(182 days)
No
The device description and intended use clearly define a simple tubing set for transferring contrast media, with no mention of any computational or analytical capabilities that would involve AI or ML. The performance studies are bench tests related to material properties and fluid transfer, not algorithmic performance.
No
The device is a sterile tubing set used for transferring contrast media, not for direct therapeutic treatment.
No
The device is described as a "sterile tubing set connection" for transferring contrast media, which is used during imaging procedures but does not perform diagnosis itself.
No
The device description clearly outlines physical components (tubing, spike, valve, caps) and bench testing related to these physical components and their interaction with fluids and chemicals, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the transfer of contrast media for imaging procedures (CT). This is a physical process of moving a substance, not a diagnostic test performed in vitro (outside the body) on a specimen to provide information about a patient's health.
- Device Description: The device is a tubing set for connecting containers and syringes. It facilitates the delivery of a substance, not the analysis of a biological sample.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological specimen to diagnose, monitor, or screen for a disease or condition.
- Performance Studies: The performance studies focus on the physical properties and functionality of the transfer set (flow rate, compatibility, microbial ingress), not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device's function is purely for the delivery of a contrast agent used in an imaging procedure.
N/A
Intended Use / Indications for Use
The ulrich Transfer Set is indicated for the transfer of OmnipaqueTM (Iohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated. whichever occurs first.
Product codes
PQH
Device Description
The ulrich Transfer Set (Transfer Set) is a sterile tubing set connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast injection systems. The Transfer Set consists of a spike with protective cap and integrated air filter on one side, 20" (50.8 cm) tubing segment and one female swabable (also referenced as swabbable) valve (Swabsite Swabbable Valve - K002689) with a protective cap on the other side. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous side
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The ulrich Transfer Set was tested for performance and verified in accordance with the following standards:
- . ISO 8536-4 - 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- . ISO 22413:2010, Transfer sets for pharmaceutical preparations -- Requirements and test methods
- . ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings (Swabsite Swabbable Valve, K002689)
Additional testing included:
- . Microbial ingress testing;
- . Chemical compatibility - Through evaluation of conformance to the approved release specification of Omnipaque.
- Extractables and simulation testing for leachable compounds and particulates. .
Test and verification results indicate that the ulrich Transfer Set complies with its predetermined specifications and the applicable standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol with three figures facing right, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
ulrich GmbH & Co. KG c/o Ms. Rita King MethodSense, Inc. PO Box 110352 Durham, North Carolina 27709
Re: K161723
Trade/Device Name: ulrich Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Sets Regulatory Class: II Product Code: PQH Dated: December 16, 2016 Received: December 19, 2016
Dear Ms. Rita King:
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.
1
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 device-related adverse events) (21 CFR 803); 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.
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" (21CFR 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,
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161723
Device Name ulrich Transfer Set
Indications for Use (Describe)
The ulrich Transfer Set is indicated for the transfer of OmnipaqueTM (Iohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated. whichever occurs first.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary
ulrich GmbH & Co. KG K161723
This 510(k) Summary is in conformance with 21CFR 807.92
| Submitter: | ulrich GmbH & Co. KG
Buchbrunnenweg 12
89081 Ulm
Germany
Phone: +49 731 9654-1714
Fax: +49 731 9654-2807 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO
MethodSense, Inc.
Email: ritaking@methodsense.com
Phone: 919-313-3961
Fax: 919-313-3979 |
| Company Contact: | Sven Erdmann
Director Development & Product Management Devices |
| Date Prepared: | December 20 2016 |
| Device Name and Classification | |
| Trade Name: | ulrich Transfer Set |
| Common Name: | Iodinated Contrast Media Transfer Set |
| Classification: | Class II |
| Regulation Number/Name: | 21 CFR 880.5440, Intravascular Administration Set |
| Classification Panel: | General Hospital Devices Branch (GHDB) |
| Product Code: | PQH |
| Predicate Device: | |
| Trade Name: | Bracco Injeneering Transfer Set |
| Common Name: | Intravascular Administration Set |
| 510(k) Submitter / Holder | Bracco Injeneering S.A. |
| 510(k) Number | K133147 |
| Classification: | Class II |
| Regulation Number: | 21 CFR 880.5440, Intravascular Administration Set |
| Classification Panel: | General Hospital |
| Product Code: | FPK |
| Reference Device: | |
| Trade Name: | Swabsite Swabbable Valve |
| Common Name: | Intravascular Administration Set Swabbable Valve |
| 510(k) Submitter / Holder | QUEST MEDICAL, INC |
| 510(k) Number | K002689 |
| Classification: | Class II |
| Regulation Number: | 21 CFR 880.5440, Intravascular Administration Set |
| Classification Panel: | General Hospital |
| Product Code: | FPA |
4
Device Description and Intended Use
The ulrich Transfer Set (Transfer Set) is a sterile tubing set connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast injection systems. The Transfer Set consists of a spike with protective cap and integrated air filter on one side, 20" (50.8 cm) tubing segment and one female swabable (also referenced as swabbable) valve (Swabsite Swabbable Valve - K002689) with a protective cap on the other side. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.
The Transfer Set is intended for the transfer of fluids from bulk containers to empty sterile syringes on syringe based contrast injector systems.
Indications for Use
The ulrich Transfer Set is indicated for the transfer of Omnipaque™ (lohexol) contrast media as supplied in an Imaging Bulk Package to non pre-filled single-use only sterile syringes on syringe-based contrast injection systems indicated for the controlled, automatic administration on the venous side of contrast media for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 8 hours have elapsed since the container was penetrated, whichever occurs first.
Risk Analysis Method
The ulrich Transfer Set was assessed to determine the risks to health associated with the use of intravascular administration sets and accessories. A risk analysis was conducted in accordance with ISO 14971:2012, Medical devices -- Application of risk management to medical devices. Several risks were assessed including, but not limited to, device malfunction, adverse tissue reaction, infection and improper use.
Substantial Equivalence
The ulrich Transfer Set is substantially equivalent to the Bracco Injeneering Transfer Set (K133147) predicate device currently on the market.
ulrich Transfer Set has the same intended use as the Bracco Injeneering Transfer Set. The ulrich Transfer Set has substantially equivalent indications for use with the Bracco Injeneering Transfer Set. Ulrich transfer set is indicated for the transfer of Omnipaque ™ (lohexol) contrast media as supplied in an Imaging Bulk Package while the Bracco Injeneering Transfer Set is indicated for the transfer of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package. ulrich Transfer Set uses equivalent overall design and operating principals to Bracco Injeneering Transfer Set.
The table below provides a detailed comparison of ulrich Transfer Set to the predicate device.
Detailed Comparison of the Subject and Predicate Device
5
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Intended Use | The transfer set is intended for the | ||
| transfer of fluids from bulk | |||
| containers to empty sterile syringes | |||
| on syringe-based contrast injection | |||
| systems. | The transfer set is intended for the | ||
| transfer of fluids from bulk containers | |||
| to empty sterile syringes on syringe | |||
| based contrast delivery systems | |||
| (injectors). | Identical to the Predicate | ||
| device. | |||
| Indications for Use | The ulrich Transfer Set is indicated | ||
| for the transfer of OmnipaqueTM | |||
| (lohexol) contrast media as supplied | |||
| in an Imaging Bulk Package to non | |||
| pre-filled single-use only sterile | |||
| syringes on syringe-based contrast | |||
| injection systems indicated for the | |||
| controlled, automatic administration | |||
| on the venous side of contrast media | |||
| for CT procedures. The Transfer Set | |||
| is to be discarded after the contrast | |||
| media container has been depleted | |||
| or 8 hours have elapsed since the | |||
| container was penetrated, whichever | |||
| occurs first. | The Bracco Injeneering Transfer Set | ||
| is a component of a contrast | |||
