(147 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and functionality of a physical containment system for surgical tissue. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is designed to contain and isolate tissue during surgical removal or morcellation, not to treat a disease or condition. It is a containment system used as an accessory during surgical procedures.
No
Explanation: The device, RedEx, is a contained extraction system designed to isolate and contain tissue during surgical removal or manual morcellation. Its function is to facilitate the physical removal of tissue, not to diagnose medical conditions.
No
The device description clearly outlines physical components such as a bag, rings, tether, introducer, and guard, and describes their physical interaction and function during a surgical procedure. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "contain[ing] and isolat[ing] tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation." This describes a surgical tool used in vivo (within the body) or for handling tissue ex vivo (outside the body) during a surgical procedure.
- Device Description: The description details a physical containment system with a bag, rings, and a guard, designed for use in laparoscopic surgery. This aligns with a surgical device, not a diagnostic test performed on samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's condition.
- Classification Regulation: The device is proposed under classification regulation 21 CFR 876.1500, which is for "Endoscope and accessories." This regulation is for surgical and examination devices, not IVDs.
- Performance Studies: The performance studies focus on the physical properties and functionality of the device (durability, puncture resistance, microbial barrier, biocompatibility, sterilization), not on the accuracy or reliability of a diagnostic test.
In summary, the RedEx is a surgical containment system, not a device used for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
RedEx is contraindicated for use with laparoscopic power and manual morcellators.
RedEx is contraindicated for use with powered cutting devices (e.g., power morcellator, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
Product codes
GCJ
Device Description
The Advanced Surgical Concepts Ltd, RedEx, is a contained extraction system; proposed under classification regulation 21 CFR 876.1500, device class II and product code GCJ.
The device is provided sterile for single use.
The RedEx consists of a flexible specimen containment Bag, with an integrated Opening Ring and Bag Tether and a separate Guard component to protect the Bag and incision.
The Bag is made from polyurethane (PU) film and comes preloaded in an Introducer. There is a Plunger to deploy the Bag into the abdominal cavity. Any FDA cleared 12mm trocar may be used as an accessory for device deployment. This is a standard sized trocar for use in laparoscopic surgery. A blue arrow on the Introducer provides the user with the correct orientation for insertion of the Introducer to ensure the Bag is correctly deployed.
After the Bag is ejected from the Introducer into the abdominal cavity, the mouth of the Bag returns to its original circular shape. The nitinol wire Opening Ring facilitates placement of the specimen in the Bag. When the specimen is encapsulated and ready for removal or extracorporeal manual morcellation the Bag Tether is pulled, closing the Bag. The Bag Tether and Opening Ring exit through the 12mm trocar, indicating the Bag is fully closed. The incision is then increased to the required size, 2.5-6cm, prior to removal of the trocar is removed, and the mouth of the Bag is opened outside the abdomen. The free end of the Guard. which includes the Guard Petals and is opposite the end with the Guard Ring, is then inserted through the mouth of the Bag followed by the Anchor Ring. The Guard is actuated by flipping the Rolling Ring inward until the incision is maximized. The Guard Petals, which are made from a tough polyethylene (PE) film, overlap and conform to the incision; protecting the incision and Bag material from inadvertent scalpel strikes and from the traumatic graspers that are used to grasp and hold the tissue specimen at the incision.
The physician then performs extracorporeal manual morcellation using manual surgical instruments (e.g., a grasper and a scalpel). When the tissue specimen has been removed, the surgeon flips the Rolling Ring in the opposite direction two or three times and pulls on the Removal Ribbon to remove the Guard. The Bag is removed by grasping the Opening Ring and carefully removing the Bag from the incision.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity, pelvic cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician/surgeon, surgical setting
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)
Substantial Equivalence Testing: Side-by-side testing was carried out on both the subject and predicate devices to demonstrate substantial equivalence. The tests primarily focused on the durability of the containment bags and the performance of the guard components. Testing included:
- Bag material and seal strength
- Bag material puncture-resistance
- Guard puncture-resistance
- Guard coverage and security
- Simulated use
Functionality Testing: Additional testing was carried out on the subject device its performance. Testing included:
- Microbial barrier testing
- Component durability testing
- Bench-top simulated use (with post-use leak testing)
- Simulated clinical use (with post-use leak testing)
- Human factors testing
- Packaging performance testing
- Stability testing
Biocompatibility: Evaluation of the biocompatibility of RedEx was carried out as per IS EN ISO 10993-1 Biological Evaluation of Medical Devices. The following biocompatibility testing was carried out by an independent laboratory (Toxikon):
- MTT Cytotoxicity test
- Intracutaneous Injection Test
- Kligman Maximization Test
All materials were found to be biocompatible.
Sterilization: ASC completed a sterilization validation using the standard VDmax 25 gamma radiation method as per ANSI/AAMI/ISO 11137-2: Sterilization of Health Care Products – Radiation – Establishing the sterilization dose - Method VDmax.
Key results: In all instances, the RedEx functioned as intended and the results observed were as expected.
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
§ 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.
0
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September 17, 2021
Advanced Surgical Concepts Ltd % Jonathan Kahan Partner Hogan Lovells US LLP Columbia Square, 555 Thirteenth Street, NW Washington, District of Columbia 20004
Re: K211234
Trade/Device Name: RedEx Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 20, 2021 Received: August 20, 2021
Dear Jonathan Kahan:
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/cfpm/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.
1
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 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 (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,
Long Chen, 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
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510(k) Number (if known)
Device Name
RedEx
Indications for Use (Describe)
The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
RedEx is contraindicated for use with laparoscopic power and manual morcellators.
RedEx is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Advanced Surqical Concepts Ltd's RedEx
Submitter
| Advanced Surgical Concepts Ltd | |
|---|---|
| Unit 4 Sunnybank Center | |
| Upper Dargle Road | |
| Bray | |
| County Wicklow | |
| A98 E339 | |
| Ireland |
| Phone: | +353 1 286 4777 |
|---|---|
| Facsimile: | +353 1 286 4776 |
| Contact Person: | Edward Hyland |
|---|---|
| ----------------- | --------------- |
| Date Prepared: | August 20, 2021 |
|---|---|
| ---------------- | ----------------- |
| Name of Device: | RedEx |
|---|---|
| Common or Usual Name: | Tissue Bag |
| Classification: | 21 CFR 876.1500, Accessory to Endoscope |
| Regulatory Class: | Class II |
| Product Code: | GCJ |
| Predicate Devices: | Applied Medical Resources Corporation's Applied Medical Tissue Containment System (K142427) a/k/a Alexis CES |
Device Description
The Advanced Surgical Concepts Ltd, RedEx, is a contained extraction system; proposed under classification regulation 21 CFR 876.1500, device class II and product code GCJ.
The device is provided sterile for single use.
The RedEx consists of a flexible specimen containment Baq, with an integrated Opening Ring and Bag Tether and a separate Guard component to protect the Bag and incision.
The Bag is made from polyurethane (PU) film and comes preloaded in an Introducer. There is a Plunger to deploy the Bag into the abdominal cavity. Any FDA cleared 12mm trocar may be used as an accessory for device deployment. This is a standard sized trocar for use in laparoscopic surgery. A blue arrow on the Introducer provides the user with the correct orientation for insertion of the Introducer to ensure the Bag is correctly deployed.
After the Baq is ejected from the Introducer into the abdominal cavity, the mouth of the Bag returns to its original circular shape. The nitinol wire Opening Ring facilitates placement of the specimen in the Bag. When the specimen is encapsulated and ready for removal or extracorporeal manual morcellation the Bag Tether is pulled, closing the Bag. The Bag Tether and Opening Ring exit through the 12mm trocar, indicating the Bag is fully closed. The incision is then increased to the required size, 2.5-6cm, prior to removal of the trocar is removed, and the mouth of the Bag is opened outside the abdomen. The free end of the Guard. which includes the Guard Petals and is opposite the end with the Guard Ring, is then inserted
4
through the mouth of the Bag followed by the Anchor Ring. The Guard is actuated by flipping the Rolling Ring inward until the incision is maximized. The Guard Petals, which are made from a tough polyethylene (PE) film, overlap and conform to the incision; protecting the incision and Bag material from inadvertent scalpel strikes and from the traumatic graspers that are used to grasp and hold the tissue specimen at the incision.
The physician then performs extracorporeal manual morcellation using manual surgical instruments (e.g., a grasper and a scalpel). When the tissue specimen has been removed, the surgeon flips the Rolling Ring in the opposite direction two or three times and pulls on the Removal Ribbon to remove the Guard. The Bag is removed by grasping the Opening Ring and carefully removing the Bag from the incision.
Intended Use / Indications for Use
The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
Contraindications:
RedEx is contraindicated for use with laparoscopic power and manual morcellators.
RedEx is contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
Comparison of Technological Characteristics with the Predicate Device:
The subject and predicate devices are both tissue containment bags intended to retrieve and contain specimens during manual morcellation. Both devices are wholly inserted into the abdominal or pelvic cavity prior to specimen placement in the bag. If the specimen requires morcellation, both bags are brought up to the incision prior to manual morcellation.
The subject and predicate devices are based on the following identical technological elements:
- . A specimen bag with an attached ring that opens once deployed in the abdominal cavity to aid encapsulation of the specimen for removal and/or extracorporeal manual morcellation at the incision site.
- o A baq tether, attached to the bag and which remains external to the abdominal cavity, for exteriorization of the mouth of the bag to facilitate extracorporeal manual morcellation.
- A guard that maximizes the incision to allow for removal and/or extracorporeal manual morcellation at the incision site.
The following technological differences exist between the subject and predicate devices:
- . The method of insertion of the bag into the abdominal cavity
- . The quard technology; although the purpose of both quards is the same, the technology is different
- Use of different materials as described in the substantial equivalence information table. ●
Performance Data
Substantial Equivalence Testing
5
Side-by-side testing was carried out on both the subject and predicate devices to demonstrate substantial equivalence. The tests primarily focused on the durability of the containment bags and the performance of the guard components. Testing included:
- Bag material and seal strength
- o Baq material puncture-resistance
- Guard puncture-resistance ●
- Guard coverage and security
- Simulated use
Functionality Testing
Additional testing was carried out on the subject device its performance. Testing included:
- Microbial barrier testing .
- . Component durability testing
- Bench-top simulated use (with post-use leak testing) ●
- Simulated clinical use (with post-use leak testing)
- Human factors testing
- Packaging performance testing ●
- Stability testing o
Biocompatibility
The subject device is a device that is in contact with tissue for a period of less than 24 hours. Evaluation of the biocompatibility of RedEx was carried out as per IS EN ISO 10993-1 Biological Evaluation of Medical Devices. The following biocompatibility testing was carried out by an independent laboratory (Toxikon):
- MTT Cytotoxicity test
- Intracutaneous Injection Test
- Kligman Maximization Test o
All materials were found to be biocompatible.
Sterilization
ASC completed a sterilization validation using the standard VDmax 25 gamma radiation method as per ANSI/AAMI/ISO 11137-2: Sterilization of Health Care Products – Radiation – Establishing the sterilization dose - Method VDmax
In all instances, the RedEx functioned as intended and the results observed were as expected.
6
| Substantial Equivalence Information | ||||
|---|---|---|---|---|
| RedEx | ||||
| K211234 | Applied Medical | |||
| Tissue | ||||
| Containment | ||||
| System | ||||
| K142427 | Comparison | Testing | ||
| Clinical | ||||
| Function | Specimen | |||
| containment Bag | Specimen | |||
| containment Bag | Simulated use | |||
| testing | ||||
| Guard to protect | ||||
| bag and incision | Guard to protect | |||
| bag and incision | Same | |||
| Sterility | Sterile, for Single | |||
| use | Sterile, for Single | |||
| Use | Same | Validated using | ||
| VDmax25 | ||||
| Packaging | Device provided in a | |||
| Tyvek/Polymer | ||||
| pouch | Device provided in | |||
| a Tyvek/Polymer | ||||
| pouch | Same | Testing carried out | ||
| following transit | ||||
| simulation: | ||||
| Bubble-leak testing | ||||
| Functionality testing | ||||
| Packaging seal | ||||
| testing | ||||
| Physical Characteristics | ||||
| Bag Size | Volume: 6000mL | |||
| Dimensions: 25cm x | ||||
| 36cm | ||||
| Opening Ring | ||||
| Diameter: 17.5cm | Volume: 3400mL | |||
| Dimensions: 22cm | ||||
| x 30cm | ||||
| Opening Ring | ||||
| Diameter: 14cm | ||||
| Volume: 6500mL | ||||
| Dimensions: 27cm | ||||
| x 38cm | ||||
| Opening Ring | ||||
| Diameter: 17cm | Larger | |||
| Opening Ring | ||||
| diameter | ||||
| Larger Bag | ||||
| capacity | Simulated use | |||
| testing | ||||
| Bag | ||||
| Composition | Polymer film | |||
| material | ||||
| Nitinol ring at the | ||||
| mouth to open Bag | ||||
| Fabric tether | ||||
| attached to ring | Polymer film | |||
| material | ||||
| Polymer ring at the | ||||
| mouth to open bag | ||||
| String tether | ||||
| attached to ring | Different | |||
| Ring, Bag and | ||||
| retrieval | ||||
