IntraMarX Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult only, IntraMarX Radiopaque Markers is dispensed by physicians to patients for oral intake.

Device Description

The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.

AI/ML Overview

The provided text describes the submission for FDA clearance of the "IntraMarX Radiopaque Markers" device (K191087) and compares it to a predicate device, the "SITZMARKS Capsule" (K181750).

However, the document does not contain specific acceptance criteria for "device performance" in terms of clinical outcomes, nor does it present a detailed study that proves the device meets such criteria in a comparative effectiveness manner (e.g., against human readers or other diagnostic methods). Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (material safety, physical properties, etc.).

Here's an analysis based on the available information, noting what's present and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy in diagnosing colonic motility issues) and thus does not report device performance against such criteria. The reported "performance" falls under non-clinical testing for safety and basic functionality.

Acceptance Criteria (Internal/Standard)	Reported Device Performance (Non-Clinical)
Cytotoxicity per ISO 10993-5	Pass
Implantation per ISO 10993-6	Pass
Sensitization per ISO 10993-10	Pass
Systemic Toxicity per ISO 10993-11	Pass
Sample Prep & Reference Materials per ISO 10993-12	Pass
Microbial Limit/Burden per USP 42-NF37 <61>	Acceptable
Microbial Limit/Burden per USP 42-NF37 <62>	Acceptable
Accelerated Aging per ASTM F1980-16	Pass
Packaging & Transportation per ASTM D4332-14	Pass
Packaging & Transportation per ASTM D4169-16	Pass
Extraction of Medical Plastics per ASTM F619-14	Pass
Radiopacity per ASTM F640-12	Pass
Heavy metal testing per ISO 8536-4	Pass
Heavy metal testing per ISO 3826-1	Pass
Validation Of Analytical Procedures per ICH Q2 (R1)	Pass
Barium ion precipitation (customer protocol)	Pass

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

The document does not describe a clinical "test set" in the context of diagnostic accuracy for colonic motility. All listed tests are non-clinical, focusing on material and physical properties of the device itself. Therefore, information on sample size and data provenance (country, retrospective/prospective) related to a clinical test set is not provided.

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

Not applicable. As no clinical test set for diagnostic performance is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

Not applicable. No clinical test set needing adjudication is described.

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

Not applicable. This device is a passive radiopaque marker, not an AI software. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements of the cited ISO, ASTM, USP, and ICH standards/protocols. For example:

Cytotoxicity: Ground truth is whether cell viability falls below a certain threshold when exposed to device materials.
Radiopacity: Ground truth is whether the markers are visible on X-ray according to the specified standard.
Heavy metal testing: Ground truth is whether heavy metal levels are within established safe limits.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm.

Summary of Device and Approval Context:

The "IntraMarX Radiopaque Markers" device is a diagnostic aid consisting of capsules containing radiopaque rings. Patients swallow the capsule, and after five days, an X-ray of the abdomen is taken to observe the remaining rings in the GI tract. Physicians interpret the location and number of rings to evaluate colonic motility in patients with severe constipation.

The FDA clearance (K191087) is based on demonstrating substantial equivalence to a previously cleared predicate device, the "SITZMARKS Capsule" (K181750). This means the applicant showed that their device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The core of this demonstration relies entirely on the non-clinical performance data listed above, proving the physical and biological safety of the marker material and its radiopacity. There is no mention of new clinical studies on diagnostic accuracy for this submission. The effectiveness is presumed to be equivalent to the predicate device, which itself would have had to demonstrate effectiveness.

Summary

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December 18, 2019

AnX Robotica Corp. % Giselle Zhang Consultant, Quality and Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746

Re: K191087

Trade/Device Name: IntraMarX Radiopaque Markers Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: November 12, 2019 Received: November 19, 2019

Dear Giselle Zhang:

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.

