OCTO

K100045 · Dalim Surgnet Corporation · GCJ · Jun 25, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100045
• Device Name: OCTO
• Applicant: Dalim Surgnet Corporation
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

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

Device Story

OCTO™ is a sterile, disposable laparoscopic instrument port; retracts small abdominal incisions to facilitate passage of multiple laparoscopic instruments and cameras into the abdomen. Used during minimally invasive abdominal laparoscopic surgery; operated by surgeons. Device maintains pneumoperitoneum and provides a stable access point for instrument manipulation. Benefits include improved access and maneuverability during laparoscopic procedures.

Clinical Evidence

Bench testing evaluated leak rates (with/without instruments, after manipulation), insufflation flow, insertion/withdrawal forces, incision size, and device fixation. Animal testing (porcine model) demonstrated ease of insertion, instrument manipulation, maintenance of pneumoperitoneum, and performance during a simulated cholecystectomy. No human clinical data provided.

Technological Characteristics

Sterile, disposable laparoscopic instrument port. Features include insufflation tubing and stopcock compatibility. Mechanical design supports instrument insertion/withdrawal and abdominal wall retraction. No software or electronic components.

Indications for Use

Indicated for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery in patients undergoing such procedures.

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.

Predicate Devices

• ASC TriPort Laparoscopic Access Device (K073719)

Submission Summary (Full Text)

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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. [phone]

FAX. [phone]

Website. http://www.dalimsurg.net

Contract person: Peter Chung

Tel [phone] Fax #: [phone] (Same with the home number) Mobil phone #: [phone] Atwood Street Pittsburgh, PA 15213 USA Email: [e-mail]

Date: 2010-June-01

- 2. Trade Name: OCTO™
- 3. Common Name: Laparoscopic Accessory
- 4. Classification Name: Endoscope and accessories
- Product Code: GCJ Regulation: 21 CFR 876.1500 Class of device: Class II.
- 5. The legally marketed device to which we are claiming equivalence: K073719 ASC TriPort Laparoscopic Access Device
- 6. 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 .

- 7. Intended Use:
The OCTOTM is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

- 8. 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
- 2) 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

- 3) 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

10. 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 [phone] or [phone] 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

4.

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*_*