(55 days)
As provided in 21 CFR 880.5200, an intravascular catheter is a device 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. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The products identified in this 510(k) notification include both standard catheters and catheters with a needle-shielding feature. The catheters listed have either a FEP polymer or Vialon material catheter. All have a luerlocking adapters to which an IV line or accessories may be attached.
The provided text describes a 510(k) premarket notification for various IV catheters (Insyte™, Angiocath™, Insyte™ Autoguard™, Angiocath™ Autoguard™, Autoguard™ Pro, Intima™, and Saf-T-Intima™). The notification focuses on a modification to the lubrication system used in the manufacturing process, making it "ozone friendly," while the catheter design and technological characteristics remain unchanged.
Here's an analysis of the acceptance criteria and study information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Attribute Tested) | Reported Device Performance (Conclusion) |
|---|---|
| Penetration | Substantially equivalent |
| Tip Adhesion | Substantially equivalent |
| Catheter / Adapter Separation Force | Substantially equivalent |
| Biocompatibility | Substantially equivalent |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "Side-by-side testing of modified and unmodified devices was conducted" but does not give a numerical sample size.
- Data Provenance: The tests were conducted internally by the manufacturer, Becton Dickinson Infusion Therapy Systems Inc., based in Sandy, UT, USA. The study design implies a comparison between modified and unmodified devices manufactured by this entity. The data is retrospective in the sense that the modified devices were tested against existing unmodified devices to demonstrate equivalence for an existing product line.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this type of submission. This 510(k) is for a manufacturing process change to an existing device and relies on nonclinical (i.e., benchtop) testing rather than clinical data requiring expert human assessment or ground truth establishment in a diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable. Since the testing involved nonclinical, side-by-side comparison of device attributes, there was no need for expert adjudication of results in the way one might evaluate diagnostic image interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The current submission is for a manufacturing process change to an intravascular catheter, which is a therapeutic device, and the evaluation relies on benchtop performance characteristics.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. This is not an AI/algorithm-based device. The "device" here refers to physical IV catheters.
7. Type of Ground Truth Used
The "ground truth" for this study was established by objective, measurable performance characteristics of the devices themselves (e.g., force required for penetration, adhesion strength, separation force). These are physical properties measured directly from the devices, not expert consensus, pathology, or outcomes data in the traditional medical sense. The "ground truth" is that the modified device should perform as well as the unmodified device on these physical metrics.
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this 510(k). This is not an AI/machine learning model that requires training data. The "study" here is a set of nonclinical bench tests.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as in point 8.
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BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com
KO13073
NOV 0 8 2001
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Premarket Notification [510(k)] Summary of Safety and Effectiveness for Insyte™, Angiocath™, Insyte™ Autoguard™, Angiocath™ Autoguard™, moyo - | | htima™, and Saf-T-Intima™, and Saf-T-Intima™ IV Catheters
| Submitter: | Becton Dickinson Infusion Therapy Systems Inc. |
|---|---|
| Address: | 9450 South State StreetSandy, UT 84070 |
| Contact Person: | Leslie Wood, Manager, Regulatory Affairs |
| Telephone Number: | (801) 565-2504 |
| FAX Number: | (801) 565-2749 |
| Date Summary Prepared: | August 9, 2001 |
| Trade Names: | Insyte™ IV Catheter; Angiocath™ IV Catheter;Insyte™ Autoguard™ IV Catheter; Angiocath™Autoguard™ IV Catheter; Autoguard™ Pro IVCatheter; Intima™ IV Catheter; and Saf-T-Intima™IV Catheter |
| Common Name: | Peripheral Intravascular Catheter orIV Catheter |
| Classification Name: | Intravascular Catheter |
Product Descriptions:
The products identified in this 510(k) notification include both standard catheters and catheters with a needle-shielding feature. The catheters listed have either a FEP polymer or Vialon material catheter. All have a luerlocking adapters to which an IV line or accessories may be attached.
Intended Use:
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.
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Technological Characteristics Comparison:
The catheter design and technological characteristics have not changed. The lubrication systems used have been modified to make the manufacturing process 'ozone friendly.'
Nonclinical Tests Support Substantial Equivalence:
Side-by-side testing of modified and unmodified devices was conducted to compare the following attributes: penetration, tip adhesion and catheter / adapter separation force.
Conclusions from Nonclinical Tests:
Data have been provided to demonstrate that product performance and biocompatibility are substantially equivalent between the modified and unmodified devices.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 82001
Ms. Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070
Re: K013073
Trade/Device Name: Insyte™, Intravascular Catheter Angiocath™, Intravascular Catheter Insyte™, Autoguard™, Intravascular Catheter Angiocath™, Autoguard™, Intravascular Catheter Autoguard™, Pro Intravascular Catheter Intima™, Intravascular Catheter Saf-T-Intima™, Intravascular Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 12, 2001 Received: September 14, 2001
Dear Ms. Wood:
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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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NOV 0 8,2001
INDICATIONS FOR USE
Device Name: Insyte™ Intravascular Catheter Angiocath™ Intravascular Catheter Insyte TM Autoguard TM Intravascular Catheter Angiocath™ Autoguard ™ Intravascular Catheter Autoquard™ Pro Intravascular Catheter Intima™ Intravascular Catheter Saf-T-Intima™ Intravascular Catheter
As provided in 21 CFR 880.5200, an intravascular catheter is a device 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. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: _ X (per 21 CFR 801.109)
OR
Over-The Counter Use: __________
Patricia Cucurullo
Division Sign-Off) ivision of Dental, Infection Control, and General Hospital De 11 (k) Number ________________________________________________________________________________________________________________________________________________________________
510(k) Lubrication System Indications for Use 8/1/01
§ 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).