← Product Code [FFX](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX) · K191087 # IntraMarX Radiopaque Markers (K191087) _Anx Robotica Corp · FFX · Dec 18, 2019 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX/K191087 ## Device Facts - **Applicant:** Anx Robotica Corp - **Product Code:** [FFX](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX.md) - **Decision Date:** Dec 18, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1725 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use 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 Story Diagnostic device for colonic motility evaluation; consists of capsule containing 24 radiopaque rings (Ring, Double-D, Tri-chamber models). Patient swallows capsule; shell dissolves in GI tract; rings remain. Physician performs abdominal X-ray 5 days post-ingestion to visualize ring location/count. Physician evaluates remaining rings to diagnose GI conditions (chronic constipation, colonic inertia, hypomotility, outlet delay). Used in clinical setting; dispensed by physician for patient oral intake. ## Clinical Evidence Bench testing only. Testing included cytotoxicity (ISO 10993-5), implantation (ISO 10993-6), sensitization (ISO 10993-10), systemic toxicity (ISO 10993-11), microbial limits (USP <61>, <62>), accelerated aging (ASTM F1980-16), packaging/transportation (ASTM D4332-14, D4169-16), radiopacity (ASTM F640-12), and heavy metal testing (ISO 8536-4, ISO 3826-1). All tests passed. ## Technological Characteristics Capsule shell: HPMC. Radiopaque markers: Polyvinyl Chloride (~45-46%), Tricotyl Trimellitate (~24-25%), Barium Sulfate (~29-30%). Single-use, non-sterile. Radiopacity per ASTM F640-12. Shelf life: 2 years. ## 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. ## Predicate Devices - SITZMARKS Capsule ([K181750](/device/K181750.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K191087 Device Name IntraMarX Radiopaque Markers #### Indications for Use (Describe) 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. 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)
| #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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. {4}------------------------------------------------ #### 6. Indication for Use Statement 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. #### 7. 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. #### 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. {5}------------------------------------------------ | Attribute | INTRAMARX | SITZMARKS | Comparison | |-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Manufacturer | Ankon Medical
Technologies (Shanghai)
Co., Ltd. | Konsyl Pharmaceuticals, Inc. | N/A | | 510(k) Number | K191087 | K181750 | N/A | | Product Code | FFX | FFX | SAME | | Regulation
Number | 876.1725 | 876.1725 | SAME | | Indications for Use | 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. | SITZMARKS capsule is a
diagnostic test indicated
for aiding 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. | SAME | | Models | Ring
Double-D
Tri-chamber | Ring
Double-D
Tri-chamber | SAME | | Mechanism of
Action | Intake Orally | Intake Orally | SAME | | Capsule Material | HPMC | N/A | NOT KNOWN | | Radiopaque
Marker Material | Polyvinyl
Chloride
~45-46%

Tricotyl
Trimellitate
~24-25% | Polyvinyl
Chloride
~47-48%

Di(2-
ethylhexyl)
phthalate
~18-19% | SAME

DIFFERENT | | 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 {6}------------------------------------------------ Page 4 of 5 K191087 {7}------------------------------------------------ #### 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. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX/K191087](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FFX/K191087) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com