← Product Code [FFX](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX) · K181750

# SITZMARKS (K181750)

_Konsyl Pharmaceuticals · FFX · Nov 15, 2018 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX/K181750

## Device Facts

- **Applicant:** Konsyl Pharmaceuticals
- **Product Code:** [FFX](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX.md)
- **Decision Date:** Nov 15, 2018
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1725
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Pediatric

## Intended Use

SITZMARKS capsule is a diagnostic test inding in the evaluation of colonic motility in patients with severe constipation, as diagnosed by your healthcare professional, but otherwise negative GI evaluations. SITZMARKS capsule, for use in adult and pediatric patients (at least 2 years old), is to be dispensed only by physicians to patients for oral intake.

## Device Story

SITZMARKS capsule is a radiopaque diagnostic marker used to assess colonic transit time. The device consists of a capsule containing radiopaque markers; ingested orally by the patient. Following ingestion, the patient undergoes abdominal X-ray imaging at specified intervals to track the movement and distribution of the markers through the colon. The healthcare provider analyzes the X-ray images to quantify colonic motility; results assist in the clinical diagnosis of constipation-related disorders. The device is intended for use in clinical settings under physician supervision.

## Technological Characteristics

Radiopaque markers contained within an ingestible capsule. The device functions as a passive diagnostic aid for radiographic visualization of gastrointestinal transit.

## Regulatory Identification

A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.

## Submission Summary (Full Text)

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November 15, 2018

Konsyl Pharmaceuticals, Inc. % Stuart Portnoy, MD Regulatory Consultant Prism Medical Device Consulting 5151 10th Rd N Arlington, VA 22205

Re: K181750

Trade/Device Name: SITZMARKS Regulation Number: 21 CFR§ 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: II Product Code: FFX Dated: October 19, 2018 Received: October 22, 2018

Dear Stuart Portnoy:

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,

# Jeffrey W. Cooper -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) K181750

Device Name SITZMARKS

#### Indications for Use (Describe)

SITZMARKS capsule is a diagnostic test inding in the evaluation of colonic motility in patients with severe constipation, as diagnosed by your healthcare professional, but otherwise negative GI evaluations. SITZMARKS capsule, for use in adult and pediatric patients (at least 2 years old), is to be dispensed only by physicians to patients for oral intake.

Type of Use (Select one or both, as applicable)

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|----------------------------------------------|
| <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C)  |

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**Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX/K181750](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX/K181750)

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