(151 days)
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.
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.
The provided text describes a 510(k) submission for the IMM™ Infusion Syringe Set. This type of regulatory submission is for medical devices and focuses on demonstrating "substantial equivalence" to a predicate device already legally marketed, rather than proving novel clinical effectiveness through a complex study design like those typically seen for new drugs or high-risk devices.
Therefore, the study presented here is primarily a bench-top performance evaluation to show that the device meets established engineering and safety standards, and functions equivalently to existing devices. It is not a clinical study involving human patients or complex AI algorithms.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device meets the specific requirements established in voluntary standards ISO8536-4 and ISO7886-1. Unfortunately, the specific acceptance criteria (e.g., minimum tensile strength, flow rate tolerances) within these standards, and the exact measured performance of the device against each criterion, are not detailed within this summary. The summary only provides a general statement of compliance.
However, based on the "Element of Comparison" table, some performance characteristics are implicitly mentioned.
| Acceptance Criterion (Implicit from Predicate Comparison & Standards) | Reported Device Performance |
|---|---|
| Tubing/fitting bonding strength: Tensile strength | >15 N |
| Flow regulator Clamping efficacy: From zero to maximum in gravity use | Met (Similar to predicate) |
| Sterility: Single use | Met (Single use) |
| Biocompatibility: Materials tested per ISO10993 | Suitable for intended use |
| Overall Functional and Performance: Per ISO8536-4 and ISO7886-1 | Meets requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the functional and performance tests.
The data provenance is not explicitly stated as "country of origin," but the manufacturing company is located in Miaoli, Taiwan. The studies appear to be retrospective bench-top tests conducted internally to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable in the context of this device and study. The "ground truth" here is compliance with engineering standards and material properties, not clinical diagnoses that would require expert human interpretation. The tests are physical and chemical evaluations.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving discrepancies in clinical image interpretation or diagnostic outcomes. For bench-top engineering tests, the outcome is usually a quantitative measurement or a pass/fail against a standard, not subject to subjective adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, potentially with AI assistance) to assess improvements in reader performance. The IMM™ Infusion Syringe Set is a manual fluid delivery device, not a diagnostic tool where human reader performance is a primary outcome.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This concept is only relevant for AI/ML-based algorithms. The IMM™ Infusion Syringe Set is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation primarily relies on:
- Engineering Standards: Compliance with international standards such as ISO8536-4 (Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity-fed) and ISO7886-1 (Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use). These standards define mechanical properties, dimensional tolerances, flow rates, sterility, etc.
- Material Compatibility/Safety Standards: Compliance with ISO10993 (Biological evaluation of medical devices).
- Predicate Device Equivalence: The performance is also benchmarked for equivalence against the predicate devices (K063851 and K792227) in key areas like construction, transparency, bonding strength, flow regulation, syringe size, interface, material, and sterility.
8. The Sample Size for the Training Set
This information is not applicable. "Training set" refers to data used to train AI/ML algorithms. The IMM™ Infusion Syringe Set is a physical medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no AI/ML algorithm or training set involved.
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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 Company107, Lane 181, Sec. 1., Yong Jane RoadChunan, Miaoli 350, Taiwan (ROC) |
|---|---|
| Contact person: | Lucy Huang, Regulatory SpecialistTel: +886-37-620236Fax: +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.
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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 ofComparison | Subject DeviceK131661 | VascularK063851 | B. BraunK792227 |
|---|---|---|---|
| Intended Use | For deliveringcontrolled volumeof fluids fromreservoirs oflabeled route ofadministration offluids by manualoperation | Same | Similar |
| Construction | Spike inlet, PVCtubing, dual checkvalve, syringe | Similar, exceptadditionalextension | Spike inlet, PVCtubing, dual checkvalve, syringe |
| Transparency | Tubing of fluid lineis transparency | Same | Same |
| Tubing/fittingbondingstrength | Tensile strength>15 N | Similar | Similar |
| Flow regulatorClampingefficacy | From zero tomaximum ingravity 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 |
| Sterilizationmethod | EtO | EtO | EtO |
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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.
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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.
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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,
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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
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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)
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Richard C. Chapman 2013.11.04 16:10:11 -05'00'
§ 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).