(176 days)
Not Found
No
The device description and intended use focus on a physical barrier and chemical disinfection using isopropyl alcohol. There is no mention of AI or ML in the provided text.
No.
The device's primary function is disinfection and providing a physical barrier against contamination, which are preventative measures rather than direct treatment or therapy for a medical condition.
No
The DualCap™ is described as a device that disinfects and provides a physical barrier to contamination for Luer access valves and IV administration line male Luer connections. It is a cleaning and protective device, not one that identifies or analyzes a disease or condition.
No
The device description clearly indicates a physical product (cap) containing a chemical (isopropyl alcohol) intended for disinfection and providing a physical barrier. There is no mention of software components.
Based on the provided information, the DualCap™ is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to disinfect and provide a physical barrier to contamination for needleless Luer access valves and IV administration line male Luer connections. This is a direct action on medical devices used for patient care, not on biological samples taken from the body.
- Device Description: The device contains isopropyl alcohol and is designed to fit onto medical device connections. This aligns with a disinfectant and barrier function, not with analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), detection of diseases, or providing information for diagnosis.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The DualCap™ does not fit this definition.
N/A
Intended Use / Indications for Use
When left in place for five (5) minutes the female component of DualCap™ disinfects needleless Luer access valves and the male component of DualCap™ disinfects the IV administration line male Luer connections; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
Product codes
QBP, LKB, FPA
Device Description
The DualCap™ is designed to fit securely on Luer access valves and IV administration line male Luer connections. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, non-pyrogenic, preservative free and DEHP free.
Additionally DualCap™, the device will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterile to the kitting manufacturer (DualCap™ will be packaged in metalized unit container and will be impervious to ETO). The Catheter Connections' DualCap™ will be incorporated into the procedure kit.
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
Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols.
Performance data gathered demonstrated that the Catheter Connections' DualCap™ is substantially equivalent to the noted predicate devices.
The Catheter Connections' DualCap™ will meet all established acceptance criteria for performance testing. This testing demonstrated that the Catheter Connections' DualCap™ is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the above noted predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K083508, K080579, K080466, K833182, K981318
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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
Catheter Connections, Inc. Donald Solomon, Ph.D. President and COO 25 White Pine Canyon Rd. Park City, Utah 84060
March 11, 2022
Re: K093229
Trade/Device Name: Catheter Connections Dualcap Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: QBP
Dear Dr. Donald Solomon:
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 8, 2010 and the correction letter dated December 14, 2018. 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,
Pror
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). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a black square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in black.
December 14, 2018
Catheter Connections, Inc. Donald Solomon 25 White Pine Canyon Rd. Park City, Utah 84060
Re: K093229
Trade/Device Name: Catheter Connections Dualcap Regulatory Class: Unclassified Product Code: OBP Dated: October 12, 2009 Received: October 14, 2009
Dear Donald Solomon:
This letter corrects our substantially equivalent letter of April 8, 2010
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
2
K093229 - Donald Solomon
statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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 (QS) 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,
FDA Tina Kiang
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
510(k) Premarket Notification Submission: CATHETER CONNECTIONS' DUALCAP™
Indications For Use
510(k) Number (if known):
Device Name: Catheter Connections' DualCap™
Indications For Use:
When left in place for five (5) minutes the female component of DualCap™ disinfects needleless Luer access valves and the male component of DualCap™ disinfects the IV administration line male Luer connections; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
An Ste for CLE
(Divišion Sign-Off) Division of Anesthesiology, General Hospital fection Control, Dental Devices
CONFIDENTIAL
10(k) Ni
4
Page 26 of 119
CATHETER CONNECTIONS, INC.
