(199 days)
Not Found
No
The device description explicitly states that the mechanism of action is "purely mechanical and does not involve any chemical activity." There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated to aid in weight management and works by creating a sensation of fullness to enable weight loss, which directly addresses a health condition.
No
Explanation: Epitomee is indicated to aid in weight management by mechanically occupying volume in the stomach to create a sensation of fullness, rather than diagnosing a condition.
No
The device description explicitly states that the device is comprised of a capsule and hydrogel particles, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Mechanism of Action: The device works mechanically by occupying volume in the stomach to create a feeling of fullness. It does not involve any chemical activity or analysis of biological samples.
- Intended Use: The intended use is to aid in weight management by creating a sensation of fullness, not by diagnosing or monitoring a disease or condition through in vitro examination of specimens.
- Device Description: The description focuses on the physical properties of the hydrogel particles and their interaction with stomach fluid.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no indication of a diagnostic purpose.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Epitomee is indicated to aid in weight management in overweight and obese adults with a Body Mass Index (BMI) of 25 - 40 kg/m², when used in conjunction with diet and exercise.
Product codes
QFQ
Device Description
The subject device of this 510(k) notification, Epitomee, is comprised of two components: The outer component is a capsule and the inner component contains superabsorbent hydrogel particles. Each particle is approximately 250 microns in size. The particles are enclosed in pH sensitive compartments. Once Epitomee is swallowed, the capsule disintegrates in the stomach and releases the pH sensitive compartments. By absorption of water in the stomach fluid, the superabsorbent particles within the compartments swell to form a three-dimensional matrix designed to occupy volume in the stomach that creates a sensation of fullness, enabling weight loss. Epitomee mechanism of action is purely mechanical and does not involve any chemical activity. Epitomee works directly in the gastrointestinal (GI) tract. Epitomee is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Non-systemic and works directly in the gastrointestinal (GI) tract (stomach)
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Not Found
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
Pivotal Clinical Study (RESET Study)
- Study Type: Prospective, randomized, double-blind, placebo-controlled, multicenter trial.
- Sample Size: 279 men and non-pregnant, non-lactating women.
- Key Results:
- Epitomee treatment group total body weight (TBW) reduction at 24-weeks post randomization was significantly greater (mean, 6.6%; SD, 6.5) than the placebo group (mean, 4.6%; SD, 4.7) (P35% (P95%).
- No difference in overall incidence of treatment-emergent gastrointestinal adverse events between groups.
Extended Study (ELECT Study)
- Study Type: Open-label, one arm extension study.
- Sample Size: 16 subjects who crossed over from placebo to Epitomee and 17 subjects who continued Epitomee.
- Key Results:
- Overall incidence of AEs was no different between subjects exposed for an entire year (27 AEs in 12 subjects) vs. those newly switched to Epitomee for 24 weeks (17 AEs in 10 subjects).
- All AEs were mild gastrointestinal (GI) events and all recovered. No deaths or SAEs.
Gastric Emptying Study
- Study Type: Prospective, single center, open-label, single-arm study.
- Sample Size: 10 healthy subjects.
- Key Results:
- Epitomee was well-tolerated with no SAEs.
- No significant effect on gastric emptying with Epitomee.
Key Metrics
- Total Body Weight (TBW) reduction at 24 weeks:
- Epitomee group: mean, 6.6% (SD, 6.5)
- Placebo group: mean, 4.6% (SD, 4.7)
- Rate of subjects with ≥ 5% TBW reduction at 24 weeks:
- Epitomee group: 55.5% (Cl: 46.1-64.6)
- Threshold: >35%
- Percentage of patients achieving specific TBW loss:
- ≥ 7.5% TBW loss: Epitomee 38.7%, Placebo 21.5%
- ≥ 10% TBW loss: Epitomee 26.9%, Placebo 10.7%
- ≥ 12.5% TBW loss: Epitomee 16.8%, Placebo 6.6%
- Patient dropouts:
- Epitomee group: 13.8%
- Control group: 14.2%
Predicate Device(s)
Gelesis Inc.'s Plenity (DEN180060)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5982 Ingested, transient, space occupying device for weight management and/or weight loss.
(a)
Identification. This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible for its intended use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, as follows:
(i) Performance bench testing in a simulated use model must evaluate device disintegration and device hydration state throughout the gastrointestinal tract;
(ii) Bioburden and moisture content assessments must evaluate device infection risk throughout the labeled shelf life; and
(iii) Performance data must support the shelf life of the device by demonstrating continued package integrity and device functionality over the labeled shelf life.
(3) Clinical performance testing must demonstrate the device performs as intended and evaluate the following:
(i) Weight change;
(ii) All adverse events, including obstruction, dilation, diarrhea, constipation, and dehydration; and
(iii) Interaction with representative medications.
