(577 days)
Not Found
No
The summary describes a gravity-fed infusion set and does not mention any AI or ML capabilities. The performance studies focus on standard device testing and compliance with relevant ISO and ASTM standards, not on algorithmic performance.
No.
The device is described as administering fluids, which is a supportive function, not a therapeutic one that treats or cures a disease.
No
The device is described as an infusion set intended to administer fluids, not to diagnose a condition or disease.
No
The device description clearly states it includes physical components like infusion sets, filters, and needles, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description focuses on the physical components and function of an infusion set (delivering fluids). It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the infusion set (compliance with standards for infusion sets, needles, etc.), not on the accuracy or reliability of diagnostic results.
In summary, the device described is an infusion set, which is a medical device used for administering fluids intravenously. It does not perform any diagnostic testing on samples taken from the body, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.
Product codes
FPA
Device Description
The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through an infusion needle under the action of gravity. The proposed devices have 8 different configurations with 4 different filter sizes, and they are provided sterile and single use.
The proposed devices include 32 models. The differences between models are described below:
| Model | Component | D3 | D3-2 | D4 | D5 | D6 | D7 | D8 | D9 |
|---|---|---|---|---|---|---|---|---|---|
| D1-3 | D1-3-2 | D1-4 | D1-5 | D1-6 | D1-7 | D1-8 | D1-9 | ||
| D2-3 | D2-3-2 | D2-4 | D2-5 | D2-6 | D2-7 | D2-8 | D2-9 | ||
| D3-3 | D3-3-2 | D3-4 | D3-5 | D3-6 | D3-7 | D3-8 | D3-9 | ||
| Air Filter | X | N.A. | X | N.A. | X | N.A. | X | X | |
| Protective Cap of Spike | X | X | N.A. | X | N.A. | X | N.A. | X | |
| Protective Cap of Spike (Steel Needle) | N.A. | N.A. | X | N.A. | X | N.A. | X | N.A. | |
| Spike | Spike with Air Filter | N.A. | X | N.A. | N.A. | N.A. | N.A. | N.A. | N.A. |
| Spike with Drip Tube and Air Filter | N.A. | N.A. | N.A. | X | N.A. | X | N.A. | N.A. | |
| Spike (Plastic) | X | N.A. | N.A. | N.A. | N.A. | N.A. | N.A. | X | |
| Spike (Steel Needle) | N.A. | N.A. | X | N.A. | X | N.A. | X | N.A. | |
| Tee | N.A. | N.A. | N.A. | N.A. | N.A. | N.A. | X | X | |
| Pinch Clamp | X | X | X | N.A. | X | N.A. | X | X | |
| Drip Tube | X | X | X | N.A. | X | N.A. | X | X | |
| Drip Chamber | X | X | X | X | X | X | X | X | |
| Flexible Tube | X | X | X | X | X | X | X | X | |
| Roller Clamp | X | X | X | X | X | X | X | X | |
| Injection Site | X | X | X | X | X | X | X | X | |
| Fluid Filter | D3: 5um | D3-2: 5um | D4: 5um | D5: 5um | D6: 5um | D7: 5um | D8: 5um | D9: 5um | |
| D1-3: 3um | D1-3-2: 3um | D1-4: 3um | D1-5: 3um | D1-6: 3um | D1-7: 3um | D1-8: 3um | D1-9: 3um | ||
| D2-3: 2um | D2-3-2: 2um | D2-4: 2um | D2-5: 2um | D2-6: 2um | D2-7: 2um | D2-8: 2um | D2-9: 2um | ||
| D3-3: 15um | D3-3-2: 15um | D3-4: 15um | D3-5: 15um | D3-6: 15um | D3-7: 15um | D3-8: 15um | D3-9: 15um | ||
| External Cone Lock Connector | X | X | X | X | X | X | X | X | |
| Protector Cap of Lock Connector | X | X | X | X | X | X | X | X | |
| Intravenous Infusion Needle | X | X | X | X | X | X | X | X |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's vascular system (vein)
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
Performance Testing:
- ISO 8536-4:2010 Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed.
- ISO 8536-14:2016 Infusion equipment for medical use-Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact.
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications.
- ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods.
- ISO 7864:2016, Sterile hypodermic needles for single use - Requirements and test methods.
- ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods.
Biocompatibility Testing:
This device is classified as: Externally communicating, Blood path Indirect, Limited contact ≤ 24 hours.
- ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
- USP Bacterial Endotoxins Test.
- USP Particular Matter in Injections.
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity.
- ISO 10993-4: 2017, Biological Evaluation of Medical Devices - Part 4: Selection of Test for Interation with Blood.
- ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11: 2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
- ASTM F756-2017 Standard Practice for Assessment of Hemolytic Properties of Materials.
