(272 days)
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.
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.
This is a 510(k) premarket notification for a medical device, not an AI/ML device, so many of the requested categories (like number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable. I will provide information relevant to a traditional medical device submission based on the provided text.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device / guidance) | Reported Device Performance (from Lily Volume Meteric Administration Set) |
|---|---|
| Meets relevant performance standards for Intravascular Administration Sets (e.g., fluid administration, structural integrity, flow control, leak prevention). | Performance testing (Bench testing) was "employed upon submission" according to the Guidance on Premarket Notification for Intravascular Administration Sets document provided by CDRH/FDA. Implies successful adherence to these standards for substantial equivalence. |
| Biocompatibility requirements met (device materials do not cause adverse biological reactions). | Biocompatibility testing was "employed upon submission." Implies compliance. |
| Sterility requirements met (device is sterile and non-pyrogenic). | Sterility testing was "employed upon submission." Device is described as "non-toxic, non-pyrogenic and sterile infusion set." Implies compliance. |
| Design allows for administration of fluids from a container to a patient's vascular system through a catheter inserted into a vein. (Functional equivalence) | "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." (Intent and design match predicate) |
| Single-use. | "The LILY Volume Meteric Administration Set...is a single-use..." |
| Non-toxic. | "The LILY Volume Meteric Administration Set...is...non-toxic..." |
| Non-pyrogenic. | "The LILY Volume Meteric Administration Set...is...non-pyrogenic..." |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for bench, biocompatibility, or sterility testing. It states these tests were "employed upon submission." It is a regulatory submission, so the provenance of the testing itself would be the manufacturer (Lily Medical Supplies Co., Ltd.) performing the tests in their facilities or through contracted labs. The data would be prospective, as it was generated to support this particular submission. There is no mention of country of origin for the data; the manufacturer is based in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device. "Ground truth" in this context refers to engineering and laboratory test results demonstrating compliance with established performance standards for infusion sets, not expert interpretation of medical images or clinical outcomes.
4. Adjudication method for the test set
Not applicable. This is a medical device performance test, not a diagnostic or interpretive task requiring adjudication of results from multiple reviewers. Performance is evaluated against objective engineering specifications and standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a conventional medical device (infusion set), not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a conventional medical device.
7. The type of ground truth used
The ground truth for this device's performance relies on several factors:
- Engineering Specifications and Standards: The device's physical properties (e.g., flow rate accuracy, drip chamber volume, material strength, connection integrity) are measured against predefined engineering standards for intravascular administration sets, often those specified in FDA guidance documents (e.g., ANSI/AAMI/ISO standards).
- Biocompatibility Testing Standards: Adherence to established ISO standards (e.g., ISO 10993 series) for evaluating the biological effects of medical devices.
- Sterility Testing Standards: Compliance with pharmacopeial and ISO standards for demonstrating sterility (e.g., absence of microorganisms) and non-pyrogenicity.
- Substantial Equivalence to a Predicate Device: The primary "ground truth" for regulatory approval in a 510(k) often comes from demonstrating that the new device is as safe and effective as a legally marketed predicate device, meaning it performs similarly and has the same intended use.
8. The sample size for the training set
Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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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.
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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.
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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 =
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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
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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
§ 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.