(276 days)
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.
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.
This document describes the Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit and its substantial equivalence to a predicate device (Complex® C Continuous Peripheral Nerve Block Needle, K121846).
The information provided focuses on demonstrating substantial equivalence through technological characteristics and performance (bench) testing, rather than a clinical study involving human readers or a standalone algorithm performance. Therefore, many of the requested items related to AI/algorithm performance are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Document # / Parameter | Title and Bench Test Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| TM-0001 | Needle & Catheter Echogenicity Test Method: Confirm needle/catheter echogenicity via ultrasound | The test subject shall be visible in the ultrasonic machine. | Pass |
| TM-0002 | Needle Electro-Stimulation Test Method: Confirm needle will transmit an electronic signal observed on a RMS multi-meter | In all current settings of stimulator from low 0.1 to high 5.0mA, the Fascile needle shall be able to transmit the signal as observed on the RMS multi-meter. | Pass |
| TM-SR004A | Needle Sharpness Inspection: Visual and dimensional inspection for needle sharpness | Continuity of needle tip / edge no deformation. | Pass |
| TM-0005 | Tensile Strength Test Method: Measure needle and catheter tensile strength | Fascile catheter body: Tensile strength for 18Ga ≥ 2.25 lbf. Tensile strength for 16GA ≥ 2.25 lbfFascile catheter hub: Tensile strength for 18Ga ≥ 2.25 lbf. Tensile strength for 16GA ≥ 2.25 lbfFascile needle hub: Tensile strength for 20Ga ≥ 12.14 lbf. Tensile strength for 18GA ≥ 2.25 lbfFascile Bond strength: ≥ 2.25 lbf | Pass |
| TM-0008 | Catheter and Extension Set Flow Test Method: Measure fluid flow rate through the extension set and catheter | Flow through predefined holes of a Fascile catheter is visible.Flow through Fascile catheter and extension set attached to a flow control tubing (test) does not drop below 20% compared to the flow of a flow control tubing alone (control). | Pass |
| TM-SR008A | Catheter Depth Mark Inspection: Visual and dimensional inspection for catheter depth marks | Depth marks exist and marking gaps meet drawing. | Pass |
| TM-SR009A | Catheter Curvature Inspection: Visual and dimensional inspection of catheter curvature | Correctness of curve orientation respect to arrow on hub. | Pass |
| TM-SR044A | Straightener Tube Test: Check for straightener tube functionality | Needle easily moves through the catheter without damage. | Pass |
| ISO 594-1:1986 | Conical Fittings with a 6% (Luer) Taper for Syringes, needles and Certain other Medical Equipment - Part 1: ISO standard test methods for ensuring leak free fluid connectors | Complies with the ISO standard | Pass |
| ISO 594-2:1998 | Conical Fittings with a 6% (Luer) Taper for Syringes, needles and Certain other Medical Equipment - Part 2: ISO standard test methods for ensuring leak free fluid connectors | Complies with the ISO standard | Pass |
| Biocompatibility (L929 Neutral Red Uptake Cytotoxicity Test) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (Intracutaneous Injection Test) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (Kligman Maximization Test) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (Systemic Injection Test) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (Rabbit Pyrogen Test) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (Hemolysis - Rabbit Blood Indirect Contact) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (Salmonella typhimurium and Escherichia coli Reverse Mutation Assay) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (Mouse Lymphoma Mutagenesis Assay with Confirmation) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (Rodent Blood MIcronucleus Assay Repeat Dose) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (28-Day systemic Toxicity in Rats via Subcutaneous Implantation) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Biocompatibility (Intramuscular Implantation Test) | Biocompatibility Testing: (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). | Meets Specific ISO Standard Requirements | PASS |
| Human Factors: Simulated Use Test | Qualified clinicians participating in the Human Factors study confirmed the usability of the Fascile kits. | Meets ISO 10555-1. | Pass |
| Packaging Testing | Product meets packaging tests per ISTA 2A. | Meets ISTA 2A | Pass |
Study Details:
This submission is a 510(k) premarket notification for a medical device (Continuous Peripheral Nerve Block Catheter and Needle Kit), which is typically based on demonstrating substantial equivalence to a predicate device through bench testing and, if applicable, animal/clinical studies. It does not involve an AI/algorithm-driven device, therefore, many of the typical AI study parameters are not applicable.
