REPROCESSED DILATING TIP TROCARS

K132629 · Stryker Sustainability Solutions · NLM · Dec 31, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K132629
• Device Name: REPROCESSED DILATING TIP TROCARS
• Applicant: Stryker Sustainability Solutions
• Product Code: NLM · Gastroenterology, Urology
• Decision Date: Dec 31, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions. The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments. The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

Device Story

Reprocessed sterile, single-patient-use surgical instruments including bladeless trocars, dilating tip trocars, and stability sleeves. Bladeless trocar features radiolucent sleeve and obturator with clear, tapered optical element for 5mm endoscope visualization. Dilating tip trocar features sharp, flat-bladed tip with spring-loaded shield to protect internal structures. Stability sleeve provides access port. All devices include dual-seal system to minimize gas leakage and stopcock valve for insufflation/desufflation. Used in OR by surgeons for minimally invasive procedures. Devices function as mechanical access ports; output is physical entry path for instruments. Reprocessing involves cleaning, decontamination, and functional testing to ensure performance equivalent to original devices.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, functional testing, and packaging validation. No clinical data presented.

Technological Characteristics

Radiolucent sleeve (cannula) and obturator. Bladeless version includes optical element; dilating tip version includes spring-loaded shield. Dual-seal system for 5mm instruments. Stopcock valve for luer lock gas insufflation. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing abdominal, thoracic, or gynecologic minimally invasive surgical procedures requiring an entry path for endoscopic instruments.

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

• Reprocessed Trocars (K062497)
• Reprocessed Xcel Bladed Trocars (K070059)
• ENDOPATH XCEL BLADELESS TROCAR WITH OPTIVIEW TECHNOLOGY ENDOPATH XCEL BLUNT TIP TROCAR WITH OPTIVIEW TECHNOLOGY (K122511)

Submission Summary (Full Text)

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## K132629

## SECTION 5: 510(k) SUMMARY

#### Submitter:

t

Stryker Sustainability Solutions 1810 W Drake Drive Tempe, Arizona 85283

#### Contact:

Amanda Babcock Regulatory Affairs Lead [phone] (o) [phone] (f) [e-mail]

Date of preparation: August 20, 2013

Trade/Proprietary Name: Reprocessed Trocars and Stability Name of device: Sleeve

> Classification Name: Laparoscope, General & Plastic Surgery, Reprocessed

| Classification<br>Information: | Class: | II |
|--------------------------------|---------------|--------------------------|
| | Panel: | Gastroenterology/Urology |
| | Product Code: | NLM |
| | Citation: | 21 CFR §876.1500 |

| Predicate<br>Device | 510(k) Title | Manufacturer |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| K062497 | Reprocessed Trocars | Stryker Sustainability Solutions |
| K070059 | Reprocessed Xcel Bladed Trocars | Stryker Sustainability Solutions |
| K122511 | ENDOPATH XCEL BLADELESS<br>TROCAR WITH OPTIVIEW<br>TECHNOLOGY ENDOPATH XCEL<br>BLUNT TIP TROCAR WITH<br>OPTIVIEW TECHNOLOGY | Ethicon Endo-Surgery |

#### Device Description:

Reprocessed Bladeless Trocar:

The Reprocessed Bladeless Trocar, is a sterile single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator contains a clear, tapered optical element. The 5 mm obturator accommodates an appropriately sized 0° endoscope and provides visibility of individual tissue layers during insertion. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

> Stryker Sustainability Solutions Reprocessed Trocars and Stability Sieeve Traditional 510(k)

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### Reprocessed Dilating Tip (Bladed) Trocar:

The Reprocessed Dilating Tip Trocar is a sterile, single patient use instrument consisting of a radiolucent sleeve (cannula) and obturator. The obturator has a sharp, flat-bladed tip and spring-loaded shield is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

#### Reprocessed Stability (Universal) Sleeve (Cannula):

The Reprocessed Stability Sleeve is a sterile, single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5 mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.

#### Indications for Use:

#### Reprocessed Bladeless Trocar:

The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.

#### Reprocessed Dilating Tip Trocar:

The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

#### Reprocessed Stability Sleeve:

The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

#### Technological Characteristics:

The design, materials, and intended use of Reprocessed Bladeless Trocar, Reprocessed Dilating Tip Trocar, and Reprocessed Stability Sleeves are identical to the predicate devices. The mechanism of action of Reprocessed Bladeless Trocar. Reprocessed Dilating Tip Trocar, and Reprocessed Stability Sleeves are identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of Bladeless Trocars. Dilating Tip Trocars, and Stability Sleeves includes removal of adherent visible soil and decontamination. Each individual Bladeless Trocar. Dilating Tip Trocar and Stability Sleeve is tested for appropriate function of its components prior to packaging and labeling operations.

> Stryker Sustainability Solutions Reprocessed Trocars and Stability Sleeve Traditional 510(k)

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## Performance data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Bladeless Trocar, Reprocessed Dilating Tip Trocar, and Reprocessed Stability Sleeves. This included the following tests:

- . Biocompatibility
- Validation of reprocessing .
- Sterilization Validation .
- 0 Function test(s)
- Packaging Validation .

Performance testing demonstrates that Reprocessed Bladeless Trocar, Reprocessed Dilating Tip Trocar, and Reprocessed Stability Sleeves perform as originally intended.

#### Conclusion:

Stryker Sustainability Solutions concludes that the reprocessed devices are as safe and effective to the predicate devices as described herein.

#### Stryker Sustainability Solutions Reprocessed Trocars and Stability Sleeve Traditional 510(k)

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized human figure with three lines representing the body, arms, and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written in bold, uppercase letters to the right of the figure. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 31, 2013

Stryker Sustainability Solutions % Ms. Amanda Babcock Regulatory Affairs Lead 1810 West Drake Drive Tempe, Arizona 85283

Re: K132629

Trade/Device Name: Reprocessed Dilating Tip Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NLM Dated: September 9, 2013 Received: September 23, 2013

Dear Ms. Babcock:

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): Jabeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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Page 2 - Ms. Amanda Babcock

..............................................................................................................................................................................

quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYowIndustry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar : S. 2013.12.31 11:34:41 -05'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K132629

Device Name: Reprocessed ENDOPATH® XCEL™ Bladeless Trocar with OPTIVIEW® Technology

Indications For Use: The Reprocessed Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.

Device Name: Reprocessed ENDOPATH® XCEL™ Dilating Tip Trocar with OPTIVIEW® Technology

Indications For Use: The Reprocessed Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

Device Name: Reprocessed ENDOPATH® XCEL™ Universal Trocar Stability Sleeve

Indications For Use: The Reprocessed Stability Sleeve has application in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.

AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)

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)

# David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K132629

> Stryker Sustainability Solutions Reprocessed Trocars and Stability Sleeve Traditional 510(k)

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