(183 days)
The product is a family of Angiographic Syringes for the injection of contrast media and saline. The syringe is for single use with US legally marketed angiographic injectors.
The Ecomed Disposable Angiographic Syringes are disposable syringes for use with contrast delivery systems that deliver contrast media or saline into the vascular system for the purpose of obtaining enhanced diagnostic images. The syringes are available in several sizes and configurations to ensure compatibility with US legally marketed contrast delivery systems.
The syringes are provided in kits that are configured from the following list of components:
- . Syringe(s)
- . Fill tube
- Vial Spike (small/large)
- . Transfer tubing set (length, y vs straight)
I will provide an answer assuming the request relates to the 'Ecomed Disposable Angiographic Syringes' as described in the provided text.
Based on the provided text, the device in question is the "Ecomed Disposable Angiographic Syringes," which are mechanical devices for injecting contrast media and saline. The text describes non-clinical performance (bench) tests to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets a specific clinical acceptance criterion with statistical performance metrics. Therefore, many of the requested fields related to diagnostic performance or human reader studies are not applicable.
Here's the information extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerically reported "device performance" in the context of diagnostic accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicit in the compliance with various ISO and ASTM standards, which cover aspects like sterility, biocompatibility, packaging, and physical performance. The "reported device performance" is a general statement that the device fulfills these standards and is substantially equivalent.
| Acceptance Criterion (Implicitly based on standards) | Reported Device Performance |
|---|---|
| Sterility (ISO 11135-1, ISO 11607-1, ASTM F1980-07) | Compliance verified |
| Biocompatibility (ISO 10993-1, -5, -10, -11; ASTM F756-13, USP <151>) | Biocompatible, compliance verified |
| Physical Performance (Leak testing, dimensional compatibility) | Stable over T=1, T=2, T=3 test intervals; dimensional compatibility verified |
| Luer connectors (ISO 594-1) | ISO 594 compliant |
| Syringe standards (ISO 7886-1) | Compliance verified |
| Risk Management (ISO 14971) | Compliance verified |
| Shelf Life | 3 years (equivalent to primary predicate) |
| Fill size compatibility | 60mL, 150mL (verified with compatible injectors) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for each individual test mentioned (e.g., how many syringes were subjected to leak testing). It only states that "Non-clinical performance (bench) tests conducted on the subject devices to support substantial equivalence includes comparison testing and physical performance testing." The data provenance is laboratory bench testing, not patient data, so country of origin or retrospective/prospective status is not applicable in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a bench study for substantial equivalence of a medical device (angiographic syringes), not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication method for the test set
Not applicable, as it is a bench testing study, not a study requiring expert adjudication of results.
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 disposable angiographic syringe, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a disposable angiographic syringe, not an algorithm.
7. The type of ground truth used
For dimensional compatibility and physical performance tests, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate/reference devices, as well as the requirements set by the various ISO and ASTM standards. For biocompatibility and sterility tests, the "ground truth" would be the chemical, biological, and physical parameters defined by the relevant standards (e.g., absence of cytotoxicity, pyrogens, harmful reactions).
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping to create a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Ecomed Solutions, LLC % Christina Henza Regulatory Ultra Lifescience Solutions, Inc 146 N. Greenview Ave Mundelein, Illinois 60060
Re: K162088
Trade/Device Name: Ecomed Disposable Angiographic Syringes Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: December 26, 2016 Received: December 28, 2016
Dear Christina Henza:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando
Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162088
Device Name
Ecomed Disposable Angiographic Syringes
Indications for Use (Describe)
The product is a family of Angiographic Syringes for the injection of contrast media and saline. The syringe is for single use with US legally marketed angiographic injectors.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510 (K) SUMMARY FOR ECOMED DISPOSABLE ANGIOGRAPHIC SYRINGES
1. Date Prepared: Jan 23, 2016
SUBMITTTER/ 510(K) HOLDER 2.
Ecomed Solutions, Inc. 214 Terrace Drive, Mundelein, IL 60060 Primary Contact: David Yurek david.yurek@ecomed-solutions.com Telephone: 866-817-7114 Fax: 847-984-9286
3. DEVICE NAME
| Proprietary Name: | Ecomed Disposable Angiographic Syringes |
|---|---|
| Common/Usual Name: | Angiographic Syringes |
| Classification Name: | Injector and Syringe, Angiographic |
| Device Class: | DXT |
| Product Code: | 21 C.F.R. § 870.1650 |
PREDICATE DEVICES 4.
The following legally marketed medical devices have been identified as predicates:
Primary Predicate:
-
Disposable Angiographic Syringes (WeiGao) K082439 ●
Reference Devices: -
Optistar Elite Injection System K073592
-
Syringe with Handi-fil K082212
-
Medrad Mark V Plus Injector K903390 ●
DEVICE DESCRIPTION ഗ്
The Ecomed Disposable Angiographic Syringes are disposable syringes for use with contrast delivery systems that deliver contrast media or saline into the vascular system for the purpose of obtaining enhanced diagnostic images. The syringes are available in several sizes and configurations to ensure compatibility with US legally marketed contrast delivery systems.
