Who is the manufacturer of Reprocessed Endoscopic Trocars and Sleeves?

Stryker Sustainability Solutions filed the 510(k) submission for Reprocessed Endoscopic Trocars and Sleeves (K201511).

What is the FDA product code for Reprocessed Endoscopic Trocars and Sleeves?

NLM. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Reprocessed Endoscopic Trocars and Sleeves?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Reprocessed Endoscopic Trocars and Sleeves?

ENDOPATH III Bladeless Trocars (K032676); ENDOPATH XCEL TROCAR WITH OPTIVIEW TECHNOLOGY (K122511).

Who can help prepare an FDA 510(k) submission like Reprocessed Endoscopic Trocars and Sleeves?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Reprocessed Endoscopic Trocars and Sleeves

K201511 · Stryker Sustainability Solutions · NLM · Jul 31, 2020 · Gastroenterology, Urology

Device Facts

Record ID	K201511
Device Name	Reprocessed Endoscopic Trocars and Sleeves
Applicant	Stryker Sustainability Solutions
Product Code	NLM · Gastroenterology, Urology
Decision Date	Jul 31, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended Use

The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The Bladeless Trocars may be used with or without visualization for primary and secondary insertions.

Device Story

Reprocessed sterile, single-patient-use endoscopic trocars and sleeves; sizes 5-12mm. Input: manual insertion into abdominal/thoracic cavity. Operation: provides entry path for endoscopic instruments; includes bladeless (optical), dilating (bladed with shield), or blunt tip obturators. Features include stopcock valves for gas insufflation/desufflation and dual-seal sleeves to minimize gas leakage. Optiview technology reduces lens smudging. Used in OR by surgeons. Output: established surgical access port. Benefits: enables minimally invasive procedures; reprocessed to restore original function; includes replacement of stability plug components. Healthcare providers use visual feedback (via endoscope) and mechanical access to perform surgery.

Clinical Evidence

Bench testing only. Testing included biocompatibility, reprocessing validation, sterilization validation, and functional performance testing (insertion force, leak testing, obturator engagement, shield lock engagement, and device integrity).

Technological Characteristics

Materials: Polycarbonate (cannula, hub, seal, stopcock, obturator tip), 300-series stainless steel (obturator shaft), rubber (gasket), polyethylene (stopcock lever). Mechanical sensing/actuation. Sterile by Ethylene Oxide. Single-patient use. No software/electronics.

Indications for Use

Indicated for patients undergoing abdominal, thoracic, or gynecologic minimally invasive surgery requiring endoscopic instrument access. Contraindicated when minimally invasive techniques are contraindicated.

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

ENDOPATH III Bladeless Trocars (K032676)
ENDOPATH XCEL TROCAR WITH OPTIVIEW TECHNOLOGY (K122511)

