(182 days)
No
The description details a standard intravascular administration set with mechanical components, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is used to administer fluids, which is a supportive function, not a direct therapeutic intervention to treat a disease or condition. It is a delivery system, not a therapeutic agent itself.
No
The device is described as an administration set for delivering fluids to a patient's vascular system, not for diagnosing conditions.
No
The device description explicitly lists physical components such as a bag spike, drip chamber, tubing, and clamps, indicating it is a hardware device for fluid administration.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein." This is a direct therapeutic or supportive function, not a diagnostic one.
- Device Description: The components listed (spikes, drip chambers, tubing, clamps, connectors, etc.) are all standard components of intravenous administration sets, which are used for delivering substances into the body, not for analyzing samples from the body.
- Lack of Diagnostic Elements: There is no mention of components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of fluids.
N/A
Intended Use / Indications for Use
The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. Prescription Use.
Product codes
FPA
Device Description
The EZ Regular consists of components commonly found on intravascular administration sets and extension sets. EZ Regular set consists of various components such as: - air vented bag spike. . - drip chamber with filter or without filter, . - roller clamp, tubing. . - flow controller. . - Y-connector, . - needle-less Y-connector, . - luer lock end catheter, . - manifold filter.
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)
Bench tests were performed. Bench testing included biocompatibility. mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
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
510(K) Summary
K08030 3
AUG - 6 2008
MEINNTECH CO., LTD. # 502, Pyeongchon IT B/D, 1113-1, Daran-dong, dongan-gu, Anyang-si, gyeonggi-do, Korea
Contact person: Contact : Ui-soo Kim, Overseas Sales Manager Korea Telephone : +82 31 381 7077 Fax +82 31 381 7053 E-mail: peter@meinntech.com Date Prepared: February 1, 2008
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- Trade Name: EZ Regular Common Name: Intravascular administration set. Classification Name: Intravascular administration set. Product code FPA, Regulation: 880.5440 Class of device: Class II.
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- The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : Kipp Group Intravascular Administration Set (K991932)
-
- Description of device: The EZ Regular consists of components commonly found on intravascular administration sets and extension sets.
EZ Regular set consists of various components such as:
- air vented bag spike. .
- drip chamber with filter or without filter, .
- roller clamp, tubing. .
- flow controller. .
- Y-connector, .
- needle-less Y-connector, .
- luer lock end catheter, .
- manifold filter. .
-
- Intended use: The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. Prescription Use.
-
- The EZ Regular Administration Sets and the predicate Technological characteristics: devices have identical technological characteristics and perform the same way as common intravascular administration sets. They are EO sterilized.
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- Performance: Bench tests were performed. Bench testing included biocompatibility. mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2008
Meinntech Company, Limited C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K080303
Trade/Device Name: EZ Regular Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 29, 2008 Received: August 1, 2008
Dear Mr. Kamm:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Mr. Kamm
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
MKormels-Verdi-forll
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):_K08 ○ 30 3
Device Name: _ EZ Regular
Indications For Use:
The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Jot All der Daomin
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________