(383 days)
Not Found
No
The summary describes a physical medical device (cannula) and its intended use and materials. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML.
Yes
The device is described as a cannula intended for cardiopulmonary bypass procedures, which are medical interventions designed to treat or manage a disease or condition.
No
Explanation: The device is a cannula used for venous access in cardiopulmonary bypass procedures, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "sterile, single use, disposable cannula" made of physical materials like polyurethane and polyethylene, and includes a dilator. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for accessing veins for cardiopulmonary bypass procedures. This is a surgical or interventional procedure, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a cannula and dilator, which are tools used for accessing and maintaining a pathway into a blood vessel. This aligns with a surgical/interventional device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
- Reagents, calibrators, or controls typically associated with IVD tests.
The device is a tool for facilitating a medical procedure (cardiopulmonary bypass), not for performing a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired. Venous access is left to the discretion of the physician.
Product codes
DWF
Device Description
A sterile, single use, disposable cannula. Polyurethane, wire reinforced thin-wall cannula with unreinforced proximal section terminating in a barbed connector. Supplied with a polyethylene dilator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility testing was performed on whole product extract and/or tubesheet slices of the ethylene oxide (EtO) sterilized test article in accordance with testing which is based on ISO 10993 Standard. Biological Evaluation of Medical Devices. The FEM II-xxx-A was used as the test article for this testing. The reports are summarized as follows:
- Cytotoxicity Test (MEM Elution Test) Under conditions of the test . article is not cytotoxic.
- Guinea Pig Maximization Study (Magnuson/Kligman) The test group and . negative control animals showed no signs of sensitization and therefore Passes Test as a grade I sensitizer (weak).
- CFR Primary Skin Irritation Test Under conditions of the test, the test article . Passes Test in accordance with requirements of CFR Title 16 Part 1500.41.
- USP Systemic Toxicity Test Under conditions of the test, the test article Passes . Test in accordance with requirements of the USP Systemic Injection Test.
- Hemolysis Test The test article had 0.0% Hemolysis.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
1 1998 DEC
Subsection II.A.
SMDA Summary of Safety and Effectiveness Information
In compliance with requirements of the Safe Medical Device Act (SMDA) of 1990, the following information is submitted as a summary of safety and effectiveness information for this 510(k) premarket notification:
1. Predicate Device Identification
A claim of substantial equivalence of the BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae is made to the following Baxter Research Medical, Inc. product family 510(k)s:
- K831769, Various Cardiovascular Surgical Devices [Dual Stage and Single Stage . Venous Return Catheters
- K891576, FEM-Flex Femoral Access Cannulation Set .
These devices were marketed prior to May 28, 1976 or have received FDA clearance to market since that date.
2. Biocompatibilitv Assessment
Biocompatibility testing was performed on whole product extract and/or tubesheet slices of the ethylene oxide (EtO) sterilized test article in accordance with testing which is based on ISO 10993 Standard. Biological Evaluation of Medical Devices.
The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are substantially equivalent in design and materials to BRMI FEM-FLEX™ II Femoral Cannulae, FEM II-xxx-A, marketed under K891576. The FEM II-xxx-A was used as the test article for this testing. The reports are summarized as follows:
- Cytotoxicity Test (MEM Elution Test) Under conditions of the test . article is not cytotoxic.
- Guinea Pig Maximization Study (Magnuson/Kligman) The test group and . negative control animals showed no signs of sensitization and therefore Passes Test as a grade I sensitizer (weak).
- CFR Primary Skin Irritation Test Under conditions of the test, the test article . Passes Test in accordance with requirements of CFR Title 16 Part 1500.41.
- USP Systemic Toxicity Test Under conditions of the test, the test article Passes . Test in accordance with requirements of the USP Systemic Injection Test.
- Hemolysis Test The test article had 0.0% Hemolysis.
1
Comparative Information 3.
Table 1. Comparison of Specifications
Proposed Venous PIFlex II Cannulae vs. Predicate FEM-II Cannulae
BRMI PIFlex-II-xxx-V
Description: A sterile, single use, disposable cannula. Polyurethane, wire reinforced thin-wall cannula with unreinforced proximal section terminating in a barbed connector. Supplied with a polyethylene dilator.
Design: BRMI will offer the cannula in the following ranges: Size: 16 - 24 Fr. Length: 12" - 20.5'
Material: Body: Polyurethane Vent Cap Body: PVC Connector: PVC Dilator: Polyethylene
Manufacturing/Inspection: SOP: Comparable to 70225 IPQA: Comparable to 80160
Labeling: Comparable to p/n 61227 Exception: additional statement "care should be taken to avoid vessel perforation". This statement will be added to IFU p/n 61227. VF-IIxxx products will be used intraoperatively and in situations which peripheral cannulation (i.e. jugular, femoral, innominate) is desired for short term cardiopulmonary bypass.
Packaging: Individually packaged in a sealed Kwik Breathe pouch.
Sterilization: EtO. Product is intended for single use only.
BRMI FEM-II-xxx-A
Description: A sterile, single use, disposable cannula. Polyurethane, wire reinforced thin-wall cannula with unreinforced proximal section terminating in a barbed connector. Supplied with a polyethylene dilator.
Design: BRMI offers the femoral access cannula in the following: Size: 8 - 28 Fr. Length: 6" - 20.5"
Material: Body: Polyurethane Vent Cap Body: PVC Connector: PVC Suture Ring: Silicone Dilator: Polyethylene Cap, Non Vent ML (T-models): ABS
Manufacturing/Inspection: SOP: BRMI p/n 70225 IPQA: BRMI p/n 80160
Labeling: BRMI p/n 61227 . FEM-II-xxx-x are for femoral access only access.
Packaging: Individually packaged in a sealed K wik Breathe pouch.
Sterilization: EtO. Product is intended for single use only.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1
Mr. John W. Smith Baxter Healthcare Corporation 6864 South 300 West Midvale, UT 84047-1051
Re: K974259 Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae Regulatory Class: II (two) 74 DWF Product Code: Dated: September 4, 1998 Received: September 24, 1998
Dear Mr. Smith:
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 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). 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS 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.
3
Page 2 - Mr. John W. Smith
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J.V Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page_______ of _______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): 长 97-4259 __________________________________________________________________________________________________________________________________________
BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Device Name: Return Cannulae, PIFlex-II-xxx-V
Indications For Use:
The BRMI Venous Flex II Peripheral and Intra-Operative Access Venous Return Cannulae, PIFlex-II-xxx-V, are intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e., right atrial appendage and right atriotomy access is desired. Venous access is left to the discretion of the physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| -- | ----------------------------------------------- |
Division of Cardiovascular, Respiratory, and Neurological Devices
| 510(k) Number | K974259 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |