(79 days)
Not Found
No
The device description and performance studies focus on the physical characteristics of the needles and sets, their electrical stimulation capabilities, and, in one case, echogenic properties for ultrasound visualization. There is no mention of any computational analysis, learning algorithms, or data processing that would indicate the use of AI or ML.
Yes
The intended use states the device is for "regional anesthesia and pain therapy" and to "inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle". This directly describes therapeutic applications.
No
The device is intended for locating peripheral nerves by stimulation and/or ultrasound visualization to facilitate the administration of anesthetic or analgesic fluid. It does not diagnose any condition or disease.
No
The device description clearly details physical components such as needles, catheters, tubing, and hubs, which are hardware. The performance studies also focus on biocompatibility and physical performance standards of these hardware components.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The B. Braun Contiplex and Stimuplex needles and sets are used directly on the patient's body to locate nerves, deliver electrical stimulation, and inject anesthetic or analgesic fluids. This is an in vivo procedure.
- Intended Use: The intended use clearly describes procedures performed on the patient for regional anesthesia and pain therapy. There is no mention of analyzing biological specimens.
- Device Description: The description focuses on the physical components used for nerve localization and fluid delivery within the body.
- Performance Studies: The performance studies mentioned relate to the physical properties of the needles and their performance during the procedure, not the analysis of biological samples.
Therefore, the B. Braun Contiplex and Stimuplex devices described are medical devices used for in vivo procedures, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The B. Braun Stimuplex® D Plus Insulated Echogenic Needle is intended for use in regional anesthesia and pain therapy to target peripheral nerves by transferring electrical impulses from a nerve stimulator and for visualization of an echogenic reflective pattern at the needle tip using an ultrasound imaging device. The needle is used to inject a single dose of local anesthetic or analgesic to the targeted nerve bundle for general and orthopedic surgery.
The B. Braun Stimuplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate by stimulation peripheral nerves by transferring electrical impulses from a nerve stimulator. The needle is used to inject a single dose of local anesthetic or analgesic to the targeted nerve bundle for general and orthopedic surgery.
The B. Braun Contiplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate, by stimulation, peripheral nerves by transferring electrical impulses from a nerve stimulator. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle for general and orthopedic surgery. The Contiplex D Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during the pre-operative, peri-operative and post-operative periods associated with general and orthopedic surgery. The Contiplex D polyamide indwelling catheter may remain indwelling for up to 72 hours.
Product codes
BSP
Device Description
The Contiplex® D Insulated Needles are intended for locating by stimulation, peripheral nerves for the administration of anesthetic or analgesic fluid to the targeted nerve. The Contiplex D needle includes an introducer catheter over the needle to facilitate the advancement of an indwelling catheter. The dielectric needle coating and electrical connection within the hub facilitate the transfer of electrical impulses from a nerve stimulator to the tip of the needle. The needle hubs include an aspiration or injection tubing line in order to facilitate the initial injection of anesthetic or analgesic fluid as well as a connecting cable, which can be attached to the cables of any of the B. Braun Nerve Stimulators listed on the product labeling. The Contiplex D needle/catheter assemblies will be available in two lengths, gauges and bevel geometries.
The Contiplex D Insulated Needles will be available in a set configuration containing one Contiplex D introducer catheter over insulated nerve stimulating needle, one polyamide open-tip catheter with threading assist guide, and one clamp style catheter connector. After needle removal, the short introducer catheter is used to thread a longer open-tip polyamide catheter into the patient. The polyamide catheter and catheter connector are used to administer the continuous flow of anesthetic or analgesic fluid to the patient for up to 72 hours.
Stimuplex® D Insulated Needles are individually packaged insulated needles, intended for the localization and stimulation of peripheral nerve bundles for "single shot" anesthesia. The Stimuplex D needle hubs, like the Contiplex D needles, include an aspiration or injection tubing line in order to facilitate the injection of anesthetic or analgesic fluid. The dielectric needle coating and electrical connection within the hub facilitate the transfer of electrical impulses from a nerve stimulator to the tip of the needle. The Stimuplex D needles can be used with any of the B. Braun Nerve Stimulators listed on the product labeling. The needles will be available in various lengths and gauge sizes with two bevel angles for some sizes.
