(207 days)
Johnson & Johnson Medical Intravascular Catheters are designed for single use. A properly placed I. V. catheter provides access to a viein 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. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi.
Intravascular catheters are single use devices which provide access to veins or arteries.
The provided text describes a 510(k) summary for Johnson & Johnson Medical's intravascular catheters, specifically addressing an additional indication for use with power injectors.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence for an additional indication for use (power injectors) for existing intravascular catheters. Therefore, the "acceptance criteria" are implied by whether the device performs comparably to predicate devices for this new use case, and whether it aligns with the power injector specifications.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Appropriateness for use with power injectors rated for a maximum of 300 psi | Bench data demonstrates that the 16 to 24 gauge JJM catheters are appropriate for use with power injectors rated for a maximum of 300 psi. |
| Technological characteristics are the same as predicate devices for this new indication | The Johnson & Johnson Medical (JJM) catheters have the same technological characteristics as the predicate devices. No changes (materials, specifications, manufacturing and sterilization processes) have been made to the currently-marketed catheters. |
| Use with power injectors claim is the same as predicate Becton-Dickinson catheters' claim. | The use with power injectors claim is the same as the Becton-Dickinson catheters claim for use with power injectors. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "bench data," which implies testing was performed on a sample of the 16 to 24 gauge JJM catheters. The exact number of catheters tested is not provided.
- Data Provenance: The data is generated from "bench data," indicating laboratory or engineering testing. The country of origin is not specified, but the applicant is Johnson & Johnson Medical in Arlington, TX, USA, suggesting the testing was likely conducted in the US or under their supervision. The study is prospective in the sense that new testing was performed to support the additional indication.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This submission describes physical performance testing ("bench data") rather than a study requiring expert interpretation of medical images or clinical outcomes. Therefore, there is no "ground truth" established by experts in the typical sense for a diagnostic device. The ground truth for performance would be based on engineering specifications and measurement devices.
4. Adjudication Method for the Test Set
N/A. This is not applicable to bench testing of physical device performance.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The device is an intravascular catheter, and the evaluation focused on its physical performance with power injectors, not on diagnostic accuracy requiring human reader interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done in the form of "bench data." This tested the device's physical capabilities (specifically, catheter integrity and suitability) with power injectors without human intervention in the performance measurement.
7. The Type of Ground Truth Used
The ground truth used was engineering specifications and physical measurement data. The "bench data" would have involved measuring the catheter's ability to withstand pressure, maintain integrity, and facilitate flow under conditions mimicking power injector use, compared against established engineering standards or predicate device performance.
8. The Sample Size for the Training Set
N/A. Since this involves physical device performance testing ("bench data") to support an additional indication, there is no "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set was Established
N/A. This concept is not applicable as there is no training set mentioned or implied for this type of device evaluation.
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AUG 20 1999
510(k) Summary
| Date | August 16, 1999 |
|---|---|
| Contact | Linda G. HillSr. Project Manager, Regulatory AffairsJohnson & Johnson Medical, Division of Ethicon, Inc.2500 East Arbrook BoulevardArlington, TX 76014-3631Telephone: (817)262-4791Telefax: (817)262-5369 |
| Trade Names | JELCO*, JELCO*-W and JELCO* PLUS Intravascular (I.V.) CathetersCATHLON* I.V. CathetersOPTIVA* I.V. CathetersPROTECTIV*, PROTECTIV*-W, PROTECTIV* PLUS and PROTECTIV* PLUS-W I.V. Catheter Safety Systems |
| Common Name | Intravascular Catheter |
| Classification | Intravascular Catheters have been classified by the General Hospital andPersonal Use Devices as Class II under 21 CFR Part 880.5200. The productcode assigned to these devices is FOZ. |
| Device Description | Intravascular catheters are single use devices which provide access to veins orarteries. |
| Continued on next page |
*Trademark
INSYTE, AUTOGUARD and VIALON are trademarks of Becton-Dickinson, Inc.
