(189 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.
No.
The device is described as a surgical retractor intended to provide access for instruments during minimally invasive laparoscopic surgery, not to treat or diagnose a disease.
No
This device is described as a surgical retractor intended to provide access for instruments during laparoscopic surgery, and it filters gas. Its function is to facilitate surgery, not to diagnose conditions or diseases.
No
The device description clearly outlines physical components (main body, wound retractor, filter) and mentions bench testing related to material properties and physical performance, 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 provide access for surgical instruments during laparoscopic surgery. This is a surgical device used in vivo (within the body) for a surgical procedure.
- Device Description: The description details a surgical retractor with ports and a wound retractor. These are physical tools used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. The device's function is purely procedural.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
OTJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity
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)
Non-clinical Test Conclusion
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
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).
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 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
2
Indications for Use
| Submission Number ( if known ) | |
|---|---|
| --------------------------------------- | -- |
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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3
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. +82-32-642-0212
Fax No. +82-32-642-0213 |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person:
(Official Correspondent) | Mtech Group
Dave Kim
7505 Fannin St. Suite 610, Houston, TX 77054, US
Tel: 713-467-2607
Email: davekim@mtech-inc.net |
| Date Prepared: | December 11, 2023 |
| 5.2 Device Identification
Device Trade Name
Model | Uni-port
UP01F, 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 Name
Classification Name, Number
Device Classification
Product Code | Single Use Manual Operated Surgical Retractor
Laparoscope, general & plastic surgery (21 CFR 876.1500)
II
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
4
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 | ||
| Surgical Retractor | Endoscopy Surgery | ||
| 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 | ||
| provide access for multiple | |||
| instruments and/or | |||
| endoscope to the | |||
| abdominal cavity through a | |||
| single incision during | |||
| minimally invasive | |||
| laparoscopic surgery. | The Glove 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. | Same as predicate | ||
| Prescription/over- | |||
| the-counter use | Prescription | Prescription | Same as predicate |
| Port No. | 1ea, 3ea, 4ea | 3ea, 4ea | The difference in |
| the number of ports | |||
| is only the | |||
| difference in the | |||
| number of | |||
| instruments used in | |||
| surgery. It does not |
Table 1, General Device Characteristics Comparison Table
5
Submitter: K232062 Dalim Medical Corp.
| | | | affect the safety and
effectiveness of the
device. |
|---------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------|
| Absolute size | 10mm25mm | 10mm25mm | Same |
| Material | Polyurethane | Polyurethane | Same |
| Disposable | Yes | Yes | Same |
| Ring Diameter | 63 / 93 mm | 60 ~ 95mm | Similar |
| Installation and
abdominal
wall inner
fixation | Wound retractor ring being
fixed inside the abdominal
wall inside. | Wound retractor ring
being fixed inside the abdominal wall inside. | Same as predicate |
| Sterilization
method | EO gas sterilization | EO gas sterilization | Same as predicate |
| Certification | CE 2165 | CE0120, ISO 9001:2008,
ISO 13485:2003,
Registration of KFDA | No significant
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 | ||
| 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 | ||
| provide access for multiple | |||
| instruments and/or | |||
| endoscope to the | |||
| abdominal cavity through a | |||
| single incision during | |||
| minimally invasive | |||
| laparoscopic surgery. | The OCTO™Port is | ||
| intended to use as a | |||
| multiple instrument | |||
| and/or camera port | |||
| during minimally invasive | |||
| abdominal laparoscopic | |||
| surgery. | 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 |
6
Submitter: Uni-port K232062 Premarket Notification: Traditional 510(k) Dalim Medical Corp.
| abdominal
wall inner
fixation | fixed inside the abdominal
wall inside. | being fixed inside the
abdominal wall inside. | |
|-------------------------------------|--------------------------------------------|--------------------------------------------------|-----------------------------|
| Sterilization
method | EO gas sterilization | EO gas sterilization | Same as predicate |
| Certification | CE 2165 | CE 0120 | No significant
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
subject device is substantially equivalent to the predicate device. |
|-----|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.9 | Declarations | This summary includes only information that is also covered in the body
of the 510(k).
This summary does not contain any puffery or unsubstantiated labeling
claims. |