(197 days)
No
The summary describes a standard peripheral IV catheter and does not mention any AI/ML components or capabilities.
No
The device is described as an intravascular catheter intended for short-term use to sample blood, monitor blood pressure, or administer fluids, which are diagnostic and supportive functions, not primarily therapeutic ones.
No
The device is described as an intravascular catheter for administering fluids, monitoring blood pressure, or sampling blood. While blood sampling can be part of a diagnostic process, the catheter itself is an access device and not described as performing analysis or interpretation to diagnose a condition.
No
The device description clearly indicates it is a physical intravascular catheter, a hardware device, and the performance studies focus on bench testing of the physical device and its materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for insertion into the patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. These are all procedures performed on the patient, not on a sample of bodily fluid or tissue outside the body for diagnostic purposes.
- Device Description: The description reinforces the intended use as an intravascular catheter for direct patient interaction.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances in samples, or providing diagnostic information based on testing bodily fluids or tissues.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a tool for accessing the vascular system for various medical procedures, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
OSPREY PERIPHERAL IV catheter is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.
Product codes
FOZ
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 (; 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
- . 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 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flow Rate: 30 mL/min
Predicate Device(s)
K952861 Angiocath & Insyte Autoguard Catheters - Becton Dickinson Vascular Access inc
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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)
Device Name
OSPREY PERIPHERAL IV Catheter System
Indications for Use (Describe)
OSPREY PERIPHERAL IV catheter is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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 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: | April 14, 2023 |
| Name of Device: | OSPREY PERIPHERAL IV Catheter System |
| Common or Usual Name: | Short-Term Less Than 30 Days Therapeutic, Intravascular Catheter |
| Classification Name: | Intravascular Catheter |
| Regulatory Class: | Class II |
| Product Code / Regulation: | FOZ / 21 CFR § 880.5200 |
| Predicate Device(s): | K952861 Angiocath & Insyte Autoguard Catheters - Becton Dickinson |
| Vascular Access inc |
Indications for Use:
OSPREY PERIPHERAL IV catheter is an intravascular catheter intended to be inserted into the patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously.
Device Description:
The OPREY IV Catheter System is a single use, sterile intravascular catheter designed to be inserted into a patient's vascular system to sample blood pressure, or administer fluids intravenously. The device has a usable length catheter of 1.67 inches in a 20 Gauge size for short-term (; 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 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.