(81 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a tissue retrieval bag, with no mention of AI or ML capabilities.
No
The device is described as a receptacle for collecting tissue and other specimens during surgical procedures, not as a device that delivers therapy or treatment. Its function is for retrieval and containment.
No
The device is described as a bag for collecting tissue, organs, and calculi during surgical procedures, and is used for the removal of specimens. Its function is to contain and retrieve, not to diagnose.
No
The device description clearly outlines physical components (cylindrical tube, polyurethane bag) and the performance studies focus on physical properties and testing (leak test, force tests, sterilization, biocompatibility), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of tissue, organs, and calculi during surgical procedures (general and laparoscopic). This is a surgical tool used in vivo (within the body) to retrieve specimens.
- Device Description: The description details a physical bag and deployer used for containing and removing specimens from the body.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a patient's health. They typically involve reagents, analyzers, or other components for testing and analysis. This device does not perform any such testing or analysis.
The device is a surgical instrument for specimen retrieval, not a diagnostic tool used for testing specimens.
N/A
Intended Use / Indications for Use
The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
Product codes
GCJ
Device Description
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 following 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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"
1
(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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3
| 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, Navi | ||
| Mumbai, 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 2404 | ||
| Ribeirão 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 (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. |
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
4
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.