(181 days)
Not Found
Not Found
No
The description focuses on the mechanical components and materials of a standard infusion set, with no mention of AI or ML capabilities.
No
The device is an administration infusion set for delivering medicine solutions like insulin, but it does not treat or cure a disease itself. It's a delivery mechanism.
No
Explanation: The device is an administration infusion set for delivering medication, not for diagnosing conditions.
No
The device description clearly outlines physical components like tubing, connectors, catheters, and materials like PVC, stainless steel, and silicone, indicating it is a hardware device.
Based on the provided information, the Talon insulin pump infusion set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous infusion of medicine solutions, such as insulin, from an external infusion pump." This describes a device used in vivo (within the body) for delivering medication.
- Device Description: The description details a device that is "distally inserted into the subcutaneous tissue of the user" and delivers medication directly into the body.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The description of the Talon infusion set does not involve any such testing of specimens.
Therefore, the Talon insulin pump infusion set is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Talon infusion set is an administration infusion set intended to be used for subcutaneous infusion of medicine solutions, such as insulin, from an external infusion pump.
Product codes
FPA
Device Description
The Talon infusion sets are connected to a medication reservoir proximally (i.e., a syringe that is placed within an infusion pump, such as an insulin pump) and distally inserted into the subcutaneous tissue of the user. The infusion set attaches to the medication reservoir by means of a female luer connector and is inserted into the patient through an introduction cannula. The 26 gauge indwelling catheter is connected to tubing of various lengths. The materials used for the components include: PVC/polyethylene; polyvinyl chloride; polytetrafluorethylene; stainless steel; polycarbonate; polypropylene; and, trace amounts of silicone as a lubricant. All of these materials are typically used in medical devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
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)
Not Found
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
ICU Medical, Inc.
APR 1 2 2004
SUMMARY OF SAFETY AND EFFECTIVENESS Talon Infusion Set
$807.92(a)(1)
Contact Person
Date of Summary Preparation:
Dale Fairchild Regulatory Manager October 10,2003
$807.92(a)(2)
Trade Name:
Common Name:
Classification Name:
Talon
Infusion Set
Intravascular administration set (21 CFR 880.5440
§807.92(a)(3)
Legally Marketed Substantially Equivalent Device: Glucopro Infusion Set
$807.92(a)(4)
Description of Device:
The Talon infusion sets are connected to a medication reservoir proximally (i.e., a syringe that is placed within an infusion pump, such as an insulin pump) and distally inserted into the subcutaneous tissue of the user. The infusion set attaches to the medication reservoir by means of a female luer connector and is inserted into the patient through an introduction
1
ICU Medical, Inc.
cannula. The 26 gauge indwelling catheter is connected to tubing of various lengths. The materials used for the components include: PVC/polyethylene; polyvinyl chloride; polytetrafluorethylene; stainless steel; polycarbonate; polypropylene; and, trace amounts of silicone as a lubricant. All of these materials are typically used in medical devices.
8807.92(a)(5)
Intended Use:
The Talon infusion set is an administration infusion set intended to be used for subcutaneous infusion of medicine solutions, such as insulin, from an external infusion pump.
8807.92(a)(6)
Comparison of Technical Characteristics:
The Talon infusion set is similar to legally marketed devices with the same intended use and design.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or waves, stacked on top of each other.
Public Health Service
APR 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dale Fairchild Regulatory Affairs Manager ICU Medical, Incorporated 951 Calle Amanecer San Clemente, California 92673
Re: K033290
Trade/Device Name: Talon Insulin Pump Infusion Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 4, 2004 Received: February 5, 2004
Dear Mr. Fairchild:
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 vour 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.
3
Page 2 - Mr. Fairchild
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 your device to procced 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours.
fthuch
for
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
4
Indications for Use
510(k) Number (if known): K033290
Device Name: Talon Infusion Set
Indications For Use: The Talon insulin pump infusion set is an administration infusion set intended to be used for subcutaneous infusion of medicine solutions, such as insulin, from an external infusion pump
1 Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Shere Raneau for ADW 4/8/04
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K033290