(42 days)
Not Found
No
The description focuses on a mechanical connecting device and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a connector, it doesn't directly provide therapy but facilitates the administration of therapeutic agents.
No
The device is a connector used for administering anesthetics and therapeutic fluids, not for diagnosing medical conditions.
No
The device description clearly describes a physical connector made of hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a connection point for administering anesthetic and fluid administration devices to a catheter for delivery of anesthetics. This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a physical connector used to link a catheter to a luer device for administering substances. It describes a mechanical connection for fluid delivery.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Screening, diagnosis, prognosis, monitoring, or prediction of disease.
- Any form of testing or analysis of biological specimens.
The device is clearly intended for the delivery of substances into the body, which falls under the category of a therapeutic or procedural device, not an in vitro diagnostic device.
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 an 18 or 20 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 18 or 20 gauge Perifix catheters for continuous administration of anesthetic agents.
Product codes
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 anesthesia and/or therapeutic fluids. Catheter connectors are commonly used in epidural anesthesia kits and nerve block kits.
The Perifix Catheter Connector is approximately 1.77 inches long and can accept B. Braun Medical Inc. 18 and 20 Ga. Standard Perifix Catheters. The connector consists of a luer device on one end for the attachment of a mating luer device. The rest of the device consists of a threading hole, 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)
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
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).
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AUG 01 2002
510(k) Summary
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 266-0500, ext. 2597
Contact: Amy S. Krall, 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.; Twist Lock Adapter Hub with Luer
lock; K840287 (Accu-Bloc Brachial Plexus Anesthesia
Tray)
K840179 (Accu-Bloc Epidural Anesthesia Tray) |
| 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 anesthesia and/or
therapeutic fluids. Catheter connectors are commonly used
in epidural anesthesia kits and nerve block kits.
The Perifix Catheter Connector is approximately 1.77
inches long and can accept B. Braun Medical Inc. 18 and
20 Ga. Standard Perifix Catheters. The connector consists
of a luer device on one end for the attachment of a mating
luer device. The rest of the device consists of a threading
hole, 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 an 18 or 20 gauge Perifix catheter for delivery of
anesthetics. The connector is used in conjunction with 18
or 20 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. Twist Lock Catherer Hub Adapter (K840179/K840287). The new catheter connector has similar indications for use as the predicate device. The design is different only in that there is a hinged clamp mechanism for the insertion and retention of the catheter, instead of a twisting screwing motion. There is also one new material in the connector. The material has been biocompatibility tested in accordance with FDA Guidance #G-95 and ISO 10993. These minor changes do not raise any new safety of efficacy issues.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 01 2002
Ms. Amy S. Krall Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
Re: K022019
Trade/Device Name: Perfix® Catheter Connector Regulation Number: 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: June 19, 2002 Received: June 20, 2002
Dear Ms. Krall:
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.
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.
3
Page 2 – Ms. Krall
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) 594-4646 . 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 Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Correspondence to Ms. Angela Smith Pending 510(k) K022019 . July 17, 2002Page 3 of 3
Indications for Use Statement
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|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--|
| - | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
510(k) Number (if known): K022019
Device Name: Perifix® Catheter Connector
Indications For Use:
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to an 18 or 20 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 18 or 20 gauge Perifix catheters for continuous administration of anesthetic agents.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
Over-The-Counter Use _____________
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OR
(Division Sign-Off) (Wision Sign-On)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________