(272 days)
Not Found
No
The document describes a standard infusion set and does not mention any AI or ML components or functionalities.
No
The device is described as an infusion set for administering fluids, which is a delivery mechanism, not a therapeutic treatment itself.
No
Explanation: The device is described as an administration set for delivering fluids, not for diagnosing medical conditions. It performs a therapeutic/delivery function rather than a diagnostic one.
No
The device description clearly states it is an "infusion set," which is a physical hardware device used to administer fluids. 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 is to "administer fluids from a container to a patient's vascular system through a catheter inserted into a vein." This describes a device used for direct patient treatment and fluid delivery, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description reinforces the function of administering fluids directly to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) to deliver fluids.
N/A
Intended Use / Indications for Use
The LILY Volume Meteric Administration Set is designed to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The LILY Volume Meteric Administration Set, CIB-100ES, CHB-120ES, CIB-150ES, is a single-use, non-toxic, non-pyrogenic and sterile infusion set to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Mentions image processing
Not Found
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)
Bench, biocompatibility, sterility are employed upon submission of this 510(K) premarket notification according to the Guidance on Premarket Notification for Intravascular Administration Sets document provided by CDRH/ FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 0 3 2004
K03.2767
510(K) Summary of Safety and Effectiveness II.
Information
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(Pcr 21 CFR 807.92)
- LILY Medical Supplies Co., Ltd. 1. Submitter: No.28-2, Shun Chan Tsan, Chu-Nan, Miao-Li Hsien, Taiwan, 350, ROC
| Contact Person: | Dr. Ke-Min Jen |
|---|---|
| Official Correspondent | |
| 886-3-5208829 (Tel) | |
| 886-3-5209783 (Fax) |
- Date Prepared: 2003/8/30 2.
-
- Device Name:
| -Proprietary Name: | LILY Volume Meteric Administration Set, CIB-100ES,
CIB-120ES, CIB-150ES |
|-----------------------|----------------------------------------------------------------------------|
| -Common Name: | Infusion Set |
| -Classification Name: | Set, Administration, Intravascular |
| -Product code: | FPA, |
| -Regulation: | 880.5440 |
4. Predicate Device:
TUTA Healthcare Burette - In Line ( 150 ml )(K023595)
న్, Device Description:
The LILY Volume Meteric Administration Set, CIB-100ES, CHB-120ES, CIB-150ES, is a single-use, non-toxic, non-pyrogenic and sterile infusion set to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
6. Intended Use:
The LILY Volume Meteric Administration Set is designed to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
7. Substantial Equivalence (SF) and Safety and Effectiveness Information:
A claim of substantial equivalence is made to TUTA Healthcare Burette - In Line ( 150 mL)(K023595). The LILY VOLUME METERIC ADMINISTRATION SET and the TUTA Healthcare Burette - In Line ( 150 mL) are designed to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
1
8. Performance Testing:
Bench, biocompatibility, sterility are employed upon submission of this 510(K) premarket notification according to the _Guidance on Premarket Notification for Intravascular Administration Sets document provided by CDRH/ FDA.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2004
LILY Medical Supplies Company, Limited C/O Dr. Ke-Min-Jen Official Correspondent Roc Chinese-European Industrial Research Society No. 58, Fu-Chiun Street Hsin-Chu City, CHINA 300 (TAIWAN)
Re: K032767
K052767
Trade/Device Name: Lily Volume Meteric Administration Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 15, 2004 Received: March 22, 2004
Dear Dr. Jen:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your bootion by (1) (1) +) + + + + + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = relerenced above and have determined are to tegally marketed predicate devices marketed in increations for use stated in the chelosary to 10g.
interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate collinered prior to thay 20, 1978, and establed in accordance with the forcements of Amendinents, of to devroes that have o Act (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosment + to (1 co) .............................................................................................................................. approval appreation (1 Mrx). - 1 ou 1.0), - 1 ou 1.0, 1 on 1.0 min of the Act include Controls provisions of the rec. "The genting 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 If your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may be subject to Such adam 6 Federal Regulations, Title 21, Parts 800 to 898. In the Collections your device can oc found in the Sode of received.
addition, FDA may publish further announcements concerning your device in the Federal Register.
Legend: = Road =
3
Page 2 - Dr. Jen
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA STISSuance of a substantial vice complies with other requirements mean that FDA has made a decemmance inter Jour Jour Federal agencies.
of the Act or any Federal statutes and regulations administered by segistering of the Act of ally receital statutes and regulations, but not limited to: registration You must colliply with an the Net 3 requirements and 801); good manufacturing practice and listing (21 CFR Fart 607), laooling (21 CFR Pat 820), and if 1
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 620), and if requirements as set forth in the quality systems (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) This letter will anow you to oegil mationing , bostantial equivalence of your device to a premarket notification. The I DA Imaling of substantial on 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), ri you desire specific advice for your de recomments of the regulation prease contact une Office or Ochiphanes and (200). " (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu-Ling, Ph.D.
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
4
Indications for Use Statement IV.
Applicant: I I ILY MEDICAL SUPPLIES CO., LTD.
510(k) Number: ___K032767
Device Name: LILY VOLUME METERIC ADMINISTRATION SET,
CIB-100ES, CIB-120ES, CIB-150ES
Indications for Use:
.
The LILY Volume Meteric Administration Set is designed to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
Prescription Use
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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