(113 days)
Not Found
No
The summary describes a mechanical port device and does not mention any software, algorithms, or AI/ML terms.
No.
The device facilitates surgical procedures by providing access to the abdominal cavity and rectum but does not directly treat a disease or condition.
No
The device is described as providing access for surgical procedures, not for diagnosing conditions. The performance studies focus on safety and effectiveness for surgical access.
No
The device description explicitly states it is comprised of physical components (trocars, insufflation tube, flexible port), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical access to the abdominal cavity and rectum for performing minimally invasive procedures. This is a surgical device, not a diagnostic test performed on samples outside the body.
- Device Description: The description of trocars and an insufflation tube bound by a flexible port aligns with surgical access devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status. The device facilitates a surgical procedure, it doesn't diagnose a condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely procedural access.
N/A
Intended Use / Indications for Use
The SILS™ Port device is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.
Product codes
GCJ, FER
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, anus, rectal
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-vivo and in vitro evaluations were performed to support the use of the SILS™ Port device for transanal access for rectal surgery. The testing included in vitro suture pull out testing as well as in vivo (porcine) transanal evaluations including insertion force, port security, visualization, removal force, and resultant trauma. The results of this testing indicate that when used for transanal access for rectal surgery, SILSTM Port is safe and effective and provides equivalent performance to the predicate device(s).
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
Covidien (formerly registered as US Surgical a division of Tyco Healthcare).
7. 510(K) SUMMARY:
FEB 2 4 2011
510(k) Summary of Safety and Effectiveness:
SUBMITTER: Covidien (formerly registered as US Surgical, a division of Tyco Healthcare) 60 Middletown Avenue North Haven, CT 06473 CONTACT PERSON: Tim M. Lohnes Manager, Regulatory Affairs Phone: (203) 492-5462 Fax: (203) 492-5029 tim.lohnes@covidien.com alternate contact: sharon.murphy@covidien.com DATE PREPARED: November 02, 2010 TRADE/PROPRIETARY NAME: SILSTM Port COMMON/USUAL NAME: Surgical Trocar CLASSIFICATION NAME: Endoscope and/or accessories PREDICATE DEVICE(S): K000180: Richard Wolf Medical Instrument Corp. Transanal Endoscopic Microsurgery (TEM) Combination System and Instrument Set K093372: Covidien SILSTM Port DEVICE DESCRIPTION: Three laparoscopic trocars and an insufflation tube bound by a flexible port. INTENDED USE: For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.
- Trademark of Covidien Christina. Casella@flextronics.com November 02, 2010
Traditional 510(k) for the SILS* Port for Trans Anal Rectal Access
1
Covidien (formerly registered as US Surgical a division of Tyco Healthcare).
MATERIALS:
CHARACTERISTICS:
PERFORMANCE DATA:
The SILSTM Port allows the use of three laparoscopic cannula and an insufflation port in a body cavity through a single incision or to the rectum via the anus (no incision).
All components of the SILS™ Port are comprised of materials that have been evaluated in accordance with ISO 10993-1: 2009, Biological Evaluation of medical devices -- Part 1: Evaluation and Testing.
In-vivo and in vitro evaluations were performed to support the use of the SILS™ Port device for transanal access for rectal surgery. The testing included in vitro suture pull out testing as well as in vivo (porcine) transanal evaluations including insertion force, port security, visualization, removal force, and resultant trauma. The results of this testing indicate that when used for transanal access for rectal surgery, SILSTM Port is safe and effective and provides equivalent performance to the predicate device(s).
- Trademark of Covidien Christina Casella@flextronics.com November 02, 2010
Traditional 510(k) for the SILS* Port for Trans Anal Rectal Access
2
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health and Human Services. The logo consists of a stylized depiction of a human figure with three lines representing the head, body, and legs. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES", which is arranged vertically.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Tim M. Lohnes RA Manager Covidien 60 Middletown Avenue NORTH HAVEN CT 06473
FEB 2 4 2011
. Re: K103253 Trade/Device Name: SILS" Port Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ and FER Dated: November 2, 2010 Received: November 30, 2010
Dear Mr. Lohnes:
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 device-related
3
Page 2
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/CDRH/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Hubert H Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
6. INDICATIONS FOR USE STATEMENT:
510(k) Number (if known): K103253
Device Name: SILSTM Port
Indications For Use:
The SILS™ Port device is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures, as well as through the anus to provide access for rectal procedures such as TEMS (Transanal Endoscopic Micro Surgery), flap revision and fistula repair.
Prescription Use: X OR Over-The-Counter Use: (Per 21 CFR 801.109)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hessen
Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
(510(k) Number K103253
- Trademark of Covidien
November 02, 2010
Attachment B, page 1 of 1
Traditional 510(k) for the SILS* Port for Trans Anal Rectal Access