The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocar with OPTWIEW Technology 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 Medline ReNewal Reprocessed 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.

Device Description

The Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology devices are sterile, single-patient use endoscopic devices used to create an access port to the inside of the body cavity to perform endoscopic surgery. The trocars accommodate instruments that are 5-mm in diameter. The trocars contain two seals, an outer integrated removable self-adjusting seal and an integrated seal. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar.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. The trocars contain OPTIVIEW Technology that reduces the incidence of trocar-induced endoscope lens smudging during endoscope insertion. Endoscope smudging occurs when bodily fluids and debris smear across the endoscope lens during a laparoscopic procedure. Trocar-induced smudging occurs when these bodily fluids and debris are deposited within the trocar's seal system when an endoscope or instrument has been exchanged through the trocar.

AI/ML Overview

This document describes a substantial equivalence determination for a reprocessed medical device, the Medline Renewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria as typically found in an AI/ML medical device submission.

Instead, this submission focuses on demonstrating that the reprocessed device is "substantially equivalent" to an already legally marketed predicate device (Ethicon ENDOPATH XCEL Trocar with OPTIVIEW Technology). The performance testing outlined is to show that the reprocessed device maintains the same functional characteristics as the predicate device after reprocessing.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, effect size) are not applicable to this type of traditional medical device submission.

Here's an attempt to extract relevant information given the context of a reprocessed traditional medical device:

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets and results in the format typically seen for AI/ML performance. Instead, it lists various functional performance studies and concludes that the reprocessed device was "found to be substantially equivalent" to the predicate. The "acceptance criteria" for a reprocessed device are generally that its performance characteristics (functional, cleaning, biocompatibility, sterilization) meet or exceed those of the original device or established standards, ensuring safety and effectiveness are maintained post-reprocessing.

Test Category	Reported Device Performance (Medline ReNewal Reprocessed ENDOPATH XCEL Trocar)	"Acceptance Criteria" (Implied from comparison to Predicate Device)
Functional Performance		Functional characteristics must be substantially equivalent to the predicate device.
Seal Leakage	Performance found to be substantially equivalent to the predicate device.	Pressure and fluid leakage rates must be comparable to or meet the performance of the predicate device.
Seal Drag	Performance found to be substantially equivalent to the predicate device.	Insertion/withdrawal force must be comparable to the predicate device to ensure smooth instrument passage.
Surface Roughness	Performance found to be substantially equivalent to the predicate device.	Surface finish must be comparable to the predicate device to prevent tissue damage and facilitate instrument use.
Endoscope Smudge	Performance found to be substantially equivalent to the predicate device.	Ability to reduce/prevent endoscope smudging (as intended by OPTIVIEW Technology) must be comparable to the predicate device.
Visualization	Performance found to be substantially equivalent to the predicate device.	Visual clarity and obstruction prevention for endoscope use, comparable to the predicate device.
Cleaning		Post-reprocessing, the device must be free from harmful levels of contaminants and visually clean.
Protein and Carbohydrates	Residual levels met acceptance criteria.	Residual protein and carbohydrate levels must be below specified safety thresholds.
Visual Inspection	Visually clean.	No visible soil, debris, or damage.
Cleaning Performance Qual.	Performance met acceptance criteria.	Validated cleaning process effectively removes contaminants.
Biocompatibility		Must be non-toxic and non-irritating, comparable to a new device.
Cytotoxicity (direct & indirect)	Met acceptance criteria.	No significant cytotoxic effects.
Irritation (whole device)	Met acceptance criteria.	No significant irritation.
Sensitization (whole device)	Met acceptance criteria.	No significant sensitization.
Pyrogenicity (direct & indirect)	Met acceptance criteria.	No significant pyrogenic response.
Acute Systemic Toxicity	Met acceptance criteria.	No significant acute systemic toxicity.
(direct & indirect)
Sterilization & Packaging		Device must be sterile and maintain sterility until use, with acceptable residual sterilant levels.
Bioburden Enumeration Testing	Met acceptance criteria.	Bioburden levels must be within acceptable limits for sterilization validation.
Ethylene Oxide & ECH Residuals	Met acceptance criteria.	Ethylene Oxide (EtO) and Ethylene Chlorohydrin (ECH) residuals must be below specified safety limits.
Product Stability	Met acceptance criteria.	The device must maintain its functional integrity and sterility over its stated shelf life after reprocessing and packaging.

