(188 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a surgical port, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
The device provides access for instruments during surgery; it does not directly treat a disease or condition.
No
The device is described as an instrument port used for surgical access, not for diagnosing medical conditions. Its purpose is to facilitate the passage of instruments into the abdominal cavity during laparoscopic surgery.
No
The device description clearly indicates it is a physical laparoscopic instrument port made of materials like a Urethane Forming Sheet, intended for surgical access. It is described as single-use and sterilized, and bench testing includes mechanical safety and in-vivo tests, all pointing to a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Endo Keeper Function: The description clearly states the Endo Keeper is a surgical instrument port used during surgery to provide access to the abdominal cavity. It is a physical tool used to facilitate a surgical procedure, not to analyze biological samples.
The information provided about the device's intended use, description, and performance studies all point to it being a surgical access device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OTJ
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.
Model/type Name : 20 model codes including X-small
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.
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)
The device consists of:
- Insert Ring: Can fix this product by contacting tightly on the inner abdominal walls. Can attach and detach on the inner abdominal walls by preventing this product from coming unstuck.
- Control Ring: Can adjust the length of sheet and could be rolled up into the incision and can make various instrument inserted into the body like the way of "Insert ring".
- Urethane forming SHEET: Is made of polyurethane film and has a part of protrusion similar to a finger. It can wrap the incision and help various instruments to be inserted into the body. The part of protrusion similar to a finger is designed to protect the incision by wrapping. It helps to reduce the period of recovery after operation.
- Remover Ring: Remove "Insert ring" out of body by pulling out the ring
- Remover Ribbon: Connection between "Insert ring" and "Remover ring" for pulling out device
- Cap (CG model): Protect to the Gas. Applied to Endo Keeper CG model (including "Gas valve")
- Cap (C model): Protect to the Gas. Applied to Endo Keeper C model (except "Gas valve")
- Port: It designed to insert a medical instrument into a hole (diameter 5~12mm). Applied to CG and C model
- Gas valve: It designed to inject the gas.
The Endo Keeper is a 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.
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)
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:
Verification 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.
The performance tests demonstrated that Endo Keeper is as safe, as effective and performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Summary
[as required by 807.92(c)]
1. Applicant
-
- Company : NELIS
-
- Address :1005. 201-Dong Bucheon Techno Park Ssangyong 3-cha Samieong-dong Qieong-qu. Bucheon-si Gyeongggi-do, 421-742 Korea
-
- Tel : +82(32)624-1697,
-
- Fax : +82(32)624-1699
-
- Homepage : www.nelis.co.kr
-
- In-charge : Director / Ryu Sung Soo / 82-10-4175-8558 / goriat2@naver.com
-
- Contact person : Peter Chung / 412-512-8802 / peterchiung210@gmail.com
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- First prepared : Mar. 9, 2015
-
- Submission date : Mar. 17, 2016
-
- 510(k) number : K152598
2. Device Information
-
- Trade Name : Endo Keeper
-
- Common Name : Endoscopy Surgery Instrument
-
- Classification Name : Laparoscopic Single Port Access Device
-
- Product Code : OTJ
-
- Requlation Number : 876.1500
-
- Class of device : Class II
-
- Panel : General & Plastic Surgery
-
- 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 |
-
- 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. -
- 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)
4
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 | ||
| Small-S-C | |||
| Small-S-CG | |||
| Small-NS | |||
| Small-NS-C | |||
| Small-NS-CG | |||
| Medium-S | |||
| Medium-S-C | |||
| Medium-S-CG | |||
| Medium-NS | |||
| Medium-NS-C | |||
| Medium-NS-CG | Small | ||
| Small-N | |||
| Medium | |||
| Medium-N | |||
| Large | |||
| 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 |
| Medium-N, Medium-NS, Medium-NS-C, Medium-NS-CG | |
| 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). |
5
- 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.
6
| No. | Part
Name | Description |
|-----|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ① | Insert
Ring | Can fix this product by contacting tightly on the inner abdominal walls
Can attach and detach on the inner abdominal walls by preventing this product from
coming unstuck. |
| ② | Control
Ring | Can adjust the length of sheet and could be rolled up into the incision and can make
various instrument inserted into the body like the way of "Insert ring". |
| ③ | Urethane
forming
SHEET | Is made of polyurethane film and has a part of protrusion similar to a finger. It can wrap
the incision and help various instruments to be inserted into the body.
The part of protrusion similar to a finger is designed to protect the incision by wrapping.
It helps to reduce the period of recovery after operation. |
| ④ | Remover
Ring | Remove "Insert ring" out of body by pulling out the ring |
| ⑤ | Remover
Ribbon | Connection between "Insert ring" and "Remover ring" for pulling out device |
| ⑥ | Cap | Protect to the Gas
Applied to Endo Keeper CG model(including "Gas valve") |
| ⑦ | Cap | Protect to the Gas
Applied to Endo Keeper C model(except "Gas valve") |
| ⑧ | Port | It designed to insert a medical instrument into a hole(diameter 5~12mm).
Applied to CG and C model |
| ⑨ | Gas
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.
7
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.
8
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.