(229 days)
Not Found
No
The device description and performance studies focus on physical, mechanical, and chemical properties of standard infusion sets and filters, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used for the delivery of fluids or medications to a patient's vascular system in I.V. therapy, indicating a therapeutic purpose.
No
The device is described as infusion sets and filters for the delivery of fluids and removal of particulate matter, which are therapeutic and drug delivery functions, not diagnostic.
No
The device description explicitly lists physical components such as protective caps, tubing, filters, and fittings, indicating it is a hardware-based medical device.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use clearly states the devices are for the "delivery of fluids from a container to a patient's vascular system" and for "removal of particulate matter during the administration of fluids or medications." This describes a therapeutic or delivery function within the patient's body (in vivo), not a diagnostic test performed on samples outside the body (in vitro).
- Device Description: The description details components like tubing, filters, and connectors used for administering fluids directly to a patient. This aligns with infusion sets and filters used in patient care, not for analyzing biological samples.
- Anatomical Site: The specified anatomical site is the "patient's vascular system," which is an in vivo location.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
Therefore, these devices fall under the category of medical devices used for patient treatment and fluid administration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system for short term infusions only.
The Precision Infusion Filter for Single Use is intended to be used with administration sets for removal of particulate matter during the administration of fluids or medications.
The Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration.
Product codes (comma separated list FDA assigned to the subject device)
FPA, FPB
Device Description
The purpose of this submission was to introduce new products into interstate commerce. This is a bundled submission which includes Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use and Extended Infusion Sets for Single Use.
Infusion Sets with Precision Filter for Single Use:
Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system under the action of gravity. The proposed devices are comprised of protective cap, closure-piercing device, air vent, drip chamber, precision filter, flexible tubing, injection site, flow regulator, clamp, conical fitting, burette and needle tube. The devices are provided sterile and single use.
Precision Infusion Filter for Single Use:
Precision Infusion Filter for Single Use is intended to be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications. The proposed devices are comprised of protective Cap and precision filter. The devices are provided sterile and single use.
Extended Infusion Sets for Single Use:
Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration. The proposed devices are comprised of protective Cap, flexible tubing, conical fitting and precision filter. The devices are provided sterile and single 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)
Clinical Testing: No clinical study is included in this submission.
Non-Clinical Test Summary
Design verification and validation were performed to ensure that the proposed devices meet its performance specifications and demonstrates equivalence to the specified predicate device. The test conducted on the proposed device are listed in following.
Physical, Mechanical and Chemical Tests performed on the proposed devices include The following items were tested on Infusion Sets with Precision Filter for Single Use:
ISO 8536-4:2010 and AMD 1 2013
ISO 8536-5: 2004
ISO 8536-14:2016
ISO 594-2:1998
ISO 7864:2016
ISO 9626:2016
The following items were tested for Precision Infusion Filter for Single Use:
ISO 8536-4: 2010 and AMD 1 2013
ISO 594-2:1998
The following items were tested for Extended Infusion Sets for Single Use:
ISO 8536-4:2010 and AMD 1 2013
ISO 594-2:1998
Sterile Barrier Packaging Testing performed on the all proposed devices, the test items are listed in following:
Seal strength: ASTM F88/F88-15
Dye Penetration: ASTM F 1929-15
Sterilization and Shelf Life Testing performed on the all proposed devices, the test items ar e listed in following:
EO residue: ISO 10993-7:2008
ECH residue: ISO 10993-7:2008
Bacteria Endotoxin Limit: USP
Shelf Life Evaluation: Physical, Mechanical, Chemical, Package and Sterility Tests were performed on aging samples to verify the claimed shelf life of the device.
Biocompatibility Test
Biocompatibility test was conducted on the largest size of proposed device, the test items include Cytotoxicity (ISO 10993-5), Intracutaneous reactivity (ISO 10993-10), Skin Sensitization (ISO 10993-10), Acute Systematic Toxicity (ISO 10993-11), Hemolysis (ASTM F756), Pyrogen (USP ), Complement activation (ISO 10993-4) and Thrombosis (ISO 10993-4).
Key results: Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
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
§ 880.5440 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 logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 26, 2019
Wuhan W.E.O Science & Technology Development Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K181870
Trade/Device Name: Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA, FPB Dated: January 9, 2019 Received: January 23, 2019
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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sapana Patel -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181870
Device Name
Infusion Sets with Precision Filter for Single Use Precision Infusion Filter for Single Use Extended Infusion sets for Single Use
Indications for Use (Describe)
The Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system for short term infusions only.
The Precision Infusion Filter for Single Use is intended to be used with administration sets for removal of particulate matter during the administration of fluids or medications.
The Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary K181870
Manufacturer's Name:
Wuhan W.E.O Science & Technology Development Co., Ltd. No.18, Huanhu Mid. Rd., Jinyin Lake, Dongxihu Dist., 430040 Wuhan, People's Republic of China
Name of Corresponding Official: Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Telephone Number: +86-21-22815850 Fax Number: 360-925-3199
Summary Date: 02/22/2019
- Trade Name: Infusion Sets with Precision Filter for Single Use Precision Infusion Filter for Single Use Extended Infusion Sets for Single Use
- Common Name: I.V. Administration Set Infusion Line Filter
- Regulation Name: Intravascular Administration Set
Regulation Number: 21 CFR 880.5440
- FPA (IV Administration Set, Extended Infusion Sets for Single Use) Product Code: FPB (Infusion Line Filter)
Predicate Devices:
Infusion Sets with Precision Filter for Single Use
Predicate Device 510(K) Number: K161898
Product Name: Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set
4
Precision Infusion Filter for Single Use Predicate
Device 510(K) Number: K974661 Product Name: 0.2u bacterial filter
Extended Infusion_Sets_for_Single_Use
Predicate Device 510(K) Number: K061115 Product Name: SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEED FLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216
Device Description:
The purpose of this submission was to introduce new products into interstate commerce. This is a bundled submission which includes Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use and Extended Infusion Sets for Single Use.
Infusion Sets with Precision Filter for Single Use:
Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system under the action of gravity. The proposed devices are comprised of protective cap, closure-piercing device, air vent, drip chamber, precision filter, flexible tubing, injection site, flow regulator, clamp, conical fitting, burette and needle tube. The devices are provided sterile and single use.
Precision Infusion Filter for Single Use:
Precision Infusion Filter for Single Use is intended to be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications. The proposed devices are comprised of protective Cap and precision filter. The devices are provided sterile and single use.
Extended Infusion Sets for Single Use:
Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration. The proposed devices are comprised of protective Cap, flexible tubing, conical fitting and precision filter. The devices are provided sterile and single use.
Indications for Use:
The Infusion Sets with Precision Filter for Single Use is indicated for the delivery of fluids from a container to a patient's vascular system for short term infusions only.
The Precision Infusion Filter for Single Use is intended to be used with administration sets or extension sets for removal of particulate matter during the administration of fluids or medications.
The Extended Infusion Sets for Single Use is intended to be used in I.V. therapy when an extended fluid path is requirement for administration.
5
| ITEM | Proposed Device | Predicate Device 1
K161898 | Discussion |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Regulation No. | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Product Code | FPA | FPA | Same |
| Class | II | II | Same |
| Indication for Use | The Infusion Sets with
Precision Filter for Single
Use is indicated for the
delivery of fluids from a
container to a patient's
vascular system for short
term infusions only. | The devices are indicated for
the delivery of fluids from a
container to a patient's
vascular system. | Discussion 1 |
| Configuration | Protector Cap of Closure-
piercing Device
Closure-piercing Device
Air Vent
Burette
Air Filter
Drip Chamber
Precision Filter
Flexible Tubing
Flow Regulator
Y Injection Site
Clamp
Conical Fitting
Protective Cap of Conical
Fitting
Needle Tube | Protector Cap of Closure-
piercing Device
Closure-piercing Device
Air Vent
Burette
Air Filter
Drip Chamber
Precision Filter
Flexible Tubing
Flow Regulator
Y Injection Site
Clamp
Conical Fitting
Protective Cap of Conical
Fitting
Needle Tube | Same |
| Material | PP, ABS, PVC, PE,
Stainless Steel,
Acrylonitrile-styrene | PC, ABS, PVC, PE, POM,
Acrylonitrile-styrene,
Stainless Steel, | Discussion 2 |
| Operation Mode | Manual | Manual | Same |
Comparison for Infusion Sets with Precision Filter for Single Use
6
| Label/Labeling | Conform with 21 CFR Part
801 | Conform with 21 CFR Part
801 | Same |
|-----------------------------------|-------------------------------------------|-------------------------------------------|--------------|
| Infusion Set
Performance | Conform with ISO 8536-4
and ISO 8536-5 | Conform with ISO 8536-4 and
ISO 8536-5 | Same |
| Needle Performance | Conform with ISO 7864 and
ISO 9626 | Conform with ISO 7864 and
ISO 9626 | Same |
| Needle gauge and
Sterilization | 22G×25mm | 22G×20mm | Discussion 3 |
| Method | EO sterilized | EO sterilized | Same |
| SAL | 10-6 | 10-6 | |
| Biocompatibility | | | |
| Cytotoxicity | No cytotoxicity | | |
| Intracutaneous
reactivity | No Intracutaneous
reactivity | | |
| Skin Sensitization | No Skin Sensitization | | |
| Acute Systematic
Toxicity | No Acute Systematic
Toxicity | Comply with ISO 10993 | Same |
| Hemolysis | No Hemolysis | | |
| Pyrogen | No Pyrogen | | |
| Complement
activation | No complement activation | | |
| Thrombosis Test | No thrombosis | | |
Discussion 1
The indication of short term infusion is not included in predicate device. However, the predicate device is same as the proposed device and also indicated for short term infusion rather than long term infusion, therefore, this difference does not affect substantially equivalence.
