OSPREY PERIPHERAL IV Catheter System

K223018 · Skydance Vascular, Inc. · FOZ · Apr 14, 2023 · General Hospital

Device Facts

• Record ID: K223018
• Device Name: OSPREY PERIPHERAL IV Catheter System
• Applicant: Skydance Vascular, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: Apr 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OSPREY PERIPHERAL IV catheter is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.

Device Story

Single-use, sterile, 20-gauge peripheral IV catheter; 1.67-inch length. Device consists of catheter, integrated access needle, and housing with flash window. Operation: clinician inserts needle into vein; observes blood flashback; advances catheter through needle via female luer hub; full engagement triggers passive spring-loaded needle retraction into housing. Output: venous access for fluid delivery or monitoring. Benefits: passive needle retraction reduces needlestick injury risk; rounded tip design facilitates off-axis infusate delivery. Used in clinical settings by healthcare providers.

Clinical Evidence

Bench testing only. No clinical data. Performance verified against ISO 10555-1, ISO 10555-5, ISO 80369-7/20, ISO 7864, ISO 9626, ISO 8536-4, USP <788>, and ISO 23908. Biocompatibility testing performed per ISO 10993-1, including genotoxicity, cytotoxicity, sensitization, irritation, systemic toxicity, and hemolysis (ASTM F756-17). Sterilization and packaging validated per ISO 14937, ISO 10993-7, and various ASTM standards.

Technological Characteristics

Materials: Polycarbonate (barrel, grip, needle hub, catheter hub), Stainless Steel (needle, spring), Polyurethane with barium sulfate (tubing). Sensing/Actuation: Passive spring-loaded needle retraction. Dimensions: 20 Gauge, 1.67-inch length. Connectivity: None. Sterilization: Ethylene Oxide (EtO). Standards: ISO 10555-1/5, ISO 80369-7/20, ISO 23908.

Indications for Use

Indicated for patients requiring short-term (<30 days) vascular access for blood sampling, blood pressure monitoring, or intravenous fluid administration.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• BD Angiocath & Insyte Autoguard Catheters (K952861)

Submission Summary (Full Text)

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April 14, 2023

SkyDance Vascular, Inc. Scott Pease Sr. VP. Regulatory Affairs and Quality Assurance 3058 Millcreek Road Pleasant Grove, Utah 84062

Re: K223018

Trade/Device Name: OSPREY PERIPHERAL IV Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: March 10, 2023 Received: March 14, 2023

Dear Scott Pease:

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/cdrh/cfdocs/cfpmn/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.

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

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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 (OS) 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,

David Walloschek

David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

510(k) Number (if known)

K223018

Device Name

OSPREY PERIPHERAL IV Catheter System

Indications for Use (Describe)

OSPREY PERIPHERAL IV catheter is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### K223018 510(k) SUMMARY

SkyDance Vascular, Inc. - OSPREY PERIPHERAL IV Catheter System

## Submitter:

| SkyDance Vascular, Inc.<br>3058 Millcreek Road<br>Pleasant Grove, UT 84062 | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Contact Phone: | (m) 678-689-8010 |
| Contact Person: | Scott Pease, Sr. VP, Regulatory Affairs & Quality Assurance<br>([e-mail]) |
| Date Prepared: | April 14, 2023 |
| Name of Device: | OSPREY PERIPHERAL IV Catheter System |
| Common or Usual Name: | Short-Term Less Than 30 Days Therapeutic, Intravascular Catheter |
| Classification Name: | Intravascular Catheter |
| Regulatory Class: | Class II |
| Product Code / Regulation: | FOZ / 21 CFR § 880.5200 |
| Predicate Device(s): | K952861 Angiocath & Insyte Autoguard Catheters - Becton Dickinson<br>Vascular Access inc |

### Indications for Use:

OSPREY PERIPHERAL IV catheter is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.

### Device Description:

The OPREY IV Catheter System is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood pressure, or administer fluids intravenously. The device has a usable length catheter of 1.67 inches in a 20 Gauge size for short-term (<30 days) use.

### Technological Characteristics:

The OSPREY PERIPHERAL IV Catheter's design deploys the catheter by passing it through its integrated access needle. Once the access needle achieves the desired venipuncture the user can quickly visualize blood through the housing's integrated flash window and immediately begin advancing the catheter through the access needle via its female tapered luer hub until it is fully enqaged. The female tapered luer hub and proximal end of the device housing becomes an integrated locking female luer interface that then simultaneously activates the passive needle retraction of the access needle within the device housing. Since the catheter is deployed through the access needle, the OSPREY PERIPHERAL IV catheter tip design is optimized to facilitate offaxis delivery of infusate.

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# Comparison to Predicate:

The OSPREY PERIPHERAL IV Catheter is similar to the predicate device, BD Angiocath & Insyte™ Autoguard™ Catheters, with the minor differences: 1) material of construction, 2) catheter location/lip geometry, 3) needle retraction deployment, 4) flow rate, are detailed within the Notes following the Substantial Equivalence Table. Both devices have the following characteristics in common: 1) both are short term catheters, 2) both are radiopaque catheters, 3) both are disposable, single use catheters, 5) both provide a shielding mechanism for the used needle.

