Endo Keeper

K152598 · Nelis · OTJ · Mar 17, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K152598
• Device Name: Endo Keeper
• Applicant: Nelis
• Product Code: OTJ · Gastroenterology, Urology
• Decision Date: Mar 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Endo Keeper 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 Story

Endo Keeper is a laparoscopic single-port access device; provides access for multiple instruments/endoscopes to abdominal cavity via single incision. Device consists of insert ring, control ring, polyurethane forming sheet, remover ring/ribbon, cap, and gas valve. Insert ring fixes device to inner abdominal wall; control ring adjusts sheet length; polyurethane sheet protects incision site. Used in clinical settings by surgeons during minimally invasive procedures. Surgeon inserts device through incision; instruments passed through ports. Gas valve allows insufflation; cap maintains pneumoperitoneum. Facilitates multi-instrument access; reduces recovery time by protecting incision. Single-use, sterile device.

Clinical Evidence

Bench testing and animal studies performed. Bench tests included comparative leak rate, tensile strength, insufflation flow rate, instrument insertion-withdrawal forces, and minimum incision size determination. Animal testing (in vivo) verified feasibility and functionality, showing no skin or fascia irritation or necrosis. No human clinical trial data presented.

Technological Characteristics

Materials: Polyurethane, ABS, Nylon, Silicon. Components: Insert ring, control ring, urethane forming sheet, remover ring/ribbon, cap, gas valve. Dimensions: 41mm to 195mm diameter; 130mm to 265mm length. Connectivity: None. Energy: None (mechanical). Sterilization: Sterile, single-use. Design: Laparoscopic port for single-incision access.

Indications for Use

Indicated for patients undergoing minimally invasive laparoscopic surgery requiring access to the abdominal cavity through a single incision for multiple instruments and/or endoscopes.

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

• Glove Port (K141715)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three human profiles facing to the right.

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

March 17, 2016

NELIS % Mr. Peter Chung Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

Re: K152598

Trade/Device Name: Endo Keeper Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OTJ Dated: January 15, 2016 Received: January 20, 2016

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K152598

Device Name Endo Keeper

Indications for Use (Describe)

The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

This device is single use and sterilized.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

[as required by 807.92(c)]

### 1. Applicant

- 1) Company : NELIS
- 2) Address :1005. 201-Dong Bucheon Techno Park Ssangyong 3-cha Samieong-dong Qieong-qu. Bucheon-si Gyeongggi-do, 421-742 Korea
- 3) Tel : [phone],
- 4) Fax : [phone]
- 5) Homepage : www.nelis.co.kr
- 6) In-charge : Director / Ryu Sung Soo / 82-10-4175-8558 / [e-mail]
- 6) Contact person : Peter Chung / 412-512-8802 / [e-mail]
- 7) Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
- 8) First prepared : Mar. 9, 2015
- 8) Submission date : Mar. 17, 2016
- 9) 510(k) number : K152598

#### 2. Device Information

- 1) Trade Name : Endo Keeper
- 2) Common Name : Endoscopy Surgery Instrument
- 3) Classification Name : Laparoscopic Single Port Access Device
- 4) Product Code : OTJ
- 5) Requlation Number : 876.1500
- 6) Class of device : Class II
- 7) Panel : General & Plastic Surgery
- 8) Model type : 20 model codes including X-samll

#### 3. The legally marketed predicate devices :

K141715 / Nelis / Glove Port

#### 4. Device description :

The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized.

| X-small | Small | Small-N | Small-S |
|--------------|-------------|------------|-------------|
| Small-NS | Medium | Medium-N | Medium-S |
| Medium-NS | Large | Large-N | XX-Large |
| Small-NS-C | Small-NS-CG | Small-S-CG | Small-S-C |
| Medium-NS-CG | Medium-NS-C | Medium-S-C | Medium-S-CG |

- 1) Model/type Name : 20 model codes including X-small
#### 2) Model guide

- (1) Main category
Size:XX-Large(195mm) > Large(125mm) > Medium(95mm) > Small(60mm) > X-small(41mm) The size is determined by "Insert ring" diameter.

