(90 days)
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.
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.
The provided text describes the regulatory clearance (510(k)) for the OSPREY Closed IV Catheter System (OspreyV2) and includes a comparison to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
Instead, the document details:
- Device Description and Intended Use: The OspreyV2 is an intravascular catheter for short-term use, blood sampling, pressure monitoring, and fluid administration, including compatibility with power injectors up to 325 psi.
- Comparison to Predicate Devices: It highlights similarities and differences with two predicate devices (OSPREY PERIPHERAL IV Catheter System and Nexiva Closed IV Catheter System) in terms of classification, indications for use, critical procedural steps, materials of construction, design characteristics, and performance attributes like flow rate.
- Performance Data (Bench Tests): The document states that bench tests were conducted to verify the device met design specifications and supported substantial equivalence, referencing a list of ISO and ASTM standards (e.g., ISO 10555-1, ISO 23908 for sharps injury protection, ISO 8536-4 for infusion equipment).
- Biocompatibility Testing: It confirms biocompatibility evaluation per ISO 10993 series standards.
- Sterilization and Packaging Validation: It outlines validation per ISO and ASTM standards.
- Absence of Clinical Testing: Explicitly states that no clinical testing was performed as it was not required to demonstrate substantial equivalence to the predicate device.
Therefore, I cannot populate the requested table and provide details about acceptance criteria or a study with AI/ML performance data because this information is not present in the provided text. The document focuses on regulatory clearance based on substantial equivalence to existing devices through non-clinical (bench) testing and material/design comparisons, not on validating an AI/ML algorithm's diagnostic or predictive performance against specific acceptance criteria.
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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
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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
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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) |
|---|---|
| ---------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------- |
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K231626 - 510(k) SUMMARY
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: | 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 IVCatheter System) – SkyDance Vascular, Inc.Class II, Intravascular Catheter, FOZ / 21 CFR § 880.5200Secondary Predicate (B) – K102520 (Nexiva Closed IV CatheterSystem) - 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.
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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.
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| Attribute | Subject - OSPREY Closed IVCatheter System (OspreyV2) | Primary Predicate (A) –OSPREY PERIPHERAL IVCatheter System (K223018) | Secondary Predicate (B) – BDNexiva Closed IV CatheterSystem (K102520) | SubstantialEquivalence |
|---|---|---|---|---|
| Classification | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter | 21 CFR §880.5200Class IIFOZ - Intravascular Catheter | Identical |
| Indications forUse | OSPREY Closed IV CatheterSystem (OspreyV2) is anintravascular catheter intended tobe inserted into the patient'svascular system for short-termuse to sample blood, monitorblood pressure, or administerfluids intravenously. Blood iscontained within the deviceduring the catheter insertionprocess aiding in the preventionof blood exposure. This cathetermay be used for any patientpopulation with considerationgiven to adequacy of vascularanatomy and appropriateness ofprocedure.The OSPREY Closed IV CatheterSystem (OspreyV2) is suitable foruse with power injectors rated fora maximum of 325 psi whenconnected to male luer lock. | An intravascular catheter isintended to be inserted into thepatient's vascular system forshort term use to sample blood,monitor blood pressure, oradminister fluids intravenously. | The Nexiva™ intravascularcatheter is inserted into a patient'svascular system for a short-termuse (less than 30 days) to sampleblood, monitor blood pressure, oradminister fluids intravascularly.The needle-shielding feature andluer access port, aid in theprevention of needle-stick injuries.Blood is contained within thedevice during the catheterinsertion process aiding in theprevention of blood exposure.This catheter may be used for anypatient population withconsideration given to adequacyof vascular anatomy andappropriateness of procedure.The 18-22 gauge Nexiva™catheters are suitable for use withpower injectors rated for amaximum of 300 psi when the lueraccess port(s) is removed and adirect connection is made. | SimilarPrimary Predicate:Subject device IFUis expanded toinclude its suitabilityfor use with powerinjectors and anypatient populationbased on vascularanatomy andappropriateness ofprocedure.SecondaryPredicate: Subjectdevice IFU isconsistent with itssuitability for usewith power injectorsand any patientpopulation based onvascular anatomyand appropriatenessof procedure.Comment #1 |
