The I.V. Catheter System is designed to gain access to and deliver a short term (<30 days) intravascular catheter into the patient's vascular system to sample blood, monitor blood pressure, or administer fluids.
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.

Device Description

The I.V. Catheter System contains a short term intravascular catheter and a catheter introducer. The intravascular catheter consists of a slender catheter tube and a catheter hub. The catheter introducer consists of a housing that contains a flash chamber, a flash plug, a stainless steel needle and a needle safety mechanism. The I.V. Catheter System is designed to reduce the risk of accidental needlesticks.

AI/ML Overview

The provided 510(k) submission for the I.V. Catheter System focuses on demonstrating substantial equivalence to predicate devices and the effectiveness of its sharps injury prevention feature.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as quantitative thresholds in the usual sense of a performance study for a diagnostic AI device. Instead, the submission focuses on meeting safety and performance aspects, particularly regarding the needlestick prevention feature, and demonstrating equivalence to existing products.

Below is a table summarizing the implicit acceptance criteria derived from the study and the reported device performance.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety - Sharps Injury Prevention
Reduces risk of accidental needlesticks	0 sharps injuries reported out of 500 insertions in a simulated use study. The device is designed with a self-blunting needle system activated automatically.
Protective feature functions reliably	0 failures of the protective feature occurred out of 500 insertions.
Usability/Usability - User Experience
Intuitive to use	"Positive responses from the 50 participants regarding insertion and use characteristics indicate the I.V. Catheter System is intuitive in nature."
Requires little or no change in usual technique	"Positive responses from the 50 participants regarding insertion and use characteristics indicate the I.V. Catheter System... requires little or no change in usual technique."
Meets customer requirements	"Positive responses from the 50 participants regarding insertion and use characteristics indicate the I.V. Catheter System... meets customer requirements."
Biocompatibility
Meets material safety and biocompatibility standards	The I.V. Catheter System meets ISO 10993-1 requirements for material safety and biocompatibility.
Needle and Catheter Standards
Introducer needle meets relevant ISO standards	The introducer needle meets the requirements of ISO 10555-5.
Catheter previously cleared by FDA	The I.V. catheter (component) has previously received FDA clearance.
Functional Equivalence to Predicate (via Comparison Matrix)	"The I.V. Catheter System is substantially equivalent to JJM's existing CRITIKON* OCR I.V. Catheter and to Bio-Plexus' existing Punctur-Guard® Blood Collection Needle." The comparison matrix (Table 1) notes numerous factors where the device is "Yes" for the intended use and technological features.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set:
- 50 participants were involved in the simulated use study.
- A total of 500 I.V. Catheter Systems were successfully inserted and evaluated.
Data Provenance: The document does not explicitly state the country of origin for the simulated use study. It is a prospective study designed to assess the device's performance in a controlled, simulated environment. The manufacturer, Johnson & Johnson Medical, is located in Arlington, Texas, USA, suggesting the study likely took place in the USA or under their direct oversight.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of submission for a physical medical device (I.V. catheter) typically does not involve "ground truth" in the same way as an AI diagnostic device (e.g., pathology, expert consensus on images).

For this device:

Ground Truth Establishment: The primary ground truth for the device's main claim (reducing needlestick injuries and functional performance) was established through direct observation and reporting of sharps injuries and failures of the protective feature during the simulated use study by the study participants and/or observers.
"Experts": The "50 participants" acted as the evaluators of the device's usability and whether it met customer requirements. Their qualifications are not specified beyond being "participants" in a simulated use study, implying they are likely healthcare professionals or trained individuals who would use such a device. There is no mention of external adjudicating experts (e.g., radiologists) in the context of this device.

4. Adjudication Method for the Test Set

The reported simulated use study assessed the occurrence of sharps injuries and failures of the protective feature, and gathered feedback on usability.

Sharps Injury/Protective Feature Failure: The criteria for these events would presumably be objective observations. There is no mention of a formal adjudication method (e.g., 2+1, 3+1 consensus) in the document. It's implied that these were directly observed and recorded events (or non-events).
User Feedback: "Positive responses" from participants regarding insertion and use characteristics suggest qualitative feedback that was summarized. The method of collating or adjudicating this feedback (e.g., specific survey questions, interview analysis) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the impact of AI algorithms on human reader performance, which is not applicable to this physical I.V. Catheter System. The study conducted was a simulated use study to evaluate safety and usability of the physical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study in the context of an algorithm or AI was not done. This product is a physical I.V. Catheter System, not an AI or software-only device. The "standalone" performance here refers to the device's inherent ability to prevent needlestick injuries and its functional operation, which was tested in the simulated use study.

7. Type of Ground Truth Used

For the key claims:

Sharps Injury Prevention & Protective Feature Functionality: The ground truth was based on direct observation of events (or non-events) during simulated use. The absence of sharps injuries and failures of the protective feature served as the ground truth for its effectiveness in this regard.
Biocompatibility & Material Standards: The ground truth was established by compliance with recognized international standards (ISO 10993-1, ISO 10555-5) through material testing.
Usability/Customer Requirements: The ground truth was gathered through participant feedback indicating satisfaction and ease of use.

