SWABCAP AND SWABFLUSH
Device Facts
| Record ID | K130975 |
|---|---|
| Device Name | SWABCAP AND SWABFLUSH |
| Applicant | Excelsior Medical Corp. |
| Product Code | QBP · General Hospital |
| Decision Date | Dec 24, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
Indications for Use
The flush syringe is intended for the flushing of IV catheters and IV 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.
Device Story
SwabCap is a sterile, single-use plastic threaded cap containing a sponge saturated with 70% isopropyl alcohol. It is designed to fit onto swab-able luer access valves. The device functions as a physical barrier to contamination and a disinfecting agent; it disinfects the valve surface within five minutes of application and maintains disinfection for up to seven days if left in place. SwabFlush consists of saline-filled syringes for flushing IV catheters and tubing. These devices are used in clinical settings to maintain catheter patency and prevent contamination of access points. Healthcare providers apply the cap to the valve; the physical presence of the cap provides a barrier between line accesses, reducing the risk of catheter-related bloodstream infections.
Clinical Evidence
Bench testing only. Includes biocompatibility studies, sterilization validation, and antimicrobial testing to support the 7-day disinfection claim.
Technological Characteristics
Plastic threaded cap; 70% isopropyl alcohol-saturated sponge; standard luer thread interface. Materials include generic plastic families (holder, cap, colorant). Sterilization via gamma irradiation. Single-use, standalone device.
Indications for Use
Indicated for use on swab-able luer access valves to protect against contamination and disinfect the valve surface prior to line access. Also indicated for flushing IV catheters and IV tubing.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- SwabCap®, Excelsior Medical Corporation (K083508)
Submission Summary (Full Text)
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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 and<br>IV tubing.<br><br>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 Avenue<br>Neptune, 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
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.
#### Intended Use/Indications for Use
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.
The purpose of this 510(k) is to extend the indications for use to include surface disinfection for up to 7 days.
" .
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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)<br>Number | SwabCap®<br>K130975 | SwabCap®<br>K083508 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | SwabCap® is intended for use on<br>swab-able luer access valves as a<br>cover to protect the luer access<br>valves from potential<br>contamination.<br><br>The SwabCap® acts as a physical<br>barrier to contamination between<br>line accesses and also serves as a<br>disinfecting cleaner for use prior<br>to line access.<br><br>SwabCap® will disinfect the<br>valve five (5) minutes after<br>application and maintains a<br>disinfected valve surface for up<br>to seven (7) days if not removed. | The SwabCap® is intended for<br>use on swab-able luer access<br>valves as a disinfecting cleaner<br>prior to line access and to act as a<br>physical barrier to contamination<br>between line accesses.<br><br>SwabCap® will disinfect the<br>valve five (5) minutes after<br>application and act as a physical<br>barrier to contamination for up to<br>ninety-six (96) hours under<br>normal conditions if not<br>removed. |
| Design | Same | Designed with standard luer<br>thread to fit on swab-able luer<br>access valves. |
| Materials | • Holder - same | • Holder - Alathon M6580 |
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### Excelsior Medical Corporation K130975
| 510(k)<br>Number | SwabCap®<br>K130975 | SwabCap®<br>K083508 |
|------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------|
| | Cap - same Sponge - same Colorant - Pantone 151C | Cap - Medical grade Santoprene Sponge - SUGI absorbent material Colorant - Pantone 151C |
| Antimicrobial<br>Agent | Same | 70% Isopropyl Alcohol |
| Dimensions | Same | Diameter 20 mm<br>Height 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.
