The PillCam Patency System is an accessory to the PillCam video capsule and is intended to verify adequate patency of the gastrointestinal tract prior to administration of the PillCam video capsule in patients with known or suspected strictures. The PillCam Patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system.

Therefore, the PillCam Patency System is intended to be used:

prior to PillCam SB capsule in adults and children from 2 years of age, or
prior to PillCam UGI, COLON, and Crohn's capsules in adults

Device Description

The PillCam Patency System is an accessory to the PillCam capsule endoscopy (CE) System and it is used for verifying the patency of the Gastrointestinal (GI) tract. The PillCam Patency System consists of the following components; The PillCam Patency capsule, the Patency scanner and TesTag (interference tester).

The Patency capsule is an ingestible and dissolvable capsule, similar in size to the PillCam CE. It is comprised of a body that surrounds a small Radio Frequency Identification (RFID) tag. The body is coated with an impermeable membrane, except for two small windows that are plugged by the Timer Plugs. The Timer plugs seal the capsule's body. If the Patency capsule is excreted structurally whole, then this confirms patency of the GI tract of the patient for objects similar in size to the capsule. However, if the capsule is retained in the GI tract, the Timer Plugs erode, allowing the penetration of body fluids into the capsule and the dissolution of the capsule's body. The remaining fragments of the capsule can pass even small orifices.

The Patency scanner may be utilized to detect RF signals from the RFID tag, to verify the PillCam Patency capsule presence in the body.

The only difference between the PillCam Patency System and the predicate device is the proposed labeling modification, to allow the use of the existing Patency capsule with the PillCam capsules that are slightly longer (PillCam COLON, Crohn's and UGI capsules). The intention of the proposed change is to offer physicians a clinical tool to evaluate the suitability of patients for CE, as an alternative to magnetic resonance enterography (MRE) or Computed Tomography (CT) which are already used in practice for this purpose.

AI/ML Overview

The provided text is a 510(k) summary for the PillCam Patency System. It references a previous submission (K053639) for clinical testing data, but the details of that study, including specific acceptance criteria and detailed device performance, are not explicitly laid out in the current document. However, based on the information provided, I can construct a response with the available data and highlight where information is missing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The current document (K180171) itself does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a readily digestible table. Instead, it refers to prior clinical testing (K053639) and general statements about the system's performance.

Criterion Type	Acceptance Criteria (Not explicitly stated in K180171)	Reported Device Performance (Leveraging K053639)
Patency Verification	(Implicit: Successful detection of intact capsule or dissolution if retained)	"In this testing, patients with known strictures ingested the Patency capsule and underwent periodic scanning until the capsule was excreted. If patency was established, capsule endoscopy procedure was performed. The results of this testing showed there were no cases of capsule retention."
Safety	(Implicit: No new safety concerns raised)	"The proposed change in this submission does not raise new performance or safety issues." "In addition, three clinical investigations demonstrate the use of Patency System prior to ingestion of longer PillCam capsules with no safety concern raised."
Diagnostic Accuracy (Sensitivity & Specificity)	(Not explicitly stated)	"Many studies in the literature have shown that the PillCam Patency System has high diagnostic sensitivity and specificity and that the use of a PillCam Patency System reduces risk of PillCam CE retention."
Dissolution Time	(Implicit: Starts dissolving after 30 hours)	"The PillCam Patency capsule is designed to start dissolving after 30 hours."

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

Test Set Sample Size: Not explicitly stated in K180171. It refers to "patients with known strictures" in the leveraged K053639 study.
Data Provenance: Not specified in K180171 (e.g., country of origin). The previous study (K053639) from which the data was leveraged would contain this information. The current submission is a regulatory document concerning a device from Israel (Given Imaging Ltd.).
Retrospective or Prospective: Not explicitly stated for the leveraged K053639 study. However, the description "patients with known strictures ingested the Patency capsule and underwent periodic scanning until the capsule was excreted" suggests a prospective clinical study design.

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

This information is not provided in the K180171 document. The document primarily focuses on the device's physical and functional characteristics and references prior clinical safety and efficacy without detailing the methodology of ground truth establishment in the studies themselves.

4. Adjudication method for the test set

This information is not provided in the K180171 document.

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 to the PillCam Patency System as described. The Patency System's function is to verify GI tract patency, primarily through the detection of an RFID tag or the capsule's dissolution, not through interpretation of images by human readers or AI. It's an accessory to a video capsule, but its own function doesn't involve image interpretation where "human readers improve with AI" would be a relevant metric.

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

Yes, the core function of the PillCam Patency System, as described, is a standalone process. The Patency scanner detects RF signals from the RFID tag, and the capsule's dissolution is a physical process, both occurring without direct human interpretive intervention during the patency verification itself. The "human-in-the-loop" aspect would be the physician's decision based on the outcome (intact capsule excreted or not), but the patency test itself does not involve AI or human image interpretation.

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

The ground truth for the efficacy aspect (successful patency verification) would likely be based on:

Direct observation of capsule excretion: If the capsule is excreted whole, patency is confirmed.
Follow-up outcomes: The success of the subsequent capsule endoscopy (e.g., no retention) after a positive patency test would serve as an outcome-based ground truth.
Clinical assessment: The resolution or passage of the capsule (or its fragments) and the patient's clinical status.

