(21 days)
No K/DEN numbers were found in the text.
Not Found
No
The 510(k) summary describes a mechanical drug dispensing spike and does not mention any AI or ML components or functionalities.
No.
The device is described as a drug dispensing spike used for reconstitution, dilution, and withdrawal of drugs, not for direct therapeutic application to a patient.
No
The Safe-Connect™ Drug Dispensing Spike is described as a device for dispensing and reconstituting drugs, facilitating drug preparation and withdrawal. Its intended use is related to drug administration, not diagnosis. There is no mention of it being used to detect, monitor, or analyze health conditions or diseases.
No
The device description and intended use clearly describe a physical, sterile, single-use spike for dispensing drugs, which is a hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dispensing drugs from drug containers," "addition of liquid diluents to powdered drug products for reconstitution," "addition of liquids to concentrated liquid drugs for dilution," and "withdrawal of the reconstituted and liquid drug products from drug containers." These are all related to the preparation and administration of medications, which is a clinical procedure performed on a patient, not a diagnostic test performed on a sample in vitro (outside the body).
- Device Description: The description reinforces its use in "general administration of fluids," again pointing towards clinical use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the handling and preparation of medications for administration.
N/A
Intended Use / Indications for Use
The Safe-Connect™ Drug Dispensing Spike is a sterile, single use, needle-less access spike for use in general administration of fluids and/or removal of drugs from standard drug containers. The Safe-Connect™ Drug Dispensing Spike may aid in the prevention of needle stick injuries.
The Safe-Connect™ Drug Dispensing Spike is a sterile, non-pyrogenic, single use device to be used in dispensing drugs from drug containers. The device is to be used by a trained healthcare professional using Aseptic Techniques for the addition of liquid diluents to powdered drug products for reconstitution, addition of liquids to concentrated liquid drugs for dilution, and/or the withdrawal of the reconstituted and liquid drug products from drug containers by the use of a standard luer tapered syringe. The device is indicated to allow for multiple accesses and withdrawals from the same drug container using standard hospital disinfectant solutions and procedures without the requirement of using a sterile cap to maintain fluid path integrity. The Safe-Connect™ Drug Dispensing Spike may aid in the prevention of needle stick injuries.
Product codes
FPA
Device Description
The Safe-Connect™ Drug Dispensing Spike is a sterile, single use, needle-less access spike for use in general administration of fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the fabrication of this Drug Dispensing Spike were evaluated with the original and proposed designs through biocompatibility testing. The proposed devices will perform in an equivalent manner to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Safe Connect™ Vial Dispensing Spike
Reference Device(s)
Not Found
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
Ko.3/783
SUMMARY OF SAFETY AND EFFECTIVENESS 10.0
| Manufacturer: | IntraVascular Incorporated
3600 Bur Wood Drive
Waukegan, Illinois 60085 |
|------------------------|-------------------------------------------------------------------------------|
| Contact: | Steve Aperavich
President, IntraVascular Incorporated |
| Telephone Number: | 847-596-7700 |
| Fax Number: | 847-596-7710 |
| Date Summary Prepared: | June 9, 2003 |
| Product Trade Name: | Safe Connect™ Drug Dispensing Spike |
| Common Name: | Needle-less Access Spike |
| | Classification: Set, Administration, IntraVascular
21 CFR 880.5440 |
| Predicate Devices: | Safe Connect™ Vial Dispensing Spike |
Description:
The Safe-Connect™ Drug Dispensing Spike is a sterile, single use, needle-less access spike for use in general administration of fluids.
Intended Uses/Indications:
The Safe-Connect [M Drug Dispensing Spike is a sterile, single use, needle-less access spike for use in general administration of fluids and/or removal of drugs from standard drug containers. The Safe-Connect™ Drug Dispensing Spike may aid in the prevention of needle stick injuries.
Substantial Equivalence:
The Safe Connect™ Drug Dispensing Spike is substantially equivalent to the current Safe Connect™ Vial Dispensing Spike in that:
- Have the same intended use. .
- . Use the same operating principle,
- Incorporate the same final design configuration
- e Are both labeled as single patient use
- Are packaged and labeled using the same materials and processes
IntraVascular Incorporated Safe-Connect™ Vial Access Spike Special 510(k) Notification
1
Summary of Testing:
All materials used in the fabrication of this Drug Dispensing Spike were evaluated with the original and proposed designs through biocompatibility testing. The proposed devices will perform in an equivalent manner to the predicate devices.
.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or progress. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL I 2003
Mr. Steve Aperavich President Intra Vascular Incorporated 3600 Bur Wood Drive Waukegan, Illinois 60085
Re: K031783
Trade/Device Name: Safe-Connect Drug Dispensing Spike Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 6, 2003 Received: June 10, 2003
Dear Mr. Aperavich:
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.
3
Page 2 - Mr. Aperavich
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) 594-4618. 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 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,
Susan Runner, DDS, MA
Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Safe-Connect™ Drug Dispensing Spike
KO31783
Indications For Use:
The Safe-Connect™ Drug Dispensing Spike is a sterile, non-pyrogenic, single use device to be used in dispensing drugs from drug containers. The device is to be used by a trained healthcare professional using Aseptic Techniques for the addition of liquid diluents to powdered drug products for reconstitution, addition of liquids to concentrated liquid drugs for dilution, and/or the withdrawal of the reconstituted and liquid drug products from drug containers by the use of a standard luer tapered syringe. The device is indicated to allow for multiple accesses and withdrawals from the same drug container using standard hospital disinfectant solutions and procedures without the requirement of using a sterile cap to maintain fluid path integrity. The Safe-Connect™ Drug Dispensing Spike may aid in the prevention of needle stick injuries.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use OR (Per 21 CFR 801.109)
Over -The-Counter Use
0 3 2
Patino Cuente
(Division Sign-Off) Division of Dental, Infection Control, And General Hospital Devices
510(k) Number K031783
IntraVascular Incorporate Safe-Connect™ Vial Dispensing Spike Special 510(k) Notification