Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
Device Facts
| Record ID | K151072 |
|---|---|
| Device Name | Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit |
| Applicant | Solo-Dex, Inc. |
| Product Code | BSP · Anesthesiology |
| Decision Date | Jan 22, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5150 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The need to inject and facilitate the continuous and/or internittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical procedures. In packaged set configurations, the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit, consisting of the peripheral nerve block needle, catheted peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative and post-operative periods associated with surgical procedures. The catheter may remain indwelling for up to 72 hours.
Device Story
Device is an over-the-needle catheter system for regional anesthesia and pain management. Clinician uses needle to locate peripheral nerves via electrical stimulation (nerve stimulator) or ultrasound visualization. Needle is withdrawn after placement, leaving catheter indwelling for up to 72 hours for continuous or intermittent infusion of local anesthetics/analgesics. Kit includes needle, catheter, stimulating cable, 0.2μ filter, extension set, and securement accessories. Used in clinical settings (OR, pre/post-op) by physicians/anesthesiologists. Output is physical access to nerve bundle for drug delivery; clinical decision-making relies on clinician's ability to confirm nerve location via stimulation or imaging. Benefits include targeted pain management and reduced systemic anesthetic requirements.
Clinical Evidence
No clinical data or animal studies were required or performed. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993-1), echogenicity, electrical stimulation conductivity, tensile/bond strength, flow performance, and leak testing (ISO 594-1/2). Human factors study confirmed usability.
Technological Characteristics
Over-the-needle catheter system. Materials: Stainless steel needle, flexible plastic catheter. Features: Echogenic needle tip (Tuohy), depth marks, curved distal catheter tip. Connectivity: Passive electrical conductivity via integrated cable for nerve stimulation. Sterilization: Sterile, single-use. Standards: ISO 10555 (catheters), ISO 10993 (biocompatibility), ISO 594 (Luer fittings), EN-13868 (kink resistance).
Indications for Use
Indicated for patients undergoing surgical procedures requiring regional anesthesia or pain management via peripheral nerve block. Facilitates continuous or intermittent infusion of local anesthetics/analgesics to targeted nerve bundles for up to 72 hours during pre-operative and post-operative periods.
Regulatory Classification
Identification
An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.
Predicate Devices
- Complex® C Continuous Peripheral Nerve Block Needle (K121846)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Solo-Dex, Inc. % Albert Rego, Ph.D. Regulatory Consultant Albert Rego, Ph.D., Inc. 27001 La Paz Road, Suite 312 Mission Viejo, California 92691
Re: K151072
Trade/Device Name: Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: December 22, 2015 Received: December 24, 2015
Dear Dr. Albert Rego:
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, 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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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.
*Tejashri Purohit-Sheth, M.D.*
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K151072
#### Device Name
Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit
#### Indications for Use (Describe)
The Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The need to inject and facilitate the continuous and/or internittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical procedures.
In packaged set configurations, the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit, consisting of the peripheral nerve block needle, catheted peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative and post-operative periods associated with surgical procedures. The catheter may remain indwelling for up to 72 hours.
Type of Use (Select one or both, as applicable)
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> |
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| <div style="display:flex; align-items:center;"><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |
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## 510(k) Summary (As required by 21 CFR 807.92)
| I. SUBMITTER: | Solo-Dex, Inc.<br>3 Moonlight Isle<br>Ladera Ranch, CA 92694<br>USA |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Albert Rego Ph.D., Inc.<br>27001 La Paz Road, Suite 312<br>Mission Viejo, CA 92691<br>Contact: Albert Rego<br>Phone: (949) 770-8710 |
| Date Prepared: | January 20, 2016 |
| II. DEVICE: | |
| Trade Name: | Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and<br>Needle Kit |
| Common Name: | Anesthesia Conduction Needle<br>[Peripheral Nerve Block Needle, Anesthetic Conduction Needles,<br>W/Wo introducer (21 CFR 868.5150)] |
| Classification Panel: | Anesthesiology |
| Regulatory Class: | Class II |
| Product Code: | BSP |
| III. PREDICATE DEVICE: | Complex® C Continuous Peripheral Nerve Block Needle (K121846) |
## IV. DEVICE DESCRIPTION:
Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. The Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.
