(168 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a laparoscopic port, with no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is described as a laparoscopic instrument port used during surgery, which facilitates instrument access but does not directly treat or diagnose a disease or condition.
No
The device description clearly states its purpose as an instrument and/or camera port during laparoscopic surgery, and performance studies focus on its mechanical functionality and ability to facilitate surgical procedures. There is no mention of diagnostic functions such as disease detection, measurement of physiological parameters, or image analysis for diagnostic purposes.
No
The device description clearly states it is a "sterile, disposable laparoscopic instrument port," which is a physical hardware device used in surgery. The performance studies also describe bench and animal testing of this physical device.
Based on the provided information, the OCTO™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. This is a surgical device used in vivo (within the body) to facilitate a surgical procedure.
- Device Description: The description reinforces its function as a sterile, disposable laparoscopic instrument port that retracts an incision to allow instruments to pass through. This is a physical tool used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to analyze biological samples to provide diagnostic or other health-related information. The OCTO™ is a surgical access device.
N/A
Intended Use / Indications for Use
The OCTO™ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
Product codes
GCJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal
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 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 - 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
f, ability to conduct a typical laparoscopic procedure: cholecystectomy
g, ability to hold OCTO™ Port in position during surgery - 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
The performance tests demonstrated that OCTO™ 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
5. 510(k) Summary
[as required by 807.92(c)]
-
- Applicant:dalim SurgNET Corporation
B-708, Woolim Blue Nine, 240-21 Yeomchang-dong, Gangseo-gu, Seoul
- Applicant:dalim SurgNET Corporation
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
-
- Trade Name: OCTO™
-
- Common Name: Laparoscopic Accessory
-
- Classification Name: Endoscope and accessories
- Product Code: GCJ Regulation: 21 CFR 876.1500 Class of device: Class II.
-
- The legally marketed device to which we are claiming equivalence: K073719 ASC TriPort Laparoscopic Access Device
-
- 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 .
-
- Intended Use:
The OCTOTM is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.
- Intended Use:
-
- 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 .
- Technological Characteristics:
9. 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
- Bench testing is performed to demonstrate the functionality and mechanical safety as following items;
-
c. insertion-withdrawal forces of instruments
-
d, determination of minimum size of skin incision
-
e, evaluation of OCTOTM Port device fixation
-
- 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
1
f, ability to conduct a typical laparoscopic procedure: cholecystectomy g, ability to hold OCTO™ Port in position during surgery
-
- 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
- Equivalence comparison and difference are performed to demonstrate the technological characteristics the predicate as following items - Equivalence comparison
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.
2
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
3
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
4
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_