(81 days)
The Medrad Manual Syringe Loader is designed as an accessory to Medrad's line of angiographic injectors and syringes. It is intended to facilitate manual syringe contrast filling. It is not intended for patient use or use as a contrast injector.
The Medrad Manual Loader is designed as an accessory to Medrad's CT and MR angiographic injectors and syringes. The system offers a manual alternative to the electronic filling function of the injectors. Due to the different configurations of the syringes for the MR and CT injectors, two options of the Manual Loader will be available, each compatible with either CT syringes or MR Syringes.
The provided document is a 510(k) summary for the Medrad Manual Syringe Loader. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it conspicuously lacks detailed acceptance criteria and a study dedicated to proving the device meets those criteria, as typically seen in submissions for AI/software as a medical device (SaMD) or devices requiring rigorous performance validation.
This is due to the nature of the device: a manual syringe loader, which is a relatively simple accessory for existing angiographic injectors. Its primary function is to facilitate manual filling, not to perform a diagnostic or therapeutic function that would require extensive performance studies with clinical endpoints or AI metrics. The FDA's substantial equivalence determination for this type of device often relies on demonstrating that its design and intended use are similar to already legally marketed devices, and that it doesn't raise new questions of safety or effectiveness.
Therefore, many of the requested categories for AI/SaMD studies are not applicable to this 510(k) submission.
Here's an analysis based on the information available:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the format typically used for performance studies of complex medical devices (e.g., sensitivity, specificity, accuracy thresholds). Instead, the "acceptance criteria" are implied by the comparison to predicate devices and the demonstration of substantial equivalence. The device's "performance" is implicitly considered acceptable if it functions as intended (manual filling of syringes) and shares similar characteristics with the predicate's filling function, without introducing new risks.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Syringe Filling Mechanism: The Medrad Manual Loader should perform the function of manually filling disposable contrast or saline syringes in a manner comparable to the filling function of existing Medrad angiographic injectors. | The Medrad Manual Loader is described as having the "same intended use as the syringe filling function of Medrad angiographic injectors." It "offers a manual alternative to the electronic filling function of the injectors." The comparison table highlights that it performs "Manual filling of disposable contrast or saline syringes." This suggests functional performance is considered equivalent for its manual function. |
| Material Compatibility: Compatible with existing Medrad CT and MR syringes. | "Due to the different configurations of the syringes for the MR and CT injectors, two options of the Manual Loader will be available, each compatible with either CT syringes or MR Syringes." This directly addresses compatibility. |
| Target User Group Appropriateness: Usable by medical imaging/hospital staff. | Stated target population is "Medical imaging/Hospital staff," which is identical to the predicate device's target population for the filling function. |
| Environmental Compatibility (Non-MR environment): Not intended for use within MRI scanning rooms. | "Not intended to be installed within the scanning rooms," distinguishing its use case from the MR-hardened predicate injectors themselves. This is a design specification rather than a performance metric, but it indicates appropriate functional design for its intended environment. |
| Safety: Does not introduce new safety concerns compared to predicate devices for the syringe filling function. | The 510(k) clearance implies that the FDA determined no new significant safety or effectiveness concerns were raised, thus finding it substantially equivalent. Specific safety tests or clinical performance data are not detailed in this summary, as is typical for low-risk, mechanically simple accessories. |
Study Details (as applicable)
Given the nature of the device, many of these detailed study aspects are not present in this 510(k) summary. The submission focuses on substantial equivalence to predicate devices, rather than a de novo performance study.
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Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. The document is a 510(k) summary for a manual accessory. There isn't a "test set" of data in the sense of clinical images or patient outcomes for performance evaluation. Instead, the "evaluation" is based on a comparison of device characteristics and intended use to predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses or measurements. This device does not generate diagnostic data or require expert interpretation for its function.
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Adjudication method for the test set:
- Not Applicable. No test set or expert adjudication is described for this type of device.
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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 not an AI/SaMD device. It's a mechanical accessory.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-based device. It's a manual mechanical loader.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. See point 2. The "ground truth" for this device's approval lies in demonstrating that its manual filling function is within acceptable engineering and safety parameters and is substantially equivalent to aspects of already cleared devices.
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The sample size for the training set:
- Not Applicable. No "training set" is relevant for this manual mechanical device.
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How the ground truth for the training set was established:
- Not Applicable. No training set or ground truth in this context.
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AUG - 1 2003
510(k) Summary – Medrad Manual Syringe Loader
| OFFICIAL CONTACT: | Andrew P. ZeltwangerRegulatory Affairs AnalystMedrad, Inc.One Medrad DriveIndianola, PA 15051(412) 767-2400 ext. 3005 |
|---|---|
| CLASSIFICATION NAME: | Angiographic Injector and Syringe [21 CFR870.1650] |
| COMMON NAME: | Syringe Loader |
| PROPRIETARY NAME(s): | Medrad Manual Syringe Loader |
| PREDICATE DEVICES: | Spectris Solaris MR Injector System (K012950)Stellant CT Injector System (K023183) |
| DEVICE DESCRIPTION: | The Medrad Manual Loader is designed as anaccessory to Medrad's CT and MR angiographicinjectors and syringes. The system offers a manualalternative to the electronic filling function of theinjectors. Due to the different configurations of thesyringes for the MR and CT injectors, two optionsof the Manual Loader will be available, eachcompatible with either CT syringes or MR Syringes. |
| INTENDED USE: | The Medrad Manual Syringe Loader is designed asan accessory to Medrad's line of angiographicinjectors and syringes. It is intended to facilitatemanual syringe contrast filling. It is not intendedfor patient use or use as a contrast injector. |
· Medrad, Inc. · 510(k) Premarket Submission ·
- Medrad Manual Syringe Loader •
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COMPARISON TO PREDICATE:
The Medrad Manual Loader is substantially equivalent to the filling function of the injector head of the Spectris Solaris MR angiographic injector. The Medrad Manual Loader has the same intended use as the syringe filling function of Medrad angiographic injectors.
In the table below, Medrad presents a comparison of the relevant device parameters between the Medrad Manual Loader and the MR/CT Injector Product Line.
| Characteristics | Medrad Manual Loader | Stellant CT/Spectris SolarisMR Injectors |
|---|---|---|
| Intended Use | Manual filling ofdisposable contrast orsaline syringes for eitherCT or MR angiographicinjectors | Electro-mechanical filling ofdisposable contrast/salinesyringes and control of deliveryof contrast agent to patientduring angiographic imagingwith CT or MR scanners |
| Target Population | Medical imaging/Hospitalstaff | Medical imaging/Hospital staff |
| Compatibility withEnvironment andother Devices | Two models available - onecompatible with syringesfor each imaging modality | Disposable contrast syringesmarketed for each injector |
| MR/CTCompatibility | Not intended to be installedwithin the scanning rooms | MR hardened for use in the MRenvironment |
· Medrad, Inc. · 510(k) Premarket Submission ·
- Medrad Manual Syringe Loader •
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Medrad, Inc. c/o Andrew P. Zeltwanger Regulatory Affairs Analyst One Medrad Drive Indianola, PA 15051
Re: K031483 Medrad Manual Syringe Loader
Regulation Number: 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: May 9, 2003 Received: July 23, 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. Andrew P. 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 (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. 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 your 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) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Intended Use
Indications for Use Statement
510(k) Number:
KO31483
Device Name: Medrad Manual Syringe Loader
Indications for Use:
The Medrad Manual Syringe Loader is designed as an accessory to Medrad's line of angiographic injectors and syringes. It is intended to facilitate manual syringe contrast filling. It is not intended for patient use or use as a contrast injector.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
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Over-the-Counter Use
510(k) Numbe
- · Medrad, Inc. · 510(k) Premarket Submission ·
- · Medrad Manual Syringe Loader ·
§ 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.