FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR

K141272 · Minimmally Invasive Devices · GCJ · Sep 4, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141272
• Device Name: FLOSHIELD 10MM ENDOSCOPIC CANNULA AND BLUNT OBTURATOR, FLOSHIELD 10MM ENDOSCOPIC CANNULA, FLOSHIELD 10MM BLUNT OBTURATOR
• Applicant: Minimmally Invasive Devices
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 4, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator is an access device indicated for use with a disposable 8.5 - 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.

Device Story

FloShield 10mm Endoscopic Cannula and Blunt Obturator is a reusable stainless steel access device for laparoscopic surgery. It functions as a port for endoscopic instruments (8.5-10mm OD). The device mates with a disposable Applied Medical 8.5-13mm Cannula Seal to maintain pneumoperitoneum. The blunt obturator facilitates insertion through an incision site. Used in clinical settings by surgeons; the device is delivered non-sterile and requires hospital-based cleaning and steam sterilization. It provides a stable passageway for instruments, enabling minimally invasive surgical access.

Clinical Evidence

Bench testing only. Performance testing verified port creation, maintenance of pneumoperitoneum, leak resistance, insufflating flow rates, insertion/removal force, and snap retention. Sterilization validation performed per ISO 17665:2006 and ANSI/AAMI ST81:2004 (R2010).

Technological Characteristics

Stainless steel construction; reusable; Hasson-style blunt obturator; female luer fitting for gas/instrument access; compatible with 8.5-13mm disposable seals; steam/moist heat sterilization; mechanical port-of-entry device.

Indications for Use

Indicated for patients undergoing general laparoscopic procedures requiring endoscopic instrument access; compatible with da Vinci Si Surgical System.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Karl Storz 10mm Reusable Trocar with Hasson Style Obturator (K943713, K943897)
• daVinci Si 8.5mm Reusable Accessory Cannula (K122532)
• daVinci Si 10mm Reusable Accessory Cannula (K122532)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 4, 2014

Minimally Invasive Devices Incorporated Ms. Trudie L. Seeger Vice President of Regulatory, Quality and Clinical Affairs 1275 Kinnear Road Columbus, Ohio 43212

Re: K141272

Trade/Device Name: FloShield 10mm Endoscopic Cannula and Blunt Obturator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 26, 2014 Received: August 27, 2014

Dear Ms. Seeger:

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 (reporting of medical

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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 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/Resourcesfor You/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.

Sincerely yours,

# David Krause -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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# Indications for Use

510(k) Number (if known) K141272

Device Name

FloShield 10mm Endoscopic Cannula and Blunt Obturator

#### Indications for Use (Describe)

The reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator is an access device indicated for use with a disposable 8.5 - 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) Summary (21 CFR §807.92(c))

| 510(k) Number: | K141272 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Minimally Invasive Devices, Inc.<br>1275 Kinnear Road<br>Columbus, Ohio 43212 |
| Contact: | Trudie L. Seeger, Ph.D.<br>V.P., Regulatory/Quality/Clinical Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Summary Prepared: | 08 Aug, 2014 |
| Device Trade Name: | FloShield 10mm Endoscopic Cannula and Blunt Obturator |
| Common Name: | Cannula and Obturator |
| Classification Name: | Laparoscope, General & Plastic Surgery (21 CFR §876.1500) |
| Product Code: | GCJ |
| Predicate Devices: | Karl Storz 10mm Reusable Trocar with Hasson Style Obturator<br>(K943713, K943897)<br>daVinci Si 8.5mm Reusable Accessory Cannula (K122532)<br>daVinci Si 10mm Reusable Accessory Cannula (K122532) |

#### Device Description:

The FloShield 10mm Endoscopic Cannula and Blunt Obturator are re-usable stainless steel endoscopic instruments delivered non-sterile to the hospital where it is cleaned, sterilized (steam / moist heat), and assembled prior to surgery. The FloShield 10mm stainless steel Cannula mates with a disposable Applied Medical 8.5 - 13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter). The stainless steel Obturator is a Hasson style, blunt tip obturator that facilitates the insertion of the cannula through an incision site.

510(k) Summary Page 1 of 3

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#### Intended Use/Indications for Use:

The reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator is an access device indicated for use with a disposable 8.5 – 13mm Cannula Seal manufactured by Applied Medical to provide a passageway for the introduction of endoscopic instruments in general laparoscopic procedures. The access device is compatible with the da Vinci Si Surgical System.

#### Comparison to Predicate Devices:

The FloShield 10mm Endoscopic Cannula and Blunt Obturator has the same design, materials and intended use as the Karl Storz 10mm Reusable Trocar with Hasson Style Obturator (K943713, K943897), the daVinci Si 10mm Reusable Accessory Cannula (K122532) and the daVinci Si 8.5mm Reusable Accessory Cannula (K122532).

#### Technological Characteristics:

The technological characteristic of the FloShield 10mm Endoscopic Cannula and Blunt Obturator are very similar to the predicate devices. All cannulas are stainless steel and reusable. The stainless steel Cannula has the ability to connect to a standard male luer fitting, via the female luer that is present on the Cannula. The device will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter). The Karl Storz 10mm Reusable Trocar has an additional stopcock valve in its Luer fitting and has a reusable gas and instrument seal. The FloShield 10mm Endoscopic Cannula, daVinci Si 8.5mm Reusable Accessory Cannula (K122532), and the daVinci 10mm Reusable Accessory Cannula all use the disposable 8.5 - 13mm Cannula Seal manufactured and supplied sterile by Applied Medical. The obturators function identically (i.e., facilitates the insertion of the cannula through an incision site) with the only difference being that the Karl Storz Hasson Style Obturator is a concal blunt obturator and the FloShield Blunt Obturator and the da Vinci Blunt Obturator are full blunt Hasson obturators. FloShield Blunt Obturator and the Karl Storz Hasson Style Obturators are made of stainless steel and the daVinci Blunt Obturator is made of plastic all devices will accommodate a standard 8.5mm to 10mm endoscopic instrument (outside diameter).

# 510(k) Summarv Page 2 of 3

# Performance Testing:

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The performance and functional testing of the FloShield 10mm Endoscopic Cannula and Blunt Obturator included tests to verify its ability to create and maintain a port of entry during simulated laparoscopic surgery, its ability to maintain pneumoperitoneum during the course of surgery and comparable functional characteristics to the predicates (Leak Resistance, Insufflating Flow Rates, Insertion and Removal Force, Snap Retention).

Sterilization validation for reusable devices was successfully performed in accordance with ISO 17665: 2006 Sterilization of Healthcare Products - Moist Heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices and ANSI/AAMI ST81:2004 (R2010): Sterilization of Medical Devices - Information to be provided by the manufacturer for the processing of re-sterilizable medical devices.

# Conclusion Drawn from Tests and Analyses:

The intended use and performance parameters of the FloShield 10mm Endoscopic Cannula and Blunt Obturator are similar or equivalent to the characteristics of the Karl Storz 10mm Reusable Trocar with Hasson Style Obturator (K943713, K943897), the daVinci Si 8.5mm Reusable Accessory Cannula (K122532), and the daVinci Si 10mm Reusable Accessory Cannula (K122532) as determined in Section 12.0 of this Premarket Notification (510(k)) submission.

510(k) Summary Page 3 of 3