(232 days)
Not Found
No
The device description and intended use focus on the physical components and their function in delivering anesthetic near a nerve. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The device is intended for use with external nerve stimulators, but the description of the device itself does not indicate any AI/ML capabilities.
Yes
The device is intended to provide continuous and/or intermittent infusions of local anesthetics and/or analgesics for pain management, which makes it a therapeutic device.
No
The device is intended for administering local anesthetics and analgesics near a nerve for pain management, not for diagnosing a condition or disease.
No
The device description clearly outlines a kit containing multiple physical components, including a catheter, needle, valve assembly, and dressings, which are hardware.
Based on the provided information, the CONTIPLEX® Stim Continuous Nerve Block Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to deliver local anesthetics and analgesics near a nerve for regional anesthesia and pain management. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The device is a kit containing components for administering medication and locating a nerve. It does not involve testing samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CONTIPLEX® Stim Continuous Nerve Block Set does not fit this definition.
N/A
Intended Use / Indications for Use
The CONTIPLEX® Stim Continuous Nerve Block Set is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and/or analgesics near a nerve for regional anesthesia and pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. Routes of administration are perineural (peripheral nerve block). The Contiplex catheter can be used for up to 72 hours.
Product codes
CAZ
Device Description
The CONTIPLEX® Stim Continuous Nerve Block Set is a kit that contains a stimulating catheter with a plastic dispensing coil, tuohy needle, sideport valve assembly, catheter connector, ChloraPrep One-Step, 3 mL Applicator and a Tegaderm Transparent Dressing. The catheter is electrically conductive and is composed of an inner metal coil and outer polyamide layer. The catheter is radiopaque and is contained in a plastic dispensing coil with an electrical connector attached to a stylet. The tuohy needle is insulated and has an attached integrated wire. The sideport valve assembly is used in the procedure to attach to the tuohy needle and a syringe containing the anesthetic solution. The Chloraprep (Mediflex) is used to prep the patient's skin prior to the procedure and the Tegaderm (3M) is a dressing.
The CONTIPLEX Stim Continuous Nerve Block Set is intended for use with B. Braun Stimuplex HNS 11, Stimuplex HNS 12, and Stimuplex Dig RC nerve stimulators. When used with the Stimuplex HNS 11 and Stimuplex HNS 12 nerve stimulators, the Stimuplex Switch may be used. When used with the Stimuplex Dig RC nerve stimulator, the Stimuplex Switch can not be used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
near a nerve (perineural)
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)
The proposed device has been subjected to biocompatibility testing to support the safety of the materials. The proposed device was also subjected to functional performance testing to support that it functions as intended. In addition, the predicate devices were subjected to some of the same functional performance tests for comparison. The results of the comparison testing support the substantial equivalence of the proposed device and the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Arrow StimuCath Continuous Nerve Block Set 510(k) K030937, PAJUNK GmbH Stimulong Plus Catheter Sets 510(k) K033018
Reference Device(s)
Not Found
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).
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JUN 2 0 2007 B. Braun Medical Inc. 510(k) Premarket Notification Summary Contiplex® Stim Continuous Nerve Block Set K063282
June 7, 2007 Page 1 of 2
5. 510(k) SUMMARY
APPLICANT:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9512 610-266-0500
Rebecca A. Stolarick, Director, Regulatory Affairs Contact: Phone: 610-596-2536 Fax: 610-266-4962 E-mail: rebecca.stolarick@bbraun.com
DEVICE NAME:
CONTIPLEX® Stim Continuous Nerve Block Set
COMMON OR USUAL NAME:
Anesthetic Conduction Kit
DEVICE
CLASSIFICATION:
21 CFR 868.5140 - Anesthetic Conduction Kit Class II, Product Code CAZ
PREDICATE
DEVICES:
Arrow StimuCath Continuous Nerve Block Set 510(k) K030937 PAJUNK GmbH Stimulong Plus Catheter Sets 510(k) K033018
DESCRIPTION:
The CONTIPLEX® Stim Continuous Nerve Block Set is a kit that contains a stimulating catheter with a plastic dispensing coil, tuohy needle, sideport valve assembly, catheter connector, ChloraPrep One-Step, 3 mL Applicator and a Tegaderm Transparent Dressing. The catheter is electrically conductive and is composed of an inner metal coil and outer polyamide layer. The catheter is radiopaque and is contained in a plastic dispensing coil with an electrical connector attached to a stylet. The tuohy needle is insulated and has an attached integrated wire. The sideport valve assembly is used in the procedure to attach to the tuohy needle and a syringe containing the anesthetic solution. The Chloraprep (Mediflex) is used to prep the patient's skin prior to the procedure and the Tegaderm (3M) is a dressing.
The CONTIPLEX Stim Continuous Nerve Block Set is intended for use with B. Braun Stimuplex HNS 11, Stimuplex HNS 12, and Stimuplex Dig RC nerve stimulators. When used with the
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B. Braun Medical Inc.
510(k) Premarket Notification Summary Contiplex® Stim Continuous Nerve Block Set K063282 June 7, 2007 Page 2 of 2
Stimuplex HNS 11 and Stimuplex HNS 12 nerve stimulators, the Stimuplex Switch may be used. When used with the Stimuplex Dig RC nerve stimulator, the Stimuplex Switch can not be used.
INTENDED USE:
The CONTIPLEX® Stim Continuous Nerve Block Set is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and/or analgesics near a nerve for regional anesthesia and pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. Routes of administration are perineural (peripheral nerve block). The Contiplex catheter can be used for up to 72 hours.
SUBSTANTIAL EQUIVALENCE:
The CONTIPLEX Stim Continuous Nerve Block Set is substantially equivalent to the predicate devices identified in this 510(k); the Arrow Stimucath device and the PAJUNK Stimulong device. The proposed CONTIPLEX Stim Continuous Nerve Block Set and the predicate devices have the same indications for use, to delivery anesthetics in epidural and nerve block procedures. The accuracy of delivery of anesthetic agents for the proposed device and predicate devices is facilitated by using an electrically conductive nerve stimulating catheter. The proposed device has been subjected to biocompatibility testing to support the safety of the materials. The proposed device was also subjected to functional performance testing to support that it functions as intended. In addition, the predicate devices were subjected to some of the same functional performance tests for comparison. The results of the comparison testing support the substantial equivalence of the proposed device and the predicate devices. The proposed device and predicate devices have similar technological characteristics. The product design, material composition and performance of the proposed device are similar to those of the predicate devices. The comparison table of the proposed device and predicate devices provided in the 510(k) provides the details of the similarities and differences. Although there are some differences, these differences do not raise any new issues of safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rebecca A. Stolarick Director, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
JUN 2 0 2007
Re: K063282
Trade/Device Name: CONTIPLEX® Stim Continuous Nerve Block Set Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: June 7, 2007 Received: June 11, 2007
Dear Ms. Stolarick:
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.
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Page 2 - Ms. Stolarick
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 (OS) 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Page _
510(k) Number (if known): K063282
CONTIPLEX® Stim Continuous Nerve Block Set Device Name:
Indications for Use:
The CONTIPLEX® Stim Continuous Nerve Block Set is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics percultures as a nerve for regional anesthesia and/or pain management during the and antergive, perioperative and post-operative periods associated with general and orthopedic surgery. Routes of administration are perineural (peripheral nerve block). The CONTIPLEX® catheter can be used for up to 72 hours.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrenee of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices CONFIDENTIAL
510(K) Number: K13282
Oul 6/19/0)