(4) Physician and patient device labeling must state:
(i) The clinical benefit of the device as assessed by using percent total body weight loss;
(ii) Treatment must be offered in combination with diet and exercise;
(iii) Instructions on how to use the device as intended including how to avoid interaction with medication; and
(iv) The shelf life of the device.
0
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 13, 2024
Epitomee Medical Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street Suite 2300 Philadelphia, Pennsylvania 19103
Re: K240544
Trade/Device Name: Epitomee Regulation Number: 21 CFR 876.5982 Regulation Name: Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss Regulatory Class: Class II Product Code: QFQ Dated: February 27, 2024 Received: August 16, 2024
Dear Janice Hogan:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
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).
Sincerely,
Anthony Lee -S
Anthony C. Lee, Ph.D., M.B.A. 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Epitomee
Indications for Use (Describe)
Epitomee is indicated to aid in weight management in overweight and obese adults with a Body Mass Index (BMI) of 25 - 40 kg/m2, when used in conjunction with diet and exercise.
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
Epitomee Medical's Epitomee
Submitter
Epitomee Medical Ltd. 17 Hatochen St. Caesarea lsrael
Contact Person: Ruthie Amir Date Prepared: September 12, 2024
Name of Device: Epitomee
Common Name: Weight management device
Regulation Number: 21 CFR 876.5982
Classification Name: Ingested, transient, space occupying device for weight management and/or weight loss
Product Code: QFQ
Regulatory Class: II
Predicate Device: Gelesis Inc.'s Plenity (DEN180060)
Device Description
The subject device of this 510(k) notification, Epitomee, is comprised of two components: The outer component is a capsule and the inner component contains superabsorbent hydrogel particles. Each particle is approximately 250 microns in size. The particles are enclosed in pH sensitive compartments. Once Epitomee is swallowed, the capsule disintegrates in the stomach and releases the pH sensitive compartments. By absorption of water in the stomach fluid, the superabsorbent particles within the compartments swell to form a three-dimensional matrix designed to occupy volume in the stomach that creates a sensation of fullness, enabling weight loss. Epitomee mechanism of action is purely mechanical and does not involve any chemical activity. Epitomee works directly in the gastrointestinal (GI) tract. Epitomee is provided non-sterile.
Intended Use / Indications for Use
Epitomee is intended to aid in weight management in overweight and obese adults with a Body Mass Index (BMI) of 25 - 40 kg/m², when used in conjunction with diet and exercise.
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Summary of Technological Characteristics
Epitomee has very similar technological characteristics compared to the predicate device. Both devices are composed of two major components: an outer capsule and an inner expendable component occupying space in the stomach. Both devices are ingestible, transient, space occupying devices designed as a standard capsule for oral intake. For both devices the oral capsule encloses self-expandable particles that form a three-dimensional matrix designed to occupy volume in the stomach, to create a sensation of fullness. The capsule of both devices disintegrates in the stomach and releases the enclosed self-expanded particles. For both devices the hydrogel particles increase their weight and dimensions after absorbing water from the stomach and both devices interact with the stomach by occupving volume. Both devices are self-disintegrated to enable natural evacuation through gastric emptying.
Although the subject device consists of a triangular arrangement and has a smaller net volume than the predicate, the triangular shape of the compartments was designed to attain relatively large dimensions, creating a space occupying tree-dimensional structure and the difference does not raise new questions of safety or effectiveness as both devices achieve their intended use by occupying volume in the stomach, thereby creating sensation of fullness. Clinical study results showed that the subject device is as safe and effective as the predicate device. In addition, despite the different materials used by the two devices utilize hydrogel materials to expand with water. Both devices have been demonstrated to be biocompatible. Furthermore, both devices are intended to degrade within the user's GI tract and be eliminated through normal bowel movements emptying.
A table comparing the key features of the subject and predicate device is provided below.