8. Sample Size for the Training Set

Not applicable. This submission describes a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" that occurs is the manufacturing process and quality control to ensure all devices meet specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm or "training set," this question does not apply.

Summary

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K980493
510(k) - I.V. Catheter System

APR 28 1998

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS for I.V. Catheter System

Johnson & Johnson Medical 2500 Arbrook Boulevard P.O. Box 90130 Arlington, Texas 76004-3130

Date: February 6, 1998

1. REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

2. CONTACT PERSON

Linda G. Hill (817) 784-4791

3. NAME OF MEDICAL DEVICE:

Catheter, Intravascular, Short Term Classification Name: Common/Usual Name: I.V. Catheter Proprietary Name: To be determined

4. DEVICE CLASSIFICATION:

The General Hospital Panel has classified Intravascular Catheters (21 CFR 880.5200) into Class II, Special Controls under section 513 of the Act.

5. STATEMENT OF SUBSTANTIAL EQUIVALENCE:

The I.V. Catheter System is substantially equivalent to JJM's existing CRITIKON* OCR I.V. Catheter and to Bio-Plexus' existing Punctur-Guard® Blood Collection Needle. See attached Comparison Matrix, Table 1.

6. INTENDED USE:

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510(k) SUMMARY (continued)

7. DESCRIPTION OF DEVICE:

8. SUMMARY OF MATERIAL TESTING:

The I.V. Catheter System meets ISO 10993-1 requirements for material safety and biocompatibility. The introducer needle meets the requirements of ISO 10555-5. The I.V. catheter has previously received FDA clearance.

9. SUMMARY OF SIMULATED USE STUDY:

There were 50 participants and a total of 500 I.V. Catheter Systems were successfully inserted and evaluated. No sharps injuries or failures of the protective feature occurred.

The results of this study support the claim that the I.V. Catheter System can reduce the risk or accidental needlestick injuries. The positive responses from the 50 participants reqarding insertion and use characteristics indicate the the I.V. Catheter System is intuitive in nature, requires little or no change in usual technique, and meets customer requirements.

10.CONCLUSION:

The material testing and simulated use data indicate that the I.V. Catheter System is safe and effective for it's intended use.

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TABLE 1. COMPARISON MATRIX

A comparison matrix for various factors is presented below for the J.V. Catheter System in comparison with CRITIKON* OCR I.V. Catheter and Punctur-Guard® Blood Collection Needle.

Factor	I.V. Catheter System	CRITIKON* OCRI.V. Catheter	Punctur-Guard®Blood CollectionNeedle
Intended Use and Claims
Same Intended Use	Yes	Yes	No
Venipuncture Device	Yes	Yes	Yes
Sharps Injury Prevention Feature	Yes	No	Yes
Reduces Risk of Accidental Needlesticks	Yes	No	Yes
Delivers Short Term Intravascular Catheter	Yes	Yes	No
Conventional Venipuncture Technique	Yes	Yes	Yes
Radiopaque Catheter	Yes	Yes	Not Applicable
Catheter Insertion Technique	1-handed or 2-handed	1-handed or 2-handed	Not Applicable
Technological Features
Same Technological Features	Yes	No	Yes
Sharps Injury Prevention Mechanism	Passive	None	Active
Self-Blunting Needle	Yes	No	Yes
Blunt Locks in Place	Yes	Not Applicable	Yes
Sharps Injury Prevention Feature RemainsActivated During Disposal	Yes	Not Applicable	Yes
Flashback Visualization	Yes	Yes	Yes
Removable Flashplug and Luer Adapter	Yes	Yes	Not Applicable

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Factor	I.V. Catheter System	CRITIKON* OCRI.V. Catheter	Punctur-Guard®Blood CollectionNeedle
Specifications
Multiple Gauge Sizes and Needle Lengths	Yes	Yes	Yes
EtO Sterilized	Yes	Yes	Yes
Other
Sharps Injury Prevention Feature is anIntegral Part of Device	Yes	Not Applicable	Yes
Minimal User Training	Yes	Yes	Yes

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 28 1998

Ms. Linda G. Hill ·Sr. Manager, Regulatory Affairs Johnson & Johnson Medical 2500 Arbrook Boulevard Arlington, Texas 76004-3130

Re : K980493 I.V. Catheter System Trade Name: Requlatory Class: II Product Code: FOZ Dated: February 6, 1998 Received: February 9, 1998

Dear Ms. Hill:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Hill

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 requlation (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 the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directør Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

Applicant

Johnson & Johnson Medical P.O. Box 90130 Arlington, Texas 76004-3130, USA

510(k) Number

This is a new submission and FDA has not assigned a number at this time

Device Name

I.V. 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.

(Please do not write below this line-Continue on another page if needed) Concurrence of CDRH Office of Deyice Evaluation (ODE)

Palman (Division Sign-Off) (Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K980423

Prescription Use V OR Per 21 CFR 801.109 (Optional Format 1-2-96)_

Over-the-Counter

Regulation Number and Section

§ 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).