(138 days)
No
The summary mentions software control but provides no indication of AI/ML capabilities, focusing instead on mechanical and functional performance testing.
No.
A therapeutic device is one that treats or heals a disease or medical condition. This device is used for surgical resection and transection of tissues, which is a procedural tool rather than a therapeutic treatment itself.
No
The device is a surgical stapler used for cutting and stapling tissue during various surgical procedures, not for diagnosing medical conditions.
No
The device description clearly states it is a physical endoscopic stapler system composed of a handle and reloads, and the performance studies include extensive hardware testing (staple formation, strength, leak-burst pressure, electrical safety, biocompatibility, etc.) in addition to software testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body (in vitro).
- Device Function: The AEON Endoscopic Powered Stapler is a surgical instrument used inside the body (in vivo) to cut and staple tissue during surgical procedures. It directly interacts with and modifies tissue within the patient.
- Intended Use: The intended use clearly describes surgical applications for resection, transection, and creation of anastomoses, all of which are surgical procedures performed on living tissue.
The description of the device and its intended use aligns with a surgical instrument, not a device used for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
The AEON Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.
Product codes
GAG, GDW
Device Description
The AEON Endoscopic Powered Stapler system is an endoscopic linear cutter and reload system that simultaneously cut and staple tissue. The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triplestaggered rows of staples.
The AEON Endoscopic Powered Stapler system is composed of an AEON Endoscopic Powered Stapler Handle and the AEON Endoscopic Stapler Reloads. Multiple staple handle lengths and multiple staple sizes are available to accommodate various tissue thicknesses.
The AEON Endoscopic Powered Stapler uses software to control operation of the stapler and is AC powered. The device is sterile packaged (Ethylene Oxide) and single use. The AEON Endoscopic Powered Stapler Handle may be reloaded and fired up to 20 times in a single procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver substance, hepatic vasculature, biliary structures, pancreas, kidney, spleen
Indicated Patient Age Range
pediatric
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)
Nonclinical testing was performed to demonstrate that the subject AEON Endoscopic Powered Stapler is substantially equivalent to predicate devices. The following testing or engineering rationale were provided in support of the substantial equivalence determination:
- Staple height and formation
- Staple line strength
- Staple line integrity
- Ex-vivo leak-burst pressure testing
- Articulation deflection
- Obstruction and lockout testing
- Functional lifecycle testing
- Deployment pressure
- Design validation
Software verification and validation testing was conducted, and software related documentation (enhanced documentation level) was provided per the FDA Guidance Document Content of Premarket Submissions for Device Software Functions.
Animal testing was performed to assess In vivo confirmation of staple line hemostasis in accordance with the FDA Guidance Document Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgerv.
Human Factors testing was executed in accordance with the FDA Guidance Document Applying Human Factors and Usability Engineering to Medical Devices.
Electrical safety and EMC testing were conducted on the subject device and the subject device complies with the IEC 60601-1 standard for safety and effectiveness and the IEC 60601-1-2 standard for EMC.
Additionally, biocompatibility of materials was assessed, and sterilization, packaging, distribution and shelf-life validations were executed.
The results of testing and evaluation listed above demonstrate that the subject AEON Endoscopic Powered Stapler is substantially equivalent to the predicate device.
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.
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
§ 878.4740 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 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.
May 07, 2024
Lexington Medical, Inc. Sali Gully Sr. Regulatory Affairs Specialist 23 Crosby Drive Bedford, Massachusetts 01730
Re: K234039
Trade/Device Name: AEON Endoscopic Powered Stapler Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical Stapler Regulatory Class: Class II Product Code: GAG, GDW Dated: December 20, 2023 Received: December 21, 2023
Dear Sali Gully:
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.
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).
1
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.
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.
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 Tek N. N. Lamichhane -S Lamichhane -S Date: 2024.05.07
104'00' Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and 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
2
Indications for Use
510(k) Number (if known) K234039
Device Name AEON™ Endoscopic Powered Stapler
Indications for Use (Describe)
The AEON Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, and pediatric surgery for resection, transection, and creation of anastomoses. The instrument may be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR Part 807.92, the following summary of information is provided:
A. Submitter Information:
Sali Gully Sr. Regulatory Affairs Specialist Lexington Medical, Inc. 23 Crosby Drive Bedford, Massachusetts 01730, USA Telephone: (617) 209-9817
Date Prepared: May 7, 2024
B. Device Information
| Trade or Proprietary Name: | AEON™ Endoscopic Powered Stapler |
|---|---|
| Common Name: | Surgical Stapler |
| Classification Name: | Implantable Staple |
| Surgical Stapler | |
| Regulation Number: | 21 CFR 878.4740, 21 CFR 878.4750 |
| Regulation Class: | II |
| Primary Product Code: | GAG |
| Secondary Product Code: | GDW |
C. Predicate Devices
510(k) number: K222210 Product Name: AEON Endoscopic Stapler Manufacturer: Lexington Medical Inc. Classification Name: Surgical Stapler, Implantable Staple Regulation Number: 21 CFR 878.4740, 21 CFR 878.4750 Product Code: GAG, GDW Regulation Class: II
Reference Device
510(k) number: K163454 Product Name: ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH Endoscopic Linear Cutter Reloads, 45mm Manufacturer: ETHICON ENDO-SURGERY, LLC Classification Name: Implantable Staple Regulation Number: 21 CFR 878.4750 Product Code: GDW Regulation Class: II
4
D. Device Description
The AEON Endoscopic Powered Stapler system is an endoscopic linear cutter and reload system that simultaneously cut and staple tissue. The AEON Endoscopic Powered Stapler places two, triple-staggered rows of titanium staples while simultaneously transecting between the two triplestaggered rows of staples.
