Digital Indeflator INFLANTE
Device Facts
| Record ID | K260035 |
|---|---|
| Device Name | Digital Indeflator INFLANTE |
| Applicant | UAB Telemedicina |
| Product Code | MAV · Cardiovascular |
| Decision Date | Sep 4, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Digital Indeflator INFLANTE is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to control the dispensing of fluids through the catheter into the vascular system manually, while monitoring the remaining fluid volume. The system is intended to be used in conjunction with legally marketed 20 mL syringes validated as compatible with the INFLANTE system.
Device Story
Digital Indeflator INFLANTE is a reusable, motorized inflation and fluid dispensing system for interventional procedures. It comprises a patient-side syringe module and a control module with a handle wheel. The device accepts a compatible 20 mL high-pressure syringe. Operation involves rotating the handle wheel to actuate a motorized gear system, which generates positive/negative pressure (-0.9 to +30 ATM/BAR) and provides haptic rotational force feedback proportional to pressure. The system features a digital display showing pressure, volume, and inflation time, including a pressure-versus-time plot. A dedicated button enables automated deflation. The device is used in clinical settings by healthcare providers; it supports one-handed operation. Safety features include automatic cessation of operation when 1 mL of fluid remains to prevent air embolism. The device is non-sterile and used with sterile drapes and compatible syringes. Output data assists clinicians in monitoring inflation parameters and fluid delivery during angioplasty.
Clinical Evidence
No clinical data. Bench testing only, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), software verification/validation (IEC 62304), and human factors/usability (IEC 62366). Functional bench testing verified pressure control, accuracy, remaining volume monitoring, drive motion, lifetime, and fault modes.
Technological Characteristics
Active medical device; motorized gear drive; microcontroller-based. Casing: aluminum (powder-coated); Control wheel: TotalPro™ HSPP plastic. Range: -0.9 to +30 ATM/BAR. Accuracy: ±3.0% of full scale. Power: 24 VDC (IEC 60601-1 certified PSU). Connectivity: digital display with graphical/numerical output. Sterilization: non-sterile (reusable, uses sterile drapes). Software: enhanced documentation level.
Indications for Use
Indicated for inflation/deflation of balloon angioplasty catheters or interventional devices, pressure/time monitoring during inflation, and manual fluid dispensing into the vascular system with volume monitoring. Intended for use with compatible 20 mL syringes.
Regulatory Classification
Special Controls
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Predicate Devices
- DiamondTOUCH™ Inflation Device and Fluid Dispensing Syringe (K160107)
Submission Summary (Full Text)
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**U.S. FOOD & DRUG**
ADMINISTRATION
September 4, 2026
UAB Telemedicina
Evaldas Kalvaitis, CEO
Vytauto Pr. 23
Kaunas, 44352
Lithuania
Re: K260035
Trade/Device Name: Digital Indeflator INFLANTE
Regulation Number: 21 CFR 870.1650
Regulation Name: Angiographic injector and syringe
Regulatory Class: Class II
Product Code: MAV
Dated: January 6, 2026
Received: January 6, 2026
Dear Evaldas Kalvaitis:
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.
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K260035 - Evaldas Kalvaitis
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-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-devices/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-advice-comprehensive-regulatory-
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K260035 - Evaldas Kalvaitis
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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,
LYDIA S. Digitally signed by LYDIA S. GLAW -S Date: 2026.09.04 16:57:00 -04'00'
Lydia Glaw
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K260035
Device Name
Digital Indeflator INFLANTE
Indications for Use (Describe)
Digital Indeflator INFLANTE is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to control the dispensing of fluids through the catheter into the vascular system manually, while monitoring the remaining fluid volume. The system is intended to be used in conjunction with legally marketed 20 mL syringes validated as compatible with the INFLANTE system.
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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FORM FDA 3881 (6/20)
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PSC Publishing Services (301) 443-6740 EF
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K260035
Digital Indeflator INFLANTE^{}[] Premarket Notification 510(k)
UAB TELEMEDICINA
# **510(k) Summary**
This 510(k) Summary is being submitted in accordance with the requirements of the guidance The510(k) Program and 21 CFR 807.92.
| **Submitter:** | **UAB TELEMEDICINA** Vytauto pr. 23 LT-44352 Kaunas, Lithuania | |
| --- | --- | --- |
| **Contact Person:** | **Paulius Dambrauskas** Head of QA/RA Phone: +37068281883 E-mail: paulius@sentante.com and **Dr. Evaldas Kalvaitis** CEO Phone: +37060604260 E-mail: evaldas@sentante.com | |
| **Submission Date:** | August 7, 2026 | |
| **Device Trade Name:** | Digital Indeflator INFLANTE | |
| **Common Name:** | Indeflator, Balloon inflation | |
| **Classification:** | Classification Name: Regulatory Class: Product Code: Subsequent Product Code: 21 CFR §: Review Panel: | Angiographic injector and syringe Class II MAV DXT 870.1650 Cardiovascular |
| **Predicate Device:** | Trade Name: Classification Name: Regulatory Class: Product Code: Subsequent Product Code: 21 CFR §: Review Panel: | DiamondTOUCH™ Inflation Device and Fluid Dispensing Syringe, K160107 Angiographic injector and syringe Class II DXT MAV 870.1650 Cardiovascular |
| **Device Description:** | The Digital Indeflator INFLANTE is a reusable digital inflation and fluid dispensing device for interventional procedures. The system consists of a patient-side syringe module and a control module that together provide a motorized drive mechanism to actuate a compatible 20 mL high-pressure syringe for the generation and control of positive and negative pressure. The device measures and displays pressure, syringe volume, and inflation time and provides tactile feedback through a control wheel. The INFLANTE controls and monitors pressure over a range of –0.9 ATM/BAR to +30 ATM/BAR (–13 PSI to 435 PSI). | |
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Digital Indeflator INFLANTE
Premarket Notification 510(k)
UAB TELEMEDICINA
| **Indications for Use:** | Digital Indeflator INFLANTE is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to control the dispensing of fluids through the catheter into the vascular system manually, while monitoring the remaining fluid volume. The system is intended to be used in conjunction with legally marketed 20 ml syringes validated as compatible with the INFLANTE system. |
| --- | --- |
| **Comparison to Predicate Device:** | | | |
| --- | --- | --- | --- |
| Property | Digital Indeflator INFLANTE | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe | Comparison |
| **Name** | Digital Indeflator INFLANTE | DiamondTOUCH Inflation Device and Fluid Dispensing Syringe | N/A |
| **Manufacturer** | Telemedicina UAB | Merit Medical Systems, Inc. | N/A |
| **510 (k) Number** | K260035 | K160107 | N/A |
| **Product code** | Angiographic injector and syringe, DXT, MAV, 21 CFR 870.1650 | Angiographic injector and syringe, DXT, MAV, 21 CFR 870.1650 | Same |
| **Classification** | Class II | Class II | Same |
| **Indication for use** | Digital Indeflator INFLANTE is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to control the dispensing of fluids through the catheter into the vascular system manually, while monitoring the remaining fluid volume. The system is intended to be used in conjunction with legally marketed 20 mL syringes validated as compatible with the INFLANTE system. | The DiamondTOUCH Inflation Syringe is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to dispense fluids into the body and monitor the pressure of that fluid. | SE |
| **An overall description of the device design** | Digital indeflator INFLANTE is a reusable device with single-use sterile drapings and single-use sterile syringe. The INFLANTE consists of motorized inflation gear and digital interface with integral display, microcomputer and handle wheel for pressure control. The INFLANTE is designed to generate positive and negative pressure, and monitor pressures over a range of -0.9 ATM/BAR to +30ATM/BAR (-13 PSI to 435 PSI). | The DiamondTOUCH™ Inflation Device and Fluid Dispensing Syringe by Merit Medical is a 30mL disposable device with an integral pressure transducer, microcomputer, back-lit LCD, threaded plunger assembly with lock/release bar, a flexible high pressure extension tube, and a three-way stopcock. The DiamondTOUCH™ is designed to generate positive and negative pressure, and monitor positive pressures over a range of -0.4 ATM/BAR to +35ATM/BAR (-6 PSI to 514 PSI). | SE |
