(37 days)
Not Found
No
The device description and performance studies focus on the physical components and mechanical performance of an I.V. extension set with a filter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is an I.V. extension set for fluid administration and filtering, not a device that directly treats a disease or condition.
No
The device is described as an I.V. extension set for fluid administration and removal of air/particulate matter, not for diagnosis.
No
The device description clearly outlines physical components such as tubing, connectors, and filters, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of fluid to a patient's vascular system and for the removal of air and particulate matter." This describes a device used in vivo (within the body) for therapeutic or supportive purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details components like Luer connectors, tubing, and filters, all consistent with a device used for fluid delivery into the bloodstream. There is no mention of reagents, sample handling, or analysis of biological samples, which are characteristic of IVDs.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes
- Diagnostic claims
- Performance metrics like sensitivity, specificity, or AUC (which are relevant to diagnostic accuracy)
The device is clearly intended for direct patient care involving the administration of fluids, placing it in the category of a medical device used for treatment or support, not diagnosis.
N/A
Intended Use / Indications for Use
The I.V. extension set with a 0.22 micron air venting filter is indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter.
Product codes (comma separated list FDA assigned to the subject device)
FPB
Device Description
The MICRO-VOLUME Extension Set product line consists of sterile, single use disposable devices indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter. These intravascular administration sets provide a clinician the ability to increase the distance between the patient and the fluid administration source. The overall set configuration consists of a female Luer connector, non-DEHP microbore tubing, a 0.22 micron hydrophilic filter, and a male Luer lock connector at the distal end of the set. The filter housing also contains a 0.1 micron hydrophobic filter which vents air to the atmosphere. The MICRO-VOLUME Extension Set with a 0.22 micron filter is designed to remove air and particulate matter and has a maximum pressure of 45 psi (2241 kPa). The product is sterile and non-pyrogenic.
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
clinician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use. The following tests were conducted to evaluate the effect of the design modification on the functional performance of the change to the male Luer component of the MICRO-VOLUME Extension Sets:
- Bond Strength tests .
- . Bond Pressure tests
- ISO Luer Tests .
- Biocompatibility .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Max pressure of 45 psi (2241 kPa).
Filter size: 0.22 micron hydrophilic filter, 0.1 micron hydrophobic filter.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Special 510(k) Premarket Notification MICRO-VOLUME Extension Set
Section 5, 510(k) Summary
. DEC - 8 2011
5. 510(k) SUMMARY
October 20, 2011
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Nanette Hedden Senior Manager, Regulatory Affairs 25212 W. Illinois Route 120 Round Lake, IL 60073 Telephone: (847) 270-4871 Fax: (847) 785-5116
DEVICE NAME: Intravenous administration extension set
Trade name: Non-DEHP MICRO-VOLUME Extension Set with 0.22 Micron Filter
| Code number | Name |
|---|---|
| 2N3347 | Non-DEHP MICRO-VOLUME Extension Set, 36" |
| 2N3350 | Non-DEHP MICRO-VOLUME Extension Set, 60" |
Table 5-1. Product Codes for Non-DEHP MICRO-VOLUME Extension Set
Common name: Extension sets with a 0.22 micron Air Eliminating Filter
Classification name: Intravascular Administration Set (21 CFR 880.5440, FPB)
PREDICATE DEVICE:
Table 5-2. Previous 510(k)
| Device | Company | Previous
510(k) | Clearance
Date |
|--------------------------------------------------------------------|----------------------|--------------------|-------------------|
| Auto Syringe MICRO-VOLUME
Extension Set with Air Venting Filter | Baxter
Healthcare | K860746 | April 7, 1986 |
==
1
DESCRIPTION OF THE DEVICE:
The MICRO-VOLUME Extension Set product line consists of sterile, single use disposable devices indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter. These intravascular administration sets provide a clinician the ability to increase the distance between the patient and the fluid administration source. The overall set configuration consists of a female Luer connector, non-DEHP microbore tubing, a 0.22 micron hydrophilic filter, and a male Luer lock connector at the distal end of the set. The filter housing also contains a 0.1 micron hydrophobic filter which vents air to the atmosphere. The MICRO-VOLUME Extension Set with a 0.22 micron filter is designed to remove air and particulate matter and has a maximum pressure of 45 psi (2241 kPa). The product is sterile and non-pyrogenic.
STATEMENT OF INTENDED USE:
The I.V. extension set with a 0.22 micron air venting filter is indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed MICRO-VOLUME Extension Sets with a 0.22 micron filter are equivalent to Baxter's current legally marketed extension sets cleared April 7, 1986 (K860746). See Table 5-2. The MICRO-VOLUME Extension Set with a 0.22 micron filter is designed to remove air and particulate matter and has a maximum pressure of 45 psi (2241 kPa). The filter housing also contains a 0.1 micron hydrophobic filter which vents air to the atmosphere. The product is sterile and non-pyrogenic. The intended use, the basic design, function and the materials for the proposed device are equivalent to the predicate device.
2
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use. The following tests were conducted to evaluate the effect of the design modification on the functional performance of the change to the male Luer component of the MICRO-VOLUME Extension Sets:
- Bond Strength tests .
- . Bond Pressure tests
- ISO Luer Tests .
- Biocompatibility .
CONCLUSION:
The MICRO-VOLUME Extension Sets are substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a person with outstretched arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Baxter Healthcare Corporation C/O Ms. Nanette Hedden Senior Manager, Regulatory Affairs 25212 W. Illinois Route 120 · Round Lake, Illinois 60073
DEC - 8 2011
Re: K113227
Trade/Device Name: MICRO-VOLUME Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Filter, Infusion Line Regulatory Class: Class II Product Code: FPB Dated: October 28, 2011 Received: November 8, 2011
Dear Ms. Hedden:
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.
4
Page 2 - Ms. Hedden
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 (OS) 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.hum.
Sincerely yours,
Cintan
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital: Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
· Device Name: MICRO-VOLUME Extension Set
Indications for Use:
The I.V. extension set with a 0.22 micron air venting filter is indicated for the administration of fluid to a patient's vascular system and for the removal of air and particulate matter.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rld C. Chagn 12/8/11
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113227