The K180171 document states: "If the Patency capsule is excreted structurally whole, then this confirms patency of the GI tract of the patient for objects similar in size to the capsule." This indicates direct observation as a primary ground truth.

8. The sample size for the training set

The K180171 document does not mention a training set. This is because the device is a physical capsule system, not an AI/ML algorithm that requires a training set. The "design" and "performance" of the capsule are based on engineering principles and clinical testing, not model training.

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

As there is no training set for this type of device, this information is not applicable.

Summary

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March 8, 2018

Given Imaging Ltd. Hilla Debby Regulatory Affairs Director 2 Hacarmet St. New Industrial Park POB 258 Yogneam, 20692 Israel

Re: K180171

Trade/Device Name: PillCam Patency System Regulation Number: 21 CFR§ 876.1300 Regulation Name: Ingestible Telemetric Gastrointestinal Capsule Imaging System Regulatory Class: II Product Code: NEZ, NSI, PGD Dated: January 15, 2018 Received: January 22, 2018

Dear Hilla Debby:

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.

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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); good manufacturing practice requirements as set forth in 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.

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.

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,

Joyce M. Whang -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

510(k) Number (if known) K180171

Device Name PillCam Patency System

Indications for Use (Describe)

Therefore, the PillCam Patency System is intended to be used:

· prior to PillCam SB capsule in adults and children from 2 years of age, or
· prior to PillCam UGI, COLON, and Crohn's capsules in adults

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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510(k) Summary

I. SUBMITTER

Submitter Name and Address:	Given Imaging Ltd. (Medtronic)2 Hacarmel StreetNew Industrial ParkPO Box 258Yokneam 20692Israel
Contact Person:	Hilla DebbyRegulatory Affairs DirectorEmail: Hilla.Debby@medtronic.com
Phone Number:	972 (4) 9097774
Fax Number:	972 (73) 2501533
Establishment Registration Number:	9710107
Date Prepared:	March 5, 2018
II. DEVICE
Device Trade Name(s):	PillCam Patency System
Device Common Name:	Ingestible telemetric gastrointestinal capsule imaging system
Classification:	Regulation No: 876.1300, Class: II: Ingestible telemetric gastrointestinal capsule imaging system, Product Code NEZ: Ingestible telemetric gastrointestinal capsule imaging system and NSI: Ingestible telemetric gastrointestinal capsule imaging systemRegulation No: 876.1330, Class II: Colon capsule endoscopy system,Product Code PGD: Colon capsule endoscopy system.Panel: Gastroenterology/Urology

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III. PREDICATE DEVICE(S)

Given AGILE Patency System and Given Platform with PillCam SB Capsules (K090557)

IV. DEVICE DESCRIPTION:

There is no change between the Predicate device (K090557) and PillCam Patency System.

The Patency scanner may be utilized to detect RF signals from the RFID tag, to verify the PillCam Patency capsule presence in the body.

V. INDICATIONS FOR USE:

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Patency capsule should only be used within the specified patient age range based on the patient age of the indicated video capsule system. K180171 Page 3 of 4

Therefore, the PillCam Patency System is intended to be used:

prior to PillCam SB capsule in adults and children from 2 years of age, or
prior to PillCam UGI, COLON, and Crohn's capsules in adults ●

VI. TECHNOLOGICAL CHARACHTERISTICS:

There is no change in the technological characteristics of PillCam Patency System from the cleared predicate device (K090557).

VII. PERFORMANCE DATA:

The PillCam Patency capsule is designed to start dissolving after 30 hours. Clinical testing provided in K053639 was leveraged in this submission. In this testing, patients with known strictures ingested the Patency capsule and underwent periodic scanning until the capsule was excreted. If patency was established, capsule endoscopy procedure was performed. The results of this testing showed there were no cases of capsule retention.

Clinical Evaluation

Many studies in the literature have shown that the PillCam Patency System has high diagnostic sensitivity and specificity and that the use of a PillCam Patency System reduces risk of PillCam CE retention.

In addition, three clinical investigations demonstrate the use of Patency System prior to ingestion of longer PillCam capsules with no safety concern raised.

Key opinion leaders (KOL) in the Inflammatory Bowel Disease (IBD) community have advised, based on their clinical experience, that it is the diameter, and not the length, which is critical for capsule passage through the GI tract. The length is not expected to represent an impediment to passage of the capsule.

The proposed change in this submission does not raise new performance or safety issues.

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VIII. CONCLUSION:

Page 4 of 4

Regulation Number and Section

§ 876.1300 Ingestible telemetric gastrointestinal capsule imaging system.

(a)
Identification. An ingestible telemetric gastrointestinal capsule imaging system is used for visualization of the small bowel mucosa as an adjunctive tool in the detection of abnormalities of the small bowel. The device captures images of the small bowel with a wireless camera contained in a capsule. This device includes an ingestible capsule (containing a light source, camera, transmitter, and battery), an antenna array, a receiving/recording unit, a data storage device, computer software to process the images, and accessories.(b)
Classification. Class II (special controls). The special control is FDA's guidance, “Class II Special Controls Guidance Document: Ingestible Telemetric Gastrointestinal Capsule Imaging Systems; Final Guidance for Industry and FDA.”