(357 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a tissue bag and guard system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to contain and isolate tissue during surgical removal or morcellation; it does not directly treat a disease or condition.
No
Explanation: The device is designed to contain and isolate tissue during surgical removal or morcellation, which is a procedural function, not a diagnostic one. It does not provide information about a patient's health status or disease.
No
The device description clearly outlines physical components made of polyurethane and polyethylene, including a tissue bag, rings, straps, and a guard system. The performance studies also focus on the physical properties and functionality of these hardware components.
Based on the provided information, the Alexis® Contained Extraction System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation." This describes a surgical tool used for physical manipulation and containment of tissue during a procedure, not for analyzing biological samples in vitro to diagnose a condition.
- Device Description: The description details a physical bag and guard system designed for containing and protecting tissue during surgical removal. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological fluids or tissues for diagnostic purposes, or any other characteristics typically associated with IVD devices.
- Performance Studies: The performance studies focus on biocompatibility, sterilization, shelf life, and functional performance related to the physical containment and manipulation of tissue during surgery. They do not involve evaluating the device's ability to provide diagnostic information.
Therefore, the Alexis® Contained Extraction System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alexis® Contained Extraction System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Alexis® Contained Extraction System is a sterile, single use tissue bag with a guard system component. The polyurethane tissue bag consists of a flexible ring, tabs, strap with a snap fastener, and an attached tether. It is available in two models GTB14 and GTB17 with the following dimensions and volumes:
Model GTB14: Ring Diameter 14 cm, Volume 3,400 mL
Model GTB17: Ring Diameter 17 cm, Volume 6,500 mL
The tissue bag is used to contain and isolate specimens for surgical removal and/or manual morcellation. The strap with snap fastener maintains the folded bag and flexible ring in a collapsed state during insertion. After the device is fully inserted and deployed into the abdominal or pelvic cavity, the opening of the bag returns to its original, circular shape, facilitating placement of the specimen in the bag. When the specimen is ready for removal and/or manual morcellation, the tether, tabs, and strap are used to maneuver the ring to the surface of the extraction site.
If the specimen requires manual morcellation, the ring may be repeatedly flipped to shorten the bag and consequently bring the specimen closer to the extraction site.
The guard system consists of a guard and a self-retaining retractor. The guard is composed of a coiled polyethylene material that conforms to the extraction site. The self-retaining retractor consists of two polyurethane rings connected by a polyurethane sheath and a tether attached to the inner ring. It helps anchor the guard at the extraction site. The guard system provides a robust barrier between the bag and sharp instruments.
The Alexis® Contained Extraction System can be inserted and retrieved either through an abdominal incision or through the vaginal canal and colpotomy. In both cases, manual morcellation is performed extracorporeally at the extraction site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal or vaginal approach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Biocompatibility:
- Evaluation in accordance with ISO 10993-1 and 2020 FDA guidance.
- Endpoints considered: Cytotoxicity, Intracutaneous Irritation, Sensitization, Acute Systemic Toxicity, Material Mediated Pyrogenicity.
- All materials found to be biocompatible for tissue contact less than 24 hours.
Sterilization/Shelf Life:
- Sterilization validation performed according to ISO 11135 - 2 (Ethylene oxide).
- Shelf life testing evaluated package integrity and device functionality after artificial aging and simulated transit conditioning.
Functional Performance:
- Design Verification testing:
- Integrity of tissue bag
- Integrity of tether to pull the tissue bag out of the extraction site
- Integrity of the guard system's material to protect the bag from incidental cuts
- Ability of the tissue bag to maintain a closed system
- Resistance of tissue bag material to penetration by blood-borne pathogens
- Ability of guard system to remain anchored at the extraction site
- Integrity of tabs and strap to assist in specimen capture
- Ability of snap fastener to withstand insertion and ability of the user to deploy for specimen capture
- Simulated use testing:
- Performed with the subject device in both an abdominal bench model and a vaginal bench model.
- Demonstrated the device's capability to perform the intended use at the different anatomical sites of insertion and retrieval.
Key result: Results of testing demonstrate that the subject Alexis® Contained Extraction System is substantially equivalent to the predicate Applied Medical Tissue Containment System, and that the subject device is as safe and effective as the predicate device.
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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March 31, 2022
Applied Medical Resources Corporation Apeksha Shanbhag Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, CA 92688
Re: K211043
Trade/Device Name: Alexis® Contained Extraction System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 3, 2022 Received: March 4, 2022
Dear Apeksha Shanbhag:
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.
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 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,
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211043
Device Name
Alexis® Contained Extraction System
Indications for Use (Describe)
The Alexis® Contained Extraction System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach.
