Cleveland Multiport Ventricular Catheter Set

K161731 · Parker Hannifin Corp. · HCA · Mar 27, 2017 · Neurology

Device Facts

• Record ID: K161731
• Device Name: Cleveland Multiport Ventricular Catheter Set
• Applicant: Parker Hannifin Corp.
• Product Code: HCA · Neurology
• Decision Date: Mar 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.

Device Story

The Cleveland Multiport Ventricular Catheter Set is a sterile, single-use device used in surgical rooms or MRI suites by clinicians to access brain ventricles. It consists of a main catheter with a central lumen for an insertion stylet and four peripheral micro-catheters. During insertion, the stylet is locked, stretching the catheter to reduce its outer diameter for atraumatic entry. Once placed, the stylet is removed, allowing the tip to relax and the micro-catheters to deploy. The proximal ends feature Luer fittings for connection to standard syringes or infusion pumps. The device facilitates CSF aspiration and fluid infusion. It provides temporary access; it is not intended for long-term implantation. The device is MRI-safe. By enabling controlled fluid delivery or removal, it assists in managing intracranial conditions requiring localized drug administration or pressure relief.

Clinical Evidence

Bench testing only. Studies included joint/bond strength, viscosity, pressure/flow, reflux, deployment/retraction, tissue insertion (bovine), bend radius, dimensional verification, particulate testing, and cadaver assessment (CT visualization). Biocompatibility testing per ISO 10993 (cytotoxicity, systemic toxicity, sensitization, hemocompatibility, pyrogenicity) and drug compatibility with Cytarabine were performed. Sterilization validated to 10^-6 SAL via ethylene oxide.

Technological Characteristics

Main catheter body: silicone elastomer; Tip: silicone; Insertion stylet: PTFE-coated nickel alloy; Micro-catheters: PTFE; Lumen extension: silicone. Dimensions: 2.5mm OD x 14.0 cm length. Connectivity: standard Luer fittings. Sterilization: Ethylene Oxide (ISO 11135-1). MRI safe (1.5T and 3.0T). No software, power sources, or radiation-emitting components.

Indications for Use

Indicated for patients requiring access to brain ventricles for cerebrospinal fluid (CSF) removal or Cytarabine injection.

Regulatory Classification

Identification

A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.

Predicate Devices

• MRI SmartFlow Flex Ventricular Catheter (K123605)

Reference Devices

• Alcyone MEMS Cannula System (K150660)
• SurgiVision Ventricular Cannula (K102101)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 27, 2017

Parker Hannifin Corporation % Lisa L. Michels, J.D. Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158

Re: K161731

Trade/Device Name: Cleveland Multiport Ventricular Catheter Set Regulation Number: 21 CFR 882.4100 Regulation Name: Ventricular Catheter Regulatory Class: Class II Product Code: HCA Dated: February 13, 2017 Received: February 21, 2017

Dear Dr. Lisa Michels:

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 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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K161731

Device Name

Cleveland Multiport Ventricular Catheter Set

Indications for Use (Describe)

The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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#### Parker Hannifin Corporation. Medical Systems Division

3007 Bunsen Avenue. Unit K Ventura CA 93003 Telephone, 805-658-2984 Facsimile: 805-658-6720

| Contact Person: | Lisa L. Michels, J.D., M.S.O.L.Q. |
|----------------------------------------------------------|-----------------------------------|
| Official Correspondent for Parker Hannifin | |
| Regulatory Compliance Associates® Inc. | |
| 10411 Corporate Drive, Suite 102 | |
| Pleasant Prairie, Wisconsin 53158 | |
| Phone: [phone] (office) / (520)-704-2700 (mobile) | |
| Email: [e-mail] | |

Date Prepared: 13-February-2017

| Trade Name: | Cleveland Multiport Ventricular Catheter Set (CMC) |
|------------------------|----------------------------------------------------|
| Common Name: | Ventricular Catheter |
| Product Code: | HCA |
| Device Classification: | 21 CFR 882.4100 |
| Regulatory Class: | Class II |

Predicate Device: MRI SmartFlow Flex Ventricular Catheter #K123605.

#### Intended Use / Indications for Use

The Cleveland Multiport Ventricular Catheter Set is indicated for gaining access to the ventricles of the brain for the removal of cerebrospinal fluid (CSF) or for injecting Cytarabine.

#### Rx or OTC Device

The Cleveland Multiport Ventricular Catheter Set is an Rx prescription device per 21 CFR Part 801, Subpart D.

#### Description of Device

The Cleveland Multiport Ventricular Catheter contains a main or central lumen for the insertion stylet which is surrounded by four minor lumens (equally spaced) that contain the microcatheters. The catheter includes a ribbed distal tip, a housing for locking the insertion stylet, and proximal male Luer fittings at the end of each micro-catheter. The ribbed distal tip of the main catheter allows the micro-catheters to retract into the main catheter, by stretching the catheter when the insertion stylet is fully inserted and locked. This stretched state allows the catheter tip outside diameter to reduce slightly for atraumatic insertion into the ventricles of the brain. Once the insertion stylet is removed the catheter tip returns to its relaxed state (larger outside diameter) and the micro-catheters deploy. The enlarged tip aids in backflow prevention during injection of fluids. The distal Luer fittings allow for connectivity to a standard syringe or infusion pumps for removal of CSF and/or infusion. The biocompatible metal insertion stylet provides temporary rigidity to the distal portion of the device during catheter insertion and is removed after placement. The Cleveland Multiport Ventricular Catheter has no software, power sources, or radiation emitting components.

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#### 510(k) Traditional Summary

Parker Hannifin Corporation Cleveland Multiport Ventricular Catheter Set (CMC)

The catheter is available in one size; Ø2.5mm OD x 14.0 cm long, with four micro catheters that deploy at the distal tip.

The Cleveland Multiport Ventricular Catheter Set is supplied sterile. The set includes the insertion stylet which facilitates placement of the catheter into the ventricles of the brain, a suture tab for anchoring the catheter and preventing movement during aspiration of fluids and four female-to-female Luer adapters for connecting each proximal end micro-catheter.

The Cleveland Multiport Ventricular Cather verification activities are included in this 510(k) submission.

#### Technological Characteristics

The Cleveland Multiport Ventricular Catheter has the same intended use/indications for use along with similar technological characteristics to predicate devices on the market with the same intended use. The following tables show the similarities and differences between the Cleveland Multiport Ventricular Catheter and the predicate devices.

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| Topic | Subject Device<br>Parker Cleveland<br>Multiport Ventricular<br>Catheter Set | Predicate Device<br>MRII SmartFlow Flex<br>Ventricular Catheter,<br>K123605 | Reference Device<br>Alcyone MEMS<br>Cannula System,<br>K150660 | Reference Device<br>SurgiVision<br>Ventricular Cannula,<br>K102101 | Discussion |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR 882.4100 | 21 CFR 882.4100 | 21 CFR 882.4060 | 21 CFR 882.4060 | Equivalent to Predicate. |
| Product Code | HCA, Class II | HCA, Class II | HCD, Class I | HCD, Class I | Equivalent to Predicate. |
| Intended Use/<br>Indications for Use | The Cleveland Multiport<br>Ventricular Catheter<br>Set is indicated for<br>gaining access to the<br>ventricles of the brain<br>for the removal of<br>cerebrospinal fluid<br>(CSF) or for injecting<br>Cytarabine. | The SmartFlow™ Flex<br>Ventricular Catheter is<br>intended for injection of<br>Cytarabine or removal<br>of CSF from the<br>ventricles during<br>intracranial procedures.<br>The device is not<br>intended for implant.<br>This device is intended<br>for "single patient use<br>only." | The Alcyone MEMS<br>Cannula (AMC) System<br>consisting of the AMC<br>and the AMC Extension<br>Line Set, is intended for<br>injection of Cytarabine<br>(cytosine arabinoside)<br>or removal of<br>cerebrospinal fluid<br>(CSF) from the<br>ventricles of the brain<br>during intracranial<br>procedures. The AMC<br>System is not intended<br>for implant. The device<br>is intended for "single<br>patient use only." | The MR Compatible<br>Ventricular Cannula is<br>intended for injection of<br>Cytarabine or removal<br>of CSF from the<br>ventricles during<br>intracranial procedures.<br>The device is not<br>intended for implant.<br>The device is intended<br>for "single patient use<br>only." | Equivalent to Predicate. |
| Single Patient Use<br>Only | Yes | Yes | Yes | Yes | Equivalent to Predicate. |
| Target Patient<br>Population | Patients needing<br>injection of Cytarabine<br>into the brain ventricles | Any Pt's needing<br>aspiration of CSF and<br>other fluids of similar<br>physical characteristics | Pt.s needing injection of<br>Cytarabine into the<br>brain ventricles or | Pt.s needing injection of<br>Cytarabine to the brain<br>ventricles or aspiration | Equivalent to Predicate. |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| | Parker Cleveland<br>Multiport Ventricular<br>Catheter Set | MRII SmartFlow Flex<br>Ventricular Catheter,<br>K123605 | Alcyone MEMS<br>Cannula System,<br>K150660 | SurgiVision<br>Ventricular Cannula,<br>K102101 | |
| | or removal of CSF from<br>the brain ventricles | from the brain<br>ventricles | aspiration of CSF from<br>the brain ventricles | of CSF from the brain<br>ventricles | |
| Anatomical Sites | Brain ventricle | Brain ventricle | Brain ventricle | Brain ventricle | Equivalent to Predicate. |
| Where used | MRI Suite / Surgical<br>Room (OR) | MRI Suite / Surgical<br>Room (OR) | MRI Diagnostic/<br>Surgical Room (OR) | MRI Diagnostic/<br>Surgical Room (OR) | Equivalent to Predicate. |
| Human Factors | a) Labeling includes<br>size and length | a) Labeling includes<br>size and length | a) Labeling includes<br>size and length | a) Labeling includes<br>size and length | Equivalent to Predicate. |
| | b) Labeling shows flow<br>vs. pressure tables | b) Labeling shows flow<br>vs. pressure tables | b) Labeling shows flow<br>vs. pressure tables | b) Labeling shows flow<br>vs. pressure tables | Equivalent to Predicate. |
| | c) Can be manipulated<br>with gloved hand | c) Can be manipulated<br>with gloved hand | c) Can be manipulated<br>with gloved hand | c) Can be manipulated<br>with gloved hand | Equivalent to Predicate. |
| Design | a) Designed to be<br>placed through a<br>prepared opening<br>through the skull and<br>dura into the brain<br>ventricle | a) Designed to be<br>placed through a<br>prepared opening<br>through the skull and<br>dura into the brain<br>ventricle | a) Designed to be<br>placed through a<br>prepared opening<br>through the skull and<br>dura into the brain<br>ventricle | a) Designed to be<br>placed through a<br>prepared opening<br>through the skull and<br>dura into the brain<br>ventricle | Equivalent to Predicate. |
| | b) Main catheter<br>section to enter the<br>brain. | b) Rigid and straight<br>section to enter the<br>brain. | b) Rigid and straight<br>section to enter the<br>brain. | b) Rigid and straight<br>section to enter the<br>brain. | Equivalent to Predicate. |
| | c) Opening at distal end<br>of micro-catheters for<br>fluid movement | c) Opening at distal end<br>for fluid movement | c) Opening at distal end<br>for fluid movement | c) Opening at distal end<br>for fluid movement | Equivalent to Predicate.<br>One hole per fluid channel. |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| | Parker Cleveland<br>Multiport Ventricular<br>Catheter Set | MRII SmartFlow Flex<br>Ventricular Catheter,<br>K123605 | Alcyone MEMS<br>Cannula System,<br>K150660 | SurgiVision<br>Ventricular Cannula,<br>K102101 | |
| | d) Four openings, no<br>side holes, at distal end<br>for fluid movement | d) Central hole, no side<br>holes, at distal end for<br>fluid movement | d) Two holes, no side<br>holes, at distal end for<br>fluid movement | d) Central hole, no side<br>holes, at distal end for<br>fluid movement | Equivalent to Predicate.<br>Both devices are moving<br>fluids and their different<br>inside/outside diameters<br>result in different flow<br>rates. This is within the<br>range of cleared<br>ventricular cannulas and<br>catheters. |
| | e) Reference side<br>markings on body of<br>device for depth<br>indication | e) No markings of<br>device body | e) Body markings<br>designed to facilitate<br>determination of the<br>insertion depth | e) No markings of<br>device body | Equivalent to Predicate.<br>Length marking on body to<br>help user determine depth<br>of insertion. Length<br>markings are common in<br>these devices to aid the<br>user in positioning. |
| Design | f) Total Length of<br>Catheter; 5.5" (14.0 cm)<br>long | f) Total length of rigid<br>section; 10.5" (30 cm)<br>long | f) Total Length of<br>Catheter; 9" (22.9 cm)<br>long | f) Length of rigid<br>section; 10.5" (30 cm)<br>long | Equivalent to Predicate.<br>Total length of catheter<br>does not impact the<br>intended usage of the<br>device. |
| | g) Main catheter Inside<br>Diameter: Ø.030"<br>(Ø0.76 mm) ID and<br>micro-catheters at tip<br>Ø.007" (Ø0.177 mm) ID | g) Inside diameter:<br>Ø.008" to .021" (Ø 0.2<br>mm to 0.53 mm) | g) Main catheter Inside<br>Diameter: Ø.010"<br>(Ø0.25 mm) with inside<br>cross-section at tip:<br>.002" x .001" (0.052 x<br>0.03mm) | g) Inside diameter:<br>Ø.008" to .021" (Ø 0.2<br>mm to 0.53 mm) | Equivalent to Predicate.<br>All devices are moving<br>fluids and their different<br>inside/outside diameters<br>result in different flow<br>rates. This is within the<br>range of cleared<br>ventricular cannulas and<br>catheters. |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| | Parker Cleveland<br>Multiport Ventricular<br>Catheter Set | MRII SmartFlow Flex<br>Ventricular Catheter,<br>K123605 | Alcyone MEMS<br>Cannula System,<br>K150660 | SurgiVision<br>Ventricular Cannula,<br>K102101 | ventricular cannulas and<br>catheters. |
| | h) Outside Diameter<br>Ø2.5mm | h) Outside Diameter: Ø<br>0.65" (1.6 mm) and<br>Ø0.080" (2.0 mm) | h) Outside Diameter: Ø<br>0.65" (1.6 mm) | h) Outside Diameter: Ø<br>0.65" (1.6 mm) and<br>Ø0.080" (2.0 mm) | Equivalent to Predicate. |
| | j) Insertion Stylet -<br>Stylet can be removed<br>after insertion | j) Insertion Stylet | j) No Stylet -<br>Sufficiently rigid to pass<br>through brain tissue<br>without additional<br>support. Rigid section<br>can be removed after<br>insertion | j) No Stylet -<br>sufficiently rigid for<br>insertion | Equivalent to Predicate.<br>Insertion Stylet and rigid<br>sections are removed after<br>insertion. |
| | k) Standard Luer | k) Standard Luer | k) Standard Luer | k) Standard Luer | Equivalent to Predicate. |
| Performance | Flow Rate: 4.93 mL/hr.<br>(1.97 mL/hr. per<br>channel) at <25 psi<br>internal pressure per<br>channel | Flow Rate: 4.0 mL/hr.<br>(0.008"ID) to 56 mL/hr.<br>(0.021"ID) at 0.7 psi | Flow Rate: 3.0 mL/hr.<br>(1.5mL/hr. per channel)<br>to 25mL/hr. at <25 psi<br>internal pressure per<br>channel | Flow Rate: 0.6 mL/hr.<br>(0.008"ID) to 34 mL/hr.<br>(0.021"ID) at 0.7 psi | Equivalent to Predicate.<br>All devices are moving<br>fluids, and the different<br>flow rates results from<br>their different diameters.<br>Pressures listed are<br>internal to the system. |
| | CSF Removal Rate:<br>1.70 mL/hr. (0.47 m/hr.<br>per channel) | Aspiration Rate:<br>Unknown | Aspiration Rate: 2.4<br>mL/hr. (1.2mL/hr. per<br>channel) using an air<br>vacuum of 10mL from a<br>syringe | Aspiration Rate: 0.1<br>mL/hr. (0.008"ID) to<br>8.7mL/hr. (0.021" ID) | Equivalent to Predicate.<br>All devices are moving<br>fluids, and the different<br>flow rates results from<br>their different diameters. |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| | Parker Cleveland<br>Multiport Ventricular<br>Catheter Set | MRII SmartFlow Flex<br>Ventricular Catheter,<br>K123605 | Alcyone MEMS<br>Cannula System,<br>K150660 | SurgiVision<br>Ventricular Cannula,<br>K102101 | |
| Energy Used | N/A | N/A | N/A | N/A | Equivalent to Predicate. |
| Electrical Safety | N/A | N/A | N/A | N/A | Equivalent to Predicate. |
| Mechanical Safety | N/A | N/A | N/A | N/A | Equivalent to Predicate. |
| Chemical safety | Micro-catheter fluid<br>pathway non-reactive<br>for Cytarabine, Saline<br>and CSF | Lumen materials non-<br>reactive to Cytarabine,<br>Saline, CSF | Lumen materials non-<br>reactive to Cytarabine,<br>Saline, CSF | Silica lumen non-<br>reactive to Cytarabine,<br>Saline, CSF | Equivalent to Predicate.<br>Materials of all devices are<br>using historically stable<br>and biologically acceptable<br>materials for ventricular<br>access devices. |
| Thermal Safety | MRI Safe. All brain<br>contacting components<br>tested safe in 1.5T and<br>3.0T environment | MRI Safe. All brain<br>contacting components<br>tested safe in a 1.5T<br>environment | MRI Safe. All brain<br>contacting components<br>tested safe in 1.5T and<br>3.0T MRI environment | MRI safe. All brain<br>contacting components<br>tested safe in a 1.5T<br>environment | Equivalent to Predicate. |
| Materials | a) Main Catheter Body:<br>silicone elastomer; Tip:<br>Silicone<br><br>b) Insertion Stylet:<br>PTFE-coated nickel<br>alloy (No fluid/patient<br>contact) | a) Rigid body: Ceramic;<br>Tip: Polymer<br><br>b) Stylet: Stainless<br>Steel | a) Rigid body: Ceramic;<br>Tip: Silicon<br><br>b) Stylet: N/A | a) Rigid body: Ceramic;<br>Tip: Polymer covered<br>silica<br><br>b) Stylet: N/A | Equivalent to Predicate.<br>Materials of all devices are<br>using historically stable<br>and biologically acceptable |
| Topic | Subject Device | Predicate Device | Reference Device | Reference Device | Discussion |
| | Parker Cleveland<br>Multiport Ventricular<br>Catheter Set | MRII SmartFlow Flex<br>Ventricular Catheter,<br>K123605 | Alcyone MEMS<br>Cannula System,<br>K150660 | SurgiVision<br>Ventricular Cannula,<br>K102101 | |
| | | | | | materials for ventricular<br>access devices. |
| | c) Deploying Micro-<br>Catheters: PTFE | c) Through lumen:<br>PEEK | c) Through lumen:<br>Polymer covered silica<br>silicon | c) Through lumen:<br>Polymer covered silica | Equivalent to Predicate.<br>Materials of all devices are<br>using historically stable<br>and biologically acceptable<br>materials for ventricular<br>access devices. |
| | d) Non-detachable<br>Lumen extension:<br>(outer supporting<br>tubing): Silicone | d) Lumen extension<br>(outer support tubing):<br>PVC extrusion | d) Detachable Lumen<br>extension (outer<br>support tubing):<br>Polymer | d) Non-detachable<br>Lumen extension (outer<br>support tubing):<br>Polymer coated silica | Equivalent to Predicate.<br>Materials of all devices are<br>using historically stable<br>and biologically acceptable<br>materials for ventricular<br>access devices. |
| | e) Proximal Connector:<br>Female Luer connector:<br>Translucent | e) Proximal Connector:<br>Female Luer connector:<br>Translucent | e) Proximal Connector:<br>Female Luer connector,<br>Translucent | e) Proximal Connector:<br>Female Luer connector,<br>Translucent | Equivalent to Predicate. |
| Compatibility with<br>environment and<br>other devices | Compatible with<br>standard syringe<br>pumps for infusion. | Compatible with…