(87 days)
No
The document describes a mechanical stapling device and its reloads, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
No.
Therapeutic devices are generally defined as those that treat or cure a disease or medical condition. While this device is used in surgery for resection, transection, and creation of anastomoses, which are surgical procedures, it is not directly treating a disease or condition itself. It is a tool used during treatment, making it a surgical instrument rather than a therapeutic device in this context.
No
Explanation: The AEON™ Endoscopic Stapler is described as a device that places staples and divides tissue for surgical procedures (resection, transection, and creation of anastomoses), which are therapeutic actions, not diagnostic ones. The performance studies also focus on product functionality and safety, not diagnostic accuracy.
No
The device description clearly describes a physical endoscopic stapler with mechanical components (staples, reload sizes, lengths) and the performance studies focus on physical characteristics and in vivo testing, indicating a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states applications in various surgical procedures for "resection, transection, and creation of anastomoses." These are all surgical actions 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.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The information provided describes a surgical instrument used during a surgical procedure on a patient, not a device used for in vitro diagnostic testing.
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.
This 510(k) reports reloads with two staple sizes (gray - 2.25mm and black - 5.0mm) and in two lengths (45mm and 60mm).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The following nonclinical tests were conducted with the AEON™ Endoscopic Stapler to verify that the proposed device is as safe and as effective as the predicate device, 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
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is made up of three intertwined snakes and a staff.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2018
Lexington Medical, Inc. Ms. Donna Gasper Management Representative 11 Executive Park Drive Billerica. MA 01862
Re: K173443
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 25, 2017 Received: November 6, 2017
Dear Ms. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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)
Device Name AEONTM 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.
| 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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Section 3 - 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
11/28/2017
4. Proposed Device Identification
Device Name: AEON™ Endoscopic Stapler Device Common Name: Stapler Classification Name: Staple, Implantable Classification Regulation: 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 Reference Device: 510(k) Number: K171589 Product Name: AEON™ Endoscopic Stapler Manufacturer: Lexington Medical, Inc.
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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 determined by the selection of the appropriate reload.
This 510(k) reports reloads with two staple sizes (gray - 2.25mm and black - 5.0mm) and in two lengths (45mm and 60mm).
8. Intended 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 as safe and as effective as the predicate device, 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 (including the implantable Titanium staple material handling and cleaning processes, and sterilization methods of the AEON™ Endoscopic Stapler are identical to the reference device AEON™ Endoscopic Stapler (K171589).
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 with 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 as effective as the predicate device based on performance testing, and is determined to be substantially equivalent to the predicate device based on intended use and technological characteristics.