(36 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 innsideration 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 luerlocking adapters to which an IV line or accessories may be attached.
The provided text is a 510(k) Premarket Notification summary for IV catheters. It focuses on demonstrating "substantial equivalence" of modified devices to previously marketed devices, primarily due to a change in the lubrication system to make the manufacturing process "ozone friendly." This document does not describe an AI device or a study involving AI. Therefore, I cannot fulfill your request for information related to AI device acceptance criteria or studies proving its effectiveness.
However, I can extract the information regarding the nonclinical tests conducted to support the substantial equivalence claim for these IV catheters, as this is the closest equivalent to "acceptance criteria and study" in the provided text.
Acceptance Criteria and Study for BD Medical Systems IV Catheters (K013800)
This document describes a premarket notification for updated IV catheters, primarily focused on a manufacturing process change (lubrication system). The "acceptance criteria" here refer to demonstrating that the modified devices perform equivalently to the predicate devices. The study's purpose was to support "substantial equivalence" to market the modified devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Attribute Compared) | Reported Device Performance (Conclusion) |
|---|---|
| Penetration | Data provided demonstrates substantial equivalence between modified and unmodified devices. |
| Tip Adhesion | Data provided demonstrates substantial equivalence between modified and unmodified devices. |
| Catheter / Adapter Separation Force | Data provided demonstrates substantial equivalence between modified and unmodified devices. |
| Biocompatibility | Data provided demonstrates substantial equivalence between modified and unmodified devices. (Implied from the "Nonclinical Tests Support Substantial Equivalence" section) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for "side-by-side testing." It only states that "side-by-side testing of modified and unmodified devices was conducted."
- Data Provenance: The data provenance is internal to Becton Dickinson Infusion Therapy Systems Inc. The study is retrospective in the sense that it compares new manufacturing process devices to existing, already marketed devices. The origin of the data (e.g., country) is not explicitly stated but is implicitly from BD's testing facilities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is a nonclinical, side-by-side performance comparison of device attributes, not a study requiring expert clinical judgment or ground truth establishment in the context of diagnoses or interpretations.
4. Adjudication Method (for the test set)
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints. This study involves objective physical attribute testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable, as the device is an IV catheter and not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable, as the device is an IV catheter and not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate devices (unmodified devices). The testing aimed to show that the performance of the modified devices aligned with, or was substantially equivalent to, the established performance of the unmodified (predicate) devices for the specified attributes.
8. The Sample Size for the Training Set
This information is not applicable, as this is not an AI device nor a study involving a "training set" in that context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as explained in point 8.
{0}------------------------------------------------
BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com
KO13800
DEC 2 1 2001
Image /page/0/Picture/3 description: The image shows the BD logo, which consists of a stylized sun and a human figure. The text "Indispensable to human health" is written below the logo. The logo and text are in black and white.
Premarket Notification [510(k)] Summary of Safety and Effectiveness for Insyte™, Angiocath™, Insyte™ Autoguard™, Angiocath™ Autoguard™, Autoguard™ Pro, 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: | October 29, 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 |
| Predicate Devices: | Same as trade names listed above. |
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 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.
{1}------------------------------------------------
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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all caps. The text is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2001
Ms. Leslie Wood Manger, Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Inc 9450 South State Street Sandy, Utah 84070
Re: K013800
Trade/Device Name: Insyte,™ IV Catheter; Angiocath,™ IV Catheter; Insyte,™ Autoguard,™ IV Catheter; Angiocath,™ Autoguard,™ IV Catheter; Autoguard,™ Pro IV Catheter; Intima, TM IV Catheter; and Saf-T-Intima, TM IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: November 14, 2001 Received: November 15, 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include controls providents 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 (1 mr), it 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.
{3}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advised that I DA 3 issualled on that your device complies with other requirements mean that IDA nas made a december and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regulations, but not limited to: registration You must comply with an the Fee b required to to to the man 801); good manufacturing practice and listing (21 CFR Part 607), laceming (21 cm (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 I his letter will anow you to begin maneting 'y of substantial equivalence of your device to 510(K) premarket nouriedion: "110 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 If you desire specific ad rise for your for in vitro diagnostic devices), please contact the and additionally 21 CPR Part 00710 108 ... Additionally, for questions on the promotion and Office of Comphance at es office of Compliance at (301) 594-4639. advertising or your are the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (21CFR Part 60197). the Act may be obtained from and Brumber (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
{4}------------------------------------------------
INDICATIONS FOR USE
Device Name:
- BD Insyte™ Intravascular Catheter
- BD Angiocath™ Intravascular Catheter
- BD Insyte™ Autoguard™ Intravascular Catheter
- BD Angiocath™ Autoguard™ Intravascular Catheter
- BD Autoquard™ Pro Intravascular Catheter
- BD Intima™ Intravascular Catheter
- BD 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 innsideration 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: _
Alberto Ciconetti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________
510(k) Lubrication System Indications for Use 11/13/01
§ 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).