| management system and is indicated | |||
| for the transfer of Isovue (lopamidol | |||
| Injection) contrast media as supplied | |||
| in an Imaging Bulk Package to empty | |||
| sterile syringes on single-use only | |||
| syringe-based contrast injection | |||
| systems indicated for the controlled, | |||
| automatic administration on the | |||
| venous side, of contrast agents for CT | |||
| procedures. The Transfer Set is to be | |||
| discarded after the contrast media | |||
| container has been depleted or 10 | |||
| hours has elapsed since the container | |||
| was penetrated, whichever occurs | |||
| first. | Substantially equivalent to the | ||
| Predicate device. | |||
| Tubing Length | 20" | 20" | Identical to the Predicate |
| device. | |||
| Single Use | Yes | Yes | Identical to the Predicate |
| device. | |||
| Biocompatible | Yes | Yes | Substantially equivalent to the |
| Predicate device. | |||
| Sterile | Yes | Yes | Identical to the Predicate |
| device. | |||
| Sterility Assurance | |||
| Level | 10-6 | 10-6 | Identical to the Predicate |
| device. | |||
| Item | Subject Device | Predicate Device | Comparison |
| ulrich Transfer Set | Bracco Injeneering Transfer Set | ||
| Sterilization Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Identical to the Predicate |
| device. | |||
| Disposable | Yes | Yes | Substantially equivalent to the |
| Predicate device. | |||
| Shelf Life | one (1) year shelf life | one (1) year shelf life | Identical to the Predicate |
| device. | |||
| Packaging | Individually packaged in a Tyvek | ||
| pouch | Individually packaged in a Tyvek | ||
| pouch | Substantially equivalent to the | ||
| Predicate device. | |||
| Microbial Ingress | |||
| Testing | Yes | Yes | Substantially equivalent to the |
| Predicate device. | |||
| Chemical Compatibility | |||
| Testing | Yes | Yes | Substantially equivalent to the |
| Predicate device. | |||
| Protective Cap for | |||
| swabable valve | Yes | No | The ulrich Transfer Set |
| provides a protective cap for | |||
| the swabbable valve. |
6
7
Reference Device
The ulrich Transfer Set uses a female swabable valve, Swabbable Valve Application (K002689) by QUEST MEDICAL, INC without any changes to the valve. Halkey-Roberts Corporation is the current legal manufacturer of the Swabsite Swabbable Valve while QUEST MEDICAL, INC is the 510(k) Submitter.
Testing
Sterilization:
The ulrich Transfer Set is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level of 10 ° in accordance with the following standard prior to commercial distribution:
- . ISO 11135-1: 2014, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
Verification results indicate that the ulrich Transfer Set complies with the standard.
Shelf-Life:
The ulrich Transfer Set is sterilized and its packaging was validated in accordance with the following standards:
- . ISO 11607-1: 2006 Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems; and
- . ISO 11607-2: 2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes.
Verification results indicate that the ulrich Transfer Set complies with the standards.
Biocompatibility:
The ulrich Transfer Set indirect patient contact materials were verified in accordance with the following standards:
- . ISO 10993-4: 2009 Biological evaluation of medical devices Part 4: Selections of tests for interactions with blood
- . ISO 10993-5: 2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization
- ISO 10993-11: 2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ASTM F756-13 Standard Practice for Assessment of Haemolytic Properties Materials ●
- ASTM F619-14 Standard Practice for Extraction of Medical Plastics ●
8
- USP 38 Pyrogen Test, 38-NF33:2015
- USP 38 2015 Bacterial Endotoxins Test .
- . USP 38 2014 Transfusion and infusion assemblies and similar medical devices
Verification results indicated that the materials comply with the standards.
Performance - Bench:
The ulrich Transfer Set was tested for performance and verified in accordance with the following standards:
- . ISO 8536-4 - 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- . ISO 22413:2010, Transfer sets for pharmaceutical preparations -- Requirements and test methods
- . ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings (Swabsite Swabbable Valve, K002689)
Additional testing included:
- . Microbial ingress testing;
- . Chemical compatibility - Through evaluation of conformance to the approved release specification of Omnipaque.
- Extractables and simulation testing for leachable compounds and particulates. .
Test and verification results indicate that the ulrich Transfer Set complies with its predetermined specifications and the applicable standards.
Substantial Equivalence Conclusion
In conclusion, the intended use for the ulrich Transfer Set is the same as that of the predicate device. The technological characteristics comparison and testing demonstrates that the ulrich Transfer Set is substantially equivalent to predicate device.