(22 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
The device is for the administration of fluids, not for treating a disease or condition.
No
The device is described as being used for the "administration of fluids from a container to the patient through a vascular access device," indicating its function is for fluid delivery, not diagnosis.
No
The device description clearly outlines physical components such as cannulas, solution sets, and tubing, and the performance studies focus on physical properties like insertion force and flow rate, indicating a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of fluids from a container to the patient through a vascular access device." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description details components like cannulas, solution sets, and medication sets used for fluid administration into the vascular system. This aligns with infusion or delivery devices, not diagnostic tests.
- No mention of in vitro testing: The text does not mention any testing of biological samples (blood, urine, tissue, etc.) outside of the body.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for fluid delivery.
N/A
Intended Use / Indications for Use
For the administration of fluids from a container to the patient through a vascular access device. The Interlink Lever Lock Cannula is indicated to function exclusively with the Interlink Injection Site as a fluid path injection device.
Product codes (comma separated list FDA assigned to the subject device)
2C9292, 2H7452, 2C6402, 2H6537, 1C8533, 1C8669, FPA
Device Description
The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of the Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets. They are single use disposable devices intended for use with a vascular device for continuous or intermittent fluid administration. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K883638 (cleared on September 23, 1988), K925126 (cleared on June 18, 1993), and K940697 (cleared on August 30, 1994).
The Interlink Lever Lock Cannula is intended to function exclusively with the Interlink Injection Site as a fluid path injection device. It has a female Luer that allows the connection of a syringe or the distal end of an Interlink Secondary Medication Set to an Interlink injection site of an Interlink solution set or an Interlink CONTINU-FLO set.
The Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They can be used for gravity or pump infusion of I.V. fluids. Interlink CONTINU-FLO Sets contain the Interlink Injection Site that can be used for the administration of secondary medication. They also contain a check valve which prevents backflow of solution from the secondary medication container into the primary container during the administration of secondary medication. Interlink Secondary Medication Sets are used in conjunction with Interlink CONTINU-FLO sets to administer intermittent fluids to the patient.
The basis for this premarket notification is a modification to the Interlink Lever Lock Cannula, which is an integral part of the Interlink System. The modification consists of replacing the solvent carrier used in the silicone lubrication process of the Interlink Lever Lock Cannula. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.
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)
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. Below is a summary of the performance assessment of the Interlink Lever Lock Cannula conducted to show that it is suitable for its intended use:
- Insertion force test
- Removal force test
- Tip protector removal force test
- Lever arm maximum activation integrity test
- ISO Luer tests on female Luer lock connector
- Lipid resistance test
- Lever lock flow test
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.
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 Interlink System
Section 5, 510(k) Summary Page 1 of 3
5. 510(k) SUMMARY
December 14, 2012
OWNER:
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Gary Chumbimune Manager, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 270-3312 Fax: (224) 270-4119
DEVICE NAME:
Trade name: Interlink System ·
| Code number | Name |
|---|---|
| 2C9292 | INTERLINK System Lever Lock Cannula with Check Valve |
| 2H7452 | Non-DEHP Secondary Medication Set with DUO-VENT Spike |
| 2C6402 | INTERLINK System Solution Set |
| 2H6537 | Non-DEHP CONTINU-FLO Solution Set |
| 1C8533 | INTERLINK System Vented CONTINU-FLO Solution Set |
| 1C8669 | INTERLINK System CONTINU-FLO Solution Set |
Table 5-1. Representative Product Codes for the Interlink System
JAN 0 8 2013
1
Special 510(k) Premarket Notification Interlink System
Common name: Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink Continu-Flo Sets.
Classification name: IV Administration Set: 21 CFR 880.5440
PREDICATE DEVICE:
Table 5-2. Previous 510(k)s
| Device | Company | Previous 510(k) | Clearance date |
|---|---|---|---|
| SafeSite TM Injection Site and SafeSite TM Blunt | |||
| Cannula | Baxter Healthcare | K883638 | September 23, 1988 |
DESCRIPTION OF THE DEVICE:
The proposed devices, which are the subject of this Special 510(k) Premarket Notification, consist of the Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets. They are single use disposable devices intended for use with a vascular device for continuous or intermittent fluid administration. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K883638 (cleared on September 23, 1988), K925126 (cleared on June 18, 1993), and K940697 (cleared on August 30, 1994).
The Interlink Lever Lock Cannula is intended to function exclusively with the Interlink Injection Site as a fluid path injection device. It has a female Luer that allows the connection of a svringe or the distal end of an Interlink Secondary Medication Set to an Interlink injection site of an Interlink solution set or an Interlink CONTINU-FLO set.
The Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets are used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They can be used for gravity or pump infusion of I.V. fluids. Interlink CONTINU-FLO Sets contain the Interlink Injection Site that can be used for the administration of secondary medication. They also contain a check valve which prevents blackflow of solution from the secondary medication container into the primary container during the administration of secondary medication. Interlink Secondary Medication Sets are used in conjunction with Interlink CONTINU-FLO sets to administer intermittent fluids to the patient.
The basis for this premarket notification is a modification to the Interlink Lever Lock Cannula, which is an integral part of the Interlink System. The modification consists of replacing the
2
solvent carrier used in the silicone lubrication process of the Interlink Lever Lock Cannula. The product labels are also being updated to add the indications for use statement of the device and clarify their use to comply with Baxter's labeling standards.
STATEMENT OF INTENDED USE:
For the administration of fluids from a container to the patient through a vascular access device. The Interlink Lever Lock Cannula is indicated to function exclusively with the Interlink Injection Site as a fluid path injection device.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The proposed devices consist of the Interlink Lever Lock Cannula, Interlink Solution Sets, Interlink Secondary Medication Sets, and Interlink CONTINU-FLO Sets. These devices are the same as the current marketed devices, previously cleared under 510(k) premarket notifications K883638 (cleared on September 23, 1988), K925126 (cleared on June 18, 1993), and K940697 (cleared on August 30, 1994). A minor modification will be made to the silicone lubrication process of the Interlink Lever Lock Cannula. The intended use, the basic design, function and the materials for the proposed device are equivalent to the predicate device.
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. Below is a summary of the performance assessment of the Interlink Lever Lock Cannula conducted to show that it is suitable for its intended use:
- · Insertion force test
- · Removal force test
- · Tip protector removal force test
- · Lever arm maximum activation integrity test
- · ISO Luer tests on female Luer lock connector
- · Lipid resistance test
- · Lever lock flow test
CONCLUSION:
The proposed devices are substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Januarv 8, 2013
Mr. Gary Chumbimune Manager, Global Regulatory Affairs Baxter Healthcare Corporation 32650 North Wilson Road ROUND LAKE IL 60073
Re: K123868
Trade/Device Name: Interlink System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 14, 2012 Received: December 17, 2012
Dear Mr. Chumbimune:
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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA bas 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 (QS) 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.htm.
Sincerely yours,
Anthong Lo m
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Interlink System
Indications for Use:
For the administration of fluids from a container to the patient through a vascular access device. The Interlink Lever Lock Cannula is indicated to function exclusively with the Interlink Injection Site as a fluid path injection device.
Over-The-Counter Use __ Prescription Use __ X AND/OR
(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)
Digitally signed by Richard C. Chapman Date: 2013.01.09 10:40:59 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: