(70 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a surgical retrieval bag, with no mention of AI or ML technologies.
No
The device is described as a retrieval bag used for the encapture and removal of organs, tissue, or fluid during laparoscopic surgery. Its function is primarily to facilitate the surgical process by containing and extracting biological material, not to diagnose, treat, or prevent a disease or condition in itself. It is an accessory to a surgical procedure rather than a direct therapeutic intervention.
No
The AEON™ Retrieval Bag is used for the "encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery," which is a surgical tool, not a diagnostic one. Diagnostic devices are used to identify a disease or condition.
No
The device description clearly outlines a physical, sterile, disposable polymeric sack with a laparoscopic introducer system, which are hardware components.
Based on the provided information, the AEON™ Retrieval Bag is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery." This describes a surgical tool used within the body for physical removal, not a device used outside the body to test samples for diagnostic purposes.
- Device Description: The description details a physical bag and introducer system for surgical use, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The focus is entirely on the mechanical process of retrieval during surgery.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The AEON™ Retrieval Bag does not fit this description.
N/A
Intended Use / Indications for Use
The AEON Retrieval Bag is a sterile single use device that can be used for the encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The AEON™ Retrieval Bag, is a sterile, disposable, single-use, individually-packaged polymeric sack with laparoscopic introducer system that is designed to facilitate the removal of tissues or organs in the process of laparoscopic surgery.
The system consists of a sack connected to a laparoscopic introducer system. The introducer system comprises an elongated rod for laparoscopic insertion, flexible arms to allow deployment of the sack in the surgical cavity, and a drawstring to facilitate sack closure and extraction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavity
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)
Nonclinical tests were conducted with the AEON™ Retrieval Bag to verify that the proposed device is safe and effective, performs as intended, and meets all design specifications. Devices are tested for bag material/seal strength, bag material/seal leak integrity, and bag resistance to breakage in simulated removal testing. Real time shelf life testing was also performed.
This submission does not include data from Clinical Studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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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 Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
March 27, 2018
Lexington Medical Inc. Donna Gasper Management Representative 11 Executive Park Drive Billerica, Massachusetts 01862
Re: K180114
Trade/Device Name: AEON Retrieval Bag Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 19, 2018 Received: March 22, 2018
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 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, Jennifer R. Stevenson -S3 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) K180114
Device Name AEON Retrieval Bag
Indications for Use (Describe)
The AEON Retrieval Bag is a sterile single use device that can be used for the encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery.
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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AEON™ Retrieval Bag
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
1/12/2018
4. Proposed Device Identification
Device Name: AEON™ Retrieval Bag Device Common Name: Retrieval Bag Classification Name: Endoscope and accessories Classification Regulation: 21 CFR 876.1500 Device Class: II Classification Panel: General & Plastic Surgery Product Code: GCJ
5. Predicate Device Identification
510(k) Number: K111845 Product Name: The Espiner Sac or E Sac Manufacturer: Espiner Medical Limited
6. Device Description
The AEON™ Retrieval Bag, is a sterile, disposable, single-use, individually-packaged polymeric sack with laparoscopic introducer system that is designed to facilitate the removal of tissues or organs in the process of laparoscopic surgery.
The system consists of a sack connected to a laparoscopic introducer system. The introducer system comprises an elongated rod for laparoscopic insertion, flexible arms to allow deployment of the sack in the surgical cavity, and a drawstring to facilitate sack closure and extraction.
4
AEON™ Retrieval Baq
7. Intended Use Statement
The AEON™ Retrieval Bag is a sterile single use device that can be used for the encapture and removal of an organ, tissue, or fluid from the body cavity during laparoscopic surgery.
8. Technological Characteristics
The AEON™ Retrieval Bag is substantially equivalent to the predicate device, as both devices are made of similar bag and introducer materials.
The current AEON Retrieval Bag devices comprise 300, 500, and 1000mL bag sizes and 10/12.5mm introducer diameters, which fall within the bag size and introducer diameter ranges established by the predicate device.
Both devices are packaged in a Tyvek peel pouch. Both devices are sterilized with Ethylene Oxide and are validated to a Sterility Assurance Level of 10^-6.
9. Performance Data
Nonclinical tests were conducted with the AEON™ Retrieval Bag to verify that the proposed device is safe and effective, performs as intended, and meets all design specifications. Devices are tested for bag material/seal strength, bag material/seal leak integrity, and bag resistance to breakage in simulated removal testing. Real time shelf life testing was also performed.
This submission does not include data from Clinical Studies.
10.Conclusion
The proposed device, the AEON™ Retrieval Bag, is demonstrated to be safe and effective based on performance testing, and is determined to be substantially equivalent to the predicate device based on intended use and technological characteristics.