(104 days)
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.
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.
The provided document describes a 510(k) premarket notification for the DermaTech Medical Sterile IV Holder, asserting its substantial equivalence to predicate devices. The study conducted focuses on non-clinical tests to support this claim, rather than human-in-the-loop performance or diagnostic accuracy studies typical for AI/ML devices.
Here's an analysis of the acceptance criteria and study as per your request:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence (Based on Non-Clinical Testing):
| Requirement | Acceptance Criteria (Predicate Match) | Reported Device Performance (DermaTech IV Holder) |
|---|---|---|
| Flow Rate | Comparable to predicate devices | Verified to be substantially equivalent |
| Backpressure | Comparable to predicate devices (no leakage under backpressure) | Verified to be substantially equivalent |
| Vacuum Leakage | Comparable to predicate devices (no leakage under vacuum) | Verified to be substantially equivalent |
| Materials | Similar to predicate devices (PVC, ABS, LDPE, Polypropylene) | All materials similar to predicate devices |
| Intended Use | Same as predicate devices | Same as predicate devices |
Note: The document explicitly states "The comparison test verifies the predicate devices and the DermaTech IV Holder are substantially Equivalent." This is the reported performance for all criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size Used for Test Set: The document does not specify the sample size for the non-clinical tests (flow rate, backpressure, vacuum leakage). It only states "The current devices were compared..."
- Data Provenance: The data provenance is not specified beyond being "non-clinical tests." It is implicit that these tests would have been conducted by DermaTech Medical or a contract testing lab. There is no information about country of origin, nor whether the tests were retrospective or prospective, though non-clinical tests are generally considered prospective in their execution.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This question is not applicable to this submission. The DermaTech IV Holder is a medical device, not an AI/ML diagnostic or prognostic tool that would require expert-established ground truth for a test set. The "ground truth" for this device's performance is derived from physical test measurements compared against predicate devices' specifications or performance.
4. Adjudication Method for the Test Set
This question is not applicable to this submission. Adjudication methods like 2+1 or 3+1 are used for expert consensus in diagnostic studies, not for non-clinical device performance testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This question is not applicable to this submission. The document describes a non-clinical study for a physical medical device (IV holder), not an AI-assisted diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This question is not applicable to this submission. This device is a physical IV holder and does not involve an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for this submission's non-clinical tests was established by measurable physical properties and performance characteristics (flow rate, backpressure leakage, vacuum leakage) of the predicate devices. The aim was to show that the DermaTech IV Holder matched these characteristics.
8. Sample Size for the Training Set
This question is not applicable to this submission. There is no AI/ML model or "training set" for this physical device.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable to this submission. There is no AI/ML model or "training set," and therefore no ground truth was established for such a set.
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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 AveCastle 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 DeviceVital Care IV Administration SetNexus 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.
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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.
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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.
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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
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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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§ 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.