- 2) Classification
- N : Remover ring and Remover ribbon or No Remover ring and Remover ribbon
- C : Cap or No cap
- G : Gas valve or No Gas valve
- S : Length (185mm), None "S"(195mm)

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Image /page/4/Figure/0 description: The image shows the text "SMALL-NS-CG" in a blue box. There are green lines pointing to each part of the text, with descriptions of what each part means. The description includes that EndoKeeper has 5 different sizes, including X-SMALL, SMALL, MEDIUM, LARGE, and XX-LARGE. Other descriptions include "With Gas valve", "With Cap", "Short length", and "No removal ring".

### ്‍ട്ര് Diameter of "Insert ring" and "Control ring"

| Diameter of "Insert ring" and "Control ring" | | | | |
|-----------------------------------------------------------|-------------|--------------|-----------------------------------------|----------|
| 41mm | 60mm | 95mm | 125mm | 195mm |
| x-small | Small | Medium | Large | XX-Large |
| | Small-N | Medium-N | Large-N | |
| | Small-S | Medium-S | | |
| | Small-NS | Medium-NS | | |
| | Small-NS-C | Medium-NS-C | | |
| | Small-NS-CG | Medium-NS-CG | | |
| | Small-S-C | Medium-S-C | | |
| | Small-S-CG | Medium-S-CG | | |
| ← Small size of abdominal incision site | | | Large size of abdominal incision site → | |
| To selection of model according to size of incision site. | | | | |

### ④ Length of "Urethane forming Sheet"

| Length of "Urethane forming Sheet" | | | |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------|
| 130mm | 185mm | 190mm | 210mm |
| x-small | Small-S<br>Small-S-C<br>Small-S-CG<br>Small-NS<br>Small-NS-C<br>Small-NS-CG<br>Medium-S<br>Medium-S-C<br>Medium-S-CG<br>Medium-NS<br>Medium-NS-C<br>Medium-NS-CG | Small<br>Small-N<br>Medium<br>Medium-N<br>Large<br>Large-N | XX-Large |
| ← Short length of abdominal wall | | Long length of abdominal wall → | |
| To selection of model according to length of incision abdominal wall. | | | |

## ട്ര "Remover ring" and "Remover ribbon"

| ex) 0000-N0-00 | |
|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| No "Remover ring (and Remover ribbon)" | |
| Applied model codes : | Small-N, Small-NS, Small-NS-C, Small-NS-CG<br>Medium-N, Medium-NS, Medium-NS-C, Medium-NS-CG<br>Large-N |
| "Remover ring" and "Remover ribbon" are remove "Insert ring" out of body by pulling out the | |
| ring. It choose by end user (doctor). | |

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- ⑥"Cap" and "Gas valve"

| ex) 0000-00-CG | |
|-------------------------------------------|---------------------------|
| C : with Cap | |
| G : with Gas valve | |
| Applied model codes : | |
| With Cap | Small-S-C, Small-NS-C |
| | Medium-S-C, Medium-NS-C |
| With Gas valve | Small-S-CG, Small-NS-CG |
| | Medium-S-CG, Medium-NS-CG |
| Cap : Protect the Gas | |
| Gas valve : It designed to inject the gas | |
| It choose by end user (doctor). | |

# 2) Model design

Image /page/5/Picture/3 description: The image shows three different views of a medical device, with labels pointing to different parts. The labels include: 1) Insert Ring, 2) Control Ring, 3) Urethane forming SHEET, 4) Remover Ring, 5) Remover Ribbon, 6) Cap, 7) Cap, 8) Port, and 9) Gas valve. The image also shows the length and diameter of the device.

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| No. | Part<br>Name | Description |
|-----|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ① | Insert<br>Ring | Can fix this product by contacting tightly on the inner abdominal walls<br>Can attach and detach on the inner abdominal walls by preventing this product from<br>coming unstuck. |
| ② | Control<br>Ring | Can adjust the length of sheet and could be rolled up into the incision and can make<br>various instrument inserted into the body like the way of "Insert ring". |
| ③ | Urethane<br>forming<br>SHEET | Is made of polyurethane film and has a part of protrusion similar to a finger. It can wrap<br>the incision and help various instruments to be inserted into the body.<br>The part of protrusion similar to a finger is designed to protect the incision by wrapping.<br>It helps to reduce the period of recovery after operation. |
| ④ | Remover<br>Ring | Remove "Insert ring" out of body by pulling out the ring |
| ⑤ | Remover<br>Ribbon | Connection between "Insert ring" and "Remover ring" for pulling out device |
| ⑥ | Cap | Protect to the Gas<br>Applied to Endo Keeper CG model(including "Gas valve") |
| ⑦ | Cap | Protect to the Gas<br>Applied to Endo Keeper C model(except "Gas valve") |
| ⑧ | Port | It designed to insert a medical instrument into a hole(diameter 5~12mm).<br>Applied to CG and C model |
| ⑨ | Gas<br>valve | It designed to inject the gas. |