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

Sample Size: Not explicitly stated in the provided text for each test. The document mentions "the proposed device" and "the predicate device" which implies comparative testing was conducted using a sufficient number of units to establish statistical equivalence for each functional and material characteristic.
Data Provenance: The studies were conducted by Medline ReNewal as part of their 510(k) submission for a reprocessed device. This is prospective testing performed to support the regulatory submission. The country of origin of the data is implied to be the US, where Medline ReNewal is based and operates.

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

This is not applicable. For this type of traditional medical device, "ground truth" is established through engineering and scientific testing against defined specifications, industry standards, and comparison with the predicate device's known performance, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation of data is being evaluated. For device performance testing, results are typically objective measurements (e.g., leakage rate, residual chemical levels) compared against defined criteria.

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 is not applicable. This submission concerns a traditional reprocessed surgical instrument, not an AI/ML device. Therefore, no MRMC study, AI assistance evaluation, or effect size related to human reader improvement is relevant.

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

This is not applicable. This submission is for a physical surgical device, not an algorithm.

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

For the functional and material tests:

Engineering Specifications: Performance against predefined engineering and material specifications.
Industry Standards: Compliance with relevant ISO, ASTM, or other industry standards (e.g., for biocompatibility, sterility).
Predicate Device Performance: Direct comparison of measurements and characteristics to the performance of a new (un-reprocessed) predicate device. For example, a leakage test result on the reprocessed device would be compared to the leakage test result on the original device.

8. The sample size for the training set

This is not applicable. This is a traditional medical device, not an AI/ML device. There is no concept of a "training set" in this context.

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

This is not applicable as there is no training set for a traditional medical device.

Summary

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

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

May 6, 2016

Surgical Instrument Service and Savings Inc. Ms. Brandi J. Panteleon Director, Quality Assurance and Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K160740

Trade/Device Name: Medline Renewal Reprocessed Endopath Xcel Trocar with Optiview Technology Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: NLM Dated: March 14, 2016 Received: March 17, 2016

Dear Ms. Panteleon:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Jennifer R. Stevenson - A

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

Enclosure

Reprocessed Single-Use Device Models Included in Clearance:

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Device Model	Device Name	OriginalManufacturer
2B5ST	ENDOPATH XCEL® Bladeless Trocar withOPTIVIEW Technology	Ethicon
2B5LT	ENDOPATH XCEL® Bladeless Trocar withOPTIVIEW Technology	Ethicon
2B5XT	ENDOPATH XCEL® Bladeless Trocar withOPTIVIEW Technology	Ethicon
2CB5ST	ENDOPATH XCEL® Universal Sleeve withOPTIVIEW Technology	Ethicon
2CB5LT	ENDOPATH XCEL® Universal Sleeve withOPTIVIEW Technology	Ethicon

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Image /page/3/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the words "Full Circle Reprocessing" are below the Renewal logo.

4.0 Indications for Use

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	TBD	K160740
Device Name	Medline ReNewal Reprocessed ENDOPATH YCEL Trocars with OPTIVIEW Technology
Submitter/Owner	Medline ReNewal2747 SW 6th St.Redmond, OR 97756
Contact Name	Brandi PanteleonDirector, Quality Assurance and Regulatory AffairsP: 541-516-4180F: 541-923-3375E: bpanteleon@medline.com
Prepared by	Stephanie Boyle MaysTechnical WriterP: 541-516-4205F: 541-923-3375E: smays@medline.com
Date Prepared	March 11, 2016
Device Names	Proprietary Name: Medline ReNewal Reprocessed ENDOPATH XCELTrocar with OPTIVIEW TechnologyCommon Name: Surgical TrocarModel No.: 2B5ST, 2B5LT and 2B5XT ENDOPATH XCEL Bladeless Trocarwith OPTIVIEW Technology and 2CB5ST and 2CB5LT ENDOPATH XCELUniversal Sleeve with OPTIVIEW Technology
Classification	Laparoscope, General & Plastic Surgery, ReprocessedProduct code: NLMClass: Class II, non-exemptRegulation: Part 876.1500 of Title 21 of the Code of Federal Regulations
PredicateDevice	K122511 ENDOPATH XCEL Trocar with OPTIVIEW Technology
DeviceDescription	The Medline ReNewal Reprocessed ENDOPATH XCEL Trocar withOPTIVIEW Technology devices are sterile, single-patient use endoscopicdevices used to create an access port to the inside of the body cavity toperform endoscopic surgery. The trocars accommodate instruments thatare 5-mm in diameter. The trocars contain two seals, an outer integratedremovable self-adjusting seal and an integrated seal. Together, these twoseals minimize gas leakage when instruments are inserted or withdrawnthrough the trocar. A stopcock valve is compatible with standard luer lockfittings and provides attachment for gas insufflation. The trocars containOPTIVIEW Technology that reduces the incidence of trocar-inducedendoscope lens smudging during endoscope insertion. Endoscopesmudging occurs when bodily fluids and debris smear across theendoscope lens during a laparoscopic procedure. Trocar-induced smudgingoccurs when these bodily fluids and debris are deposited within the trocar'sseal system when an endoscope or instrument has been exchangedthrough the trocar.
Indication for Use	The Medline ReNewal Reprocessed ENDOPATH XCEL Bladeless Trocarwith OPTIVIEW Technology has applications in abdominal, thoracic andgynecologic minimally invasive surgical procedures to establish a path ofentry for endoscopic instruments. The trocar may be used with or withoutvisualization for primary and secondary insertions.The Medline ReNewal Reprocessed ENDOPATH XCEL Universal TrocarStability Sleeve with OPTIVIEW Technology has applications in thoracic,gynecologic laparoscopy and other abdominal procedures to establish apath of entry for endoscopic instruments.
TechnologicalCharacteristics	The technological characteristics and the fundamental scientific technologyof the subject device are identical to the predicate device. The proposeddevice is a reprocessed version of the predicate device.
PerformanceTesting	The functional characteristics of the proposed device have been evaluatedand were found to be substantially equivalent to the predicate device basedon the following tests:Simulated use and artificial soiling; Functional performance studies: seal leakage; seal drag; surface roughness; endoscope smudge; and Visualization. Cleaning: protein and carbohydrates; visual inspection; and cleaning performance qualification. Biocompatibility: cytotoxicity (direct and indirect); irritation (whole device); sensitization (whole device) pyrogenicity (direct and indirect); and acute systemic toxicity (direct and indirect). Sterilization and packaging validations: bioburden enumeration testing; and ethylene oxide and ethylene chlorohydrin residuals testing. Product stability.
Conclusion	In accordance with 21 CFR Part 807, and based on a comparison ofIndications for Use, technological characteristics and performance data,Medline ReNewal concludes that the proposed Medline ReNewalReprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology issubstantially equivalent to the predicate device.

Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology

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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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, and below it is the phrase "Full Circle Reprocessing" in smaller letters.

5.0 510(k) Summary

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Image /page/5/Picture/0 description: The image shows the Medline Renewal logo. The word "MEDLINE" is in blue, with a blue star-like symbol to the left. To the right of "MEDLINE" is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in smaller blue font below it.

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Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters next to it. The Renewal logo is in green and blue letters, and below it is the phrase "Full Circle Reprocessing".

