Who is the manufacturer of OSPREY Closed IV Catheter System (OspreyV2)?

Skydance Vascular, Inc. filed the 510(k) submission for OSPREY Closed IV Catheter System (OspreyV2) (K231626).

What is the FDA product code for OSPREY Closed IV Catheter System (OspreyV2)?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for OSPREY Closed IV Catheter System (OspreyV2)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for OSPREY Closed IV Catheter System (OspreyV2)?

OSPREY PERIPHERAL IV Catheter System (K223018); Nexiva Closed IV Catheter System (K102520).

Who can help prepare an FDA 510(k) submission like OSPREY Closed IV Catheter System (OspreyV2)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

OSPREY Closed IV Catheter System (OspreyV2)

K231626 · Skydance Vascular, Inc. · FOZ · Aug 31, 2023 · General Hospital

Device Facts

Record ID	K231626
Device Name	OSPREY Closed IV Catheter System (OspreyV2)
Applicant	Skydance Vascular, Inc.
Product Code	FOZ · General Hospital
Decision Date	Aug 31, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5200
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

OSPREY Closed IV Catheter System (OspreyV2) is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The OSPREY Closed IV Catheter System (OspreyV2) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock.

Device Story

Single-use, sterile, peripheral intravascular catheter; designed for short-term vascular access. Device features clear housing with integrated wings/ribs; beveled access needle; integrated extension tube with pinch clamp; female luer with porous vent plug. Operation: user inserts needle into vein; visualizes blood flashback in housing; advances catheter through needle; full advancement of catheter hub triggers passive, spring-loaded retraction of needle into housing. Used in clinical settings by healthcare providers. Output: venous access for fluid delivery, blood sampling, or pressure monitoring. Benefits: integrated needle-shielding reduces needle-stick risk; closed system design prevents blood exposure during insertion; power injector compatibility (up to 325 psi) supports clinical utility.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and biocompatibility evaluation.

Technological Characteristics

Materials: Polycarbonate (housing, grip, hub, luer adapter), stainless steel (needle, spring), polyurethane (tubing), polypropylene (pinch clamp), porous polyethylene/CMC (vent plug). Principle: Passive spring-loaded needle retraction. Connectivity: Luer lock. Sterilization: Ethylene Oxide (EtO). Standards: ISO 10555-1/5, ISO 80369-7/20, ISO 8536-4/8, ISO 7864, ISO 9626, ISO 23908.

Indications for Use

Indicated for short-term (<30 days) intravascular access for blood sampling, blood pressure monitoring, or intravenous fluid administration in any patient population, contingent on vascular anatomy and procedure appropriateness. Suitable for power injection up to 325 psi.

