(31 days)
No
The summary describes a mechanical surgical stapler and cutter with a powered articulation mechanism and safety features. There is no mention of any computational analysis, learning, or adaptive capabilities that would indicate the presence of AI or ML.
No.
The device is described as an endoscopic linear cutter and stapler used for transection, resection, and/or creation of anastomoses, which are surgical functions rather than therapeutic ones directly treating a condition.
No
The device description indicates it is a surgical tool used for cutting and stapling tissue, not for diagnosis.
No
The device description clearly outlines a physical instrument (endoscopic linear cutter) with mechanical components, staples, and a battery pack. There is no mention of software being 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 describes a surgical instrument used for cutting and stapling tissue during various surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The description details a mechanical device with a cutting and stapling mechanism, battery power, and articulation. This aligns with a surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is purely mechanical and surgical.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing 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
Device Description
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters 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 FLEX™ 45 Powered Plus instruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long.
The ECHELON FLEX™ 60 Powered Plus instruments 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
pediatric
Intended User / Care Setting
multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
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:
All verification requirements met criteria for success. The determination of substantial equivalence relied on testing including bench studies that evaluated consistent staple formation.
Formed Staple Height (FSH), Staple Line Integrity (SLI), Force to Close, Staple Line Reinforcement compatibility, Staple Line Visual Analysis, Reload installation Force, Feedback/Safety System-Reliability -Lockout, Firing System - Stall Force - Low and Firing System - Return Home position were evaluated for the subject device to support substantial equivalence to the predicate device.
Key Metrics
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.
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 15, 2020
Ethicon Endo-Surgery, LLC Ekta Patel Senior Regulatory Affairs Specialist 4545 Creek Road Blue Ash, Ohio 45242
Re: K202665
Trade/Device Name: Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: September 10, 2020 Received: September 14, 2020
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/cdrl/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.
1
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 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 (OS) 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,
For Cindy Chowdhury Assistant Director DHT4B: Division of Infection Control and Plastic 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
510(k) Number (if known) K202665
Device Name
ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic innear cutters and reloads
Indications for Use (Describe)
ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads are intended for transection, resection of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing 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
Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969
Phone: 513-337-1124 Fax: 513-337-4366
Contact Person: Ekta Patel, MS, MSM Date Prepared: September 10, 2020
II. SUBJECT DEVICES
Trade Names:
- ECHELON FLEX™ 45mm Powered Plus Articulating Endoscopic Linear Cutters ●
- ECHELON FLEX™ 60mm Powered Plus Articulating Endoscopic Linear Cutters ●
| Common or Usual Name: | Surgical Stapler with Implantable Staples | |
|---|---|---|
| Classification Name: | Staple, implantable (21 CFR 878.4750) | |
| Regulatory Class: | II | |
| Product Code: | GDW |
III. PREDICATE DEVICES
| Predicate Device
510(k) Number | Predicate Device Name | Predicate Device
Product Codes |
|-----------------------------------|-----------------------------------------------------------------------------------|-----------------------------------|
| K163454 | ECHELON FLEX™ 45mm Powered Plus Articulating
Endoscopic Linear Cutters | PSEE45A, PLEE45A,
PCEE45A |
| K160521 | ECHELON FLEX™ 60mm Powered Plus Compact
Articulating Endoscopic Linear Cutters | PCEE60A |
| K140560 | ECHELON FLEX™ 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):
- Reference K-numbers K163454 and K183435: reference to 45mm and 60mm ECHELON . ENDOPATH™ (reloads) which are used in conjugation with 45mm and 60mm ECHELON FLEXTM Powered Plus Articulating Endoscopic Linear Cutters respectively. There are no modifications to the reloads; this 510(k) submission is only subjected to the ECHELON FLEXTM Powered Plus Articulating Endoscopic Linear Cutters.
| 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 | Reload Codes for 60mm | Corresponding Reload Color |
|---|---|---|
| 45mm | ||
| GST45B | GST60B | Blue |
| GST45D | GST60D | Gold |
| GST45G | GST60G | Green |
| GST45T | GST60T | Black |
| GST45W | GST60W | White |
*No change to stapler reloads
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IV. DEVICE DESCRIPTION
The ECHELON FLEX™ Powered Plus Articulating Endoscopic Linear Cutters 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 FLEX™ 45 Powered Plus instruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long.