| CriticalProceduralSteps | Remove the device from thepackaging and inspect beforeuse. | Remove the device from thepackaging and inspect beforeuse. | Remove the device from thepackaging and inspect beforeuse. | Identical |
| Attribute | Subject – OSPREY Closed IVCatheter System (OspreyV2) | Primary Predicate (A) –OSPREY PERIPHERAL IVCatheter System (K223018) | Secondary Predicate (B) – BDNexiva Closed IV CatheterSystem (K102520) | SubstantialEquivalence |
| Insert needle into the target veinand observe blood flashbackresponse. | Insert needle into the target veinand observe blood flashbackresponse. | Insert needle into the target veinand observe blood flashbackresponse. | ||
| Advance catheter into the veinwhile maintaining needle position. | Advance catheter into the veinwhile maintaining needleposition. | Advance catheter into the veinwhile maintaining needleposition. | ||
| Activate the spring-loaded needleretraction feature. | Activate the spring-loadedneedle retraction feature. | Withdrawal of needle activatesneedle tip safety feature. | ||
| Stabilize the catheter, apply thedressing, remove the porous flowplug and connect the IV set usingthe luer adapter. | Stabilize the catheter, apply thedressing and connect the IV setusing the luer adapter. | Stabilize the catheter, apply thedressing, remove the porousflow plug and connect the IV setusing the luer adapter. | ||
| Materials ofConstruction | 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 | componentryassociated with | |
| Needle: Stainless Steel | Needle: Stainless Steel | Needle: Stainless Steel | integrated extensiontubing, the materials | |
| Needle Tip Shield: N/A | Needle Tip Shield: N/A | Needle Tip Shield:Polycarbonate | of construction of theSubject device arethe same. The | |
| Spring: Stainless Steel | Spring: Stainless Steel | Spring: N/A | additionalcomponents of the | |
| Catheter Tubing: Polyurethanew/ radiopaque barium sulfate | Catheter Tubing: Polyurethanew/ radiopaque barium sulfate | Catheter Tubing: Polyurethanew/ radiopaque barium sulfate | subject device weretested forbiocompatibility in | |
| Adhesive: Loctite | Adhesive: Loctite | Adhesive: Unknown | accordance withISO10993-1. | |
| Catheter Hub: Polycarbonate | Catheter Hub: Polycarbonate | Catheter Adapter: Copolyester | Therefore, theaddition of thecomponentry | |
| Attribute | Subject – OSPREY Closed IVCatheter System (OspreyV2) | Primary Predicate (A) –OSPREY PERIPHERAL IVCatheter System (K223018) | Secondary Predicate (B) – BDNexiva Closed IV CatheterSystem (K102520) | SubstantialEquivalence |
| Catheter Wing Adapter: N/A | Catheter Wing Adapter: N/A | Catheter Wing Adapter: TPE(Thermoplastic Elastomer) | associated with theintegrated extensiontubing does not raisenew or differentquestions of safetyand 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: PorousPolyethylene w/ CarboxymethylCellulose (CMC) | Porous Flow Plug: N/A | Porous Flow Plug: PorousPolyethylene w/ CarboxymethylCellulose (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 | SimilarComment #2 | |
| Needle Tip: Beveled | Needle Tip: Beveled | Needle Tip: Beveled | ||
| Catheter Tip: Rounded Tip | Catheter Tip: Rounded Tip | Catheter Tip: Tapered Tip | ||
| Needle Retraction: | Needle Retraction: | Needle Retraction: N/A | ||
| DesignCharacteristics | Spring loaded retraction | Spring loaded retraction | ||
| IV Set Connection:Female Locking Luer Hub | IV Set Connection:Female Locking Luer Hub | IV Set Connection:Female Locking Luer Hub(Single Port Configuration) | ||
| Visualization: Flashback | Visualization: Flashback | Visualization: Flashback | ||
| Catheter OD: 0.041 – 0.043 in.Catheter ID: 0.025 – 0.031 in.Catheter Length: 1.37 in. | Catheter OD: 0.041 – 0.043 in.Catheter ID: 0.025 – 0.031 in.Catheter Length: 1.67 in. | Catheter OD: 0.042 – 0.045 in.Catheter ID: 0.031 – 0.034 in.Catheter Length: 1.25 in. | ||
| Attribute | Subject - OSPREY Closed IVCatheter System (OspreyV2) | Primary Predicate (A) -OSPREY PERIPHERAL IVCatheter System (K223018) | Secondary Predicate (B) – BDNexiva Closed IV CatheterSystem (K102520) | SubstantialEquivalence |
| Integrated Extension Tube:Incorporates an integratedextension tube, including a pinchclamp and female luer withporous (vent) plug. | Integrated Extension Tube: N/A | Integrated Extension Tube:Incorporates an integratedextension tube, including a pinchclamp and female luer withporous (vent) plug. | ||
| Power Injector:The OSPREY Closed IV CatheterSystem (OspreyV2) is suitable foruse with power injectors rated fora maximum of 325 psi whenconnected to male luer lock. | Power Injector: N/A | Power Injector:The 18-22 gauge NexivaTMcatheters are suitable for usewith power injectors rated for amaximum of 300 psi when theluer access port(s) is removedand a direct connection is made. | ||
| Flashback Chamber /Technology:YesSharps Prevention Feature:YesRadiopaque:Yes | Flashback Chamber /Technology:YesSharps Prevention Feature:YesRadiopaque:Yes | Flashback Chamber /Technology:YesSharps Prevention Feature:YesRadiopaque:Yes | Identical | |
