PillCam Patency System

K180171 · Given Imaging , Ltd. · NSI · Mar 8, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K180171
• Device Name: PillCam Patency System
• Applicant: Given Imaging , Ltd.
• Product Code: NSI · Gastroenterology, Urology
• Decision Date: Mar 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

PillCam Patency System verifies GI tract patency before video capsule endoscopy. System includes ingestible dissolvable Patency capsule containing RFID tag, Patency scanner, and TesTag interference tester. Capsule body features timer plugs; if retained, plugs erode, allowing fluid ingress and body dissolution to facilitate passage of fragments. Scanner detects RFID signal to confirm capsule presence. Used in clinical settings by physicians to assess patient suitability for capsule endoscopy, serving as alternative to MRE or CT. Confirmed patency allows safe administration of PillCam video capsules. Benefits include reduced risk of capsule retention in patients with strictures.

Clinical Evidence

Leveraged clinical data from K053639; patients with known strictures ingested Patency capsule with no cases of retention. Literature review confirms high diagnostic sensitivity/specificity and reduced risk of capsule retention. Three additional clinical investigations support use of Patency System prior to longer PillCam capsules with no safety concerns.

Technological Characteristics

Ingestible dissolvable capsule containing RFID tag; body coated with impermeable membrane; timer plugs seal body. Scanner detects RF signals. No change from predicate K090557.

Indications for Use

Indicated for patients with known or suspected GI strictures requiring patency verification before PillCam video capsule administration. Use prior to PillCam SB in adults and children ≥2 years; use prior to PillCam UGI, COLON, and Crohn's capsules in adults.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

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

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> 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)<br>2 Hacarmel Street<br>New Industrial Park<br>PO Box 258<br>Yokneam 20692<br>Israel |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hilla Debby<br>Regulatory Affairs Director<br>Email: [e-mail] |
| 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 system<br>Regulation No: 876.1330, Class II: Colon capsule endoscopy system,<br>Product Code PGD: Colon capsule endoscopy system.<br>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 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.

## V. INDICATIONS FOR USE:

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

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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:

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