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.

AI/ML Overview

The provided text describes the OSPREY PERIPHERAL IV Catheter System, its intended use, technological characteristics, and comparison to a predicate device (BD Angiocath & Insyte Autoguard Catheters) to demonstrate substantial equivalence, rather than detailing a study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity commonly associated with AI/ML devices. Therefore, much of the requested information regarding AI/ML device studies (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable or available in this document.

However, based on the provided text, I can infer the acceptance criteria relate to meeting established medical device standards for performance, biocompatibility, sterilization, and packaging, as well as demonstrating that the device's characteristics do not raise new or different questions of safety or effectiveness compared to the predicate device.

Here's a breakdown of the available information structured as requested, with details that are not applicable or unavailable marked as such:

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implied from Standards)	Reported Device Performance
Performance	General Intravascular Catheter Requirements: - Conformance to ISO 10555-1 (General requirements for sterile, single-use intravascular catheters).- Conformance to ISO 10555-5 (Over-needle Peripheral catheters).- Conformance to ISO 80369-7 (Luer connectors).- Conformance to ISO 80369-20 (Common test methods for small-bore connectors).- Conformance to ISO 7864 (Sterile hypodermic needles).- Conformance to ISO 9626 (Stainless steel needle tubing).- Conformance to ISO 8536-4 (Infusion sets for gravity feed).- Conformance to USP <788> (Particulate Matter for Injections).- Functionality of Sharps Prevention Feature per ISO 23908.	Bench tests were conducted to verify that the proposed device met all design specifications. (Specific quantitative results for each standard are not provided, but the conclusion states "Bench tests were conducted to verify that the proposed device met all design specifications and to support substantial equivalence to the predicate device.")Key Performance Aspects Mentioned:- Sharps Prevention Feature: "performs as intended" (per ISO 23908:2011).- Flow Rate: 30 mL/min (Applicant states this is "adequate to support its referenced Indications for Use, as the flow rate is significantly greater than sizing parameters of clinically prescribed flow rates for both gravity infusion and legally marketed volumetric pumps... substantially greater than the maximum programable flow rate for legally marketed volumetric pumps (999 ml./hr).")- Dimensions: Catheter OD: 0.041 - 0.043 in., Catheter ID: 0.025 - 0.031 in., Catheter Length: 1.67 in. (Stated to be "appropriate for a 20GA catheter per ISO 10555-5").- Design Characteristics (e.g., Catheter-Needle Interface, Tip, Needle Retraction): Differences compared to predicate device were found not to "alter or raise different questions of safety and effectiveness" (Notes 2 & 3).
Biocompatibility	Conformance to ISO 10993-1 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing) and FDA guidance for: - Genotoxicity, Carcinogenicity, Reproductive Toxicity (ISO 10993-3).- Interactions with Blood, Hemolytic Properties (ISO 10993-4, ASTM F756-17).- Cytotoxicity (ISO 10993-5).- Local Effects after Implantation (ISO 10993-6).- Irritation and Skin Sensitization (ISO 10993-10).- Systemic Toxicity (ISO 10993-11).- Sample preparation and reference materials (ISO 10993-12).- Pyrogenicity (USP-NF <151>).	"Tested per ISO 10993-1: PASS" (for Externally communicating, Circulation blood path, Prolonged contact (> 24 hours to 30 days)). The document confirms testing for all listed biological endpoints.
Sterilization & Packaging	Conformance to:- ISO 14937 (Sterilization process characterization and validation).- AAMI TIR56 (Guidance for EtO sterilization).- ISO 10993-7 (Ethylene oxide sterilization residuals).- ASTM F1980-16 (Accelerated Aging).- ASTM D4332-14 (Conditioning Containers).- ASTM D4169-16 (Performance Testing of Shipping Containers).- ASTM F1886-16 (Integrity of Seals by Visual Inspection).- ASTM F2096-11 (Detecting Gross Leaks).- ASTM F1929-15 (Detecting Seal Leaks by Dye Penetration).- ASTM F88-15 (Seal Strength).	"EtO Sterilized" and "Sterile Barrier: Individual Tyvek and PET Pouches." (The document implies successful validation against these standards as part of the substantially equivalent determination; specific results are not detailed beyond listing the standards.)

Regarding AI/ML specific information (not applicable to this medical device filing):

Sample size used for the test set and the data provenance: Not applicable. This is a medical device (catheter) 510(k) filing, not an AI/ML device. The "test set" in this context refers to physical units of the catheter system subjected to bench and biocompatibility testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images) is not relevant here. The ground truth for device performance is based on established engineering and biological standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Device testing against standards does not typically involve adjudication in this manner.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic or interpretative device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is objective measurements against harmonized engineering and biological standards (e.g., ISO, ASTM, USP) and the demonstration that the device's intended use and technological characteristics are substantially equivalent to a predicate device whose safety and efficacy have been established.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of the Study (Bench and Biocompatibility Testing):

The "study" referenced in the document consists of various bench tests and biocompatibility evaluations performed on the OSPREY PERIPHERAL IV Catheter System.

Objective: To verify that the proposed device met all design specifications and to support substantial equivalence to the predicate device (BD Angiocath & Insyte Autoguard Catheters).
Methodology: The device was tested in accordance with a comprehensive list of international and national standards covering:
- Performance: General requirements for intravascular catheters, specific requirements for over-needle peripheral catheters, small-bore connectors (Luer taper), common test methods for connectors, sterile hypodermic needles, stainless steel needle tubing, infusion equipment, particulate matter, and sharps injury protection.
- Biocompatibility: Evaluation based on ISO 10993-1, covering aspects like genotoxicity, blood interactions, cytotoxicity, local effects, irritation, systemic toxicity, and pyrogenicity.
- Sterilization and Packaging: Validation of the Ethylene Oxide (EtO) sterilization process and sterile barrier packaging against relevant ISO and ASTM standards.
Results: The document concludes that "Bench tests were conducted to verify that the proposed device met all design specifications and to support substantial equivalence to the predicate device." Specifically, it states the biocompatibility testing "Tested per ISO 10993-1: PASS" and that the sharps prevention feature "performs as intended" per ISO 23908:2011. Differences in certain characteristics (materials, design, flow rate) were deemed not to raise "new or different questions of safety or effectiveness."
Conclusion: The tests demonstrated that the OSPREY PERIPHERAL IV Catheter System is substantially equivalent to the predicate device with respect to indications for use and technological characteristics, and therefore meets the regulatory requirements for market clearance.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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)

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)

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 Druq 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}------------------------------------------------

K223018 510(k) SUMMARY

SkyDance Vascular, Inc. - OSPREY PERIPHERAL IV Catheter System

Submitter:

SkyDance Vascular, Inc.3058 Millcreek RoadPleasant 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:	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 DickinsonVascular Access inc

Indications for Use:

Device Description:

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.