| tether | ||||
| materials | Bag seal strength | |||
| testing (standalone | ||||
| & comparative) | ||||
| Bag puncture- | ||||
| resistance testing | ||||
| (comparative) | ||||
| Tether strength | ||||
| testing | ||||
| Biocompatibility | ||||
| testing | ||||
| Bacterial | ||||
| penetration testing | ||||
| Guard | Guard with anchor | |||
| ring, sleeve and | ||||
| adjustable petals | ||||
| Actuated/retracted | ||||
| by rolling down the | ||||
| Rolling Ring | Ratcheted guard | |||
| strip | ||||
| Actuated by | ||||
| pulling open the | ||||
| guard | Different | |||
| overall Guard | ||||
| design | ||||
| Both intended | ||||
| to maximize | ||||
| and protect | Simulated use | |||
| testing (standalone | ||||
| & comparative) | ||||
| Post-use Bag leak- | ||||
| testing | ||||
| Guard puncture | ||||
| resistance | ||||
| (standalone & | ||||
| Substantial Equivalence Information | ||||
| RedEx | ||||
| K211234 | Applied Medical | |||
| Tissue | ||||
| Containment | ||||
| System | ||||
| K142427 | Comparison | Testing | ||
| the incision | ||||
| area | comparative) | |||
| Guard security | ||||
| (comparative) | ||||
| Guard coverage | ||||
| (comparative) | ||||
| Opening Ring | Composed of nitinol | |||
| Welded inside a | ||||
| pocket at the mouth | ||||
| of the Bag that | ||||
| allows for closure | ||||
| Facilitates | ||||
| specimen | ||||
| encapsulation | Composed of thick | |||
| polymer | ||||
| Welded directly to | ||||
| the bag and does | ||||
| not close | ||||
| Facilitates | ||||
| specimen | ||||
| encapsulation | Different | |||
| materials | ||||
| Ring welded | ||||
| into a pocket | ||||
| to allow Bag | ||||
| closure. | Simulated use | |||
| testing (standalone | ||||
| & comparative) | ||||
| Ring strength | ||||
| testing | ||||
| Use | ||||
| Manual | ||||
| Morcellation | ||||
| Process | Opening ring | |||
| exteriorized through | ||||
| incision | ||||
| Guard placed in | ||||
| mouth of Bag | ||||
| Manual morcellation | ||||
| undertaken | Opening ring | |||
| exteriorized | ||||
| through incision | ||||
| Guard placed in | ||||
| mouth of bag | ||||
| Manual | ||||
| morcellation | ||||
| undertaken | Same | Simulated use | ||
| Bag | ||||
| Introduction | ||||
| Process | Bag provided pre- | |||
| loaded in Introducer | ||||
| with Plunger. | ||||
| Delivered through a | ||||
| 12mm trocar | ||||
| accessory. | ||||
| Pneumoperitoneum | ||||
| maintained. | Bag folded before | |||
| insertion | ||||
| Deployed through | ||||
| open incision. | ||||
| Pneumoperitoneu | ||||
| m re-established | ||||
| after deployment. | Provided pre- | |||
| rolled in an | ||||
| Introducer | Simulated use | |||
| (standalone & | ||||
| comparative) | ||||
| Incision size | 2.5-6cm | 2.5-4cm | Larger | |
| incision length | ||||
| range | Guard coverage | |||
| testing | ||||
| (comparative) | ||||
| Guard security | ||||
| testing | ||||
| (comparative) | ||||
| Simulated use | ||||
| Tissue | ||||
| Encapsulation | Tissue introduced | |||
| into open mouth of | ||||
| Bag. | Tissue introduced | |||
| into open mouth of | ||||
| bag. | ||||
| Bag cannot be | ||||
| closed | Bag is closed | |||
| before | ||||
| exteriorization | Simulated use | |||
| (standalone & | ||||
| comparative) | ||||
| Substantial Equivalence Information | ||||
| RedEx | ||||
| K211234 | Applied Medical | |||
| Tissue | ||||
| Containment | ||||
| System | Comparison | Testing | ||
| K142427 | ||||
| RedEx Bag can be | ||||
| fully closed by | ||||
| pulling on the tether | ||||
| Bag Removal | IFU instructs | |||
| surgeon to pull | ||||
| upwards on | ||||
| Opening Ring | IFU instructs | |||
| surgeon to pull | ||||
| upwards on | ||||
| Opening Ring and | ||||
| tether | No use of | |||
| tether when | ||||
| removing | Simulated use | |||
| testing (standalone | ||||
| & comparative) |
7
8
Conclusions
RedEx is as safe and effective as the Applied Medical Tissue Containment System/Alexis CES. RedEx has the same intended use and indications, and similar technological characteristics and principles of operation as its predicate device. In addition, the minor technological differences between RedEx and its predicate device raise no new issues of safety or effectiveness. Thus, RedEx is substantially equivalent.