(266 days)
No
The description focuses on mechanical components and functions (luer connection, silicone membrane) and does not mention any computational or data-driven processes indicative of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device facilitates the administration of fluids or medications and blood sampling, but it does not directly treat a disease or condition itself.
No
The device is described as a "needleless accessory" for blood sampling, injection, or infusion of fluids/medications. Its function is to facilitate the administration or collection of substances, not to diagnose a condition.
No
The device description clearly outlines physical components like a polycarbonate housing and a silicone membrane, indicating it is a hardware device, not software-only.
Based on the provided information, the InfuSite Needleless Access Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "blood sampling, intermittent injection or infusion of fluids or medications." This describes a device used for accessing the patient's bloodstream for therapeutic or diagnostic purposes in vivo (within the living body), not for testing samples in vitro (in a lab setting).
- Device Description: The description focuses on the physical components and how it connects to luer systems for fluid transfer and blood sampling. There is no mention of reagents, assays, or any components used for analyzing biological samples outside of the body.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.) for specific markers.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
- Performance metrics related to diagnostic accuracy (sensitivity, specificity, etc.).
The InfuSite Needleless Access Device is a medical device used for patient access and fluid management, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.
Product codes
FPA
Device Description
The InfuSite Needleless Access Device is a closed system needleless multi-purpose catheter accessory, permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer systems. The InfuSite Needleless Access Device has a polycarbonate male/female luer housing with a swabable silicone membrane, which opens automatically upon connection with a male luer and closes automatically when the male luer is disconnected. Disinfection must be carried out before and after use. The InfuSite contains no metallic components.
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)
Performance testing demonstrates that the device is substantially equivalent to the predicate devices (SmartSite, K960280, Swabsite K002689).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smartsite K960280, Swabsite K002689
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
K112073
APR 1 1 2012
PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)
Date of Preparation: July 6, 2011
Applicant:
Rx Devices LLC 2030 Oakes Blvd. Naples, FL 34119
Contact Individual: Charles Hokanson, CEO (610 715-3263) hokanson@earthlink.net
Trade Name: InfuSite Needleless Access Device
Common Name: Needleless Access Device
Regulation Number: 880.5440
FPA Product Code:
Classification Name: Set, Administration, Intravascular
Classification: Class II
Predicate Device Name: Smartsite K960280, Swabsite K002689
Device Description:
The InfuSite Needleless Access Device is a closed system needleless multi-purpose catheter accessory, permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer systems. The InfuSite Needleless Access Device has a polycarbonate male/female luer housing with a swabable silicone membrane, which opens automatically upon connection with a male luer and closes automatically when the male luer is disconnected. Disinfection must be carried out before and after use. The InfuSite contains no metallic components.
1
Intended Use:
The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.
Technology Characteristics:
The InfuSite Needleless Access Device is substantially equivalent to the predicate devices. No new materials or new issues of safety and efficacy have been introduced with this device.
Summary of Design Control Activities:
The Infusite was designed and developed in accordance ISO and FDA design control guidelines. Biocompatibility data demonstrates that the materials used are non-irritant and non-toxic. Performance testing demonstrates that the device is substantially equivalent to the predicate devices (SmartSite, K960280, Swabsite K002689). Risk Assessment was conducted in compliance with ISO 14971.
Conclusion:
The indications for use are identical to the predicate devices. The materials and technology of the InfuSite Needleless Access Device are equivalent to the predicate devices and no new issues of safety and efficacy have been introduced with this device. Biocompatibility testing, performance testing and risk assessment demonstrate that the InfuSite Needleless Access Device is substantially equivalent to the predicate devices, and safe and effective, when used in accordance with the supplied instructions for use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Charles Hokanson CEO Rx Devices LLC 2030 Oakes Blvd. Naples, Florida 34119
ARR. 1 1 2012
Re: K112073
Trade/Device Name: InfuSite Needleless Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 12, 2012 Received: March 14, 2012
Dear Mr. Hokanson:
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 (for the indications for use stated in the enclosure) 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. 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.
3
Page 2 - Mr. Hokanson
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony. D. Awuta
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
InfuSite Needleless Access Device Device Name:
Indications For Use:
The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.
Prescription Use X (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) | |
|---|---|
| (Division Sign-Off) | 4/12/12 |
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112073