(29 days)
The Modrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.
The Medrad Swabbable Valve Transfer Set (SVTS) is a modified Medrad Transfer Set (K022431). The SVTS is a medical disposable device used to transfer contrast media and saline from a spikeable container to a power injector syringe. The SVTS is works in conjunction with the MR-CT Fill Station, and facilitates the delivery of contrast agent and/or saline into a syringe.
The provided document is a 510(k) premarket notification for a medical device modification, specifically the Medrad Swabbable Valve Transfer Set (SVTS). This type of document is a regulatory submission to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than a study proving performance against acceptance criteria in the way a clinical trial for an AI/ML device would.
Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, and MRMC studies) are not applicable to this submission. The document focuses on comparing the modified device to a predicate device and demonstrating substantial equivalence.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here refer to the design specifications and safety requirements that the modified device must meet and be "substantially equivalent" to in comparison with the predicate device. The performance is reported in terms of meeting these specifications and maintaining existing safety standards.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (vs. Predicate) |
|---|---|---|
| Device Components | Tubing Length | 23.0 in. (Predicate: 20.0 in.) - Change |
| Tubing Inner Diameter | 0.120 in. (Predicate: 0.110 in.) - Change | |
| Female Luer | Polycarbonate, Clear, Merit Medical Female Luer (Predicate: None) - Addition | |
| Dust Cap | No Dust Cap (Predicate: Polypropylene Dust Cap) - Removal | |
| Valve Type | Swabbable Threaded Valve (Halkey-Roberts) (Predicate: One-way Stopcock, Pinch Clamp) - Change | |
| Other Components (Spike, Adhesive) | Same as Predicate | |
| Safety Requirements | Biocompatibility | Tested to ISO/AAMI 10993-7 (Same as Predicate) |
| Sterility | Ethylene Oxide (EtO) Sterilized (Same as Predicate) | |
| Intended Use | Delivery of contrast media and saline into a syringe. | No change to the intended use. The SVTS is a needle-free system, potentially aiding needle-stick injury prevention. |
| Mechanical/Functional (Implied) | Functionality as a transfer set for contrast/saline with a power injector. | Implied "substantial equivalence" to the predicate, meaning it performs the same function safely despite modifications. No specific performance metrics like flow rates or durability are listed as "acceptance criteria" directly in this summary, but these would be part of an underlying design validation. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of this 510(k) submission. This is a device modification submission, not a study evaluating an AI/ML diagnostic or prognostic tool. The "test set" would typically refer to physical units of the device tested against engineering specifications and biocompatibility standards, not a dataset for an algorithm. Clinical trials or large-scale human data collection are generally not required for these types of Class II device modifications unless significant new risks are introduced.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "ground truth" established by experts in the sense of AI/ML or clinical diagnosis. The "truth" here is engineering compliance and biocompatibility. The regulatory body (FDA) reviews the submission.
4. Adjudication Method for the Test Set
Not applicable. There's no "adjudication" of device performance in the sense of expert review for ambiguous cases. Device compliance is determined through testing against predetermined specifications and standards (e.g., ISO for biocompatibility).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a physical medical device (a transfer set), not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
The "ground truth" for this device modification is compliance with established engineering specifications, safety standards (e.g., ISO/AAMI for biocompatibility), and demonstration that the modified design maintains the intended function without raising new questions of safety or effectiveness when compared to the predicate device. This is based on design verification and validation testing results, not clinical outcomes or expert consensus on diagnostic images.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
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K 031808
JUL 1 1 2003
Special 510(k) Summary – Medrad Swabbable Valve Transfer Set
| OFFICIAL CONTACT: | Andrew P. ZeltwangerRegulatory Affairs AnalystMedrad, Inc.One Medrad DriveIndianola, PA 15051(412) 767-2400 ext. 3005 |
|---|---|
| CLASSIFICATION NAME: | Tubing, Fluid Delivery [21 CFR 880.5440] |
| COMMON NAME(s): | SVTSTransfer Set |
| PROPRIETARY NAME(s): | Medrad Swabbable Valve Transfer Set |
| PREDICATE DEVICE(s): | Medrad Transfer Set (K022431) |
| DEVICE DESCRIPTION: | The Medrad Swabbable Valve Transfer Set (SVTS)is a modified Medrad Transfer Set (K022431). TheSVTS is a medical disposable device used totransfer contrast media and saline from a spikeablecontainer to a power injector syringe. The SVTS isworks in conjunction with the MR-CT Fill Station,and facilitates the delivery of contrast agent and/orsaline into a syringe. |
| INTENDED USE: | The Medrad Swabbable Valve Transfer Set (SVTS)is intended to be used in the delivery of contrastmedia and saline into a syringe. |
| COMPARISON TO PREDICATE: | The following table shows a comparison betweenthe device components of the SVTS and thepredicate device, the Medrad Transfer Set(K022431). |
- · Medrad, Inc. · Special 510(k) Device Modification ·
• Medrad Swabbable Valve Transfer Set • Confidential •
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| Predicate Device | Modified Device | ||
|---|---|---|---|
| Medrad Stellant Transfer Set[equivalent to the MedradTransfer Set (K022431)] | Swabbable Valve Transfer Set | ||
| DeviceComponents | Illustration | Image: Predicate Device Illustration | Image: Modified Device Illustration |
| Spike | Hyperal Vented Spike | Same | |
| Tubing | 20.0 in. Length.160 in. Outer Diameter.110 in. Inner DiameterPVC - Medical Grade | 23.0 in. Length.160 in. Outer Diameter (Same).120 in. Inner DiameterPVC - Medical Grade (Same) | |
| Female Luer | None | Polycarbonate, Clear, MeritMedical Female Luer | |
| Dust Cap | Polypropylene Dust Cap | No Dust Cap | |
| Valve | One-way Stopcock,Pinch Clamp | Swabbable Threaded Valve(Halkey-Roberts) | |
| Adhesive | 3321 Light Cure AdhesiveCyclohexanone Solvent | SameSame | |
| SafetyRequirements | Biocompatibility | Tested to ISO/AAMI 10993-7 | Same |
| Sterility | Ethylene Oxide (EtO) Sterilized | Same |
- · Medrad, Inc. · Special 510(k) Device Modification ·
- Medrad Swabbable Valve Transfer Set Confidential •
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
JUL I 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Andrew P. Zeltwanger Regulatory Affairs Analyst Medrad, Incorporated One Medrad Drive Indianola, Pennsylvania 15051
Re: K031808
Trade/Device Name: Medrad Swabbable Valve Transfer Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPK, FPA Dated: June 6, 2003 Received: June 18, 2003
Dear Mr. Zeltwanger:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Zeltwanger
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 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Susan Runne
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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K03/808
Intended Use
There has been no change to the indications of use as a result of the proposed modifications described in this submission.
Indications for Use Statement
510(k) Number:
Device Name: Medrad Swabbable Valve Transfer Set
Indications for Use:
The Modrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.
Concurrence of CDRH, Office of Device Evaluation (OL
Patricia Cicente
Prescription Use
or
· Medrad, Inc. · Special 510(k) Device Modification · · Medrad Swabbable Valve Transfer Set · Confidential ·
§ 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.