The OCTO™ Port is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.

AI/ML Overview

The provided text describes modifications to an existing device (OCTO™ Port) and asserts its substantial equivalence to a predicate device (OCTO™ K100045) rather than presenting detailed acceptance criteria and a study to prove they are met. The document focuses on demonstrating that the new modifications do not alter the fundamental safety or effectiveness of the device.

Here's an analysis based on the information provided and how it relates to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria with corresponding performance results in a tabular format. Instead, it lists general types of bench tests conducted to ensure the device performs as expected after modifications.

Acceptance Criteria	Reported Device Performance
Appearance inspection	Not specified (implied to pass)
Dimension test	Not specified (implied to pass)
Pressure leak test	Not specified (implied to pass)
Tensile strength test	Not specified (implied to pass)
Pressure injection test	Not specified (implied to pass)
Instrument insertion/removal test	Not specified (implied to pass)
Insertion test	Not specified (implied to pass)
Fixation test	Not specified (implied to pass)
Leak resistance	Not specified (implied to pass)
Cannula insertion and removal evaluation	Not specified (implied to pass)
Device compatibility	Not specified (implied to pass)
One-handed use	Not specified (implied to pass)
Retractor removal test	Not specified (implied to pass)
Insufflation tube fixation forces maintain pneumoperitoneum	Not specified (implied to pass)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for any of the bench tests listed. It states "The testing scope for Bench Test was selected to include..." which indicates tests were performed, but no details on the number of samples or data provenance are given.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

This information is not applicable or provided in the context of this 510(k) submission. No clinical study involving experts establishing ground truth is described. The assessment is based on physical and functional changes to the device compared to a predicate.

4. Adjudication Method for the Test Set

This information is not applicable or provided. There's no mention of expert adjudication for the bench tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or mentioned. The device is a surgical access port, not an imaging or diagnostic device that would typically involve MRMC studies for AI assistance.

6. Standalone (Algorithm Only) Performance

This is not applicable as the device is a physical surgical instrument, not an algorithm or AI.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For the bench tests, the "ground truth" would be established engineering specifications, performance standards, and comparisons to the known performance of the predicate device. For example, "pressure leak test" would likely have a pre-defined maximum allowable leak rate, and the test results would be compared against that.

8. Sample Size for the Training Set

This is not applicable as the device is not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as the device is not an AI or machine learning model.

Summary Explanation:

This 510(k) submission (K112196) is for modifications to an already cleared medical device (OCTO™ Port, predicate K100045). The purpose of the submission is to demonstrate "substantial equivalence" of the modified device to the predicate. This means showing that the changes (e.g., color, thickness, gas valve addition/relocation) do not fundamentally alter the device's safety, effectiveness, indications for use, or technological characteristics.

Instead of presenting detailed acceptance criteria and performance data for a novel device, the submission asserts that:

The modified system has the "same intended use and fundamental scientific technology" as the previously-cleared system.
"Performance testing (Bench)" was conducted to include a list of various physical and mechanical tests (e.g., pressure leak, tensile strength, instrument insertion/removal). However, no specific acceptance criteria or quantitative performance results for these tests are provided in this summary. The implication is that the device passed these tests and met internal specifications consistent with its intended use and comparison to the predicate.
"No additional animal testing was performed" because the mechanism and materials are "identical and consistent with the previously submitted models."
"No additional biocompatibility testing was performed" for the same reason.

In essence, the "study" proving the device meets criteria is a battery of specified bench tests, but the specific quantifiable passing criteria and detailed results are not included in this high-level summary. The FDA's clearance (SEP 14 2011) indicates that they were satisfied with the provided information, which presumably included detailed test reports that are not part of this public summary.

