SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.

Device Description

SwabCap is a plastic threaded cap that houses a small sponge saturated with 70% isopropyl alcohol. The device is designed to securely fit on swab-able luer access valves to disinfect the valve surface and maintain antiseptic conditions between line accesses. SwabCap" is a sterile, single-use device, provided as a stand-alone product.

AI/ML Overview

This FDA 510(k) summary for the SwabCap® device (K130975) focuses on demonstrating substantial equivalence to a predicate device (SwabCap® K083508) rather than providing a detailed study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial for a novel AI device. The submission is primarily aimed at extending the indications for use (from 96 hours to 7 days of disinfection) for a modified version of an already cleared device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, sample size for training set, ground truth for training set) are not applicable or explicitly mentioned in this type of regulatory submission as they would be for an AI/ML medical device.

However, I can extract the relevant information and infer some aspects based on the provided document.

Acceptance Criteria and Device Performance

The acceptance criteria here are implicitly related to maintaining the efficacy of disinfection for an extended period (up to 7 days) while demonstrating safety and substantial equivalence to the predicate device. The performance is assessed through non-clinical testing.

Acceptance Criteria (Implied)	Reported Device Performance
Disinfect the valve within five (5) minutes after application.	SwabCap® will disinfect the valve five (5) minutes after application. (Stated in Indications for Use document, consistent with predicate).
Maintain a disinfected valve surface for up to seven (7) days.	SwabCap® maintains a disinfected valve surface for up to seven (7) days if not removed. (This is the new extended indication and is the primary performance claim supported by the non-clinical testing).
Act as a physical barrier to contamination.	The SwabCap® acts as a physical barrier to contamination between line accesses. (Stated in Indications for Use document, consistent with predicate).
Biocompatibility	Biocompatibility studies were undertaken to support the changes to the product. (Implied successful completion to meet safety requirements).
Sterilization validation	Sterilization validation was undertaken to support the changes to the product. (Implied successful completion to ensure sterility, device is sterile via Gamma irradiation).
Antimicrobial efficacy for extended duration (up to 7 days).	Antimicrobial testing was undertaken to support the changes to the product and its intended use. (Implied successful completion to demonstrate efficacy for the 7-day claim).
Substantial Equivalence to Predicate (K083508)	The data provided within the 510(k) submission support that the product is as safe and as effective as the predicate device, and therefore, is substantially equivalent to the identified predicate device.

Study Details (Based on available information)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided summary. As this is a non-clinical submission for a device component, these "test sets" would likely refer to laboratory samples (e.g., luer access valves, material samples) subjected to standardized testing protocols, not a human patient cohort.
- Data Provenance: Not specified. Experiments would typically be conducted in a controlled lab setting, likely in the US where the manufacturer is located, or by certified contract research organizations. The testing described is prospective, in that it evaluates the device's performance under controlled conditions.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/mentioned. For non-clinical antimicrobial efficacy, toxicology, and sterilization testing, the "ground truth" is established by validated laboratory assays and adherence to relevant standards (e.g., ISO, ASTM, USP). The expertise would be in microbiology, material science, and toxicology, employed by the testing facility, rather than clinical experts for ground truth labeling.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for human interpretation tasks, not for non-clinical laboratory testing of device efficacy. Assays have defined endpoints and criteria for success, typically interpreted by a single qualified lab technician or scientist according to a protocol.
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
- No. This is not an AI/ML device, and thus an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm; it is a physical medical device (disinfectant cap). Its performance is inherently "standalone" in the sense that it mechanically disinfects, without human interpretation in its function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Validated Laboratory Assays: This includes standardized microbiological methods to quantify bacterial reduction/inhibition, chemical analysis to verify alcohol concentration, and material science tests for biocompatibility and structural integrity. The "ground truth" is the quantitative result of these assays compared against predetermined acceptance limits derived from regulatory standards and scientific principles.
The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.

Summary

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

Excelsior Medical Corp. John Linfante 1933 Heck Ave Neptune, NJ 07753

March 31, 2022

Re: K130975

Trade/Device Name: Swabcap And Swabflush Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP

Dear John Linfante:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 24, 2013 and the correction letter dated March 6, 2019. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation 880.5440.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, Ob-Gyn, General Hospital and Urology Devices, 240-402-6029, Payal.Patel(@fda.hhs.gov.

Sincerely.

Payal Patel Assistant Director for General Hospital Devices DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, Ob-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of a seal on the left, followed by the letters "FDA" in a black square, and the words "U.S. FOOD & DRUG ADMINISTRATION" to the right. The seal features an eagle and other symbols, while the text is in a bold, sans-serif font.

March 6. 2019

Excelsior Medical Corp. John Linfante 1933 Heck Ave Neptune. NJ 07753

Re: K130975

Trade/Device Name: SwabCap® and SwabFlush® Regulatory Class: Unclassified Product Code: QBP Dated: April 8, 2013 Received: April 8, 2013

Dear John Linfante:

This letter corrects our substantially equivalent letter of December 24, 2013.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially 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. Iisting 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.

