(30 days)
This device is used during laparoscopy, creating a point of entry for laparoscopic instruments into the abdominal cavity.
The Auto Suture™ Locking Trocar is a sterile, single-use device designed for primary punctures during laparoscopy.
The provided document is a 510(k) summary for the Auto Suture™ Locking Trocar. It does not contain information about the acceptance criteria and study details as requested for a device involving AI or complex performance metrics. The device in question is a surgical trocar, which is a mechanical device, and the document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than detailed performance reporting against specific clinical acceptance criteria.
Therefore, many of the requested sections about AI-specific criteria, human reader studies, ground truth establishment, sample sizes for training/test sets, and expert qualifications are not applicable or cannot be extracted from this document.
Here's what can be extracted based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document states: "Bench Performance testing was conducted to demonstrate that the Auto Suture™ Locking Trocar is substantially equivalent to the predicate device and performs as intended."
Specific quantitative acceptance criteria are not provided in this summary. The performance is described in terms of "substantial equivalence" to the predicate device and "performs as intended," without explicit metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: The testing appears to be "Bench Performance testing," implying laboratory-based testing rather than clinical data from human subjects. No information on country of origin or retrospective/prospective nature is provided, as it's not a clinical study.
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. Ground truth, in the context of expert review, is typically relevant for interpretative devices (like imaging AI). For a mechanical surgical trocar, performance is assessed through engineering and biocompatibility testing, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as it's not an interpretative study requiring adjudication.
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. This device is a surgical trocar, not an AI-powered diagnostic or interpretive tool. No human reader studies or AI assistance are mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, the "ground truth" would be established by engineering specifications, safety standards (e.g., ISO 10993-1 for materials), and functional requirements met through mechanical testing. The document states "All components of the Auto Suture™ Locking Trocar are comprised of materials which are in accordance with ISO 10993-1," which refers to biocompatibility standards. Specific functional "ground truth" for dimensions, strength, seal integrity, etc., would be defined by internal specifications and predicate device performance, but not explicitly detailed in this summary.
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning device.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9, 2015
Covidien Mr. Michael Koczocik Product Specialist, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
Re: K152565
Trade/Device Name: Auto Suture™ Locking Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: September 1, 2015 Received: September 9, 2015
Dear Mr. Koczocik:
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS)
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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.
Sincerelv vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 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)
Device Name
Auto Suture™ Locking Trocar
Indications for Use (Describe)
This device is used during laparoscopy, creating a point of entry for laparoscopic instruments into the abdominal cavity.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-5740 Fr
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510(k) Summary
This 510(k) summary of data used to demonstrate substantial equivalence is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98
| NAME: | COVIDIEN |
|---|---|
| ADDRESS: | 60 Middletown AvenueNorth Haven, Connecticut 06473 USA |
| CONTACT PERSON: | Michael KoczocikProduct Specialist, Regulatory Affairs |
| PHONE NUMBER: | (203) 492-6312 |
| FAX NUMBER: | (203) 492-5029 |
| DATE PREPARRED: | September 1, 2015 |
| TRADE/PROPRIETARY NAME: | Auto Suture™ Locking Trocar |
| COMMON/USUAL NAME: | Surgical Trocar |
| CLASSIFICATION NAME: | Endoscope and Accessories per 21 CFR §876.1500 |
| PRODUCT CODE: | GCJ |
| CLASSIFICATION PANEL NAME: | Gastroenterology and Urology |
| FDA PANEL NUMBER: | 78 |
| DEVICE CLASS: | Pursuant to 21 CFR § 876.1500 an endoscope andaccessories is a Class II device |
| PREDICATE DEVICE(S): | Auto Suture™ Locking Trocar K912980 |
| DEVICE DESCRIPTION: | The Auto Suture™ Locking Trocar is a sterile,single-use device designed for primary puncturesduring laparoscopy. |
| INTENDED USE: | This device is used during laparoscopy, creating aport of entry for laparoscopic instruments into theabdominal cavity. |
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| SUMMARY COMPARING THETECHNOLOGICALCHARACTERISTICS OF THEPROPOSED AND PREDICATEDEVICE(S) | The Auto Suture™ Locking Trocar is designed toprovide a port of entry for laparoscopic instrumentsinto the abdominal cavity. It consists of a two piecedesign; a housing cannula and an obturator. Thehousing consists of a duck bill valve to provide andair-tight seal for insertion and removal ofinstruments. The cannula contains a component atthe distal end that expands laterally, enlarging thediameter of the sleeve to secure the trocar sleeve tothe inner abdominal wall. The outer abdominal wallis secured by sliding the rubber ring toward thepatient. |
|---|---|
| MATERIALS: | All components of the Auto Suture™ Locking Trocarare comprised of materials which are in accordancewith ISO 10993-1 |
| PERFORMANCE DATA: | Bench Performance testing was conducted todemonstrate that the Auto Suture™ Locking Trocaris substantially equivalent to the predicate deviceand performs as intended |
| CONCLUSION: | The change is sterilization from gamma radiation toEthylene Oxide (EtO), and material change do notalter the performance of the device. The device isdetermined to be substantially equivalent to thepredicate device (Auto Suture™ Locking TrocarK912980). |
§ 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.