## V. INDICATIONS FOR USE:
The Solo-Dex Fascile® Continuous Peripheral Nerve Block Needle is intended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The need to inject and facilitate the continuous and/or intermittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical procedures.
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In packaged set configurations, the Solo-Dex Fascile® Continuous Peripheral Nerve Block Set, consisting of the peripheral nerve block needle, catheter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative and postoperative periods associated with surgical procedures. The catheter may remain indwelling for up to 72 hours.
## VI. TECHNOLOGICAL CHARACTERISTICS:
Solo-Dex Fascile® Continuous Peripheral Nerve Block Needle has the same fundamental scientific technology as the Complex® C Continuous Peripheral Nerve Block Needle (K121846).
## VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The comparison of features and operation principles between Solo-Dex Fascile® Continuous Peripheral Nerve Block Needle from Solo-Dex, Inc., and Complex® C Continuous Peripheral Nerve Block Needle (K121846) from B. Braun Medical, Inc. is listed as follows:
| Parameter | Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit 510(k) - (K151072) | Complex® C Continuous Peripheral Nerve Block Needle 510(k) (K121846), B. Braun Medical, Inc. | Comparison Substantially Equivalent or Equivalent |
|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Common Name | Peripheral Nerve Block Needle, Anesthetic Conduction Needles, W/Wo introducer (21 CFR 868.5150) | Peripheral Nerve Block Needle, Anesthetic Conduction Needles, W/Wo introducer (21 CFR 868.5150) | Substantially Equivalent |
| General Characteristics | | | |
| Description | Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. The Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure. The description of key components are as follows:<br><br>1. Catheter and Needle Combination: The needle provides the clinician with the ability of placing the catheter / needle combination at the regional block site. Upon placement, the needle is withdrawn leaving the catheter intact and available for infusion when connected to a syringe or infusion pump.<br><br>2. Stimulating Cable: Fascile kit includes a stimulating cable that when connected to the needle provides electrical stimulation to the targeted nerve bundle if required | The Contiplex® C Continuous Peripheral Nerve Block Needle is a needle comprised of an open tip catheter over an insulated needle with a positioning component, a needle hub with integrated injection tubing and cable, and connection tubing. The key components in B. Braun system are as follows:<br><br>1. Catheter and Needle Combination: The combination is used for placing the needle and catheter at the regional block site. After placement at the site, the needle is withdrawn with the catheter remaining at the site. The catheter may be attached to a syringe or infusion pump.<br><br>2. Stimulating Cable: The stimulating cable is integrated into the needle. The needle may provide stimulation to the targeted nerve bundle if required. | Substantially Equivalent<br><br>Substantially Equivalent<br><br>Substantially Equivalent |
| Parameter | Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit 510(k) - (K151072) | Complex® C Continuous Peripheral Nerve Block Needle 510(k) (K121846), B. Braun Medical, Inc. | Comparison Substantially Equivalent or Equivalent |
| | 3. 0.2μ Filter: A 0.2μ filter is available within the kit and may be used for particle filtration of the anesthetic drug. The kit utilizes the Perifix 0.2μ filter (or equivalent). | 3. 0.2μ Filter: The B. Braun Perifix 0.2μ filter is available within the kit and may be used for particle filtra- tion of the anesthetic drug. | Substantially Equivalent |
| | 4. Adhesive strips and transparent occlusive dressing: Adhesive strips and occlusive dressing are available within the kit and may be used for securing the catheter at the insertion site. The adhesive strips and occlusive dressing are off the shelf components. | 4. Perifix PinPad Filter Fixation Device: The B. Braun Perifix PinPad is used for securing the Perifix 0.2μ Filter. | Substantially Equivalent (securement devices) |
| | 5. Extension Set: The Extension Set serves as the interface between the needle / catheter and the syringe / infusion pump. | 5. Extension Set: Same as Solo- Dex Fascile kit. | Substantially Equivalent |
