(35 days)
The SILS™ Port is indicated for multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures. The SILS™ 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.
Three laparoscopic trocars and an insufflation tube bound by a flexible port.
This document describes a 510(k) premarket notification for the Covidien SILS™ Port, a surgical trocar. The information provided is primarily for regulatory clearance and does not contain the detailed study results typically associated with establishing specific performance criteria for AI/ML devices. Therefore, I cannot fully complete all sections of your request based solely on the provided text.
Specifically, this submission is for a medical device (surgical port/trocar), not an AI/ML diagnostic or assistive device. The "performance data" section in the summary mentions "In-vitro and in-vivo testing has been performed in support of the intended use of this device," but it does not specify acceptance criteria, effect sizes, reader studies, ground truth, or sample sizes in the way one would for an AI/ML product.
However, I will extract and infer what I can from the provided text to address your points as best as possible.
Acceptance Criteria and Study for Covidien SILS™ Port (Surgical Trocar):
Based on the provided 510(k) summary, detailed acceptance criteria and a study design for AI/ML performance metrics are not applicable or provided, as this is a physical medical device (surgical port/trocar). The "acceptance" is primarily based on substantial equivalence to predicate devices and meeting safety and material biocompatibility standards.
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device and not an AI/ML algorithm, the concept of a "device performance" table as you might expect for an AI/ML product (e.g., sensitivity, specificity) is not present. Instead, performance relates to its functional use and safety. The document states:
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (Summary) |
|---|---|
| Material Biocompatibility: Conformance to ISO 10993-1:2003 for materials. | "All components of the SILS™ 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." |
| Functional Performance: Ability to provide multiple instrument/camera access, maintain pneumoperitoneum through a single incision for laparoscopic procedures. | "In-vitro and in-vivo testing has been performed in support of the intended use of this device." (No specific metrics or results are detailed in this summary.) |
| Substantial Equivalence: To predicate devices (Covidien SILS™ Port K082619, Dexide Trocar K981941). | The FDA granted 510(k) clearance, indicating a determination of substantial equivalence. |
For the remainder of your questions, the information is not present in the provided 510(k) summary as these questions are typically relevant to AI/ML device studies, not traditional medical device clearance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This information is not typically part of a 510(k) summary for a physical medical device in the context of an AI/ML algorithm. The document mentions "in-vitro and in-vivo testing" but does not detail the sample sizes or provenance for these tests in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: As this device is not an AI/ML algorithm requiring expert interpretation of outputs, this information is not relevant or included in the 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: This concept is not relevant to the clearance of this physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided: This type of study is specifically for AI/ML diagnostic or assistive devices and is not relevant to the SILS™ Port.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: The SILS™ Port is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided (in the context of AI/ML): For a physical device, "ground truth" might relate to physical tests (e.g., material strength tests, leakage tests), but this is not specified in the summary nor is it the "ground truth" relevant to AI/ML performance.
8. The sample size for the training set
- Not Applicable / Not Provided: There is no AI/ML algorithm to train for this device.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: There is no AI/ML algorithm to train for this device.
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Covidien EP (formerly registered as Tyco Healthcare, LP)
6093372
Page 1 of 1
| 510(k) Summary of Safety and Effectiveness | |||
|---|---|---|---|
| SUBMITTER: | Covidien LP (formerly registered as Tyco Healthcare, LP)60 Middletown AvenueNorth Haven, CT 06473Tel. No .: (203) 492-5000 | ||
| CONTACT PERSON: | Angela Van ArsdaleAssociate, Regulatory AffairsPhone: (203) 492-5496Fax:(203) 492-5029 | DEC - 3 2009 | |
| DATE PREPARED: | October 30, 2009 | ||
| TRADE/PROPRIETARY NAME: | SILS™ Port | ||
| COMMON/USUAL NAME: | Surgical Trocar | ||
| CLASSIFICATION NAME: | Endoscope and/or accessories | ||
| PREDICATE DEVICE(S): | Covidien SILS™ Port (K082619) | ||
| Dexide Trocar (K981941) | |||
| DEVICE DESCRIPTION: | Three laparoscopic trocars and an insufflation tube bound by aflexible port. | ||
| INTENDED USE: | The SILS™ Port is indicated for multiple instrument or cameraaccess to the abdominal cavity through a single incision forperforming minimally invasive laparoscopic procedures.The SILS™ Port provides the ability to use three conventionallaparoscopic trocars and an insufflation port through a singleincision while providing the ability to maintainpneumoperitoneum. | ||
| TECHNOLOGICALCHARACTERISTICS: ` | |||
| MATERIALS: | All components of the SILS™ Port are comprised of materialsthat 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 ofthe intended use of this device. | ||
Page 21 of 33
™Trademark
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ー、す រុ
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling 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 W-O66-0609 Silver Spring, MD 20993-0002
Covidien LP % Ms. Angela Van Arsdale Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
DEC - 3 2009
Re: K093372
Trade/Device Name: SILS™ Port 15mm Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: November 24, 2009 Received: November 25, 2009
Dear Ms. Van Arsdale:
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 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
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Page 2 - Ms. Angela Van Arsdale
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Covidien LP (formerly registered as Tyco Healthcare, LP)
Indications For Use
510(k) Number (if known):
Device Name: SILS™ Port 15 mm
Indications for Use:
The SILS™ Port is indicated 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kareem S. Burney for NRO
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093372
Special 510(k) Premarket Notification 10/30/2009
Page 19 of 33 TM Trademark
§ 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.