(104 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical properties and fluid flow, with no mention of AI/ML terms or functionalities.
No
The device is described as an anchoring system for administering fluids through an IV, which is a supportive function for drug delivery, not a direct therapeutic action in itself.
No
Explanation: The device is described as an "intravascular administration set to administer fluids," an "anchoring system," and a "securing method to administer IV fluids." Its function is to facilitate fluid delivery, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like tubing, luer locks, clam shell holders, and a Velcro strap, indicating it is a hardware device.
Based on the provided information, the DermaTech IV Holder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for administering fluids through a catheter or needle inserted into a patient's artery or vein. This is a direct therapeutic or supportive function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details components for fluid administration and anchoring, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DermaTech IV Holder's function is entirely focused on the delivery of substances into the body.
N/A
Intended Use / Indications for Use
The DermaTech IV Holder is intended as an intravascular administration set to administer fluids through a catheter or needle inserted into a patients artery or vein.
Product codes (comma separated list FDA assigned to the subject device)
FPA, KMK
Device Description
The DermaTech Sterile IV Holder is a sterile tape-less anchoring system comprising of Non-pyrogenic, PVC tubing with ABS male and female luer locks at each end, two Low Density Polyethylene Clam Shell tubing holders with a Polypropylene Hybrid Stretch Bonded Laminate Velcro strap. Once a needle or catheter is inserted into the artery or vein the DermaTech Sterile IV Holder is attached and provides a app-lecs a securing method to administer IV fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's artery or vein (vascular system)
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)
Non-clinical Tests: The current devices where compared for flow rate, backpressure leakage, and vacuum Leakage to the DermaTech IV Holder. The comparison test verifies the predicate devices and the DermaTech IV Holder are substantially Equivalent.
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.
Not Found
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.
BD Posiflow Positive Displacement Device, Vital Care IV Administration Set, Nexus TKO Needleless Access Device
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
K06 0488
Image /page/0/Picture/1 description: The image shows the logo for DermaTech Medical. The word "DermaTech" is in a bold, sans-serif font, with a black swoosh underneath. The word "Medical" is in a smaller, sans-serif font and is located below the swoosh.
JUN - 8 2006
1000
DermaTech Medical 1971 S. Estes St. Lakewood, Colorado 80227 Tel: 303.763.5787 Fax: 303.984.0413
Premarket Notification [510(k)] Summary
| Submitter: | DermaTech Medical |
|---|---|
| Address: | 1971 S. Estes St. |
| Lakewood, Colorado 80227 | |
| Contact Person: | Glenn Thibault (Consultant) |
| Address: | 102 Heritage Ave |
| Castle Rock, Colorado 80104 | |
| Telephone Number: | 303.596.1108 |
| FAX Number: | 303.320.4664 |
| Date Prepared: | February 20, 2006 |
| Trade Name: | DermaTech Medical Sterile IV Holder |
| Common Name: | DermaTech Medical Sterile IV Holder |
| Classification Name: | IV Administration Set |
| Predicate Devices: | BD Posiflow Positive Displacement Device |
| Vital Care IV Administration Set | |
| Nexus TKO Needleless Access Device |
Description:
The DermaTech Sterile IV Holder is a sterile tape-less anchoring system comprising of Non-pyrogenic, PVC tubing with ABS male and female luer locks at each end, two Low Density Polyethylene Clam Shell tubing holders with a Polypropylene Hybrid Stretch Bonded Laminate Velcro strap. Once a needle or catheter is inserted into the artery or vein the DermaTech Sterile IV Holder is attached and provides a app-lecs a securing method to administer IV fluids.
1
Image /page/1/Picture/1 description: The image shows the logo for DermaTech Medical. The text "DermaTech" is in a stylized font at the top of the image. Below that is a black graphic, and below that is the word "Medical" in a simple font.
Intended Use:
DermaTech IV Holder is a device intended to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a patient's artery or vein.
Technological Characteristics Comparison:
All Materials are similar to the predicate devices; the product is used for IV administration in a tapeless manner. The Set is connected utilizing common male and female Luer Locks.
Non-clinical Tests Support Substantial Equivalence:
The current devices where compared for flow rate, backpressure leakage, and vacuum Leakage to the DermaTech IV Holder.
Conclusions from Non-clinical Tests:
The comparison test verifies the predicate devices and the DermaTech IV Holder are substantially Equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2006
DermaTech Medical, Incorporated C/O Mr. Glenn Thibault Consultant G & N Consulting 102 Heritage Avenue Castle Rock, Colorado 80104
Re: K060488
Trade/Device Name: DermaTech IV Holder Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, KMK Dated: April 21, 2006 Received: April 21, 2006
Dear Mr. Thibault:
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. Thibault
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Syndie H. Michael Omd.
Chíu 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): K060488
Device Name: DermaTech IV Holder
Indications For Use: The DermaTech IV Holder is intended as an intravascular administration set to administer fluids through a catheter or needle inserted into a patients artery or vein.
Prescription Use X (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)
Ciptura V. nuth
ா Sign-Off) of of Anesthesiology, General Hospital, Control, Control, Dental Devices
000x) Number:_K46q488
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