(270 days)
No
The summary describes a mechanical surgical stapler and its reloads, with no mention of AI or ML capabilities. The focus is on the physical function of stapling and transecting tissue.
No.
The device is used for surgical resection, transection, and creation of anastomoses, which are surgical procedures, not therapeutic treatments in themselves, but rather enabling interventions.
No
Explanation: The device description and intended use clearly state that the AEON™ Endoscopic Stapler is used for surgical procedures (resection, transection, creation of anastomoses) by placing staples, not for diagnosing conditions.
No
The device description clearly describes a physical surgical stapler and its reloads, which are hardware components. The 510(k) is for a revision to the labeling of this hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical stapler used for resection, transection, and creation of anastomoses in various surgical procedures. This is a direct surgical intervention on the patient's body.
- Device Description: The description details a mechanical device that places staples and transects tissue. This is a surgical tool, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, urine, etc.) taken from the body to diagnose a condition or monitor health.
IVD devices are used to perform tests on specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. This device is used inside the body (in vivo) during surgery.
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. The instrument may also be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.
Product codes
GDW, GAG
Device Description
The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload.
This 510(k) revises the labeling, including indications, contraindications, and warnings, for the AEON Endoscopic Stapler.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general, abdominal, gynecologic, pediatric, thoracic and urologic surgery (for resection, transection, and creation of anastomoses).
liver substance, hepatic vasculature, biliary structures, pancreas, kidney and spleen (for transection).
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
A combination of real-world evidence and published clinical studies was provided to support the revised labeling.
The real-world evidence addressed the safety and effectiveness of the AEON™ Endoscopic Stapler in the liver, spleen, and pancreas.
Summary of Performance Studies
The results of the retrospective clinical studies show no complications associated with the AEON™ Endoscopic Stapler thus concluding the device safe and effective for use in expanded indications.
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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2023
Lexington Medical Inc. Rainer Maas Director of QA/RA 23 Crosby Drive Bedford, Massachusetts 01730
Re: K222210
Trade/Device Name: AEON Endoscopic Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: March 17, 2023 Received: March 17, 2023
Dear Rainer 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
1
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 medical devices and radiation-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 Mark Mark Trumbore -S Trumbore -S Date: 2023.04.21 08:07:48 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General 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) K222210
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. The instrument may also be used for transection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.
| 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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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. 23 Crosby Drive Bedford, Massachusetts 01730 USA
2. Contact Person
Rainer Maas Position: Director of QA/RA Tel: +1 978-273-1946 Email: rainer@lexington-med.com
3. Date Prepared
03/16/2023
4. Proposed Device Identification
Device Name: AEON™ Endoscopic Stapler Device Common Name: Stapler Classification Name: Staple, Implantable Classification Regulation: 21 CFR 878.4750, 21 CFR 878.4740 Device Class: II Classification Panel: General & Plastic Surgery Primary Product Code: GAG Secondary Product Code: GDW
5. Predicate Device Identification
510(k) Number: K201882 Product Name: AEON™ Endoscopic Stapler Manufacturer: Lexington Medical Inc.
Predicate Device:
510(k) Number: K201882 Product Name: AEON™ Endoscopic Stapler Manufacturer: Lexington Medical, Inc.
Reference Device:
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510(k) Number: K163454 Product Name: The ENDOPATH ECHELON and ECHELON FLEX families of endoscopic linear cutters and reloads Manufacturer: Ethicon Endo-surgery, LLC
5
6. Device Description
The AEON™ Endoscopic Stapler places two triple-staggered rows of titanium staples while simultaneously transecting between the two triple-staggered rows of staples. The size of the staples and staple line length are based on the selection of the Stapler Reload.
This 510(k) revises the labeling, including indications, contraindications, and warnings, for the AEON Endoscopic Stapler.
7. Indications For Use
The AEON™ Endoscopic Stapler has applications in general, abdominal, gynecologic, pediatric, thoracic and urologic 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.
8. Technological Characteristics
The AEON™ Endoscopic Stapler is identical to the predicate device with the exception of modified labeling.
| Proposed Device | Predicate Device | |
|---|---|---|
| ITEM | AEON Endoscopic Stapler | AEON Endoscopic Stapler |
| K201882 (currently marketed | ||
| device) | ||
| Product Code | GAG, GDW | GDW |
| Regulation No. | 21 CFR 878.4750 | |
| 21 CFR 878.4740 | 21 CFR 878.4750 | |
| Class | II | II |
| Indications for Use | The AEON™ Endoscopic | |
| Stapler has applications in | ||
| general, abdominal, | ||
| gynecologic, pediatric, and | ||
| thoracic 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. | ||
| Configuration | Same | Tissue Stop |
| Anvil | ||
| Cut Line | ||
| Blade | ||
| Cartridge | ||
| Operation Principle | Same | Manual |
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| Cutting Mechanism | Same | Linear Knife |
|---|---|---|
| Suture Length | Same | 30, 45, 60mm |
| Open Staple Height | Same | 2.0, 2.5, 3.25, 4.0, 5.0mm |
| Staple Material | Same | Titanium |
| Stapler Materials | Stainless Steel, Polycarbonate | Stainless Steel, Polycarbonate |
| Single Patient Use & | ||
| Disposable | Same | Yes |
| Labeling | Conforms to 21 CFR Part 801 | Conforms to 21 CFR Part 801 |
9. Performance Data
A combination of real-world evidence and published clinical studies was provided to support the revised labeling.
The real-world evidence addressed the safety and effectiveness of the AEON™ Endoscopic Stapler in the liver, spleen, and pancreas. The results of the retrospective clinical studies show no complications associated with the AEON™ Endoscopic Stapler thus concluding the device safe and effective for use in expanded indications.
7
10. 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, intended use, and technological characteristics.