| Performance | Flow Rate: 30 mL/min | Flow Rate: 30 mL/min | Flow Rate: 58 mL/min | SimilarBoth the subjectdevice and thePrimary Predicatedevice have thesame flow rate todeliver fluids to thevessel.Performance testingof the subject devicedemonstrates thedifference in flowrate between the |
| Attribute | Subject - OSPREY Closed IVCatheter System (OspreyV2) | Primary Predicate (A) –OSPREY PERIPHERAL IVCatheter System (K223018) | Secondary Predicate (B) – BDNexiva Closed IV CatheterSystem (K102520) | SubstantialEquivalence |
| subject andsecondary predicatedevices do not raisenew or differentquestions of safetyand effectiveness. | ||||
| Biocompatibility | Tested per ISO 10993-1: PASS | Tested per ISO 10993-1: PASS | Tested per ISO 10993-1: PASS | Identical |
| Sterilization | EtO Sterilized | EtO Sterilized | EtO Sterilized | Identical |
| Packaging | Sterile Barrier: Individual Tyvekand PET Pouches | Sterile Barrier: Individual Tyvekand PET Pouches | Sterile Barrier: Thermal FormedTray w/ Tyvek Lid | Identical |
| Shelf Life | 6 - Months | 6 - Months | Unknown | SimilarPrimary Predicate,has the same shelflife.SecondaryPredicate: Thesubject deviceperformance wastested over theproposed self-lifeand therefore thepotential differencedoes not raise newor different questionsof safety andeffectiveness. |
Comparison Table of Subject Device to Both the Primary Predicate (A) and Secondary Predicate (B) Devices Table I:
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Discussion of Differences in Technological Characteristics
Comment #1: The IFU of the Subject device is similar to that of the Primary Predicate, as the OSPREY Closed IV Catheter System (OspreyV2) is also 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. It is different based with power injectors and the inclusion of an integrated extension tube. The subject device performance testing demonstrates that the difference in intended use does not raise new or different questions of safety and effectiveness.
The subject device is similar in comparison to the Secondary Predicate as the IFU includes a needle-shielding feature which aids in the prevention of needle-stick injuries. Blood is contained within the catheter insertion process aiding in the prevention of blood exposure. The catheters may be used for any patient population given to adequacy of vascular anatomy and appropriateness of procedure. Additionally, both the Subject and Secondary Predicate devices are suitable for use with power injectors. When considering the devices use (Subject and both the Primary & Secondary Predicate), the appropriateness of the patient's vascular anatomy must be taken into consideration. The Subjects devices IFU do not raise new or different questions of safety and effectiveness.
Comment #2: The subject and primary predicate devices are similar with the differences being the catherer length and integrated extension tubing. The subject device performance and biocompatibility testing demonstrates that the differences between the subject and primary predicate device do not raise new or different questions of safety and effectiveness. All other components are the same.
The subject device performance was tested in accordance with the bench testing listed below, particularly ISO 23908: 2011, ISO 10555-1: 2013. ISO 10555-5:2013, and ISO 8536-4:2019. Therefore, the difference in the needle retraction feature, the maximum power injection rate, and catheter dimensions do not raise new or different questions of safety and effectiveness.
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Summary of Performance Data:
Bench tests were conducted to verify that the subject device met all design specifications and to support substantial equivalence to the predicate devices. Bench testing was performed on the subject device (OSPREY Closed IV Catheter System (OspreyV2)) 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 8536-8:2015; Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus.
- 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 Iniections (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
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
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- . ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests interactions with blood for
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- . 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
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 Medical Devices for
- 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 Packaging by Visual Inspection Flexible
- 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
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Clinical Testing:
No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.
Conclusion:
The differences between the subject device and both the primary predicate and secondary predicate devices do not raise new or different questions of safety and effectiveness. The subject device, OSPREY Closed IV Catheter System (OsperyV2) device is substantially equivalent to both the Primary Predicate (A) OSPREY PERIPHERAL IV Catheter System and the Secondary Predicate (B) Nexiva™ Closed IV Catheter System, with respect to indications for use and technological characteristics.
§ 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).