SwabCap ™ is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. SwabCap ™ will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed.

Device Description

The SwabCap™ is designed to securely fit on swab-able luer access valves. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, preservative free and DEHP free.

AI/ML Overview

The provided text describes a medical device called "SwabCap™" and its regulatory clearance based on substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, study details, or performance data in the format requested. Instead, it focuses on the administrative aspects of its FDA 510(k) clearance.

Therefore, I cannot populate the table or provide detailed answers to most of your questions as the information is not present in the provided text.

Here's what I can extract from the document regarding the device and its claims, alongside areas where information is missing:

Device: SwabCap™

Intended Use: For use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses. It is claimed to disinfect the valve 5 minutes after application and act as a physical barrier for up to 96 hours.

I cannot create a table of acceptance criteria and reported device performance because this information is not provided in the document. The document states that the device is "substantially equivalent" to predicate devices based on intended use, design, technology, antimicrobial agent, and performance, but it does not detail the specific performance metrics or acceptance criteria used to establish this.

Here’s a breakdown of the specific information requested and whether it's available:

A table of acceptance criteria and the reported device performance:
- Not available. The document asserts substantial equivalence based on performance but does not quantify or present specific acceptance criteria or corresponding performance results.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. There is no mention of specific studies or test sets (like clinical trials or lab tests with sample sizes) used to support the performance claims. The clearance is based on substantial equivalence to existing predicate devices.
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/Not available. Since there are no detailed de novo performance studies described, there's no mention of experts establishing ground truth for a test set. The review process involved FDA officials evaluating the submission for substantial equivalence.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. No test set or adjudication method is described.
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. This device is a medical accessory, not an AI imaging or diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available directly for this device. The concept of "ground truth" as typically used for AI or diagnostic devices is not explicitly stated. The regulatory decision is based on comparing the device's characteristics and claims to those of legally marketed predicate devices, implying that the established safety and effectiveness of the predicates serve as a benchmark.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.

What the document does tell us:

Predicate Devices:
- Effectiv™ Cap, Hospira, Inc., K080579
- Curos Port Protector, Ivera Medical, K080466
- Alcohol Prep Pad, Professional Disposables Inc. (510(k) Number: Unknown)
Key features of SwabCap™ for comparison:
- Intended Use: Same as the description above.
- Antimicrobial Agent: 70% Isopropyl Alcohol (similar to predicates)
- Additional Claims: DEHP, Latex, and Preservative Free.
- Sterilization: Gamma Irradiated.
- Packaging: Individually wrapped with peel-off foil lid.
Basis of Clearance: Substantial equivalence to the listed predicate devices based on intended use, design, technology, antimicrobial agent, and performance. The clearance is a reaffirmation of a prior determination, with an administrative change to its categorization.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left, and the FDA logo on the right. The FDA logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

Excelsior Medical Corp. Roshana Ahmed Manager c/o CanReg, Incorporated 4 Innovation Drive Dundas, On, L2H 7P3 Canada

March 11, 2022

Re: K083508

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

Dear Roshana Ahmed:

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 April 28, 2009 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 & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine. The agency's name is written in bold, sans-serif font, with "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.

March 6, 2019

Excelsior Medical Corp. Roshana Ahmed Manager 4 Innovation Drive Dundas. Ontario. L2H 7P3 Canada

Re: K083508 Trade/Device Name: SwabCapTM Regulatory Class: Unclassified Product Code: QBP Dated: November 24, 2008 Received: November 26, 2008

Dear Roshana Ahmed:

This letter corrects our substantially equivalent letter of April 28, 2009.

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 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.

