(32 days)
ACUVANCE PLUS Safety IV Catheter: 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 selfblunting 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.
PROTECTIV PLUS Safety IV Catheter: The PROTECTIV PLUS I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
OPTIVA IV Catheter: The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G 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) Pre-Market Notification for IV catheters and focuses on regulatory approval based on substantial equivalence to predicate devices, rather than detailed performance studies with specific acceptance criteria as one might find for more complex software or AI-driven medical devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in this document.
However, I can extract the information available and indicate what is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to current material for the catheter tube | "Bench testing and biocompatibility data demonstrate that the new material is equivalent to the current material." |
| Indication for Use: Access to vein or artery | Remains the same as predicate devices; "A properly placed I.V. catheter provides access to a vein or artery." |
| Indication for Use: Single use | Remains the same as predicate devices; "The I.V. Catheter System is designed for single use." |
| Needlestick protection feature (ACUVANCE PLUS) | "risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically" |
| Minimize inadvertent needlesticks (PROTECTIV PLUS) | "a needle guard can be locked over the introducer needle" |
| Compatibility with power injectors (14-22G for ACUVANCE PLUS, 16G-24G for PROTECTIV PLUS and OPTIVA) | "may be used with power injectors up to 300 psi." |
| Any patient population consideration for size, solution, duration of therapy | Remains the same as predicate devices. |
| All other technological characteristics remain the same as predicate devices | "All other technological characteristics of the new device remain the same as those of the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "bench testing and biocompatibility data" but does not detail the number of devices or tests performed.
- Data Provenance: Not specified. The nature of "bench testing" suggests laboratory/in-vitro testing, but the country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. This document is a 510(k) summary for a physical medical device, not a study involving expert-established ground truth for diagnostic accuracy (e.g., in imaging or pathology). The performance data cited is for material equivalence based on bench and biocompatibility tests.
4. Adjudication method for the test set
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are relevant for clinical trials or studies where human expert disagreement needs resolution, particularly in diagnostic contexts. This is not described in the context of this device's performance data.
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 a conventional medical device (IV catheter), not an AI-driven or diagnostic system that would involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a conventional medical device (IV catheter), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the performance of the predicate device's material and the established standards for "bench testing and biocompatibility." The document implies that the new material's performance was compared directly against these established baselines and standards, rather than requiring expert consensus, pathology, or outcomes data for a diagnostic purpose.
8. The sample size for the training set
- Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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ACUVANCE® PLUS Safety IV Catheter, PROTECTIV PLUS® Safety IV Catheter, OPTIVA® IV Catheter 510(k) Summary of Safety and Effectiveness
Company
Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242
MAR 2 8 2003
Contact
Katie Fordyce Regulatory Affairs Associate II
Date Prepared:
February 21, 2003
Name of Device
Trade Name: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter Classification Name: Catheter, Intravascular (short-term)
Predicate Devices: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter
Device Description: Intravascular catheters are single use devices which provide access to veins or arteries.
Indications for Use:
ACUVANCE PLUS Safety IV Catheter: 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 selfblunting 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.
PROTECTIV PLUS Safety IV Catheter: The PROTECTIV PLUS I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
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OPTIVA IV Catheter: The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
Technological Characteristics: The catheter tube material has been modified for the IV Catheters. This new material is a different formulation of the material in the predicate devices. All other technological characteristics of the new device remain the same as those of the predicate device.
Performance Data: Bench testing and biocompatibility data demonstrate that the new material is equivalent to the current material.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Public Health Service
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2003
Ms. Katie Fordyce Regulatory Affairs Associate II Ethicon Endo-Surgery, Incorporated 4545 Creek Road Cincinnati, Ohio 45242
Re: K030571
Trade/Device Name: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 21, 2003 Received: February 24, 2003
Dear Ms. Fordyce:
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 - Ms. Fordyce
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 vours.
Susan Bunner
Susan Runner, DDS, MA Interim 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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510(k) Number (if known): K 030571
Device Name: ACUVANCE PLUS Safety IV Catheter, PROTECTIV PLUS Safety IV Catheter, OPTIVA IV Catheter
Indications for Use:
ACUVANCE PLUS Safety IV Catheter:
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 injector up to 300 psi.
PROTECTIV PLUS Safety IV Catheter
The PROTECTIV PLUS Safety I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. The PROTECTIV PLUS Safety I.V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
OPTIVA IV Catheter:
The OPTIVA I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or artery. 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. 16G to 24G catheters may be used with power injectors up to 300 psi.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
of CDRH, Office of Device Evaluation (ODE)
taltaux Vicente
(Optional Format 3-10-98)
(División Sign-On)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
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).