(42 days)
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Not Found
No
The summary describes a mechanical device for fluid transfer and filtration, with no mention of AI or ML capabilities.
No
The document describes a withdrawal cannula for transferring liquid and mentions safety for the patient through filtration and prevention of contamination and aerosols. While it interacts with patient fluids, its primary function is liquid transfer and contamination prevention, not directly treating a disease or condition.
No
The device is described as a "withdrawal cannula" for transferring liquid, preventing contamination, and filtering particles. Its function is to facilitate the safe transfer and handling of liquids, not to diagnose a condition or disease.
No
The device description clearly describes a physical medical device (withdrawal cannula) with hardware components (hydrophobic membrane, fluid filter). There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for transferring liquids between syringes and vials, filtering particles, and preventing contamination and aerosols. This is a function related to the preparation and administration of substances, not the testing of biological samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device described is a medical device used in the process of handling and preparing medications or other liquids for administration, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Withdrawal cannula for single use sterile transfer of liquid from a syringe vial and vice versa. Air enters and exits through a hydrophobic membrane which avoids extraneous contamination of the vial and syringe contents and prevents liquid aerosols from escaping into the environment. The integrated fluid filter provides for reliable filtration of particles and ensures a high degree of safety for patient.
Product codes
LHI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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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.
0
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 stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Reinhard Hopf Manager, Requlatory Affairs Clinico® Clinico Medical GmbH Robert-Koch-Straße 5 D-36222 Bad Hersfeld
വല്ല 2 2 1997
Re : K974198 Trade Name: Taky-Spike Plus Regulatory Class: II Product Code: LHI November 6, 1997 Dated: November 10, 1997 Received:
Dear Dr. Hopf:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ್ಕೆ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
1
Page 2 - Dr. Hopf
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely Yours
Timothy A. Ulatowski
Timo A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications For Use:
Page 1 of 1
510(k) Number (if known): K 974198 laky - Spike Plus Device Name:
With drawal cannula for single use sterile transfer of liquid from a syrings vial and vice versa. Air enters and exits the through a hydrophobic membrane which avoide extraneous contamination of the vist and syringe contents and prevents liquid aerosols from escaping into the environment. The integrated fluid filter provides for reliable filtration o particles and ensures a high degree of safety patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cucenotti
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)