(80 days)
Not Found
No
The device description details a purely mechanical infusion set with no mention of software, algorithms, or data processing capabilities that would indicate the presence of AI/ML.
No.
The device is described as an "infusion set" intended for the "subcutaneous infusion of fluid medicines," meaning it delivers medication, but it is not the medication itself. Therefore, it is a delivery device, not a therapeutic agent.
No
The device is an infusion set, which is used for delivering fluid medicines into the body, not for diagnosing conditions.
No
The device description details multiple physical components made of various materials (copolyester blend, PVC, stainless steel, HDPE, LDPE, ABS) and mentions sterilization and packaging, indicating it is a hardware device.
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 subcutaneous infusion of fluid medicines." This describes a device used to deliver substances into the body, not to test samples from the body to diagnose or monitor conditions.
- Device Description: The description details components like needles, tubing, connectors, and clamps, all consistent with a device for delivering fluids. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly designed for therapeutic delivery, not diagnostic testing.
N/A
Intended Use / Indications for Use
Intended for the subcutaneous infusion of fluid medicines.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
FlowEase [Subcutaneous] Infusion Set is a single use disposable device intended for the subcutaneous infusion of fluid medicines.
The FlowEase [Subcutaneous] Infusion Set consists of a copolyester blend Female ISO 594-2 Luer Lock Connector attached to a 24 inch length of non-DEHP PVC Tubing that is connected to a non-DEHP PVC Hub with wings. The Hub holds a 24-Gauge thin wall AISI 304 stainless steel Needle with a 90° bend at the distal end.
A medical grade UV-curable acrylated urethane Adhesive is placed on the outside bend of the needle to secure it within the Hub.
The FlowEase [Subcutaneous] Infusion Set also includes a HDPE Bantam Slide Clamp used to start and stop fluid flow. The needle is supplied covered with an LDPE Needle Protector, and the Female Luer Lock Connector is covered with an ABS Male ISO 594-2 Luer Lock Cap.
The FlowEase [Subcutaneous] Infusion Set will be marketed with a 24-Gauge thin wall needle that will be available in three needle lengths: 6 mm, 9 mm, and 12 mm. Each set will be packaged with a commercially available dressing, used to hold the device in place on the patient.
The FlowEase [Subcutaneous] Infusion Set is provided Gamma sterilized and non-pyrogenic. Each Set is packaged individually in a medical grade thermoformed copolyester tray with a Tyvek® lid, labeled according to needle size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
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)
Device performance and safety have been verified through functional and biocompatibility testing. Testing against established standards and guidelines for its intended use demonstrate that the proposed device is as safe and effective as the predicate devices.
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
Kızıфaz
Page 1 of 3 Section 5. 510(k) Summary
Traditional 510(k) Premarket Notification FlowEase [Subcuraneous| Infusion Set
5. 510(K) SUMMARY
JUN 2 9 2012
DATE SUMMARY PREPARED: 05 February 2012
OWNER:
CONTACT PERSON:
Baxter Healthcare Corporation One Baxter Way Westlake Village, CA 91362 Niedre M. Heckman, MS, MPH, RAC Manager, Regulatory Affairs Baxter Healthcare Corporation One Baxter Way Westlake Village. CA 91362 Telephone: 805-372-4096 Fax: 805-372-3042 Email: niedre_heckman @ baxter.com Trade Name:
DEVICE NAME:
FlowEase [Subcutaneous] Infusion Set IV Administration Set 21 CFR 880.5440, Set, Administration, Intravascular Class II FPA
Table 5-1. Predicate Devices
Common Name:
Classification:
Product Code:
Class:
| Predicate
510(k) | Device Name | Company | Clearance
Date |
|---------------------|------------------------------------------------|-------------------------------|-------------------|
| K925362 | Baxter SUB-Q-Set® Subcutaneous Infusion
Set | Baxter Healthcare Corporation | 08/28/1993 |
| K102512 | RMS Subcutaneous Needle Set | Repro-Med Systems, Inc. | 05/20/2011 |
| K020530 | Evans SubQ | Evans Medical Inc. | 04/29/2002 |
1
Traditional 510(k) Premarket Notification
FlowEase [Subcutaneous] Infusion Set
112409
Page 2 of 3 Section 5, 510(k) Summary
DEVICE DESCRIPTION:
FlowEase [Subcutaneous] Infusion Set is a single use disposable device intended for the subcutaneous infusion of fluid medicines.
The FlowEase [Subcutaneous] Infusion Set consists of a copolyester blend Female ISO 594-2 Luer Lock Connector attached to a 24 inch length of non-DEHP PVC Tubing that is connected to a non-DEHP PVC Hub with wings. The Hub holds a 24-Gauge thin wall AISI 304 stainless steel Needle with a 90° bend at the distal end.
A medical grade UV-curable acrylated urethane Adhesive is placed on the outside bend of the needle to secure it within the Hub.
The FlowEase [Subcutaneous] Infusion Set also includes a HDPE Bantam Slide Clamp used to start and stop fluid flow. The needle is supplied covered with an LDPE Needle Protector, and the Female Luer Lock Connector is covered with an ABS Male ISO 594-2 Luer Lock Cap.
The FlowEase [Subcutaneous] Infusion Set will be marketed with a 24-Gauge thin wall needle that will be available in three needle lengths: 6 mm, 9 mm, and 12 mm. Each set will be packaged with a commercially available dressing, used to hold the device in place on the patient.
The FlowEase [Subcutaneous] Infusion Set is provided Gamma sterilized and non-pyrogenic. Each Set is packaged individually in a medical grade thermoformed copolyester tray with a Tyvek® lid, labeled according to needle size.
2
K.121092
Traditional 510(k) Premarker Notification FlowEase (Subcutaneous) Infusion Set
Page 3 of 3 Section 5, 510(k) Summary
STATEMENT OF INTENDED USE: TECHNOLOGICAL CHARACTERISTICS:
ASSESSMENT OF NONCLINICAL DATA:
CONCLUSIONS:
Intended for the subcutaneous infusion of fluid medicines.
The FlowEase [Subcutancous] Infusion Set is substantially equivalent to the predicate devices with regard to technological characteristics, performance, and intended use.
Baxter Healthcare Corporation conducts risk analysis according to the requirements of ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices.
Device performance and safety have been verified through functional and biocompatibility testing.
The FlowEase [Subcutaneous] Infusion Set is substantially equivalent to the predicate devices. Testing against established standards and guidelines for its intended use demonstrate that the proposed device is as safe and effective as the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Niedre Heckman Manager, Regulatory Affairs Baxter Healthcare Corporation One Baxter Way Westlake Village, California 91362
JUN 2 9 2012
Re: K121092
Trade/Device Name: FlowEase Subcutaneous Infusion Set Regulation Number: 21 CFR 880,5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 6, 2012 Received: April 10, 2012
Dear Ms. Heckman:
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 (sec 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. Heckman
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/ ucm 15809.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/MedicalDcvices/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/McdicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for the benefit of
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KI2I\$\$92
Traditional SI0(k) Premarket Notification FlowEase (Subcutaneous) Infusion Set
Page I of I Section 4. Indications for Use
- INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
FlowEase [Subcutaneous] Infusion Set
Indication(s) for Use:
Intended for the subcutaneous infusion of fluid medicines.
D Prescription Use: 21 CFR 801 Subpart D
AND/OR
Over-the-Counter Use: T 21 CFR 801 Subpan C
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard C Chapman 6/28/12
Page _ of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
21092 510(k) Number: