(170 days)
No
The summary describes a mechanical stapling device and its performance testing, with no mention of AI or ML capabilities.
No.
The device is a surgical stapler used for resection, transection, and creation of anastomoses, which are surgical procedures, not therapeutic treatments.
No
The device description clearly states its function is to place staples and divide tissue for surgical procedures, which is a therapeutic action, not a diagnostic one.
No
The device description clearly describes a physical endoscopic stapler that places staples and divides tissue, indicating it is a hardware device. The performance studies also focus on physical characteristics and biological interactions, not software performance.
Based on the provided information, the AEON™ Endoscopic Stapler is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states applications in various surgical procedures for "resection, transection, and creation of anastomoses." These are surgical interventions performed directly on the patient's body.
- Device Description: The device description details a surgical stapler that places staples and divides tissue. This is a mechanical surgical tool.
- 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. The AEON™ Endoscopic Stapler does not perform this function.
The "In Vitro" testing mentioned in the performance studies refers to testing performed outside of a living organism (e.g., on tissue samples or models) to evaluate the device's mechanical properties and performance, not to diagnose a condition in a patient.
N/A
Intended Use / Indications for Use
The AEON Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.
Product codes
GDW
Device Description
The AEON™ Endoscopic Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples is determined by the selection of the appropriate reload that is available in two staple sizes (tan - 3.25mm, purple - 4.0mm) and in one length (60mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general, abdominal, gynecologic, pediatric, and thoracic surgery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following nonclinical tests were conducted with the AEON™ Endoscopic Stapler to verify that the proposed device is safe and effective, performs as intended, and meets all design specifications: In Vitro: Rotation and Articulation, Safety Mechanism Performance, Firing Force, Retraction Force, Staple Formation, Staple and Cut Line Length, Staple Line Pressure Test, Staple Line Tensile Test, Package Integrity, Shelf Life. In Vivo: Burst Evaluation, Hemostasis Evaluation, Staple Formation, Biocompatibility (Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity per ISO-10993-1:2009 Biological evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process), Endotoxin Limit. This submission does not include data from Clinical Studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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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 seal of the Department of Health & Human Services. 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 17, 2017
Lexington Medical Inc. Donna Gasper Management Representative 11 Executive Park Dr. Billerica, Massachusetts 01862
Re: K171589
Trade/Device Name: AEON Endoscopic Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: October 13, 2017 Received: October 17, 2017
Dear Donna Gasper:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171589
Device Name AEON Endoscopic Stapler
Indications for Use (Describe)
The AEON Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
1. Submitter Information
Lexington Medical, Inc. 11 Executive Park Drive Billerica, Massachusetts 01862 USA
2. Contact Person
Donna L. Gasper Position: Management Representative Tel: +1 617-209-9817 Email: Donna@Lexington-Med.com
3. Date Prepared
11/16/2017
4. Device Identification
510(k) Number: K171589 Device Name: AEON™ Endoscopic Stapler Device Common Name: Stapler Classification Name: Staple, Implantable Classification Requlation: 21 CFR 878.4750 Device Class: II Classification Panel: General & Plastic Surgery Product Code: GDW
5. Predicate Device Identification
510(k) Number: K141367 Product Name: ELC Series Endoscopic Linear Cutter and Single Use Loading Unit Manufacturer: Touchstone International Medical Science Co., Ltd.
6. Reference Device Identification
Reference Device:
510(k) Number: K061095 Product Name: Auto Suture™ ENDO GIA™ Stapler Manufacturer: United States Surgical, a division of Tyco Health Group LP
7. Device Description
The AEON™ Endoscopic Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from a central line. The size of the staples is
4
determined by the selection of the appropriate reload that is available in two staple sizes (tan - 3.25mm, purple - 4.0mm) and in one length (60mm).
8. Indications For Use Statement
The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses.
9. Technological Characteristics
The AEON™ Endoscopic Stapler is substantially equivalent to the predicate device with regards to staple technologies.
10. Performance Data
The following nonclinical tests were conducted with the AEON™ Endoscopic Stapler to verify that the proposed device is safe and effective, performs as intended, and meets all design specifications:
In Vitro:
- Rotation and Articulation
- Safety Mechanism Performance ●
- Firing Force ●
- Retraction Force
- Staple Formation
- Staple and Cut Line Length
- Staple Line Pressure Test
- Staple Line Tensile Test ●
- Package Integrity
- Shelf Life
In Vivo:
- Burst Evaluation
- Hemostasis Evaluation ●
- Staple Formation
- Biocompatibility (Cytotoxicity, Sensitization, and Irritation/Intracutaneous Reactivity per ISO-10993-1:2009 Biological evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process)
- Endotoxin Limit
This submission does not include data from Clinical Studies.
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11.Materials
All materials of the AEON™ Endoscopic Stapler are similar to the predicate device ELC Series Endoscopic Linear Cutter and Single Use Loading Unit (K141367). Chemical analysis testing was performed to confirm that the implantable Titanium staples conform to ASTM F67 - 13 Standard Specification for Unalloyed Titanium, for Surgical Implant Applications.
12. Conclusion
The proposed device, the AEON™ Endoscopic Stapler, is demonstrated to be as safe and effective as the predicate device based on performance testing, and is determined to be substantially equivalent to the predicate device based on intended use, technological characteristics, and performance testing.