(59 days)
No
The device description is purely mechanical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development and validation.
No.
The device facilitates surgical access but does not directly treat a disease or condition.
No
The device is described as laparoscopic trocars and an insufflation tube for surgical access, not for detecting, diagnosing, or treating a condition.
No
The device description explicitly states it consists of "Three laparoscopic trocars and an insufflation tube bound by a flexible port," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing access to the abdominal cavity for surgical procedures. This is a surgical access device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a physical device (trocars, insufflation tube, flexible port) used for surgical access. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures
Product codes
GCJ
Device Description
Three laparoscopic trocars and an insufflation tube bound by a flexible port.
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)
In-vitro and in-vivo testing has been performed in support of the intended use of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K981941: Dexide™ Multaport Cannula Reducer and Accessories, K012539: Versa Step™ Reposable System, K954108: Modified Versaport™ Trocar, K072814: Convenience Kit for "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures.", K945457: Auto Suture™ Modified Grip, K073170: R-Port II Laparoscopic Access Device
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
Kob2619
510(K) SUMMARY:
510(k) Summary of Safety and Effectiveness:
SUBMITTER:
Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473
CONTACT PERSON:
Robert Zott Program Director, Regulatory Affairs Phone: (203) 492-6013 Fax: (203) 492-5029
DATE PREPARED:
TRADE/PROPRIETARY NAME:
COMMON/USUAL NAME:
CLASSIFICATION NAME:
PREDICATE DEVICE(S):
September 8, 2008
SILSTM Port
Surgical Trocar
Endoscope and/or accessories
K981941: Dexide™ Multaport Cannula Reducer and Accessories
K012539: Versa Step™ Reposable System
K954108: Modified Versaport™ Trocar
K072814: Convenience Kit for "Single-Incision Laparoscopic Surgery and other advanced laparoscopic procedures."
K945457: Auto Suture™ Modified Grip
K073170: R-Port II Laparoscopic Access Device
Three laparoscopic trocars and an insufflation tube bound by a flexible port.
DEVICE DESCRIPTION:
1
9 2619
INTENDED USE:
TECHNOLOGICAL CHARACTERISTICS:
MATERIALS:
For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures
The SILSTM Port provides the ability to use three conventional laparoscopic trocars and an insufflation port through a single incision while providing the ability to maintain pneumoperitoneum.
All components of the SILSTM Port are comprised of materials that have been evaluated in accordance with ISO 10993-1: 2003, Biological Evaluation of medical devices --Part 1: Evaluation and Testing.
PERFORMANCE DATA:
In-vitro and in-vivo testing has been performed in support of the intended use of this device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing the federal government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the left side of the eagle, while "USA" is positioned on the right side.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Covidien % Mr. Robert Zott Regulatory Affairs Program Director 60 Middletown Avenue North Haven, Connecticut 06473
NOV - 7 2008
Re: K082619
Trade/Device Name: SILS™ Port Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 27, 2008 Received: October 28, 2008
Dear Mr. Zott:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr. Robert Zott
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Ko82619
Indications for Use
510(k) Number (if known):
Device Name:
SILS ™ Port
Indications For Use:
For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures
Prescription Use (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)
(Division Sign-On)
Division of General. Restorative, and Neurological Devices
K082619 510(k) Number_
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