(252 days)
No
The device is a simple mechanical cap for Luer fittings and the description and performance studies focus on its physical properties and compliance with standards, with no mention of AI or ML.
No
The device is described as a cap for Luer fittings on medical devices, used to cover fittings and securely join them. Its intended use and description do not suggest it is used for treating or diagnosing a disease or condition, but rather as an accessory component.
No
Explanation: The device is a cap for Luer fittings, designed to cover and secure connections on medical devices. Its function is to provide a sterile seal and compatibility, which are not diagnostic activities. The description and intended use clearly indicate it's a physical component for medical device management, not for diagnosing conditions.
No
The device description clearly states it is an injection molded, polyethylene component, which is a physical hardware product, 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 male Luer fittings on medical devices like manifolds, stopcocks, or IV sets. This is a mechanical function related to fluid delivery systems, not the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details a physical cap made of polyethylene for covering Luer fittings. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing specimens, detecting analytes, or providing diagnostic information. The focus is entirely on the physical function of capping a connection.
Therefore, the Female Luer Lock Cap is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Female Luer Lock Cap is indicated for use as a cap for male Luer fittings on medical devices such as manifolds, stopcocks or IV sets.
Product codes
FPA
Device Description
The Female Luer Lock Cap is an individually packaged, sterile, single use disposable product used to cover male Luer fittings. Luer fittings are commonly used on IV administration products and accessories to provide universal compatibility and are well established in the market. Luer lock fittings are securely joined by means of a tabbed hub on the female fitting which screws into threads in a sleeve on the male fitting. The Female Luer Lock Cap is an injection molded, polyethylene component. Polyethylene material is durable, biologically inert, gamma stable, and used extensively in the medical device industry. The product is terminally gamma sterilized to a Sterility Assurance Level (SAL) of 10-6.
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
The user group consists of those involved in pharmacy compounding, mainly pharmacy technicians and pharmacists, as well as health care professionals. Covering Luer fittings helps reduce the risk of touch contamination and medication leakage.
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
Bench testing was performed to demonstrate that the subject device is substantially equivalent to the predicate device, and that the basic design and function of the Female Luer Lock Cap complies with International Standards that specify dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for intravascular applications of medical devices and accessories.
Shelf life testing includes both simulated and real time aged product for both package integrity and product performance testing. Product and packaging underwent simulated distribution and conditioning prior to shelf life testing. Product and packaging testing are summarized in Table 5-2; testing is performed at multiple time points to support a shelf life of three years.
A product risk analysis was conducted according to ISO 14971 Medical devices - Application of risk management to medical devices and there were no new issues of safety and effectiveness.
Performance bench testing results meet acceptance criteria and verified the Female Luer Lock Cap meets applicable Industry Standard requirements for the design and functional performance, biocompatibility, sterilization and packaging, and demonstrates substantial equivalently to the predicate device.
No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2020
MedSafety Solutions LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K200425
Trade/Device Name: Female Luer Lock Cap Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: September 14, 2020 Received: September 16, 2020
Dear Prithul Bom:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Payal Patel for Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200425
Device Name Female Luer Lock Cap
Indications for Use (Describe)
The Female Luer Lock Cap is indicated for use as a cap for male Luer fittings on medical devices such as manifolds, stopcocks or IV sets.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 5: 510(K) SUMMARY
510(K) SUMMARY: K200425
DATE PREPARED: 10/19/2020
OWNER:
MedSafety Solutions LLC 7012 S. Revere Pkwy, Suite #120 Centennial, Colorado 80112
CONTACT PERSON:
Richard Weiskopf Sr. Director Quality & Regulatory Phone: 720-500-2500 ext. 210 Fax: 720-500-2571 Email: rich@medsafetysolutions.com
IDENTIFICATION OF THE DEVICE:
| Trade Name: | Female Luer Lock Cap |
|---|---|
| Common Name: | Female Luer Lock Cap |
| Classification Name: | IV Administration Set |
| Classification Panel: | 80 General Hospital |
| Classification: | 21 CRF 880.5440 |
| Class: | Class II |
| Product Code: | FPA |
| Subject Device Model No: | 75309 |
PREDICATE DEVICE(S):
| Device: | Dual Luer Lock Cap |
|---|---|
| Company: | Baxter Healthcare Corporation |
| 510(k) Number: | K101385 |
| Clearance Date: | June 22, 2010 |
DESCRIPTION OF DEVICE:
The Female Luer Lock Cap is an individually packaged, sterile, single use disposable product used to cover male Luer fittings. Luer fittings are commonly used on IV administration products and accessories to provide universal compatibility and are well established in the market. Luer lock fittings are securely joined by means of a tabbed hub on the female fitting which screws into threads in a sleeve on the male fitting. The Female Luer Lock Cap is an injection molded, polyethylene component. Polyethylene material is durable, biologically inert, gamma stable, and used extensively in the medical device industry. The product is terminally gamma sterilized to a Sterility Assurance Level (SAL) of 10-6.