The syringes are provided in kits that are configured from the following list of components:
- . Syringe(s)
- . Fill tube
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- Vial Spike (small/large)
- . Transfer tubing set (length, y vs straight)
Kit Contents:
| Ecomed Kit Number | Kit Contents | MaximumPressure | CompatibleSystem |
|---|---|---|---|
| ECO-200360 | 150mL syringeJ shaped Fill tube (7.2 inch) | 1200 psi | Angiomat |
| ECO-100150 | 150mL syringeJ shaped Fill tube (7.2 inch) | 1200 psi | Mark IV and MarkV Plus |
| ECO-200801 | 60 mL SyringeY-type transfer tubing set (90 inch)large spike (3 inch) | 300 psi | Optistar Elite andOptistar LE |
| ECO-200800 | (2) 60 mL syringesY-type transfer tubing set (90 inch)large spike, small spike (3 inch) | 300 psi | Optistar Elite andOptistar LE |
INDICATIONS FOR USE 6.
The product is a family of Angiographic Syringes for the injection of contrast media and saline. The syringe is for single use with US legally marketed angiographic injectors.
PRINCIPLES OF OPERATION 7.
The principle of operation of the proposed Ecomed Disposable Angiographic Syringes are identical to the predicates, with the only variation being that they have the ability to connect to different injector systems which are supported by the inclusion of associated reference devices.
The Ecomed Disposable Angiographic Syringes are connected to US commercially available injector systems Angiomat, Mark IV and Mark V Plus, Optistar Elite and Optistar LE
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF PROPOSED COMPARED 8. TO THE PREDICATE DEVICE
The proposed Ecomed Disposable Angiographic Syringes are substantially equivalent in both function and use to the predicate device, K082439 (cleared on 03/23/2009). Reference devices K073592 (cleared on 05/07/20008), K082212 (cleared on 01/22/2009) and K903390 (cleared on 09/26/1990) are used to support dimensional variations from the predicate devices.
The predicate device and all of the reference devices are class II legally marketed devices as shown by the associated 510(k) numbers and clearance dates. All of the devices are disposable Angiographic Syringes for use with angiographic injectors, FDA product code DXT regulation number 870.1650.
All of the devices have the same intended use and primary technological characteristics. The different technological characteristics include dimensional differences between the syringes for the purpose of compatibility with different injectors. Comparison testing to reference devices Optistar Elite Injection
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System cleared via K073592 (05/07/20008), Syringe with Handi-fil (Angiomat) K082212 (01/22/2009) and Medrad Mark V Plus Injector K903390 (09/26/1990) are used to support dimensional variations from the predicate devices. The different technological characteristics are included in the risk assessment and testing (see section 14, 15, and 18). No new questions of safety and effectiveness were introduced.
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| Identification | Proposed Device | Predicate Device(Primary) | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
|---|---|---|---|---|---|---|
| Name | Ecomed DisposableAngiographic Syringes | DisposableAngiographic Syringes(WeiGao) | Optistar Elite InjectionSystem | Syringe with Handi-fil | Medrad Mark V PlusInjector | |
| Regulatory Information | 510(k)# | K162088 | K082439 | K073592 | K082212 | K903390 |
| Predicates | K082439 | K072696 | K984088 | K963071 | Unavailable | |
| Product Code | DXT | DXT | DXT | DXT | DXT | |
| Class | 2 | 2 | 2 | 2 | 2 | |
| CombinationProduct | No | No | No | No | No | |
| RegulationNumber | 870.1650 | 870.1650 | 870.1650 | 870.1650 | 870.1650 | |
| RegulationGeneric Name | Injector and Syringe,Angiographic | Injector and Syringe,Angiographic | Injector and Syringe,Angiographic | Injector and Syringe,Angiographic | Injector and Syringe,Angiographic | |
| Intended use | RegulationIntended Use | "used to inject contrastmaterial into the heart,great vessels, andcoronary arteries tostudy the heart andvessels by x-rayphotography." | "used to inject contrastmaterial into the heart,great vessels, andcoronary arteries tostudy the heart andvessels by x-rayphotography." | "used to injectcontrast material intothe heart, greatvessels, and coronaryarteries to study theheart and vessels by x-ray photography." | "used to injectcontrast materialinto the heart, greatvessels, andcoronary arteries tostudy the heart andvessels by x-rayphotography." | "used to injectcontrast materialinto the heart, greatvessels, andcoronary arteries tostudy the heart andvessels by x-rayphotography." |
| Indications | The product is a familyof Angiographic Syringesfor the injection ofcontrast media andsaline. The syringe is forsingle use with USlegally marketedangiographic injectors. | DisposableAngiographic Syringe isintended for theinjection of contrastmedia or saline. Thissyringe is for single usewith US legallymarketed angiographicinjectors. | The Optistar EliteInjection System is acontrast deliverysystem and is designedto inject MR contrastmedia and flushingsolutions into apatient's vascularsystem to obtaindiagnostic imageswhen used withMagneticResonance Imagingequipment. | The Syringe withHandi-Fil is part ofthe contrast deliverysystem which isdesigned to injectradiopaque contrastmedia and/or salineinto the vascularsystem forAngiographic or CTprocedures asprescribed byqualified healthcareprofessionals | This device isintended to be usedspecifically for thepurposes of injectingintravenous contrastmedium intohumans fordiagnostic studies. | |
