(235 days)
The provided text states "Reference Device(s) Not Found". Therefore, there are no reference devices to list.
No
The device description and performance studies focus on the mechanical and material properties of a disposable surgical trocar, with no mention of AI or ML capabilities.
No
The device is a surgical instrument used to establish a path of entry for other endoscopic instruments during minimally invasive procedures. It does not directly provide therapy or treatment.
No
This device is a surgical instrument (trocar) designed to create a path of entry for other endoscopic instruments during minimally invasive procedures. Its purpose is to facilitate access rather than to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components (sleeve, obturator, seals, stopcock valve) and the performance studies focus on physical properties, biocompatibility, and sterilization of these physical components. There is no mention of software as a component or function of the device.
Based on the provided information, the Monik™ - Disposable Endoscopic Trocar is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is used in surgical procedures to establish a path of entry for endoscopic instruments. This is a surgical tool used in vivo (within the body).
- Device Description: The description details a physical instrument (trocar, sleeve, obturator, seals, stopcock valve) used for surgical access and gas management.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, tissue, or other bodily fluids, to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on physical properties, biocompatibility, sterilization, packaging, and shelf life, which are typical for surgical devices, not IVDs.
IVD devices are designed to perform tests on samples taken from the body to provide diagnostic information. The Monik™ Trocar is a surgical instrument used to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
The Monik™ - Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
Product codes
GCJ
Device Description
The Disposable Endoscopic Trocar is sterile single patient use instrument consisting of a radiolucent sleeve and obturator in sizes 5mm, 10mm, 12mm long and 15mm diameter. The obturator contains a clear tapered optical element. The 10mm, 12mm diameter obturators accommodate an appropriately sided 0° endoscope and provide visibility of individual tissue layers during insertion. The trocar sleeves for the 5 mm, 10 mm, 12mm, 12mm long and 15 mm devices contain two seals. An outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 mm to 15 mm in diameter where indicated and an internal seal. Together these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, thoracic, gynecologic
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)
Performance Tests: The Monik™ Disposable Endoscopic Trocar was subjected to performance testing and biocompatibility testing of the Trocar material in accordance with EN ISO 10993-1.2020. Evaluated for: Dimensions, Fitness Property, Confirmation firmness test, Flexibility, Air blocking & sealing test, Trocar puncture & removal test, Sterility USP , Biocompatibility as per ISO 10993-1.
Biocompatibility: Evaluation conducted in accordance with Guidance document 'Use of International Standard ISO 10993-1, ''Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" September 8, 2023 and International Standards ISO 10993-1 "Biological evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process". Tests performed: In vitro cytotoxicity test, Skin sensitization test, Intracutaneous reactivity test. Test results suggest the subject device is biocompatible.
Sterilization: Monik™ Trocar is sterilized by Ethylene Oxide Method as per EN ISO 11135:2014. The validation used an overkill (half-cycle approach) method in a fixed chamber, demonstrating a sterility assurance level of 10⁻⁶. Ethylene oxide residuals were tested and met ISO 10993-7 requirements.
Packaging & Shelf life: Packaging validation as per ISO 11607, Shelf life validation as per ICH Q1A (R2) & ISO 11607, Transportation Study as per ASTM D 999 & ASTM D 5276.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sterility assurance level of 10⁻⁶.
Maximum residual levels after Ethylene Oxide sterilization:
- Ethylene Oxide: 4 mg in first 24 hr & 60 mg in first 30d
- Ethylene Chlorohydrins: 9 mg in first 24 hr & 60 mg in first 30d
- Ethylene Glycol: 9 mg in first 24 hr & 60 mg in first 30d
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the words "U.S. FOOD & DRUG ADMINISTRATION" stacked below it.
May24, 2024
M/s. Meril Endo Surgery Private Limited. Chetan Patel Manager - Regulatory Affairs Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala Vapi. Gujarat 396191 India
Re: K233386
Trade/Device Name: Monik™ - Disposable Endoscopic Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 28, 2023 Received: October 2, 2023
Dear Chetan Patel:
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 (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" (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).
1
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 medical devices and radiation-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 Long H. Chen
Long H. Chen -S-s
Date: 2024.05.24 08:23:11 -04'00'
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 Ouality Center for Devices and Radiological Health
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3
Indications for Use
Submission Number (if known)
Device Name
Monik™ - Disposable Endoscopic Trocar
Indications for Use (Describe)
The Monik™ - Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
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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Image /page/4/Picture/3 description: The image contains the logo for Meril Endo Surgery. The logo features the word "Meril" in a sans-serif font, with a small yellow dot above the "i". The text "Endo Surgery" is written in a larger, bold, sans-serif font below the logo.
I. SUBMITTER
M/s. Meril Endo Surgery Private Limited. Third Floor, E1 – E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi – 396191 Gujarat, India. Tel. No: +91-260-3052100, Fax: +91-260-3052125 Web site: www.merillife.com
Applicant Information
Mr. Umesh Sharma
General Manager – Quality Assurance / Regulatory Affairs
E-mail: umesh.sharma@merillife.com
Primary Correspondent Information
Chetan Patel Manager – Regulatory Affairs E-mail: chetan.patel@merillife.com
Date Prepared: September 30tt, 2023
II. SUBJECT DEVICE
| Trade / Proprietary Name | Monik™ - Disposable Endoscopic Trocar | |
|---|---|---|
| Common Name | Disposable Endoscopic Trocar | |
| Classification | Endoscope and Accessories | |
| Regulatory Class | II | |
| Product Code | GCJ | |
| Regulation Number | 21 CFR Part 876.1500 | |
| Review Panel | General & Plastic Surgery |
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Image /page/5/Picture/3 description: The image contains a logo for a company called "Meril Endo Surgery". The word "Meril" is in a large, sans-serif font and is white against a blue background. There is a small yellow dot above the "i" in "Meril". Below the blue rectangle, the words "Endo Surgery" are written in a smaller, gray, sans-serif font.
