(23 days)
A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.
Intravascular catheters are single use devices which provide access to veins or arteries.
The provided text describes a 510(k) submission for the PROTECTIV ACUVANCE IV Catheter System. This document focuses on the device's capability for use with power injectors up to 300 psi, rather than a diagnostic AI device requiring the kind of extensive performance evaluation breakdown requested in the prompt.
Therefore, many of the requested categories are not applicable to this submission. However, I can extract the relevant information regarding acceptance criteria and the study that demonstrates the device meets these criteria.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Appropriate for use with power injectors | Bench testing demonstrates that the 14 to 22 gauge ACUVANCE catheters are appropriate for use with power injectors up to 300 psi. |
| Withstands pressure up to 300 psi | (Implied by the above statement through "appropriate for use with power injectors up to 300 psi") |
| Maintains functional integrity during infusion | (Implied by the above statement) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of patient data or clinical trials. The "performance data" refers to bench testing. Therefore, details like sample size for a test set, country of origin, or retrospective/prospective nature are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance evaluation was bench testing, not an assessment requiring expert interpretation of diagnostic data.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used
For the specific claim of "use with power injectors up to 300 psi," the ground truth was established through bench testing results. This means physical measurements and observations during simulated use conditions.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would involve a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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Ethicon Endo-Surgery, Inc. Ethicon Blude Barger J, inci
K012/28
PROTECTIV* ACUVANCE IV Catheter System 510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
Contact
Katie Fordyce Regulatory Affairs Associate
Date Prepared:
July 6, 2001
Name of Device
Trade Name: PROTECTIV* ACUVANCE IV Catheter System Classification Name: Catheter, Intravascular (short-term)
Predicate Devices: PROTECTIV* ACUVANCE IV Catheter System
Device Description: Intravascular catheters are single use devices which provide access to veins or arteries.
Intended Use: A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.
Technological Characteristics: The technological characteristics of the new device are the same as those of the predicate device. No changes (materials, specifications, manufacturing or sterilization processes) have been made to the currently marketed catheters. The catheters differ from the currently marketed catheters only in the instructions for use which now include use of the 14 to 22 gauge catheters with power injectors up to 300 psi. The use with power injectors claim is the same as the claim on other Ethicon Endo-Surgery (previously Johnson & Johnson Medical) catheters with regard to use with power injectors.
Performance Data: Bench testing demonstrates that the 14 to 22 gauge ACUVANCE catheters are appropriate for use with power injectors up to 300 psi.
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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
AUG 1 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Katie Fordyce Regulatory Affairs Associate Ethicon Endo-Surgery, Incorporated 4545 Creek Road Cincinnati, Ohio 45242-2839
K012128 Re : PROTECTIV ACUVANCE IV Catheter Trade/Device Name: System 880.5200 Regulation Number: Regulatory Class: II Product Code: FOZ Dated: July 6, 2001 Received: July 9, 2001
Dear Ms. Fordyce:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marke is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate abe beaud 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.
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Page 2 - Ms. Fordyce
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does curs response co figation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compreated as (advertising of your device, please contact the office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
hy A. Ulatowski Time Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K 012128
Device Name: PROTECTIV* ACUVANCE IV Catheter System_
Indications for Use:
A properly placed I.V. catheter provides access to a vein or artery. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 14 to 22 gauge catheters may be used with power injectors up to 300 psi.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
(Optional Format 3-10-98)
Pattria Cucenote
Division of Dental. and General Hospital 510(k) Number .
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).