(144 days)
The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.
The CIMPAX® C-CAT catheter kit is a sterile, single use, closed tip, multi-perforated catheter with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. The kit is intended for adult patients requiring the delivery of contiguous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management or as perineural delivery. Routes of administration may be intraoperative or percutaneous. The device is intended to be used in healthcare /hospital facilities.
The CIMPAX® C-CAT catheter is a multi-perforated catheter supplied in a kit which contains components for catheter placement. The drug infusion segment is placed between the blue tip of the catheter and the first blue marking after the tip. The catheter is designed with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. Attached to the catheter is a standard female luer lock that is compatible with and can be used with infusion pumps as well as with syringes for bolus injections with standard make luer connections.
The catheter is placed usually through an incision or wound in order to provide continuous or intermittent administration of local anesthetic to the area affected. This allows only the local nerve endings (pain receptors) to be anesthetized as opposed to giving a systemic pain relief medication to the patient.
The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the CIMPAX C-CAT Anaesthesia Catheter kit. This document is a regulatory submission for medical devices, demonstrating substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria for an AI/ML product.
Therefore, the document does not contain any information related to:
- Acceptance criteria for an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, AUC).
- A study proving an AI/ML device meets acceptance criteria.
- Sample sizes for test sets or data provenance for AI/ML model evaluation.
- Number of experts, qualifications of experts, or adjudication methods for establishing ground truth in the context of AI/ML.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone AI algorithm performance.
- Type of ground truth used for AI/ML model evaluation (e.g., pathology, outcomes data).
- Sample size for training sets or how ground truth was established for training sets in an AI/ML context.
The document discusses acceptance criteria and studies, but these relate to the physical and biological safety and performance of a medical catheter, not an AI/ML device. For example, it mentions:
- Non-Clinical Testing: Bench testing including mechanical and performance testing (e.g., peak tensile force, burst pressure, kink testing, liquid leakage under pressure, radiopacity, flow testing), biocompatibility, sterilization, packaging, and shelf-life testing.
- Biocompatibility Testing: According to ISO 10993-1 series, covering cytotoxicity, sensitization, irritation, systemic toxicity, Ames Test, in vitro mammalian chromosome aberration, hemolytic properties, and material mediated rabbit pyrogen.
- Flow Test: Performed according to DS/EN 1618, measuring water flow through the catheter.
- Tensile strength: Tested in accordance with ISO 10555-1.
- Packaging: Complies with ISO 11607-1:2014 and EN 865-5:2009.
- Stability: Tested according to ASTM F 1980 Accelerated Aging and ISO 11607-1:2009.
- Sterilization: Method is Ethylene Oxide (EO), complying with EN ISO 11135-1.
In summary, the provided text describes the regulatory process for a physical medical device (an anesthesia catheter) and outlines its non-clinical performance and safety testing to demonstrate substantial equivalence, not information relevant to the performance and acceptance of an AI/ML device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cimpax ApS % Kathleen Johnson President Medical Device Approvals, Inc. 104 Harrison Ave. Fairfield, Iowa 52556
Re: K191470
Trade/Device Name: C-CAT Anaesthesia Catheter kit Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: August 26, 2019 Received: August 27, 2019
Dear Kathleen Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmr/pmn.cfm_identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name CIMPAX C-CAT Anaesthesia Catheter
Indications for Use (Describe)
The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthes) to or around surgical wound sites for preoperative, perioperative and postoperative pain management . Routes of administration may be intraoperative or percutaneous.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over The Counter Use (21 C.ER 801 Submart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Section 5. 510(k) Summary K191470
SUBMITTER:
OFFICIAL CORRESPONDENT:
DEVICE NAME:
CIMPAX ApS Lille Pilevang 4 3550 Slangerup Denmark
Kathleen Johnson Medical Device Approvals, Inc 104 E. Harrison Ave. Fairfield, IA 52556 610-527-0585 kathleen@mdapprovals.com
CIMPAX C-CAT Anesthesia Catheter Kit including models: C44-21-005
C44-21-010 C44-21-015 C44-21-018 C44-21-020
Anesthesia catheter
868.5120 Class II
COMMON OR USUAL NAME:
DEVICE CLASSIFICATION:
iFlow Soaker Catheter K043456
BSO
PREDICATE DEVICE:
{4}------------------------------------------------
INTENDED USE:
The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.
DEVICE DESCRIPTION:
The CIMPAX® C-CAT catheter kit is a sterile, single use, closed tip, multi-perforated catheter with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. The kit is intended for adult patients requiring the delivery of contiguous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management or as perineural delivery. Routes of administration may be intraoperative or percutaneous. The device is intended to be used in healthcare /hospital facilities.