The Female Luer Lock Cap is not associated with any specific medical condition. The user group consists of those involved in pharmacy compounding, mainly pharmacy
4
technicians and pharmacists, as well as health care professionals. Covering Luer fittings helps reduce the risk of touch contamination and medication leakage.
The basis for the premarket notification is a new device that has not been marketed previously by MedSafety Solutions. The Indications for Use, the basic design and function for the subject device are equivalent to the legally marketed predicate device.
INDICATIONS FOR USE:
The Female Luer Lock Cap is indicated for use as a cap for male Luer fittings on medical devices such as manifolds, stopcocks or IV sets.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The proposed device is substantially equivalent to Baxter Healthcare's current legally marketed device cleared under 510(k) premarket notification K101385 cleared June 22, 2010 given that the subject device has the same Indications for Use, basic design, and function as the predicate device.
The primary difference between the predicate device and the subject device is that the predicate has both male and female Luer connections whereas the subject device only has a male Luer lock connection.
The change in material from the predicate device from Polypropylene to Polyethylene does not raise new questions of safety or efficacy. Polypropylene and Polyethylene are both used extensively for medical products. Polyethylene was selected for the subject device because of its low moisture absorption, is biologically inert, gamma stable, is mechanically stable and the material's sustainability (i.e. recyclable). Performance testing of the subject device for the design and functional performance and biocompatibility assessment have demonstrated the subject device is substantially equivalent to the predicate device.
| Feature /
Specification | Predicate Device
Dual Luer Lock
Cap
K101385 | Subject Device
Female Luer Lock
Cap | Comparison |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Classification | Class II -FPA
IV Administration Set | Class II -FPA
IV Administration Set | Identical |
| 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. | The Female Luer
Lock Cap is
indicated for use as
a cap for male Luer
fittings on medical
devices such as
manifolds, stopcocks
or IV sets. | Substantially
Equivalent -
difference is the
predicate has both
male and female
Luer connections
whereas the subject
device only has a |
| Feature /
Specification | Predicate Device
Dual Luer Lock
Cap
K101385 | Subject Device
Female Luer Lock
Cap | Comparison |
| | | | male Luer lock
connection |
| Sterile | Yes | Yes | Identical |
| Sterility
Assurance Level | SAL of 10-6 | SAL of 10-6 | Identical |
| Single Use | Yes | Yes | Identical |
| Non-Pyrogenic | Yes | Yes | Identical |
| Materials | Injection molded,
Polypropylene
component
Biocompatibility
ISO 10993
• Cytotoxicity
• Sensitization
• Intracutaneous
Reactivity/
Irritation
• Systemic
Toxicity
• Hemo-
compatibility
• Material-
Mediated
Pyrogen
• Subacute
toxicity
• Subchronic
toxicity
Material shelf-life
ISO 594
• Ease of
assembly
ISO 80369-7
• Positive Pressure
Liquid Leakage
• Sub-atmospheric
Pressure Air
Leakage
• Stress Cracking
• Resistance to | Injection molded,
Polypropylene
component
Biocompatibility
ISO 10993
• Cytotoxicity
• Sensitization
• Intracutaneous
Reactivity/
Irritation
• Systemic
Toxicity
• Hemo-
compatibility
• Material-
Mediated
Pyrogen
• Subacute
toxicity
• Subchronic
toxicity
Material shelf-life
ISO 594
• Ease of
assembly
ISO 80369-7
• Positive Pressure
Liquid Leakage
• Sub-atmospheric
Pressure Air
Leakage
• Stress Cracking
• Resistance to | Substantially
Equivalent - material
difference does not
raise new questions
of safety or
effectiveness |
| Feature /
Specification | Predicate Device
Dual Luer Lock
Cap
K101385 | Subject Device
Female Luer Lock
Cap | Comparison |
| | Axial Load
• Resistance to
Separation from
Unscrewing
• Resistance to
Overriding | Axial Load
• Resistance to
Separation from
Unscrewing
• Resistance to
Overriding | |
Table 5-1: Comparison of Technological Characteristics
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6
PERFORMANCE DATA:
Bench testing was performed to demonstrate that the subject device is substantially equivalent to the predicate device, and that the basic design and function of the Female Luer Lock Cap complies with International Standards that specify dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for intravascular applications of medical devices and accessories.