	Predicate Device	Proposed Device
DeviceCharacteristic	Ethicon ENDOPATHXCEL Trocar withOPTIVIEW Technology	Medline ReNewalReprocessed ENDOPATHXCEL Trocar withOPTIVIEW Technology	ComparisonAnalysis
510(k) Number	K122511	TBD	NAa
Indications forUse	The ENDOPATH XCELBladeless Trocar withOPTIVIEW Technology hasapplications in abdominal,thoracic and gynecologicminimally invasive surgicalprocedures to establish apath of entry forendoscopic instruments.The trocar may be usedwith or without visualizationfor primary and secondaryinsertions.The ENDOPATH XCELUniversal Trocar StabilitySleeve with OPTIVIEWTechnology hasapplications in thoracic,gynecologic laparoscopyand other abdominalprocedures to establish apath of entry forendoscopic instruments.	The Medline ReNewalReprocessed ENDOPATHXCEL Bladeless Trocar withOPTIVIEW Technology hasapplications in abdominal,thoracic and gynecologicminimally invasive surgicalprocedures to establish apath of entry for endoscopicinstruments. The trocar maybe used with or withoutvisualization for primary andsecondary insertions.The Medline ReNewalReprocessed ENDOPATHXCEL Universal TrocarStability Sleeve withOPTIVIEW Technology hasapplications in thoracic,gynecologic laparoscopyand other abdominalprocedures to establish apath of entry for endoscopicinstruments.	Same
DesignConfigurationand Models	ENDOPATH XCEL withOPTIVIEW TechnologyBladeless Trocar models:• 2B5ST Trocar, 5- x75-mm stability sleeve;• 2B5LT Trocar, 5- x100-mm, stability sleeve;• 2B5XT Trocar, 5- x150-mm, stability sleeve.	Medline ReNewalReprocessed ENDOPATHXCEL with OPTIVIEWTechnologyBladeless Trocar models:• 2B5ST Trocar, 5- x75-mm stability sleeve;• 2B5LT Trocar, 5- x100-mm, stability sleeve;• 2B5XT Trocar, 5- x150-mm, stability sleeve.
	Predicate Device	Proposed Device
DeviceCharacteristic	Ethicon ENDOPATH XCELTrocar with OPTIVIEWTechnology	Medline ReNewalReprocessed ENDOPATHXCEL Trocar withOPTIVIEW Technology	ComparisonAnalysis
DesignConfigurationand Model(concluded)	Universal Trocar StabilitySleeve models:• 2CB5ST 5- x 75-mmSleeve (cannula);• 2CB5LT 5- x 100-mmSleeve (cannula)	Universal Trocar StabilitySleeve models:• 2CB5ST 5- x 75-mmSleeve (cannula);• 2CB5LT 5- x 100-mmSleeve (cannula)	Same
TechnologicalAttributes	ENDOPATH XCEL Trocarswith OPTIVIEW Technologyconsist of two components:a sleeve and an obturator.The sleeve and obturator areused to create the accessport. The obturator is asubsystem used to assist inthe process of installing thesleeve port through the bodytissue. After installation, theobturator is not required fortrocar performance. Thebladeless trocar obturatorsaccommodate anappropriately sized 0°endoscope and providevisibility of individual tissuelayers during insertion.The sleeve has anintegrated two-seal systemfor maintainingpneumoperitoneum. Thetrocar sleeves contain twoseals, an outer integratedremovable self-adjustingseal that accommodatesinstruments 5-mm indiameter and an internalseal. Together these two	The Medline ReNewalReprocessed ENDOPATHXCEL Trocars withOPTIVIEW Technologyconsist of two components:a sleeve and an obturator.The sleeve and obturator areused to create the accessport. The obturator is asubsystem used to assist inthe process of installing thesleeve port through the bodytissue. After installation, theobturator is not required fortrocar performance. Thebladeless trocar obturatorsaccommodate anappropriately sized 0°endoscope and providevisibility of individual tissuelayers during insertion.The sleeve has anintegrated two-seal systemfor maintainingpneumoperitoneum. Thetrocar sleeves contain twoseals, an outer integratedremovable self-adjustingseal that accommodatesinstruments 5-mm indiameter and an internalseal. Together these two	Same
DeviceCharacteristic	Predicate Device	Proposed Device	ComparisonAnalysis
	Ethicon ENDOPATH XCELTrocar with OPTIVIEWTechnology	Medline ReNewalReprocessed ENDOPATHXCEL Trocar withOPTIVIEW Technology
TechnologicalCharacteristics(concluded)	seals minimize gas leakage5-mm in when instrumentsare inserted through orcompletely withdrawn fromthe trocar. The sleeve has awelded stopcock assembly,which is compatible withstandard Luer lock fittings,and provides attachment forgas insufflation anddesufflation of thepneumoperitoneum. Thesleeve cannula containsintegrated stability threadsfor abdominal wall retention.	seals minimize gas leakage5-mm in when instrumentsare inserted through orcompletely withdrawn fromthe trocar. The sleeve has awelded stopcock assembly,which is compatible withstandard Luer lock fittings,and provides attachment forgas insufflation anddesufflation of thepneumoperitoneum. Thesleeve cannula containsintegrated stability threadsfor abdominal wall retention.

Predicate and Medline ReNewal Reprocessed ENDOPATH XCEL Trocar Table 1: with OPTIVIEW Technology comparison chart.

continued

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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the words "Full Circle Reprocessing" are in smaller letters below the Renewal logo.

Predicate and Medline ReNewal Reprocessed ENDOPATH XCEL Trocar Table 1: with OPTIVIEW Technology comparison chart (continued).

(continued)

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Image /page/8/Picture/0 description: The image contains the logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, and the Renewal Full Circle Reprocessing logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the Full Circle Reprocessing logo is in smaller blue letters below the Renewal logo.

Predicate and Medline ReNewal Reprocessed ENDOPATH XCEL Trocar Table 1: with OPTIVIEW Technology comparison chart (concluded).

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.