(142 days)
No
The device description and performance studies focus on mechanical and electrical aspects of a surgical stapler, with no mention of AI or ML capabilities.
No.
The device is a surgical stapler used for transection and/or creation of anastomoses during surgical procedures, which is an operative function rather than a therapeutic one.
No
Explanation: The device description states its purpose is for "transection, and/or creation of anastomoses" and to "simultaneously cut and staple tissue." These are surgical actions, not diagnostic ones.
No
The device description clearly states it is a sterile, single-patient-use instrument that simultaneously cuts and staples tissue, and includes a primary lithium battery pack. This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical instrument used for cutting and stapling tissue within the body during surgical procedures. This is an in vivo application.
- Device Description: The description details a surgical stapler, a tool used directly on living tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside the body to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device is a surgical tool used for physical manipulation of tissue during surgery.
N/A
Intended Use / Indications for Use
The ECHELON FLEX™, ECHELON™ 3000, and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, 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 of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Product codes
GAG
Device Description
The ECHELONTM 3000 45 mm and 60 mm Staplers 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.
The ECHELON™ 3000 45 mm Staplers have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long.
The ECHELON™ 3000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm 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 instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section.
The instruments are packaged 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 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
liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen
Indicated Patient Age Range
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
Bench Testing: Formed Staple Height (FSH), Staple Line Integrity (SLI), Force to Close, Staple Line Visual Analysis, Staple Line Strength.
Animal Testing: In-vivo testing evaluations included
- Acute Hemostasis evaluation study
- Tissue Healing response, Survival Study
Clinical studies: The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence.
Biocompatibility: studies was performed and confirmed that the Subject device is biocompatible for the intended patient contact profile.
Electrical Safety and Electromagnetic Compatibility: The Electrical Safety and Electromagnetic Compatibility of the subject device conforms with the requirements of the FDA recognized standards for Medical Electrical Equipment.
Human Factors Testing/Usability Study: was conducted to evaluate the performance of the subject device and Instruction for Use (IFU) and establish objective evidence that the device can be used safely as intended by representative users in the intended environment.
Key Results: The conclusions of the testing criteria demonstrate that the subject device, ECHELON™ 3000 performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4740 Surgical stapler.
(a) Surgical stapler for external use.
(1)
Identification. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.(b) Surgical stapler for internal use.
(1)
Identification. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
(viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
(
1 ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;(
2 ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;(
3 ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;(
4 ) Avoidance of use of the stapler on the aorta;(
5 ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;(
6 ) Ensuring stapler compatibility with staples; and(
7 ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to be compatible.
(E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
(F) Information regarding tissues on which the stapler is intended to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical characteristics necessary for proper device selection.
0
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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 8, 2022 Ethicon Endo-Surgery, LLC Ekta Patel Senior Regulatory Affairs Specialist 4545 Creek Road Blue Ash, Ohio 45242
Re: K213633
Trade/Device Name: ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical Stapler Regulatory Class: Class II Product Code: GAG Dated: March 8, 2022 Received: March 9, 2022
Dear Ekta Patel:
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 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
1
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 (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,
Mark Trumbore 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
510(k) Number (if known) K213633
Device Name ECHELON™ 3000
Indications for Use (Describe)
The ECHELON FLEX™, ECHELON™ 3000, and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, 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 of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
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: Ekta Patel Senior Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. Phone: 513-337-1124 Email: epatelho@its.jnj.com
Date Prepared: November 15, 2021
II. SUBJECT DEVICES
Trade Names:
- ECHELON™ 3000 45mm Stapler ●
- ECHELON™ 3000 60mm Stapler ●
| Common or Usual Name: | Surgical Stapler |
|---|---|
| Classification Name: | Surgical Stapler (21 CFR 878.4740) |
| Regulatory Class: | II |
| Product Code: | GAG |
PREDICATE DEVICES III.
| Predicate Device
510(k) Number | Predicate Device Name | Predicate Device
Product Codes |
|-----------------------------------|------------------------------------------------------------------------------------|-----------------------------------|
| K163454 | ECHELON FLEXTM 45mm Powered Plus Articulating
Endoscopic Linear Cutters | PSEE45A, PLEE45A,
PCEE45A |
| K160521 | ECHELON FLEXTM 60mm Powered Plus Compact
Articulating Endoscopic Linear Cutters | PCEE60A |
| K140560 | ECHELON FLEXTM 60mm Powered Plus Articulating
Endoscopic Linear Cutters | PSEE60A and
PLEE60A |
These predicates have not been subjected to a recall related to these design modifications.
