The locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.

Device Description

The CleverLock Guidewire Locking Device and Biopsy Cap is an accessory used with compatible endoscopic devices to lock the wire guide(s) in place during endoscopic procedures. The two components of the device are the guidewire locking device and the biopsy cap. The skirt portion of the locking device is designed to attach to the biopsy port located on the endoscope barrel. The rigid skirt is matched to fit the scope handle to prevent its rotating during a wire engagement or disengagement. The lock arm has three (3) locking mechanisms (wire slots): inner slot, outer slot and lower slot to accommodate up to three (3) guidewires. The locking feature has a geometry which results in an "audible" click with tactile feedback when the wire has been fully engaged. The biopsy cap is comprised of a cap seal and inner seal. The cap seal sits on top of the locking device skirt. The cap seal is designed with a self-closing slit to minimize fluid passage when all devices are removed from the biopsy channel. The inner seal attaches to the snap fit portion of the locking device; and is designed with a round opening to minimize fluid passage when there is a device inserted into the biopsy channel. The CleverLock Locking Device and Biopsy Cap is available in one model only (MAJ-2455). The proposed CleverLock Locking Device and Biopsy Cap will be sold sterile and is intended for single patient use only.

AI/ML Overview

The provided text describes the "CleverLock Guidewire Locking Device and Biopsy Cap" and its substantial equivalence to a predicate device. It includes information on non-clinical testing, but it does not contain the specific details required to fully address your request, particularly regarding clinical studies, acceptance criteria for performance metrics, sample sizes for test and training sets for an AI/algorithm, expert qualifications, or multi-reader multi-case studies.

The device described is a physical medical device, not an AI/algorithm. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable.

Below is an attempt to answer the relevant parts based on the provided text, and I will explicitly state when the information is unavailable.

Acceptance Criteria and Study for CleverLock Guidewire Locking Device and Biopsy Cap

The provided 510(k) summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not describe an AI/algorithm, therefore, many of the typical acceptance criteria and study details for AI-powered devices are not present.

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

The document details various bench tests performed, but it does not explicitly state specific numerical acceptance criteria or reported performance values for each test. The "Conclusion" section only broadly states that the device is "substantially equivalent" and "presents no new questions of safety or effectiveness," implying that the device met internal performance specifications without providing the quantitative details.

Test Name	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Scope Engagement Test	Implicitly, device must properly engage with scope.	Implied successful performance as per conclusion.
Wire Locking Force Test	Implicitly, sufficient force to lock guidewire.	Implied successful performance as per conclusion.
Wire Retention and Lock Removal	Implicitly, secure retention and easy removal.	Implied successful performance as per conclusion.
Insertion Force Test	Implicitly, acceptable insertion force.	Implied successful performance as per conclusion.
Leak Test	Implicitly, minimal fluid passage/no excessive leakage.	Implied successful performance as per conclusion.
Brush, Unlocking Test	Implicitly, proper function during brushing.	Implied successful performance as per conclusion.
Angle Test	Implicitly, function across relevant angles.	Implied successful performance as per conclusion.
Decay Test	Implicitly, maintain function over time.	Implied successful performance as per conclusion.
Biocompatibility	Compliance with ISO-10993 standards.	"Biocompatibility Tests passed"
Sterilization	Compliance with specified ANSI/AAMI/ISO standards.	"Sterilization Validation passed"
Packaging Integrity	Compliance with ANSI/AAMI/ISO 11607-1.	"support a labeled three-year shelf life"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described is primarily non-clinical bench testing. Details on the number of samples tested for each bench test, or any "data provenance" in the sense of patient data, are not disclosed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the device is a physical medical device, not an AI/algorithm that requires expert-established ground truth for a test set. The validation relies on engineering and biological testing standards.

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

This information is not applicable as the described testing does not involve human interpretation or adjudication in the context of an AI/algorithm's output.

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 information is not applicable as the device is a physical medical device, not an AI system designed to assist human readers.

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

This information is not applicable as the device is a physical medical device, not an AI algorithm. Its performance is inherent in its design and manufacturing, validated through bench testing.

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

For the biological aspects (biocompatibility, sterilization), the "ground truth" is defined by compliance with established international standards (ISO, USP, ANSI/AAMI/ISO). For the mechanical/performance tests, the "ground truth" would be the device meeting pre-defined engineering specifications and functional requirements as determined by the manufacturer's design verification process. No "expert consensus," "pathology," or "outcomes data" in the clinical sense is mentioned for the evaluation of this specific device's performance.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device, not an AI/algorithm that undergoes training.

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

This information is not applicable as the device is a physical medical device, not an AI/algorithm that undergoes training.

Summary

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April 4, 2019

Olympus Surgical Technologies America Mary Anne Patella Senior Specialist, Regulatory Affairs 136 Turnpike Road Southborough, MA 01772-2104

Re: K190164

Trade/Device Name: CleverLock Guidewire Locking Device and Biopsy Cap Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODC Dated: January 30, 2019 Received: January 31, 2019

Dear Mary Anne Patella:

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 mav, 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 avare 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 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.

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark J. Antonino -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K190164

Device Name

CleverLock Guidewire Locking Device and Biopsy Cap

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K190164 Page 1 of 4

510(k) Summary CleverLock Guidewire Locking Device and Biopsy Cap

General Information

Contract Manufacturer:	PMC, LLC1451 S. Miller AvenueShelbyville, IN 46176Phone: 317-421-2515
Establishment Registration Number:	3010408671
510(k) Submitter:	Olympus Surgical TechnologiesAmericaGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104Phone: 508-804-2600Fax: 508-804-2624
Establishment Registration Number:	3003790304
Contact Person:	Mary Anne PatellaSenior Specialist, Regulatory Affairs508-804-2771Maryanne.patella@olympus-osta.com
Date Prepared:	January 29, 2019

Device Description

Classification Name:	Endoscope and accessories
Regulation Number:	21 CFR 876.1500
Product Code:	ODC
Device Class:	Class II
Review Panel:	Gastroenterology/Urology
Trade Name:	CleverLock Guidewire Locking Deviceand Biopsy Cap
Generic/Common Name:	Locking device

Predicate DeviceWilson-Cook USW Cap and Wire Lock

K040137

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Product Description

The skirt portion of the locking device is designed to attach to the biopsy port located on the endoscope barrel. The rigid skirt is matched to fit the scope handle to prevent its rotating during a wire engagement or disengagement. The lock arm has three (3) locking mechanisms (wire slots): inner slot, outer slot and lower slot to accommodate up to three (3) guidewires. The locking feature has a geometry which results in an "audible" click with tactile feedback when the wire has been fully engaged.

The biopsy cap is comprised of a cap seal and inner seal. The cap seal sits on top of the locking device skirt. The cap seal is designed with a self-closing slit to minimize fluid passage when all devices are removed from the biopsy channel. The inner seal attaches to the snap fit portion of the locking device; and is designed with a round opening to minimize fluid passage when there is a device inserted into the biopsy channel.

The CleverLock Locking Device and Biopsy Cap is available in one model only (MAJ-2455). The proposed CleverLock Locking Device and Biopsy Cap will be sold sterile and is intended for single patient use only.

Intended Use

Technological Characteristics

The CleverLock has the same basic technological characteristics as the predicate Fusion Wire Guide Locking Device cleared under K040137. The subject and predicate device operate in the same manner to lock the wire guide(s) in place during endoscopic procedures. The indications for use of the CleverLock are the same as that of the predicate.

A detailed comparison of the CleverLock and its' predicate is provided in the following table.

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Traditional 510(k) Notification

January 29, 2019

Table 5.1 Comparison of Proposed and Predicate Device
Device Name/ Characteristics	Proposed Device	Predicate Device (K040137)	Comments
Indications for Use	CleverLock Guidewire and Biopsy CapThe locking device is an accessory used with endoscopic devices to lock the wire guide(s) in place during endoscopic procedures (e.g. ERCP). The integrated biopsy cap is designed to prevent reflux of body fluids.	Fusion Wire Guide Locking DeviceThe Wilson-Cook USW Cap and Wire Lock Device is an accessory to be used with endoscopic biliary devices to lock the wire guide(s) in place during ERCP procedures.	Same as predicate
Device Function	Guidewire Locking Device with Biopsy Cap	Guidewire Locking Device with Cap	Same as predicate
Mechanics of Action	Manual	Manual	Same as predicate
Indirect Patient Contacting Materials	Main body: Polycarbonate Makrolon Rx2530	Plastic, unknown formulation	Similar to predicate; any differences confirmed through testing.
	Seal, Inside Rubber: Silicone KE-944-U	Rubber, unknown formulation
	Seal Cover: Silicone KEG-2001-50-A/B
Biocompatible	Yes	Unknown	Biocompatibility Tests passed
Sterilization	Gamma Radiation	Ethylene Oxide	Sterilization Validation passed
Single Use Only	Yes	Yes	Same as predicate
Attaches directly to the accessory port	Yes	Yes	Same as predicate
Double valve biopsy cap	Yes	Yes	Same as predicate
Wire Guide Diameter	.035"	.035"	Same as predicate
Secure guidewires of various sizes	.025" to .035" ET Guidewires.018" to .025" ERCP Guidewires	.025" or .018" guidewires	Same as predicate
Multiple locking positions	3	2	Similar to predicate

	Table 5.1 Comparison of Proposed and Predicate Device

Summary of Non-Clinical Testing

Biocompatibility:

Biocompatibility testing on all patient contacting surfaces has been performed in compliance to relevant requirements of ISO-10993. Biocompatibility testing included the following tests:

ISO 10993-5: 2009 Biological evaluation of medical devices Part5: Tests for . in vitro cytotoxicity

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ISO 10993-10: 2010 Biological evaluation of medical devices. Tests for . irritation and sensitization
ISO 10993-11: 2017 Biological evaluation of medical devices Part 11: Tests . for systemic toxicity
United States Pharmacopeia 41, National Formulary 36, 2018. <151> Pyrogen ● Test

Sterilization:

The CleverLock will be delivered in a sterile state and is intended for single patient use only. Sterilization (gamma radiation) and packaging of the device was validated using the following standards:

ANSI/AAMI/ISO 11607-1:2006 Packaging for terminally sterilized medical ● devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ANSI/AAMI/ISO 11137-2:2013 Sterilization of health-care products -Radiation - Part 2: Establishing the sterilization dose

Packaging integrity and performance testing on devices that had undergone accelerated aging support a labeled three-year shelf life.

Bench testing:

During design verification, the output of the design process was evaluated against the physical and performance specifications. The following performance tests were conducted:

Scope Engagement Test
Wire Locking Force Test ●
Wire Retention and Lock Removal ●
Insertion Force Test
Leak Test ●
Brush, Unlocking Test ●
Angle Test
Decay Test ●

Conclusion:

In summary, the CleverLock Guidewire Locking Device and Biopsy Cap is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.

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.