The Stimuplex® D Plus Insulated Echogenic Needles are designed to provide the clinician with two modalities to locate peripheral nerves for nerve block procedures; through electrical stimulation and ultrasound imaging. The dielectric coating and electrical connection within the hub facilitate the transfer of electrical impulses from a nerve stimulator to the tip of the needle. The Stimuplex D Plus needles can be used with any of the B. Braun Nerve Stimulators listed on the product labeling. In addition, the needles are designed with etched markings to help reflect an image of the needle when using an ultrasound imaging machine. Once the nerve is located, the Stimuplex D Plus needles include a tubing line in order to permit the 'single shot' injection of local anesthetic fluid to the nerve. The needles will be available in various lengths and gauge sizes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound imaging
Anatomical Site
Peripheral nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician (regional anesthesia and pain therapy)
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)
Biocompatibility testing was completed to address any differences in materials and to verify that no new issues of safety have been introduced with the proposed devices. Additionally, performance testing was completed to verify that all design input requirements of the proposed devices have been met. A comparative evaluation of the needles under ultrasound was completed to demonstrate there are no differences between the proposed and predicate device, which raise new issues of safety or effectiveness.
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
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
5. 510(k) SUMMARY
April 13, 2010
APR 1 0 2010
KLOOZ41
SUBMITTER:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500
Contact: Lisa Giaquinto, Sr. Analyst, Regulatory Affairs Phone: (610) 596-2354 Fax: (610) 266-4962 E-mail: lisa.giaquinto@bbraun.com
DEVICE NAME:
Contiplex® D Insulated Needles Stimuplex® D Insulated Needles Stimuplex® D Plus Insulated Echogenic Needles
COMMON OR USUAL NAME:
Needles, Conduction, Anesthetic (W/Wo Introducer)
DEVICE CLASSIFICATION:
Class II, Product Code BSP 868.5150
PREDICATE DEVICES:
Contiplex® Continuous Nerve Block Set, B. Braun Medical, Inc., K090995, Class II, CAZ, 868.5140 (containing Contiplex Tuohy and Straight Needle components, Class II, BSP 868.5150)
EchoStim® Facet Tip, Havel, Inc., K063380, Class II, BSP, 868.5150
DESCRIPTION:
The Contiplex® D Insulated Needles are intended for locating by stimulation, peripheral nerves for the administration of anesthetic or analgesic fluid to the targeted nerve. The Contiplex D needle includes an introducer catheter over the needle to facilitate the advancement of an indwelling catheter. The dielectric needle coating and electrical connection within the hub facilitate the transfer of electrical impulses from a nerve stimulator to the tip of the needle. The needle hubs include an aspiration or injection tubing line in order to facilitate the initial injection of anesthetic or analgesic fluid as well as a connecting cable, which can be attached to the cables of any of the B. Braun Nerve Stimulators listed on the product labeling. The Contiplex D needle/catheter assemblies will be available in two lengths, gauges and bevel geometries.
1
The Contiplex D Insulated Needles will be available in a set configuration containing one Contiplex D introducer catheter over insulated nerve stimulating needle, one polyamide open-tip catheter with threading assist guide, and one clamp style catheter connector. After needle removal, the short introducer catheter is used to thread a longer open-tip polyamide catheter into the patient. The polyamide catheter and catheter connector are used to administer the continuous flow of anesthetic or analgesic fluid to the patient for up to 72 hours.
Stimuplex® D Insulated Needles are individually The packaged insulated needles, intended for the localization and stimulation of peripheral nerve bundles for "single shot" anesthesia. The Stimuplex D needle hubs, like the Contiplex D needles, include an aspiration or injection tubing line in order to facilitate the injection of anesthetic or analgesic fluid. The dielectric needle coating and electrical connection within the hub facilitate the transfer of electrical impulses from a nerve stimulator to the tip of the needle. The Stimuplex D needles can be used with any of the B. Braun Nerve Stimulators listed on the product labeling. The needles will be available in various lengths and gauge sizes with two bevel angles for some sizes.
The Stimuplex® D Plus Insulated Echogenic Needles are designed to provide the clinician with two modalities to locate peripheral nerves for nerve block procedures; through electrical stimulation and ultrasound imaging. The dielectric coating and electrical connection within the hub facilitate the transfer of electrical impulses from a nerve stimulator to the tip of the needle. The Stimuplex D Plus needles can be used with any of the B. Braun Nerve Stimulators listed on the product labeling. In addition, the needles are designed with etched markings to help reflect an image of the needle when using an ultrasound imaging machine. Once the nerve is located, the Stimuplex D Plus needles include a tubing line in order to permit the 'single shot' injection of local anesthetic fluid to the nerve. The needles will be available in various lengths and gauge sizes.
INTENDED USE:
The B. Braun Contiplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate, by stimulation, peripheral nerves by transferring electrical impulses from a nerve stimulator. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle for general and orthopedic surgery.
The Contiplex D Continuous Nerve Block Set is intended to provide continuous and/or intermittent infusion of local
2
anesthetics and analgesics for peripheral plexus anesthesia and pain management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The Contiplex D polyamide catheter may remain indwelling for up to 72 hours.
