(90 days)
Not Found
No
The 510(k) summary describes a mechanical intravascular catheter system and does not mention any AI or ML components, algorithms, or functionalities. The performance studies are limited to bench testing.
No.
A therapeutic device is typically designed to treat or alleviate a disease or medical condition. This device is an IV catheter used for administering fluids or sampling blood, which are diagnostic or supportive functions rather than direct therapeutic actions.
No
The device is an intravascular catheter used for sampling blood, monitoring blood pressure, or administering fluids. While monitoring blood pressure can be part of diagnosis, the primary function of the catheter itself is not to diagnose. It collects or delivers, rather than analyzes for diagnostic interpretation.
No
The device description clearly outlines a physical, hardware-based medical device (intravascular catheter) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be inserted into the patient's vascular system for short-term use to sample blood pressure, or administer fluids intravenously. This is a direct interaction with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a catheter system designed for insertion into the vascular system.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The blood sampling mentioned is for pressure monitoring or potentially for collection for later in vitro testing, but the device itself is not performing the diagnostic test.
IVD devices are specifically designed to perform tests on specimens outside the body to provide diagnostic information. This device is designed for direct interaction with the patient's vascular system for therapeutic or monitoring purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
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 (: 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
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 (: 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
12
- . 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
13
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.