(27 days)
Medrad Qwik-Fit Syringes are indicated to contain and hold contrast media and assist in delivery of same, to effect CT and MRI diagnostics. They are indicated for single-use only.
The Medrad Quik-Fit Syringe comprises a clear plastic syringe barrel with anta plunger assembly that moved within the need and flushing solutions for delivery by the injector into humans.
This 510(k) premarket notification (K013815) is for modifications to the Medrad Quik-Fit Syringe, specifically concerning the plunger assembly. It is a "Special 510(k)" indicating that the changes are minor and do not significantly alter the intended use, fundamental scientific technology, or safety and effectiveness of the device. Therefore, the submission focuses on demonstrating substantial equivalence to the previously cleared predicate device (K964642) rather than conducting a full de novo study with extensive acceptance criteria and performance evaluations comparable to a new device.
The study presented here is an equivalence study to demonstrate that the modified device is as safe and effective as the predicate device, not a study to prove a specific level of clinical performance against defined acceptance criteria in a clinical setting. The "acceptance criteria" in this context refer to demonstrating that the modified device performs comparably to the predicate device in relevant physical and functional characteristics.
Here's an breakdown based on your requested information, acknowledging the nature of this 510(k):
1. Table of Acceptance Criteria and Reported Device Performance
For this Special 510(k), the "acceptance criteria" are implied by the features of the predicate device and the successful completion of testing to show that the modified device performs equivalently. The "reported device performance" is essentially the determination that the modified device meets the predicate device's performance.
| Acceptance Criteria (Implied by Predicate Device) | Reported Device Performance (Modified Device) |
|---|---|
| Packaging: Same as predicate | Same |
| Labeling: Same as predicate | Same |
| Shelf Life: 5 Years | Same |
| Single Use: Yes | Yes |
| Intended Use: Assist in intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes. | Same |
| Indications for Use: Contain and hold contrast media and assist in delivery for CT and MRI diagnostics; single-use only. | Same |
| Sterility: Ethylene Oxide (EtO) at 8.4% and 91.6% HCFC-124 | Same |
| Plunger Materials in Contact with Fluid Path: Synthetic Polyisoprene (Predicate) | Thermoplastic Elastomer and ABS polymer (Modified - this is the change, but performance is equivalent) |
| Latex Content: Latex Free | Same |
| Parameters for Use: All available Injector/Syringe configurations & volume options | Same |
| Pressure Capabilities / Compatible With Intended Injectors: Yes | Yes |
| Safety and Effectiveness: As safe and effective as the current device (predicate). | Modifications satisfactorily completed to show it is as safe and effective as the current device. |
2. Sample Size Used for the Test Set and the Data Provenance
Since this is a Special 510(k) focused on material changes to a plunger in an existing device, a "test set" in the sense of patient data is not applicable. The testing would have involved bench testing and engineering evaluations of the modified syringe.
- Sample Size: The document does not specify the exact sample sizes for the engineering tests conducted. These would typically be determined by internal quality control and verification protocols for the specific tests performed (e.g., burst pressure, leakage, plunger movement force, material compatibility).
- Data Provenance: The data provenance would be from internal Medrad Inc. testing and engineering evaluations conducted in the USA. The type of data would be retrospective in the sense that it's comparing a modified component to an already established predicate, but generated prospectively for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for this type of submission. "Ground truth" in the context of clinical diagnostics or image analysis (where experts define disease presence/absence) is not relevant here. The "truth" for this device relates to its physical performance characteristics and adherence to engineering specifications. These are assessed through objective measurements, not expert consensus on clinical findings.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data, which is not part of this device's evaluation. Engineering tests rely on objective measurements and established pass/fail criteria.
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 device is a syringe, not an AI-powered diagnostic tool. MRMC studies are for evaluating the performance of diagnostic tools (often AI-based) and their impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used
For this device, the "ground truth" is defined by:
- Engineering Specifications: The established performance parameters (e.g., pressure capabilities, material integrity, sterility).
- Predicate Device Performance: The known and demonstrated performance of the previously cleared Medrad Disposable Syringes (K964642), against which the modified device is evaluated for equivalence.