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set (Bench Testing): The document does not specify the exact sample size (number of devices tested) for each bench test, but it indicates that tests were performed to demonstrate compliance with ISO standards and internal test methods. For example, for "Tensile Strength Test Method" and "Catheter and Extension Set Flow Test Method," these would typically involve a statistically relevant number of units.
- Data Provenance: Not explicitly stated, but assumed to be from manufacturing/testing facilities of Solo-Dex, Inc. within the USA, given the submission location and company address. The studies are prospective in nature, as they involve testing newly manufactured devices against predetermined criteria.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Experts for Bench Testing: For bench tests, the "ground truth" is defined by established international standards (e.g., ISO 10555, ISO 594-1/2, ISO 10993-1) and internal engineering specifications. There is no mention of "experts" establish ground truth in the context of clinical interpretation, as this is a device performance study.
- Experts for Human Factors Study: Qualified clinicians participated in the Human Factors study to confirm usability. The specific number or detailed qualifications beyond "qualified clinicians" are not provided.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This concept is not applicable to the bench testing performed for this device. Bench tests have objective Pass/Fail criteria based on measurements against defined standards.
- For the Human Factors study, "qualified clinicians participating... confirmed the usability," suggesting a consensus or satisfaction-based assessment, but no formal adjudication method (like 2+1 or 3+1) is described.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a physical medical instrument (catheter and needle kit) for anesthesia and pain therapy, not an AI or imaging-based diagnostic tool. No AI component is involved, and therefore, no MRMC study was conducted.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Bench Testing: The "ground truth" refers to the established specifications and limits set by international standards (e.g., ISO 10555, ISO 594, ISO 10993) and the manufacturer's internal engineering requirements (e.g., for echogenicity, electrical conductivity, tensile strength, flow rate, sharpness, depth marks, curvature, straightener tube functionality, packaging).
- For Biocompatibility: The ground truth is compliance with the requirements of ISO 10993-1, which involves standard biological tests.
- For Human Factors: The ground truth for usability was established by "qualified clinicians" confirming the device's usability according to ISO 10555-1.
7. The sample size for the training set
- Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing process are validated through engineering principles and bench testing.
8. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/algorithm, this question is not relevant to this device.
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary (As required by 21 CFR 807.92)
| I. SUBMITTER: | Solo-Dex, Inc.3 Moonlight IsleLadera Ranch, CA 92694USA |
|---|---|
| Contact Person: | Albert Rego Ph.D., Inc.27001 La Paz Road, Suite 312Mission Viejo, CA 92691Contact: Albert RegoPhone: (949) 770-8710 |
| Date Prepared: | January 20, 2016 |
| II. DEVICE: | |
| Trade Name: | Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter andNeedle Kit |
| Common Name: | Anesthesia Conduction Needle[Peripheral Nerve Block Needle, Anesthetic Conduction Needles,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: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.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: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.2. Stimulating Cable: The stimulating cable is integrated into the needle. The needle may provide stimulation to the targeted nerve bundle if required. | Substantially EquivalentSubstantially EquivalentSubstantially 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.2. Fascile kits include 3, 5 and 20 ml syringes and (2) hypodermic needles as accessories for clinician use if desired.3. Fascile kits provide securement device(s) for the catheter 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.2. Contiplex C kits do not include syringes or hypodermic needles as accessories for clinician use.3. Contiplex C kits provide a securement device for the filter 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-eral Nerve Block Catheter and NeedleKit 510(k) - (K151072) | Complex® C Continuous Peripher-al Nerve Block Needle 510(k)(K121846), B. Braun Medical, Inc. | ComparisonSubstantiallyEquivalent orEquivalent |
| Drug CompatibilityRequirement (Cathe-ter and Extension Set) | Drug study has demonstrated Fascileis compatible for use with local anes-thetic agent (Ropivacaine HCL 2mg/ml). Fascile is used for Pain Man-agement and delivery of anestheticagents for regional anesthesia andpain management. | Contiplex C is designed for PainManagement therapy and deliveryof anesthetic agents. Drug compat-ibility data is not available. | Assumed Sub-stantiallyEquivalent |
| Packaging Testing | Product meets packaging tests perISTA 2A. | Not available. | Assumed Sub-stantiallyEquivalent |
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The differences that are identified in the table above were mitigated and addressed through product performance evaluations. The results are summarized in the Performance Data as given in the tables below.
VIII. PERFORMANCE DATA:
Biocompatibility Testing: Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter/Needle Kit
| Test | Meets Specific ISO Standard Requirements(Pass/Fail) |
|---|---|
| L929 Neutral Red Uptake Cytotoxicity Test | PASS |
| Intracutaneous Injection Test | PASS |
| Kligman Maximization Test | PASS |
| Systemic Injection Test | PASS |
| Rabbit Pyrogen Test | PASS |
| Hemolysis - Rabbit Blood Indirect Contact | PASS |
| Salmonella typhimurium and Escherichia coli Reverse Mutation Assay | PASS |
| Mouse Lymphoma Mutagenesis Assay with Confirmation | PASS |
| Rodent Blood MIcronucleus Assay Repeat Dose | PASS |
| 28-Day systemic Toxicity in Rats via Subcutaneous Implantation | PASS |
| Intramuscular Implantation Test | PASS |
Table Summary of Bench (Performance) Testing
| Test Document # | Title | Bench Test Description | Acceptance criteria | Result |
|---|---|---|---|---|
| TM-0001 | Needle & Catheter Echogenicity TestMethod | Confirm needle/catheterechogenicity via ultrasound | The test subject shall be visible in theultrasonic machine. | Pass |
| TM-0002 | Needle Electro-Stimulation TestMethod | Confirm needle will transmitan electronic signal observedon a RMS multi-meter | In all current settings of stimulatorfrom low 0.1 to high 5.0mA, the Fascileneedle shall be able to transmit thesignal as observed on the RMS multi-meter | Pass |
| TM-SR004A | Needle Sharpness Inspection | Visual and dimensional in-spection for needle sharpness | Continuity of needle tip / edge nodeformation. | Pass |
| TM-0005 | Tensile Strength Test Method | Measure needle and cathetertensile strength | Fascile catheter body:Tensile strength for 18Ga ≥ 2.25 lbf.Tensile strength for 16GA ≥ 2.25 lbfFascile catheter hub:Tensile strength for 18Ga ≥ 2.25 lbf.Tensile strength for 16GA ≥ 2.25 lbfFascile needle hub: | Pass |
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| Tensile strength for 20Ga $\geq$ 12.14 lbf.Tensile strength for 18GA $\geq$ 2.25 lbfFascile Bond strength:$\geq$ 2.25 lbf | ||||
|---|---|---|---|---|
| Test Document # | Title | Bench Test Description | Acceptance criteria | Result |
| TM-0008 | Catheter and Extension Set Flow Test Method | Measure fluid flow rate through the extension set and catheter | Flow through predefined holes of a Fascile catheter is visible.Flow through Fascile catheter and extension set attached to a flow control tubing (test) does not drop below 20% compared to the flow of a flow control tubing alone (control). | Pass |
| TM-SR008A | Catheter Depth Mark Inspection | Visual and dimensional inspection for catheter depth marks | Depth marks exist and marking gaps meet drawing. | Pass |
| TM-SR009A | Catheter Curvature Inspection | Visual and dimensional inspection of catheter curvature | Correctness of curve orientation respect to arrow on hub. | Pass |
| TM-SR044A | Straightener Tube Test | Check for straightener tube functionality | Needle easily moves through the catheter without damage. | Pass |
| ISO 594-1:1986 | Conical Fittings with a 6% (Luer) Taper for Syringes, needles and Certain other Medical Equipment - Part 1 | ISO standard test methods for ensuring leak free fluid connectors | Complies with the ISO standard | Pass |
| ISO 594-2:1998 | Conical Fittings with a 6% (Luer) Taper for Syringes, needles and Certain other Medical Equipment - Part 2 | ISO standard test methods for ensuring leak free fluid connectors | Complies with the ISO standard | Pass |
IX. SUMMARY OF ANIMAL AND CLINICAL STUDIES RESULTS:
Animal Study:
The Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit does not require animal performance testing. There are no animal testing requirements for this Class II product.
Clinical Study:
The Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit does not require a clinical study. There are no clinical study requirements for this Class II product.
CONCLUSION:
Based on the results of biocompatibility and performance testing, the proposed Solo-Dex Fascile® Continuous Peripheral Nerve Block Catheter and Needle Kit is considered substantially equivalent to the predicate device and as safe, as effective, and performs as well as the legally marketed (predicate) device.
§ 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).