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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3
510(k) Summary - K211043
| 510(k) Submitter: | Applied Medical Resources Corporation
22872 Avenida Empresa
Rancho Santa Margarita, CA 92688
(949) 713 - 8000 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Apeksha Shanbhag
Regulatory Affairs Manager
Applied Medical Resources Corporation
Tel: (949) 547-4136
Fax: (949) 713-8205
Email: apeksha.shanbhag@appliedmedical.com |
| Preparation Date: | March 30, 2022 |
| Trade Name: | Alexis® Contained Extraction System |
| Common Name: | Tissue Bag |
| Classification: | Regulation: 21 CFR 876.1500, Endoscope and Accessories
Device Class: Class II
Product Code: GCJ (endoscope and accessories) |
| Predicate Device: | Applied Medical Tissue Containment System
510(k)#: K142427
Product Code: GCJ
The predicate device has not been subject to a design related recall. |
| Device Description: | The Alexis® Contained Extraction System is a sterile, single use tissue
bag with a guard system component. The polyurethane tissue bag consists
of a flexible ring, tabs, strap with a snap fastener, and an attached tether
It is available in two models GTB14 and GTB17 with the following
dimensions and volumes: |
| Model | Ring
Diameter | Volume |
|-------|------------------|----------|
| GTB14 | 14 cm | 3,400 mL |
| GTB17 | 17 cm | 6,500 mL |
The tissue bag is used to contain and isolate specimens for surgical removal and/or manual morcellation. The strap with snap fastener maintains the folded bag and flexible ring in a collapsed state during insertion. After the device is fully inserted and deployed into the abdominal or pelvic cavity, the opening of the bag returns to its original, circular shape, facilitating placement of the specimen in the bag. When
4
the specimen is ready for removal and/or manual morcellation, the tether, tabs, and strap are used to maneuver the ring to the surface of the extraction site.
If the specimen requires manual morcellation. the ring may be repeatedly flipped to shorten the bag and consequently bring the specimen closer to the extraction site.
The guard system consists of a guard and a self-retaining retractor. The guard is composed of a coiled polyethylene material that conforms to the extraction site. The self-retaining retractor consists of two polyurethane rings connected by a polyurethane sheath and a tether attached to the inner ring. It helps anchor the guard at the extraction site. The guard system provides a robust barrier between the bag and sharp instruments.
The Alexis® Contained Extraction System can be inserted and retrieved either through an abdominal incision or through the vaginal canal and colpotomy. In both cases, manual morcellation is performed extracorporeally at the extraction site.
- Indications for use: The Alexis® Contained Extraction System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach.
Comparison with the Predicate Device:
The subject and predicate devices are both single use tissue bags intended to retrieve and contain specimen during extracorporeal manual morcellation.
| | Applied Medical Tissue
Containment System
(Predicate Device) | Alexis Contained Extraction
System
(Subject Device) |
|------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
use | To contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation | Same |
| Indications
for use | Used to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation. | Used to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach. |
| Description | Consists of a tissue bag and a guard component. | Consists of a tissue bag and a guard system component. The bag includes tabs and a strap with a snap fastener. |
| Size | Min: 10 cm diameter, 2,500 mL volume
Max: 25 cm diameter, 20,000 mL | Min: 14 cm diameter, 3,400 mL volume
Max: 17 cm diameter, 6,500 mL |
The following table provides a comparison with the predicate:
5
| volume | volume | |
|---|---|---|
| Anatomical | ||
| Site | Bag is inserted and retrieved through | |
| an abdominal incision. | Bag is inserted and retrieved through | |
| an abdominal incision or colpotomy. | ||
| Packaging | ||
| material | Mylar/Tyvek Pouch | Nylon/Tyvek Pouch |
| Sterilization | ||
| method | Radiation sterilization | Ethylene Oxide (EO) sterilization |
These differences in technological characteristics do not raise different questions of safety or effectiveness.
Discussion of Performance Data
The following performance data is provided in support of the substantial equivalence determination.
Biocompatibility
Biocompatibility evaluation of the subject device was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and 2020 FDA guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. " The subject device contacts tissue for less than 24 hours, so the following endpoints were considered, and all materials were found to be biocompatible:
- Cytotoxicity ●
- Intracutaneous Irritation
- Sensitization
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
Sterilization/Shelf Life
Sterilization validation was performed in accordance with ISO 11135 - 2, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
Shelf life testing was performed to evaluate package integrity and device functionality following artificial aging and simulated transit conditioning.
Functional Performance
Design Verification testing was performed with the subject device. The following performance characteristics were evaluated:
- Integrity of tissue bag ●
- Integrity of tether to pull the tissue bag out of the extraction site
- Integrity of the guard system's material to protect the bag from incidental cuts ●
510(k) Summary
6
- Ability of the tissue bag to maintain a closed system ●
- Resistance of tissue bag material to penetration by blood-borne pathogens
- Ability of guard system to remain anchored at the extraction site
- Integrity of tabs and strap to assist in specimen capture
- Ability of snap fastener to withstand insertion and ability of the user to deploy for specimen o capture
Additionally, simulated use testing was performed with the subject device in both an abdominal bench model and a vaginal bench model to ensure that the device would perform as intended. This testing demonstrated the subject device's capability to perform the intended use at the different anatomical sites of insertion and retrieval.
Conclusion:
Results of testing demonstrate that the subject Alexis® Contained Extraction System is substantially equivalent to the predicate Applied Medical Tissue Containment System, and that the subject device is as safe and effective as the predicate device.