The AEON Endoscopic Powered Stapler system is composed of an AEON Endoscopic Powered Stapler Handle and the AEON Endoscopic Stapler Reloads. Multiple staple handle lengths and multiple staple sizes are available to accommodate various tissue thicknesses.
The AEON Endoscopic Powered Stapler uses software to control operation of the stapler and is AC powered. The device is sterile packaged (Ethylene Oxide) and single use. The AEON Endoscopic Powered Stapler Handle may be reloaded and fired up to 20 times in a single procedure.
E. Indications for Use
The AEON Endoscopic Powered Stapler has applications in general, abdominal, gynecologic, and pediatric surgery for resection, transection of anastomoses. The instrument may be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen.
F. Technological Characteristics
Surgical stapling is the technological principle for both the subject and the predicate devices. Instrumentation is used for transection, and/or creation of anastomoses. Overall, the subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, indications, material composition, principle of operation, function, and packaging. Additionally, the reference device is used to support the performance testing for powered stapler applications.
| | AEON Endoscopic
Powered Stapler | AEON Endoscopic
Stapler | The ECHELON
ENDOPATH / ECHELON
FLEX | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| ITEM | Subject Device
(K234039) | Predicate Device
(K222210) | Reference Device (K163454) | SE |
| 510(k)
Number | K234039 | K222210 | K163454 | Yes |
| Product Code | GDW, GAG | GDW, GAG | GDW | Yes |
| Regulation
No. | 878.4750, 878.4740 | 878.4750, 878.4740 | 878.4750 | Yes |
| Class | II | II | II | Yes |
| | AEON Endoscopic
Powered Stapler | AEON Endoscopic
Stapler | The ECHELON
ENDOPATH / ECHELON | |
| | | | FLEX | |
| ITEM | Subject Device
(K234039) | Predicate Device
(K222210) | Reference Device (K163454) | SE |
| Indications
for Use | The AEON Endoscopic
Powered Stapler has
applications in general,
abdominal,
gynecologic, and
pediatric surgery for
resection, transection,
and creation of
anastomoses. The
instrument may be used
for transection and
resection of liver
substance, hepatic
vasculature, biliary
structures, pancreas,
kidney and spleen. | The AEON Endoscopic
Stapler has applications
in general, abdominal,
gynecologic, pediatric,
and thoracic surgery for
resection, transection,
and creation of
anastomoses. The
instrument may also be
used for transection and
resection of liver
substance, hepatic
vasculature, biliary
structures, pancreas,
kidney, and spleen. | The ENDOPATH ECHELON 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 for 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. | Yes |
| Reload | Tissue Stop | Tissue Stop | Tissue Stop | Yes |
| Features | Anvil | Anvil | Anvil | Yes |
| | Cut Line | Cut Line | Cut Line | Yes |
| | Knife | Knife | Knife | Yes |
| | Cartridge | Cartridge | Cartridge | Yes |
| Operation
Principle | Powered | Manual | Powered | Yes |
| Cutting
Mechanism | Linear Knife | Linear Knife | Linear Knife | Yes |
| Cutting
Length | 26, 41, 56mm | 26, 41, 56mm | 42, 53mm | Yes |
| Open Staple
Height | 2.0, 2.5, 3.25, 4.0,
5.0mm | 2.0, 2.5, 3.25, 4.0, 5.0mm | 2.0, 2.6, 3.6, 3.8, 4.1, 4.2 mm | Yes |
| Closed Staple
Height | 0.75, 1.0, 1.5, 1.8,
2.2mm | 0.75, 1.0, 1.5, 1.8, 2.2mm | 0.75, 1.0, 1.5, 1.8, 2.0, 2.3mm | Yes |
| Single Patient
Use | Yes | Yes | Yes | Yes |
| Sterilization
Method | EO Sterilized | EO Sterilized | Gamma Sterilized | Yes |
5
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject AEON Endoscopic Powered Stapler is substantially equivalent to predicate devices. The following testing or engineering rationale were provided in support of the substantial equivalence determination:
6
- Staple height and formation -
- -Staple line strength
- Staple line integrity -
- Ex-vivo leak-burst pressure testing -
- -Articulation deflection
- -Obstruction and lockout testing
- -Functional lifecycle testing
- Deployment pressure -
- Design validation -
Software verification and validation testing was conducted, and software related documentation (enhanced documentation level) was provided per the FDA Guidance Document Content of Premarket Submissions for Device Software Functions.
Animal testing was performed to assess In vivo confirmation of staple line hemostasis in accordance with the FDA Guidance Document Premarket Notification (510(k)) Submissions for Bipolar Electrosurgical Vessel Sealers for General Surgerv.
Human Factors testing was executed in accordance with the FDA Guidance Document Applying Human Factors and Usability Engineering to Medical Devices.
Electrical safety and EMC testing were conducted on the subject device and the subject device complies with the IEC 60601-1 standard for safety and effectiveness and the IEC 60601-1-2 standard for EMC.
Additionally, biocompatibility of materials was assessed, and sterilization, packaging, distribution and shelf-life validations were executed.
The results of testing and evaluation listed above demonstrate that the subject AEON Endoscopic Powered Stapler is substantially equivalent to the predicate device.
H. Conclusions
The comparison of intended use and technological characteristics along with the non-clinical data support the safety and performance of the device. The hardware and software verification and validation demonstrate that the AEON Endoscopic Powered Stapler performs as intended in the specified use conditions.