{4}------------------------------------------------

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 IVCatheter System	Predicate - BD Angiocath & Insyte™Autoguard™ Catheters (K952861)	Substantial Equivalence
Classification	21 CFR §880.5200Class IIFOZ - Intravascular Catheter	21 CFR §880.5200Class IIFOZ - Intravascular Catheter	Identical
Indications for Use	OSPREY PERIPHERAL IV catheter isan intravascular catheter intended to beinserted into the patient's vascularsystem for short-term use to sampleblood, monitor blood pressure, oradminister fluids intravenously.	An intravascular catheter is intended tobe inserted into the patient's vascularsystem for short term use to sampleblood, monitor blood pressure, oradminister fluids intravenously.	Identical
Critical ProceduralSteps	Remove the device from the packagingand inspect before use.Insert needle into the target vein andobserve blood flashback response.Advance catheter into the vein whilemaintaining needle position.Activate the spring-loaded needleretraction feature.Stabilize the catheter, apply the dressingand connect the IV set using the lueradapter.	Remove the device from the packagingand inspect before use.Insert needle into the target vein andobserve blood flashback response.Advance catheter into the vein whilemaintaining needle position.Activate the spring-loaded needleretraction feature.Stabilize the catheter, apply the dressingand connect the IV set using the lueradapter.	Identical
Materials ofConstruction	Barrel (Housing): Polycarbonate	Barrel: Polycarbonate
Attribute	Subject - OSPREY PERIPHERAL IVCatheter System	Predicate - BD Angiocath & Insyte™Autoguard™ Catheters (K952861)	Substantial Equivalence
	Grip: Polycarbonate	Grip: Polycarbonate	Different
	Needle Hub: Polycarbonate	Needle Hub: Polycarbonate	Materials are well known; bench andbiocompatibility testing demonstrate nodifferent questions of safety or effectivenesswere raised.
	Needle: Stainless Steel	Needle: Stainless Steel
	Spring: Stainless Steel	Spring: Stainless Steel
	Catheter Tubing: Polyurethane w/radiopaque barium sulfate	Catheter Tubing: Polyurethane w/radiopaque barium sulfate	Differences are discussed in Note 1
	Adhesive: Loctite	Adhesive: Unknown
	Catheter Hub: Polycarbonate	Catheter Adapter: Polypropylene
		Lubricants: Silicone
		Safety Activation Button:Polycarbonate
		Porous Flow Plug: Porous Polyethylenew/ Carboxymethyl Cellulose (CMC)
		Catheter Wedge: Stainless Steel
DesignCharacteristics	Catheter-Needle Interface: Catheterthrough the needleNeedle Tip: BeveledCatheter Tip: Rounded Tip	Catheter-Needle Interface:Catheter over the needleNeedle Tip: BeveledCatheter Tip: Tapered Tip	DifferentBoth the subject device and the predicatedevice utilize a needle and catheter tube todeliver fluids directly into the vessel. Thedifferences in the tip shape and interface donot alter or raise different questions of safetyand effectiveness.
			Differences are discussed in Note 2
Attribute	Subject - OSPREY PERIPHERAL IVCatheter System	Predicate - BD Angiocath & Insyte™Autoguard™ Catheters (K952861)	Substantial Equivalence
	Needle Retraction:Spring loaded retraction	Needle Retraction:Spring loaded retraction	DifferentBoth the subject device and the predicatedevice utilize a spring-loaded needleretraction mechanism to permanently retractthe needle into the catheter housing. Thedifferences in activation method do not alterraise different questions of safety andeffectiveness.
			Differences are discussed in Note 3
	IV Set Connection:Female Locking Luer Hub	IV Set Connection:Female Locking Luer Hub	Identical
	Visualization: Flashback	Visualization: Flashback	Identical
			Different
	Catheter OD: 0.041 - 0.043 in.Catheter ID: 0.025 - 0.031 in.Catheter Length: 1.67 in.	Catheter OD: 0.041 - 0.044 in.Catheter ID: 0.030 - 0.033 in.Catheter Length: 1.88 in.	The differences in dimensions do not alter orraise different questions of safety andeffectiveness, as the associated OD isappropriate for a 20GA catheter per ISO10555-5.
	Flashback Chamber / Technology:Yes	Flashback Chamber / Technology:Yes
Performance	Sharps Prevention Feature:Yes	Sharps Prevention Feature:Yes	Identical
	Radiopaque:Yes	Radiopaque:Yes
Attribute	Subject - OSPREY PERIPHERAL IVCatheter System	Predicate - BD Angiocath & Insyte™Autoguard™ Catheters (K952861)	Substantial Equivalence
	Flow Rate: 30 mL/min	Flow Rate: 54 mL/min	DifferentBoth the subject device and the predicatedevice provide clinically acceptable flow ratesto deliver fluids to the vessel. The differentflow rates do not alter or raise differentquestions of safety and effectiveness.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 andPET Pouches	Sterile Barrier: Individual Tyvek and PETPouches	Identical

{5}------------------------------------------------

{6}------------------------------------------------

{7}------------------------------------------------

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

{8}------------------------------------------------

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.

{9}------------------------------------------------

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

{10}------------------------------------------------

. 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.

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).