(44 days)
No
The summary describes a purely mechanical connecting device with no mention of software, algorithms, or data processing.
No
This device is a connector for administering anesthetic and fluid, not the anesthetic agent itself or a device that directly performs a therapeutic action.
No
The device is described as a connection device for administering anesthetic and fluid administration, not for diagnosis.
No
The device description clearly describes a physical, hardware component (a connector) used to connect catheters and luer devices. There is no mention of software functionality.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect devices for the delivery of anesthetic agents through a catheter. This is a direct administration of a substance into the body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical connector for fluid administration, not a device used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
The device is clearly intended for in vivo use, facilitating the delivery of medication directly to a patient.
N/A
Intended Use / Indications for Use
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to 20 - 24 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 20 - 24 gauge Perifix catheters for continuous administration of anesthetic agents.
Product codes
CAZ, BSO
Device Description
The Perifix Catheter Connector is a connecting device used to connect an anesthesia conduction catheter (most commonly an epidural or nerve block catheter) to a luer device for the administration of anesthetic fluids. Catheter connectors are commonly used in epidural anesthesia kits and nerve block kits.
The Perifix Catheter Connector will be available in two different configurations. The first configuration is the one cleared in 510(k) K022019. The second configuration is cleared in the 510(k) K032144. This 510(k) submission is to expand the indications for use for the first configuration to include the 24 Ga. Perifix catheter.
The Perifix Catheter Connector is approximately 1.77 inches long and 0.43 inches in diameter. The connector consists of a luer device on one end for the attachment of a mating luer device, a threading hole, compressible catheter channel and hinged clamp mechanism.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
FEB - 4 2004
7.0 510(k) Summary
. .
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500, ext. 2597
Contact: Amy Smith, RA Specialist |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Perifix® Catheter Connector |
| COMMON OR USUAL
NAME: | Anesthesia Catheter Connector |
| DEVICE
CLASSIFICATION: | Class II per Code of Federal Regulations, Title 21, § 868.5120 -
Anesthesia Conduction Catheter, 868.5140 - Anesthesia
Conduction Catheter Kit |
| PREDICATE DEVICE: | B. Braun Medical Inc.; Perifix Catheter Connector; K022019 |
| DESCRIPTION: | The Perifix Catheter Connector is a connecting device used to
connect an anesthesia conduction catheter (most commonly an
epidural or nerve block catheter) to a luer device for the
administration of anesthetic fluids. Catheter connectors are
commonly used in epidural anesthesia kits and nerve block kits.
The Perifix Catheter Connector will be available in two different
configurations. The first configuration is the one cleared in 510(k)
K022019. The second configuration is cleared in the 510(k)
K032144. This 510(k) submission is to expand the indications for
use for the first configuration to include the 24 Ga. Perifix catheter.
The Perifix Catheter Connector is approximately 1.77 inches long
and 0.43 inches in diameter. The connector consists of a luer
device on one end for the attachment of a mating luer device, a threading hole, compressible catheter channel and hinged clamp mechanism. |
| INTENDED USE: | A connection device used to provide various anesthetic and fluid
administration devices with a single, common access point to 20 -
24 gauge Perifix catheter for delivery of anesthetics. The
connector is used in conjunction with 20 - 24 gauge Perifix
catheters for continuous administration of anesthetic agents. |
1
SUBSTANTIAL EQUIVALENCE:
The Perifix® Catheter Connector indications for use cleared in K022019 are being revised to include use with a 24 Ga. Perifix catheter. The only change to this device is a change to the material of the compressible catheter channel. This change was made due to a reformulation by the supplier. This minor change does not raise any new issucs of safety or efficacy.
000012
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2004
B. Braun Medical Incorporated Amy Smith, RAC Regulatory Affairs Specialist MFG. DIV. 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K033952
Trade/Device Name: Perifix Catheter Connector Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSO Dated: December 19, 2003 Received: December 22, 2003
Dear Ms. Smith:
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 Medica 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 regulytions affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 8010 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register
3
Page 2 - Ms. Smith
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 sct 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). please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Chuls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosurc
4
2.0 Indications for Use Statement
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Perifix® Catheter Connector Device Name:
Indications For Use:
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to 20 - 24 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 20 - 24 gauge Perifix catheters for continuous administration of anesthetic agents.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Usc
sAM
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Device
510(k) Number: K033752
000005