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Digital Indeflator INFLANTE
Premarket Notification 510(k)
UAB TELEMEDICINA
| **Operation principle** | To increase pressure the wheel handle should be rotated clockwise until the desired pressure is achieved. | To increase pressure the handle should be rotated clockwise until the desired pressure is achieved. | Same |
| --- | --- | --- | --- |
| **Device control (inflation/fluid dispensing control)** | Inflation or fluid dispensing is initiated by rotating the handle wheel clockwise and adjusted by rotating it anticlockwise, with all movements transmitted through a motorized gear system. | Inflation or fluid dispensing is controlled by handle rotation, clockwise or anticlockwise, directly adjusting the plunger position. | SE |
| | The INFLANTE, through a motorized gear system, generates haptic rotational force feedback – the higher the pressure, the greater the torque required to turn the handle wheel. | Haptic resistance is generated through a direct mechanical pressure response. Handle wheel rotation provides rotational force feedback – the higher the pressure, the greater the torque required to turn the handle wheel. | SE |
| | 2.5 ml ± 0.10 ml of fluid is dispensed at pressure levels from -0.9 to 2 ATM/BAR (-13 to 29 PSI) per 360° clockwise turn of the syringe plunger handle, and above 2 BAR, the dispensing speed decreases to 0.5 ml ± 0.10 ml per 360° clockwise turn of the syringe plunger handle. | 0.57ml ± 0.10ml fluid dispensed for each 360° clockwise turn of the syringe plunger handle. | SE |
| **Device control (deflation)** | To deflate balloon the handle wheel should be rotated counterclockwise to release pressure or a dedicated deflate button could be pressed for an automatic release of pressure and generate a negative pressure. | To deflate balloon the handle should be rotated counterclockwise to release pressure to 25 ATM or lower, then the lock/release bar squeezed and pulled back to generate a negative pressure. | SE |
| | The INFLANTE provides an automated release and negative-pressure generation via a dedicated deflation button | Manual force applied through a lock/release bar. | |
| **System Technology** | Active medical device with microcontroller, motorized gear and firmware. The INFLANTE incorporates a motorized gear applied to the syringe to support pressure control. | Active medical device with microcontroller and firmware. The device relies on manual operator input. | SE |
| | This motorized gear applied to the syringe also enables the one-handed functionality of the INFLANTE device. | The device requires two-handed operation | |
| **Digital display** | Exhibits pressure and time information both visually through scales and numerically. Also displays the pressure vs. time plot. INFLANTE displays pressure and time information both graphically and numerically, and additionally | Exhibits pressure and time information both visually through scales and numerically. | SE |
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Digital Indeflator INFLANTE
Premarket Notification 510(k)
UAB TELEMEDICINA
| | includes features such as a pressure-versus-time plot, error messages, and guidance messages. | | |
| --- | --- | --- | --- |
| Availability of data | INFLANTE displays the full pressure-versus-time plot for the last inflation and provides access to the plots of the previous 50 inflations. | Displays the highest point of pressure associated with the last inflation, which is available on the display until next inflation. | SE |
| Timer | Integrated timer with start/stop and reset controls | Integrated timer | SE |
| Operating range | -0.9 ATM/BAR to 30 ATM/BAR (-13 PSI to 435 PSI) | -0.4 ATM/BAR to 35 ATM/BAR (-6 PSI to 514 PSI) | SE |
| Accuracy | ±3.0% of full scale at 10°C to 40°C | ±3.0% of full scale at 10°C to 40°C | SE |
| Liquid Temp | 10° C to 40° C | 10° C to 40° C | Same |
| Humidity | 20% to 90% | 20% to 90% | Same |
| Operation Range | Non-condensing humidity | Non-condensing humidity | Same |
| Syringe Volume | 20 ml | 30 ml | SE |
| | INFLANTE additionally provides a display of the remaining fluid volume and incorporates a safety feature that automatically stops operation when 1 mL of volume remains to prevent potential air embolism. | | |
| Materials | The Digital Indeflator INFLANTE, designed to avoid direct contact with the patient, incorporate surface materials as follows: - Casing of the device (both Syringe and Control modules) are made of aluminum, coated with powder paint that does not contain chromium and lead compounds. - Control wheel is made of biocompatible plastic (TotalPro™ HSPP). - Control module including the wheel handle are intended to be draped with transparent drape. Liquid contacting materials: polycarbonate (compatible syringe). | Housing and handle: polycarbonate. Liquid contacting materials: polycarbonate. | SE |
| Energy sources | Active power supply is required: Medical grade (IEC 60601-1 certified) PSU, input current 1,5 A, input voltage up to 250 VAC, 50-60 Hz, output 24 VDC. | Active power supply is required: Internal battery: fully manual, battery-powered up to 10 hours, in case of fully active device. | SE |
| Sterility | Digital Indeflator INFLANTE is a non-sterile, reusable device used with sterile syringe. INFLANTE is not | Device is sterile and dedicated for single patient use only, not reusable, re-processable or re-sterilizable. | SE |
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Digital Indeflator INFLANTE
Premarket Notification 510(k)
UAB TELEMEDICINA
classified as a sterile or sterilizable device. It is considered a non-critical device with respect to cross-contamination risk. Cleaning is performed according to standard healthcare facility procedures. A sterile barrier is achieved by placing sterile drapes over the modules, and sterile compatible syringe are required for operation.
**Summary of Non-clinical Data:**
**Performance and Nonclinical Testing**
Performance testing of the Digital Indeflator INFLANTE was conducted based on the device risk analysis and in accordance with applicable FDA guidance documents and FDA-recognized international consensus standards.
**Electrical Safety and Electromagnetic Compatibility (EMC)**
Electrical safety and electromagnetic compatibility testing were performed in accordance with IEC 60601-1 (Medical electrical equipment – General requirements for basic safety and essential performance, Edition 3.2) and IEC 60601-1-2 (Electromagnetic disturbances – Requirements and tests, Edition 4.1). The device was found to comply with the applicable requirements of these standards.
**Software Verification and Validation**
Software verification and validation activities were conducted in accordance with FDA's Guidance for the Content of Premarket Submissions for Device Software Functions and IEC 62304 (Medical device software – Software life cycle processes, Edition 1.1). The software was classified under the enhanced documentation level, as a software failure or latent defect could result in serious injury or death to the patient or operator.
**Human Factors and Usability Engineering**
Usability and human factors evaluation was conducted in accordance with the FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices, IEC 62366 (Edition 1.1), and IEC 60601-1-6 (Edition 3.2).
**Bench and Performance Testing**
The device design and performance were verified through bench testing of key functional parameters, including:
- Syringe pressure control and monitoring
- Statistical analysis of pressure accuracy
- Accuracy of remaining volume measurement
- Control of syringe drive motion
- Operating modes evaluation
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Digital Indeflator INFLANTE
Premarket Notification 510(k)
UAB TELEMEDICINA
- Lifetime testing
- Simulated use testing
- Fault mode simulation test
- Overtemperature protection test
- Output mode test
The results of the nonclinical testing support a determination of substantial equivalence between the Digital Indeflator INFLANTE and the predicate device.
**Summary of Clinical Data:**
No clinical investigations have been performed on the Digital Indeflator INFLANTE.
**Summary of Substantial Equivalence:**
The INFLANTE Digital Indeflator is substantially equivalent to the specified predicate device, sharing the same intended use, the same principle of operation, and similar underlying technologies. INFLANTE has been demonstrated to be substantially equivalent through comprehensive safety, performance, and human factors testing. The indications for use and the identified technological differences between INFLANTE and the predicate device that impact substantial equivalence.
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