OCTO by DALIM SURGNET CORPORATION

The OCTOTM 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 the 510(k) submission for the OCTO™ laparoscopic accessory, focusing on its substantial equivalence to a predicate device. The information presented is primarily about performance testing related to the device's mechanical functionality and surgical utility, rather than AI-driven diagnostic or prognostic capabilities. Therefore, many of the requested categories related to AI performance metrics (e.g., expert consensus, MRMC studies, training set details) are not applicable to this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Testing)	Reported Performance (Summary)
Comparative leak rate test (without instruments, with instruments, after vigorous manipulation of instruments vs. predicate device(s))	Performed; demonstrates functionality and mechanical safety. The conclusion states the device is "as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
Insufflation flow rate	Performed; demonstrates functionality and mechanical safety.
Insertion-withdrawal forces of instruments	Performed; demonstrates functionality and mechanical safety.
Determination of minimum size of skin incision	Performed; demonstrates functionality and mechanical safety.
Evaluation of OCTOTM Port device fixation	Performed; demonstrates functionality and mechanical safety.

Acceptance Criteria (Animal Test)	Reported Performance (Summary)
Ease of port insertion	Performed; demonstrates ability for OCTO™. The conclusion states the device is "as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
Ease of instrument insertion and withdrawal	Performed; demonstrates ability for OCTO™.
Ability to maintain pneumoperitoneum	Performed; demonstrates ability for OCTO™.
Ability to manipulate instruments for laparoscopic surgery	Performed; demonstrates ability for OCTO™.
Ability to conduct a typical laparoscopic procedure (cholecystectomy)	Performed; demonstrates ability for OCTO™.
Ability to hold OCTO™ Port in position during surgery	Performed; demonstrates ability for OCTO™.

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

Bench Testing: No specific sample sizes are mentioned for the bench tests. The data provenance is implied to be laboratory testing.
Animal Testing: No specific sample size (number of animals) is mentioned for the animal tests. The data provenance is animal studies.
Retrospective/Prospective: Not applicable, as this is primarily a device performance evaluation, not a clinical study on human data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The tests described are physical and mechanical performance tests, and animal studies, not expert-based diagnostic evaluations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for human-read interpretations or clinical outcomes, not for mechanical device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

No. This is a submission for a laparoscopic accessory, not an AI-driven diagnostic device. Therefore, no MRMC study or AI improvement statistics are relevant or provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

Bench Testing: Ground truth is based on engineering specifications, physical measurements, and comparison to predicate device performance (e.g., measured leak rates, forces, dimensions).
Animal Testing: Ground truth is based on direct observation of the device's functionality during animal surgical procedures by the testing personnel.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no training set.

Summary

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K100045

5. 510(k) Summary

[as required by 807.92(c)]

1. Applicant:dalim SurgNET Corporation
  B-708, Woolim Blue Nine, 240-21 Yeomchang-dong, Gangseo-gu, Seoul

157-779, Korea

TEL. +82 2 335 1651

FAX. +82 2 323 1651

Website. http://www.dalimsurg.net

Contract person: Peter Chung

Tel 412-687-3976 Fax #: 412-687-3976 (Same with the home number) Mobil phone #: 412-512-8802) 300 Atwood Street Pittsburgh, PA 15213 USA Email: pittcmi@hotmail.com

Date: 2010-June-01

1. Trade Name: OCTO™
1. Common Name: Laparoscopic Accessory
1. Classification Name: Endoscope and accessories
- Product Code: GCJ Regulation: 21 CFR 876.1500 Class of device: Class II.
1. The legally marketed device to which we are claiming equivalence: K073719 ASC TriPort Laparoscopic Access Device
1. Description of device:

The OCTOTM is a sterile, disposable laparoscopic instrument port which

retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen .

1. Intended Use:
  The OCTOTM is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
1. Technological Characteristics:
  The OCTOTh is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen .

9. Performance data:

1. Bench testing is performed to demonstrate the functionality and mechanical safety as following items;
  a, comparative leak rate test to evaluate the leak rate without instruments, with instruments, and after vigorous manipulation of instruments vs. predicate device(s) b, insufflation flow rate
c. insertion-withdrawal forces of instruments
d, determination of minimum size of skin incision
e, evaluation of OCTOTM Port device fixation
1. Animal test is performed to demonstrate the ability for OCTOTM as following items a, ease of port insertion
- b. ease of instrument insertion and withdrawal
- c, ability to maintain pneumoperitoneum
- d, ability to manipulate instruments for laparoscopic surgery

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f, ability to conduct a typical laparoscopic procedure: cholecystectomy g, ability to hold OCTO™ Port in position during surgery

1. Equivalence comparison and difference are performed to demonstrate the technological characteristics the predicate as following items - Equivalence comparison
  a, device insertion procedure b, minimum length of skin incision

c, insertion device support mechanism, d, length of the device

e, number of flexible/rigid ports f, dimension of the access port,

g, angles of flexibility h, use with insufflation tubing and stopcock
Difference

the no. of ports, and maximum device diameter.

The differences do not adversely affect the safety and effectiveness of OCTO™ Port

Conclusion:

The performance tests demonstrated that OCTO™ Port is as safe, as effective and performs in a substantially equivalent manner to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

JUN 2 5 2010

Dalim SurgNET Corporation % Mr. Peter Chung 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K100045

Trade/Device Name: OCTO™ Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: June 02, 2010 Received: June 11, 2010

Dear Mr. Chung:

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

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Page 2 - Mr. Peter Chung

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 (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/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.fda.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.

cerely 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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Indications for Use Statement

Indications for Use

110004 510(k) Number (if known): Koo

Device Name: OCTO™

Indications For Use:

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

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

il RP Ogle. Sur nxm

(Division Sign-Off) (Division Sign of Surgical, Orthopedic, Divisionative Devices

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510(k) Number_

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.