(93 days)
The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses
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 to remove the "MR Unsafe" from the MRI Safety Information section of the Instructions for Use (IFU).
This document describes the AEON Endoscopic Stapler and a 510(k) submission (K201882) to remove the "MR Unsafe" designation from its Instructions for Use (IFU). The information provided does not pertain to an AI/ML device or its performance study; rather, it details the testing conducted for MRI safety of a physical medical device. Therefore, I cannot extract information related to AI/ML device acceptance criteria, human reader improvement with AI assistance, or related aspects.
However, I can provide the acceptance criteria and study information that is present in the document regarding the MRI compatibility testing of the AEON Endoscopic Stapler.
Acceptance Criteria and Study for MRI Compatibility of AEON Endoscopic Stapler
The provided document describes the modification to the AEON Endoscopic Stapler to remove the "MR Unsafe" designation from its IFU. The study conducted was to demonstrate MRI safety, not the performance of an AI/ML diagnostic device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (ASTM Standard) | Reported Device Performance (Summary) |
|---|---|
| ASTM F2182 "RF Heating" | Device met standards for MRI safety |
| ASTM F2052 "Force" | Device met standards for MRI safety |
| ASTM F2213 "Torque" | Device met standards for MRI safety |
| ASTM F2119 "Image Artifact" | Device met standards for MRI safety |
| ASTM F2503 "Marking Medical Devices" | Device met standards for MRI safety |
Note: The document states that the testing showed "all stapler reload sizes meet the ASTM standards for removal of the 'MR Unsafe' designation," implying successful adherence to the acceptance criteria for each standard.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "worst-case staple line size" was tested, implying a representative sample of the device was used for the physical testing. However, a specific numerical sample size (e.g., number of stapler units tested) is not explicitly stated in the provided text.
- Data Provenance: The data is generated from nonclinical, laboratory-based performance tests conducted in a controlled environment as part of a 510(k) submission. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA by a company located in Massachusetts, USA. The study design is prospective in nature, as new testing was performed to support the change in MRI safety labeling.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This question is not applicable as the study did not involve human interpretation or subjective assessment by experts to establish ground truth. The ground truth for MRI safety is established by adherence to quantitative and qualitative criteria defined within the specified ASTM standards.
4. Adjudication Method for the Test Set
This question is not applicable. The assessment was based on physical performance of the device against predefined engineering standards (ASTM), not on expert consensus or human reading.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This study concerns the physical MRI safety of a surgical stapler, not the performance of an AI-assisted diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This study pertains to a physical medical device.
7. The Type of Ground Truth Used
The ground truth used for this study was defined by established engineering standards (ASTM) for MRI safety of medical devices. Performance was measured against the acceptance criteria outlined within these standards (e.g., specific thresholds for RF heating, image artifact levels, force, and torque).
8. The Sample Size for the Training Set
This question is not applicable. This study involves physical device testing, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable. No training set was used.
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October 9, 2020
Lexington Medical Inc. Rainer Maas Director of QA/RA 11 Executive Park Drive Billerica, Massachusetts 01862
Re: K201882
Trade/Device Name: AEON Endoscopic Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: July 7, 2020 Received: July 8, 2020
Dear Mr. Maas:
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
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801); medical device 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 (QS) 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 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,
Cindy Chowdhury, Ph.D., M.B.A. Acting 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) K201882
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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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
Rainer Maas Position: Director of QA/RA Tel: +1 978-273-1946 Email: rainer@Lexington-Med.com
3. Date Prepared
July 6, 2020
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: Il Classification Panel: General & Plastic Surgery Product Code: GDW
5. Predicate Device Identification
510(k) Number: K182380 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 to remove the "MR Unsafe" from the MRI Safety Information section of the Instructions for Use (IFU).
7. Indications for Use Statement
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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 (K182380) have the same operating principle and mechanism of action. The user interface and operation instructions have minor changes that do not affect the safety or efficacy of the modified device. The materials comprising the modified device are identical to the predicate 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 packaging with minor changes that do not affect the safety or efficacy of the modified device. 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 (K182380) have the same technological characteristics, except for the change to the IFU to remove "MR Unsafe" for the MRI Safety Information section. 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 the ASTM standards for removal of the "MR Unsafe" designation and that the proposed modification is substantially equivalent to the predicate device.
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 the worst-case staple line size:
- ASTM F2182 "RF Heating" i)
- ASTM F2052 "Force" ii)
- iii) ASTM F2213 "Torque"
- iv) ASTM F2119 "Image Artifact"
- v) ASTM F2503 "Marking Medical Devices"
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 (K182380).
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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.
§ 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.