- Regulatory Standards: Adherence to relevant FDA regulations and consensus standards for medical devices and syringes.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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DEC 1 3 2001
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter's Name: Submitter's Address: Telephone Number: Fax Number: Contact Person: Date:
Proprietary Name: Common Name: Classification: Classification Name:
Medrad Inc. One Medrad Drive, Indianola, PA 15051 USA (412) 767-2400, ext. 3536 (412) 767-2499 Frank Pelc November 15, 2001
Quik-Fit Syringe Syringe, Angiographic Class II, DXT Injector and Syringe, Angiographic
Predicate Device:
Medrad Disposable Syringes: K964642
Device Description - The Medrad Quik-Fit Syringe comprises a clear plastic syringe barrel with anta Device Description - The Mourad Quilt in by mgo confige of the syringe fits onto plunger assembly that moved within the need and flushing solutions for delivery by the injector into humans.
Description of Changes - This Special 510(k) premarket notification is being submitted due to modifications to the syringe plunger assembly.
Substantial Equivalence - The modified Medrad Quik-Fit Syringe described in this 510(k) ourseanthan Equivaloneo - The mountent to the Medrad Quik-Fit Syringes described in premarket notification is oubotantially oqtin intended use, labeling, packaging, and sterilization RS04042. The proposed, modified device are unchanged from the current, predicate device. procode for the proposalive to the modifications have been satisfactorily completed to show that it is as safe and effective as the current device.
A table comparing the features of the predicate device and modified device is provided below.
| Feature | Predicate Device (K964642) | Proposed Device |
|---|---|---|
| Packaging | Same | Same |
| Labeling | Same | Same |
| Shelf Life | 5 Years | Same |
| Single Use | Yes | Yes |
| Intended Use | Medrad Qwik-Fit Syringes areintended to assist in theintravascular delivery of contrastmedia and flushing solutions atcontrolled flow rates and volumes. | Same |
| Indications for Use | Medrad Qwik-Fit Syringes areindicated to contain and holdcontrast media and assist indelivery of same, to effect CT andMRI diagnostics. They areindicated for single-use only. | Same |
| Sterility | Ethylene Oxide (EtO) at 8.4% and91.6% HCFC-124 | Same |
| Plunger Materials In Contact WithFluid Path | Synthetic Polyisoprene | Thermoplastic Elastomer andABS polymer |
| Latex Content | Latex Free | Same |
| Parameters for Use | All available Injector/Syringeconfigurations & volume options | Same |
| Pressure CapabilitiesCompatible With IntendedInjectors | Yes | Yes |
Comparison of Features
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with three curved lines representing the eagle's body and wings. The emblem is black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frank W. Pelc III Regulatory Affairs Coordinator Medrad, Inc. One Medrad Drive Indianola, PA 15051-0780
DEC 1 3 2001
K013815 Re:
Medrad Qwik-Fit Syringe Regulation Number: 870.1650 Regulation Name: Angiographic injector and syringe. Regulatory Class: Class II Product Code: DXT Dated: November 15, 2001 Received: November 16, 2001
Dear Mr. Pelc:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for referentour above and narro to legally marketed predicate devices marketed in interstate commerce use sured in the encreated of the Medical Device Amendments, or to devices that provision in the 77, 1970, and candance with the provisions of the Federal Food, Drug, and Cosmetic nat (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 ecan of provision 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.
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Frank W. Pelc III
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter wifi anow you to ough and inding of substantial equivalence of your device to a legally prematics notification: "The PDF milling sification for your device and thus, 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 II you desire specific ad rios for you in vitro diagnostic devices), please contact the Office of additionally 21 CHC Fur 6071 o Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1800. Iffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). It guiation entitied, "Misoranainities of responsibilities under the Act may be obtained from the Division Other general 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,
X. Walter Tell
ram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
KO13815 510(k) Number:
Device Name: Medrad Qwik-Fit Syringe
Indications for Use/Intended Use:
Medrad Qwik-Fit Syringes are indicated to contain and hold contrast media and assist in delivery of same, to effect CT and MRI diagnostics. They are indicated for single-use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013815
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.