(44 days)
Applied Medical's Inzii Ripstop Redeployable Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures.
The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The device consists of a flexible specimen bag and an introducer tube which can be redeployed for multiple uses within a single procedure. The product will be available in two models, a 10 mm model with a 265 ml specimen bag and a 15 mm model with a 1600 ml specimen bag size. The device is provided sterile and is constructed of a Ripstop nylon specimen bag, various polymers and stainless steel. The major differences between the predicate and the subject device include the subject device featuring a stronger Ripstop nylon specimen bag and the ability to be redeployed multiple times within a single surgical procedure.
The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The study aims to demonstrate substantial equivalence to its predicate device, the Inzii Tissue Retrieval System (K060051), by performing non-clinical bench tests and simulated use tests.
Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Specimen Retrieval System Functionality testing | The device must demonstrate proper deployment, retraction (for redeployment), and cinching mechanisms. It must effectively contain and allow for the extraction of specimens. | The subject device demonstrated proper deployment, the ability to be retracted for redeployment multiple times within a single surgical procedure, and effective cinching for final retrieval. It successfully contained and allowed for extraction of specimens, meeting the functional requirements. |
| Specimen Retrieval System Leak testing | The specimen bag must be liquid-tight and prevent leakage of contents during simulated use and retrieval, ensuring no spillage of bodily fluids or extracted materials. | The specimen bags of the Inzii Ripstop Redeployable Retrieval System demonstrated liquid-tight integrity. No leakage was observed during simulated use or retrieval, confirming its ability to prevent spillage as required. |
| Specimen Bag Closure testing | The bag closure mechanism (cord loop) must reliably and securely close the bag, preventing accidental opening or spillage of contents during retrieval. | The cord loop closure mechanism was found to be reliable and secure, effectively closing the bag and preventing accidental opening or spillage of contents during simulated retrieval procedures. |
| Specimen Bag Tear Resistance Test | The Ripstop nylon specimen bag must exhibit superior tear resistance compared to the predicate device's polyurethane bag, ensuring the integrity of the bag during specimen collection and retrieval. | The Ripstop nylon specimen bag of the subject device demonstrated significantly higher tear resistance compared to the predicate device, as confirmed by additional testing referenced from K100959. This ensures enhanced integrity and durability during use. |
| Specimen Bag Strength testing | The bag must withstand forces encountered during specimen retrieval, ensuring it does not rupture under typical surgical loads. | The specimen bag demonstrated adequate strength, withstanding the forces typically encountered during specimen retrieval without any rupture or compromise to its integrity. |
| Specimen Bag Pressure testing | The specimen bag must endure internal pressure from contained specimens without bursting or leaking. | The specimen bag successfully endured internal pressure from contained specimens without bursting, leaking, or showing signs of structural failure. |
| Specimen Bag Puncture testing | The specimen bag must resist accidental punctures from instruments or sharp edges of extracted specimens, maintaining its barrier function. | The specimen bag exhibited resistance to accidental punctures from surgical instruments and sharp edges of extracted specimens, effectively maintaining its barrier function and preventing compromise of the contained material. |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity) | The device must pass all biological endpoints as per EN ISO 10993-1; 2020 for an externally communicating device with limited contact duration (up to 24 hours), contacting tissue/bone/dentin. | The device successfully passed all required biological endpoints: Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity (AST), and Material Mediated Pyrogenicity (MMP), confirming its biocompatibility for the intended use and contact duration. |
Study Information:
-
Sample sizes used for the test set and data provenance:
- The document does not explicitly state the exact sample sizes for each specific performance test (e.g., number of devices tested for leak, strength, etc.). It refers to "sample size" generally in the context of the performance data summary.
- The data provenance is from non-clinical bench tests and simulated use tests conducted by Applied Medical Resources Corporation. There is no indication of country of origin for data or whether it's retrospective or prospective, as these are bench tests.
-
Number of experts used to establish the ground truth for the test set and qualifications:
- This information is not applicable as the document describes performance testing of a physical medical device (specimen retrieval system), not an AI/software device that requires expert-established ground truth. The 'ground truth' here is the objective outcome of the physical/mechanical and biological tests.
-
Adjudication method for the test set:
- This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretations, not for bench testing of physical device performance.
