(189 days)
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.)
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.
This document describes a 510(k) premarket notification for the "Swabsite Swabbable Valve." It's a needle-free valve for IV administration, asserting substantial equivalence to a predicate device (Smartsite Access Pin, K970485). The submission focuses on non-clinical data to prove this equivalence.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the submission focuses on demonstrating "substantial equivalence" to a predicate device rather than defining specific quantitative acceptance criteria for performance in the clinical sense (e.g., sensitivity, specificity for a diagnostic device). The acceptance criteria were primarily related to safety and effectiveness, as determined by non-clinical testing data to show equivalence to the predicate.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | Substantial equivalence to predicate device (Smartsite Access Pin, K970485) | "The Swabsite Swabbable Valve has been shown to be substantially equivalent to the predicate device by non-clinical performance testing data." |
| Performance Testing | Performance analogous to predicate device | Testing involved "performance testing" (details not specified) |
| Biocompatibility | Biologically compatible with human contact | Testing involved "biocompatibility testing" (details not specified) |
| Microbial Barrier Challenge | Effective barrier against microbial ingress | Testing involved "a microbial barrier challenge of the valves" (details not specified) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document only mentions "non-clinical performance testing data."
- Data Provenance: Not specified, but given it's non-clinical testing, it would be laboratory-based data, not human patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This was a non-clinical device performance and safety evaluation. Experts might have designed or overseen the testing, but there's no mention of experts establishing a "ground truth" for a test set in the way one would for, say, image analysis or diagnostic studies.
- Qualifications of Experts: Not applicable for establishing ground truth in this context.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no "test set" requiring adjudication in the context of human interpretation or diagnostic accuracy. The testing was non-clinical.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This was a non-clinical device safety and performance evaluation, not a study involving human readers or diagnostic interpretation.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in the sense that the device's performance was evaluated independently through non-clinical laboratory testing. There is no "algorithm" here, but the device's physical/mechanical/biological properties were tested directly. The results of these tests (performance, biocompatibility, microbial barrier) were then used to justify substantial equivalence.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth was based on objective measurements and established standards for device performance, biocompatibility, and microbial barrier integrity as determined through non-clinical laboratory testing. The implicit "ground truth" for substantial equivalence was the performance of the predicate device.
8. Sample Size for the Training Set
- Sample Size: Not applicable. There is no "training set" in the context of this device. This is a physical medical device, not an AI or machine learning algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable, as there is no training set.
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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
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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.
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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
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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 ---
§ 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.