- USP Pyrogen Test.
Sterility, Shipping and Shelf-life:
- ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials.
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration.
- A ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
March 25, 2022
Jiangsu Suyun Medical Materials Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K202437
Trade/Device Name: Infusion Sets for Single Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 22, 2022 Received: February 24, 2022
Dear Diana Hong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gang Peng for Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202437
Device Name Infusion Sets for Single Use
Indications for Use (Describe)
The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.
Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K202437 510(k) Summary
-
- Date of Preparation: 3/22/2022
-
- Sponsor Identification
Jiangsu Suyun Medical Materials Co., Ltd.
No.18, Jinqiao Road, Dapu Industrial Park, Lianyungang Economic Development Zone Lianyungang, Jiangsu, 222002, China
Establishment Registration Number: 3003717263
Contact Person: Guangning Xu Position: Management Representative Tel: +86-518-85608151 Fax: +86-518-85608151 Email: quality(@suyunmedical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
-
- Identification of Proposed Device
Trade Name: Infusion Sets for Single Use Common Name: Disposable Infusion Set
- Identification of Proposed Device
Regulatory Information Classification Name: Intravascular Administration Set Classification: II; Product Code: FPA Regulation Number: 21 CFR 880.5440
-
Identification of Predicate Device 5.
510(k) Number: K163160 Product Name: Sterile Single-use Infusion Set -
- Indication for Use Statement:
The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.
- Indication for Use Statement:
7. Device Description
The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through an infusion needle under the action of gravity. The proposed devices have 8 different configurations with 4 different filter sizes, and they are provided sterile and single use.
The proposed devices include 32 models. The differences between models are described below:
5
| Table 1 the differences in components for each model | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Model | D3 | D3-2 | D4 | D5 | D6 | D7 | D8 | D9 | |
| Component | D1-3 | D1-3-2 | D1-4 | D1-5 | D1-6 | D1-7 | D1-8 | D1-9 | |
| D2-3 | D2-3-2 | D2-4 | D2-5 | D2-6 | D2-7 | D2-8 | D2-9 | ||
| D3-3 | D3-3-2 | D3-4 | D3-5 | D3-6 | D3-7 | D3-8 | D3-9 | ||
| Air Filter | X | N.A. | X | N.A. | X | N.A. | X | X | |
| Protective Cap of Spike | X | X | N.A. | X | N.A. | X | N.A. | X | |
| Protective Cap of Spike | |||||||||
| (Steel Needle) | N.A. | N.A. | X | N.A. | X | N.A. | X | N.A. | |
| Spike | Spike with Air Filter | N.A. | X | N.A. | N.A. | N.A. | N.A. | N.A. | N.A. |
| Spike with Drip Tube and Air Filter | N.A. | N.A. | N.A. | X | N.A. | X | N.A. | N.A. | |
| Spike (Plastic) | X | N.A. | N.A. | N.A. | N.A. | N.A. | N.A. | X | |
| Spike (Steel Needle) | N.A. | N.A. | X | N.A. | X | N.A. | X | N.A. | |
| Tee | N.A. | N.A. | N.A. | N.A. | N.A. | N.A. | X | X | |
| Pinch Clamp | X | X | X | N.A. | X | N.A. | X | X | |
| Drip Tube | X | X | X | N.A. | X | N.A. | X | X | |
| Drip Chamber | X | X | X | X | X | X | X | X | |
| Flexible Tube | X | X | X | X | X | X | X | X | |
| Roller Clamp | X | X | X | X | X | X | X | X | |
| Injection Site | X | X | X | X | X | X | X | X | |
| Fluid Filter | D3: 5um | D3-2: 5um | D4: 5um | D5: 5um | D6: 5um | D7: 5um | D8: 5um | D9: 5um | |
| D1-3: 3um | D1-3-2: 3um | D1-4: 3um | D1-5: 3um | D1-6: 3um | D1-7: 3um | D1-8: 3um | D1-9: 3um | ||
| D2-3: 2um | D2-3-2: 2um | D2-4: 2um | D2-5: 2um | D2-6: 2um | D2-7: 2um | D2-8: 2um | D2-9: 2um | ||
| D3-3: 15um | D3-3-2: 15um | D3-4: 15um | D3-5: 15um | D3-6: 15um | D3-7: 15um | D3-8: 15um | D3-9: 15um | ||
| External Cone Lock | |||||||||
| Connector | X | X | X | X | X | X | X | X | |
| Protector Cap of Lock | |||||||||
| Connector | X | X | X | X | X | X | X | X | |
| Intravenous Infusion Needle | X | X | X | X | X | X | X | X |
Table 1 the differences in components for each model
6
Note: X= the proposed device has this component; N.A. = the proposed device does not have this component
7
8. Summary of Technological characteristics
| ITEM | Proposed Device | Predicate Device
K163160 | Remark |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Regulation No. | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Product Code | FPA | FPA | Same |
| Class | II | II | Same |
| Indications for Use | The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours. | The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. | Different
Analysis 1 |
| Configuration | Protective Cap of Spike
Spike (one plastic spike / one metal spike/ two metal spikes)
Multiple air filters, including:
Air filter with tubing integrate with plastic spike (model: D3/D1-3/D2-3/D3-3 and D9/D1-9/D2-9/D3-9);
Air filter without tubing integrate with plastic spike (model: D3-2/D1-3-2/D2-3-2/D3-3-2 and D5/D1-5/D2-5/D3-5 and D7/D1-7/D2-7/D3-7)
Stand-alone Air filter unit (model: D4/D1-4/D2-4/D3-4 and D6/D1-6/D2-6/D3-6 and D8/D1-8/D2-8/D3-8)
Fluid Filter near the patient access
Drip Chamber integrate with the spike OR,
Drip Chamber is several inches below the Spike | Protective Cap of Spike
Spike (plastic spike)
Air filter without tubing integrate with plastic spike
Fluid Filter integrate with the Drip Chamber
Drip Chamber integrate with the spike | Same
Different
Analysis 2 |
| Flexible Tube | | | Same |
| Table 2 General Comparison | |
|---|---|
8
| Roller Clamp | Same | ||
|---|---|---|---|
| Drip Tube | Same | ||
| Injection Site | Same | ||
| Luer Lock Connector | Same | ||
| Protector Cap of Lock Connector | Same | ||
| Operation Mode | Manual | Manual | Same |
| Label/Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | Same |
SE Analysis 1-Indications for Use
The proposed device and the predicate device has the same intended use, they are both intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The intended duration of use is included in the indications for use of proposed device, and it provides safety information for the end user. Therefore, the difference on indications for use does not raise new question on safety and effectiveness of the proposed device.
SE Analysis 2-Configuraiton
The proposed device and predicate device have the similar configurations (protector cap, spike, air filter, fluid filter, drip chamber, flexible tube, roller clamp, drip tube, injection site and luer lock connector) to achieve the intended use. The differences are mainly in some components structure (spike, air filter, fluid filter and drip chamber) which look different than the predicate device. The detail analysis on components are listed as following:
Spike:
The proposed device has one plastic spike / one metal spikes, while the predicate device only have one plastic spike. The metal spike of the proposed device is also used to pierce and penetrate the closure of a fluid container, and it facilitates piercing and penetrate because it has lower penetration resistance than the plastic spike. The two metal spikes are applicable to the simultaneous transfusion of two liquid container. In addition, the metal spikes meet the dimensions requirements of closure-piercing device specified in ISO 8536-3.
Air filter:
The proposed device has Multiple air filters, including: Air filter with tubing integrate with plastic spike; Air filter without tubing integrate with plastic spike and Stand-alone Air filter unit. The predicate device only has Air filter without tubing integrate with plastic spike. The air filter with tubing integrate with plastic spike and Stand-alone Air filter unit play the same role as Air filter without tubing integrate with plastic spike; they are all used to make the air entering the fluid bottle during infusion to maintains a balance of pressure inside of the rigid container. In addition, all of the air filters of the proposed device don't affect the flow rate of proposed device when air entering the rigid container passes through the air filter.
The spike of Stand-alone Air filter unit of proposed device is capable of piercing and penetrating the closure of a fluid container without pre-piercing, which is also meet the requirement of ISO 8536-4.
9
Fluid Filter
The fluid filter of predicate device is within in the drip chamber. The fluid filter of proposed device is near the patient access, this position is acceptable based on ISO 8536-9. The proposed device has four type of fluid filter (2, 3, 5, and 15um filter size) and they are capable of more than 80% latex particle retention. The fluid filters of proposed device meet the fluid filter requirement specified in ISO 8536-3.
Drip Chamber
The proposed device has drip chamber integrates with the spike OR Drip Chamber being several inches below the Spike. The predicate device's drip chamber only integrates with the spike. The Drip Chamber being several inches below the Spike facilitates the observation of the fall of drops when the liquid container is hung high. In addition, the drip chamber of the proposed device meet the requirement of drip chamber specified in ISO 8536-3.
Based on above analysis, the proposed device and predicate device have the similar configurations to achieve the intended use. The differences that mainly in some components structure (spike, air filter, fluid filter and drip chamber) which look different than the predicate device don't raise new problem on safety and effectiveness of proposed device.