#### Table VII - I: Subject / Predicate Device Comparison of Intended Use, Materials and Technological Characteristics

| Attribute | Subject - OSPREY PERIPHERAL IV<br>Catheter System | Predicate - BD Angiocath & Insyte™<br>Autoguard™ Catheters (K952861) | Substantial Equivalence |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR §880.5200<br>Class II<br>FOZ - Intravascular Catheter | 21 CFR §880.5200<br>Class II<br>FOZ - Intravascular Catheter | Identical |
| Indications for Use | OSPREY PERIPHERAL IV catheter is<br>an intravascular catheter intended to be<br>inserted into the patient's vascular<br>system for short-term use to sample<br>blood, monitor blood pressure, or<br>administer fluids intravenously. | An intravascular catheter is intended to<br>be inserted into the patient's vascular<br>system for short term use to sample<br>blood, monitor blood pressure, or<br>administer fluids intravenously. | Identical |
| Critical Procedural<br>Steps | Remove the device from the packaging<br>and inspect before use.<br>Insert needle into the target vein and<br>observe blood flashback response.<br>Advance catheter into the vein while<br>maintaining needle position.<br>Activate the spring-loaded needle<br>retraction feature.<br>Stabilize the catheter, apply the dressing<br>and connect the IV set using the luer<br>adapter. | Remove the device from the packaging<br>and inspect before use.<br>Insert needle into the target vein and<br>observe blood flashback response.<br>Advance catheter into the vein while<br>maintaining needle position.<br>Activate the spring-loaded needle<br>retraction feature.<br>Stabilize the catheter, apply the dressing<br>and connect the IV set using the luer<br>adapter. | Identical |
| Materials of<br>Construction | Barrel (Housing): Polycarbonate | Barrel: Polycarbonate | |
| Attribute | Subject - OSPREY PERIPHERAL IV<br>Catheter System | Predicate - BD Angiocath & Insyte™<br>Autoguard™ Catheters (K952861) | Substantial Equivalence |
| | Grip: Polycarbonate | Grip: Polycarbonate | Different |
| | Needle Hub: Polycarbonate | Needle Hub: Polycarbonate | Materials are well known; bench and<br>biocompatibility testing demonstrate no<br>different questions of safety or effectiveness<br>were raised. |
| | Needle: Stainless Steel | Needle: Stainless Steel | |
| | Spring: Stainless Steel | Spring: Stainless Steel | |
| | Catheter Tubing: Polyurethane w/<br>radiopaque barium sulfate | Catheter Tubing: Polyurethane w/<br>radiopaque barium sulfate | Differences are discussed in Note 1 |
| | Adhesive: Loctite | Adhesive: Unknown | |
| | Catheter Hub: Polycarbonate | Catheter Adapter: Polypropylene | |
| | | Lubricants: Silicone | |
| | | Safety Activation Button:<br>Polycarbonate | |
| | | Porous Flow Plug: Porous Polyethylene<br>w/ Carboxymethyl Cellulose (CMC) | |
| | | Catheter Wedge: Stainless Steel | |
| Design<br>Characteristics | Catheter-Needle Interface: Catheter<br>through the needle<br>Needle Tip: Beveled<br>Catheter Tip: Rounded Tip | Catheter-Needle Interface:<br>Catheter over the needle<br>Needle Tip: Beveled<br>Catheter Tip: Tapered Tip | Different<br>Both the subject device and the predicate<br>device utilize a needle and catheter tube to<br>deliver fluids directly into the vessel. The<br>differences in the tip shape and interface do<br>not alter or raise different questions of safety<br>and effectiveness. |
| | | | Differences are discussed in Note 2 |
| Attribute | Subject - OSPREY PERIPHERAL IV<br>Catheter System | Predicate - BD Angiocath & Insyte™<br>Autoguard™ Catheters (K952861) | Substantial Equivalence |
| | Needle Retraction:<br>Spring loaded retraction | Needle Retraction:<br>Spring loaded retraction | Different<br>Both the subject device and the predicate<br>device utilize a spring-loaded needle<br>retraction mechanism to permanently retract<br>the needle into the catheter housing. The<br>differences in activation method do not alter<br>raise different questions of safety and<br>effectiveness. |
| | | | Differences are discussed in Note 3 |
| | IV Set Connection:<br>Female Locking Luer Hub | IV Set Connection:<br>Female Locking Luer Hub | Identical |
| | Visualization: Flashback | Visualization: Flashback | Identical |
| | | | Different |
| | Catheter OD: 0.041 - 0.043 in.<br>Catheter ID: 0.025 - 0.031 in.<br>Catheter Length: 1.67 in. | Catheter OD: 0.041 - 0.044 in.<br>Catheter ID: 0.030 - 0.033 in.<br>Catheter Length: 1.88 in. | The differences in dimensions do not alter or<br>raise different questions of safety and<br>effectiveness, as the associated OD is<br>appropriate for a 20GA catheter per ISO<br>10555-5. |
| | Flashback Chamber / Technology:<br>Yes | Flashback Chamber / Technology:<br>Yes | |
| Performance | Sharps Prevention Feature:<br>Yes | Sharps Prevention Feature:<br>Yes | Identical |
| | Radiopaque:<br>Yes | Radiopaque:<br>Yes | |
| Attribute | Subject - OSPREY PERIPHERAL IV<br>Catheter System | Predicate - BD Angiocath & Insyte™<br>Autoguard™ Catheters (K952861) | Substantial Equivalence |
| | Flow Rate: 30 mL/min | Flow Rate: 54 mL/min | Different<br>Both the subject device and the predicate<br>device provide clinically acceptable flow rates<br>to deliver fluids to the vessel. The different<br>flow rates do not alter or raise different<br>questions of safety and effectiveness.<br>Differences are discussed in Note 4 |
| Biocompatibility | Tested per ISO 10993-1: PASS | Tested per ISO 10993-1: PASS | Identical |
| Sterilization | EtO Sterilized | EtO Sterilized | Identical |
| Packaging | Sterile Barrier: Individual Tyvek and<br>PET Pouches | Sterile Barrier: Individual Tyvek and PET<br>Pouches | Identical |

