(44 days)
No
The 510(k) summary describes a mechanical surgical device for tissue retrieval and extraction. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance testing focuses on mechanical properties and functionality.
No
The device is described as a receptacle for collecting and extracting tissue, not for treating a disease or condition.
No
The device is described as a receptacle for the collection and extraction of tissue, organs, and calculi during surgical procedures, not for diagnostic purposes.
No
The device description clearly states it is a physical device consisting of a specimen bag, introducer tube, and is constructed of materials like Ripstop nylon, polymers, and stainless steel. It is a hardware device used in surgical procedures.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures." This describes a device used during a surgical procedure to physically remove specimens from the body.
- Device Description: The description details a physical bag and introducer tube for containing and extracting specimens. It doesn't mention any components or processes related to testing or analyzing biological samples outside of the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
This device is a surgical tool for specimen retrieval, not a diagnostic device that performs tests on samples.
N/A
Intended Use / 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.
Product codes
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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
- 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)
Based on the intended use, technological characteristics, and performance testing results, the subject device is considered substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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
3
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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4
510(k) Summary – K232880
| 510(K) Submitter: | Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Niharika Niranjan Mirji
Regulatory Affairs Associate Specialist
Applied Medical Resources Corp.
niharikaniranjan.mirji@appliedmedical.com
Tel: (949) 713-7579
Fax: (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 & Accessories
Device Class: Class II
Product Code: GCJ |
| Predicate Device: | Trade Name: Inzii Tissue Retrieval System
510(k) #: K060051
Device Class: Class II
Product Code: GCJ |
| Reference Device: | Trade Name: Inzii Universal Retrieval System
510(k) #: K100959
Device Class: Class II
Product Code: GCJ |
5
| Device Description: | 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. |
| --------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- 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.
6
| Characteristics | Predicate Specimen Retrieval
System K060051 (10mm, 15mm) | Ripstop Redeployable Retrieval System
(10mm, 15mm) |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Applied Medical Inzii retrieval
systems are indicated for use as
receptacles for the collection and
extraction of tissue, organs,
and
during
calculi
general
and
laparoscopic surgical procedures. | Same |
| System Design | A tubular structure that contains the
bag in rolled up form. Activation of a
mechanism deploys the bag into the
body cavity. Supports automatically
open the bag which can be detached
from the deployment mechanism and
cinched closed. Specimen bag can be
reopened after it is cinched closed | A tubular structure with bag supplied in a
deployed state. The bag is retracted into the
introducer tube, followed by the activation
of a mechanism that deploys the bag into
the body cavity. Supports automatically
open the bag to collect the sample. The bag
can be deployed multiple times. This is
followed by final deployment where the
bag can be detached from the deployment
mechanism and cinched closed. Specimen
bag can be reopened after it is cinched
closed. |
| Usage | Disposable single use | Same |
| Bag volume | 225 ml | 265 ml (10 mm model)
1600 ml (15 mm model) |
| Introducer tube outer
diameter | 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 from
polyurethane. | The specimen bag is made from Ripstop
nylon. |
| | The introducer mechanism is made
of various metal and polymer
materials. | The introducer mechanism is made of same
materials as the predicate and includes an
additional adhesive. |
| Sterilization | Radiation sterilization (E-Beam) | Ethylene Oxide sterilization (EO) |
| Biocompatibility | Compliant with ISO 10993 series
and 2020 FDA guidance document
Use of International Standard ISO
10993-1, "Biological evaluation of
medical devices – Part 1: Evaluation
and testing within a risk management
process" | same |
| Compatibility with
environment and other
devices | Device is compatible with 10mm
trocars or larger | The 10 mm device is compatible with
11mm trocars or larger.
The 15 mm device is compatible with
15mm trocars or larger. |
| Standards met | There currently are no recognized
performance standards for specimen
retrieval systems of this type. For
that reason, Applied Medical
Resources Corporation constructed
specific protocols and test methods
to measure system performance to
allow comparison with the predicate
device. The test data confirmed
equivalence in performance, safety,
and efficacy between subject and
predicate devices. | Same |
Table 1: Substantial Equivalency Comparison
7
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.
8
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.