(76 days)
Not Found
No
The device description explicitly states it is a "passive device" with an "internal mechanism" for sealing, and there is no mention of AI, ML, or related concepts in the provided text.
No.
The device is designed for safe handling of fluids to prevent leakage and contamination during preparation, administration, and waste handling of substances like chemotherapy, not for direct therapeutic treatment of a patient's disease or condition.
No
The device is designed for safe handling and transfer of fluids, particularly hazardous ones, to prevent leakage and contamination. It does not perform any diagnostic function.
No
The device description clearly describes a physical, mechanical luer connector with an internal sealing mechanism, not a software product.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device's function as providing leak-free handling of fluids (chemotherapy, radioactive isotopes, blood products, etc.) during drug preparation, administration, and waste handling. This is a function related to the handling and delivery of substances, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description focuses on the mechanical design of the luer connector and its ability to seal upon disconnection to prevent leakage. This reinforces its role in fluid handling, not diagnostic testing.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Using reagents or assays
The device is a medical device used in the context of patient care and drug handling, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Safety Male Luer is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, during all three phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling.. The Safety Male Luer is intended to reduce environmental surface contamination of the work area.
The Safety Male Luer is indicated for use when reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The SML is a sealed male luer. The SML is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling.
The SML is a passive device – it requires no cap and automatically seals upon disconnection. An optional female cap will be provided for transport and an optional priming cap will be provided to allow the user to prime as necessary.
The Safety Male Luer (SML) is a unique male luer connector that is intended to be used with the currently marketed SmartSite® Needle Free Valve port and standard open female luers. The SML design includes an internal mechanism that causes the luer to seal when disconnected. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer. Thus, the SML is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products. Furthermore, the SML reduces environmental surface contamination of the work surface when used to reconstitute, dispense/transfer, administer, and dispose of hazardous or non-hazardous fluids when used in conjunction with SmarSite® Needle-Free Valve port.
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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data indicate that the Alaris® Safety Male Luer meets specified requirements and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
ORIGINAL PREMARKET 510
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products®
SAFETY MALE LUER
JAN 1 2 2006
SUBMITTER INFORMATION
| A. | Company Name: | Cardinal Health, Alaris® Products |
|---|---|---|
| B. | Company Address: | 10221 Wateridge Circle |
| San Diego, CA 92121-2733 | ||
| C. | Company Phone: | |
| Company Fax: | (858) 458-7830 | |
| (858) 458-6114 | ||
| D. | Contact Person: | Stacy L. Lewis |
| Sr. Regulatory Affairs Specialist | ||
| Cardinal Health, Alaris® Products | ||
| E. | Date Summary Prepared: | October 25, 2005 |
DEVICE IDENTIFICATION
| A. | Generic Device Name: | Intravascular Administration Set |
|---|---|---|
| B. | Trade/Proprietary Name: | Alaris® Safety Male Luer |
| C. | Classification: | Class II |
| D. | Product Code: | FPA, Intravascular Administration Set |
DEVICE DESCRIPTION
The SML is a sealed male luer. The SML is designed to promote safe handling of fluids and medications, particularly hazardous or cytotoxic drugs. Leakage of drug into the environments is effectively avoided during all phases of drug handling when the SML is used in conjunction with the SmartSite® Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling.
1
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products SAFETY MALE LUER Page 2 of 3
DEVICE DESCRIPTION (Continued)
The SML is a passive device – it requires no cap and automatically seals upon disconnection. An optional female cap will be provided for transport and an optional priming cap will be provided to allow the user to prime as necessary.
The Safety Male Luer (SML) is a unique male luer connector that is intended to be used with the currently marketed SmartSite® Needle Free Valve port and standard open female luers. The SML design includes an internal mechanism that causes the luer to seal when disconnected. In doing so, it prevents the dripping or accidental spillage of fluids that otherwise occur when using a standard, unsealed male luer. Thus, the SML is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products. Furthermore, the SML reduces environmental surface contamination of the work surface when used to reconstitute, dispense/transfer, administer, and dispose of hazardous or non-hazardous fluids when used in conjunction with SmarSite® Needle-Free Valve port.
SUBSTANTIAL EQUIVALENCE
The Cardinal Health, Alaris® Products Safety Male Luer is of comparable type and is substantially equivalent to the following predicate devices:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| PhaSeal System | Carmel Pharma AB | K972527 | 9/18/97 |
| CML 1000 | ICU Medical, Inc. | K051437 | 8/3/05 |
INTENDED USE
The Safety Male Luer is intended to provide leak-free handling of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, during all three phases of drug handling when the SML is used in conjunction with the SmartSite®
2
KOS-304-9
ORIGINAL PREMARK
SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris® Products SAFETY MALE LUER Page 3 of 3
INTENDED USE (Continued)
Needle Free Valve port: the preparation of the drug, the administration of the drug to the patient, and waste handling.. The Safety Male Luer is intended to reduce environmental surface contamination of the work area.
TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Alaris® Safety Male Luer and the predicate devices has been performed. The results of this comparison demonstrate that the Alaris® Safety Male Luer is equivalent to the marketed predicate devices in technological characteristics.
PERFORMANCE DATA
The performance data indicate that the Alaris® Safety Male Luer meets specified requirements and is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight, with three curved lines representing the wings and a human profile in the negative space.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2006
Ms. Stacy L. Lewis Senior Regulatory Affairs Specialist Cardinal Health, Alaris® Products 10221 Wateridge Circle San Diego, California 92121-2772
Re: K053049
Trade/Device Name: Alaris® Safety Male Luer Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 25, 2005 Received: October 28, 2005
Dear Ms. Lewis:
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 cnactment 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. Fxisting 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.
4
Page 2 - Ms. Lewis
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number:
K053049 (To Be Assigned By FDA)
Device Trade Name:
Indications For Use:
The Safety Male Luer is indicated for use when reconstituting, dispensing/ transferring, administering, and disposal of potentially hazardous fluids, such as chemotherapy, radioactive isotopes, and blood products, as well as non-hazardous fluids. The Safety Male Luer is intended for use with the SmartSite® Needle Free Valve port or standard open female luers.
Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D. mc
tion, and :nanges
K45↓49