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Note 1 - The additional materials of construction for the referenced Predicate (BD Angiocath & Insyte™ Autoguard™ Catheters - K952861) are not required to ensure the safety and efficacy of the Subject (OSPREY PERIPHERAL IV Catheter System), specifically the Predicate devices Needle Stick Safety Feature is an activation button, while the Subject devices Needle Stick Safety Feature is passive and therefore doesn't require the additional component. These new or different questions of safety or effectiveness.

Note 2 – While the Predicate device incorporates the traditional over-the-needle PV design that must enter the the of the needle, but also requires further advancement to allow for the catheter (mounted over-the-needle) to enter the Subject device, the insertion process requires the clinical to only enter the vessel with the tip of the cather, as it resides within the needle and therefore will already reside within the Subject devices catheter is deployed through the access needle it allows for the rounded tip to be designed with a directional flow feature with annot be achieved with the Predicate devices over-theneedle tapered catheter, as is needs to pass through the skin and vessel wall. These different questions of safety or effectiveness.

Note 3 – The Subject device has been designed with passive nechnology activated upon fully advancing the catheter, while the Predicate device design is active, requiring an additional step by the activation button. These differences do not raise new or different questions of safety or effectiveness, as both the Subject and Predicate devices are designed inside

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their respective barrel (housing) when the safety function is activated to prevent accidental needlesting per ISO 23908:2011 demonstrated that the safety mechanism feature performs as intended.

Note 4 – Though the stated flow rate of the Subject device is less than that of the Predicate, it is adequate to support its referenced Indications for Use, as the flow rate is significantly greating parameters of clinically prescribed flow rates for both gravity infusion and legally marketed volumetric pumps. The Subject device flow rate of 30 mL/m which is substantially greater than the maximum programable flow rate for legally marketed voluments pumps (999 ml./hr). Therefore, these new or different questions of safety or effectiveness.

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# Summary of Performance Data:

Bench tests were conducted to verify that the proposed device met all design specifications and to support substantial equivalence to the predicate device. Bench testing was performed on the subject device (OSPREY PERIPHERAL IV Catheter System) in accordance with the standards below.

## Performance

- ISO 10555-1: 2013 + A1:2017 Sterile, single-use intravascular catheters Part 1: . General requirements
- ISO 10555-5 :2013 Intravascular catheters – Sterile and single-use catheters Part 5: Over-needle Peripheral catheters
- ISO 80369-7:2021; Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications.
- . ISO 80369-20:2015; Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
- ISO 7864:2016; Sterile hypodermic needles for single use - Requirements and test methods.
- ISO 9626:2016; Stainless steel needle tubing for the manufacture of medical devices.
- . ISO 8536-4:2019; Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed.
- . USP <788>; Particulate Matter for Injections (Method 1 Light Obscuration Particle Count Test).
- . ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.

## Biocompatibility

Subject device classified as: Externally communicating, Circulation blood path, Prolonged contact (> 24 hours to 30 days)

A biocompatibility evaluation, in accordance with 1) ISO 10993-1:2018, Biological Evaluationof Medical Devices Part 1: Evaluation and Testing and 2) FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued Sept. 4, 2020), was conducted. The following testing was undertaken to support the biocompatibility of the subject devices:

- . ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- . ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- . ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- . ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cvtotoxicitv
- . ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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- . ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- . USP-NF <151> Pyrogen Test

## Sterilization and Packaging validation

- ISO 14937:2009 Sterilization of health care products-General requirements for . characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical device
- . AAMI TIR56:2013 Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
- . ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM D4332-14: Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM D4169-16: Standard Practice for Performance Testing of Shipping Containers and Systems
- . ASTM F1886-16: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- . ASTM F2096-11 (2019): Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- . ASTM F1929-15: Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ASTM F88-15: Standard Test Method for Seal Strength of Flexible Barrier Materials

## Conclusion:

The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The OSPREY PERIPHERAL IV Catheter System is substantially equivalent to the BD Anqiocath & Insyte Autoquard Catheters with respect to indications for use and technological characteristics.