(273 days)
Not Found
No
The summary describes a mechanical surgical access device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an access port for surgical instruments and does not directly treat or diagnose a medical condition.
No
The device is described as an access port for surgical instruments during minimally invasive laparoscopic surgery. Its intended use and description focus on providing physical access and not on diagnosing a condition or disease. The performance studies also center on mechanical functionality rather than diagnostic accuracy.
No
The device description clearly indicates it is a physical, single-use, sterilized laparoscopic instrument port used during surgery, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide access for surgical instruments during minimally invasive laparoscopic surgery. This is a surgical device used in vivo (within the body) for a surgical procedure.
- Device Description: The description confirms it's a laparoscopic instrument port used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The Glove Port 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 Glove Port 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.
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
minimally invasive laparoscopic surgery
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 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 GLOVE PORT device fixation
The Device is investigated for function and effectiveness to compare the operation of function between Glove Port 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.
The performance tests demonstrated that GLOVE PORT 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure in profile, with three faces overlapping to create a sense of depth and community. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2015
NELIS % Mr. Peter Chung Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213
Re: K141715
Trade/Device Name: Glove Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OTJ Dated: February 10, 2015 Received: February 23, 2015
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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" (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 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 -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141715
Device Name Glove Port
Indications for Use (Describe)
The Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
Type of Use (Select one or both, as applicable)
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."
3
510(k) Summary
[as required by 807.92(c)]
1. Applicant
-
- Company : NELIS
-
- Address :1005, 201-Dong Bucheon Techno Park Ssangyong 3-cha Samjeong-dong Ojeong-gu, Bucheon-si Gyeongggi-do, 421-742 Korea
-
- Tel : +82(32)624-1697,
-
- Fax : +82(32)624-1699
-
- Homepage : www.nelis.co.kr
-
- Contact person : Peter Chung, 412-687-3976
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date : Apr. 23, 2014
2. Device Information
-
- Trade Name : GLOVE PORT
-
- Common Name : Endoscopy Surgery Instrument
-
- Classification Name : Laparoscope, general & plastic surgery
-
- Product Code : OTJ
-
- Regulation Number : 876.1500
-
- Class of device : Class II
-
- Panel : General & Plastic Surgery
3. The legally marketed predicate devices :
4. Device description :
The Glove Port 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.
5. Intended Use :
The Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.
6. Technological Characteristics :
The GLOVE PORT is laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen .
7. Performance data:
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 GLOVE PORT device fixation
4
8. Predicate device comparison table
| Manufactu
rer | NELIS | Covidien | Advanced Surgical
Concepts | | | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------------|-------------------------------------------------------|
| 510(k) No. | K141715 | K073719 | K093372 | | | |
| Indication
for use | The Glove Port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. | The ASC TriPort Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. | The SILSTM Port is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures. | | | |
| Product
name | Endoscopy Surgery Instrument | Surgical Trocar | Laparoscopic
Accessory | | | |
| Trade
name | Glove Port
Original | Glove Port
H | Glove Port A | Glove Port
AT | SILSTM Port | ASC TriPort
Laparoscopic
Access Device |
| Model | 60ea | 14ea | 33ea | 9ea | 3 ea | 4ea |
| Product
configuration | Image: Glove Port Original | Image: Glove Port H | Image: Glove Port A | Image: Glove Port AT | Image: SILSTM Port | Image: ASC TriPort Laparoscopic Access Device |
| Material | Polyurethane | Polyurethane | Polyurethane | Polyurethane | Silicone | Silicone |
| Port No. | 34 ea | 3 ea | | | | 34 ea |
| Absolute
size | 10mm25mm | 25mm | | | | 10mm25mm |
| Installation
and
abdominal
wall inner
fixation | Wound retractor ring being fixed inside the abdominal wall inside. | | | | Non-fixed | Distal ring being fixed in the abdominal wall inside. |
| Sterilization
method | EO Gas sterilization | | | | Gamma sterilization
(Cobalt-60) | Gamma sterilization
(Cobalt-60) |
| Certification | CE0120, ISO 9001:2008, ISO 13485:2003, Registration of KFDA | | | | Registered 510(k)
by FDA | Registered 510(k)
by FDA |
9. Conclusion:
The Device is investigated for function and effectiveness to compare the operation of function between Glove Port 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 Glove Port is substantially equivalent to the legally marketed predicate device.
The performance tests demonstrated that GLOVE PORT is as safe, as effective and performs in a substantially equivalent manner to the predicate device.