Summary

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K112196

Page 1 of 3

510(k) Summary

SEP 1 4 2011

Submitter: Dalim SurgNET Co. Du Pyo Hong C-308, High Tech Venture, 647-26 Deungchon-dong, Gangseo-gu, Seoul 157-030, Korea Phone: 82-2-3663-6669 Fax: 82-2-2668-6669

Official Correspondent: Kodent Inc. April Lee 325 N Puente St. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-0116

Device Information

Trade Name: OCTO™ Port Common Name: Laparoscopic Accessory Classification Name: Endoscope and accessories Product Code: OTJ Regulation Number: 21 CFR 876.1500 Date of Submission: 7/25/2011

Indications for Use

The OCTO™ Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

Device Description & Technological Characteristics

The purpose of the device modification is to pursue the variety of products for surgeon's preference. Since the submission of the traditional 510(k), K100045, a number of additional nonsignificant modifications were made to the parent OCTO™ as follow:

The color of the device is changed from light blue to upgrade a brand image. .
The thickness of bottom ring of wound retractor is changed to make easy insertion into incision.
The thickness of silicon around the top ring of wound retractor is changed to make easy retraction. ●
The height of wound retractor has been lengthened to be used in obese patients. ●

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KII2196

Page 2 of 3

The gas valve was added to OT501S2, whereas the predicate device, OT501S, did not have gas ● valve
The port cap is made to be rotated in 360 degrees due to the preference of users. ●
The location of gas valve is changed to give more spaces for instruments during the surgery. .
The gas valve lever is loosened to make easy to control. .
The connection notches are attached on the port cap to make easy attachment and detachment of . the port cap from wound retractor.
The outer part of retractor is modified to be easily connected from the port cap by snapping. .
A silicone protector is added due to the preference of users. .
The arrangement and size of ports are changed to give wider range of ports. .
The heights of the ports are changed to give more spaces between instruments ●
12mm universal sealing is modified to make easy to insert clippers and other instruments. .

The modified system has the same intended use and fundamental scientific technology as the previously-cleared system, OCTO™

The OCTO™ Port is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.

Materials:

Wound retractor, remover, sealing, gas pipe were made of Silicon Rubber compound. Upper Frame, lower frame, port cap and the port were made of Acrylonitrile, Butadience, and Styrene copolymer. Gas valve was made of polycarbonate.

Performance testing (Bench):

The testing scope for Bench Test was selected to include appearance inspection, dimension test, pressure leak test, tensile strength test, pressure injection test, instrument insertion/removal test, insertion test, fixation test, leak resistance, cannula insertion and removal evaluation, device compatibility, one handed use, retractor removal test and insufflations tube fixation forces maintain pneumoperitomeum.

Performance testing (Animal):

Since the mechanism of the device, the material used on the instruction of using the device are identical and consistent with the previously submitted models, no additional animal testing was performed.

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K112196

Page 3.83

Biocompatibility Testing:

Since the mechanism of the device, the material used on the instruction of using the device are identical and consistent with the previously submitted models, no additional biocompatibility testing was performed.

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

The name of the device: OCTO™

510(k) Number: K100045

Comparison to Predicate Devices:

The comparisons have established that the subject of OCTO™Port is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate device of the type currently marketed in the U.S.

Conclusion:

Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate devices and effective when used as intended.

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Image /page/3/Picture/1 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle. Inside the circle is a stylized emblem consisting of three curved lines that resemble a bird in flight or a flowing ribbon. The emblem is positioned in the center of the circular text.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Dalim SurgNET Co. % Kodent, Inc. Ms. April Lee 325 N Puente Street. Unit B Brea, California 92821 .

Re: K112196 Trade/Device Name: OCTO Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OTJ Dated: August 25, 2011 Received: August 29, 2011

SEP 1 4 2011

Dear Ms. Lee:

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 (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. 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.

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

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Page 2 - Ms. April Lee

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.lda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KII 2196

Indication for Use

510(K) Number (if known):

112196

Device Name: OCTO™Port

Indication for Use:

The OCTO™ Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

Prescription Use

AND/OR

Over-The-Counter _________

(Part 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Neil R.P. Ogden for mkm
(Division Sign Off)

Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112196

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.