| Identification | Proposed Device | Predicate Device(Primary) | Reference Device 1 | Reference Device 2 | Reference Device 3 | |
| Name | Ecomed DisposableAngiographic Syringes | DisposableAngiographic Syringes(WeiGao) | Optistar EliteInjection System | Syringe with Handi-fil | Medrad Mark VPlus Injector | |
| Anatomicalsites | Peripheral Intravenous | Peripheral Intravenous | PeripheralIntravenous | PeripheralIntravenous | PeripheralIntravenous | |
| Contact Type | External communicatingdevice -blood path,indirect | External communicatingdevice -blood path,indirect | Externalcommunicating device-blood path, indirect | Externalcommunicatingdevice -blood path,indirect | Externalcommunicatingdevice -blood path,indirect | |
| Contactduration | Limited ≤ 24 hours | Limited ≤ 24 hours | Limited ≤ 24 hours | Limited ≤ 24 hours | Limited ≤ 24 hours | |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible | Biocompatible | |
| Storageconditions | General warehouse. | General warehouse. | General warehouse. | General warehouse. | General warehouse. | |
| Shelf Life | 3 years | 3 years | 5 years | 3 years | 3 years | |
| Luer connectors | ISO 594 compliant | ISO 594 compliant | ISO 594 compliant | ISO 594 compliant | ISO 594 compliant | |
| Fill size | 60mL150 mL | 60 mL110mL200mL | 60mL | 150mL200mL | 150mL | |
| Technology | Compatibleinjectors | OptistarAngiomatMark IV and Mark V Plus | StellantSpectrisSolarisCT900 & CT900ADVDual Shot CT | Optistar | Angiomat | Mark IV and Mark VPlus |
Table 1. Comparison of Ecomed Disposable Angiographic Syringes with Predicate Devices
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SUMMARY OF NON-CLINICAL TESTING PERFORMANCE AS BASIS OF 9. SUBSTANTIAL EQUIVALENCE
The performance standards listed below were used to demonstrate substantial equivalence of the proposed Ecomed Disposable Angiographic Syringes to the predicate device included in K082439 (cleared on 03/23/2009). Reference devices cleared via K073592 (cleared on 05/07/20008), K082212 (cleared on 01/22/2009) and K903390 (cleared on 09/26/1990) are used to support dimensional variations from the predicate devices and confirmation of equivalence is shown by comparison testing.
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Non-clinical performance (bench) tests conducted on the subject devices to support substantial equivalence includes comparison testing and physical performance testing. Comparison testing was performed at T=0 to demonstrate dimensional compatibility with competitive syringe delivery systems by verifying the key physical dimensions that interact with the syringe delivery system (Barrel and Plunger dimensions). Physical Performance testing includes leak testing and an examination of fill tube diameters and extension tube diameters which are shown by the results to be stable over the T=1, T=2, and T=3 test intervals.
Testing was performed to verify compliance of the Ecomed Disposable Angiographic Syringes with the following standards:
- ISO 11135-1 sterilization of health-care products ethylene oxide requirements for the development, validation and routine control of a sterilization process for medical devices. (Sterility)
- · ISO 11607-1 packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging systems [including: amendment 1 (2014)]. (Sterility)
- ASTM F1980-07 (Reapproved 2011), standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
- · ISO 10993-1 (2009), "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process"
- · ISO 10993-5 (2010), "Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 (2009), "Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization"
- · ISO 10993-11 biological evaluation of medical devices part 11: tests for systemic toxici-ty. (Biocompatibility)
- USP <151> pyrogen test (usp rabbit test). (Sterility)
- · ASTM F756-13 standard practice for assessment of he-molytic properties of materi-als. (Biocompatibility)
- ISO 7886-1 sterile hypodermic syringes for single use part 1: syringes for manual use [includ-ing: technical corrigendum 1 (1995)]. (General Plastic Surgery/General Hospital
- ISO 594-1 conical fittings with a 6% (luer) taper for syringes, needles and certain other med-ical equipment - part 1: general require-ments. (General Plastic Surgery/General Hospital)
- ISO 14971 (2007), "Medical Devices-Risk Management, Part 1: Application of Risk Analysis to Medical Devices"
The results of this testing as confirm that the Ecomed Disposable Angiographic Syringes are substantially equivalent to the predicate and reference devices.
CONCLUSION DRAWN FROM NON-CLINICAL AND CLINICAL TESTS 10.
Based on the information and supporting documentation provided in the premarket notification, the Ecomed Disposable Angiographic Syringes are substantially equivalent to the cited predicate devices.
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Testing demonstrates that the Ecomed Disposable Angiographic Syringes fulfill prospectively defined design and performance specifications.
§ 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.