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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Uni-port device, which is described as a medical device for laparoscopic surgery. It details the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI or algorithm performance, nor does it discuss acceptance criteria in the context of an AI/ML device. The text exclusively describes a physical medical device (a surgical retractor) and its technical equivalence to existing devices through bench testing and material comparisons.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and reported device performance (for an AI/ML context)
Sample sizes for test sets or data provenance (related to AI/ML)
Number of experts or their qualifications for ground truth establishment (related to AI/ML)
Adjudication method (related to AI/ML)
MRMC comparative effectiveness study or human reader improvement with AI
Standalone (algorithm-only) performance
Type of ground truth used (expert consensus, pathology, outcomes data - related to AI/ML)
Sample size for the training set (related to AI/ML)
How ground truth for the training set was established (related to AI/ML)

The acceptance criteria and studies mentioned in the document are for a traditional physical medical device, focusing on:

Shelf-Life Test
ISO 10993-5 - Cytotoxicity
ISO 10993-10 - Sensitization & Intracutaneous Reactivity
ISO 10993-11 - Acute systemic toxicity & Pyrogens
Other bench testing: Surface, Measurement, Tensile strength, Airtightness, Fatigue resistance, Extractable substances, Comparative performance.

The conclusion is that "All the test results support substantial equivalence to the predicate devices" and "Bench test results allowed to conclude that Uni-port is substantially equivalent to the predicate devices for its intended use."

To summarize, while the document confirms the device meets acceptance criteria for a physical medical device, it does not provide the specific AI/ML-related details requested in your prompt.

Summary

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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 ( if known )
---------------------------------------	--

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.Address: 102-606&609(Ho), 397, Seokcheon-ro, Bucheon-si, Gyeonggi-do, Republic of Korea (14449)Phone No. +82-32-642-0212Fax No. +82-32-642-0213
Contact Person:(Official Correspondent)	Mtech GroupDave Kim7505 Fannin St. Suite 610, Houston, TX 77054, USTel: 713-467-2607Email: davekim@mtech-inc.net
Date Prepared:	December 11, 2023
5.2 Device IdentificationDevice Trade NameModel	Uni-portUP01F, UP03F, UP04F, UP01FL, UP03FL, UP04FL,UP04FSP, UP04FSP-A, UP04FSP-B, UP04FSP-C,UP01FV2-D, UP01FLV2-D, UP03FV2-B, UP03FV2-F,UP03FLV2-B, UP03FLV2-F, UP04FV2-B, UP04FV2-F,UP04FLV2-B, UP04FLV2-F, UP03FSV2SP, UP03FSV2SP-A, UP03FV2SP, UP03FV2SP-A, UP03FV2SP-B,UP04FV2SP, UP04FV2SP-A, UP04FV2SP-B
Common NameClassification Name, NumberDevice ClassificationProduct Code	Single Use Manual Operated Surgical RetractorLaparoscope, general & plastic surgery (21 CFR 876.1500)IIOTI

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 OperatedSurgical Retractor	Endoscopy SurgeryInstrument	-
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 toprovide access for multipleinstruments and/orendoscope to theabdominal cavity through asingle incision duringminimally invasivelaparoscopic surgery.	The Glove Port Is intendedto provide access formultiple instrumentsand/or endoscope to theabdominal cavity througha single incision duringminimally invasivelaparoscopic surgery.	Same as predicate
Prescription/over-the-counter use	Prescription	Prescription	Same as predicate
Port No.	1ea, 3ea, 4ea	3ea, 4ea	The difference inthe number of portsis only thedifference in thenumber ofinstruments used insurgery. It does not

Table 1, General Device Characteristics Comparison Table

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Submitter: K232062 Dalim Medical Corp.

			affect the safety andeffectiveness of thedevice.
Absolute size	10mm~25mm	10mm~25mm	Same
Material	Polyurethane	Polyurethane	Same
Disposable	Yes	Yes	Same
Ring Diameter	63 / 93 mm	60 ~ 95mm	Similar
Installation andabdominalwall innerfixation	Wound retractor ring beingfixed inside the abdominalwall inside.	Wound retractor ringbeing fixed inside the abdominal wall inside.	Same as predicate
Sterilizationmethod	EO gas sterilization	EO gas sterilization	Same as predicate
Certification	CE 2165	CE0120, ISO 9001:2008,ISO 13485:2003,Registration of KFDA	No significantdifference

Table 2. General Device Characteristics Comparison Table

Item	Subject	Reference device	Remark
Manufacturer	Dalim Medical Corp.	Dalim SurgNET Co.
Product Name	Single Use Manual OperatedSurgical 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 toprovide access for multipleinstruments and/orendoscope to theabdominal cavity through asingle incision duringminimally invasivelaparoscopic surgery.	The OCTO™Port isintended to use as amultiple instrumentand/or camera portduring minimally invasiveabdominal laparoscopicsurgery.	Same
Prescription/over-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.

abdominalwall innerfixation	fixed inside the abdominalwall inside.	being fixed inside theabdominal wall inside.
Sterilizationmethod	EO gas sterilization	EO gas sterilization	Same as predicate
Certification	CE 2165	CE 0120	No significantdfference

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 thesubject device is substantially equivalent to the predicate device.
5.9	Declarations	This summary includes only information that is also covered in the bodyof the 510(k).This summary does not contain any puffery or unsubstantiated labelingclaims.

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.