IntraMarX 3D Radiopaque Marker

K201106 · Anx Robotica Corp · FFX · May 21, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K201106
• Device Name: IntraMarX 3D Radiopaque Marker
• Applicant: Anx Robotica Corp
• Product Code: FFX · Gastroenterology, Urology
• Decision Date: May 21, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1725
• Device Class: Class 2

Indications for Use

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 Story

Diagnostic device for colonic motility evaluation; consists of HPMC capsule containing 24 radiopaque markers (thermoplastic elastomer and barium sulfate). Patient swallows capsule; shell dissolves in GI tract; markers remain. Five days post-ingestion, physician performs abdominal X-ray to visualize marker location and count. Physician evaluates remaining markers to diagnose GI conditions (e.g., chronic constipation, colonic inertia, hypomotility, outlet delay). Used in clinical setting; physician-prescribed and patient-administered.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-6 (implantation), ISO 10993-10 (sensitization), and ISO 10993-11 (systemic/subacute toxicity). Radiopacity verified per ASTM F640-12.

Technological Characteristics

Capsule material: HPMC. Marker material: Thermoplastic elastomer (50%) and Barium sulfate. Radiopacity tested per ASTM F640-12. Biocompatibility per ISO 10993 series. Single-use, non-sterile. Marker diameters: 2.0mm, 3mm, 4.5mm.

Indications for Use

Indicated for adult patients with severe constipation and negative GI evaluations to assist in colonic motility assessment.

Regulatory Classification

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.

Predicate Devices

• IntraMarX Radiopaque Marker (K191087)

Submission Summary (Full Text)

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

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.

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

| <div> <span> <span style="text-decoration: line-through;">×</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span>□ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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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: [e-mail] Phone: [phone]

# 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] 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

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.

### 7. 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.

#### 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 Medical<br>Technologies (Shanghai)<br>Co., Ltd. | Ankon Medical<br>Technologies (Shanghai)<br>Co., Ltd. | N/A |
| 510(k) Number | K191087 | N/A | N/A |
| Product Code | FFX | FFX | SAME |
| Regulation<br>Number | 876.1725 | 876.1725 | SAME |
| Indications for Use | IntraMarX Radiopaque<br>Markers is a diagnostic<br>test indicated for assisting<br>in the evaluation of<br>colonic motility in patients<br>with severe constipation,<br>as diagnosed by a<br>healthcare professional,<br>but otherwise negative Gl<br>evaluations. For use in<br>adult only, IntraMarX<br>Radiopaque Markers is<br>dispensed by physicians<br>to patients for oral intake. | IntraMarX 3D Radiopaque<br>Markers is a diagnostic<br>test indicated for assisting<br>in the evaluation of<br>colonic motility in patients<br>with severe constipation,<br>as diagnosed by a<br>healthcare professional,<br>but otherwise negative GI<br>evaluations. For use in<br>adult, IntraMarX 3D<br>Radiopaque Markers is<br>dispensed only by<br>physicians to patients for<br>oral intake. | SAME |
| Models | Ring<br>Double-D<br>Tri-chamber | Ring<br>Dot<br>Tri-chamber | SIMILAR |
| Mechanism of<br>Action | Intake Orally | Intake Orally | SAME |
| Capsule Material | HPMC | HPMC | SAME |
| Radiopaque<br>Marker Material | Polyvinyl<br>Chloride<br>$~45-46%$ | Thermoplas<br>tic<br>Elastomer<br>$50%$ | SIMILAR |
| | Tricotyl<br>Trimellitate<br>$~25-25%$ | None<br>N/A | DIFFERENT |
| Attribute | PREDICATE DEVICE | SUBJECT DEVICE | Comparison |
| Barium<br>Sulfate | ~29-30% | Barium<br>sulfate | SIMILAR |
| Sterile | No | No | SAME |
| Single-Use | Yes | Yes | SAME |
| Shelf Life | 2 Years | 2 Years | SAME |
| Capsule number of<br>Inner package box | 10 capsules/box | 10 capsules/box<br>3 capsules/box<br>1 capsule/box | DIFFERENT |
| Image Area<br>diameter | 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.