(238 days)
No
The device description and performance studies focus on the physical properties and radiopacity of the markers, and the physician makes the diagnosis based on visual interpretation of the X-ray. There is no mention of automated analysis or algorithms.
No
The device is described as a "diagnostic test indicated for assisting in the evaluation of colonic motility." It helps physicians make a diagnosis, it does not treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "IntraMarX Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility." The "Device Description" also mentions its use for "diagnosis of many GI conditions."
No
The device is a physical capsule containing radiopaque rings, which is swallowed by the patient. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Mechanism: The IntraMarX Radiopaque Markers are swallowed and remain within the patient's body. The diagnostic information is obtained through an X-ray scan of the patient's GI tract, not from testing a sample taken from the body.
- Intended Use: The intended use is to assist in the evaluation of colonic motility by observing the location of the markers within the body via imaging.
Therefore, while it is a diagnostic device, it operates in vivo (within the living body) rather than in vitro (in glass, referring to laboratory testing of samples).
N/A
Intended Use / 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.
Product codes
FFX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
GI tract / colonic
Indicated Patient Age Range
adult only
Intended User / Care Setting
Physicians dispensing to patients for oral intake.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 – Acceptable
- . Microbial Limit/ Microbial Burden testing per USP 42-NF37:2019 – 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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)
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) |
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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
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.
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| 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
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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 – Acceptable
- . Microbial Limit/ Microbial Burden testing per USP 42-NF37:2019 – 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.