(69 days)
No
The device description and performance studies focus on the physical components and basic functionality of an infusion set, with no mention of AI or ML.
Yes
The device is intended to provide subcutaneous infusion of medicine, which is a therapeutic function.
No
This device is described as an "Infusion Set" intended to provide subcutaneous infusion of medicine. Its function is to deliver medicine, not to diagnose a condition.
No
The device description clearly outlines physical components like a needle, tubing, luer lock, and adhesive dressing, indicating it is a hardware device.
Based on the provided information, the "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Infusion Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide subcutaneous infusion of medicine from an external infusion pump or syringe. This involves delivering a substance into the body, not testing a sample from the body.
- Device Description: The device is a physical set for delivering fluids, consisting of a needle, tubing, and connectors. It does not involve any components for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis.
Therefore, the "Evans Sub-Q" is a medical device for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe. (The device is supplied sterile, for single use only. It is a prescription device)
Product codes
FPA
Device Description
The device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The infusion set has a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end, connected by 42" of 2mm medical grade tubing. The luer lock connects to the infusion pump device. The device is for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
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)
Testing information and Conclusion 1 esting information and Coxectars Sub-Q'' (Catalog # MC4206) Winged In an material respons, are is substantially equivalent to several similar devices Subculancous Intusion between betting was performed according to internal company ancady on the OD mance. Testing many was actual device performance satisfies the design intent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Minimed MMT-106. MMT-107, MMT-133, K961474
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
Ko20530
APR 2 9 2002
EXHIBIT 2
Evans Medical, Inc. 295 Old Limekiln Road Chalfont, PA 18914 Phone 215-249-4882 Fax 215-249-4883 Contact: Paul Lambert January 7, 2002
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device: Proprietary-Trade Name: "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Tissue Infusion Set Classification Name: FPA Common/Usual Name: I.V. Administration Set
-
- Equivalent legally marketed device: This device is similar in design and in function to the Minimed MMT-106. MMT-107, MMT-133, K961474.
-
- Indications for Use (intended use): "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe. (The device is supplied sterile, for single use only. It is a prescription device)
-
- Description of the device: The device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The infusion set has a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end, connected by 42" of 2mm medical grade tubing. The luer lock connects to the infusion pump device. The device is for single use.
1
-
- Safety and Effectiveness, comparison to predicate device:
| Comparison Areas | Minimed MMT-106. MMT-
107, MMT-133, K961474; | "Evans Sub-Q" (Catalog #
MC4206) Winged
Subcutaneous Tissue
Infusion Set |
|---------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Indications for use | Intended to provide
subcutaneous infusion of
medicine from an external
infusion pump | Intended to provide
subcutaneous infusion of
medicine from an external
Infusion pump or syringe |
| Materials | Medical grade plastics and
stainless steel needle | SAME |
| Packaging | Packed sterile for single
patient use | SAME |
-
- Testing information and Conclusion
1 esting information and Coxectars Sub-Q'' (Catalog # MC4206) Winged In an material respons, are is substantially equivalent to several similar devices Subculancous Intusion between betting was performed according to internal company ancady on the OD mance. Testing many was actual device performance satisfies the design intent.
- Testing information and Conclusion
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2002
Evans Medical, Incorporated C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015
Re: K020530
Trade/Device Name: Evans SUB-Q ( Catalog MC4206) Winged Subcutaneous Tissue Infusion Set Regulation Number: 880.5440 Regulation Name: I.V. Adminstration Set Regulatory Class: II Product Code: FPA Dated: February 18, 2002 Received: February 19, 2002
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.
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
3
Page 2 - Mr. Daniel Kamm
of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal buts requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Part 007), as clima (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the qualify is a 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 110(k) premarket notification. The FDA finding of substantial equivalence of your device to 310(K) promised notificate 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 II you desire specific act 100 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. ad vertibing or joint on 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 the ret may be volumer 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 W. Klatowski
Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
4
j) Indications for Use
510(k) Number K020530
510(k) Namber K02053 -Evalis Sub-Q (Catalog in IPO 1200) Nation of medicine from an external infusion pump or syringe. .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_
OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
Patrice Cucenile
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number _