III. PREDICATE DEVICE
| Subject device | Predicate device | ||
|---|---|---|---|
| Trade Name | Manufacturer | 510 (K) No. | |
| MonikTM - Disposable | |||
| Endoscopic Trocar | ENDOPATH® III Bladeless | ||
| Trocars (Primary Predicate) | Ethicon Endo-Surgery, Inc. | K032676 | |
| Disposable Bladeless Trocar | Changzhou Xin Neng Yuan | ||
| Medical Stapler Co., Ltd | K190029 |
IV. Device Description
The Disposable Endoscopic Trocar is sterile single patient use instrument consisting of a radiolucent sleeve and obturator in sizes 5mm, 10mm, 12mm long and 15mm diameter. The obturator contains a clear tapered optical element. The 10mm, 12mm diameter obturators accommodate an appropriately sided 0° endoscope and provide visibility of individual tissue layers during insertion. The trocar sleeves for the 5 mm, 10 mm, 12mm, 12mm long and 15 mm devices contain two seals. An outer integrated removable self-adjusting seal that accommodates instruments ranging from 5 mm to 15 mm in diameter where indicated and an internal seal. Together these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.
V. Indications for Use
The Disposable Endoscopic Trocar has applications in abdominal, thoracic and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
VI. Substantial Equivalence
The Monik™ Trocar is substantially equivalent to marketed predicate device with respect to intended use and technological characteristics. The Monik™ Trocar operates on the same principle as predicate devices. The results demonstrated that the subject device is as safe and as effective as the predicates. Substantial equivalence is based on the following parameters:
-
- Intended use
-
- Principle of Operation
-
- Product design
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Image /page/6/Picture/3 description: The image shows the logo for Meril Endo Surgery. The logo consists of the word "Meril" in a white sans-serif font, with two small circles above the "i", one yellow and one white. The word "Meril" is set against a blue background. Below the blue rectangle is the text "Endo Surgery" in a gray sans-serif font.
-
- Single use
-
- Sterilisation method
-
- Packaging
-
- Performance
-
- Biocompatibility
VII. Preclinical Data
Performance Tests
The Monik™ Disposable Endoscopic Trocar was subjected to the performance testing and biocompatibility testing of the Trocar material in accordance to EN ISO 10993-1.2020 has been performed to further ensure substantial equivalence to the predicate devices. The safety and effectiveness of the Monik™ Disposable Endoscopic Trocar has been evaluated for the following performance and safety requirements.
-
- Dimensions
- Fitness Property 2.
- Confirmation firmness test 3.
-
- Flexibility
-
- Air blocking & sealing test
-
- Trocar puncture & removal test
-
- Sterility USP
-
- Biocompatibility as per ISO 10993-1
Biocompatibility
The biocompatibility evaluation for Monik™ Trocar was conducted in accordance with Guidance document 'Use of International Standard ISO 10993-1, ''Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" September 8, 2023 and International Standards ISO 10993-1 "Biological evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process" as recognized by FDA. Based on attachment A (Table A.1) of the FDA guidance, following tests were identified and performed.
- In vitro cytotoxicity test
- Skin sensitization test
- Intracutaneous reactivity test
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Image /page/7/Picture/3 description: The image features the logo for Meril Endo Surgery. The logo consists of the word "Meril" in a clean, sans-serif font, with a light blue background. Above the "i" in Meril are two small circles, one white and one yellow. Below the blue square is the text "Endo Surgery" in a gray, sans-serif font.
The test results suggest that the subject device is biocompatible.
Sterilization
Monik™ Trocar is sterilized by Ethylene Oxide Method as per EN ISO 11135:2014. (Medical Devices -Validation & Routine Control of Ethylene Oxide Sterilization.
The Ethylene oxide sterilization process is validated as per ISO 11135. The method used for ethylene oxide sterilization validation was overkill (half-cycle approach) method in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7 requirements.
The sterilization processes have demonstrated a sterility assurance level of 10 °.
The maximum residual levels after Ethylene Oxide sterilization are as under.
- Ethylene Oxide: 4 mg in first 24 hr & 60 mg in first 30d
- . Ethylene Chlorohydrins: 9 mg in first 24 hr & 60 mg in first 30d
- . Ethylene Glycol: 9 mg in first 24 hr & 60 mg in first 30d
Packaging & Shelf life
Following packaging and shelf life study was conducted to ensure package integrity throughout the shelf life.
- . Packaging validation as per ISO 11607
- Shelf life validation as per ICH Q1A (R2) & ISO 11607 .
- . Transportation Study as per ASTM D 999 & ASTM D 5276
VIII. Conclusion
Monik™ Disposable Endoscopic Trocar is substantially equivalent to currently marketed device and present no substantial differences in design, material, intended use and function to predicate device. The performance, biocompatibility, sterilization, packaging and shelf life study conducted on Monik™ Disposable Endoscopic Trocar demonstrated the device is as safe and as effective as the predicate device. Hence, Monik™ Disposable Endoscopic Trocar will perform as intended in the specified use conditions.