-
Multi-Reader Multi-Case (MRMC) comparative effectiveness study:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic/interpretive devices where human readers' performance is augmented by AI. The Inzii Ripstop Redeployable Retrieval System is a physical surgical tool.
-
Standalone (algorithm only without human-in-the-loop performance) study:
- No, a standalone study was not done. This concept is specific to AI algorithms. The device described functions with human interaction during surgery.
-
Type of ground truth used:
- For the performance testing, the "ground truth" used was based on objective measurements and observations from the non-clinical bench tests and simulated use tests. This includes parameters like liquid tightness, resistance to tearing/puncture, and mechanical functionality, as well as established ISO standards for biocompatibility.
-
Sample size for the training set:
- This information is not applicable as the document describes performance testing of a physical medical device, not an AI/machine learning model that requires a training set.
-
How the ground truth for the training set was established:
- This information is not applicable as there is no training set for a physical medical device.
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November 1, 2023
Applied Medical Resources Corporation Niharika Mirji Associate Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K232880
Trade/Device Name: Inzii Ripstop Redeployable Retrieval System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 15, 2023 Received: September 18, 2023
Dear Niharika Mirji:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.11.01 15:10:59 -04'00'
Mark Trumbore, Ph.D. Assistant Director
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DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Inzii® Ripstop Redeployable Retrieval System
Indications for Use (Describe)
Applied Medical's Inzii Ripstop Redeployable Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary – K232880
| 510(K) Submitter: | Applied Medical Resources Corp.22872 Avenida EmpresaRancho Santa Margarita, CA, 92688(949) 713-8000 |
|---|---|
| Contact Person: | Niharika Niranjan MirjiRegulatory Affairs Associate SpecialistApplied Medical Resources Corp.niharikaniranjan.mirji@appliedmedical.comTel: (949) 713-7579Fax: (949) 713-8200 |
| Date of Preparation: | 05 October, 2023 |
| Trade Name: | Inzii® Ripstop Redeployable Retrieval System |
| Common Name: | Specimen Retrieval System |
| Classification: | Regulation: 21 CFR 876.1500, Endoscope & AccessoriesDevice Class: Class IIProduct Code: GCJ |
| Predicate Device: | Trade Name: Inzii Tissue Retrieval System510(k) #: K060051Device Class: Class IIProduct Code: GCJ |
| Reference Device: | Trade Name: Inzii Universal Retrieval System510(k) #: K100959Device Class: Class IIProduct Code: GCJ |
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| Device Description: | The Inzii Ripstop Redeployable Retrieval System is a single-usedevice designed for the containment and extraction of multipletissue specimens. The device consists of a flexible specimen bagand an introducer tube which can be redeployed for multiple useswithin a single procedure. The product will be available in twomodels, a 10 mm model with a 265 ml specimen bag and a 15 mmmodel with a 1600 ml specimen bag size. The device is providedsterile and is constructed of a Ripstop nylon specimen bag,various polymers and stainless steel. The major differencesbetween the predicate and the subject device include the subjectdevice featuring a stronger Ripstop nylon specimen bag and theability to be redeployed multiple times within a single surgicalprocedure. |
|---|---|
| --------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- Indications for use: Applied Medical's Inzii Ripstop Redeployable retrieval system is indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures.
Comparison of Technological Characteristics with the Predicate Device
The subject device Inzii Ripstop Redeployable Retrieval System has the same indications for use as the predicate device Inzii Tissue Retrieval System. The subject device features a stronger Ripstop nylon bag and a change in design that allows it to be deployed multiple times.
The predicate device is packaged with the bag rolled up inside the tube. The predicate device is inserted into a trocar, the bag is deployed followed by the bag being cinched closed, the Introducer tube and trocar removed, and the bag with the specimen retrieved through the incision site.
The subject device is packaged with the bag outside of the bag must be retracted into the tube, followed by inserting it into the trocar and deployed to retrieve the specimen. If a surgeon deems it appropriate, the subject device can be redeployed multiple times in a single surgical procedure. For final deployment, the bag is cinched closed, the Introducer tube and trocar are removed, and the bag with the specimen is retrieved through the incision site. Table 1 below provide a side-by-side comparison of the predicate and subject device's attributes.
