(401 days)
Not Found
No
The device description focuses on physical markers and a calculation based on their position and number on an X-ray, with no mention of AI/ML in the process.
No
The device is used for evaluation and diagnosis of colonic transit time, not for treating any condition.
Yes
The device is used for the "evaluation of colonic transit" and to "aid in differentiating slow and normal constipation," which are diagnostic purposes to understand the nature of a patient's condition.
No
The device description explicitly states that Transit-Pellets are physical radiopaque markers made of Barium Sulphate and Silicone rubber, placed in vegetarian capsules. This is a physical medical 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 Function: The Transit-Pellets device is swallowed by the patient and its movement through the gastrointestinal tract is tracked using imaging (radiography). It does not analyze a sample taken from the body.
- Intended Use: The intended use is to evaluate colonic transit within the body, not to analyze a sample outside the body.
Therefore, Transit-Pellets is a medical device used in vivo (within the living organism) for diagnostic purposes, but it does not fit the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.
Product codes (comma separated list FDA assigned to the subject device)
FFX
Device Description
Transit-Pellets is intended to be used for evaluation of colonic transit time in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Ten (10) radiopaque markers per day are swallowed for six consecutive days. On day seven an abdominal radiograph is taken. Based on the number of retained markers and the position in colon a colonic transit time is calculated and compared to reference values. Both total transit and segmental transit dysfunction in the colon can be evaluated with the device. By dividing the particle dose on day six by taking five (5) markers in the morning and five (5) markers in the evening, the whole range of transit times (slow, normal, rapid) transit can be measured from the radiograph.
Transit-Pellets is a convenience package of radiopaque markers (22% Barium Sulphate, 78% Elastosil® R 401/60 Silicone rubber) placed in vegetarian capsules from cellulose (HPMC, Hydroxypropyl-methylcellulose), intended for single patient use. The dimension of the markers is 2x4.5mm (ring-formed markers) and 6x2mm (tube-formed markers). The capsules are packed in a blister pack and the blister pack is placed inside a folding box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
abdominal radiograph or fluoroscopy
Anatomical Site
Gastrointestinal tract/colon
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Hospitals, clinics
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)
Transit-Pellets have a size 8 mm will have a slower emptying rate from the stomach and thus the transit time from the stomach to the colon will be delayed and can lead to a falsely prolonged value of colonic transit time. Studies with markers
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
August 8, 2019
Medifactia AB % Connie Qiu Regulatory Consultant III M Squared Associates, Inc 575 8th Ave Suite 1212 New York, NY 10018
Re: K181760
Trade/Device Name: Transit-Pellets Regulation Number: 21 CFR 876.1725 Regulation Name: Gastrointestinal Motility Monitoring System Regulatory Class: Class II Product Code: FFX Dated: December 27, 2018 Received: July 12, 2019
Dear Connie Qiu:
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
1
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,
for
Martha W. Betz, PhD Acting Assistant Division 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) K181760
Device Name Transit-Pellets
Indications for Use (Describe)
For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) number: K181760
In accordance with 21 CFR 807.92, the following information constitutes the Medifactia AB summary for the Transit-Pellets.
Submission Date l.
July 11, 2019
II. Submitter Medifactia AB
Lumaparksvagen 7 Stockholm SE 120 30 Sweden Contact person: Diana Nyström Phone number: +46 (0) 31-787 70 77 E-mail: diana.nystrom@medifactia.com
Official Correspondent: Connie Qui Regulatory Consultant M Squared Associates, Inc. 575 8th Avenue, Rm 1212 New York, New York 10018 Ph: 347-954-0411 Fax: 702-562-9797 E-mail: CQui@Msquaredassociates.com
III. Device
Name of device: Transit-Pellets Common or usual name: Radiopaque markers Classification name: Gastrointestinal motility monitoring system Regulatory number: 21 CFR 876.1725 Regulation Class: II Product code: FFX Panel: Gastroenterology/Urology
IV. Predicate device
| 510(k) | Company | Device |
|---|---|---|
| K881609 | Lafayette Pharmacal, Inc | Sitzmarks |
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V. Device Description
Transit-Pellets is intended to be used for evaluation of colonic transit time in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Ten (10) radiopaque markers per day are swallowed for six consecutive days. On day seven an abdominal radiograph is taken. Based on the number of retained markers and the position in colon a colonic transit time is calculated and compared to reference values. Both total transit and segmental transit dysfunction in the colon can be evaluated with the device. By dividing the particle dose on day six by taking five (5) markers in the morning and five (5) markers in the evening, the whole range of transit times (slow, normal, rapid) transit can be measured from the radiograph.
