(30 days)
Not Found
No
The device description and performance studies focus on mechanical function and equivalence to a predicate device, with no mention of AI/ML terms or image processing.
No.
The device facilitates entry into the abdominal cavity for laparoscopic instruments; it does not treat a disease or condition itself.
No
Explanation: The device description states its use for creating a point of entry for laparoscopic instruments, which is an interventional/surgical procedure, not a diagnostic one.
No
The device description explicitly states it is a "sterile, single-use device designed for primary punctures during laparoscopy," which describes a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to create a point of entry for laparoscopic instruments into the abdominal cavity during surgery. This is a surgical procedure performed on a living patient.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are performed outside of the body.
- Device Description: The description confirms it's a surgical tool used for primary punctures during laparoscopy.
The information clearly indicates this device is used in vivo (within a living organism) for a surgical procedure, not in vitro (in a lab setting) for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
This device is used during laparoscopy, creating a point of entry for laparoscopic instruments into the abdominal cavity.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Auto Suture™ Locking Trocar is a sterile, single-use device designed for primary punctures during laparoscopy. The Auto Suture™ Locking Trocar is designed to provide a port of entry for laparoscopic instruments into the abdominal cavity. It consists of a two piece design; a housing cannula and an obturator. The housing consists of a duck bill valve to provide and air-tight seal for insertion and removal of instruments. The cannula contains a component at the distal end that expands laterally, enlarging the diameter of the sleeve to secure the trocar sleeve to the inner abdominal wall. The outer abdominal wall is secured by sliding the rubber ring toward the patient.
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)
Bench Performance testing was conducted to demonstrate that the Auto Suture™ Locking Trocar is substantially equivalent to the predicate device and performs as intended. The change is sterilization from gamma radiation to Ethylene Oxide (EtO), and material change do not alter the performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Auto Suture™ Locking Trocar K912980
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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)
1
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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 Avenue |
| North Haven, Connecticut 06473 USA | |
| CONTACT PERSON: | Michael Koczocik |
| Product 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 and |
| accessories 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 punctures | |
| during laparoscopy. | |
| INTENDED USE: | This device is used during laparoscopy, creating a |
| port of entry for laparoscopic instruments into the | |
| abdominal cavity. |
4
| SUMMARY COMPARING THE
TECHNOLOGICAL
CHARACTERISTICS OF THE
PROPOSED AND PREDICATE
DEVICE(S) | The Auto Suture™ Locking Trocar is designed to
provide a port of entry for laparoscopic instruments
into the abdominal cavity. It consists of a two piece
design; a housing cannula and an obturator. The
housing consists of a duck bill valve to provide and
air-tight seal for insertion and removal of
instruments. The cannula contains a component at
the distal end that expands laterally, enlarging the
diameter of the sleeve to secure the trocar sleeve to
the inner abdominal wall. The outer abdominal wall
is secured by sliding the rubber ring toward the
patient. |
|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MATERIALS: | All components of the Auto Suture™ Locking Trocar
are comprised of materials which are in accordance
with ISO 10993-1 |
| PERFORMANCE DATA: | Bench Performance testing was conducted to
demonstrate that the Auto Suture™ Locking Trocar
is substantially equivalent to the predicate device
and performs as intended |
| CONCLUSION: | The change is sterilization from gamma radiation to
Ethylene Oxide (EtO), and material change do not
alter the performance of the device. The device is
determined to be substantially equivalent to the
predicate device (Auto Suture™ Locking Trocar
K912980). |