The B. Braun Stimuplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate by stimulation peripheral nerves by transferring electrical impulses from a nerve stimulator. The needle is used to inject a single dose of anesthetic or analgesic fluid to the targeted nerve bundle for general and orthopedic surgery.
The B. Braun Stimuplex® D' Plus Insulated Echogenic Needle is intended for use in regional anesthesia and pain therapy to target peripheral nerves by transferring electrical impulses from t a nerve stimulator and by visualization of an echogenic reflective pattern at the needle tip using an ultrasound imaging device. The needle is used to inject a single dose of anesthetic or analgesic fluid to the targeted nerve bundle for general and orthopedic surgery.
The Contiplex® D Insulated Needles, Stimuplex® D Insulated Needles and Stimuplex® D Plus Insulated Echogenic Needles have the same intended use and are similar in design to the Contiplex Tuohy and Straight needles included in the Contiplex® Continuous Nerve Block Set (K090995). The proposed devices and predicate device incorporate insulated stimulating needles to locate by stimulation, targeted nerve bundles, in order to perform peripheral nerve block procedures. Biocompatibility testing was completed to address any differences in materials and to verify that no new issues of safety have been introduced with the proposed devices. Additionally, performance testing was completed to verify that all design input requirements of the proposed devices have been met. The following performance standards were considered in evaluating the performance of the proposed devices: ISO 9626:1991/Amd. 1:2001(E) "Stainless steel needle tubing for the manufacture of medical devices." ISO 7864:1993(E) "Sterile hypodermic needles for single use." ISO 594-2:1998 "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Part 2: Lock fittings." The results of biocompatibility and performance testing demonstrate the proposed devices raise no new issues of safety or effectiveness when compared to the predicate device.
The Stimuplex D Plus Insulated Echogenic Needles also have similar indications and technological characteristics as Havel Inc.'s EchoStim® needles. Both the proposed needles and predicate needles are indicated for locating by stimulation,
SUBSTANTIAL EQUIVALENCE:
3
targeted nerve bundles, in order to perform peripheral nerve block procedures. In addition, both the Stimuplex D Plus needles and the EchoStim® needles incorporate etched markings near the needle tip, which help the needles to be visualized under ultrasound. A comparative evaluation of the needles under ultrasound was completed to demonstrate there are no differences between the proposed and predicate device, which raise new issues of safety or effectiveness.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Lisa Giaquinto Senior Analyst, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K100241
Trade/Device Name: Stimuplex D Plus Insulated Echogenic Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: January 21, 2010 Received: January 27, 2010
APR 1 6 2010
Dear Ms. Giaquinto:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, nowever, 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.
5
Page 2- Ms. Giaquinto
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh for
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
January 20, 2010
INDICATIONS FOR USE STATEMENT
Page of
510(k) Number (if known): _______________
Device Names: Stimuplex® D Plus Insulated Echogenic Needle
Indications For Use:
The B. Braun Stimuplex® D Plus Insulated Echogenic Needle is intended for use in regional anesthesia and pain therapy to target peripheral nerves by transferring electrical impulses from a nerve stimulator and for visualization of an echogenic reflective pattern at the needle tip using an ultrasound imaging device. The needle is used to inject a single dose of local anesthetic or analgesic to the targeted nerve bundle for general and orthopedic surgery.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
18
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital · fection Control, Dental Devices
1100241 J10(k) Number: _
7
January 20, 2010
INDICATIONS FOR USE STATEMENT
Page l
510(k) Number (if known): _
Device Names: Stimuplex® D Insulated Needle
Indications For Use:
The B. Braun Stimuplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate by stimulation peripheral nerves by transferring electrical impulses from a nerve stimulator. The needle is used to inject a single dose of local anesthetic or analgesic to the targeted nerve bundle for general and orthopedic surgery.
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K100241 510(k) Number:
8
4. INDICATIONS FOR USE STATEMENT
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Names: Contiplex® D Insulated Needles
Indications For Use:
The B. Braun Contiplex® D Insulated Needle is intended for use in regional anesthesia and pain therapy to locate, by stimulation, peripheral nerves by transferring electrical impulses from a therapy to tocate, by summation, perspiect and facilitate the continuous administration of local anesthetics or analgesics to the targeted nerve bundle for general and orthopedic surgery.
The Continuous D Continuous Nerve Block Set is intended to provide continuous and/or I he Countines D Continuous Tre re and analgesics for peripheral plexus anesthesia and paint management during the pre-operative, perioperative and post-operative periods associated with general and orthopedic surgery. The Contiplex D polyamide indwelling catheter may remain indwelling 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schulthe
(Division Sign-Üir ; Division of Anestosibiligy Coneral Hospital Infection Control, Dental Bonces
5.10(k) Number: K100241