10
| Item | Proposed Device | Predicate Device K163160 | Remark |
|---|---|---|---|
| Infusion Set Performance | Conform with ISO 8536-4:2010 | Conform with ISO 8536-4:2010 | Same |
| Needle performance | Conform with ISO 7864: 2016 | ||
| ISO 9626: 2016 | Conform with ISO 7864: 2016 | ||
| ISO 9626: 2016 | Same | ||
| Needle guage | 21G | 21G | Same |
| Capacity (ml) | 20, 21, 22, 23, 25 | 19, 21, 23 | Different |
| Analysis 3 | |||
| Patient | |||
| contact | |||
| Material | Spike | Acrylonitrile Butadine | |
| Styrene (ABS) | |||
| Polyethylene (PE) | |||
| Stainless Steel 304 (SUS304) | Spike | ||
| HDPE | |||
| Tee | Polyvinyl Chloride (PVC) | Tee | |
| Unknown | |||
| Drip Tube | Acrylonitrile Butadine | ||
| Styrene (ABS) | Drip tube | ||
| Unknown | |||
| Drip Chamber | Polyvinyl Chloride (PVC) | Drip Chamber | |
| PVC | |||
| Flexible Tube | Polyvinyl Chloride (PVC) | Flexible Tube | |
| PVC | |||
| Fluid Filter | Methyl Metha Acrylate ABS(MABS) | ||
| Polypropylene (PP) | Fluid Filter | ||
| ABS | |||
| External Cone Lock Connector | Acrylonitrile Butadine | ||
| Styrene (ABS) | External Cone Lock Connector | ||
| Unknown | |||
| Injection Site | Polyisoprene | Injection Site | |
| ABS | |||
| Intravenous Infusion Needle | Polyvinyl Chloride (PVC) | ||
| Acrylonitrile Butadine Styrene (ABS) | |||
| Stainless Steel 304 ( SUS304) | Intravenous Infusion Needle | ||
| Unknown | |||
| BiocompatibilitydD | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | |
| Skin Sensitization | No Skin Sensitization | No Skin Sensitization | |
| Different | |||
| Analysis 4 | |||
| Intracutaneous reactivity | No Intracutaneous reactivity | No Intracutaneous reactivity |
Table 3 Safety and Effectiveness Comparison for Infusion Set for Single Use
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| Acute
Systematic
Toxicity | No Acute Systematic Toxicity | No Acute Systematic
Toxicity |
|---------------------------------|------------------------------|---------------------------------|
| Pyrogen | No Pyrogen | No Pyrogen |
| Vivo
Thromboresist
ance | No Thromboresistance / | / |
| Complement
Activation | No Complement Activation / | / |
| Hemolysis | No Hemolysis | No Hemolysis |
| Sterilization | | |
| Method | EO sterilized | EO sterilized |
| SAL | 10-6 | 10-6
Same |
| Endotoxin
Limit | 20 EU per device | 20 EU per device |
SE Analysis 3 - Capacity
The proposed device has different total length and difference configuration, so it has different capacity. The slight difference on the capacity between the proposed device and predicate device capacity cannot affect the devices' intended use. Therefore, the difference on capacity will not raise any safety and effectiveness of proposed device.
SE Analysis 4 - Patient contact Material and Biocompatibility
The patient contact materials for proposed device are different from predicate device. However, the biocompatibility test for proposed device was performed on the proposed device and there are two more biological compatibility test items than those of predicate device, Vivo Thromboresistance and Complement Activation. And the test results show there is no adverse effect on the material. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
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- Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Testing
Performance Testing
- A ISO 8536-4:2010 Infusion equipment for medical use- Part 4: Infusion sets for single use, gravity feed.
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ISO 8536-14:2016 Infusion equipment for medical use-Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact.
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ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications-Part 7: Connectors for intravascular or hypodermic applications.
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ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications-Part 20: Common test methods.
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ISO 7864:2016, Sterile hypodermic needles for single use - Requirements and test methods.
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ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods.
BiocompatibilityTesting
This device is classified as: Externally communicating, Blood path Indirect, Limited contact ≤ 24 hours.
- A ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
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USP Bacterial Endotoxins Test.
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USP Particular Matter in Injections.
- A ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity.
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ISO 10993-4: 2017, Biological Evaluation of Medical Devices - Part 4: Selection of Test for Interation with Blood.
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ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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ISO 10993-11: 2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
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ASTM F756-2017 Standard Practice for Assessment of Hemolytic Properties of Materials.
- USP Pyrogen Test. >
Sterility, Shipping and Shelf-life:
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ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials.
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration.
- A ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
No clinical study is included in this submission.
9. Conclusion
The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The Infusion Sets for Single Use are substantially equivalent to the Sterile Single Use Infusion Sets K163160 with respect to indications for use, treatment method, and technological characteristics.