## 3) Model measurement and classification

| Name | Length | Diameter | Remover ribbon |
|--------------|--------|----------|----------------|
| X-small | 130mm | 41 mm | N/A |
| Small | 190mm | 60mm | 280mm |
| Small-N | 190mm | N/A | N/A |
| Small-S | 185mm | 60mm | 280mm |
| Small-NS | 185mm | 60mm | N/A |
| Medium | 190mm | 95mm | 280mm |
| Medium-N | 190mm | 95mm | N/A |
| Medium-S | 185mm | 95mm | 280mm |
| Medium-NS | 185mm | 95mm | N/A |
| Large | 190mm | 125mm | 280mm |
| Large-N | 190mm | 125mm | N/A |
| XX-Large | 210mm | 195mm | N/A |
| Small-NS-C | 265mm | 60mm | N/A |
| Small-NS-CG | 265mm | 60mm | N/A |
| Small-S-C | 265mm | 60mm | 280mm |
| Small-S-CG | 265mm | 60mm | 280mm |
| Medium-NS-C | 265mm | 95mm | N/A |
| Medium-NS-CG | 265mm | 95mm | N/A |
| Medium-S-C | 265mm | 95mm | 280mm |
| Medium-S-CG | 265mm | 95mm | 280mm |

# 5. Intended Use :

The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

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## 6. Technological characteristics :

The Endo Keeper is same intended use to Glove port (K141715). When compare with Glove port, it is same materials, structure and component.

The Endo Keeper is laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.

The Urethane Forming Sheet (components of the Endo Keeper) function is to cover the incision site of abdominal.

When comparing Endo Keeper and Glove port(K141715), raw material is same of all components. (Used raw materials : Polyurethane, ABS, Nylon, Silicon)

Proposed device is similar components compared to Glove port (K141715).

(Same : Insert ring, Control ring, Urethane forming sheet, Cap, Gas valve, Remover ring and Remover ribbon. Except components of Opening ring and Extractioin pocket.)

## 7. Performance data:

Bench testing is performed to demonstrate the functionality and mechanical safety as following items

- a. Comparative leak rate test
- b. Tensile strength test
- c. Insufflation flow rate test
- d. Insertion-withdrawal forces of instrument test
- e. Determination of minimum size of skin incision test
- f. in-vivo test

### Animal test

Varification of feasibility and functionality of Endo Keeper. The test results, there were no irritations and necrosis of the skin and fascia.

According to ISO 10993-2 and ISO 10993-1

#### Illustration 2. Test System

Image /page/7/Figure/19 description: The image shows a flowchart with eight steps. Step 1 is "Identification of product and System", followed by Step 2 "Anesthesia", Step 3 "Make Incision", and Step 4 "Product Insertion". Step 5 is "Do procedure", followed by Step 6 "Remove product", Step 7 "Close incision", and Step 8 "Evaluate The results".

## 8. Predicate device comparison

## Predicate device - Glove Port (K141715)

Proposed device and predicate device is manufactured by NELIS. The Endo Keeper have a identical intended use to the Glove Port in that they are indicated to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. The components of the proposed device have identical appearance, fuction, purpose and material. Technical caracteristics is same of change of port during operation, gas leakage, abdominal wall inner clear visual field, installation in abdominal wall inner fixation and removal.

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### 9. Conclusion:

The Device is investigated for function and effectiveness to compare the operation of function between Endo Keeper and predicate devices. Comparison results demonstrate that the specifications and performance of the device are same as functional and effective as the legally marketed predicate device.

Therefore, it is concluded that Endo Keeper is substantially equivalent to the legally marketed predicate device.

According to animal test results, the Endo Keeper is verified of feasibility and functionality. The test results, there were no irritations and necrosis of the skin and fascia. It can be possible to have a single incision during minimally invasive laparoscopic surgery.

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