Shelf life testing includes both simulated and real time aged product for both package integrity and product performance testing. Product and packaging underwent simulated distribution and conditioning prior to shelf life testing. Product and packaging testing are summarized in Table 5-2; testing is performed at multiple time points to support a shelf life of three years.
A product risk analysis was conducted according to ISO 14971 Medical devices -Application of risk management to medical devices and there were no new issues of safety and effectiveness.
Performance bench testing results meet acceptance criteria and verified the Female Luer Lock Cap meets applicable Industry Standard requirements for the design and functional performance, biocompatibility, sterilization and packaging, and demonstrates substantial equivalently to the predicate device.
| Table 5-2: Performance Summary | ||
|---|---|---|
| -- | -------------------------------- | -- |
| Performance Test | Testing Standard |
|---|---|
| Luer Connector | |
| Standard | ISO 594 Conical fittings with 6% (Luer) taper for syringes, |
| needles, and certain other medical equipment Part 1: General & | |
| Part 2: Lock fittings (FDA FR 6-129) | |
| • Ease of assembly | |
| Performance Test | Testing Standard |
| Luer Connector | |
| Standard | ISO 80369-7 Small-bore connectors for liquids and gases in |
| healthcare applications - Part 7: Connectors with 6% (Luer) | |
| taper for intravascular or hypodermic applications (FDA FR 5- |
-
|
| | • Positive Pressure Liquid Leakage |
| | • Sub-atmospheric Pressure Air Leakage |
| | • Stress Cracking |
| | • Resistance to Separation from Axial Load |
| | • Resistance to Separation from Unscrewing
• Resistance to Overriding |
| Biocompatibility | ISO 10993-1 Biological Evaluation of Medical Devices - Part 1:
Evaluation and Testing (FDA FR 2-258) |
| | • Cytotoxicity |
| | • Sensitization |
| | • Intracutaneous Reactivity / Irritation |
| | • Systemic Toxicity |
| | • Hemocompatibility |
| | • Material-Mediated Pyrogen |
| | • Bacterial Endotoxins Test
• Subacute Toxicity
• Subchronic Toxicity |
| Sterilization | ANSI/AAMI/ISO11137-1 Sterilization of health care products.
Radiation - Part 1: Requirements for development, validation
and routine control of a sterilization process for medical devices
(FDA FR 14-528) and ANSI/AAMI/ISO 11137-2 Sterilization of
health care products - Radiation - Part 2: Establishing the
sterilization dose (FDA FR 14-409) |
| | • VDmax15
• Sterility Assurance Level of 10-6 |
| Package Integrity | ASTM F1929-15 Standard Test Method for Detecting Seal Leaks
in Porous Medical Packaging by Dye Penetration (FDA FR 14-
484)
ASTM F88/F88M-15 Standard Test Method for Seal Strength of
Flexible Barrier Materials (FDA FR 14-482) |
7
8
ASSESSMENT OF CLINICAL DATA:
There were no clinical studies conducted in support of a substantial equivalence determination.
CONCLUSION:
Review of the bench performance test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility demonstrate that the subject device, Female Luer Lock Cap is substantially equivalent to the predicate device, the Baxter Dual Luer Lock Cap (K101385). Any differences between the subject and the predicate device do not raise any issues of safety and effectiveness.