The AutoCap RX Integrated Biopsy Cap and Guidewire Locking Device is intended to facilitate placement of the guidewire and lock it into place during ERCP procedures. The device access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the ERCP procedure, and provides access for irrigation.

Device Description

The AutoCap RX is an integrated biopsy cap and guidewire locking device that fits on the biopsy port of an endoscope. The device is an accessory to be used with endoscopic devices to facilitate device passage, maintain insufflation, and lock the guidewire(s) in place during ERCP procedures. The AutoCap RX combines the locking device and the biopsy cap of the predicate, RX Locking Device and Biopsy Cap (K010610), into one integrated unit.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called AutoCap RX. It is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device. This type of document focuses on engineering and performance validation rather than clinical studies with human participants comparing AI performance.

Therefore, the requested information regarding AI-specific criteria (such as multi-reader multi-case studies, AI effect size, ground truth establishment for AI training sets, etc.) is not applicable to this document.

However, I can extract information related to the device's acceptance criteria and the engineering study that proves it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of specified bench tests, demonstrating the device's ability to perform its intended functions. The performance is reported as "passing."

Acceptance Criteria (Bench Test)	Reported Device Performance	Comments
Scope Attachment and Detachment	Passing	Device successfully attaches to and detaches from the endoscope.
Biopsy Cap Bile Leakage	Passing	Minimizes leakage of biomaterial from the biopsy port.
Insufflation Ability	Passing	Helps maintain insufflation.
Device Passability	Passing	Allows for endoscopic device passage and exchange.
Guidewire Slippage	Passing	Successfully locks the guidewire(s) in place.
Scope Suction Ability	Passing	Demonstrated proper suction functionality.
Simulated Use Testing	Passing	Performance validated under simulated use conditions.
Biocompatibility (ISO 10993)	Passing	Confirmed biocompatible for intended use (surface contact, limited duration, mucosal membrane contact).
Packaging Validation	Passing	Maintains integrity and sterility over labeled shelf life.
Sterilization Validation	Passing	Meets ISO 11135 requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each bench test (e.g., number of devices tested for bile leakage). It states that "All testing was passing."

Sample Size: Not explicitly stated as a number of devices/tests for each criterion, but implied to be sufficient for engineering validation.
Data Provenance: The tests are "non-clinical performance bench testing" and "simulated use testing." This indicates in-vitro laboratory testing, not human patient data. The country of origin for the data is not specified, but the submission is to the U.S. FDA, implying the tests were conducted to meet U.S. regulatory standards. The data is prospective in the sense that it was generated specifically for this regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable. The "ground truth" for these engineering bench tests is defined by objective physical measurements and functional performance criteria as specified in the test protocols, not by expert interpretation of clinical images or data.
Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would have been performed by qualified engineers or technicians adhering to established testing standards.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical studies or image review. For bench testing, the results are typically quantitative measurements or pass/fail determinations based on predefined specifications, not subjective interpretation requiring re-adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the subject of this 510(k) submission.

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

Standalone Performance: No, a standalone algorithm performance evaluation was not done. The AutoCap RX is a mechanical/physical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering performance specifications and physical measurements demonstrating the device's ability to facilitate guidewire placement, lock guidewires, maintain insufflation, minimize leakage, and allow for device passage/exchange. It also includes biocompatibility testing against ISO 10993 and sterilization/packaging validation. It is not based on expert consensus, pathology, or outcomes data in a clinical setting.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a physical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 6, 2021

Boston Scientific Corporation Kyra McNamara Regulatory Affairs Specialist II 100 Boston Scientific Wav Marlborough, MA 01752

Re: K210353

Trade/Device Name: AutoCap RX Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: February 5, 2021 Received: February 8, 2021

Dear Kyra McNamara:

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 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

{1}------------------------------------------------

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 (OS) 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 mediation-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,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210353

Device Name AutoCap RX

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.

