(113 days)
385301, 13360-48
Not Found
No
The device description and performance studies focus on the physical properties and fluid flow characteristics of a simple tubing extension set, with no mention of AI or ML.
No.
The device is described as an "Extension Set" intended for the conduction of fluids or medications. It extends the length of other delivery devices but does not itself provide a therapeutic effect. Its function is limited to fluid transfer, not treatment.
No
The device description clearly states its purpose is for the "conduction of fluids or medications" and to "extend the length of another fluid or medication delivery device." There is no mention of diagnostic functions such as measuring, analyzing, or interpreting biological signals or data for diagnostic purposes.
No
The device description clearly states it is a physical device consisting of flexible plastic tubing and luer lock fittings, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "conduction of fluids or medications" and to "extend the length of another fluid or medication delivery device." This describes a device used in vivo (within the body) for delivering substances, not for testing samples in vitro (outside the body).
- Device Description: The description of flexible tubing and luer lock fittings is consistent with devices used for fluid delivery in a clinical setting, not for laboratory diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This extension set does not fit that description.
N/A
Intended Use / Indications for Use
The Extension Set is intended for the conduction of fluids or medications.
The extension set is used to extend the length of another fluid or medication delivery device to provide continued fluid flow.
Product codes
FPA
Device Description
The Extension Set is a device used to supplement Epimed's current line of regional anesthesia catheters. The Extension Set consists of flexible plastic tubing, a male luer lock fitting on one end and a female luer lock fitting on the other end. Extension sets will be provided as a sterile, single use, disposable devices. The Extension Set will be available in a variety of lengths ranging from 12" to 60".
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 testing performed on the Extension Set to compare performance characteristics to the predicate device(s) confirmed that the performance of the Epimed Extension Set is similar to that of the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The devices were tested with regard to Fitting Bond Strength, Tubing Tensile Strength, Quantitative Flow, Qualitative Flow and Priming Volume.
Predicate Device(s)
Becton Dickinson Medical Systems Luer Lok™ Microbore Extension Set, Catalog # 385301, Abbott Hospital Products Microbore Extension Set, Catalog # 13360-48
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
JUL 12 2002
K 02 0926
Section II
510(K) Summary
Company Information:
Epimed International, Inc. PO Box 1128 Gloversville, NY 12078 (518) 725-0209 Contact: Christopher B. Lake Manager of RA/QA
Date Prepared:
March 6, 2002
Trade Name:
Extension Set
Common Name:
Extension Set
Product Class/Classification:
Class II
Predicate Device(s):
Becton Dickinson Medical Systems Luer Lok™ Microbore Extension Set, Catalog # 385301
Abbott Hospital Products Microbore Extension Set, Catalog # 13360-48
Description:
The Extension Set is a device used to supplement Epimed's current line of regional anesthesia catheters. The Extension Set consists of flexible plastic tubing, a male luer lock fitting on one end and a female luer lock fitting on the other end. Extension sets will be provided as a sterile, single use, disposable devices. The Extension Set will be available in a variety of lengths ranging from 12" to 60".
1
Intended Use:
The Extension Set is intended for the conduction of fluids or medications.
Comparison to Predicate:
The Extension Set has similar physical and technical characteristics to the Luer-Lok™ Microbore Extension Set marketed by Becton-Dickonson Medical Systems and the Microbore Extension Set marketed by Abbott Hospital Products.
Non-Clinical Data:
Bench testing performed on the Extension Set to compare performance characteristics to the predicate device(s) confirmed that the performance of the Epimed Extension Set is similar to that of the predicate device(s). The devices were tested with regard to Fitting Bond Strength, Tubing Tensile Strength, Quantitative Flow, Qualitative Flow and Priming Volume.
Conclusion:
The testing performed and comparison to the predicate device(s) demonstrate that the Extension Set is safe and effective and is substantially equivalent to the predicate device(s).
Very truly yours.
Epimed International, Inc.
Chryslen
Christopher B. Lake Manager of Regulatory Affairs/Quality Assurance
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring three angled lines that suggest a serpent entwined around a staff.
Public Health Service
JUL 12 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Christopher Lake Manager of RA/QA Epimed International, Incorporated 141 Sal Landrio Drive Johnstown, New York 12095
Re: K020926
Trade/Device Name: Extension Set, Models 1911-512 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 24, 2002 Received: June 27, 2002
Dear Mr. Lake:
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.
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
3
Page 2 – Mr. Lake
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
of I Page 1
K020926 510(k) Number (if known):
Extension Set Device Name:
Indications For Use:
The extension set is used to extend the length of another fluid or medication delivery device to provide continued fluid flow.
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Ky. Aulatonk
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D firfan dilumber ______________________________________________________________________________________________________________________________________________________________