| Indications for Use | The Solo-Dex Fascile® Continuous Peripheral Nerve Block Needle is in- tended for use in regional anesthesia and pain therapy to locate peripheral nerves by transferring electrical im- pulses from a nerve stimulator, or to be seen by ultrasound visualization of the device. The needle is used to in- ject and facilitate the continuous and/or intermittent administration of local anesthetics or analgesics to the targeted nerve bundle in surgical pro- cedures. | The Contiplex C Continuous Peripheral Nerve Block Needle is intended for use in regional anes- thesia and pain therapy to locate peripheral nerves by transferring electrical impulses from a nerve stimulator or by ultrasound visual- ization of the device. The needle is used to inject and facilitate the continuous administration of local anesthetics or analgesics to the target nerve bundle in general and orthopedic surgery. | Substantially Equivalent |
| | In packaged set configurations, the Solo-Dex Fascile® Continuous Periph- eral Nerve Block Set, consisting of the peripheral nerve block needle, cathe- ter, and related peripheral nerve block procedural accessories, is intended to provide continuous and/or intermit- tent infusion of local anesthetics and analgesics for peripheral plexus anes- thesia and pain management during pre-operative, peri-operative and post-operative periods associated with surgical procedures. The catheter may remain indwelling for up to 72 hours. | In set configuration, the B. Braun Contiplex C Continuous Peripheral Nerve Block Set, consisting of the peripheral nerve block needle catheter, and related peripheral nerve block procedural accesso- ries, is intended to provide contin- uous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management during pre-operative, perioperative, and post- operative periods associated with general and orthopedic surgery. The catheter may remain indwell- ing for up to 72 hours. | |
| Technological Characteristics | | | |
| Basic Design | This is an over the needle catheter system. | This is an over the needle catheter system. | Substantially Equivalent |
| Parameter | Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit 510(k) - (K151072) | Complex® C Continuous Peripheral Nerve Block Needle 510(k) (K121846), B. Braun Medical, Inc. | Comparison Substantially Equivalent or Equivalent |
| Principle of Operation: Nerve Location | The proposed device incorporates two methods for locating the targeted nerve bundle: (1) Stimulation and (2) Ultrasonic. Both devices are used for placing an indwelling catheter in position local to the target nerve. | The predicate device incorporates two methods for locating the targeted nerve bundle: (1) Stimulation and (2) Ultrasonic. Both devices are used for placing an indwelling catheter in position local to the target nerve. | Substantially Equivalent |
| Primary Difference Between Two Devices | 1. Fascile utilizes multiple catheter / needle lengths (70 mm, 100 mm and 150 mm) based on the kit configuration. A clinician selects the appropriate needle/catheter lengths based on the location of the nerve block site.<br>2. Fascile kits include 3, 5 and 20 ml syringes and (2) hypodermic needles as accessories for clinician use if desired.<br>3. Fascile kits provide securement device(s) for the <i>catheter</i> after placement. | 1. Contiplex C utilizes a dedicated length catheter / needle length of 188 mm. The clinician adjusts the catheter / needle length, based on the location of the nerve block site, using the provided C-Clip positioning device.<br>2. Contiplex C kits do not include syringes or hypodermic needles as accessories for clinician use.<br>3. Contiplex C kits provide a securement device for the <i>filter</i> after catheter placement. | Substantially Equivalent in terms of form, fit, function |
| Configuration | Fascile has a primary Catheter and Needle combination along with supporting accessories. The typical kit configuration includes syringes, needles, securement devices, filter and extension set. Except for the extension set, all accessories are off the shelf items. | Contiplex C has a primary Catheter and Needle combination along with supporting accessories. The Contiplex C kit configuration includes an extension set, filter and securement device. | Substantially Equivalent |
| Primary Needle | | | |
| Echogenic Needle | Fascile Needle is designed to be Echogenic. Needle is made from stainless steel. | Needle is designed to be Echogenic. Needle is made from stainless steel. | Substantially Equivalent |
| Needle Stimulation: Conductivity | Fascile Needle provides conductivity by means of a cable and external current source. | Contiplex C Needle provides conductivity by means of an integrated cable and external current source. | Substantially Equivalent |
| Needle Sharp (Penetration) | Fascile Needle is sharp enabling a clinician to penetrate tissue. Needle tip: Touhy. | Contiplex C Needle is sharp enabling a clinician to penetrate tissue. Needle tip: block bevel. | Substantially Equivalent |
| Needle and Catheter Hub Bond Strength | Conforms to ISO- 10555, Intravascular Catheters- Sterile and single Use Catheters - Part 1: General Requirements | Bond Strength testing is claimed in 510(k) Summary | Substantially Equivalent |
| Parameter | Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit 510(k) - (K151072) | Complex® C Continuous Peripheral Nerve Block Needle 510(k) (K121846), B. Braun Medical, Inc. | Comparison Substantially Equivalent or Equivalent |
| Primary Catheter Design | The catheter has an open end with side ports facilitating drug delivery. The catheter has a curved distal tip designed to keep the catheter near the nerve. | Contiplex C catheter has an open end at the tip for drug delivery. | Substantially Equivalent |
| Catheter Material | Catheter is made from a flexible plastic material. | Catheter is made from a flexible plastic material. | Substantially Equivalent |
| Depth Marks | Catheter is printed with depth marks. | Catheter is printed with depth marks. | Substantially Equivalent |
| Curvature to Position Around the Nerve(s) | The catheter curvature allows the catheter to remain close to the nerve. | Contiplex C is a straight catheter. | Substantially Equivalent in terms of form, fit, function |
| Other Components Extension Set - not made with Diethylhexylphthalate (DEHP) | Yes | Yes | Substantially Equivalent |
| Single, Single Use, and Disposable | Yes | Yes | Substantially Equivalent |
| Performance Data Biocompatibility (Externally Communicating Devices (needle, Catheter, and Extension Set) | Conformance to ISO 10993-1. Needle testing for limited exposure (<24 hours) and Catheter testing for prolonged exposure (>24hrs and <30 days). | Conformance to ISO 10993-1. Needle testing for limited exposure (<24 hours) and Catheter testing for prolonged exposure (>24hrs and <30 days). | Substantially Equivalent |
| Stimulation conductivity test | Conductivity test passed. | Conductivity claimed in 510(k) Summary. | Substantially Equivalent |
| Kink Resistance | Passed EN-13868. | Passed EN-13868. | Substantially Equivalent |
| Leakage | Passes ISO-594-1 and ISO-594-2 requirements for conical fitting. Luer junction was tested for leak tests. | Passes ISO-594-1 and ISO 594-2 requirements for conical fitting. Luer junction was tested for leak tests. | Substantially Equivalent |
| Human Factors: Simulated Use Test | Qualified clinicians participating in the Human factors study confirmed the usability of the Fascile kits. Meets ISO 10555-1. | Not available. | |
| Bond Strength and Pull Strength | | Not available. | |
| Needle Resistance to Corrosion | Needle complies with ISO-7864 and ISO-9626 and is manufactured from stainless steel. | Needle complies with ISO-7864 and ISO-9626 and is manufactured from stainless steel. | Substantially Equivalent |
| Flow Performance and Pump Compatibility | Catheter flow rate complies with ISO 10555-5 acceptance criteria (catheter flow between 90% and 115%). Flow restriction is 1% or less. | Not available. | Assumed Substantially Equivalent |
| Single Use, Sterile | Fascile kits are labeled single use only and sold sterile. | Contiplex C kits are labeled single use only and sold sterile. | Substantially Equivalent |
| Tubing - not made with Diethylhexylphthalate (DEHP) | All components not made with Diethylhexylphthalate (DEHP). | Labeled as "not made with Diethylhexylphthalate (DEHP)" | Substantially Equivalent |
| Parameter | Solo-Dex Fascile® Continuous Periph-<br>eral Nerve Block Catheter and Needle<br>Kit 510(k) - (K151072) | Complex® C Continuous Peripher-<br>al Nerve Block Needle 510(k)<br>(K121846), B. Braun Medical, Inc.…