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

OSPREY PERIPHERAL IV Catheter System (K223018)
Nexiva Closed IV Catheter System (K102520)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 31, 2023 SkyDance Vascular, Inc. Scott Pease Sr. VP, Regulatory Affairs and Quality Assurance 3058 Millcreek Road Pleasant Grove, Utah 84062 ## Re: K231626 Trade/Device Name: OSPREY Closed IV Catheter System (OspreyV2) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: May 31, 2023 Received: June 2, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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, Porsche Bennett Porsche Bennett For David Wolloscheck, Ph.D. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231626 Device Name OSPREY Closed IV Catheter System (OspreyV2) Indications for Use (Describe) OSPREY Closed IV Catheter System (Osprey V2) is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood pressure, or administer fluids intravenously. Blood is contained within the device during the catheter insertion of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The OSPREY Closed IV Catheter System (OspreyV2) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock. Type of Use (Select one or both, as applicable): | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| |----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| #### 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}------------------------------------------------ ### K231626 - 510(k) SUMMARY #### Submitter | SkyDance Vascular, Inc. 3058 Millcreek Road Pleasant Grove, UT 84062 | |----------------------------------------------------------------------------| |----------------------------------------------------------------------------| | Contact Phone: | (m) 678-689-8010 | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Scott Pease, Sr. VP, Regulatory Affairs & Quality Assurance (scott.pease@skydancevascular.com) | | Date Prepared: | August 31, 2023 | | Name of Device: | OSPREY Closed IV Catheter System (OspreyV2) | | Common or Usual Name: | Intravascular Catheter | | Classification Name: | Intravascular Catheter | | Regulatory Class: | Class II | | Product Code / Regulation: | FOZ / 21 CFR § 880.5200 | | Predicate Device(s): | Primary Predicate (A) - K223018 (OSPREY PERIPHERAL IV Catheter System) – SkyDance Vascular, Inc. Class II, Intravascular Catheter, FOZ / 21 CFR § 880.5200 Secondary Predicate (B) – K102520 (Nexiva Closed IV Catheter System) - Becton Dickinson Vascular Access Inc. Class II, Intravascular Catheter, FOZ / 21 CFR § 880.5200 | #### Indications for Use OSPREY Closed IV Catheter System (OspreyV2) 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. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The OSPREY Closed IV Catheter System (OspreyV2) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock. {4}------------------------------------------------ #### Device Description The OPREY Closed IV Catheter System (OspreyV2) is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously for short-term (<30 days) use. The device is constructed with a clear housing having integrated wings and ribs to assist with its handling, a beveled needle that allows the catheter to be deployed through it and the needle fully and permanently passively retracts into the housing when the catheter hub with its integrated extension tube, including an incorporated pinch clamp, female luer with porous (vent) plug is fully advanced. The device is placed in a thermal formed tray that goes into a Tyvek pouch providing the sterile barrier. #### Principles of Operation The OSPREY Closed IV Catheter System (OspreyV2) 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 the pink catheter hub having an integrated extension tube, including an incorporated pinch clamp, female luer with porous (vent) plug. Upon fully advancing the catheter hub within the proximal end of the device housing it simultaneously activates the passive needle retraction of the access needle within the device housing. Since the catheter is deployed through the access needle, the OspreyV2 catheter tip design is optimized to facilitate offaxis delivery of infusate. Additionally, the OspreyV2 is suitable for use with power injectors when connected to male luer lock. #### Technological Characteristic Comparison to Predicate The OSPREY Closed IV Catheter System (OpsreyV2) is similar to the predicate devices, OSPREY PERIPHERAL IV Catheter System and Nexiva Closed IV Catheter System. Each of the devices have the following characteristics in common: 1) they are short term catheters, 2) they are radiopaque catheters, 3) they are peripheral catheters, 4) they are disposable, single use catheters, 5) they provide a shielding mechanism for the used needle. Additionally, the OSPREY Closed IV Catheter System (OpsreyV2) incorporates an integrated extension tube, including a pinch clamp, and female luer with porous (vent) plug, as well as the ability to use with a power injector, consistent with the Nexiva Closed IV Catheter System. {5}------------------------------------------------ | Attribute | Subject - OSPREY Closed IV Catheter System (OspreyV2) | Primary Predicate (A) – OSPREY PERIPHERAL IV Catheter System (K223018) | Secondary Predicate (B) – BD Nexiva Closed IV Catheter System (K102520) | Substantial Equivalence | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | 21 CFR §880.5200 Class II FOZ - Intravascular Catheter | 21 CFR §880.5200 Class II FOZ - Intravascular Catheter | 21 CFR §880.5200 Class II FOZ - Intravascular Catheter | Identical | | Indications for Use | OSPREY Closed IV Catheter System (OspreyV2) 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. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The OSPREY Closed IV Catheter System (OspreyV2) is suitable for use with power injectors rated for a maximum of 325 psi when connected to male luer lock. | An intravascular catheter is intended to be inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids intravenously. | The Nexiva™ intravascular catheter is inserted into a patient's vascular system for a short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port, aid in the prevention of needle-stick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The 18-22 gauge Nexiva™ catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made. | Similar Primary Predicate: Subject device IFU is expanded to include its suitability for use with power injectors and any patient population based on vascular anatomy and appropriateness of procedure. Secondary Predicate: Subject device IFU is consistent with its suitability for use with power injectors and any patient population based on vascular anatomy and appropriateness of procedure. Comment #1 | | Critical Procedural Steps | Remove the device from the packaging and inspect before use. | Remove the device from the packaging and inspect before use. | Remove the device from the packaging and inspect before use. | Identical | | Attribute | Subject – OSPREY Closed IV Catheter System (OspreyV2) | Primary Predicate (A) – OSPREY PERIPHERAL IV Catheter System (K223018) | Secondary Predicate (B) – BD Nexiva Closed IV Catheter System (K102520) | Substantial Equivalence | | | Insert needle into the target vein and observe blood flashback response. | Insert needle into the target vein and observe blood flashback response. | Insert needle into the target vein and observe blood flashback response. | | | | Advance catheter into the vein while maintaining needle position. | Advance catheter into the vein while maintaining needle position. | Advance catheter into the vein while maintaining needle position. | | | | Activate the spring-loaded needle retraction feature. | Activate the spring-loaded needle retraction feature. | Withdrawal of needle activates needle tip safety feature. | | | | Stabilize the catheter, apply the dressing, remove the porous flow plug and connect the IV set using the luer adapter. | Stabilize the catheter, apply the dressing and connect the IV set using the luer adapter. | Stabilize the catheter, apply the dressing, remove the porous flow plug and connect the IV set using the luer adapter. | | | Materials of Construction | Barrel (Housing): Polycarbonate | Barrel (Housing): Polycarbonate | Barrel (Housing): N/A | Similar | | | Grip: Polycarbonate | Grip: Polycarbonate | Grip: Polycarbonate | Primary Predicate: Excluding | | | Needle Hub: Polycarbonate | Needle Hub: Polycarbonate | Needle Hub: Polycarbonate | componentry associated with | | | Needle: Stainless Steel | Needle: Stainless Steel | Needle: Stainless Steel | integrated extension tubing, the materials | | | Needle Tip Shield: N/A | Needle Tip Shield: N/A | Needle Tip Shield: Polycarbonate | of construction of the Subject device are the same. The | | | Spring: Stainless Steel | Spring: Stainless Steel | Spring: N/A | additional components of the | | | Catheter Tubing: Polyurethane w/ radiopaque barium sulfate | Catheter Tubing: Polyurethane w/ radiopaque barium sulfate | Catheter Tubing: Polyurethane w/ radiopaque barium sulfate | subject device were tested for biocompatibility in | | | Adhesive: Loctite | Adhesive: Loctite | Adhesive: Unknown | accordance with ISO10993-1. | | | Catheter Hub: Polycarbonate | Catheter Hub: Polycarbonate | Catheter Adapter: Copolyester | Therefore, the addition of the componentry | | Attribute | Subject – OSPREY Closed IV Catheter System (OspreyV2) | Primary Predicate (A) – OSPREY PERIPHERAL IV Catheter System (K223018) | Secondary Predicate (B) – BD Nexiva Closed IV Catheter System (K102520) | Substantial Equivalence | | | Catheter Wing Adapter: N/A | Catheter Wing Adapter: N/A | Catheter Wing Adapter: TPE (Thermoplastic Elastomer) | associated with the integrated extension tubing does not raise new or different questions of safety and effectiveness. | | | Pinch Clamp: Polypropylene | Pinch Clamp: N/A | Pinch Clamp: Acetal | | | | Extension Tubing: Tygon® | Extension Tubing: N/A | Extension Tubing: Polyurethane | | | | Luer Adapter: Polycarbonate | Luer Adapter: Polycarbonate | Luer Adapter: Copolyester | | | | Porous Flow Plug: Porous Polyethylene w/ Carboxymethyl Cellulose (CMC) | Porous Flow Plug: N/A | Porous Flow Plug: Porous Polyethylene w/ Carboxymethyl Cellulose (CMC) | | | | Lubricants: N/A | Lubricants: N/A | Lubricants: Unknown | | | | Safety Activation Button: N/A | Safety Activation Button: N/A | Safety Activation Button: N/A | | | | Catheter-Needle Interface: Catheter through the needle | Catheter-Needle Interface: Catheter through the needle | Catheter-Needle Interface: Catheter over the needle | Similar Comment #2 | | | Needle Tip: Beveled | Needle Tip: Beveled | Needle Tip: Beveled | | | | Catheter Tip: Rounded Tip…

OSPREY Closed IV Catheter System (OspreyV2)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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OSPREY Closed IV Catheter System (OspreyV2)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Product Code Matches

Special Control Matches

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