(89 days)
Not Found
No
The document describes a mechanical surgical stapler and a labeling change. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
A therapeutic device is one that treats a disease or condition. This device is a surgical stapler used for resection, transection, and creating anastomoses, which are surgical procedures, but the device itself is not providing therapy.
No
The device is an endoscopic stapler used for surgical procedures (resection, transection, and creation of anastomoses) by placing staples and dividing tissue, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "handle and reload" which are physical components, and the modification is a change in the Instructions for Use (IFU) for this physical device. The performance studies also involve testing of physical characteristics like firing force and burst pressure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures (resection, transection, and creation of anastomoses) in various anatomical areas. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a surgical stapler that physically interacts with tissue to cut and staple it.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is clearly a surgical instrument used during a surgical procedure, not a diagnostic tool used on biological samples.
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 and staple line length are based on the selection of the Stapler Reload open staple height and staple line length. The AEON™ Endoscopic Stapler handle and reload are sterile, single use devices.
The modification presented in this 510(k) is a change in the product Instructions for Use (IFU) labeling to add the following two (2) contraindications:
-
- "The AEON™ Endoscopic Stapler is contraindicated for use on the heart, central circulatory system, or central nervous system."
-
- "Do not use the AEON™ Endoscopic Stapler 2.0 mm staples on the aorta, any tissue that compresses to less than 0.75 mm in thickness, or any tissue that does not comfortably compress to 0.75 mm."
This second contraindication is associated with the addition of an AEON Endoscopic Stapler reload staple height of 2.0mm and the compressed tissue thickness contraindication associated with this staple height.
- "Do not use the AEON™ Endoscopic Stapler 2.0 mm staples on the aorta, any tissue that compresses to less than 0.75 mm in thickness, or any tissue that does not comfortably compress to 0.75 mm."
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.
Contraindicated for use on the heart, central circulatory system, or central nervous system.
Do not use the AEON™ Endoscopic Stapler 2.0 mm staples on the aorta.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Testing consisted of the following performance tests for each stapler reload size:
- i) Firing and retraction force.
- ii) Formed staple shape.
- Suture line burst pressure in porcine intestine. III)
- Tensile strength of staple line. iv)
This submission does not include data from Clinical Studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below it.
November 28, 2018
Lexington Medical, Inc. Mr. Douglas MacBride Management Representative 11 Executive Park Drive Billerica. Massachusetts 01862
Re: K182380
Trade/Device Name: AEON Endoscopic Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: August 29, 2018 Received: August 31, 2018
Dear Mr. MacBride:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-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,
Cynthia Chang -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) K182380
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.
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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Section 3 - 510(k) Summary
This 510(k) Summary of 510(k) 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
Douglas MacBride Position: Management Representative Tel: +1 617-209-9817 Email: doug@Lexington-Med.com
3. Date Prepared
11/1/2018
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: K173443 Product Name: AEON™ Endoscopic Stapler Manufacturer: Lexington Medical, Inc.
6. 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 and staple line length are based on the selection of the Stapler Reload open staple height and staple line length. The AEON™ Endoscopic Stapler handle and reload are sterile, single use devices.
The modification presented in this 510(k) is a change in the product Instructions for Use (IFU) labeling to add the following two (2) contraindications:
-
- "The AEON™ Endoscopic Stapler is contraindicated for use on the heart, central circulatory system, or central nervous system."
4
-
- "Do not use the AEON™ Endoscopic Stapler 2.0 mm staples on the aorta, any tissue that compresses to less than 0.75 mm in thickness, or any tissue that does not comfortably compress to 0.75 mm."
This second contraindication is associated with the addition of an AEON Endoscopic Stapler reload staple height of 2.0mm and the compressed tissue thickness contraindication associated with this staple height.
- "Do not use the AEON™ Endoscopic Stapler 2.0 mm staples on the aorta, any tissue that compresses to less than 0.75 mm in thickness, or any tissue that does not comfortably compress to 0.75 mm."
7. 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.
8. Substantial Equivalence
The indications for use and intended use of the modified device are identical to the predicate device.
The proposed modification and predicate device (K173443) have the same operating principle and mechanism of action. The user interface and operation instructions are identical for the modified and predicate device. The materials comprising the modified device are identical to the predicate device. Both devices fire staples made of identical Unalloyed Titanium per ASTM F67. Staple raw material, forming process, cleaning/passivation, and assembly processes are identical. Both devices are sealed in identical packaging. Both devices are sterilized with the identical Ethylene Oxide (ETO) gas sterilization cycle to a Sterility Assurance Level of 10^-6.
The proposed modification and predicate device (K173443) have the same technological characteristics, except with the minor design change of adding a 2.0mm open staple height, 45mm staple line length reload. The proposed modification does not raise any additional questions of safety and effectiveness. Testing of the proposed modification shows that all stapler reload sizes meet all performance specification requirements and that the proposed modification is substantially equivalent to the predicate device.
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9. 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:
Testing consisted of the following performance tests for each stapler reload size:
- i) Firing and retraction force.
- ii) Formed staple shape.
- Suture line burst pressure in porcine intestine. III)
- Tensile strength of staple line. iv)
This submission does not include data from Clinical Studies.
10. Materials
All materials (including the implantable Titanium staple material handling and cleaning processes, and sterilization methods of the proposed modified AEON™ Endoscopic Stapler are identical to the predicate device AEON™ Endoscopic Stapler (K173443).
11.Conclusion
The proposed device, a modified version of 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 performance testing, intended use, and technological characteristics.