| | Epitomee Medical's
Epitomee
(Subject Device) | Gelesis Inc/'s Plenity
(DEN180060)
(Predicate Device) |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Class | II | II |
| CFR Regulation | 21 CFR 876.5982 | 21 CFR 876.5982 |
| Product Code | QFQ | QFQ |
| Intended Use | Epitomee is indicated to aid in
weight management in
overweight and obese adults
with a Body Mass Index (BMI)
of 25 - 40 kg/m², when used in
conjunction with diet and
exercise. | Plenity is indicated to aid in
weight management in
overweight and obese adults
with a Body Mass Index (BMI)
of 25 - 40 kg/m², when used in
conjunction with diet and
exercise. |
| | Epitomee Medical's
Epitomee
(Subject Device) | Gelesis Inc/'s Plenity
(DEN180060)
(Predicate Device) |
| Treated area/Site of application in the body | Non-systemic and works directly in the gastrointestinal (GI) tract (stomach) | Non-systemic and works directly in the gastrointestinal (GI) tract (stomach) |
| System components | An outer capsule that is swallowed by the patients and an inner expendable device occupying space in the stomach | An outer capsule that is swallowed by the patients and an inner expendable device occupying space in the stomach |
| Administration | Standard capsule for oral intake;
2 capsules per day (one capsule before lunch and one capsule before dinner) with water | Standard capsule for oral intake;
6 capsules per day (3 capsules before lunch and 3 capsules before dinner) with water |
| Duration of Use | 6 months | 6 months |
| Device Design/Mode of Action | The device is an ingestible, transient, space occupying device designed as a standard capsule for oral intake.
The oral capsule contains thousands of particles. The particles are contained in compartments and can each hydrate up to 100 times their original weight, to form a three-dimensional matrix designed to occupy volume in the stomach.. | The device is an ingestible, transient, space occupying device designed as a standard capsule for oral intake.
The oral capsule contains thousands of Plenity particles. The particles are non-clustering and can each hydrate up to 100 times their original weight, to form a three-dimensional matrix designed to occupy volume in the stomach. |
| Capsule Material | Pharmaceutical grade hydroxypropyl methylcellulose (HPMC) capsule | Porcine gelatin capsule |
| Biocompatibility | Biocompatible | Biocompatible |
| | Epitomee Medical's
Epitomee
(Subject Device) | Gelesis Inc/'s Plenity
(DEN180060)
(Predicate Device) |
| Compartment Size
Deployed | Particles contained in three
compartments that form a
three-dimensional triangular
matrix once hydrated in the
stomach. The total net volume
in the stomach is 17cc, with
each edge of triangular matrix
having a dimension of 62 mm | The Plenity device does not
contain a compartment. It
contains thousands of particles
that form a non-clustering
three-dimensional matrix in the
stomach once hydrated. The
total volume is approximately
one quarter of the stomach
volume |
| Self-Expanding | Self-expanding when hydrated | Self-expanding when hydrated |
| Principles of
Operation | The capsule disintegrates in the
stomach, allowing water to
penetrate the envelope and
hydrate the gel particles. The
expansion of the particles
results in unfolding of the device
into a three-dimensional matrix
composed of 3 identical
compartments occupying
volume in the stomach.
The hydrogel particles increase
their weight and volume after
absorbing the water from the
stomach.
When fully hydrated, the
Epitome structure occupies
only about 17cc net volume in
the stomach, with each edge of
the triangular matrix having a
dimension of 62 mm,
generating a space occupying
tree-dimensional structure to
create a sensation of fullness. | The capsule disintegrates in
the stomach allowing water to
hydrate the gel particles. The
gel particles spread and form a
three-dimensional matrix
occupying volume in the
stomach.
The hydrogel particles increase
their weight and volume after
absorbing the water from the
stomach.
When fully hydrated, the
Plenity particles occupy about
quarter of average stomach
volume to create a sensation of
fullness. |
| Release characteristics of
substances | The capsule disintegrates in the
stomach and releases the
particles enclosed in the
compartments | The capsule disintegrates in
the stomach and releases the
contained particles. |
| | Epitomee Medical's Epitomee
(Subject Device) | Gelesis Inc/'s Plenity
(DEN180060)
(Predicate Device) |
| | Degradation mechanism
and profile | Epitomee self-disintegrates. |
| | Epitomee passes through the
pylorus and device breaks
down in the small intestine
where the hydrogel particles
are free to flow with the mix
outside the body. | Plenity passes through the
digestive system maintaining
its three-dimensional structure
in the stomach and small
intestine before breaking down
in the colon and flowing freely
with the mix outside the body.
The water is then released and
reabsorbed by the body.
Plenity particles are eliminated
through normal bowel
movements. |
Epitomee Substantial Equivalence Chart
6
7
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Performance Data
Nonclinical and clinical studies have been conducted to demonstrate the performance of Epitomee.
Biocompatibility
Epitomee underwent biocompatibility assessment according to ISO 10993-1 requirements for a device having permanent (> 30 days) surface contact with mucosal membranes. All the biological endpoints have been addressed by biocompatibility studies and/or rationales as the device components have long and documented history of safe use. Endpoints considered are:
- Cytotoxicity
- Sensitization ●
- Irritation ●
- Acute Systemic Toxicity ●
- Genotoxicity
- Sub-chronic Toxicity ●
- Chronic Toxicity
- Carcinogenicity ●
- Material Mediated Pyrogenicity ●
- Implantation
9
Nonclinical Testing
Bench testing has been conducted to demonstrate that the Epitomee meets its specification as functions as intended. The testing includes:
- Device dimensional verification ●
- Device inflation .
- Device functional performance ●
- Device mechanical Integrity ●
- Device loss of rigidity ●
- Device inflation with different beverages and food mediums .
- Shape retention ●
- Device clearance from stomach
- Device degradation in intestine ●
- Device irregular surface test ●
- . Device interaction with medication
The in vitro tests of inflation and degradation were verified by ex vivo studies. In addition, potential interaction between the Epitomee and Metformin was evaluated. GLP animal studies were conducted to demonstrate the device safety in vivo.
Clinical Data
The performance of Epitomee is supported by multiple clinical studies.
Pivotal Clinical Study (RESET Study)
The RESET study was a prospective, randomized, double-blind, placebo-controlled, multicenter trial to support the use of Epitomee for weight reductions in patients. The study enrolled 279 men and non-pregnant, non-lactating women, 18 years of age or older, who are overweight (body mass index [BMI] of 25-30 kg/m²) or obese (BMI of 30-40 kg/m²), with and without prediabetes. All 9 sites enrolled in the study were in the US, located across 9 different states.
The subjects were evenly matched for gender and age groups with females constituting 80.4% and 79.4% of the Epitomee and placebo groups, respectively, and the majority of subjects being between 40 and 65 years of age (66.7% and 67.4% in the Epitomee and placebo groups, respectively). Mean BMI was 34.1 in Epitomee group and 33.7 in the placebo group. The majority of the study subjects were Caucasian, with 70.3% and 65.2% of the recruited in the Epitomee and placebo groups, respectively. Black or African American subjects constituted 21.0% and 24.1% of the total sample in the Epitomee and placebo groups, respectively.
Eligible subjects were randomized to test or placebo arms. Subjects were to take one capsule of the investigational device or placebo twice daily, with 2 cups of water half-hour before the main meals, for 24 weeks. Subjects in both groups received the same program of diet, physical activity, and behavior therapy. Efficacy and safety assessments were conducted up to week 24 since start of the study treatment. An additional safety assessment was conducted at week 28.
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The study demonstrated that both co-primary endpoints were successfully met. Epitomee treatment group total body weight (TBW) reduction at 24-weeks post randomization was significantly greater (mean, 6.6%; SD, 6.5) than the placebo group (mean, 4.6%; SD, 4.7) (P35% (P95%). The overall incidence of treatment-emergent gastrointestinal adverse events was no different in the Epitomee group vs. the control group.
Notably, the safety and efficacy performance of Epitomee as shown in the RESET study was very similar to that of the predicate device.
Extended Study (ELECT Study)
The ELECT study assessed the effect of Epitomee on body weight after an additional exposure of 24 weeks in subjects from the RESET pivotal study. Subjects from Epitomee and Placebo
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groups in the RESET study who completed the 24-week treatment period and had at least 3% weight loss were offered to participate in this extended study. The ELECT study is an openlabel, one arm extension study and all subjects were treated with Epitomee, twice daily. Sixteen (16) subjects who were assigned to the placebo during RESET crossed over to the Epitomee group (Placebo-Epitomee) and 17 subjects who were assigned to the Epitomee group during the RESET continued Epitomee for an additional 24 weeks (Epitomee-Epitomee).
Safety results from the ELECT study showed that the overall incidence of AEs was no different between the Epitomee subjects who were exposed for an entire year (27 AEs in 12 [70.6%] subjects) versus the Placebo subjects who were switched to Epitomee and were exposed to Epitomee for the first time for a period of 24 weeks (17 AEs in 10 [62.5%] subjects). All AEs in the ELECT study were mild gastrointestinal (GI) events, and all recovered. There were no deaths or SAEs.
Gastric Emptying Study
Epitomee Medical has conducted a prospective, single center, open-label, single-arm study to examine the effect of the Epitomee device on gastric emptying rate in healthy subjects. Ten (10) healthy subjects were enrolled in the study. Subjects completed a gastric emptying test using gastric scintigraphy before taking Epitomee (baseline). Following the baseline scintigraphy, the subjects received the Epitomee device treatment for 10 consecutive days. and underwent another gastric emptying test with capsule intake prior to the test meal.
The results showed that Epitomee was well-tolerated and had a favorable safety profile with no SAEs. There was no significant effect on gastric emptying with Epitomee.
Conclusions
Epitomee is as safe and effective as its predicate device. Epitomee has the same intended use and indications for use, and similar technological characteristics as its predicate device. The minor technological differences between Epitomee and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that Epitomee is as safe and effective as the predicate device. Thus, Epitomee is substantially equivalent.