4
Reference device(s):
-
. K-number K202665: references 45mm and 60mm ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters, cleared under a Special 510(k) Premarket Notification.
*Both K202665 and current subject device ECHELON™ 3000 has the same predicate device -
K-numbers K163454 and K183435: references 45mm and 60mm ECHELON . ENDOPATH™ (reloads) which are used in conjugation with ECHELON™ 3000 45 mm and 60mm Stapler respectively. There are no modifications to the reloads; this 510(k) submission is associated with the ECHELONTM 3000 stapler only.
| Reference Device K-Number | Reference Device Name | Reference Device Product Codes |
|---|---|---|
| K163454 | ECHELON ENDOPATH™ Endoscopic Linear Cutter Reloads, 45mm (+ Gripping Surface Technology) | GST45B, GST45D, GST45G, GST45T, GST45W |
| K183435 | ECHELON ENDOPATH™ Endoscopic Linear Cutter Reloads, 60mm (+ Gripping Surface Technology) | GST60B, GST60D, GST60G, GST60T, GST60W |
Table 5-1: Reference devices* (Reloads) used with the Subject Devices (Stapler)
*No change to stapler reloads
| Table 5-2: Reload codes and corresponding reload color | ||||
|---|---|---|---|---|
| Reloads Codes for
| 45mm | Reload Codes for 60mm | Corresponding Reload Color |
|---|---|---|
| GST45B | GST60B | Blue |
| GST45D | GST60D | Gold |
| GST45G | GST60G | Green |
| GST45T | GST60T | Black |
| GST45W | GST60W | White |
*No change to stapler reloads
5
IV. DEVICE DESCRIPTION
The ECHELONTM 3000 45 mm and 60 mm Staplers 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.
The ECHELON™ 3000 45 mm Staplers have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long.
The ECHELON™ 3000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm 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 instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section.
The instruments are packaged 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 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.
V. INDICATIONS FOR USE
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 of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Note: only the ECHELON™ 3000 staplers are the Subject of this 510(k) submission.
6
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
ECHELONTM 3000 Stapler is substantially equivalent to ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters with respect to operating principle of device and Intended use of the device. Both the devices are sterile, single use device which are powered using lithium battery. The key technological difference between the subject and the predicate device is the embedded software in Subject device to fire the device.
The subject and predicate staplers have the following identical features:
- Indication for Use
- Intended use ●
- Contraindications
- Compatible Reloads (Subject device will be using the previously 510k cleared reloads used with the predicate device)
- Materials
- Operational principles
The following differences exist between the subject and predicate staplers:
- Control Mechanism Embedded software ●
- Sterilization Method
- Powered Articulation ●
- Increased Articulation and Jaw aperture
- Multifunctional "Home button"
- Haptic alerts
- Anvil Component Dimension Change ●
- Motor Firing Speed Change
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 Testing: Formed Staple Height (FSH), Staple Line Integrity (SLI), Force to Close, Staple Line Visual Analysis, Staple Line Strength.
Animal Testing: In-vivo testing evaluations included
- Acute Hemostasis evaluation study
- Tissue Healing response, Survival Study ●
Clinical studies: The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence.
Biocompatibility: studies was performed and confirmed that the Subject device is biocompatible for the intended patient contact profile.
7
Electrical Safety and Electromagnetic Compatibility: The Electrical Safety and Electromagnetic Compatibility of the subject device conforms with the requirements of the FDA recognized standards for Medical Electrical Equipment.
Human Factors Testing/Usability Study: was conducted to evaluate the performance of the subject device and Instruction for Use (IFU) and establish objective evidence that the device can be used safely as intended by representative users in the intended environment.
VII. CONCLUSIONS
The conclusions of the testing criteria demonstrate that the subject device, ECHELON™ 3000 performs substantially equivalent to the predicate device and does not raise new questions of safety and effectiveness.