IntraMarX 3D 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, IntraMarX 3D Radiopaque Markers is dispensed only by physicians to patients for oral intake.

Device Description

The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many Gl conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule is swallowed by the patient under 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 x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the Gl 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the IntraMarX 3D Radiopaque Marker, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting new acceptance criteria for novel performance claims. The "acceptance criteria" here are therefore inferred from the comparison of characteristics and the non-clinical performance data, which aim to show the device meets existing standards and is as safe and effective as the predicate.

Acceptance Criterion (Inferred from Substantial Equivalence and Standards)	Reported Device Performance (IntraMarX 3D)
Biocompatibility:
- Absence of Cytotoxicity	Pass (per ISO 10993-5)
- Acceptable Implantation Response	Pass (per ISO 10993-6)
- Absence of Intracutaneous Reactivity/Sensitization	Pass (per ISO 10993-10)
- Absence of Material-Mediated Pyrogenicity/Systemic/Subacute Toxicity	Pass (per ISO 10993-11)
Radiopacity:	Pass (per ASTM F640-12)
Functional Equivalence:	- Same Indications for Use as predicate.- Same Mechanism of Action (oral intake).- Same Capsule Material (HPMC).- Similar Radiopaque Marker Material (Thermoplastic Elastomer 50% for subject vs. Polyvinyl Chloride 45-46% for predicate, both with Barium Sulfate).- Same Sterile status (No), Single-Use (Yes), Shelf Life (2 Years).- Differences in capsule packaging and image area diameter are acknowledged but not stated to impact safety/effectiveness as they don't raise new questions.
Safety and Effectiveness:	Performance testing demonstrated the IntraMarX 3D is as safe and effective as the predicate device.

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

The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The studies mentioned are primarily non-clinical (biocompatibility, radiopacity). The data provenance is generally not explicitly stated beyond implying these are results from tests conducted by the manufacturer, Ankon Medical Technologies (Shanghai) Co., Ltd., to support substantial equivalence. It does not refer to patient data or clinical studies.

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

This information is not provided in the document. The studies mentioned are non-clinical hardware/material tests rather than diagnostic performance studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided as the document does not describe a clinical study or a test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The document focuses on showing substantial equivalence of a physical medical device (radiopaque markers) to a predicate device, based on material properties and non-clinical performance, not on the diagnostic accuracy of an AI algorithm or its impact on human reader performance.

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

This device, the "IntraMarX 3D Radiopaque Marker," is a physical diagnostic aid. It is not an AI algorithm and therefore, no standalone algorithm performance study was mentioned or would be applicable in this context. The "diagnosis" is made by a physician based on the visualization of the markers on an X-ray.

7. The Type of Ground Truth Used

For the non-clinical tests (biocompatibility, radiopacity), the "ground truth" implicitly comes from the established pass/fail criteria of the referenced international and national standards (ISO, ASTM). For example, a material either passes or fails the cytotoxicity test based on the standard's definition. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the device, as it's not a diagnostic algorithm being evaluated for accuracy against such benchmarks.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The IntraMarX 3D Radiopaque Marker is a physical device, not an AI algorithm that requires a training set.

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

This information is not applicable/not provided for the same reason as above.

Summary

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May 21, 2020

AnX Robotica Corp. % Randy Jiang Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Rd, Bldg 1, Suite 300 Austin, TX 78746

Re: K201106

Trade/Device Name: IntraMarX 3D Radiopaque Marker Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal motility monitoring system Regulatory Class: II Product Code: FFX Dated: April 23, 2020 Received: April 24, 2020

Dear Randy Jiang:

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

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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

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Indications for Use

510(k) Number (if known) K201106

Device Name IntraMarX 3D 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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K201106 Page 1 of 4 Page 1 of 4

510(k) Summary

IntraMarX 3D Radiopaque Marker

1. Submission Sponsor

AnX Robotica Corp. 1047 Serpentine Ln. Suite 100 Pleasanton, CA 94566 Contact Person: Steven Gu, Director of Quality Assurance and Regulatory Affairs Email: steven.gu@anxrobotics.com Phone: 510-449-2956

2. Submission Correspondent

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

3. Date Prepared

05/4/2020

4. Device Identification

Trade/Proprietary Name:	IntraMarX 3D Radiopaque Marker
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):

Device name: IntraMarX Radiopaque Marker 510(k) number: K191087 Manufacturer: Ankon Medical Technologies (Shanghai) Co., Ltd.

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6. Indication for Use Statement

7. Device Description

8. Substantial Equivalence Discussion

The following table compares the IntraMarX 3D to the predicate device with respect to indications for use, principles of operation, technological characteristics, capsule material, 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	PREDICATE DEVICE	SUBJECT DEVICE	Comparison
Manufacturer	Ankon MedicalTechnologies (Shanghai)Co., Ltd.	Ankon MedicalTechnologies (Shanghai)Co., Ltd.	N/A
510(k) Number	K191087	N/A	N/A
Product Code	FFX	FFX	SAME
RegulationNumber	876.1725	876.1725	SAME
Indications for Use	IntraMarX RadiopaqueMarkers is a diagnostictest indicated for assistingin the evaluation ofcolonic motility in patientswith severe constipation,as diagnosed by ahealthcare professional,but otherwise negative Glevaluations. For use inadult only, IntraMarXRadiopaque Markers isdispensed by physiciansto patients for oral intake.	IntraMarX 3D RadiopaqueMarkers is a diagnostictest indicated for assistingin the evaluation ofcolonic motility in patientswith severe constipation,as diagnosed by ahealthcare professional,but otherwise negative GIevaluations. For use inadult, IntraMarX 3DRadiopaque Markers isdispensed only byphysicians to patients fororal intake.	SAME
Models	RingDouble-DTri-chamber	RingDotTri-chamber	SIMILAR
Mechanism ofAction	Intake Orally	Intake Orally	SAME
Capsule Material	HPMC	HPMC	SAME
RadiopaqueMarker Material	PolyvinylChloride$~45-46%$	ThermoplasticElastomer$50%$	SIMILAR
	TricotylTrimellitate$~25-25%$	NoneN/A	DIFFERENT
Attribute	PREDICATE DEVICE	SUBJECT DEVICE	Comparison
BariumSulfate	~29-30%	Bariumsulfate	SIMILAR
Sterile	No	No	SAME
Single-Use	Yes	Yes	SAME
Shelf Life	2 Years	2 Years	SAME
Capsule number ofInner package box	10 capsules/box	10 capsules/box3 capsules/box1 capsule/box	DIFFERENT
Image Areadiameter	4.5mm	2.0mm, 3mm, 4.5mm	DIFFERENT
Biocompatibility	Pass	Pass	SAME

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

To demonstrate safety and effectiveness of IntraMarX 3D 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 3D 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
Intracutaneous reactivity testing/Sensitization testing per ISO 10993-10 - Pass
. Material-mediated pyrogenicity /Systemic toxicity testing/Subacute toxicity testing per ISO 10993-11 — Pass
Radiopacity testing per ASTM F640-12 - Pass

10. Statement of Substantial Equivalence

The IntraMarX 3D 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 3D is as safe and effective as the predicate device. Therefore, the IntraMarX 3D is substantially equivalent to the predicate device.

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).