The CIMPAX® C-CAT catheter is a multi-perforated catheter supplied in a kit which contains components for catheter placement. The drug infusion segment is placed between the blue tip of the catheter and the first blue marking after the tip. The catheter is designed with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. Attached to the catheter is a standard female luer lock that is compatible with and can be used with infusion pumps as well as with syringes for bolus injections with standard make luer connections.
The catheter is placed usually through an incision or wound in order to provide continuous or intermittent administration of local anesthetic to the area affected. This allows only the local nerve endings (pain receptors) to be anesthetized as opposed to giving a systemic pain relief medication to the patient.
{5}------------------------------------------------
| C-CATCatheter KitComponent | Description | Classification | ProductCode | Manufacturer | Predicate Device or510(k) # |
|---|---|---|---|---|---|
| CIMPAX® C-CAT catheter(one of thefollowing) | C-Cat:Ref #C44-21-005C44-21-010C44-21-015C44-21-018C44-21-020 | 868.5120 ClassII | BSO | CIMPAX | Subject device |
| Number of microholes and fenestratedlength6 holes covering 2.5cm12 holes covering 6.5cm30 holes covering 15cm42 holes covering 21cm60 holes covering 30cm | |||||
| Totalcatheterlength70 cm70 cm70 cm70 cm85 cm | |||||
| Antibacterialfilter with cap#R-0051 | 0.2µm PES membrane | 868.5130 ClassII | BSN | GBUK Group | K170900 |
| Piston Syringe | Syringe | 880.5860 ClassII | FMF | Hindustan | K945225 |
| OTNIntroducerneedle withsheath | Peelable introducer needle | 870.1340 ClassII | DYB | Summit MedicalProducts | K102460 |
| Needle | 18Ga x 90 mm | 880.5510 ClassII | FMI | Hindustan | K945225 |
| Closure Strips | Tape or bandage | 880.5240 | KGXClass I510(k)exempt | Pharmaplast | FDA registeredcompany, productlisted |
| PU Dressing | hydrophilic dressings | 878.4018 | NAC | Pharmaplast | FDA registeredcompany, productlisted |
The CIMPAX® C-CAT catheter kit consists of the following components:
{6}------------------------------------------------
SUBSTANTIAL EQUIVALENCE:
The CIMPAX C-Cat Anesthesia Catheter is substantialy equivalent to the iFlow Soaker Catheter K994374, in intended use, classification and design. Both devices are available in 5 fenestrated lengths, both are implantable for up to 5 days, both are supplied and packaged as a kit with a peel away introducer needle, occlusive wound dressing and catheter securing adhesive.
The subject device has undergone the following nor tensile strength, burst pressure, kink testing, liquid leakage under pressure, radiopacity, flow testing, particulate matter in including testing, biocompatibility testing according to ISO 10993-1 requirements as well as additional FDA required testing.
| Comparison feature | CIMPAX® C-CAT | Predicate Device: Soaker/Silver Soaker CatheterK043456 |
|---|---|---|
| Indications for Use | The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices,is intended for the delivery of contiguous or intermittent delivery of medication(such as local anesthetics or narcotics) to or around surgical wound sites forpreoperative, perioperative and postoperative pain management or as perineuraldelivery. Routes of administration may be intraoperative or percutaneous. | The Soaker/Silver Soaker Catheter is a single patient use only, andintended for use to provide continuous or intermittent delivery of localanesthetics or narcotics to surgical wound sites and/or close proximity tonerves outside of the epidural space. Routes of administration may beintraoperative or percutaneous.The Soaker/Silver Soaker Catheter is intended to be used I-FlowCorporation's ON-Q, PainBuster and Nerve Block pain managementkits. |
{7}------------------------------------------------
| Product description: | The CIMPAX® C-CAT catheter is a multi-perforated catheter with a specifiedfenestrated length that incorporates micro-holes placed in a spiral pattern toprovide 360° drug distribution. The catheter is radiopaque and has fourgraduated distance markings along its length for positional reference.The drug infusion segment is placed between the blue tip of the catheter andthe first blue marking after the tip.Attached on the catheter is a standard female luer lock that is compatible andcan be used with infusion pumps as well as with syringes for bolus injections withstandard male luer connections. The catheter can be used with specified pumpflow rates of up to 250ml/hour. The C-CAT catheter is available in 5 differentvariants, covering the number of holes, fenestrated length (2,5-30 cm) and totallength of the catheter.The CIMPAX® C-CAT catheter is supplied in a kit which includes standardmaterial/components for applying the catheter to the surgical site. The kit isavailable in two configurations. Kit configuration one includes the CIMPAX® C-CAT catheter with a cap, an Antibacterial filter with cap, a syringe, a needle, anintroducer needle with a sheath, strips and PU wound dressing.Enclosed in the second kit configuration also named C- CAT light; is theCIMPAX® C-CAT catheter, an Antibacterial filter with cap, and a syringe.All standard components included in the kit are finished components andare accessories to the CIMPAX® C-CAT catheter. | The Soaker/Silver Soaker Catheter is a closed tip multi-holed catheter witha fenestrated length that incorporates holes in a helical pattern that allowfor homogenous flow of analgesia into a surgical wound. The Soaker/SilverSoaker Catheter is radiopaque and has graduated markings along thelength of the catheter for positional reference.It is supplied and packaged as a kit with a peel-away introducer needle,occlusive wound dressing and catheter securement adhesive. |
|---|---|---|
| ---------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
{8}------------------------------------------------
| Accessories to Catheter foundin kit | Kit configuration 1:• OTN Introducer needle with sheath• Infiltration needle (for optional use)• Antibacterial filter• Dressing• 2ml Priming syringe• StripsKit configuration 2:• Antibacterial filter• 2 ml Priming syringeIn comparison to predicate device, CIMPAX C-CAT manufactureradditionally supplies the following components in both kit configurationsfor convenience:• 2ml syringe for priming of catheter• Antibacterial filter for filtration of anesthetics and analgesics.• Included in kit to support use with bolus injections with standardmale luer connections.In configuration 1 an infiltration needle is provided for optional use.Use of accessories in applying and using the catheter is substantiallyequivalent to predicate device. | • peel-away introducer needle,• occlusive wound dressing• catheter securement adhesive.According to Instructions for Use for Soaker/Silver Soaker Catheter, primingof catheter with a 5ml syringe. |
|---|---|---|
| ----------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
{9}------------------------------------------------
| Page | 7 | of | 11 | |
|---|---|---|---|---|
| Technical characteristics | ||
|---|---|---|
| Design | The CIMPAX® C-CAT an aesthesia catheter is multi- perforated and theholes of the catheter are placed in a spiral pattern to provide 360° drugdistribution.The drug infusion segment is placed between the blue tip of the catheter andthe first blue marking after the tip. | The Soaker/Silver Soaker Catheter delivers local anesthetics or narcoticsthrough a fenestrated section at the distal end of a closed catheter. |
| Dimensions | Cather size: 17GCatheter perforated lengths:2.5 cm, 6.5 cm, 15 cm, 21 cm, 30 cm | Cather size: 19GCatheter perforated lengths: 2.5 cm, 6.5cm, 12.5 cm, 19 cm, 25 cm |
| Operating principles | C-CAT Catheter is inserted to or around surgical wound site using accessorycomponents.The catheter is connected to infusion pumps and/or bolus injection syringesand continuously delivers local anesthetics to site. | The Soaker/Silver Soaker Catheter is inserted to or around surgical woundsite using accessory components.The catheter is connected to infusion pumps and continuouslydelivers local anesthetics to site. |
| Contraindications | The CIMPAX® C-CAT catheter cannot be used for intravenous orepidural delivery. | The Soaker/Silver Soaker Catheter is not intended for vascular or epiduraldrug administration. |
| Material | Polyamide Pebax® | Polyamide |
| Safety and Performance testing (Bench testing) | ||
| Biocompatibility | Biocompatibility safety assessment of the C-CAT catheter was validated bytesting according to the ISO 10993 "Biological Evaluation of Medical Devices"series.None of the tested material showed signs of toxic reactions, in theperformed tests. | Biological testing is in conformance with ISO 10993 Part 1 for fluid pathcomponents |
| Flow test | Flow rate of 0.5-10ml/hr. when regulated with the infusion pump and up to 250ml/per hour as a bolus when needed | Flow rate of 1 - 14 ml/per hour depending on type of I-Flow ON-Q infiltrationpumps. |
{10}------------------------------------------------
| Flow rate testing for the CIMPAX® C-CAT catheter was performed inaccordance to DS/EN 1618 "Catheters other than intravascular catheters - Testmethods for common properties".Flow rate test principle is the measurement of water flow through the cathetermeasured volumetrically.Flow rate test method is equivalent to test method utilized for predicate devicein ISO 10555-1.The Flow rate test results confirm that the CIMPAX®C-CAT catheter offers minimal flow resistance and does not restrict or reduceflow when used with specified pump flow rates up to 250 ml per hour. | ||
|---|---|---|
| Tensile strength | Tensile properties for the C-CAT catheter are tested in accordance with ISO10555-1 "Sterile, Single Use Intravascular Catheters- Part 1: GeneralRequirements" Test method to determine the tensile force that will breakcatheter test material.The test confirmed that tensile strength of the C-CAT catheter fulfilleddesign requirement. | Tensile Strength meet or exceed current design and comply with ISO 10555-1 "Sterile, Single Use Intravascular Catheters- Part 1 |
| Packaging | CIMPAX® C-CAT Anaesthesia Catheter packaging complies to ISO 11607-1:2014 "Packaging for terminally sterilized medical devices -- Part 1:Requirements for materials, sterile barrier systems and packaging systems" andtested in accordance to EN 865-5:2009 "Packaging for terminally sterilizedmedical devices -- Part 5: Sealable pouches and reels of porous materials andplastic film | Packaging is in conformance with theStandard EN 868-1 (Packaging Materials and Systems for Medical Devices whichare to be Sterilized). |
| construction. Requirements and Test Methods". The packaging seal strength ismeasured before and after sterilization. The seal strength before and aftersterilization is within the specified minimum value.The C-CAT Catheter kit sterile barrier is for the blister/Tyvekpouch.The packaging process for the C-CAT catheter is validated according to ISO11607-2:2014: "Packaging for terminally sterilized medical devices - Part 2:Validation requirements for the process of forming, sealing and assemblyprocess" | ||
| Stability | The established shelf life is tested according to ASTM F 1980 Accelerated Agingof Sterile Medical Device Packages and in accordance to ISO 11607-1:2009"Packaging for terminally sterilized medical devices-Part 1: Requirements formaterials, sterile barrier systems and packaging systems".Stability is verified by conducting a sterility and mechanical test ateach defined aging time interval. | |
| Sterilization | Sterilization method: Ethylene Oxide (EO)Sterilization process complies to EN ISO 11135 - 1: "Sterilization ofhealth care products-Ethylene oxide- Part1: Requirements fordevelopment, validation and routine control of a sterilization process formedical devices" | Sterilization method: Ethylene Oxide (EO) |
{11}------------------------------------------------
{12}------------------------------------------------
NON-CLINICAL TESTING:
The CIMPAX C-CAT Catheter has been validated by bench testing including mechanical and performance testing with direct comparison to the predicate, biocompatibility, sterilization, packaging and shelf-life testing.
Testing to validate the performance of the C-Cat Catheter throughout its expected life cycle has been performed. Mechanical testing including Peak tensile force, Burst pressure, Kink Testing, Liquid Leakage under pressure and radiopacity have been performed on sterilized, real time aged product.
Biocompatibility testing was conducted on all patient contacting materials and includes the following products:
Device Name: CIMPAX® C-CAT Anaesthesia Catheter kit
Category: External communication device, tissue/bone contact for prolonged duration (ISO 10993-1:2009 Annex A)
Product variants covered by the mentioned biocompatibility tests:
| C-CAT; Ref. | Description |
|---|---|
| C44-21-005 | with 6 holes covering 2.5 cm |
| C44-21-010 | with 12 holes covering 6.5 cm |
| C44-21-015 | with 30 holes covering 15 cm |
| C44-21-018 | with 42 holes covering 21 cm |
| C44-21-020 * | with 60 holes covering 30 cm |
| C-CAT light; Ref. | Description |
| C44-21-105 | with 6 holes covering 2.5 cm |
| C44-21-110 | with 12 holes covering 6.5 cm |
| C44-21-115 | with 30 holes covering 15 cm |
| C44-21-118 | with 42 holes covering 21 cm |
| C44-21-120 | with 60 holes covering 30 cm |
| C-CAT NRFit; Ref. | Description |
| C44-22-005 | with 6 holes covering 2.5 cm |
| C44-22-010 | with 12 holes covering 6.5 cm |
| C44-22-015 | with 30 holes covering 15 cm |
| C44-22-018 | with 42 holes covering 21 cm |
| C44-22-020 | with 60 holes covering 30 cm |
Test sample condition: Extraction for the bio tests performed of finished product (sterilized and packed according to validated processes).
The following tests were performed to demonstrate biocompatibility of the subject device: Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Systemic Toxicity Acute Systemic Toxicity
{13}------------------------------------------------
Subacute Systemic Toxicity Ames Test Invitro Mammalian Chromosome Aberration Hemolytic Properties of Materials Material Mediated Rabbit Pyrogen
CONCLUSION:
The CIMPAX C-CAT Anesthesia catheter and the predicate device has the same intended use of continuous and intermittent delivery of pain medication to or around a surgical wound for pain management. The principle of operation and technological characteristics of the subject device and the predicate device are similar, and the differences do not raise different questions of safety and effectiveness. The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).