(145 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a surgical trocar, with no mention of AI or ML.
No
The device is described as a "single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures," specifically a "Bladeless Trocar" for accessing the abdomen during laparoscopy. Its function is to provide an entry point and maintain insufflation, not to directly treat a medical condition.
No.
Explanation: The device, a bladeless trocar, is described as a single-use medical device providing a port for inserting endoscopic instruments during procedures. Its function is to create and maintain access to the abdomen for surgical instruments, emphasizing gas leakage minimization and constant abdominal pressure, rather than to diagnose medical conditions.
No
The device description clearly outlines a physical, sterile, single-use instrument with components like a sleeve, seals, and a stopcock valve, 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 to "have a port to insert endoscopic instruments for endoscopic procedures." This describes a surgical access device used during a procedure on the patient's body.
- Device Description: The description details a "Bladeless Trocar" used for "access into the abdomen of laparoscopy" to insert surgical instruments. This is a surgical instrument used for creating a port of entry into the body cavity.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the ENPOLE device does not mention any testing of samples or analysis of biological material.
Therefore, the ENPOLE device, as described, is a surgical instrument used for access during endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ENPOLE is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Bladeless Trocar is a sterile single patient use instrument consisting of a sleeve in sizes from 5 mm to 12 mm diameters. The trocar sleeve for the devices contains two seal, an outer integrated self-adjusting seal that accommodates instruments ranging from 5 mm to 12.5 mm in diameter where indicated and an internal seal. Together, these seal minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5 mm trocar sleeve accommodates only 5 mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.
Bladeless trocar is access into the abdomen of laparoscopy that is particular to the insertion of surgical instruments through small incisions. The sleeve penetrated into the intra-abdominal by the obturator is inserted and fixed in the abdominal wall, which is a principle that allows laparoscopy to be performed at a constant abdominal pressure state by keeping it sealed to the outside of the human body.
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)
Test results for: Appearance, Dimension, Air leakage, Seal test, Instrument compatibility test all passed internal standards.
Non-clinical tests performed: Packaging Validation, E.O sterilization Validation, Bioburden Test, E.O gas residue Test, Shelf-Life Test/Real-time Sterility Test, Transport Validation, Biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
June 18, 2024
Yuwonmeditech Co., Ltd. Bae Ji Hyeon Manager, Regulatory Affairs Rm 103, 104, 108, 113, 114, 117, Donghwa Medical Instrument 147-1, Donghwagongdan-ro, Munmak-eup Wonju-si, Gangwon-do 26365 Korea. South
Re: K240196
Trade/Device Name: Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 20, 2024 Received: May 20, 2024
Dear Bae Ji Hyeon :
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.
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.06.18 08:49:59 -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
2
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12)
Indications for Use (Describe)
ENPOLE is a single-use medical device to have a port to insert endoscopic instruments for endoscopic 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
(ENPOLE® Bladeless Trocar)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: 18/01/2024
1. SUBMITTER
Submitter's Name: YUWONMEDITECH CO., LTD. Submitter's Address: 103, 104, 108, 113, 114, 117, Donghwa Medical Instrument Complex, 147-1, Donghwagongdan, Munmak-eup, Wonju-si, Gangwon-do, Korea Telephone Number: +82-33-743-0081 Fax: +82-33-743-0081
2. CONTACT PERSON
Byung-kyu, Park Quality Management Representative
Ji-Hyeon, Bae Manager, Regulatory Affairs
TEL. +82-33-743-0081 E-Mail: bkpark@yuwonmeditech.com, jhbae@yuwonmeditech.com Address: 103, 104, 108, 113, 114, 117, Donghwa Medical Instrument Complex, 147-1, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea
3. DEVICE INFORMATION
Trade Name: ENPOLE® Bladeless Trocar Common Name: Bladeless Trocar Product Code: GCJ Classification Regulation: 21 CFR 876.1500 Device Class: Class II Classification Panel: General and Plastic Surgery
4. PREDICATE DEVICE
The proposed ENPOLE® Bladeless trocars are substantially equivalent to the predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Decision Date |
|---|---|---|---|
| CORE-Trocar | INCORE CO.,LTD. | K211148 | 05/19/2022 |
1
5
5. DEVICE DESCRIPTION
The Bladeless Trocar is a sterile single patient use instrument consisting of a sleeve in sizes from 5 mm to 12 mm diameters. The trocar sleeve for the devices contains two seal, an outer integrated self-adjusting seal that accommodates instruments ranging from 5 mm to 12.5 mm in diameter where indicated and an internal seal. Together, these seal minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5 mm trocar sleeve accommodates only 5 mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation.
Bladeless trocar is access into the abdomen of laparoscopy that is particular to the insertion of surgical instruments through small incisions. The sleeve penetrated into the intra- abdominal by the obturator is inserted and fixed in the abdominal wall, which is a principle that allows laparoscopy to be performed at a constant abdominal pressure state by keeping it sealed to the outside of the human body.
6. INDICATIONS FOR USE
ENPOLE Trocar is a single-use medical device to have a port to insert endoscopic instruments for endoscopic procedures.
7. SUBSTANTIAL EQUIVALENCE
The proposed ENPOLE® Bladeless Trocars have the same technology and functional characteristics as the predicate systems. The intended use, operating principles, performance specifications, sterilization and expiration dating of the subject device are the same as the predicate device.
| Descriptive Information | Subject Device | Predicate Device (K211148) |
|---|---|---|
| Manufacturer | YUWONMEDITECH CO., LTD. | INCORE CO., LTD. |
| Model Name | ENPOLE | CORE-TROCAR |
| Classification | ||
| Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Code | GCJ | GCJ |
| Classification | Class II | Class II |
| Device Classification | ||
| Name | Laparoscope, General & Plastic | |
| Surgery | Laparoscope, General & Plastic | |
| Surgery | ||
| Indications for Use | ENPOLE Trocar is a single-use | |
| medical device to have a port | ||
| to insert endoscopic | ||
| instruments for endoscopic | ||
| procedures. | A single-use medical device to | |
| have a port to insert | ||
| endoscopic instruments for | ||
| endoscopic procedures. | ||
| Compared elements | Cannula | |
| Tip of obturator | Cannula | |
| Tip of obturator |
7.1 Comparison Table
6
| Picture | Image: Medical device | Image: Medical device |
|---|---|---|
| Dimension | Diameter: 5, 10, 11, 12 | |
| mm | Diameter: 2 ~ 12 mm | |
| Length: 60, 75,100 mm | Length: 100 ~ 150 mm | |
| Sterilization | EO Sterilization (S.A.L. 10-6) | EO Sterilization (S.A.L. 10-6) |
| Shelf Life | 5 years | 3 years |
| Single use / Re-use | Single-use | Single-use |
8. PERFORMANCE DATA
| Test | Criteria | Standard | Result |
|---|---|---|---|
| Appearance | Internal standard | Internal standard | Pass |
| Dimension | Internal standard | Internal standard | Pass |
| Air leakage | Internal standard | Internal standard | Pass |
| Seal test | Internal standard | Internal standard | Pass |
| Instrument compatibility test | Internal standard | Internal standard | Pass |
9. NON-CLINICAL TEST
- Packaging Validation -
- -E.O sterilization Validation
- -Bioburden Test, E.O gas residue Test
- -Shelf-Life Test/Real-time Sterility Test
- Transport Validation -
- Biocompatibility -
10. Conclusion
Based upon the test results, the proposed ENPOLE® Bladeless Trocars are substantially equivalent in performance to the predicate devices cleared to market via 510(k) K211148. The proposed ENPOLE® Bladeless Trocars do not introduce any new issues of safety and effectiveness.