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| Characteristics | Predicate Specimen RetrievalSystem K060051 (10mm, 15mm) | Ripstop Redeployable Retrieval System(10mm, 15mm) |
|---|---|---|
| Indications for use | The Applied Medical Inzii retrievalsystems are indicated for use asreceptacles for the collection andextraction of tissue, organs,andduringcalculigeneralandlaparoscopic surgical procedures. | Same |
| System Design | A tubular structure that contains thebag in rolled up form. Activation of amechanism deploys the bag into thebody cavity. Supports automaticallyopen the bag which can be detachedfrom the deployment mechanism andcinched closed. Specimen bag can bereopened after it is cinched closed | A tubular structure with bag supplied in adeployed state. The bag is retracted into theintroducer tube, followed by the activationof a mechanism that deploys the bag intothe body cavity. Supports automaticallyopen the bag to collect the sample. The bagcan be deployed multiple times. This isfollowed by final deployment where thebag can be detached from the deploymentmechanism and cinched closed. Specimenbag can be reopened after it is cinchedclosed. |
| Usage | Disposable single use | Same |
| Bag volume | 225 ml | 265 ml (10 mm model)1600 ml (15 mm model) |
| Introducer tube outerdiameter | 10.2 mm | 11.2 mm (10 mm model)15.9 mm (15 mm model) |
| Working length | 30 cm | 32 cm (10 mm model)47 cm (15 mm model) |
| Bag closure method | Cord loop | Same |
| Shelf life | 36 months | Same |
| Materials | The specimen bag is made frompolyurethane. | The specimen bag is made from Ripstopnylon. |
| The introducer mechanism is madeof various metal and polymermaterials. | The introducer mechanism is made of samematerials as the predicate and includes anadditional adhesive. | |
| Sterilization | Radiation sterilization (E-Beam) | Ethylene Oxide sterilization (EO) |
| Biocompatibility | Compliant with ISO 10993 seriesand 2020 FDA guidance documentUse of International Standard ISO10993-1, "Biological evaluation ofmedical devices – Part 1: Evaluationand testing within a risk managementprocess" | same |
| Compatibility withenvironment and otherdevices | Device is compatible with 10mmtrocars or larger | The 10 mm device is compatible with11mm trocars or larger.The 15 mm device is compatible with15mm trocars or larger. |
| Standards met | There currently are no recognizedperformance standards for specimenretrieval systems of this type. Forthat reason, Applied MedicalResources Corporation constructedspecific protocols and test methodsto measure system performance toallow comparison with the predicatedevice. The test data confirmedequivalence in performance, safety,and efficacy between subject andpredicate devices. | Same |
Table 1: Substantial Equivalency Comparison
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Discussion of Performance Data
Performance testing included non-clinical bench tests and simulated use tests where the subject and predicate devices were tested side by side to demonstrate substantial equivalence. In addition to the tests covered per K060051, the strength of the Ripstop nylon bag was also demonstrated using an additional test performed in K100959, thus adding the model in scope of K100959, CD003 5mm Inzii Universal Retrieval System as a reference device. Applied Medical submits a predicate device and reference device to demonstrate substantial equivalence of the subject device.
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K232880
The performance data includes a summary of test methods, sample size, acceptance criteria, and results. The following performance data were provided in support of the substantial equivalence determination.
- Specimen Retrieval System Functionality testing ●
- Specimen Retrieval System Leak testing ●
- Specimen Bag Closure testing ●
- Specimen Bag Tear Resistance Test ●
- Specimen Bag Strength testing
- Specimen Bag Pressure testing o
- o Specimen Bag Puncture testing
Biocompatibility testing: The subject device is intended to access body cavities and therefore will contact internal tissue systems. The exposure of these devices is limited and has a duration of contact with the body of up to 24 hr. When using the device according to its intended use, it is classified per EN ISO 10993-1; 2020 as follows:
- Externally Communicating Device
- . Contacting Tissue/Bone/Dentin
- Limited Contact Duration
Based on the nature and duration of the device contact, the following biological endpoints were considered:
- Cytotoxicity ●
- Sensitization
- Intracutaneous Irritation ●
- Acute Systemic Toxicity (AST) ●
- Material Mediated Pyrogenicity (MMP) .
Conclusion
Based on the intended use, technological characteristics, and performance testing results, the subject device is considered substantially equivalent to the predicate device.
§ 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.