(16 days)
The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.
The EMED VersaRate™ Flow Rate Controller is a disposable device allowing users to adjust the flow rate of fluids. The EMED VersaRate™ Flow Rate Controller can be connected to commercially available administration sets and fluid sources utilizing standard luer lock connectors.
The EMED VersaRate™ Flow Rate Controller (K123729) is intended for use in the intravascular infusion of fluids delivered to the patient in a precise manner for no longer than 72 hours.
The device's performance was evaluated against internal product specifications and requirements, as well as by comparison to a predicate device, the Baxter Extension Set w/Flow Regulator (K890489).
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Characteristic | VersaRate™ Flow Rate Controller Reported Performance | Predicate Device (Baxter Extension Set w/Flow Regulator) Performance |
|---|---|---|
| Flow Rate Control Range | 5 – 230 mL/hr at 80 cm head height | 5 – 250 mL/hr |
| Residual Volume of Set | < 0.25 ml | 2.9 mL |
| Duration of Use | Performance remains within tolerance up to 72 hrs. | Performance remains within tolerance up to 24 hrs. |
| Pressure | Up to 25 psi | Up to 3 psi |
In addition, the following biocompatibility tests were performed with "Pass" results, indicating compliance with the respective standards:
- Biocompatibility (ISO 10993-5): Cytotoxicity (Neutral Red Uptake) - Pass
- Biocompatibility (ISO 10993-10): Sensitization (Kligman Maximization) - Pass
- Biocompatibility (ISO 10993-10): Irritation (Intracutaneous Injection) - Pass
- Biocompatibility (ISO 10993-11): Acute systemic toxicity (Systemic Injection) - Pass
- Biocompatibility (ISO 10993-11): Pyrogenicity (Rabbit Pyrogen) - Pass
- Biocompatibility (ISO 10993-4): Hemocompatibility (Unactivated Partial Thromboplastin Time) - Pass
- Biocompatibility (ASTM 756): Hemolysis (complete) - Pass
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set for the performance characteristics. The results are presented as summary performance metrics (e.g., flow rate range, residual volume). The data provenance is not specified beyond "testing results performed to establish conformance of the VersaRate™ Flow Rate Controller to internal product specifications and requirements, as well as equivalence to the predicate device." It's indicated as laboratory testing, not human patient data, and is retrospective for the predicate comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for the performance tests (flow rate, residual volume, duration of use, pressure) would be objective measurements obtained through laboratory testing, not human expert assessment. Biocompatibility tests are standardized protocols.
4. Adjudication Method for the Test Set
Not applicable. As described above, the performance and biocompatibility data are derived from objective measurements and standardized tests, not expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a medical device for fluid control, not an imaging or diagnostic device that would typically involve a multi-reader multi-case study with human readers and AI assistance. The study focuses on direct device performance and equivalence to a predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence, the performance testing described is a "standalone" evaluation of the device's physical and functional capabilities, independent of human interaction beyond operating the test equipment. No AI algorithm is involved in this device.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on objective physical measurements and standardized laboratory test results. For example:
- Flow Rate Control Range: Measured flow rates at specified conditions.
- Residual Volume: Measured volume.
- Duration of Use: Time until performance deviates from tolerance.
- Pressure: Measured pressure.
- Biocompatibility: Results of standardized biological assays conforming to ISO and ASTM standards.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical flow controller, not an AI/ML-based device that requires a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an algorithm was used.
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Section 5. 510(k) Summary
K123729 K Number
Submission Date:
11/6/12
Class II
General Information
Classification
Trade Name
VersaRate™ Flow Rate Controller
Common Name:
I.V. Flow Controller
Classification Name and Reference:
Intravascular Administration Set
21 CFR §880.5440
Submitter
Peter Kollings EMED Technologies Corporation 1264 Hawks Flight Ct., Ste. 200 El Dorado Hills, Ca 95762 916.932.0071 x114 Tel: 916.932.0074 Fax:
Intended Use
The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.
Predicate Device(s)
Baxter Extension Set w/Flow Regulator (K890489)
Device Description
The EMED VersaRate™ Flow Rate Controller is a disposable device allowing users to adjust the flow rate of fluids. The EMED VersaRate™ Flow Rate Controller can be connected to commercially available administration sets and fluid sources utilizing standard luer lock connectors.
Materials and Characteristics
The EMED VersaRate™ Flow Rate Controller is equivalent in performance, physical properties, using similar materials, and having the same indications for use as the
DEC 2 1 2012
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predicate device. Therefore no new issues of safety or effectiveness are introduced by the minimal differences in design.
Table 5-1 below provides a comparison of technological and other characteristics of the EMED VersaRate™ Flow Rate Controller and the predicate.
| EMED VersaRate™Flow Rate Controller | Baxter Extension Setw/Flow Regulator | |
|---|---|---|
| Indications for Use | The VersaRate™ FlowRate Controller isintended for use in theintravascular infusion offluids to be delivered tothe patient in a precisemanner for no longer than72 hours. | The Extension set withFlow Regulator isintended for use in theadministration ofintravenous fluids to bedelivered to the patient ina precise manner over aspecified period of time. |
| Flow ControlMaterial/Components | Biocompatible, non-toxicmaterials widely used inmedical products, such as:Luer: PVCTubing: PVCRegulator: Polycarbonateand styrene-ethylene-butylene | Biocompatible, non-toxicmaterials widely used inmedical products. |
| Method ofSterilization | Ethylene Oxide | Radiation |
| Principle of Flow RateControl | The fluid path of theVersaRate™ Flow RateController is regulated byrotating the flow dial toalter dimensions of theinternal fluid path, therebyaltering the flow rate. | Fluid flow is regulated byrotating the diaphragmholder to create arestrictive path of varyingdepth thereby altering therate of fluidadministration. |
| Length | 16 cm | 46 cm |
Table 5-1
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Performance
Table 5-2 below summarizes testing results performed to establish conformance of the VersaRate™ Flow Rate Controller to internal product specifications and requirements, as well as equivalence to the predicate device.
Table 5-2
| VersaRate™ Flow RateController | Baxter Extension Setw/Flow Regulator | |
|---|---|---|
| Flow Rate ControlRange | 5 – 230 mL/hr at 80 cmhead height | 5 – 250 mL/hr |
| Residual Volume ofSet | < 0.25 ml | 2.9 mL |
| Duration of Use | Performance remainswithin tolerance up to 72hrs. | Performance remainswithin tolerance up to 24hrs. |
| Pressure | Up to 25 psi | Up to 3 psi |
The outcomes of these tests further indicate that the VersaRate™ Flow Rate Controller is substantially equivalent to the predicate in performance, effectiveness, and safety.
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Biocompatibility
In accordance with ISO 10993, studies were performed including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemocompatibility. Table 5-3 presents a summary of testing and results indicating compliance with biocompatibility standards.
| Table 5-3 | |
|---|---|
| ----------- | -- |
| Test Performed | Standard | Test Name | TestResult | Other Name |
|---|---|---|---|---|
| Biocompatibility | ISO 10993-5 | Cytotoxicity | Pass | Neutral RedUptake |
| Biocompatibility | ISO 10993-10 | Sensitization | Pass | KligmanMaximization |
| Biocompatibility | ISO 10993-10 | Irritation | Pass | IntracutaneousInjection |
| Biocompatibility | ISO 10993-11 | Acute systemictoxicity | Pass | Systemic Injection |
| Biocompatibility | ISO 10993-11 | Pyrogenecity | Pass | Rabbit Pyrogen |
| Biocompatibility | ISO 10993-4 | Hemocompatibility | Pass | Unactivated PartialThromboplastinTime |
| Biocompatibility | ASTM 756 | Hemocompatibility | Pass | Hemolysis(complete) |
Sterility, Shelf-life, and Packaging
The VersaRate™ Flow Rate Controller will be sterilized to a sterility assurance level (SAL) of 10 of 10 and with a shelf life of 4 years.
Summary of Substantial Equivalence
The EMED Technologies Corporation VersaRate™ Flow Rate Controller is substantially equivalent to the commercially available predicate device in terms of function, safety, performance, intended use, technology/principles and mechanical properties. Differences between the EMED VersaRate™ Flow Rate Controller and the predicate do not raise any new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the text "Public Health Service" in a bold, serif font. The text is stacked vertically, with "Public Health" on the first line and "Service" on the second line. The text is black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2012
EMED Technologies Corporation C/O Mr. Morten S. Christensen Staff Engineer Underwriters Laboratories, Incorporated 455 East Trimble Road SAN JOSE CA 95131-1230
Re: K123729
Trade/Device Name: VersaRate™ Flow Rate Controller Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA . Dated: November 29, 2012 Received: December 5, 2012
Dear Mr. Christensen:
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. 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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Page 2 - Mr. Christensen
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony Lo m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4. Indications for Use Statement
510(k) Number (if known):
Device Name:
Indications for Use:
[TBD] K123729
VersaRate™ Flow Rate Controller
The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CDRI
12/19/12
Division Sign-Off) (Division Sign-con)
Division of Anesthesiology, General Hospital Division Control, Dental Devices
:10(k) Number: K123729
Section 4, Page 1
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.