(35 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use as a simple cap, with no mention of AI or ML technologies.
No.
The device is a cap for Luer ports on medical devices, used to cover open ports. It does not exert any direct therapeutic effect on a patient.
No
The device is described as a "cap for male or female Luer ports on medical devices." Its intended use is to "cover an open Luer port after the Luer port has been accessed and is no longer in use." This function is for containment and protection, not for diagnosing a medical condition.
No
The device description explicitly states it is a "sterile Dual Luer Lock Cap" and describes its physical components (male and female Luer lock connections), indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cap Luer ports on medical devices. This is a mechanical function related to maintaining sterility and preventing leakage, not for performing tests on samples taken from the human body.
- Device Description: The description focuses on the physical design and function of the cap for covering Luer ports. There is no mention of reagents, samples, or any process related to analyzing biological materials.
- Lack of IVD Indicators: The document does not contain any of the typical indicators of an IVD, such as:
- Mention of analyzing samples (blood, urine, tissue, etc.)
- Reference to diagnostic purposes or providing information about a patient's health status.
- Description of assays, reagents, or analytical methods.
The device is a simple accessory for medical devices, designed to maintain the integrity of Luer connections.
N/A
Intended Use / Indications for Use
The Dual Luer Lock Cap is indicated for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The subject of this submission is a sterile Dual Luer Lock Cap which will be used to cover male or female Luer ports on medical devices. The proposed Dual Luer Lock Cap will replace the existing Dual Luer Lock Cap and will be sold as a cap to cover an open Luer port after the Luer port has been accessed and is no longer in use. The Dual Luer Lock Cap consists of an integrated design with a male Luer lock connection on one end and a female Luer lock connection on the other end.
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)
Performance Data: The Dual Luer Lock Cap meets the Bench performance testing requirement according to ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements and ISO 594-2:1986 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings Luer requirements. The Dual Luer Lock Cap is a cap for male or female Luer ports on medical devices.
Biocompatibility: Biocompatibility assessment of the Dual Luer Lock Cap has been conducted based on ISO 10993-1 - Biological Evaluation of Medical Devices. Based upon the results of this prolonged duration, external communicating, indirect blood path testing the material used to fabricate the Dual Luer Lock Cap has been shown to be biocompatible and appropriate for its intended use.
Baxter Healthcare Corporation conducts risk analyses and design verification tests are based on the result of these analyses. All test results meet the acceptance criteria and support that the device is appropriately designed for the intended use. The Dual Luer Lock Cap meets the Bench performance testing requirement according to ISO 594-1 and 594-2 specified as follows:
- Air leakage
- · Separation Force
- Unscrewing torque
- Ease of assembly
- Stress cracking
- Liquid leakage test
- · Luer gauging
- · Resistance to overriding
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
5. 510(k) SUMMARY
June 14, 2010
OWNER:
JUN 2 2 2 2010
Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015
CONTACT PERSON:
Nanette Hedden Senior Manager, Global Regulatory Affairs 1620 Waukegan Road McGaw Park, IL, 60085 Telephone: (847) 270-4871 Fax: (847) 785-5116
DEVICE NAME:
Trade name: Dual Luer Lock Cap
Common name: IV Administration Set
Classification name: IV Administration Set, 21 CFR 880.5440, FPA, Class II
PREDICATE DEVICE:
| Device | Company | Previous
510(k) | Clearance date |
|--------------------|----------------------|--------------------|----------------|
| Dual Luer Lock Cap | Baxter
Healthcare | K981318 | April 22, 1998 |
Table 5-1. Previous 510(k)s
1
DESCRIPTION OF THE DEVICE:
The subject of this submission is a sterile Dual Luer Lock Cap which will be used to cover male or female Luer ports on medical devices. The proposed Dual Luer Lock Cap will replace the existing Dual Luer Lock Cap and will be sold as a cap to cover an open Luer port after the Luer port has been accessed and is no longer in use. The Dual Luer Lock Cap consists of an integrated design with a male Luer lock connection on one end and a female Luer lock connection on the other end.
STATEMENT OF INTENDED USE:
The Dual Luer Lock Cap is indicated for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
The Dual Luer Lock Cap is an injection molded, polypropylene component. The intended use and function of the proposed Dual Luer Lock Cap is identical to the predicate device.
Performance Data: The Dual Luer Lock Cap meets the Bench performance testing requirement according to ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements and ISO 594-2:1986 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings Luer requirements. The Dual Luer Lock Cap is a cap for male or female Luer ports on medical devices.
Biocompatibility: Biocompatibility assessment of the Dual Luer Lock Cap has been conducted based on ISO 10993-1 - Biological Evaluation of Medical Devices. Based upon the results of this prolonged duration, external communicating, indirect blood path testing the material used to fabricate the Dual Luer Lock Cap has been shown to be biocompatible and appropriate for its intended use.
DISCUSSION OF NONCLINICAL TESTS:
Baxter Healthcare Corporation conducts risk analyses and design verification tests are based on the result of these analyses. All test results meet the acceptance criteria and support that the device is appropriately designed for the intended use. The Dual Luer Lock Cap meets the Bench performance testing requirement according to ISO 594-1 and 594-2 specified as follows:
2
K101385
Special 510(k) Premarket Notification Dual Luer Lock Cap
- Air leakage
- · Separation Force
- Unscrewing torque
- Ease of assembly
- Stress cracking
- Liquid leakage test
- · Luer gauging
- · Resistance to overriding
CONCLUSION:
The Dual Luer Lock Cap is substantially equivalent to Baxter's current legally marketed Dual Luer Lock Cap cleared April 22, 1998 (K981318).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or shapes, arranged in a vertical stack.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 2 2010
Ms. Nanette Hedden Senior Manager, Global Regulatory Affairs Baxter Healthcare Corporation 1620 Waukegan Road McGaw Park, Illinois 60085
Re: K101385
Trade/Device Name: Dual Luer Lock Cap, Model 2C650 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 14, 2010 Received: June 16, 2010
Dear Ms. Hedden:
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.
4
Page 2- Ms. Hedden
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 go to
http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours
Susan Penrose
Anthony D. Watson, B.S., M.S., M.B.A. 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 (if known): K (0) 385
Device Name: Dual Luer Lock Cap
Indications for Use:
The Dual Luer Lock Cap is indicated for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.
Prescription Use _________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rell C. Angan 6/22/2010
(Division Sign-Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital 'nfection Control, Dental Devices
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
- ' - ' - ' ' ' } Number:
510(k) Number: