The 60 mm reload creates a 61 mm staple line and cuts tissue approximately 52 mm beyond the tissue stop.
The 80 mm reload creates an 81 mm staple line and cuts tissue approximately 72 mm beyond the tissue stop.
The 100 mm reload creates a 101 mm staple line and cuts tissue approximately 92 mm beyond the tissue stop.
The instruments are shipped without a reload and must be loaded prior to use. The instrument may be loaded eight times for a maximum of eight firings per instrument during a single procedure.
IV. INDICATIONS FOR USE
The ECHELON LINEAR™ Cutters have application in gastrointestinal, thoracic, and pediatric surgery for transection, resection, and the creation of anastomoses.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE V. PREDICATE DEVICE
ECHELON LINEAR™ Cutter is substantially equivalent to PROXIMATE® Linear Cutters with respect to operating principle of device and Intended Use of the device. Both the devices are sterile, single use manual devices. The key technological difference between the Subject and the predicate device is the change to the reloads with the addition of GST technology and a new 3D style anvil pocket.
The Subject device is a next generation Linear Cutter to be used in open procedures requiring a surgical stapler. To improve stapling performance, the Subject device incorporates proven GST Reload Technology, leveraged from Ethicon Endocutters, and new 3-D B-shaped final staple form into the new ECHELON LINEARTM Cutter Reload as shown in illustration 5-1.
6
Illustration 5-1: GST Reload Technology and 3-D Final Staple Form
Image /page/6/Picture/2 description: The image contains two separate images with text below each. The image on the left is a close-up of a blue object with a textured surface, and the text below it reads "GST". The image on the right is a 3-D rendering of a metal object, and the text below it reads "3-D".
The Subject and predicate staplers have the following identical features:
- Indication (the compatibility with staple line reinforcement materials has not been evaluated ● for the Subject device and thus has been removed)
- Intended use
- Contraindications ●
- Materials
- MR compatibility
- Sterilization Method
- Operational principles ●
The following differences exist between the Subject and predicate staplers:
- Reloads: Subject device reloads contain GST technology used in Ethicon Endocutters along with a new 3D style anvil pocket. Also, only the newly designed Green and Blue reloads will be compatible with the device.
- New handle half coupling. The two device halves can be joined proximally or separated when maneuvering on tissue.
- . Clamp arm that latches when the device is clamped closed and unlatches by pressing the clamp release button.
- Firing knob consists of dual foldable firing knobs that can be activated from either the left ● side or the right side of the assembled device.
VI. PERFORMANCE DATA:
7
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 Testing:
- Device Stapling Performance and Comparison to Predicate ●
- Formed Staple Height (FSH) O
- Staple Form Quality (SFO) O
- Staple Line Integrity (SLI) о
- Device Functional Requirement ●
- Force to Close/Clamping Force O
- O Force to Fire
- Force to Couple/Decouple Device Halves о
- Force to Press Clamp Release Button O
- Human Factor Report o
- Product Characterization ●
- o Staple line Strength Test
Animal Testing: In-vivo testing evaluations included
- Acute Hemostasis evaluation study
- Tissue Healing response, Survival Study using both gastrointestinal and pulmonary models.
Clinical studies: The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence.
Biocompatibility: studies were performed and confirmed that the Subject device is biocompatible for the intended patient contact profile.
Electrical Safety and Electromagnetic Compatibility: This device is not powered and therefore this does not apply.
VII. CONCLUSIONS
The conclusions of the testing criteria demonstrate that the Subject device: ECHELON LINEAR™ CUTTER performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.