(260 days)
No
The device description and performance studies focus on the physical and chemical properties of the cap and disinfectant, with no mention of AI or ML.
No
Explanation: The device is intended to disinfect luer access valves and act as a barrier to contamination, rather than directly treating a medical condition or disease in a patient.
No
The device is described as a disinfecting cleaner and a physical barrier to contamination for luer access valves. It does not perform any diagnostic function such as detecting, identifying, or monitoring a disease or condition.
No
The device description explicitly states it is a "plastic threaded cap that houses a small sponge saturated with 70% isopropyl alcohol," indicating it is a physical hardware device with a chemical component, not software.
Based on the provided information, the SwabCap® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that SwabCap® is for protecting and disinfecting luer access valves. This is a device used externally on medical equipment, not for testing samples taken from the human body to diagnose conditions.
- Device Description: The description details a physical cap with an alcohol-saturated sponge, designed to fit on a valve. This aligns with a medical device used for disinfection and protection, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the SwabCap® is a medical device used for disinfection and protection of medical equipment, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
QBP, LKB
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.
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)
Non-clinical testing including biocompatibility studies, sterilization validation, and antimicrobial testing were undertaken to support the changes to the product and its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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
3
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 |
| 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. |
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
5
Excelsior Medical Corporation K130975
510(k) Summary
DEC 2 4 2013
| Manufacturer Name: | Excelsior Medical Corporation |
|---|---|
| Address: | 1933 Heck Avenue |
| 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.
" .
Page 1 of 3
6
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 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 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. |
| Design | Same | Designed with standard luer
thread to fit on swab-able luer
access valves. |
| Materials | • Holder - same | • Holder - Alathon M6580 |
7
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 |
| Antimicrobial
Agent | Same | 70% Isopropyl Alcohol |
| Dimensions | Same | Diameter 20 mm
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.