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

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K130975 - John Linfante

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html : 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number:	K130975
Device Name:	SwabFlush® (3 mL saline in 10 mL syringe, 5 mL saline in 10 mL syringe, and 10 mL saline in 10 mL syringe)
Indication for Use:	The flush syringe is intended for the flushing of IV catheters andIV tubing.SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.

510(k) Number:

K130975

Device Name:

SwabFlush® (3 mL saline in 10 mL syringe, 5 mL saline in 10 mL syringe, and 10 mL saline in 10 mL syringe)

Indication for Use:

The flush syringe is intended for the flushing of IV catheters andIV tubing.SwabCap® is intended for use on swab-able luer access valves as a cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.

Prescription Use X (21 CFR Part 801 Subpart D)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sreekanth - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Division Sign-Off Office of Device Evaluation

K130975 510(k) ==

V1-132

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Indications for Use

K130975 · 510(k) Number:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SwabCap® Device Name:

SwabCap® is intended for use on swab-able luer access valves as a Indication for Use: cover to protect the luer access valves from potential contamination. The SwabCap® acts as a physical barrier to contamination between line accesses and also serves as a disinfecting cleaner for use prior to line access. SwabCap® will disinfect the valve five (5) minutes after application and maintains a disinfected valve surface for up to seven (7) days if not removed.

X Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sreekanth ... , : ... ... ... Gutala - S .

Division Sign-Off Office of Device Evaluation

K130975 510(k)

V1-131

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Excelsior Medical Corporation K130975

510(k) Summary

DEC 2 4 2013

Manufacturer Name:	Excelsior Medical Corporation
Address:	1933 Heck AvenueNeptune, NJ 07753
Contact Name:	John Linfante
Title:	VP Regulatory and Quality Assurance
Phone Number:	732-643-6088
Fax Number:	732-776-7600
Date Prepared:	November 1, 2013

Device Proprietary Name:	SwabCap®
Device Common or Usual Name:	Device Disinfectant Cap
Classification Name:	Pad, Alcohol, Device Disinfectant
Classification Code:	LKB
Regulation Number:	N/A
Device Classification	Unclassified

Predicate Devices:

Substantial equivalence is claimed to the following device as related to intended use, design, and material characteristics:

SwabCap®, Excelsior Medical Corporation, K083508 .

Description of the Device

Intended Use/Indications for Use

The purpose of this 510(k) is to extend the indications for use to include surface disinfection for up to 7 days.

" .

Page 1 of 3

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Summary of Technological Characteristics

The subject SwabCap® has similar technological characteristics as the predicate device in terms of design, chemical composition, and materials of construction.

Both devices are designed with a standard luer thread to fit on swab-able luer access valves. There have been no changes to the product dimensions, antimicrobial agent, and sterilization processes.

Slight modifications of the cap and colorant resin materials, as well as the foil lid cover were made to improve manufacturing efficiency or due to product availability. All changes were made within the same generic material families and were implemented under design controls.

Comparison of Substantial Equivalence

The Substantial Equivalence table below compares the intended use and key technological and design characteristics of the subject and predicate devices. A discussion of the similarities and differences in technological characteristics is provided above.

510(k)Number	SwabCap®K130975	SwabCap®K083508
Intended Use	SwabCap® is intended for use onswab-able luer access valves as acover to protect the luer accessvalves from potentialcontamination.The SwabCap® acts as a physicalbarrier to contamination betweenline accesses and also serves as adisinfecting cleaner for use priorto line access.SwabCap® will disinfect thevalve five (5) minutes afterapplication and maintains adisinfected valve surface for upto seven (7) days if not removed.	The SwabCap® is intended foruse on swab-able luer accessvalves as a disinfecting cleanerprior to line access and to act as aphysical barrier to contaminationbetween line accesses.SwabCap® will disinfect thevalve five (5) minutes afterapplication and act as a physicalbarrier to contamination for up toninety-six (96) hours undernormal conditions if notremoved.
Design	Same	Designed with standard luerthread to fit on swab-able lueraccess valves.
Materials	• Holder - same	• Holder - Alathon M6580

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Excelsior Medical Corporation K130975

510(k)Number	SwabCap®K130975	SwabCap®K083508
	Cap - same Sponge - same Colorant - Pantone 151C	Cap - Medical grade Santoprene Sponge - SUGI absorbent material Colorant - Pantone 151C
AntimicrobialAgent	Same	70% Isopropyl Alcohol
Dimensions	Same	Diameter 20 mmHeight 13.5 mm
Sterility	Same	Gamma irradiated

Non-Clinical Testing

Non-clinical testing including biocompatibility studies, sterilization validation, and antimicrobial testing were undertaken to support the changes to the product and its intended use.

Conclusion

The data provided within the 510(k) submission support that the product is as safe and as effective as the predicate device, and therefore, is substantially equivalent to the identified predicate device.

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.