(79 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a mechanical connector for anesthetic administration, with no mention of AI or ML capabilities.
No.
The device is a connector for administering anesthetic agents, not a device that directly performs a therapeutic action.
No
The device is described as a "connection device" for administering anesthetic and fluid, not for diagnosing medical conditions.
No
The device description clearly describes a physical connector made of materials with specific dimensions and mechanical features (luer device, threading hole, compressible catheter channel, hinged clamp mechanism). This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for connecting anesthetic and fluid administration devices to a catheter for the delivery of anesthetics. This is a direct medical intervention on a patient, not a test performed on a sample taken from the body.
- Device Description: The description details a physical connector used in conjunction with catheters for administering fluids. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the physical connection and delivery of substances to the body.
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 18 - 19 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 18 - 19 gauge Perifix catheters for continuous administration of anesthetic agents.
Product codes (comma separated list FDA assigned to the subject device)
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. This new configuration is the same as the previously cleared device except it has a slightly larger inner diameter to more easily accept 18 - 19 gauge Perifix catheters, and the device is made with clear/translucent materials to easily distinguish it from the first configuration which is yellow.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT = 1 2003
Image /page/0/Picture/1 description: The image shows handwritten text and numbers. The text "K032144" is written diagonally. Below the text, the numbers "7.0" and "5" are visible. The handwriting appears to be in black ink on a white background.
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. This new configuration is the same as the previously
cleared device except it has a slightly larger inner diameter to more
easily accept 18 - 19 gauge Perifix catheters, and the device is
made with clear/translucent materials to easily distinguish it from
the first configuration which is yellow. |
| | 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 18 -
19 gauge Perifix catheter for delivery of anesthetics. The
connector is used in conjunction with 18 - 19 gauge Perifix
catheters for continuous administration of anesthetic agents. |
1
SUBSTANTIAL EQUIVALENCE:
The Perifix® Catheter Connector is substantially equivalent to the B. Braun Medical Inc. Perifix Catheter Connector, K022019. The Perifix Catheter Connector will be available in two different configurations. The first configuration is the one cleared in K022019. The new configuration is the same as the predicate device except it has a slightly larger inner diameter to more easily accept 18 - 19 gauge Perifix catheters, and the device is made with clear/translucent materials to easily distinguish it from the first configuration which has yellow components. These minor changes do not raise any new issues of safety or efficacy.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 1 2003
Ms. Amy Smith Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
Re: K032144
Trade/Device Name: Perifix Catheter Connector Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ, BSO Dated: June 10, 2003 Received: June 14, 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 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.
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 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), 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,
Susan Runyon
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
2.0 Indications for Use Statement
Page
KO32144 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 18 - 19 gauge Perifix catheter for delivery of anesthetics, The connector is used in conjunction with 18 - 19 gauge Perifix catheters for continuous administration of anesthetic agents.
DAu
Division Sian-Off on of Anesthesiology, General Hospital, Infection Control, Dental D
510(k) Number: K03Z144
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use