(189 days)
Not Found
No
The device description and performance studies focus on the mechanical function and physical properties of a needle-free valve, with no mention of AI or ML technologies.
No
The device is described as an IV administration set accessory that allows needleless luer connections, facilitating the addition of medication into IV sets without needles. It does not perform any therapeutic function on its own.
No
The device is described as an accessory for IV administration sets to add medication without needles and does not mention diagnosis.
No
The device description clearly describes a physical, mechanical valve with a silicone stem, indicating it is a hardware device, not software.
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 accessing IV administration sets, medication vials, blood types, and solution bags. This is related to administering substances to a patient, not for performing tests on samples taken from the body to diagnose a condition.
- Device Description: The description details a needle-free valve for adding medication to IV sets. This is a medical device used in the process of patient care, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
The device is a medical device used in the administration of fluids and medications to patients.
N/A
Intended Use / Indications for Use
The intended use for the Swabsite Swabbable Valve is to allow access to IV administration sets, medication vials. blood types, and solution bags with one convenient device without the use of needles or blunt cannulas.
The SWABSITE injection port is an IV administration set accessory that allows needleless luer connections to luer access devices (syringes, etc.)
Product codes
FPA
Device Description
The Swabsite Swabbable Valve is a needle free valve that allows the user to add medication into IV sets without the use of a needle. When the valve is in the closed position it has a flat, smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve, the silicone stem opens in the middle creating a fluid path. When the male connector is removed from the valve, the body of the valve forces the stem shut and maintains a sealed fluid path. A cap is not required to seal the valve or to maintain sterility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Swabsite Swabbable Valve has been shown to be substantially equivalent to the predicate device by non-clinical performance testing data. The testing involved performance testing, biocompatibility testing, and a microbial barrier challenge of the valves.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
SWABSITE SWABBABLE VALVE 510(K) PREMARKET NOTIFICATION SUMMARY
- SUMBITTER'S NAME:
Quest Medical, Inc. One Allentown Parkway Allen. Texas 75002 (972) 390-9800 (972) 390-2881 FAX
Proprietary Name: Swabsite
Intravascular Administration Set
Intravascular Administration Set
August 28, 2000
Swabbable Valve
Swabbable Valve
Doug Bryan QA Manager
DATE PREPARED:
CONTACT PERSON:
- DEVICE NAME:
Common Names:
Classification Names:
-
PREDICATE DEVICE:
-
DEVICE DESCRIPTION:
INTENDED USE: 5.
I.V. Fluid Transfer Set Smartsite Access Pin, K970485 The Swabsite Swabbable Valve is a needle free valve that allows the user to add medication into IV sets without the use of a needle. When the valve is in the closed position it has a flat, smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve, the silicone
stem opens in the middle creating a fluid path. When the male connector is removed from the valve, the body of the valve forces the stem shut and maintains a sealed fluid path. A cap is not required to seal the valve or to maintain sterility.
The intended use for the Swabsite Swabbable Valve is to allow access to IV administration sets, medication vials. blood types, and solution bags with one
1
TECHNOLOGICAL 6. CHARACTERISTICS: convenient device without the use of needles or blunt cannulas.
The Swabsite Swabbable Valve allows needleless access to IV administration sets, medication vials, blood tubes, and solution bags. The technological characteristics of the device are similar to the Smartsite Access Pin (K970485) and raises no new questions of safety and effectiveness. Quest concludes that the SwabSite Swabbable Valve is substantially equivalent to current marketed devices.
7. NON-CLINICAL DATA:
The Swabsite Swabbable Valve has been shown to be substantially equivalent to the predicate device by non-clinical performance testing data. The testing involved performance testing, biocompatibility testing, and a microbial barrier challenge of the valves.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread.
MAR - 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Doug Bryan Mr. Doug Bryan
Plant Quality Assurance & Regulatory Affairs Manager Quest Medical, Incorporated One Allentown 75002 Allen, Texas
Re : K002689 Swabsite Swabbable Valve Trade Name: Regulatory Class: II Product Code: FPA February 7, 20001 Dated: February 8, 2001 Received:
Dear Mr. Bryan:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceies. beve and we have determined the market the device referenced above the indications for device is substancially cquivalene ally marketed predicate use stated in the encrobare, or onmerce prior to May 28, 1976, devices marketed in theorbed al Device American or to the enactment date of the nassified in accordance with the devices that have been recrabblians of Cosmetic Act (Act) .
provisions of the Federal Food, Drug, and Cosm to the general provisions of the rederal rood, avay, subject to the general The general controls controls provisions of the Act. controls provibloms of include requirements for annual provisions of the Act incraac requirementiacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II If your device is crabbirled (boodsmarket Approval), it may Existing major be subject to such additional controls. be subject to sach addrois device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal kegularioner rrors termination assumes compliance with substantly equivalenceuring Practice requirements, as set the Current Sood handsusseem Regulation (QS) for Medical Forth In the Quarrey Byson (21 CFR Part 820) and that, beview. School QS inspections, the Food and Drug Chrough periodic go inspecify such assumptions. Failure to Adminiberation (GMP regulation may result in regulatory In addition, FDA may publish further announcements action. accron. I wour device in the Federal Register. Please note: concerning your device in and ification submission does
3
Page 2 - Mr. Bryan
not affect any obligation you might have under sections 531 not arrest any obs of for devices under the Electronic chrough 342 or on control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your in your device of your device to a legally marketed predicate device results in a classification for your markees problems, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known)
Device Name
Quest Medical, Inc. Swabsite Swabbable Valve
Indications for Use
The SWABSITE injection port is an IV administration set accessory that allows needleless luer connections to luer access devices (syringes, etc.)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
Patino Cucente
(Division Sign-Off) Tivision of Dental, Infection Control, General Hospital Devices 1 100k) Number ---