K Number

Device Name

Transit-Pellets

Manufacturer

Medifactia AB

Date Cleared

2023-01-18

(195 days)

Product Code

FFX

Regulation Number

876.1725

Intended Use

For evaluation of colonic transit in adult and pediatic patients (at least 2 years old) with chronic constipation and used to aid in differentiating slow and normal transit constipation.

Device Description

The device 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 in adults and pediatric patients (at least 2 years old). 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 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. The device is a convenience package of radiopaque markers (22% Barium Sulphate, 78% Elastosil® R 401/60 Silicone rubber) placed in vegetarian capsules from cellulose (HPMC, Hydroxypropylmethylcellulose), 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 is placed inside a folding box.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K181760

Reference Devices

K181750

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical markers and their visualization via radiograph to calculate transit time based on simple counting and position, with no mention of AI/ML for image analysis or interpretation.

Therapeutic

The device is used for evaluation and diagnosis of colonic transit time, not for treatment or therapy.

Diagnostic

Yes

The device aids in differentiating slow and normal transit constipation, which is a diagnostic purpose. It evaluates colonic transit time to provide information useful for diagnosing the type of constipation.

SaMD (Software as a Medical Device)

The device description explicitly states the device is a "convenience package of radiopaque markers" which are physical components (barium sulphate and silicone rubber) in vegetarian capsules. This is a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze specimens taken from the human body. The definition of an IVD involves examining samples like blood, urine, tissue, etc., outside of the body to obtain information about a person's health.
This device is swallowed and remains within the body. The radiopaque markers are ingested and their movement through the colon is tracked using imaging (radiographs). This is an in vivo process, not in vitro.
The analysis is based on imaging, not biochemical or biological analysis of a specimen. The determination of colonic transit time is made by counting and locating the markers on an X-ray image.

Therefore, while this device is used for diagnostic purposes (evaluating colonic transit), it does not fit the definition of an In Vitro Diagnostic device. It is an in vivo diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For evaluation of colonic transit in adult and pediatic patients (at least 2 years old) with chronic constipation and used to aid in differentiating slow and normal transit constipation.

Product codes

FFX

Device Description

The device is a convenience package of radiopaque markers (22% Barium Sulphate, 78% Elastosil® R 401/60 Silicone rubber) placed in vegetarian capsules from cellulose (HPMC, Hydroxypropylmethylcellulose), 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 is placed inside a folding box.

There is no change to the Transit-Pellets previously cleared in K181760 for this expanded patient population.

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 and pediatric patients (at least 2 years old)

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

A Post-Market Clinical Follow-Up (PMCF) study provided supports the safe and effective use of barium sulphate impregnated particles to measure colonic transit time in pediatric patients at least 2 years old. The literature review carried out during the PMCF study identified 18 clinical investigations performed on similar devices to be of satisfactory quality. In summary, the device performance and safety were successfully measured colonic transit time on 1054 children and young adults. In 12 of the 18 clinical investigations, the principle of taking markers for six days were applied. No device related adverse event reported in any of the clinical investigations.

Further, a user survey, also part of the PMCF study, confirmed that the Transit-Pellets and the Transit-Pellets principle are used to measure colonic transit time in children and young adults with no adverse events or side-effects identified. The survey also confirmed that some professional users inform patients that they can open the capsules and only swallow the markers. The Transit-Pellets meets of the professional users.

Key Metrics

Not Found

Predicate Device(s)

K181760

Reference Device(s)

K181750

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 18, 2023

Medifactia AB % Cherita James Regulatory Consultant M Squared Associates Inc. 127 West 30th Street 9th Floor New York, NY 10001

Re: K222000

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 16, 2022 Received: December 16, 2022

Dear Cherita James:

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/cdri/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 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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).

Sincerelv.

Sivakami Venkatachalam -S

for

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

Indications for Use

510(k) Number (if known) K222000

Device Name

Transit-Pellets

Indications for Use (Describe)

For evaluation of colonic transit in adult and pediatic patients (at least 2 years old) with chronic constipation and used to aid in differentiating slow and normal transit 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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In accordance with 21 CFR 807.92, the following information constitutes the Medifactia AB summary for the Transit-Pellets.

l. Submission Date

January 11, 2023

II. Submitter

Medifactia AB

C/O IOffice Business Center

Kungsgatan 60

Stockholm

Sweden 11122

Contact person: Diana Nyström

Phone number: +46 (0) 31-787 70 77

E-mail: diana.nystrom@medifactia.com

Official Correspondent: Cherita James Regulatory Consultant M Squared Associates, Inc. 127 West 30th St, Floor 9 New York, New York 10001 Ph: 347-954-0624 E-mail: Cjames@Msquaredassociates.com

III. Device

Name of device: Transit-Pellets Common or usual name: System, Gastrointestinal Motility Regulatory class: Class II according to 876.1725

Classification code: FFX

Panel: Gastroenterology/Urology

IV. Predicate device

510(k)	Company	Device
Primary: K181760	Medifactia	Transit-Pellets
Reference: K181750	Konsyl Pharmaceuticals	Sitzmarks

V. Device Description

There is no change to the Transit-Pellets previously cleared in K181760 for this expanded patient population.

