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.

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 Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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 Together, these two seals minimize qas leakage when instruments are inserted or withdrawn through the trocar.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.

AI/ML Overview

The provided text is a 510(k) summary for the reprocessing of endoscopic trocars and sleeves. It outlines the device description, indications for use, and a comparison to predicate devices, focusing on the equivalence of the reprocessed devices to the original, new devices. However, the document does NOT contain information about a study proving the device meets acceptance criteria in the way one might expect for a digital health or AI/ML-enabled medical device, as it's not evaluating algorithm performance.

Instead, this document describes the validation of reprocessing for a physical medical device. The "acceptance criteria" here refer to the performance standards that the reprocessed physical device must meet to demonstrate it is "at least as safe and effective" as the original, new device.

Therefore, I will interpret the request in the context of the provided document, addressing the closest equivalents to the requested information. It's important to note that many of the requested fields (e.g., number of experts for ground truth, MRMC study, training set sample size) are not applicable to the type of device and study described in this 510(k) summary.

Acceptance Criteria and Study for Reprocessed Endoscopic Trocars and Sleeves

The document describes the regulatory submission for the reprocessing of Endoscopic Trocars and Sleeves, asserting their substantial equivalence to predicate (new) devices. The acceptance criteria and the "study" proving this equivalence are based on a set of bench and laboratory tests designed to demonstrate that the reprocessed devices maintain their original performance, safety, and effectiveness.

1. A table of acceptance criteria and the reported device performance

The document does not provide a quantitative table of acceptance criteria and reported numerical performance values for each test. Instead, it lists the types of performance tests conducted and then makes a general statement about their outcome. The implicit acceptance criterion for each test is that the reprocessed device performs comparably to the new device and maintains its safety and effectiveness.

Category	Specific Test / Criterion	Reported Device Performance
Biocompatibility	Biocompatibility testing. (Implicit criterion: no unacceptable biological risk introduced by reprocessing).	Conducted. (Implicitly: The reprocessed devices meet biocompatibility standards and are as safe as the predicate devices).
Reprocessing Valid.	Validation of Reprocessing (e.g., cleaning efficacy, material compatibility after reprocessing cycles). (Implicit criterion: reprocessing effectively cleans and does not degrade the device below performance standards, with a limit of 1 reprocessing cycle).	Conducted. The devices are reprocessed no more than one (1) time. Each reprocessed device is tracked and rejected if it reaches the maximum number of cycles. Reprocessing is restricted to devices not previously reprocessed by others. (Implicitly: Validated as effective).
Sterilization Valid.	Sterilization Validation (e.g., sterility assurance level, material compatibility with sterilization method). (Implicit criterion: device maintains sterility after reprocessing and sterilization without degradation).	Conducted. (Implicitly: Devices are sterile by Ethylene Oxide and maintain their integrity).
Functional Performance	- Device Aesthetics- Peak Insertion Force- Stability Plug 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	Bench and laboratory testing were conducted to demonstrate performance. The performance testing demonstrates that reprocessed devices are as safe and effective as the predicate and operate as originally intended.
Aging/Durability	(Implicit criterion: device functions after reprocessing and maintains properties for intended shelf life).	Reprocessed no more than one (1) time; implies that performance is maintained for this single reprocessing cycle.
Packaging Validation	Packaging Validation. (Implicit criterion: packaging maintains sterility and device integrity).	Conducted.

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each of the conducted tests (e.g., number of reprocessed trocars tested for leak, insertion force, etc.).
The data provenance is from bench and laboratory testing conducted by Stryker Sustainability Solutions. It is prospective in the sense that the tests were specifically performed to support this 510(k) submission, not retrospectively analyzed from existing data. The country of origin for the testing is not explicitly stated but can be inferred as the United States, given the FDA submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable in the context of this device and study. The "ground truth" for a reprocessed physical device is established by engineering specifications, material properties, and functional performance benchmarks derived from the original, new predicate devices. It does not involve expert readers reviewing images or clinical data for diagnosis. The "experts" involved are likely engineers, quality assurance personnel, and regulatory affairs specialists who designed and executed the tests and evaluated the results against objective performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing medical images) to establish a consensus ground truth. For physical device performance testing, acceptance is determined by meeting pre-defined quantitative or qualitative engineering specifications, not human consensus on a clinical outcome.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This is a submission for a reprocessed physical medical device, not an AI/AI-assisted device. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on engineering specifications and functional performance characteristics of the original, new predicate devices. The reprocessed devices are tested to ensure they maintain these validated characteristics. This includes:

Physical dimensions and integrity
Mechanical function (e.g., insertion force, leak tests, engagement of components)
Material properties (implied by biocompatibility and sterilization validation)
Sterility

Essentially, the ground truth is the "performance profile of a new, unused device."

8. The sample size for the training set

This question is not applicable. This is a physical medical device undergoing reprocessing validation, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable for the same reason as point 8.

