Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a simple disinfecting cap with isopropyl alcohol, with no mention of AI or ML capabilities.

Therapeutic

No
A therapeutic device is one that treats or alleviates a disease or condition. The SwabCap™ is a disinfecting cleaner and physical barrier for luer access valves, which serves a preventative rather than a therapeutic function.

Diagnostic

No
The device is a disinfecting cleaner and physical barrier, not a tool for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical cap containing isopropyl alcohol, indicating it is a hardware device with a chemical component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SwabCap™ is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the SwabCap™ is for disinfecting and acting as a physical barrier on luer access valves prior to line access. This is a direct interaction with a medical device (the valve) and the patient's access point, not for testing samples in vitro (outside the body).
Device Description: The description focuses on the physical design of the cap and the presence of isopropyl alcohol for disinfection. There is no mention of analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: The provided information does not include any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Mentioning assays, reagents, or laboratory procedures

The SwabCap™ is a medical device used for infection control and maintaining the sterility of a patient's intravenous access point. It falls under the category of devices used in patient care, not for laboratory testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

QBP

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.

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)

Not Found

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.

K080579, K080466, Unknown

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

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.

Summary

0

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,

P

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

1

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

2

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

3

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: __

4

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

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.

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.

5

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
Device Name	SwabCap™	Effectiv™ Cap	Curos™ Port
Protector	Alcohol Prep
Pad
Manufacturer	Excelsior
Medical Corp.	Hospira, Inc.	Ivera Medical
Corporation	Professional
Disposables Inc.
Intended Use	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.	The Effectiv™
Cap is a device
containing 70%
IPA. When left
in place for 5 to
10 minutes the
cap
decontaminates
the injection
port; thereafter
the cap provides
a physical barrier
during intended
use.	The Curos™ Port
Protector is a
device
containing 70%
Isopropyl
alcohol. When
left in
place for 5 to 15
minutes the
Curos™ Port
Protector
decontaminates
the injection
port; thereafter
the Curos™ Port
Protector
provides a
physical barrier
during the
intended use.	For topical
cleansing prior
to injections or
venipuncture.
Each soft pad is
saturated with
70% isopropyl
alcohol.

Table J-1: Comparison to Predicates for SwabCap"

349

6

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.

i