VI. Intended use

For evaluation of colonic transit in adult and pediatric patients (at least 2 years old) with chronic constipation and used to aid in differentiating slow and normal transit constipation.

VII. Comparison of the technology characteristics with the predicate devices

	Subject device	Primary Predicate	Reference Predicate	SE
	Medifactia AB
Transit-Pellets	Medifactia AB
Transit-Pellets	Konsyl
Pharmaceuticals
Sitzmarks
K#	K222000	K181760	K181750
Indication for
use/
Intended use	For evaluation of
colonic transit in adult
and pediatric patients
(at least 2 years old)
with chronic
constipation and used
to aid in
differentiating slow
and normal transit
constipation.	For evaluation of
colonic transit in
adult patients with
chronic
constipation and
used to aid in
differentiating slow
and normal
constipation.	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.	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.	Measuring and
using colonic transit
time to evaluate
patients with
chronic (severe)
constipation.	X
Target
population	Adult and pediatric
patients (at least 2
years old) patients
with chronic (severe)
constipation.	Adult patients with
chronic (severe)
constipation.	Adult and pediatric
patients (at least 2
years old) patients
with chronic
(severe)
constipation.	X
	Subject device	Primary Predicate	Reference Predicate	SE
	Medifactia AB
Transit-Pellets	Medifactia AB
Transit-Pellets	Konsyl
Pharmaceuticals
			Sitzmarks

Anatomical site	Gastrointestinal
tract/colon	Gastrointestinal
tract/colon	Gastrointestinal
tract/colon	X
Where used	Hospitals, clinics	Hospitals, clinics	Hospitals, clinics	X
Design	Ring-formed and
tube-formed markers.	Ring-formed and
tube-formed
markers.	Three different
shapes of markers:
O Rings, Double D
and Tri-Chamber.	X
Dimensions/
Capsule size	2 x 4.5mm, 6 x 2mm
Size -00-	2 x 4.5mm, 6 x
2mm
Size -00-	1mm x 4.5mm
Size -00-	X
Materials	Markers: Barium
sulphate, Elastosil® R
401/60 Silicone
rubber
Capsules: HPMC,
Hydroxypropyl-
methylcellulose	Markers: Barium
sulphate, Elastosil®
R 401/60 Silicone
rubber
Capsules: HPMC,
Hydroxypropyl-
methylcellulose	Radiopaque Marker
• Polyvinyl Chloride
Resin (PVC)
• Bis(2-ethylhexyl)
Phthalate (DEHP)
• Epoxides Soya Oil
• Calcium/Zinc
Stabilizers
• Phosphate
Stabilizer
• Fatty Ester &
Polyamide
Lubricants
• Ultramarine
Tinting Agents
• Barium Sulfate
• Dioctyl Phthalate	X
	Subject device	Primary Predicate	Reference Predicate	SE
	Medifactia AB
Transit-Pellets	Medifactia AB
Transit-Pellets	Konsyl
Pharmaceuticals
Sitzmarks
			• Mono &
Diglycerides
Capsules:
Hypromellosa
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. 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.	Colonic Transit
Time (CTT/OATT)
numerical values
reported in days.	Colonic Transit Time
(CTT/OATT)
numerical values
reported in hours.	x
Biocompatibility	Yes, safe for intended
use
ISO 10993-5, -10, and
-11	Yes, safe for
intended use
ISO 10993-5, -10,
and -11	No information	x
Packaging	Blister and folding box	Blister and folding
box	Folder combo/single
pack	x
Sterile	No	No	No	x
	Subject device	Primary Predicate	Reference Predicate	SE
	Medifactia AB
Transit-Pellets	Medifactia AB
Transit-Pellets	Konsyl
Pharmaceuticals
Sitzmarks
Shelf life	2.5 years	2.5 years	Unknown
Rx Only	Yes	Yes	Yes	×

VIII. Performance testing

Transit-Pellets have a size