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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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K083508 - Roshana Ahmed

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 medical devices and radiation-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

Enclosure

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K083508

Excelsior Medical Corporation Traditional 510(k)

SwabCap™

Indications for Use

510(k) Number:	K083508
Device Name:	SwabCap TM
Indication for Use:	SwabCap TM is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses.
	SwabCap TM will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to

ninety-six (96) hours under normal conditions 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)

H. Ol
for

Division Sign-Off . Office of Device Evaluation

510(k)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KO83508 510(k) Number: __

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510(k) Summary of Safety and Effectiveness

Manufacture Name:	Excelsior Medical Corporation
Contact Name:	John Linfante
Title	VP Regulatory and Quality Assurance
Postal Address:	1933 Heck Avenue
	Neptune, NJ 07753
Phone Number:	732-643-6088
Fax:	732-776-7600
Date:	February 12, 2009
Device Proprietary Names:	SwabCap™
Device Common or Usual Name:	Alcohol pad
Classification Name:	Pad, Alcohol, Device Disinfectant
Classification Code	LKB
Classification Panel	General Hospital
Regulation Number	N/A

Predicate Device:

Substantial equivalence is claimed to the following devices as related to intended use and design characteristics:

Effectiv™ Cap, Hospira, Inc., K080579 .
. Curos Port Protector, Ivera Medical, K080466
Alcohol Prep Pad, Professional Disposables Inc. 510(k) Number: Unknown .

Description of the Device

Intended Use of the Device

SwabCap" is intended for use on swab-able luer access valves as a disinfecting cleaner prior to line access and to act as a physical barrier to contamination between line accesses.

SwabCap" will disinfect the valve five (5) minutes after application and act as a physical barrier to contamination for up to ninety-six (96) hours under normal conditions if not removed.

Substantial Equivalence

The SwabCap " is similar to the predicate devices based on the intended use, design, technology, antimicrobial agent and performance.

Conclusion

Based on the information provided in this 510(k) premarket notification, the SwabCap" is substantially equivalent in terms of safety and effectiveness to the predicate devices identified above.

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K083505
2 of 3

SwabCap™

Section J - Substantial Equivalence

Table J-1 compares the SwabCap™ to the predicate devices.

510(k) Number	K083508	K080579	K080466	Unknown
Device Name	SwabCap™	Effectiv™ Cap	Curos™ PortProtector	Alcohol PrepPad
Manufacturer	ExcelsiorMedical Corp.	Hospira, Inc.	Ivera MedicalCorporation	ProfessionalDisposables Inc.
Intended Use	SwabCap™ isintended for useon swab-ableluer accessvalves as adisinfectingcleaner prior toline access andto act as aphysical barrierto contaminationbetween lineaccesses.	The Effectiv™Cap is a devicecontaining 70%IPA. When leftin place for 5 to10 minutes thecapdecontaminatesthe injectionport; thereafterthe cap providesa physical barrierduring intendeduse.	The Curos™ PortProtector is adevicecontaining 70%Isopropylalcohol. Whenleft inplace for 5 to 15minutes theCuros™ PortProtectordecontaminatesthe injectionport; thereafterthe Curos™ PortProtectorprovides aphysical barrierduring theintended use.	For topicalcleansing priorto injections orvenipuncture.Each soft pad issaturated with70% isopropylalcohol.For professionaland hospital use.
AdditionalClaims	DEHP, Latexand PreservativeFree	DEHP and LatexFree	unknown	unknown
AntimicrobialAgent	70% IsopropylAlcohol	70% IsopropylAlcohol	70% IsopropylAlcohol	70% IsopropylAlcohol
Sterilization	GammaIrradiated	Unknown	Non-sterile	Gammairradiated
Packaging	Individuallywrapped withpeel off foil lid	Individuallywrapped withpeel off foil lid	Individuallywrapped.	Individuallypackaged inpackets.

Table J-1: Comparison to Predicates for SwabCap"

349

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Image /page/6/Picture/1 description: The image shows the word "SwabCap" in a stylized font, with the letters slightly spaced apart. Above the word "SwabCap", there are two lines of text that appear to be handwritten. The first line of text is "K08352", and the second line of text is "3df3".

Discussion:

The SwabCap™ device is similar to the predicate devices in terms of intended use, design and material characteristics.

Conclusion:

It is concluded that the SwabCap™ device is substantially equivalent to the predicate devices.

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.