(134 days)
An intravascular administration set intended to administer fluids from a fluid container (IV bag) to a patient's vascular system through a needle or catheter inserted into a vein.
AnesFlow™ Dual Drip Intravenous Infusion Set is an intravenous infusion set incorporating two drip chambers of different flow characteristics (micro and macro drip chambers), intended to provide the operator with a greater flexibility of controlling the intravenous fluids infusion rate (i.g., slow rate through the micro-drip and/or fast rate through the macro-drip).
Acceptance Criteria and Device Performance for AnesFlow™ Dual Drip Intravenous Infusion Set (K990496)
This 510(k) summary for the AnesFlow™ Dual Drip Intravenous Infusion Set focuses on establishing substantial equivalence to predicate devices rather than proving specific device performance criteria through a dedicated study with pre-defined acceptance criteria. The submission aims to demonstrate that the new device is as safe and effective as legally marketed predicate devices. Therefore, the information provided primarily addresses the functional equivalence and intended use alignment.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission based on substantial equivalence, there are no explicit, quantifiable "acceptance criteria" presented as one might find in a performance study for a novel device. Instead, the "performance" is implicitly deemed acceptable if the device aligns with the predicate devices in its intended use and fundamental operating principles.
| Feature / Criterion | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in 510(k) summary) |
|---|---|---|
| Intended Use | Administration of intravenous (IV) fluids from a fluid container to a patient's vascular system. | "Disposable device, intended for administration of intravenous (IV) fluids." |
| Basic Functionality | Ability to safely and effectively administer IV fluids. | "intravenous infusion set incorporating two drip chambers of different flow characteristics (micro and macro drip chambers), intended to provide the operator with a greater flexibility of controlling the intravenous fluids infusion rate..." |
| Flow Characteristics (Micro-drip) | Should be comparable to existing micro-drip IV sets (e.g., 60 drops/ml). | Incorporated a "60 drop" chamber, similar to predicate device #1. |
| Flow Characteristics (Macro-drip) | Should be comparable to existing macro-drip IV sets (e.g., 15 drops/ml). | Incorporated a "15 drops/ml" chamber, similar to predicate devices #2 and #3. |
| Fluid Infusion Rate Control | Should allow for controlled infusion rates. | "provide the operator with a greater flexibility of controlling the intravenous fluids infusion rate (i.g., slow rate through the micro-drip and/or fast rate through the macro-drip)." |
| Safety | No new safety concerns identified compared to predicate devices. | Implicitly deemed safe through substantial equivalence to legally marketed devices. |
| Material/Design Characteristics | Materials and design should be suitable for IV fluid administration and compatible with existing standards. | "Although the physical characteristics differ among the devices, the devices are substantially functionally equivalent in their intended use for administering IV fluids." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not describe a specific test set or a study with a defined sample size for the AnesFlow™ device itself. The submission relies on the established safety and efficacy of the predicate devices. Therefore, there's no information on:
- Sample size: Not applicable, as no new performance study data is presented.
- Data provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As no new performance study was conducted for the AnesFlow™ device, there was no need for experts to establish a "ground truth" for a test set. The substantial equivalence argument relies on the well-established clinical use and regulatory approval of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No new test set data was presented or adjudicated.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is rarely required for 510(k) submissions focusing on substantial equivalence for devices like IV sets, as they generally don't involve interpretation tasks by multiple readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The AnesFlow™ device is a medical device (intravenous infusion set), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and efficacy of the legally marketed predicate devices. The claim of substantial equivalence means that the AnesFlow™ device is considered as safe and effective because its intended use, fundamental technological characteristics, and performance are similar to devices already found acceptable by the FDA.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/algorithm-driven device, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device.
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Innovative Design Associates
Admir Hadzic, MD,Ph.D., CEO Jerry D. Vloka, MD, Ph.D., President 561 East Saddle River Road, Upper Saddle River, NJ 07458 tel/fax (201) 760-9550
10. 510(k) SUMMARY
Submitter: Innovative Design Associates
Sabanter Frinterative - River Road, Upper Saddle River, NJ 07458; tel/fax (201) 760-9550 Contact Person: Jerry D. Vloka, M.D., Ph.D. Date of preparation: February 8, 1999.
| Proprietary Name | AnesFlow™ Dual Drip Intravenous Infusion Set |
|---|---|
| Common Name | Intravenous infusion set with two drip chambers |
| Classification Name | Intravascular Administration Set |
| Description of the device | AnesFlow™ Dual Drip Intravenous Infusion Set is anintravenous infusion set incorporating two drip chambers ofdifferent flow characteristics (micro and macro dripchambers), intended to provide the operator with a greaterflexibility of controlling the intravenous fluids infusion rate(i.g., slow rate through the micro-drip and/or fast ratethrough the macro-drip). |
| Intended use of the device | AnesFlow™ Dual Drip Intravenous Infusion Set is adisposable device, intended for administration of intravenous(IV) fluids. |
| Substantially equivalent legallymarketed devices | #1 Additiv®; Primary IV Set (60 drops/ml) with 3 InjectionSites; Manufactured by McGaw, Inc. Irvine, Ca USA 92714-5895 |
| Explanation: Although the physicalcharacteristics differ among the devices,the devices are substantially functionallyequivalent in their intended use foradministering IV fluids. The means forcontrolling the IV fluid infusion rate arealso identical. | #2 Additiv®; Primary IV Set (15 drops/ml) with CheckValve and 2 Injection Sites; Manufactured by McGaw, Inc.Irvine, Ca USA 92714-5895 |
| The main significant physical differenceis that AnesFlow™ Dual Drip IntravenousInfusion Set incorporates two dripchambers (60 drop as in #1, and 15drops/ml as in #2 and #3). The principlesin their use are however, also identical tothose in #1-3. | #3 Anesthesia I.V. Set (15 drops/ml) vented set with in-linebackcheck valve, three Y-injection sites, two four-waystopcocks, and male luer slip adapter; Product code AD-153Y-2DS; manufactured by B/Braun Medical Inc.,Bethlehem, PA 18018. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 1 1999
Jerry D. Vloka, M.D., Ph.D. President Innovative Design Associates 561 East Saddle River Road Upper Saddle River, New Jersey 07458
Re : K990496 AnesFlow™ Dual Drip Intravenous Infusion Trade Name: Set Requlatory Class: II Product Code: FPA May 21, 1999 Dated: Received: May 24, 1999
Dear Dr. Vloka:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Vloka
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Kunns
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known): K990496
"AnesFlow" Dual Drip IV Infusion Set Device Name:
Indications for use:
An intravascular administration set intended to administer fluids from a fluid container (IV bag) to a patient's vascular system through a needle or catheter inserted into a vein.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Patrice Crescenti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 90496 510(k) Number .
Prescription Use / Over-The-Counter
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
(Optimal Format 1-2-96)
§ 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.