(137 days)
Not Found
No
The 510(k) summary describes a physical catheter device for delivering anesthetic. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on MRI compatibility and equivalence to a predicate device.
Yes
The device is intended for the administration of local anesthetics and analgesics for pain management and anesthesia, which are therapeutic interventions.
No
The device description indicates that these catheters are for the administration of local anesthetic agents for continuous epidural or caudal anesthesia and pain management. It does not mention any diagnostic capabilities.
No
The device description clearly describes a physical catheter, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of local anesthetic agents into the epidural space or for continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. This is a therapeutic and pain management application, not a diagnostic one.
- Device Description: The device is a catheter designed for delivering substances into the body. It does not perform any tests on samples taken from the body to provide diagnostic information.
- Lack of Diagnostic Language: The text does not mention any diagnostic procedures, analysis of biological samples, or the provision of information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device is used to deliver medication directly into the body.
N/A
Intended Use / Indications for Use
The PERIFIX FX Springwound Epidural Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours.
The Contiplex FX catheter is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.
Product codes
BSO, CAZ
Device Description
The FX catheters are regional anesthesia catheres intended to provide, via percutaneous administration, continuous and/or internittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. The catheters may remain indwwelling for up to 72 hours. Routes of administration are epidural (peripheral nerve block (PNB)). The catheter is available in both open and closed tip designs. The open-tip polyamide catheter is intended to facilitate continuous delivery of anesthetic fluid via one opening at the tip, while the closed-tip polyamide catheter facilitates the administration of anesthetic through three sideports. Both catheters have ink markings, which are located in 10 mm increments along the catheter. The ink markings provide a visual indication of the depth of catheter insertion. When used according to the conditions listed on the product labeling, the FX Catheters may remain in a patient while in an MR environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space, peripheral plexus
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)
MRI testing was performed
Testing supports the device being labeled as MRI Conditional. No changes have been made to the device therefore, the device continues to be safe and effective and performs the same as the predicate device.
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
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).
0
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September 15, 2023
B. Braun Medical Inc. Tracy Larish RA Technical Manager 3773 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K231242
Trade/Device Name: Perifix FX Catheter: Contiplex FX Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO, CAZ Dated: March 25, 2023 Received: May 1, 2023
Dear Tracy Larish:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
K231242
Device Name
Perifix FX Catheter; Contiplex FX Catheter
Indications for Use (Describe)
The PERIFIX FX Springwound Epidural Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours.
The Contiplex FX catheter is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| 510(k) #: | K231242 | 510(k) Summary | Prepared on: 2023-09-15 |
|---|---|---|---|
| ----------- | --------- | ---------------- | ------------------------- |
Contact Details
| 21 CFR 807.92(a)(1) | |
|---|---|
| Applicant Name | B. Braun Medical Inc. |
| Applicant Address | 3773 Corporate Parkway Center Valley PA 18034 United States |
| Applicant Contact Telephone | 484-375-9064 |
| Applicant Contact | Mrs. Tracy Larish |
| Applicant Contact Email | tracy.larish@bbraunusa.com |
Device Name
| 21 CFR 807.92(a)(2) | |
|---|---|
| Device Trade Name | Perifix FX Catheter; Contiplex FX Catheter |
| Common Name | Anesthesia conduction catheter |
| Classification Name | Catheter, Conduction, Anesthetic |
| Regulation Number | 868.5120 |
| Product Code | BSO/CAZ |
Legally Marketed Predicate Devices
| 21 CFR 807.92(a)(3) | ||
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K991879 | Perifix FX catheter (Micor Epiflex) | BSO |
| K113059 | Contiplex FX Continous Nerve Block Set | CAZ |
Device Description Summary
| 21 CFR 807.92(a)(4) | |
|---|---|
| -- | --------------------- |
The FX catheters are regional anesthesia catheres intended to provide, via percutaneous administration, continuous and/or internittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. The catheters may remain indwwelling for up to 72 hours. Routes of administration are epidural (peripheral nerve block (PNB)). The catheter is available in both open and closed tip designs. The open-tip polyamide catheter is intended to facilitate continuous delivery of anesthetic fluid via one opening at the tip, while the closed-tip polyamide catheter facilitates the administration of anesthetic through three sideports. Both catheters have ink markings, which are located in 10 mm increments along the catheter. The ink markings provide a visual indication of the depth of catheter insertion. When used according to the conditions listed on the product labeling, the FX Catheters may remain in a patient while in an MR environment.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The PERIFIX FX Springwound Epidural Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours.
The Contiplex FX catheter is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.
4
Indications for Use Comparison
The indications for use are the same for the proposed device as they are for the predicate(s).
Technological Comparison
The Technological characteristics of the proposed device are the predicate device. There is no change in the design, functional performance, materials or packaging from the proposed device to the predicate(s).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
MRI testing was performed
Testing supports the device being labeled as MRI Conditional. No changes have been made to the device therefore, the device continues to be safe and effective and performs the same as the predicate device.
21 CFR 807.92(a)(6)