(96 days)
Not Found
No
The device description focuses on the physical components and materials of administration sets, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device is used for the administration of blood and blood by-products, which is a supportive function rather than a direct therapeutic intervention.
No
Explanation: The device is an "intravascular administration set for administration of I.V. solutions or blood," which is used for treatment/administration, not diagnosis. Its intended use is "Administration of blood and blood by-products."
No
The device description clearly states it involves physical components like tubing, connecting parts, and injection sites, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Administration of blood and blood by-products." This describes a device used in vivo (within the body) for delivering substances directly into the bloodstream.
- Device Description: The description details an "intravascular administration set" involving tubing and connecting parts for delivering solutions or blood. This aligns with an in vivo administration device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting to gain diagnostic information. This device's function is to administer substances to the patient, not to analyze samples from the patient.
N/A
Intended Use / Indications for Use
Administration of blood and blood by-products.
Product codes (comma separated list FDA assigned to the subject device)
BRZ
Device Description
Fenwal markets a broad range of intravascular administration sets for administration of I.V. solutions or blood involving hundreds of different sets marketed. While the design of these sets differs for each particular application, they are all based on a common basic design involving polyvinyl chloride extruded tubings, with attendant extruded or injection molded connecting parts of other thermoplastics (such as acrylic, ABS, nylon, and similar polymers) plus latex and synthetic rubber injection sites.
Transfusion sets have been classified by the General Hospital and Personal Use Section of the General Medical Device Panel as Class II in 21 CFR 880.5440 under the classification name intravascular administration set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
5. 510(K) SUMMARY
Date Prepared:
November 2, 2007
Owner and Contact Person:
| Name: Sharyn Orton, PhD |
|---|
| Title: Director, Regulatory Affairs |
| Fenwal, Inc. |
| Address (street): Three Corporate Drive |
| Address (City, State, Zip Code): Lake Zurich, IL 60047 |
| Telephone: (847) 550-7908 |
| Fax: (847) 550-2960 |
| E-mail: sharyn.orton@fenwalinc.com |
| Owner/Operator Number 9098803 |
Device Name(s):
- (4C2160) Blood Component Recipient Set with Standard Size Filter
- (4C2161) Y-Type Blood Component Recipient Set with Standard Size Filter
- (4C2223) Blood Component Infusion Set with Side Arm Luer Connector
Common Name:
Set, Blood Transfusion
Classification Name:
Intravascular Administration Set (21 CFR 880.5440)
Legally Marketed Device:
Blood/Solution Set with Pressure Pump (K881321)
Radiation Sterilized Administration Sets (K811078)
1
Device Description
Fenwal markets a broad range of intravascular administration sets for administration of I.V. solutions or blood involving hundreds of different sets marketed. While the design of these sets differs for each particular application, they are all based on a common basic design involving polyvinyl chloride extruded tubings, with attendant extruded or injection molded connecting parts of other thermoplastics (such as acrylic, ABS, nylon, and similar polymers) plus latex and synthetic rubber injection sites.
Transfusion sets have been classified by the General Hospital and Personal Use Section of the General Medical Device Panel as Class II in 21 CFR 880.5440 under the classification name intravascular administration set.
Statement of Intended Use
Administration of blood and blood by-products.
Technological Characteristics
Fenwal Blood Transfusion Sets are designed to transfuse blood components such as platelets, plasma products, cryoprecipitate and leukocytes. The Y-type set has a small surface area filter and the set offers the user the flexibility of starting the infusion with saline and rinsing the container and tubing of blood components before completing the transfusion. The transfusion set with the luer connector has a filter screen in the distal needle/catheter adapter to minimize platelet loss. The side arm Luer connector facilitates syringe-push technique, suitable for infusion.
2
Page 3 of 3 Section 5: 510(k) Summary or 510(k) Statement
Conclusion
The devices listed in this summary have been cleared for Baxter Healthcare Corporation under 510(k) numbers K881321 and K811078, which showed the product to be safe and effective. Since this 510(k) notification is only being submitted to obtain a number under Fenwal, the safety and effectiveness for these products have not changed.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sharyn Orton Ph. D. Director, Regulatory Affairs Fenwal, Incorporated Three Corporate Drive, 2nd Floor Lake Zurich, Illinois 60047
MAR - 3 2008
Re: K073339 Trade/Device Name: (4C2160) Blood Component Recipient Set with Standard Size Filter (4C2161) Y-Type Blood Component Recipient Set with Standard Size Filter (4C2223) Blood Component Infusion Set with Side Arm Luer Regulation Number: 21 CFR 880.5440 Regulation Name: Blood Transfusion Set Regulatory Class: II Product Code: BRZ Dated: February 7, 2008 Received: February 11, 2008
Dear Dr. Orton:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Dr. Orton
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. INDICATION FOR USE STATEMENT
510(k) Number (If Known):
Not yet assigned
Device Names:
(4C2160) Blood Component Recipient Set with Standard Size Filter
(4C2161) Y-Type Blood Component Recipient Set with Standard Size Filter
(4C2223) Blood Component Infusion Set with Side Arm Luer
Indication(s) for Use:
Administration of blood and blood by-products.
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)
Cinta D.n
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Fenwal Confidential