Related Devices

K160740 — Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology · Surgical Instrument Service and Savings, Inc. · May 6, 2016
K153258 — Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars · Surgical Instrument Service and Savings (Dba Medline Renewal · Apr 5, 2016
K121240 — REPROCESSED ENDOSCOPIC TROCARS · Sterilmed, Inc. · Jun 11, 2012
K132629 — REPROCESSED DILATING TIP TROCARS · Stryker Sustainability Solutions · Dec 31, 2013
K043592 — REPROCESSED ENDOSCOPIC TROCAR · Sterilmed, Inc. · May 23, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 31, 2020 Stryker Sustainability Solutions Ms. Ramona Kulik, BS MET Staff Specialist, Regulatory Affairs 1810 W. Drake Drive Tempe. Arizona 85283 Re: K201511 Trade/Device Name: Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5ST, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NLM Dated: June 2, 2020 Received: June 5, 2020 Dear Ms.Kulik: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201511 #### Device Name Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) #### Indications for Use (Describe) The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2CB5ST, 2CB5LT) have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The Bladeless Trocars may be used with or without visualization for primary and secondary insertions. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED#### 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." {3}------------------------------------------------ # Reprocessed Device Models Included in Submission K201511: | OM | Model | Description | Sleeve | Shaft | Shaft | |---------|---------|-------------------------------------------------------------|-----------|----------|--------| | | Numbers | | Style | Diameter | Length | | Ethicon | B5LT | XCEL Bladeless Trocar | Stability | 5mm | 100mm | | Ethicon | B5ST | XCEL Bladeless Trocar | Stability | 5mm | 75mm | | Ethicon | B11LT | XCEL Bladeless Trocar | Stability | 11mm | 100mm | | Ethicon | B12LT | XCEL Bladeless Trocar | Stability | 12mm | 100mm | | Ethicon | H12LP | XCEL Blunt Tip Trocar | Smooth | 12mm | 100mm | | Ethicon | D5LT | XCEL Dilating Tip Trocar | Stability | 5mm | 100mm | | Ethicon | D5ST | XCEL Dilating Tip Trocar | Stability | 5mm | 75mm | | Ethicon | D11LT | XCEL Dilating Tip Trocar | Stability | 11mm | 100mm | | Ethicon | D12LT | XCEL Dilating Tip Trocar | Stability | 12mm | 100mm | | Ethicon | 2B5ST | XCEL Bladeless Trocar w/Optiview Technology | Stability | 5mm | 75mm | | Ethicon | 2B5LT | XCEL Bladeless Trocar w/Optiview Technology | Stability | 5mm | 100mm | | Ethicon | 2D5ST | XCEL Dilating Tip Trocar w/Optiview Technology | Stability | 5mm | 75mm | | Ethicon | 2D5LT | XCEL Dilating Tip Trocar w/Optiview Technology | Stability | 5mm | 100mm | | Ethicon | CB5LT | XCEL Trocar Sleeve | Stability | 5mm | 100mm | | Ethicon | CB5ST | XCEL Trocar Sleeve | Stability | 5mm | 75mm | | Ethicon | CB11LT | XCEL Trocar Sleeve | Stability | 11mm | 100mm | | Ethicon | CB12LT | XCEL Trocar Sleeve | Stability | 12mm | 100mm | | Ethicon | 2CB5LT | XCEL Universal Stability Sleeve w/Optiview Technology | Stability | 5mm | 100mm | | Ethicon | 2CB5ST | XCEL Universal Stability Sleeve w/Optiview Technology | Stability | 5mm | 75mm | {4}------------------------------------------------ # K201511 ## 510(k) SUMMARY #### Submitter: Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283 ## Contact: Ms. Ramona Kulik, BS MET Staff Specialist, Regulatory Affairs 480-763-2952 (c) 480-763-2965 (f) ramona.kulik@stryker.com ## Date of Preparation: # Name of Device: | Trade/Proprietary Name: | Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, B5ST, CB11LT,CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) | |-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Common Name: | Trocars and Sleeves | | Classification Information: | Laparoscope, General and Plastic Surgery, Reprocessed | | Regulation Number: | 876.1500 | | Product Code: | NLM | #### Predicate Device: | 510(k) Number | 510(k) Title | Original Manufacturer | |---------------|--------------------------------------------------|------------------------------| | K032676 | ENDOPATH III Bladeless Trocars | ETHICON ENDO-SURGERY, LLC | | K122511 | ENDOPATH XCEL TROCAR WITH OPTIVIEW TECHNOLOGY | ETHICON ENDO-SURGERY, LLC | {5}------------------------------------------------ ### Device Description: The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5LT, B5ST, CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) are sterile, single patient use instruments consisting of a radiolucent sleeve (cannula) and obturators in sizes ranging from 5-12 mm in diameter. There different obturators; Bladeless, Dilating Tip (Bladed) and Blunt Tip. The bladeless obturator contains a clear, tapered optical element, and when used with an endoscope provides visibility of individual tissue layers during insertion. The Dilating Tip (Bladed) obturator has a sharp, flat-bladed tip and spring-loaded shield. The 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 Blunt Tip obturator has a blunt plastic tip which gently moves aside any viscera that may be adjacent to abdominal or thoracic wall. The trocar sleeve contains two seals that accommodate instruments. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. Please note that the 5mm bladeless trocar cannula without Optiview Technology does not have the outer integrated self-adjusting seal and only accommodates 5mm instruments. 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. Trocars with Optiview Technology incorporates a design enhancement that reduces the incidence of trocar induced endoscope lens smudging during endoscope insertion. The Reprocessed Sleeves are sterile, single patient use devices with a radiolucent sleeve (cannula). The trocar sleeve contains two seals that accommodate instruments. Together, these two seals minimize qas leakage when instruments are inserted or withdrawn through the trocar. Please note that the 5mm trocar cannula without Optiview Technology does not have the outer integrated self-adjusting seal and only accommodates 5mm instruments. 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. | OM | Model Numbers | Description | Sleeve Style | Shaft Diameter | Shaft Length | |---------|------------------|-----------------------------|-----------------|-------------------|-----------------| | Ethicon | B5LT | XCEL Bladeless Trocar | Stability | 5mm | 100mm | | Ethicon | B5ST | XCEL Bladeless Trocar | Stability | 5mm | 75mm | | Ethicon | B11LT | XCEL Bladeless Trocar | Stability | 11mm | 100mm | | Ethicon | B12LT | XCEL Bladeless Trocar | Stability | 12mm | 100mm | | Ethicon | H12LP | XCEL Blunt Tip Trocar | Smooth | 12mm | 100mm | | Ethicon | D5LT | XCEL Dilating Tip Trocar | Stability | 5mm | 100mm | | Ethicon | D5ST | XCEL Dilating Tip Trocar | Stability | 5mm | 75mm | | Ethicon | D11LT | XCEL Dilating Tip Trocar | Stability | 11mm | 100mm | | Ethicon | D12LT | XCEL Dilating Tip Trocar | Stability | 12mm | 100mm | The model numbers included in the scope of this submission are as follows: {6}------------------------------------------------ | Ethicon | 2B5ST | XCEL Bladeless Trocar w/Optiview Technology | Stability | 5mm | 75mm | |---------|--------|-------------------------------------------------------------|-----------|------|-------| | Ethicon | 2B5LT | XCEL Bladeless Trocar w/Optiview Technology | Stability | 5mm | 100mm | | Ethicon | 2D5ST | XCEL Dilating Tip Trocar w/Optiview Technology | Stability | 5mm | 75mm | | Ethicon | 2D5LT | XCEL Dilating Tip Trocar w/Optiview Technology | Stability | 5mm | 100mm | | Ethicon | CB5LT | XCEL Trocar Sleeve | Stability | 5mm | 100mm | | Ethicon | CB5ST | XCEL Trocar Sleeve | Stability | 5mm | 75mm | | Ethicon | CB11LT | XCEL Trocar Sleeve | Stability | 11mm | 100mm | | Ethicon | CB12LT | XCEL Trocar Sleeve | Stability | 12mm | 100mm | | Ethicon | 2CB5LT | XCEL Universal Stability Sleeve w/Optiview Technology | Stability | 5mm | 100mm | | Ethicon | 2CB5ST | XCEL Universal Stability Sleeve w/Optiview Technology | Stability | 5mm | 75mm | ## Indications for Use: The Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5ST,CB11LT, CB12LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The Bladeless Trocars may be used with or without visualization for primary and secondary insertions. ### Substantial Equivalence Table of Reprocessed Endoscopic Trocars and Sleeves and Endopath Bladeless Trocars, Endopath Blunt Tip Trocars, Endopath Dilating Tip Trocars and Ehicon Endopath XCEL Trocars (Bladeless, Blunt Tip, Dilating Tip) with Optiview Technology: | Characteristic | Ethicon Endo-Surgery (K032676) Endopath Bladeless Trocars Endopath Blunt Tip Trocars Endopath Dilating Tip Trocars | Ethicon Endo-Surgery Ethicon Endopath XCEL Trocars Bladeless, Blunt Tip, Dilating Tip w/Optiview Technology K122511 | Stryker Sustainability Solutions Reprocessed Endoscopic Trocars and Sleeves | | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Indications for Use | The Endopath 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 | The Endopath XCEL Bladeless Trocar with Optiview Technology has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may | The Reprocessed Endoscopic Trocars and Sleeves have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The Bladeless Trocars may be used with or | | | | | primary and secondary insertions. | be used with or without visualization for primary and secondary insertions. | without visualization for primary and secondary insertions. | | | | The Endopath Blunt Tip Trocar has applications in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments. | The Endopath XCEL Blunt Tip Trocar with Optiview Technology has applications in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments. | | | | | The Endopath Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy ant other abdominal procedures to establish a path of entry for endoscopic instruments. | The Endopath XCEL Dilating Tip Trocar with Optiview Technology has applications in thoracic, gynecologic laparoscopy ant other abdominal procedures to establish a path of entry for endoscopic instruments. | | | | | | The Endopath XCEL Universal Trocar Stability Sleeve with Optiview Technology has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments. | | | | Contra-indications | This device is not intended for use when minimally invasive techniques are contraindicated. | The device is not intended for use when minimally invasive techniques are contraindicated. | Any uses generally contraindicated for minimally invasive techniques. | | Materials | | | | | | | Cannula Shaft | Polycarbonate | Polycarbonate | Polycarbonate | | | Cannula Hub/Housing | Polycarbonate | Polycarbonate | Polycarbonate | | | Cannula Seal | Polycarbonate | Polycarbonate | Polycarbonate | | | Cannula Gasket | Rubber | Rubber | Rubber | | Material composition | Stopcock Valve | Polycarbonate | Polycarbonate | Polycarbonate | | | Stopcock Lever | Polyethylene | Polyethylene | Polyethylene | | | Obturator Shaft | Stainless Steel (300 series) Polycarbonate (Blunt Tip Trocar- H12LP) | Stainless Steel (300 series) Polycarbonate (Blunt Tip Trocar-H12LP) | Stainless Steel (300 series) Polycarbonate (Blunt Tip Trocar- H12LP) | | | Obturator Tip | Polycarbonate | Polycarbonate | Polycarbonate | | Sterility | | Sterile by Irradiation | Sterile by Irradiation | Sterile by Ethylene Oxide | | Uses | | Single-patient use | Single-patient use | Single-patient use | | Pyrogenicity | No | No | No | | {7}------------------------------------------------ {8}------------------------------------------------ ### Summary of Technological Characteristics: The design, materials, and intended use of Reprocessed Endoscopic Trocars and Sleeves are identical to the predicate devices. The mechanism of Reprocessed Endoscopic Trocars and 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 Endoscopic Trocars and Sleeves includes removal of adherent visible soil and decontamination and replacement of the stability plug suture clips and stability plug clamp. Each individual Endoscopic Trocars and Sleeves are tested for appropriate function of its components prior to packaging and labeling operations. #### Performance Data: Bench and laboratory testing were conducted to demonstrate performance (safety and effectiveness) of Reprocessed Endoscopic Trocars and Sleeves. This included the following tests: - Biocompatibilitv ● - Validation of Reprocessing - Sterilization Validation - . Functional Performance Testing Device Aesthetics Peak Insertion Force Stability Pluq Clip Integrity Stability Plug Clamp Integrity Trocar Leak Test Obturator Engagement Cannula Housing Integrity Obturator Housing Integrity Cannula Sleeve Integrity Insertion/Withdrawal Forces - Obturator to Cannula Device Integrity Peak Insertion Force Obturator Engagement Shield Lock Engagement Force Blade Shield Engagement - Packaging Validation ● The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended. The Reprocessed Endoscopic Trocars and Sleeves are reprocessed no more than one (1) time. Each reprocessed device is tracked with a Stryker pad print on the device indicating the device has been reprocessed one (1) time. Once the device reaches the maximum number or reprocessing cycles, it is rejected and taken out of service. Reprocessing is conducted only by Stryker Sustainability Solutions. Stryker Sustainability Solutions restricts its reprocessing to exclude devices previously reprocessed by other companies. {9}------------------------------------------------ ## Conclusion: The results of bench and laboratory testing demonstrate that the Reprocessed Endoscopic Trocars and Sleeves (B11LT, B12LT, B5ST, CB11LT, CB12LT, CB5LT, CB5LT, CB5ST, D11LT, D12LT, D5LT, D5ST, H12LP, 2B5LT, 2B5ST, 2D5LT, 2D5ST, 2CB5ST, 2CB5LT) are at least as safe and effective and perform as well as the identified legally marketed predicate devices as described herein.