(151 days)
Not Found
No
The device description and intended use clearly state that the device is manually operated and does not mention any computational or algorithmic components that would suggest AI/ML. The performance studies focus on meeting voluntary standards for infusion sets and syringes, not on algorithmic performance.
No.
The device is described as an "Infusion Syringe Set" intended for delivering controlled volumes of fluids, which functions as a delivery system rather than a device that provides therapy itself.
No
The device description states its purpose is for "delivering controlled volume of fluids," indicating a therapeutic rather than a diagnostic function. There is no mention of identifying a disease or condition.
No
The device description clearly states it is a "single use product which contains disposable parts of one spike infusion set... and a control syringe". This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation." This describes a device used for administering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description details a system for connecting to fluid reservoirs and delivering fluid, including a syringe and a spike infusion set. This aligns with a device used for infusion or injection, not for in vitro diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the delivery of fluids.
N/A
Intended Use / Indications for Use
IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.
Product codes (comma separated list FDA assigned to the subject device)
FMF(880.5860), FPA (880.5440)
Device Description
IMM 110 Infusion Syringe Set is single use product which contains disposable parts of one spike infusion set for connecting to fluid reservoir and fluid delivery, and a control syringe for delivery fluid supply from a solution bag to access device for purpose of delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation. The distal end of the set is a dual valve with 6% taper design for connecting to other access device such as needles before use. The IMM Infusion Syringe Set is provided sterile in fluid path, and to be disposed after single patient use.
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)
The non-clinical functional and performance tests demonstrated that IMM™ Infusion Syringe Kit meets the specific requirements established in voluntary standards: ISO8536-4 and ISO7886-1.
All verification and validation test data indicated that the IMM Infusion syringe set can perform as intended use and is substantially equivalent to the predicate device.
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
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
Innovative Medical Manufacturing Company
107, Lane 181, Sec.1, Yong Jane Rd., Chunan, Miaoli 350, Taiwan, ROC TEL:037-620236 FAX:037-620239 E-mail:service@immc.com.tw Unified Code:16980249
510(k) Summary of Safety and Effectiveness
1. General Information
| Submitted by: | Innovative Medical Manufacturing Company
107, Lane 181, Sec. 1., Yong Jane Road
Chunan, Miaoli 350, Taiwan (ROC) |
|----------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Lucy Huang, Regulatory Specialist
Tel: +886-37-620236
Fax: +886-37-620239 |
| Date of preparation: | 10/14/2013 |
| | NOV 05 2013 |
2. Device Information
| Common Name: | Syringe Kit |
|---|---|
| Proprietary Name: | IMMTM Infusion Syringe Set |
| Classification | Piston Syringe; Intravascular Administration Set |
| Name: | |
| Product code: | FMF(880.5860) |
| FPA (880.5440) |
3. Predicate Device
| Trade Name | 510(k) Number | Decision Date |
|---|---|---|
| Vascular Auto-Fill Syringe Kit | K063851 | 2007/1/26 |
| Multi-Ad Dispensing system | K792227 | 1979/12/20 |
4. Device Description
IMM 110 Infusion Syringe Set is single use product which contains disposable parts of one spike infusion set for connecting to fluid reservoir and fluid delivery, and a control syringe for delivery fluid supply from a solution bag to access device for purpose of delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation. The distal end of the set is a dual valve with 6% taper design for connecting to other access device such as needles before use. The IMM Infusion Syringe Set is provided sterile in fluid path, and to be disposed after single patient use.
1
Innovative Medical Manufacturing Company
107, Lane 181, Sec.1, Yong Jane Rd., Chunan, Miaoli 350, Taiwan, ROC TEL:037-620236 FAX:037-620239 E-mail:service@immc.com.tw Unified Code:16980249
5. Indication for Use
IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.
6. Technological Characteristics
The IMM™ Infusion Syringe Set is single use device, and can be delivered in unit sterile package or in bulk non-sterile shipment for further packaging. It allows easy operation and replacement before use.
7. Substantial equivalence
The IMM™ Infusion Syringe Set has the same indication for use and similar characters with the predicated device. The technological characteristics of the IMM device are as same as the predicate device.
| Element of
Comparison | Subject Device
K131661 | Vascular
K063851 | B. Braun
K792227 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------|
| Intended Use | For delivering
controlled volume
of fluids from
reservoirs of
labeled route of
administration of
fluids by manual
operation | Same | Similar |
| Construction | Spike inlet, PVC
tubing, dual check
valve, syringe | Similar, except
additional
extension | Spike inlet, PVC
tubing, dual check
valve, syringe |
| Transparency | Tubing of fluid line
is transparency | Same | Same |
| Tubing/fitting
bonding
strength | Tensile strength
15 N | Similar | Similar |
| Flow regulator
Clamping
efficacy | From zero to
maximum in
gravity use | Same | Same |
| Syringe | 12ml | 12ml | 10ml |
| Interface | Luer fitting | Luer fitting | Luer fitting |
| Material | PP, PVC, PC, ABS | PP, PVC, PC, ABS | Similar |
| Sterility | Single use | Same | Same |
| Sterilization
method | EtO | EtO | EtO |
2
Innovative Medical Manufacturing Company
107, Lane 181, Sec.1, Yong Jane Rd., Chunan, Miaoli 350, Taiwan, ROC TEL: 037-620236 FAX:037-620239 E-mail:service@immc.com.tw Unified Code:16980249
8. Performance Summary
The non-clinical functional and performance tests demonstrated that IMM™ Infusion Syringe Kit meets the specific requirements established in voluntary standards: ISO8536-4 and ISO7886-1.
9. Material
The Infusion syringe set is composed of materials that have been tested in accordance with ISO10993 and have been determined to be suitable for the intended use of this product.
10. Safety and Effectiveness
All verification and validation test data indicated that the IMM Infusion syringe set can perform as intended use and is substantially equivalent to the predicate device.
5-3
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5,2013
Innovative Medical Manufacturing Company Ms. Lucy Huang Regulation Specialist No .. 107, Lane 181, Sect 1., Yong Jane Road Chunan, MIAOLI CHINA 350
Re: K131661
Trade/Device Name: IMM™ Infusion Syringe Set Regulation Number: 21 CFR 880.5860, 21 CFR 880.5840 Regulation Name: Piston Syringe, Intravascular Administration Set Regulatory Class: II Product Code: FMF, FPA Dated: September 13, 2013 Received: September 25, 2013
Dear Ms.Huang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
4
Page 2 - Ms. Huang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/7 description: The image shows the text "Mary Surfammer -S". The text is in a bold, sans-serif font. The word "Mary" is in a larger font size than the rest of the text. The word "Surfammer" is stylized with a wave-like design. The "-S" is in a smaller font size than the rest of the text.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K131661 510(k) Number (if known):
Device Name: IMM™ Infusion Syringe Set
Indications for Use:
IMM™ Infusion Syringe Set is intended for delivering controlled volume of fluids from reservoirs consistent with the labeled route of administration of fluids by manual operation.
Prescription Use Over-The-Counter Use (Part 21 CFR 801 Subpart AND/OR (21 CFR 801 Subpart C) D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of __ 1_
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Richard C. Chapman 2013.11.04 16:10:11 -05'00'