(147 days)
The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.
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 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.
The provided text describes the RedEx device, a contained extraction system for tissue removal during surgery, and its comparison to a predicate device to establish substantial equivalence for FDA clearance. However, it does not contain a study that establishes clear acceptance criteria or reports device performance against such criteria in the quantifiable way requested. Instead, it details various performance tests conducted to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot populate the table or answer all sub-questions as requested because the specific acceptance criteria and detailed device performance outcomes are not explicitly stated in the provided text in a quantifiable manner (e.g., sensitivity, specificity, accuracy, or specific thresholds for durability, puncture resistance etc.). The document focuses on demonstrating that the RedEx device performs "as intended" and "as expected" and is "as safe and effective" as the predicate device through various testing, rather than presenting a study with pre-defined, quantifiable acceptance criteria and the RedEx's performance against them.
Here's what can be extracted and what is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document in a quantifiable format. The document states that "In all instances, the RedEx functioned as intended and the results observed were as expected" for the various tests. It also mentions testing areas like "Bag material and seal strength," "Bag material puncture-resistance," "Guard puncture-resistance," "Guard coverage and security," and "Simulated use," but does not provide specific numerical acceptance criteria (e.g., minimum tensile strength, maximum puncture force, minimum coverage percentage) or the corresponding measured performance values for the RedEx device for these tests. The comparison is framed in terms of "Substantial Equivalence," implying that its performance was comparable to the predicate for these aspects.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "Side-by-side testing" and "Additional testing" but does not provide the number of units or cases used in these tests.
- Data Provenance: The document implies the tests were conducted by the manufacturer, Advanced Surgical Concepts Ltd, potentially with independent laboratory assistance for biocompatibility (Toxikon). The data is associated with the device's premarket notification (K211234). There is no mention of country of origin for data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts and qualifications: Not mentioned. The testing described is primarily bench-top and simulated use. There is no mention of human experts establishing ground truth for the performance of the device in a clinical context within this document.
4. Adjudication method for the test set:
- Adjudication method: Not mentioned. Given the nature of the bench and simulated use testing, a formal adjudication method by experts is unlikely to have been part of the evaluation for these specific performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC study: Not applicable/Not mentioned. The device is a contained extraction system (medical device), not an AI-based diagnostic tool for interpretation by human readers. Therefore, an MRMC study or AI-related improvement metrics are not relevant or discussed in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone algorithm performance: Not applicable/Not mentioned. This is not an AI-driven device.
7. The type of ground truth used:
- Type of ground truth: For the performance tests listed (e.g., material strength, puncture resistance, simulated use), the "ground truth" would be established by physical measurements, engineering standards, and functional assessments against design specifications or a predicate device's performance. There is no biological or diagnostic "ground truth" (like pathology or clinical outcomes) being assessed in the context of these specific performance tests described.
8. The sample size for the training set:
- Training set sample size: Not applicable/Not mentioned. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- How ground truth was established for training set: Not applicable/Not mentioned for the same reason as above.
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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.
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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
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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
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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.
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| Substantial Equivalence Information | ||||
|---|---|---|---|---|
| RedExK211234 | Applied MedicalTissueContainmentSystemK142427 | Comparison | Testing | |
| ClinicalFunction | Specimencontainment Bag | Specimencontainment Bag | Simulated usetesting | |
| Guard to protectbag and incision | Guard to protectbag and incision | Same | ||
| Sterility | Sterile, for Singleuse | Sterile, for SingleUse | Same | Validated usingVDmax25 |
| Packaging | Device provided in aTyvek/Polymerpouch | Device provided ina Tyvek/Polymerpouch | Same | Testing carried outfollowing transitsimulation:Bubble-leak testingFunctionality testingPackaging sealtesting |
| Physical Characteristics | ||||
| Bag Size | Volume: 6000mLDimensions: 25cm x36cmOpening RingDiameter: 17.5cm | Volume: 3400mLDimensions: 22cmx 30cmOpening RingDiameter: 14cmVolume: 6500mLDimensions: 27cmx 38cmOpening RingDiameter: 17cm | LargerOpening RingdiameterLarger Bagcapacity | Simulated usetesting |
| BagComposition | Polymer filmmaterialNitinol ring at themouth to open BagFabric tetherattached to ring | Polymer filmmaterialPolymer ring at themouth to open bagString tetherattached to ring | DifferentRing, Bag andretrievaltethermaterials | Bag seal strengthtesting (standalone& comparative)Bag puncture-resistance testing(comparative)Tether strengthtestingBiocompatibilitytestingBacterialpenetration testing |
| Guard | Guard with anchorring, sleeve andadjustable petalsActuated/retractedby rolling down theRolling Ring | Ratcheted guardstripActuated bypulling open theguard | Differentoverall GuarddesignBoth intendedto maximizeand protect | Simulated usetesting (standalone& comparative)Post-use Bag leak-testingGuard punctureresistance(standalone & |
| Substantial Equivalence Information | ||||
| RedExK211234 | Applied MedicalTissueContainmentSystemK142427 | Comparison | Testing | |
| the incisionarea | comparative)Guard security(comparative)Guard coverage(comparative) | |||
| Opening Ring | Composed of nitinolWelded inside apocket at the mouthof the Bag thatallows for closureFacilitatesspecimenencapsulation | Composed of thickpolymerWelded directly tothe bag and doesnot closeFacilitatesspecimenencapsulation | DifferentmaterialsRing weldedinto a pocketto allow Bagclosure. | Simulated usetesting (standalone& comparative)Ring strengthtesting |
| Use | ||||
| ManualMorcellationProcess | Opening ringexteriorized throughincisionGuard placed inmouth of BagManual morcellationundertaken | Opening ringexteriorizedthrough incisionGuard placed inmouth of bagManualmorcellationundertaken | Same | Simulated use |
| BagIntroductionProcess | Bag provided pre-loaded in Introducerwith Plunger.Delivered through a12mm trocaraccessory.Pneumoperitoneummaintained. | Bag folded beforeinsertionDeployed throughopen incision.Pneumoperitoneum re-establishedafter deployment. | Provided pre-rolled in anIntroducer | Simulated use(standalone &comparative) |
| Incision size | 2.5-6cm | 2.5-4cm | Largerincision lengthrange | Guard coveragetesting(comparative)Guard securitytesting(comparative)Simulated use |
| TissueEncapsulation | Tissue introducedinto open mouth ofBag. | Tissue introducedinto open mouth ofbag.Bag cannot beclosed | Bag is closedbeforeexteriorization | Simulated use(standalone &comparative) |
| Substantial Equivalence Information | ||||
| RedExK211234 | Applied MedicalTissueContainmentSystem | Comparison | Testing | |
| K142427 | ||||
| RedEx Bag can befully closed bypulling on the tether | ||||
| Bag Removal | IFU instructssurgeon to pullupwards onOpening Ring | IFU instructssurgeon to pullupwards onOpening Ring andtether | No use oftether whenremoving | Simulated usetesting (standalone& comparative) |
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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.
§ 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.