(134 days)
Not Found
Not Found
No
The description focuses on the mechanical components and functionality of an IV set, with no mention of AI or ML terms or capabilities.
No
Explanation: A therapeutic device is one that treats a disease or condition. This device is used for administering fluids, which is supportive care, not a direct therapy.
No
The device description clearly states it is an "intravenous infusion set intended to administer fluids," which is a therapeutic function, not a diagnostic one. It controls flow rates, but does not diagnose conditions.
No
The device description clearly states it is an "intravenous infusion set incorporating two drip chambers," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to administer fluids directly into a patient's vascular system. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the mechanics of fluid delivery and flow control, not on analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
FPA
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
#1 Additiv®; Primary IV Set (60 drops/ml) with 3 Injection Sites; Manufactured by McGaw, Inc. Irvine, Ca USA 92714- 5895, #2 Additiv®; Primary IV Set (15 drops/ml) with Check Valve and 2 Injection Sites; Manufactured by McGaw, Inc. Irvine, Ca USA 92714-5895, #3 Anesthesia I.V. Set (15 drops/ml) vented set with in-line backcheck valve, three Y-injection sites, two four-way stopcocks, and male luer slip adapter; Product code AD- 153Y-2DS; manufactured by B/Braun Medical Inc., Bethlehem, PA 18018.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 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). | |
| Intended use of the device | AnesFlow™ Dual Drip Intravenous Infusion Set is a |
| disposable device, intended for administration of intravenous | |
| (IV) fluids. | |
| Substantially equivalent legally | |
| marketed devices | #1 Additiv®; Primary IV Set (60 drops/ml) with 3 Injection |
| Sites; Manufactured by McGaw, Inc. Irvine, Ca USA 92714- | |
| 5895 | |
| Explanation: Although the physical | |
| characteristics differ among the devices, | |
| the devices are substantially functionally | |
| equivalent in their intended use for | |
| administering IV fluids. The means for | |
| controlling the IV fluid infusion rate are | |
| also identical. | #2 Additiv®; Primary IV Set (15 drops/ml) with Check |
| Valve and 2 Injection Sites; Manufactured by McGaw, Inc. | |
| Irvine, Ca USA 92714-5895 | |
| The main significant physical difference | |
| is that AnesFlow™ Dual Drip Intravenous | |
| Infusion Set incorporates two drip | |
| chambers (60 drop as in #1, and 15 | |
| drops/ml as in #2 and #3). The principles | |
| in their use are however, also identical to | |
| those in #1-3. | #3 Anesthesia I.V. Set (15 drops/ml) vented set with in-line |
| backcheck valve, three Y-injection sites, two four-way | |
| stopcocks, and male luer slip adapter; Product code AD- | |
| 153Y-2DS; manufactured by B/Braun Medical Inc., | |
| Bethlehem, PA 18018. |
1
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.
2
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
3
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)