The EzCatch Tissue Retrieval Bag consists of a long cylindrical tube (Deployer Handpiece) and a polyurethane bag (Tissue Retrieval Bag) that minimizes spillage and intraoperative contamination by isolating and containing specimens. This device is designed for introduction and use through all appropriately sized trocar sleeve (of generally 10mm size). The EzCatch Tissue Retrieval Bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopic pregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowel and other tissue structures.

AI/ML Overview

The medical device in question is the Ez Catch Auto, Ez Catch YR, and Ez Catch TR, which are tissue retrieval bags indicated for use as a receptacle for the collection of tissue, organs, and calculi during general and laparoscopic procedures.

Acceptance Criteria and Device Performance:

The document does not explicitly state acceptance criteria in a table format with corresponding reported device performance metrics for the tested parameters. However, it lists several non-clinical tests performed, implying that the device successfully met the internal criteria for these tests to support a claim of substantial equivalence.

Based on the information provided, here's a table summarizing the tests performed, which indirectly represent areas where the device needed to perform acceptably:

Test/Criteria Category	Reported Device Performance (Implied by successful testing)
Leak Test	Met internal specifications for leak integrity
Force to push out retracted bag test	Met internal specifications for deployment force
Force to withdraw retracted bag test	Met internal specifications for retraction force
Penetration force test	Met internal specifications for resistance to penetration
Tightening Line Tensile Strength Test	Met internal specifications for tensile strength
Retracted Bag Peeling Force Test	Met internal specifications for peeling force
Sterilization validation	Successfully validated for sterilization effectiveness
EO, ECH residues	Levels within acceptable limits
Shelf Life testing	Demonstrated acceptable shelf life
Biocompatibility testing (ISO 10993-1)	Met biocompatibility standards

Study Information:

The document describes a series of non-clinical tests conducted on the subject device to demonstrate its performance and safety, and to support its substantial equivalence to a predicate device (K201243 - Disposable Specimen Retrieval Bag).

Sample sizes used for the test set and the data provenance:
The document does not explicitly state the specific sample sizes used for each of the non-clinical tests (e.g., number of bags tested for the leak test). It only states that "non-clinical tests were performed in the subject device." The data provenance is implied to be from internal testing conducted by the manufacturer, Veol Medical Technologies Pvt Ltd, given the submission is for their device. The tests are "retrospective" in the sense that they were conducted for regulatory submission, not as a prospective clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the non-clinical tests described. Ground truth and expert consensus are typically associated with clinical studies involving human interpretation or pathology, which are not outlined here. The "ground truth" for non-clinical tests would be the established engineering specifications and regulatory standards (e.g., ISO 10993-1).
Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 refer to independent review of cases, typically in clinical studies, to establish ground truth or resolve discrepancies in interpretations. For non-clinical tests, performance is measured against predefined, objective specifications.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The document describes a medical device (tissue retrieval bag), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/algorithm-based device.
The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by established engineering specifications, performance standards, and regulatory requirements (e.g., ISO 10993-1 for biocompatibility). The success of the tests indicates that the device met these objective criteria.
The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set."
How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.

Summary

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April 15, 2024

Veol Medical Technologies Pvt Ltd. % Bruno Milhoci Regulatory Affairs Consultant Passarini Rua Alice Além Saadi, Av. Pres. Castelo Branco, 855 - Sala 2404 Ribeirão Preto, SP 14096-570 Brazil

Re: K240205

Trade/Device Name: Ez Catch Auto; Ez Catch YR; Ez Catch TR Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: January 15, 2024 Received: January 25, 2024

Dear Bruno Milhoci:

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.

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"

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(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 OS 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 (QS) 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. Mark Digitally signed by Mark Trumbore -S Date: 2024.04.15 15:10:38
Trumbore -S - Date: 2024.04.15 15:10:38
2019-04-04 - 04:00: Mark Trumbore, 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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Indications for Use

Submission Number (if known)

Device Name

Ez Catch Auto;

Ez Catch YR;

Ez Catch TR

Indications for Use (Describe)

The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic 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		Prepared on:	2024-04-08
Contact Details			21 CFR 807.92(a)(1)
Applicant Name	Veol Medical Technologies Pvt Ltd.
Applicant Address	A 747, MIDC Pawane, TTC Industrial Area, Kopar Khairane, NaviMumbai, Maharashtra 400705 Navi Mumbai Maharashtra 400705 India
Applicant Contact Telephone	+918552932249
Applicant Contact	Ms. Sneha Pandit
Applicant Contact Email	sp@veolmedtech.com
Correspondent Name	Passarini
Correspondent Address	Rua Alice Além Saadi, Av. Pres. Castelo Branco, 855 - Sala 2404Ribeirão Preto sp 14096-570 Brazil
Correspondent Contact Telephone	+5516982160239
Correspondent Contact	Mr. Bruno Milhoci
Correspondent Contact Email	bruno@passarini.com.br
Device Name			21 CFR 807.92(a)(2)
Device Trade Name	Ez Catch Auto;Ez Catch YR;Ez Catch TR
Common Name	Endoscope and accessories
Classification Name	Laparoscope, General & Plastic Surgery
Regulation Number	876.1500
Product Code(s)	GCJ
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K201243	Disposable Specimen Retrieval Bag	GCJ
Device Description Summary			21 CFR 807.92(a)(4)
The EzCatch Tissue Retrieval Bag consists of a long cylindrical tube (Deployer Handpiece) and a polyurethane bag (TissueRetrieval Bag) that minimizes spillage and intraoperative contamination by isolating and containing specimens. This device is designedfor introduction and use through all appropriately sized trocar sleeve (of generally 10mm size).The EzCatch Tissue Retrieval Bag has application for safe, convenient removal of tissue specimens such as the appendix, an ectopicpregnancy, gallbladder, gallstones, lymph nodes, ovaries, small sections of bowel and other tissue structures.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.

Indications for Use Comparison

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

The indications for use are the same

Technological Comparison

Based on the comparison table above, the subject device and the predicate device are substantially equivament.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The non-clinical tests were performed in the subject device. In total 6 comparative tests were performed: - Leak Test

Force to push out retracted bag test
Force to withdraw retracted bag test
Penetration force test
Tightening Line Tensile Strength Test
Retracted Bag Peeling Force Test
The followinf tests were conducted in the subject device:
Sterilization validation
EO, ECH residues
Shelf Life testing
Biocompatibility testing accoding to ISO10993-1

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent to the predicate devices.

Regulation Number and Section

§ 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.