Summary

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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

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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

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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)

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)

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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 TipTrocar	Stability	5mm	100mm
Ethicon	D5ST	XCEL Dilating TipTrocar	Stability	5mm	75mm
Ethicon	D11LT	XCEL Dilating TipTrocar	Stability	11mm	100mm
Ethicon	D12LT	XCEL Dilating TipTrocar	Stability	12mm	100mm
Ethicon	2B5ST	XCEL Bladeless Trocarw/Optiview Technology	Stability	5mm	75mm
Ethicon	2B5LT	XCEL Bladeless Trocarw/Optiview Technology	Stability	5mm	100mm
Ethicon	2D5ST	XCEL Dilating TipTrocar w/OptiviewTechnology	Stability	5mm	75mm
Ethicon	2D5LT	XCEL Dilating TipTrocar w/OptiviewTechnology	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 UniversalStability Sleevew/Optiview Technology	Stability	5mm	100mm
Ethicon	2CB5ST	XCEL UniversalStability Sleevew/Optiview Technology	Stability	5mm	75mm

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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 WITHOPTIVIEW TECHNOLOGY	ETHICON ENDO-SURGERY,LLC

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Device Description:

Trocars with Optiview Technology incorporates a design enhancement that reduces the incidence of trocar induced endoscope lens smudging during endoscope insertion.

OM	ModelNumbers	Description	SleeveStyle	ShaftDiameter	ShaftLength
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 TipTrocar	Stability	5mm	100mm
Ethicon	D5ST	XCEL Dilating TipTrocar	Stability	5mm	75mm
Ethicon	D11LT	XCEL Dilating TipTrocar	Stability	11mm	100mm
Ethicon	D12LT	XCEL Dilating TipTrocar	Stability	12mm	100mm

The model numbers included in the scope of this submission are as follows:

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Ethicon	2B5ST	XCEL Bladeless Trocarw/Optiview Technology	Stability	5mm	75mm
Ethicon	2B5LT	XCEL Bladeless Trocarw/Optiview Technology	Stability	5mm	100mm
Ethicon	2D5ST	XCEL Dilating TipTrocar w/OptiviewTechnology	Stability	5mm	75mm
Ethicon	2D5LT	XCEL Dilating TipTrocar w/OptiviewTechnology	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 UniversalStability Sleevew/Optiview Technology	Stability	5mm	100mm
Ethicon	2CB5ST	XCEL UniversalStability Sleevew/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 BladelessTrocarsEndopath Blunt TipTrocarsEndopath Dilating TipTrocars	Ethicon Endo-SurgeryEthicon Endopath XCELTrocarsBladeless, Blunt Tip,Dilating Tip w/OptiviewTechnologyK122511	Stryker SustainabilitySolutionsReprocessed EndoscopicTrocars and Sleeves
Indications for Use	The Endopath BladelessTrocar has applications inabdominal, thoracic, andgynecologic minimallyinvasive surgical procedures toestablish a path of entry forendoscopic instruments. Thetrocar may be used with orwithout visualization for	The Endopath XCELBladeless Trocar withOptiview Technology hasapplications in abdominal,thoracic, and gynecologicminimally invasive surgicalprocedures to establish a pathof entry for endoscopicinstruments. The trocar may	The Reprocessed EndoscopicTrocars and Sleeves haveapplications in abdominal,thoracic, and gynecologicminimally invasive surgicalprocedures to establish a pathof entry for endoscopicinstruments. The BladelessTrocars may be used with or
		primary and secondaryinsertions.	be used with or withoutvisualization for primary andsecondary insertions.	without visualization forprimary and secondaryinsertions.
		The Endopath Blunt TipTrocar has applications inthoracic, gynecologic,laparoscopic and otherabdominal procedures toestablish a path of entry forminimally invasiveinstruments.	The Endopath XCEL BluntTip Trocar with OptiviewTechnology has applications inthoracic, gynecologic,laparoscopic and otherabdominal procedures toestablish a path of entry forminimally invasiveinstruments.
		The Endopath Dilating TipTrocar has applications inthoracic, gynecologiclaparoscopy ant otherabdominal procedures toestablish a path of entry forendoscopic instruments.	The Endopath XCEL DilatingTip Trocar with OptiviewTechnology has applications inthoracic, gynecologiclaparoscopy ant otherabdominal procedures toestablish a path of entry forendoscopic instruments.
			The Endopath XCELUniversal Trocar StabilitySleeve with OptiviewTechnology has applications inthoracic, gynecologiclaparoscopy and otherabdominal procedures toestablish a path of entry forendoscopic instruments.
	Contra-indications	This device is not intended foruse when minimally invasivetechniques are contraindicated.	The device is not intended foruse when minimally invasivetechniques are contraindicated.	Any uses generallycontraindicated for minimallyinvasive techniques.
Materials
	CannulaShaft	Polycarbonate	Polycarbonate	Polycarbonate
	CannulaHub/Housing	Polycarbonate	Polycarbonate	Polycarbonate
	Cannula Seal	Polycarbonate	Polycarbonate	Polycarbonate
	CannulaGasket	Rubber	Rubber	Rubber
Material composition	StopcockValve	Polycarbonate	Polycarbonate	Polycarbonate
	StopcockLever	Polyethylene	Polyethylene	Polyethylene
	ObturatorShaft	Stainless Steel (300 series)Polycarbonate (Blunt TipTrocar- H12LP)	Stainless Steel (300 series)Polycarbonate (Blunt TipTrocar-H12LP)	Stainless Steel (300 series)Polycarbonate (Blunt TipTrocar- H12LP)
	ObturatorTip	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

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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.

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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.

Regulation Number and Section

§ 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.