v- l
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510(k) Summary, Continued
| Indications | The intravascular catheters and safety systems are designed for single use. A properly placed intravascular 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. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi. |
|---|---|
| Contra-indications | The devices are not designed, sold or intended for use except as indicated. |
| Predicate Devices | The intravascular catheters with the proposed additional indication for use (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. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi) are substantially equivalent to the currently-marketed catheters: JELCO*, JELCO*-W, and JELCO* PLUS, I.V. CathetersCATHLON* I.V. CathetersOPTIVA* I.V. CathetersPROTECTIV*, PROTECTIV*-W, PROTECTIV* PLUS, and PROTECTIV* PLUS-W I.V. Catheter Safety SystemsBecton-Dickinson INSYTE®, INSYTE®-w AND INSYTE® AUTOGUARD TM I.V. CATHETERS |
Continued on next page
*Trademark
INSYTE, AUTOGUARI) and VIAI.ON are trademarks of Becton-Dickinson, Inc.
v-2
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510(k) Summary, Continued
| TechnologicalCharacteristicsComparison | The Johnson & Johnson Medical (JJM) catheters have the same technologicalcharacteristics as the predicate devices. The catheters with the proposedadditional indication for use are identical to the currently-marketed catheters.No changes (materials, specifications, manufacturing and sterilizationprocesses) have been made to the currently-marketed catheters. The cathetersdiffer from the currently-marketed JJM catheters only in the instructions foruse which now include use of the 16 to 24 gauge catheters with powerinjectors for which the maximum rated pressure is 300 psi. The use withpower injectors claim is the same as the Becton-Dickinson catheters claim foruse with power injectors. |
|---|---|
| PerformanceData | Bench data demonstrates that the 16 to 24 gauge JJM catheters are appropriatefor use with power injectors rated for a maximum of 300 psi. |
| Conclusions | In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFRPart 807, and based upon the information provided in this premarketnotification, Johnson & Johnson Medical, Division of Ethicon, Inc.,concludes that the modified devices are safe, effective and substantiallyequivalent to the predicate devices. |
| OtherInformation | Johnson & Johnson Medical will update and include in this summary anyother information deemed reasonable necessary by the FDA. |
*Trademark
INSYTE, AUTOGUARD and VIALON are trademarks of Becton-Dickinson, Inc.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings and body.
ﻬﺎ
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1999
Ms. Linda G. Hill Sr. Project Manager, regulatory Affairs Johnson & Johnson Medical, Division Of Ethicon, Incorporated 2500 East Arbrook Boulevard 76014-3631 Arlington Texas
K990236 Re : Modification Of Jelco*, Jelco*-W And Jelco* Plus Trade Name: I.V. Catheters Requlatory Class: II Product Code: FOZ Dated: July 01, 1999 Received: July 02, 1999
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 bommerce 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Hill
This letter will allow you to begin marketing your device as This lected will arrow you co bogin manifaction. The Frankinding described in your from premation nevice to a legally marketed of substantial equivalence on foassification for your device and predicate actice rebaries to proceed to the market. thus, permics your acvice for your device on our labeling if you desire specific advice for your for your for in for institro regulation (21 crk Fare over and auther office of Compliance at diagnostic devices), prease concact circums on the promotion and in (301) 594-4692. Addictionally, Ese contact the Office of Also, please note the regulation Compliance at (301) 594-4639. Compilance at (3017-594-1059) Rise, Frience to premarket notification' (21 spranding by referenation on your responsibilities CFR 807.97). Crk 807.977. Other general division of Small under the Act may be Obcarned Iron Inter (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours;
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Indications for Use
1290236 510(k) Number:
Device Name: JELCO*, CATHLON* AND OPTIVA* I.V. Catheters and PROTECTIV* I.V. Catheter Safety Systems
Indications for Use:
Johnson & Johnson Medical Intravascular Catheters are designed for single use. A properly placed I. V. catheter provides access to a viein 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. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED.) ==============================================================================================================================================================================
Concurence of CDRH, Office of Device Evaluation (ODE)
Prescription Use A (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
*Trademark
Patricia Crescenti
İV
§ 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).