(146 days)
CLC 2000 Ultra-Site Valve
Not Found
No
The device description focuses on mechanical features and material composition, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an accessory to a vascular access device used for fluid administration or withdrawal, and it passively aids in reducing needlestick injuries. It does not directly treat or diagnose a medical condition.
No
The TEGO™ Needle Free Access Device is described as an accessory to vascular access devices for the administration or withdrawal of fluids, for capping catheters, and for maintaining patency. Its function is to facilitate access and prevent issues like blood reflux, not to diagnose medical conditions or analyze patient data.
No
The device description clearly outlines a physical, hardware-based medical device made of materials like polycarbonate, silicone rubber, and polyethylene, intended for capping vascular access devices. It does not describe software.
Based on the provided information, the TEGO™ Needle Free Access Device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states it's an accessory to vascular access devices (catheters) for the administration or withdrawal of fluids from a patient. This involves interacting directly with the patient's circulatory system.
- Device Description: The description focuses on its function as a needle-free capping device for catheters, facilitating fluid flow and preventing blood reflux. It describes a mechanical device for managing fluid access to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide information about a patient's health status. IVDs typically involve analyzing blood, urine, tissue, or other biological samples.
The TEGO™ is a medical device used for patient care, specifically related to vascular access, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TEGO is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Adminstration Set for the adminstration of fluids or withdraw of fluids from a patient through a cannula or needle placed in the vein or artery. The Gumby is a needle-free, closed capping device which will prevent blood loss or air entrainment through the catheter. The TEGO will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.
The TEGO™ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an intravascular Administration Set for the administration or withdraw of fluids from a patient through a cannula or needle placed in the vein or artery. The TEGO™ is a needle-free capping device which close the end of the catheter. The TEGO™ will permit a necess to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The TEGO is a one piece, swab-able, needle-free catheter patency device. The TEGO is intended for the capping of venous and arterial access devices. The TEGO has a low deadspace, a straight fluid path, high flow rate and straight hale purchant and ergonomically pleasing profile. When a fluid adminstration device is removed from the TEGO an automatic positive displacement of fluid will exit the device and provent blood reflux. The TEGO will permit the use of normal saline for what is known as a rountine flush and patency rodintenance of the venous or arterial access device.
The materials include polycarbonate, silicone rubber, polyethlene 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
Venous and arterial access devices, vein or artery.
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.
CLC 2000 Ultra-Site Valve
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
K040710 192
AUG 1 1 2004
SUMMARY OF SAFETY AND EFFECTIVENESS TEGO (NEEDLE- FREE ACCESS DEVICE)
5807.92(a)(1)
Contact Person
Date of Summary Preparation:
8807.92(a)(2)
Trade Name:
Common Name:
Classification Name:
8807.92(a)(3)
Legally Marketed Substantially Equivalent Devices:
8807.92(a)(4)
Description of Device:
Regulatory Manager August 10, 2004
Dale Fairchild
TEGO
Needle-Free Access Device
Intravascular administration set (21 CFR 880.5440
CLC 2000 Ultra-Site Valve
The TEGO is a one piece, swab-able, needle-free catheter patency device. The TEGO is intended for the capping of venous and arterial access devices. The TEGO has a low deadspace, a straight fluid path, high flow rate and straight hale purchant and ergonomically pleasing profile. When a fluid
1
K0407/0
adminstration device is removed from the TEGO an automatic positive displacement of fluid will exit the device and provent blood reflux. The TEGO will permit the use of normal saline for what is known as a rountine flush and patency rodintenance of the venous or arterial access device.
The materials include polycarbonate, silicone rubber, polyethlene 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 TEGO is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Adminstration Set for the adminstration of fluids or withdraw of fluids from a patient through a cannula or needle placed in the vein or artery. The Gumby is a needle-free, closed capping device which will prevent blood loss or air entrainment through the catheter. The TEGO will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.
8807.92(a)(6)
Comparison of Technical Characteristics:
The TEGO is similar to legally marketed devices with the same intended use and design.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2004
Mr. Dale Fairchild Regulatory Affairs Manager ICU Medical, Incorporated 951 Calle Amanecer San Clemente, California 92673
Re: K040710
Trade/Device Name: TEGO™ Needle Free Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: FPA Dated: June 24, 2004 Received: June 25, 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 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.
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 (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.
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 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 (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,
Carls
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 Statement
510(k) Number: K040710
TEGO™ Needle Free Access Device Device Name:
The TEGO™ Needle Free Access Device is intended for use Indications For Use: rndreations I of Or Ober - access device (catheter) used in Hemodialysis or as an as an accessory to a vascular Administration Set for the administration or withdraw of accessory to an intravascular Fiammistically of a cartery. The TEGY'' is a a needle-free capping device which close the end of the catheter. The TEGO™ will permit a necess to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.
| Prescription Use X | OR | Over-The-Counter-Use |
|---|---|---|
| (Per 21 CFR 801.109) | (optional format 1-2-9) |
(Please do not write below this line-continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antr ioz
ision Sigr ion of Anesthesiologi Division Control, Dent
510(k) Number: