K232062 · Dalim Medical Corp. · OTJ · Jan 16, 2024 · Gastroenterology, Urology
Device Facts
Record ID
K232062
Device Name
Uni-port
Applicant
Dalim Medical Corp.
Product Code
OTJ · Gastroenterology, Urology
Decision Date
Jan 16, 2024
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Uni-port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
Device Story
Uni-port is a single-use, manually operated surgical retractor; facilitates access for multiple instruments and/or endoscopes to the abdominal cavity through a single incision. Components include a main body with multiple ports (5mm, 12mm, 15mm, 28mm), a flexible polyurethane wound retractor with two rings for abdominal wall fixation, and a separate filter for gas management. Used in clinical settings by surgeons during laparoscopic procedures. The device provides a stable access point, allowing for instrument manipulation and visualization while maintaining pneumoperitoneum. Benefits include reduced incision count and improved surgical access.
Clinical Evidence
Bench testing only. Testing included shelf-life, biocompatibility (ISO 10993-5 cytotoxicity, ISO 10993-10 sensitization/intracutaneous reactivity, ISO 10993-11 acute systemic toxicity/pyrogens), and mechanical performance (surface, measurement, tensile strength, airtightness, fatigue resistance, extractable substances). Results support substantial equivalence.
Technological Characteristics
Materials: Polyurethane film. Design: Manual surgical retractor with main body, wound retractor, and filter. Ports: 5mm, 12mm, 15mm, 28mm. Sterilization: EO gas. Single-use, disposable. No electronic components or software.
Indications for Use
Indicated for patients undergoing minimally invasive laparoscopic surgery requiring access to the abdominal cavity via a single incision.
Regulatory Classification
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.
Special Controls
*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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 16, 2024
Dalim Medical Corp. Dave Kim Official Correspondent 102-606 and 609(Ho), 397, Seokcheon-ro Bucheon-si, Gyeonggi-do 14449, Korea, South
Re: K232062
Trade/Device Name: Uni-port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OTJ Dated: July 7, 2023 Received: July 11, 2023
Dear Dave Kim:
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" (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).
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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 Mark Mark Trumbore -S Trumbore -S Date: 2024.01.16 12:56:07
> -05'00' 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 ( <i>if known</i> ) | |
|---------------------------------------|--|
|---------------------------------------|--|
K232062
Device Name
Uni-port
Indications for Use (Describe)
The Uni-port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
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 K232062
The following 510(k) summary is being submitted as required by 21 CFR Part 807.92;
| 5.1 Submitter: | Dalim Medical Corp.<br>Address: 102-606&609(Ho), 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do, Republic of Korea (14449)<br>Phone No. +82-32-642-0212<br>Fax No. +82-32-642-0213 |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:<br>(Official Correspondent) | Mtech Group<br>Dave Kim<br>7505 Fannin St. Suite 610, Houston, TX 77054, US<br>Tel: 713-467-2607<br>Email: davekim@mtech-inc.net |
| Date Prepared: | December 11, 2023 |
| 5.2 Device Identification<br>Device Trade Name<br>Model | Uni-port<br>UP01F, UP03F, UP04F, UP01FL, UP03FL, UP04FL,<br>UP04FSP, UP04FSP-A, UP04FSP-B, UP04FSP-C,<br>UP01FV2-D, UP01FLV2-D, UP03FV2-B, UP03FV2-F,<br>UP03FLV2-B, UP03FLV2-F, UP04FV2-B, UP04FV2-F,<br>UP04FLV2-B, UP04FLV2-F, UP03FSV2SP, UP03FSV2SP-<br>A, UP03FV2SP, UP03FV2SP-A, UP03FV2SP-B,<br>UP04FV2SP, UP04FV2SP-A, UP04FV2SP-B |
| Common Name<br>Classification Name, Number<br>Device Classification<br>Product Code | Single Use Manual Operated Surgical Retractor<br>Laparoscope, general & plastic surgery (21 CFR 876.1500)<br>II<br>OTI |
#### 5.3 Predicated or legally marketed devices which are substantially equivalent Predicated device: K141715, "GLOVE PORT", manufactured by "NELIS Corp."
Reference device: K112196, "OCTO™ port", manufactured by Dalim SurgNET Co.
#### 5.4 Device Description
Uni-port is a single use manual operated surgical retractor comprised of three components; main body, wound retractor and filter
The main body consist of combinations of several ports of various size (5mm, 12mm, 15mm and 28mm).
The wound retractor is a flexible polyurethane film that has two rings attached at each end and a Thandle connected with thread for easily removal after procedure. The single (lower) ring is inserted into the abdomen for fixation and double (upper) ring is connected with main body.
The filter is provided separately to filter out harmful gas generated in the abdominal cavity, it is easy to ensure a clear view.
#### 5.5 Statement of Indication for use
The Uni-port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
#### 5.6 Non-clinical Test Conclusion
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The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- Shelf- Life Test
- ISO 10993-5- Cytotoxicity
- ISO 10993-10 Sensitization & Intracutatneous Reactivity
- · ISO 10993-11 Acute systemic toxicity & Pyrogens
· Other bench testing- Surface, Measurement, Tensile strength, Airtightness, Fatigue resistance, Extractable substances, Comparative performance
Bench test results allowed to conclude that Uni-port is substantially equivalent to the predicate devices for its intended use.
#### 5.7 Technical Characteristics and Substantial Equivalence
The Uni-port is substantially equivalent to GLOVE PORT (K141715). The following comparison table is presented to demonstrate substantial equivalence.
The Uni-port does not have a new intended use. It shows equivalent specifications with the predicate devices in most of the parameters. However, there are no significant differences in some parameters [Port No., Ring diameter] between the Uni-port and Predicate Device [GLOVE PORT (K141715)].
| Item | Subject | Predicate device | Remark |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Dalim Medical Corp. | NELIS Corp. | - |
| Product Name | Single Use Manual Operated<br>Surgical Retractor | Endoscopy Surgery<br>Instrument | - |
| Brand Name | Uni-port | GLOVE PORT | - |
| 510K No | K232062 | K141715 | - |
| Design | Image: Uni-port | Image: GLOVE PORT | |
| Indications for Use | The Uni-port is intended to<br>provide access for multiple<br>instruments and/or<br>endoscope to the<br>abdominal cavity through a<br>single incision during<br>minimally invasive<br>laparoscopic surgery. | The Glove Port Is intended<br>to provide access for<br>multiple instruments<br>and/or endoscope to the<br>abdominal cavity through<br>a single incision during<br>minimally invasive<br>laparoscopic surgery. | Same as predicate |
| Prescription/over-<br>the-counter use | Prescription | Prescription | Same as predicate |
| Port No. | 1ea, 3ea, 4ea | 3ea, 4ea | The difference in<br>the number of ports<br>is only the<br>difference in the<br>number of<br>instruments used in<br>surgery. It does not |
Table 1, General Device Characteristics Comparison Table
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Submitter: K232062 Dalim Medical Corp.
| | | | affect the safety and<br>effectiveness of the<br>device. |
|---------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------|
| Absolute size | 10mm~25mm | 10mm~25mm | Same |
| Material | Polyurethane | Polyurethane | Same |
| Disposable | Yes | Yes | Same |
| Ring Diameter | 63 / 93 mm | 60 ~ 95mm | Similar |
| Installation and<br>abdominal<br>wall inner<br>fixation | Wound retractor ring being<br>fixed inside the abdominal<br>wall inside. | Wound retractor ring<br>being fixed inside the abdominal wall inside. | Same as predicate |
| Sterilization<br>method | EO gas sterilization | EO gas sterilization | Same as predicate |
| Certification | CE 2165 | CE0120, ISO 9001:2008,<br>ISO 13485:2003,<br>Registration of KFDA | No significant<br>difference |
### Table 2. General Device Characteristics Comparison Table
| Item | Subject | Reference device | Remark |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Manufacturer | Dalim Medical Corp. | Dalim SurgNET Co. | |
| Product Name | Single Use Manual Operated<br>Surgical Retractor | Laparoscopic Accessory | |
| Brand Name | Uni-port | OCTO™ port | |
| 510K NO | K232062 | K112196 | |
| Design | Image: Uni-port design | Image: OCTO™ port design | |
| Indications for Use | The Uni-port is intended to<br>provide access for multiple<br>instruments and/or<br>endoscope to the<br>abdominal cavity through a<br>single incision during<br>minimally invasive<br>laparoscopic surgery. | The OCTO™Port is<br>intended to use as a<br>multiple instrument<br>and/or camera port<br>during minimally invasive<br>abdominal laparoscopic<br>surgery. | Same |
| Prescription/over-<br>the-counter use | Prescription | Prescription | Same |
| Port No. | 1ea, 3ea, 4ea | 1ea, 3ea, 4ea | Same |
| Absolute size | 10mm~25mm | 15~50mm | Similar |
| Material | Polyurethane | Silicone | Different |
| Disposable | Yes | Yes | Same |
| Installation and | Wound retractor ring being | Wound retractor ring | Same as predicate |
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Submitter: Uni-port K232062 Premarket Notification: Traditional 510(k) Dalim Medical Corp.
| abdominal<br>wall inner<br>fixation | fixed inside the abdominal<br>wall inside. | being fixed inside the<br>abdominal wall inside. | |
|-------------------------------------|--------------------------------------------|--------------------------------------------------|-----------------------------|
| Sterilization<br>method | EO gas sterilization | EO gas sterilization | Same as predicate |
| Certification | CE 2165 | CE 0120 | No significant<br>dfference |
Although the subject device and predicate device are no significant differences in some parameters, the differences do not affect the substantial equivalence of the subject device when compared to the predicate device.
| 5.8 | Conclusion | Based on the testing results, Dalim Medical Corp. concludes that the<br>subject device is substantially equivalent to the predicate device. |
|-----|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.9 | Declarations | This summary includes only information that is also covered in the body<br>of the 510(k).<br>This summary does not contain any puffery or unsubstantiated labeling<br>claims. |
