Auto Suture Locking Trocar

K152565 · Covidien · GCJ · Oct 9, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K152565
• Device Name: Auto Suture Locking Trocar
• Applicant: Covidien
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 9, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

This device is used during laparoscopy, creating a port of entry for laparoscopic instruments into the abdominal cavity.

Device Story

Auto Suture™ Locking Trocar is a sterile, single-use surgical instrument for laparoscopic access. Device consists of two-piece design: housing cannula and obturator. Housing features duck bill valve for air-tight seal during instrument insertion/removal. Cannula includes distal component that expands laterally to secure sleeve to inner abdominal wall; rubber ring slides toward patient to secure outer abdominal wall. Used in clinical/OR settings by surgeons to facilitate instrument passage into abdominal cavity. Device provides stable port for laparoscopic surgery, enabling minimally invasive access.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Two-piece design (housing cannula and obturator); duck bill valve for air-tight seal; laterally expanding distal component for abdominal wall securement; rubber ring for external securement. Materials comply with ISO 10993-1. Sterilization method: Ethylene Oxide (EtO).

Indications for Use

Indicated for use during laparoscopic procedures to create a point of entry for laparoscopic instruments into the abdominal cavity.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Auto Suture™ Locking Trocar (K912980)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

K152565

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)

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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<br>North Haven, Connecticut 06473 USA |
| CONTACT PERSON: | Michael Koczocik<br>Product Specialist, Regulatory Affairs |
| PHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| 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 §<br>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<br>accessories is a Class II device |
| PREDICATE DEVICE(S): | Auto Suture™ Locking Trocar K912980 |
| DEVICE DESCRIPTION: | The Auto Suture™ Locking Trocar is a sterile,<br>single-use device designed for primary punctures<br>during laparoscopy. |
| INTENDED USE: | This device is used during laparoscopy, creating a<br>port of entry for laparoscopic instruments into the<br>abdominal cavity. |

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| SUMMARY COMPARING THE<br>TECHNOLOGICAL<br>CHARACTERISTICS OF THE<br>PROPOSED AND PREDICATE<br>DEVICE(S) | The Auto Suture™ Locking Trocar is designed to<br>provide a port of entry for laparoscopic instruments<br>into the abdominal cavity. It consists of a two piece<br>design; a housing cannula and an obturator. The<br>housing consists of a duck bill valve to provide and<br>air-tight seal for insertion and removal of<br>instruments. The cannula contains a component at<br>the distal end that expands laterally, enlarging the<br>diameter of the sleeve to secure the trocar sleeve to<br>the inner abdominal wall. The outer abdominal wall<br>is secured by sliding the rubber ring toward the<br>patient. |
|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MATERIALS: | All components of the Auto Suture™ Locking Trocar<br>are comprised of materials which are in accordance<br>with ISO 10993-1 |
| PERFORMANCE DATA: | Bench Performance testing was conducted to<br>demonstrate that the Auto Suture™ Locking Trocar<br>is substantially equivalent to the predicate device<br>and performs as intended |
| CONCLUSION: | The change is sterilization from gamma radiation to<br>Ethylene Oxide (EtO), and material change do not<br>alter the performance of the device. The device is<br>determined to be substantially equivalent to the<br>predicate device (Auto Suture™ Locking Trocar<br>K912980). |