Transit-Pellets is a convenience package of radiopaque markers (22% Barium Sulphate, 78% Elastosil® R 401/60 Silicone rubber) placed in veqetarian capsules from cellulose (HPMC, Hydroxypropyl-methylcellulose), intended for single patient use. The dimension of the markers is 2x4.5mm (ring-formed markers) and 6x2mm (tube-formed markers). The capsules are packed in a blister pack and the blister pack is placed inside a folding box.
VI. Intended use
For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.
| Device name | Company Device | Predicate Device | SE |
|---|---|---|---|
| Applicant | Medifactia AB | ||
| Transit-Pellets | Lafayette Pharmacal, Inc | ||
| Sitzmarks | |||
| K# | -- | K881609 | |
| Indication for use | |||
| Intended use | For evaluation of colonic | ||
| transit in patients with | |||
| chronic constipation and | |||
| used to aid in differentiating | |||
| slow and normal | |||
| constipation. | For evaluation of colonic | ||
| transit in patients with | |||
| chronic constipation and | |||
| used to aid in | |||
| differentiating slow and | |||
| normal constipation. | X | ||
| Application | Measuring and using | ||
| colonic transit time to | |||
| evaluate patients with | |||
| chronic (severe) | |||
| constipation. | Measuring and using | ||
| colonic transit time to | |||
| evaluate patients with | |||
| chronic (severe) | |||
| constipation. | X | ||
| Target population | Adult patients with chronic | ||
| (severe) constipation. | Adult patients with chronic | ||
| (severe) constipation. | X | ||
| Anatomical site | Gastrointestinal tract/colon | Gastrointestinal tract/colon | X |
| Where used | Hospitals, clinics | Hospitals, clinics | X |
| Device name | Company Device | Predicate Device | SE |
| Applicant | Medifactia AB | Lafayette Pharmacal, Inc | |
| Transit-Pellets | Sitzmarks | ||
| Design | Ring-formed and tube- | ||
| formed markers. | Three different shapes of | ||
| markers: O Rings, Double | |||
| D and Tri-Chamber. | X | ||
| Dimensions | 2 x 4.5mm, 6 x 2mm | 1mm x 4.5mm | X |
| Materials | Markers: Barium sulphate, | ||
| Elastosil® R 401/60 | |||
| Silicone rubber | |||
| Capsules: HPMC, | |||
| Hydroxypropyl- | |||
| methylcellulose | Copied from | ||
| www.sitzmarks.com: | |||
| Markers: Rings- | |||
| Polyvinylchloride, Barium | |||
| sulphate, DEHP, soya oil, | |||
| calcium, zinc, phosphate, | |||
| ultramarine tinting agent, | |||
| mono & diglycerides, DOP | |||
| plasticizer | |||
| Capsules: Hypromellosa | |||
| Copied from 510(k); | |||
| Markers: Radiopaque | |||
| polyvinyl chloride | |||
| Gelatin capsules | X | ||
| Principle of | |||
| operation | Patient swallows a fixed | ||
| dose radiopaque marker for | |||
| a number of days. On day | |||
| 7 a single abdominal | |||
| radiograph or fluoroscopy | |||
| is taken. Based on the | |||
| number of retained markers | |||
| on abdominal film and their | |||
| position in colon a colonic | |||
| transit time is calculated | |||
| and compared to reference | |||
| value. | Patient swallows a fixed | ||
| dose radiopaque marker | |||
| for a number of days. | |||
| Several abdominal | |||
| radiographs may be | |||
| necessary. Based on the | |||
| number of retained | |||
| markers on abdominal | |||
| film(s) and their position in | |||
| colon a colonic transit time | |||
| is calculated and | |||
| compared to reference | |||
| value. | X | ||
| Performance | Colonic Transit Time | ||
| (CTT/OATT) numerical | |||
| values reported in days. | |||
| ASTM F640-12 RO | |||
| confirmed. | Colonic Transit Time | ||
| (CTT/OATT) numerical | |||
| values reported in hours. | X | ||
| Biocompatibility | Yes, safe for intended use | ||
| ISO 10993-5 | |||
| ISO10993-10 | |||
| ISO 10993-11 | No information | ||
| Packaging | Blister and folding box | Blister and folding box | X |
| Sterile | No | No | X |
| Shelf Life | 2.5 years | unknown | X |
| Rx Only | Yes | Yes | X |
VII. Comparison of the technology characteristics with the predicate devices
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6
VIII. Performance testing
Transit-Pellets have a size 8 mm will have a slower emptying rate from the stomach and thus the transit time from the stomach to the colon will be delayed and can lead to a falsely prolonged value of colonic transit time. Studies with markers