(85 days)
Not Found
Not Found
No
The summary describes a simple mechanical device (stopcock and manifold) for fluid delivery and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a flow control and conduit device for IV fluid delivery, which is supportive care rather than a direct therapeutic action or treatment for a disease.
No
Explanation: The device is described as a flow control and conduit device for IV fluid delivery, not for diagnosing medical conditions.
No
The device description explicitly states "Medline Stopcock and Manifold," which are physical hardware components used for IV fluid delivery. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "IV fluid delivery to the patient's vascular system." This involves direct interaction with the patient's body for therapeutic purposes (delivering fluids).
- IVD Definition: In vitro diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
This device does not fit the definition of an IVD as it is used for delivering substances into the body, not for analyzing specimens from the body.
N/A
Intended Use / Indications for Use
The Mediane Stopcock and Manifold are indicated to serve as flow controls and conduit devices for IV fluid delivery to the patient's vascular system.
Product codes
DTL
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR - 3 2012
Medline Industries, Inc. c/o Mr. Matt Clausen Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060
Re: K120069
Trade/Device Name: Medline Stopcock and Manifold Regulation Number: 21 CFR 870.4290 Regulation Number: 21 CFK 870.4270
Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold or Fitting Regulatory Class: Class II Product Code: DTL Dated: January 11, 2012 Received: January 13, 2012
Dear Mr. Clausen:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(K) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substantially equively in in referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed provice Amendments. for use stated in the enclosure) to regally manced to doctor Device Amendments, or to
commerce prior to May 28, 1976, the enactment decided of the Federal Food. Drug. commerce prior to May 28, 1970, the enactiven and of the Federal Food, Drug, devices that have been reclassified in accordance was are archarted application (PMA).
and Cosmetic Act (Act) that do not require approval or provisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The Act. The Act. The Act. The Act. The Act. The Act. The Act. The You may, therefore, market the actives, subject to the gents for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Acc, labeling, qualvitions against misbranding and devices, good manufacturing places, not evaluate information related to contract liability.
adulteration. Please note: CDRH does' not evaluate information truthfull and not adulteration. Please note: CDKH does not evaluate informations of misleading.
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
If your device is classified (see above) into enter class if (special)
may be subject to additional controls . . Existing major regulations affecting your device can be
1
Page 2 - Mr. Matt Clausen
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 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. J
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.htm1 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.
$\pi.g. Hillen
Gram D. Zuckerman, M.D. Director . Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K12øø69
Indications for Use
510(k) Number (if known): K (20069
Device Name:
Medline Stopcock and Manifold
Indications For Use:
The Mediane Stopcock and Manifold are indicated to serve as flow controls and conduit devices for IV fluid delivery to the patient's vascular system.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
M. A. Hilleben
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K120069