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.

AI/ML Overview

The provided text describes the regulatory filing for a medical device called the "Female Luer Lock Cap" and details its equivalence to a predicate device. It is a 510(k) summary, which focuses on demonstrating substantial equivalence rather than a new clinical trial for effectiveness. Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, effect sizes, specific expert qualifications, or training set sizes) is not applicable or present in this document.

However, I can extract the acceptance criteria and a summary of the performance testing as requested for the substantial equivalence determination for this non-AI/ML medical device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the international standards that the Female Luer Lock Cap is tested against. The document states that "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."

Here's a table summarizing the tests, the standards they adhere to (which define the acceptance criteria), and the general reported outcome:

Performance Test Category	Testing Standard(s) / Acceptance Criteria	Reported Device Performance
Luer Connector Standard	ISO 594 Part 1 & Part 2 (FDA FR 6-129):	Meets standard requirements
	- Ease of assembly
	ISO 80369-7 (FDA FR 5-115):	Meets standard requirements
	- 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 (FDA FR 2-258):	Meets standard requirements
	- Cytotoxicity
	- Sensitization
	- Intracutaneous Reactivity / Irritation
	- Systemic Toxicity
	- Hemocompatibility
	- Material-Mediated Pyrogen
	- Bacterial Endotoxins Test
	- Subacute Toxicity
	- Subchronic Toxicity
Sterilization	ANSI/AAMI/ISO 11137-1 & 11137-2 (FDA FR 14-528 & 14-409):	Meets standard requirements
	- VDmax15
	- Sterility Assurance Level (SAL) of 10-6	Achieved SAL of 10-6
Package Integrity	ASTM F1929-15 (FDA FR 14-484):	Meets standard requirements
	- Detecting Seal Leaks by Dye Penetration
	ASTM F88/F88M-15 (FDA FR 14-482):	Meets standard requirements
	- Seal Strength of Flexible Barrier Materials
Shelf Life	No specific standard listed, but tests for "package integrity and product performance" at "multiple time points" for "three years" are mentioned.	Three-year shelf life supported

Additional Information (Not Applicable for this type of device/submission)

The following information is typically relevant for AI/ML device studies involving human interpretation and clinical data, which is not the case for this 510(k) submission of a physical luer lock cap.

Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the device and packaging used for bench testing. The provenance of these physical samples (e.g., from which manufacturing batch) is not specified, nor is it typically required for this type of summary. Data provenance like "country of origin of data" or "retrospective/prospective" refers to clinical data, which was not used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties (like leakage, strength, or sterility) is established by adherence to physical test standards and instrumentation, not human expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no human interpretation or subjective assessment that would require adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a physical medical device, not an AI-powered diagnostic/assistance tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance is objective measurement based on established international and ASTM standards (e.g., ISO 594, ISO 80369-7, ISO 10993-1, ISO 11137, ASTM F1929, ASTM F88/F88M) for physical and biological properties.
The sample size for the training set: Not applicable. There is no AI/ML model being trained.
How the ground truth for the training set was established: Not applicable.

Summary

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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.

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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 not associated with any specific medical condition. The user group consists of those involved in pharmacy compounding, mainly pharmacy

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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 DeviceDual Luer LockCapK101385	Subject DeviceFemale Luer LockCap	Comparison
ProductClassification	Class II -FPAIV Administration Set	Class II -FPAIV Administration Set	Identical
Indications forUse	The Dual Luer LockCap is indicated foruse as a cap formale or female Luerports on medicaldevices such asmanifolds, stopcocksor sets.	The Female LuerLock Cap isindicated for use asa cap for male Luerfittings on medicaldevices such asmanifolds, stopcocksor IV sets.	SubstantiallyEquivalent -difference is thepredicate has bothmale and femaleLuer connectionswhereas the subjectdevice only has a
Feature /Specification	Predicate DeviceDual Luer LockCapK101385	Subject DeviceFemale Luer LockCap	Comparison
			male Luer lockconnection
Sterile	Yes	Yes	Identical
SterilityAssurance Level	SAL of 10-6	SAL of 10-6	Identical
Single Use	Yes	Yes	Identical
Non-Pyrogenic	Yes	Yes	Identical
Materials	Injection molded,PolypropylenecomponentBiocompatibilityISO 10993• Cytotoxicity• Sensitization• IntracutaneousReactivity/Irritation• SystemicToxicity• Hemo-compatibility• Material-MediatedPyrogen• Subacutetoxicity• SubchronictoxicityMaterial shelf-lifeISO 594• Ease ofassemblyISO 80369-7• Positive PressureLiquid Leakage• Sub-atmosphericPressure AirLeakage• Stress Cracking• Resistance to	Injection molded,PolypropylenecomponentBiocompatibilityISO 10993• Cytotoxicity• Sensitization• IntracutaneousReactivity/Irritation• SystemicToxicity• Hemo-compatibility• Material-MediatedPyrogen• Subacutetoxicity• SubchronictoxicityMaterial shelf-lifeISO 594• Ease ofassemblyISO 80369-7• Positive PressureLiquid Leakage• Sub-atmosphericPressure AirLeakage• Stress Cracking• Resistance to	SubstantiallyEquivalent - materialdifference does notraise new questionsof safety oreffectiveness
Feature /Specification	Predicate DeviceDual Luer LockCapK101385	Subject DeviceFemale Luer LockCap	Comparison
	Axial Load• Resistance toSeparation fromUnscrewing• Resistance toOverriding	Axial Load• Resistance toSeparation fromUnscrewing• Resistance toOverriding

Table 5-1: Comparison of Technological Characteristics

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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 ConnectorStandard	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 ConnectorStandard	ISO 80369-7 Small-bore connectors for liquids and gases inhealthcare applications - Part 7: Connectors with 6% (Luer)taper for intravascular or hypodermic applications (FDA FR 5-115)
	• 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, validationand routine control of a sterilization process for medical devices(FDA FR 14-528) and ANSI/AAMI/ISO 11137-2 Sterilization ofhealth care products - Radiation - Part 2: Establishing thesterilization dose (FDA FR 14-409)
	• VDmax15• Sterility Assurance Level of 10-6
Package Integrity	ASTM F1929-15 Standard Test Method for Detecting Seal Leaksin Porous Medical Packaging by Dye Penetration (FDA FR 14-484)ASTM F88/F88M-15 Standard Test Method for Seal Strength ofFlexible Barrier Materials (FDA FR 14-482)

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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.

Regulation Number and Section

§ 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.