The ECHELON FLEX™ 60 Powered Plus instruments 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, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing 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 indications for Use. Note: only the ECHELON FLEX Powered Plus Articulating endoscopic linear cutters are the subject of this 510(k) submission.
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VI. COMPARISON OF CHARACTERISTICS WITH THE PREDICATE DEVICES
- A) Technological Characteristic:
Surgical stapling is the technological principle for both the subject and predicate device. It is based on the use of endoscopic instrumentation for transection, resection, and/or creation of anastomoses.
The subject and predicate staplers have the following identical features:
- Intended use ●
- Indications for Use ●
- Contraindications ●
- . Compatible Reloads (Subject device will be using the previously 510k cleared reloads used with the predicate device)
- Materials
- MR compatibility
- Operational principles ●
The following differences exist between the subject and predicate staplers:
- Anvil Component Dimension Change
- Motor Firing Speed Change ●
- Channel Change (60 mm only) ●
- B) Performance Data:
Risk analyses for each device modification are provided, according to the 2014 FDA Guidance for Industry and Food and Drug Administration Staff, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. Verification testing to confirm device modifications do not raise new issues of safety or effectiveness have been conducted.
Clinical studies:
Clinical studies were not required to demonstrate substantial equivalence.
Bench Testing:
All verification requirements met criteria for success. The determination of substantial equivalence relied on testing including bench studies that evaluated consistent staple formation.
Formed Staple Height (FSH), Staple Line Integrity (SLI), Force to Close, Staple Line Reinforcement compatibility, Staple Line Visual Analysis, Reload installation Force, Feedback/Safety System-Reliability -Lockout, Firing System - Stall Force - Low and Firing System - Return Home position were evaluated for the subject device to support substantial equivalence to the predicate device.
7
Sterilization:
The subject device will be sterilized by Cobalt 60 irradiation. The device will be validated to a minimum sterilization (radiation) dose of 25kGy to achieve a 106 sterility assurance level (SAL).
The sterilization process will be validated, and sterilization dose will be established per the requirements of the following FDA recognized standards:
ISO 11737-1:2018: Sterilization of health care products - Microbiological methods Part 1: Determination of a population of microorganisms on products. (FDA Recognized Number -14-514)
ISO 11737-2:2009: Sterilization of medical devices - Microbiological Methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process. (FDA Recognized Number 1-327)
ISO 11137-1:2006/AMD 2:2018: Sterilization of health care products - Radiation - Part 1: Requirements for development validation and routine control of a sterilization process for medical devices (FDA Recognized Number 14-528)
ISO 11137-2:2013: Sterilization of medical devices - Radiation - Part 2: Establishing the sterilization does (FDA Recognized Number 14-409)
Biocompatibility Testing:
Biocompatibility testing was not required for this submission as no new materials were introduced on this device. All materials are already cleared under the predicate device submission.
Electrical Safety and Electromagnetic Compatibility:
The Electrical Safety and Electromagnetic Compatibility of the subject device conforms with the requirements of the following FDA recognized standards:
IEC 60601-1-6:2013: Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -Collateral standard: Usability (FDA Recognition Number 5-89)
IEC 60601-1-2:2014: Medical electrical equipment - Pat 1-6: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbance (FDA Recognition Number 19-8)
VII. CONCLUSIONS
The risk profile of the device has not changed as a result of the described changes while having the same intended use as the predicate device; furthermore, the performance of the modified device is consistent with the predicate device and does not raise any new questions of safety and effectiveness.