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}------------------------------------------------

510(k) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Primary Contact: Kyra McNamara Regulatory Affairs Specialist II Telephone: (508) 382-0375

Date Prepared: 27 April 2021

2. Device:

Trade Name:	AutoCap™ RX
Classification Name:	Endoscope and Accessories
Regulation Number:	21 CFR 876.1500
Product Code:	ODC
Regulatory Class:	Class II

{4}------------------------------------------------

3. Predicate Device:

Trade Name:	RX Locking Device & Biopsy Cap
Manufacturer:	Boston Scientific
510(k) Number:	K010610
Classification Name:	Endoscope and Accessories
Regulation Number:	21 CFR 876.1500
Product Code:	ODC
Regulatory Class:	Class II

{5}------------------------------------------------

4. Device Description

Materials and patient contact potential of the AutoCap RX components are provided below.

Component	Material Name	Patient Contacting
Housing	Plastic	No
Biopsy Cap	Silicone	Yes-Indirect
Foam Insert	Polyurethane Foam	Yes-Indirect

Testing was conducted per the requirements of 1SO 10993-1 based on the biocompatibility classification of the device (category: surface, contact duration: limited (<24 hours), and body contact: mucosal membrane). Testing performed per ISO 10993-1 confirmed that the AutoCap RX is biocompatible for its intended use.

5. Indications for Use:

The AutoCap RX Integrated Biopsy Cap and Guidewire Locking Device is intended to facilitate placement of the guidewire and lock it into place during ERCP procedures. The device also provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the ERCP procedure, and provides access for irrigation.

The AutoCap RX and the predicate, RX Locking Device and Biopsy Cap (K010610), share the same intended use, to facilitate placement of the guidewire and lock it into place during ERCP procedures. Although the Indications for Use of the AutoCap RX specifically identify its use to maintain insufflation and minimize leakage of biomaterial, these are not new uses. Maintaining Insufflation and minimizing leakage of biomaterials are generally established performance requirements of a biopsy cap. The RX Locking Device and Biopsy Cap was designed to meet these same performance capabilities per K010610.

6. Comparison of Technological Characteristics with the Predicate Device

The device consists of a plastic housing that holds a silicone biopsy cap with a foam insert. The plastic housing has molded guidewire locking slots to hold up to two guidewires. The plastic housing fits directly onto the biopsy port of the endoscope. The AutoCap RX is compatible with Olympus ERCP scopes. The AutoCap RX is substantially s equivalent to the predicate, RX Locking Device and Biopsy Cap (K010610), in terms of technological characteristics. Both have two guidewire locking slots and a silicone biopsy cap to facilitate device passage. Both devices attach to the scope via a press fit.

{6}------------------------------------------------

The AutoCap RX device combines the functionality of the RX Locking Device and Biopsy Cap (K010610) into an integrated unit allowing for a single attachment mechanism. The AutoCap RX secures directly around the scope and the housing will sit flush with the scope port.

Both the AutoCap RX and the RX Locking Device and Biopsy Cap (K010610) incorporate a silicone cap with a foam insert to minimize leakage of fluid and air while allowing for device exchange. The AutoCap RX incorporates additional molded silicone features within the cap to minimize leakage of fluid and air while allowing for device passage during endoscopic procedures.

Comparative bench testing confirms the ability of both AutoCap RX and predicate RX Locking Device and Biopsy Cap (K010610) to meet its intended use. The AutoCap RX is substantially equivalent to the predicate, RX Locking Device and Biopsy Cap (K010610), in terms of performance and technological characteristics.

7. Performance Data

Non-clinical performance bench testing, simulated use testing, biocompatibility per the requirements of ISO 10993, packaging, and sterilization validation per the requirements of ISO 11135 were completed to evaluate the design of the AutoCap RX for its indications for use.

Bench Testing included:

. Scope Attachment and detachment
Biopsy Cap Bile Leakage ●
Insufflation Ability ●
Device Passability
. Guidewire Slippage
. Scope Suction Ability
. Simulated Use testing

All testing was passing and demonstrates the device's ability to fulfill non-clinical performance bench testing, biocompatibility, packaging, and sterilization requirements. The results of the predicate device are also included in the performance section and are comparable to the proposed device.

Both the AutoCap RX and the predicate RX Locking Device and Biopsy Cap (K010610) are provided sterile with a labeled shelf life. Aging testing on both the packaging and device confirm performance over the labeled shelf life.

Conclusion

The information provided in this submission demonstrates that the proposed AutoCap RX is substantially equivalent to the RX Locking Device and Biopsy Cap (K010610).

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.