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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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

for

Shani P. Haugen, Ph.D. Acting 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

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Indications for Use

510(k) Number (if known) K191087

Device Name IntraMarX Radiopaque Markers

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)

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510(k) Summary

IntraMarX Radiopaque Markers

1. Submission Sponsor

AnX Robotica Corp. 7213 Regency Court Plano, TX 75024 Contact: Lin Wang Title: Regulatory Assurance Manager

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Contact: Giselle Zhang Title: Consultant, Quality and Regulatory

3. Date Prepared

12/10/2019

4. Device Identification

Trade/Proprietary Name:	IntraMarX Radiopaque Markers
Common/Usual Name:	Gastrointestinal motility monitoring system
Classification Name:	Gastrointestinal Motility Monitoring System
Regulation Number:	876.1725
Product Code:	FFX
Classification:	II
Classification Panel:	Gastroenterology/Urology

5. Legally Marketed Predicate Device(s): SITZMARKS Capsule

The SITZMARKS Capsule is manufactured by Konsyl Pharmaceuticals, Inc. cleared by K181750 on 11/15/2018. SITZMARKS' Radiopaque Markers are for assisting in the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility, and outlet delay and bowel obstruction. Each capsule contains 24 radiopaque markers that are visible throughout the digestive tract via X-ray. The markers are available in three different shapes: O-Ring, Double D, and Tri-Chambers.

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6. Indication for Use Statement

7. Device Description

8. Substantial Equivalence Discussion

The following table compares the IntraMarX to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

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Attribute	INTRAMARX	SITZMARKS	Comparison
Manufacturer	Ankon MedicalTechnologies (Shanghai)Co., Ltd.	Konsyl Pharmaceuticals, Inc.	N/A
510(k) Number	K191087	K181750	N/A
Product Code	FFX	FFX	SAME
RegulationNumber	876.1725	876.1725	SAME
Indications for Use	IntraMarX RadiopaqueMarkers is a diagnostictest indicated forassisting in theevaluation of colonicmotility in patients withsevere constipation, asdiagnosed by ahealthcare professional,but otherwise negativeGI evaluations. For use inadult only, IntraMarXRadiopaque Markers isdispensed by physiciansto patients for oralintake.	SITZMARKS capsule is adiagnostic test indicatedfor aiding in theevaluation of colonicmotility in patients withsevere constipation, asdiagnosed by yourhealthcare professional,but otherwise negative GIevaluations. SITZMARKScapsule, for use in adultand pediatric patients (atleast 2 years old), is to bedispensed only byphysicians to patients fororal intake.	SAME
Models	RingDouble-DTri-chamber	RingDouble-DTri-chamber	SAME
Mechanism ofAction	Intake Orally	Intake Orally	SAME
Capsule Material	HPMC	N/A	NOT KNOWN
RadiopaqueMarker Material	PolyvinylChloride~45-46%TricotylTrimellitate~24-25%	PolyvinylChloride~47-48%Di(2-ethylhexyl)phthalate~18-19%	SAMEDIFFERENT
Attribute	INTRAMARX	SITZMARKS	Comparison
	Barium Sulfate~29-30%	Barium Sulfate~33-34%	SAME
Sterile	No	No	SAME
Single-Use	Yes	Yes	SAME
Shelf Life	2 Years	N/A	NOT KNOWN
Cytotoxicity	Pass	Pass	SAME

Table 5A – Comparison of Characteristics

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Page 4 of 5 K191087

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9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of IntraMarX and to show substantial equivalence to the predicate device, Ankon completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The IntraMarX passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, and its substantial equivalence to the predicate device:

Cytotoxicity testing per ISO 10993-5 - Pass
. Implantation testing per ISO 10993-6 - Pass
. Sensitization testing per ISO 10993-10 - Pass
. Systemic Toxicity testing per ISO 10993-11 - Pass
Sample Preparation and Reference Materials testing per ISO 10993-12 – Pass
. Microbial Limit/ Microbial Burden testing per USP 42-NF37:2019 <61> – Acceptable
. Microbial Limit/ Microbial Burden testing per USP 42-NF37:2019 <62> – Acceptable
Accelerated Aging testing per ASTM F1980-16 - Pass
Packaging and Transportation testing per ASTM D4332-14 – Pass
. Packaging and Transportation testing per ASTM D4169-16 – Pass
Extraction of Medical Plastics per ASTM F619-14 – Pass
. Radiopacity testing per ASTM F640-12 - Pass
. Heavy metal testing per ISO 8536-4 - Pass
. Heavy metal testing per ISO 3826-1 - Pass
. Validation Of Analytical Procedures per ICH Q2 (R1) – Pass
Barium ion precipitation per customer provided protocol – Pass

10. Statement of Substantial Equivalence

The IntraMarX has the same intended use as the predicate device, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the IntraMarX is as safe and effective as the predicate device. Therefore, the IntraMarX is substantially equivalent to the SITZMARKS.

Regulation Number and Section

§ 876.1725 Gastrointestinal motility monitoring system.

(a)
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.(b)
Classification. Class II (performance standards).