510(k) Premarket Notification Submission: CATHETER CONNECTIONS' DUALCAP™
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for CATHETER CONNECTIONS' DUALCAP™
SUBMITTER:
Catheter Connections, Inc. 25 White Pine Canyon Rd. Park City, UT 84060
APR - 8 2010
ESTABLISHMENT REGISTRATION NUMBER:
(Will be completed within 15 days on 510(k) clearance)
CONTACT:
Donald D. Solomon, Ph.D. President and COO Telephone: (801) 209-1269 Fax: (435) 647-3939 Email: dsolomon@cathconn.com
DATE PREPARED:
October 12, 2009
NAME OF MEDICAL DEVICE:
Trade/Device Name: Regulation Classification Name: Common/Usual Name: Classification Advisory Panel: Regulatory Class: Classification Product Code: Regulation Number:
Catheter Connections' DualCap™
Pad, alcohol, device disinfectant Alcohol Pad General Hospital UNCLASSIFIED гкв UNCLASSIFIED
PREDICATE DEVICES:
Substantial equivalence is claimed to the following devices as related to intended use and design characteristics:
Trade/Device Name: Regulation Classification Name: Common/Usual Name: Classification Advisory Panel: Regulatory Class: Classification Product Code: Regulation Number:
Swab™ Cap (K083508), Excelsior Medical Corporation
Pad, alcohol, device disinfectant Alcohol Pad General Hospital UNCLASSIFIED LKB UNCLASSIFIED
CONFIDENTIAL
5
| Trade/Device Name: | Effectiv™ Cap (K080579), Hospira, Inc. |
|---|---|
| Regulation Classification Name: | Pad, alcohol, device disinfectant |
| Common/Usual Name: | Alcohol Pad |
| Classification Advisory Panel: | General Hospital |
| Regulatory Class: | UNCLASSIFIED |
| Classification Product Code: | LKB |
| Regulation Number: | UNCLASSIFIED |
| Trade/Device Name: | Curos™ Port Protector (K080466), Ivera Medical |
| Regulation Classification Name: | None |
| Common/Usual Name: | Pad, alcohol, device disinfectant |
| Classification Panel: | General Hospital |
| Regulatory Class: | UNCLASSIFIED |
| Classification Product Code: | LKB |
| Regulation Number: | None |
| Trade/Device Name: | Aplicare Alcohol Prep Pad (K833182), Aplicare, Inc. |
| Regulation Classification Name: | Pad, alcohol, device disinfectant |
| Common/Usual Name: | Alcohol Pad |
| Classification Advisory Panel: | General Hospital |
| Regulatory Class: | UNCLASSIFIED |
| Classification Product Code: | LKB |
| Regulation Number: | None |
| Trade/Device Name: | Dual Luer Lock Cap (K981318), Baxter Healthcare |
| Corporation, Inc. | |
| Regulation Classification Name: | Set, Administration, Intravascular |
| Common/Usual Name: | Male/female Luer port caps |
| Classification Product Code: | General Hospital |
| Regulatory Class: | II |
| Classification Product Code: | FPA |
| Regulation Number: | 880.5440 |
DEVICE DESCRIPTION:
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.
The DualCap™ is designed to fit securely on Luer access valves and IV administration line male Luer connections. The cap contains 70% isopropyl alcohol. The product is intended for single-use and is provided sterile, latex free, non-pyrogenic, preservative free and DEHP free.
CONFIDENTIAL
6
CATHETER CONNECTIONS, INC.
510(k) Premarket Notification Submission: CATHETER CONNECTIONS' DUALCAP™
Additionally DualCap™, the device will be marketed for use as an accessory in procedure kits. When being used in procedural kits, the product will be shipped bulk sterile to the kitting manufacturer (DualCap™ will be packaged in metalized unit container and will be impervious to ETO). The Catheter Connections' DualCap™ will be incorporated into the procedure kit.
INTENDED USE:
DualCap™ is intended for use on Luer access valves and the IV administration line male Luer connections. DualCap™ will disinfect and decontaminate the valve and male Luer and act as a barrier to contamination between IV administration line accesses.
DualCap™ will disinfect the connections within five (5) minutes after application and act as a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
INDICATIONS FOR USE:
When left in place for five (5) minutes the female component of DualCap™ disinfects needleless Luer access valves and the male component of DualCap™ disinfects the IV administration line male Luer connections; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
New device is compared to Marketed Device? Yes. It is compared to legally marketed predicates.
Does the new device have the same indication statements? Yes.
Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended use of the device.
Does the new device have the same technological characteristics, e.g. design, material, etc. ? Yes. The Catheter Connections' DualCap™ is substantially equivalent design, materials, and method of use. The basic fundamental scientific technology of the device has not changed.
Could the new characteristics affect safety or effectiveness? No.
CONFIDENTIAL
7
CATHETER CONNECTIONS, INC. 510(k) Premarket Notification Submission: CATHETER CONNECTIONS' DUALCAP™
Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.
Sterilization requirements of ISO 11137: 2006, Sterilization of health care products -Radiation
Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
These and other standards were used to determine the appropriate methods for evaluating the device's performance.
Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols.
Do performance data demonstrate equivalence? Yes. Performance data gathered demonstrated that the Catheter Connections' DualCap™ is substantially equivalent to the noted predicate devices.
CONCLUSION
The Catheter Connections' DualCap™ will meet all established acceptance criteria for performance testing. This testing demonstrated that the Catheter Connections' DualCap™ is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the above noted predicate devices.