C-CAT Anaesthesia Catheter kit

K191470 · Cimpax Aps · BSO · Oct 25, 2019 · Anesthesiology

Device Facts

• Record ID: K191470
• Device Name: C-CAT Anaesthesia Catheter kit
• Applicant: Cimpax Aps
• Product Code: BSO · Anesthesiology
• Decision Date: Oct 25, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

CIMPAX C-CAT is a sterile, single-use, multi-perforated catheter kit for local anesthetic delivery. Catheter features spiral-patterned micro-holes for 360° drug distribution, radiopaque material, and graduated markings for positioning. Used in hospital/healthcare facilities by clinicians. Input: medication (local anesthetics/narcotics) via infusion pump or syringe bolus. Output: localized drug infusion at surgical wound sites. Benefits: targeted pain relief at nerve endings, reducing need for systemic analgesics. Kit includes introducer needle, antibacterial filter, syringe, and dressing. Catheter connects via standard female luer lock.

Clinical Evidence

Bench testing only. No clinical data. Performance validated via mechanical testing (tensile force, burst pressure, kink, leakage, radiopacity), flow rate testing (up to 250 ml/hr), and biocompatibility (ISO 10993-1).

Technological Characteristics

Material: Polyamide Pebax. Design: Multi-perforated, closed-tip catheter with spiral micro-holes. Dimensions: 17G, lengths 2.5-30 cm. Connectivity: Standard female luer lock for infusion pumps/syringes. Sterilization: Ethylene Oxide (EO) per EN ISO 11135-1. Packaging: ISO 11607-1/2 compliant.

Indications for Use

Indicated for adult patients requiring continuous or intermittent delivery of local anesthetics or narcotics to or around surgical wound sites for preoperative, perioperative, and postoperative pain management or perineural delivery. Contraindicated for intravenous or epidural delivery.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• iFlow Soaker Catheter (K043456)

Reference Devices

• Antibacterial filter (K170900)
• Piston Syringe (K945225)
• OTN Introducer needle (K102460)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K191470

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) |

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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 [e-mail]

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:

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## 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.

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| C-CAT<br>Catheter Kit<br>Component | Description | Classification | Product<br>Code | Manufacturer | Predicate Device or<br>510(k) # |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------------|----------------------------|----------------------------------------------|
| CIMPAX® C-<br>CAT catheter<br>(one of the<br>following) | C-Cat:<br>Ref #<br>C44-21-<br>005<br>C44-21-<br>010<br>C44-21-<br>015<br>C44-21-<br>018<br>C44-21-<br>020<br> | 868.5120 Class<br>II | BSO | CIMPAX | Subject device |
| | Number of micro<br>holes and fenestrated<br>length<br>6 holes covering 2.5<br>cm<br>12 holes covering 6.5<br>cm<br>30 holes covering 15<br>cm<br>42 holes covering 21<br>cm<br>60 holes covering 30<br>cm | | | | |
| | Total<br>catheter<br>length<br>70 cm<br>70 cm<br>70 cm<br>70 cm<br>85 cm | | | | |
| Antibacterial<br>filter with cap<br>#R-0051 | 0.2µm PES membrane | 868.5130 Class<br>II | BSN | GBUK Group | K170900 |
| Piston Syringe | Syringe | 880.5860 Class<br>II | FMF | Hindustan | K945225 |
| OTN<br>Introducer<br>needle with<br>sheath | Peelable introducer needle | 870.1340 Class<br>II | DYB | Summit Medical<br>Products | K102460 |
| Needle | 18Ga x 90 mm | 880.5510 Class<br>II | FMI | Hindustan | K945225 |
| Closure Strips | Tape or bandage | 880.5240 | KGX<br>Class I<br>510(k)<br>exempt | Pharmaplast | FDA registered<br>company, product<br>listed |
| PU Dressing | hydrophilic dressings | 878.4018 | NAC | Pharmaplast | FDA registered<br>company, product<br>listed |

# The CIMPAX® C-CAT catheter kit consists of the following components:

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# 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 Catheter<br>K043456 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices,<br>is intended for the delivery of contiguous or intermittent delivery of medication<br>(such as local anesthetics or narcotics) to or around surgical wound sites for<br>preoperative, perioperative and postoperative pain management or as perineural<br>delivery. Routes of administration may be intraoperative or percutaneous. | The Soaker/Silver Soaker Catheter is a single patient use only, and<br>intended for use to provide continuous or intermittent delivery of local<br>anesthetics or narcotics to surgical wound sites and/or close proximity to<br>nerves outside of the epidural space. Routes of administration may be<br>intraoperative or percutaneous.<br>The Soaker/Silver Soaker Catheter is intended to be used I-Flow<br>Corporation's ON-Q, PainBuster and Nerve Block pain management<br>kits. |

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| Product description: | The CIMPAX® C-CAT catheter is a multi-perforated catheter with a specified<br>fenestrated length that incorporates micro-holes placed in a spiral pattern to<br>provide 360° drug distribution. The catheter is radiopaque and has four<br>graduated distance markings along its length for positional reference.<br>The drug infusion segment is placed between the blue tip of the catheter and<br>the first blue marking after the tip.<br>Attached on the catheter is a standard female luer lock that is compatible and<br>can be used with infusion pumps as well as with syringes for bolus injections with<br>standard male luer connections. The catheter can be used with specified pump<br>flow rates of up to 250ml/hour. The C-CAT catheter is available in 5 different<br>variants, covering the number of holes, fenestrated length (2,5-30 cm) and total<br>length of the catheter.<br>The CIMPAX® C-CAT catheter is supplied in a kit which includes standard<br>material/components for applying the catheter to the surgical site. The kit is<br>available in two configurations. Kit configuration one includes the CIMPAX® C-<br>CAT catheter with a cap, an Antibacterial filter with cap, a syringe, a needle, an<br>introducer needle with a sheath, strips and PU wound dressing.<br>Enclosed in the second kit configuration also named C- CAT light; is the<br>CIMPAX® C-CAT catheter, an Antibacterial filter with cap, and a syringe.<br>All standard components included in the kit are finished components and<br>are accessories to the CIMPAX® C-CAT catheter. | The Soaker/Silver Soaker Catheter is a closed tip multi-holed catheter with<br>a fenestrated length that incorporates holes in a helical pattern that allow<br>for homogenous flow of analgesia into a surgical wound. The Soaker/Silver<br>Soaker Catheter is radiopaque and has graduated markings along the<br>length of the catheter for positional reference.<br>It is supplied and packaged as a kit with a peel-away introducer needle,<br>occlusive wound dressing and catheter securement adhesive. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Accessories to Catheter found<br>in kit | Kit configuration 1:<br>• OTN Introducer needle with sheath<br>• Infiltration needle (for optional use)<br>• Antibacterial filter<br>• Dressing<br>• 2ml Priming syringe<br>• Strips<br><br>Kit configuration 2:<br>• Antibacterial filter<br>• 2 ml Priming syringe<br><br>In comparison to predicate device, CIMPAX C-CAT manufacturer<br>additionally supplies the following components in both kit configurations<br>for convenience:<br>• 2ml syringe for priming of catheter<br>• Antibacterial filter for filtration of anesthetics and analgesics.<br>• Included in kit to support use with bolus injections with standard<br>male luer connections.<br>In configuration 1 an infiltration needle is provided for optional use.<br>Use of accessories in applying and using the catheter is substantially<br>equivalent to predicate device. | • peel-away introducer needle,<br>• occlusive wound dressing<br>• catheter securement adhesive.<br><br>According to Instructions for Use for Soaker/Silver Soaker Catheter, priming<br>of catheter with a 5ml syringe. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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| Technical characteristics | | |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | The CIMPAX® C-CAT an aesthesia catheter is multi- perforated and the<br>holes of the catheter are placed in a spiral pattern to provide 360° drug<br>distribution.<br>The drug infusion segment is placed between the blue tip of the catheter and<br>the first blue marking after the tip. | The Soaker/Silver Soaker Catheter delivers local anesthetics or narcotics<br>through a fenestrated section at the distal end of a closed catheter. |
| Dimensions | Cather size: 17G<br>Catheter perforated lengths:<br>2.5 cm, 6.5 cm, 15 cm, 21 cm, 30 cm | Cather size: 19G<br>Catheter perforated lengths: 2.5 cm, 6.5<br>cm, 12.5 cm, 19 cm, 25 cm |
| Operating principles | C-CAT Catheter is inserted to or around surgical wound site using accessory<br>components.<br>The catheter is connected to infusion pumps and/or bolus injection syringes<br>and continuously delivers local anesthetics to site. | The Soaker/Silver Soaker Catheter is inserted to or around surgical wound<br>site using accessory components.<br>The catheter is connected to infusion pumps and continuously<br>delivers local anesthetics to site. |
| Contraindications | The CIMPAX® C-CAT catheter cannot be used for intravenous or<br>epidural delivery. | The Soaker/Silver Soaker Catheter is not intended for vascular or epidural<br>drug administration. |
| Material | Polyamide Pebax® | Polyamide |
| Safety and Performance testing (Bench testing) | | |
| Biocompatibility | Biocompatibility safety assessment of the C-CAT catheter was validated by<br>testing according to the ISO 10993 "Biological Evaluation of Medical Devices"<br>series.<br>None of the tested material showed signs of toxic reactions, in the<br>performed tests. | Biological testing is in conformance with ISO 10993 Part 1 for fluid path<br>components |
| Flow test | Flow rate of 0.5-10ml/hr. when regulated with the infusion pump and up to 250<br>ml/per hour as a bolus when needed | Flow rate of 1 - 14 ml/per hour depending on type of I-Flow ON-Q infiltration<br>pumps. |

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| | Flow rate testing for the CIMPAX® C-CAT catheter was performed in<br>accordance to DS/EN 1618 "Catheters other than intravascular catheters - Test<br>methods for common properties".<br>Flow rate test principle is the measurement of water flow through the catheter<br>measured volumetrically.<br>Flow rate test method is equivalent to test method utilized for predicate device<br>in ISO 10555-1.<br>The Flow rate test results confirm that the CIMPAX®<br>C-CAT catheter offers minimal flow resistance and does not restrict or reduce<br>flow 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 ISO<br>10555-1 "Sterile, Single Use Intravascular Catheters- Part 1: General<br>Requirements" Test method to determine the tensile force that will break<br>catheter test material.<br>The test confirmed that tensile strength of the C-CAT catheter fulfilled<br>design requirement. | Tensile Strength meet or exceed current design and comply with ISO 10555-<br>1 "Sterile, Single Use Intravascular Catheters- Part 1 |
| Packaging | CIMPAX® C-CAT Anaesthesia Catheter packaging complies to ISO 11607-<br>1:2014 "Packaging for terminally sterilized medical devices -- Part 1:<br>Requirements for materials, sterile barrier systems and packaging systems" and<br>tested in accordance to EN 865-5:2009 "Packaging for terminally sterilized<br>medical devices -- Part 5: Sealable pouches and reels of porous materials and<br>plastic film | Packaging is in conformance with the<br>Standard EN 868-1 (Packaging Materials and Systems for Medical Devices which<br>are to be Sterilized). |
| | | |
| | construction. Requirements and Test Methods". The packaging seal strength is<br>measured before and after sterilization. The seal strength before and after<br>sterilization is within the specified minimum value.<br>The C-CAT Catheter kit sterile barrier is for the blister/Tyvek<br>pouch.<br>The packaging process for the C-CAT catheter is validated according to ISO<br>11607-2:2014: "Packaging for terminally sterilized medical devices - Part 2:<br>Validation requirements for the process of forming, sealing and assembly<br>process" | |
| Stability | The established shelf life is tested according to ASTM F 1980 Accelerated Aging<br>of Sterile Medical Device Packages and in accordance to ISO 11607-1:2009<br>"Packaging for terminally sterilized medical devices-Part 1: Requirements for<br>materials, sterile barrier systems and packaging systems".<br>Stability is verified by conducting a sterility and mechanical test at<br>each defined aging time interval. | |
| Sterilization | Sterilization method: Ethylene Oxide (EO)<br>Sterilization process complies to EN ISO 11135 - 1: "Sterilization of<br>health care products-Ethylene oxide- Part1: Requirements for<br>development, validation and routine control of a sterilization process for<br>medical devices" | Sterilization method: Ethylene Oxide (EO) |

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## 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

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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.