Discussion 2
The material for proposed device is different from predicate device. However, the biocompatibility test for proposed device has been conducted and the test result conform with requirements of ISO 10993 standards. Therefore, this difference does not affect substantially equivalence.
Discussion 3
The needle length for proposed device is different from predicate device. However, this difference is just in dimension. Different length will be selected by physician per patient's condition. This difference does not affect intended use. Therefore, this difference does not affect substantially equivalence.
7
Comparison for Precision Infusion Filter for Single Use
| ITEM | Proposed Device | Predicate
Device 2 | Discussion |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Regulation No. | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Product Code | FPB | FPB | Same |
| Class | II | II | Same |
| Intended Use | The Precision Infusion Filter
for Single Use is intended
to be used with administration
sets or extension sets for removal
of particulate matter during
the administration of fluids
or medications. | The 0.2µ bacterial filter
can be used with
administration sets or
extension sets for
removal of particulate
matter during the
administration of fluids
or medications. | Same |
| Configuration | Protective Cap
Precision Filter | Protective Cap | Same |
| Material | PP, Acrylonitrile-styrene | Unknown | Discussion 4 |
| Operation Mode | Manual | Manual | Same |
| Pore Size of
Membrane | 1.2µm, 0.2µm | 0.2µm | Discussion 5 |
| Sterilization | | | |
| Method | EO sterilized | EO sterilized | |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | |
| Biocompatibility | Comply with ISO 10993 | Comply with ISO 10993 | Same |
Discussion 4
The material for predicate device is unknown and substantially equivalence between proposed device and predicate device cannot be determined. However, the biocompatibility test for proposed device has been conducted and the test result conform with requirements of ISO 10993 standards. Therefore, this difference does not affect substantially equivalence.
Discussion 5
The proposed device has the additional pore size 1.2um compared to predicate device. However, the filter performance has tested and the test result can meet the acceptance criteria. Therefore, this difference does not affect substantially equivalence.
8
| Comparison for Extended Infusion Sets for Single Use | |||||||
|---|---|---|---|---|---|---|---|
| ------------------------------------------------------ | -- | -- | -- | -- | -- | -- | -- |
| ITEM | Proposed Device | Predicate Device 3
K061115 | Discussion |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Regulation No. | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Product Code | FPA | FPA | Same |
| Class | II | II | Same |
| Intended Use | The Extended Infusion
Sets for Single Use is
intended to be used in
I.V. therapy when an
extended fluid path is
requirement for
administration. | Indicated as a single use,
sterile device for use in I.V.
therapy when an extended
fluid path is requirement for
administration. Environment
of use: Hospital, Emergency
Medical Services settings,
wherever I.V. fluid
administration may be
indicated. | Discussion 6 |
| Configuration | Protective Cap
Precision Filter
Flexible tubing
Conical fitting | Protective Cap
Precision Filter
Flexible tubing
Conical fitting | Same |
| Material | PP, ABS, PVC, AS | Unknown | Discussion 7 |
| Operation Mode | Manual | Manual | Same |
| Pore Size of
Membrane | 1.2µm, 0.2µm | 1.2µm, 0.2µm | Same |
| Sterilization | | | |
| Method | EO sterilized | EO sterilized | |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | |
| Biocompatibility | Comply with ISO 10993 | Comply with ISO 10993 | Same |
Discussion 6
The indication for use of proposed device does not specify the en vironment of use. However, the proposed device shall be also used in the environment wherever I.V. fluid administration is required. Therefore, this difference does not affect substantially equivalence.
Discussion 7
The material for predicate device is unknown. However, the biocompatibility test for proposed device has been conducted and the test result conform with requirements of ISO 10993 standards. Therefore, this difference does not affect substantially equivalence.
9
Clinical Testing: No clinical study is included in this submission.
Non-Clinical Test Summary
Design verification and validation were performed to ensure that the proposed devices meet its performance specifications and demonstrates equivalence to the specified predicate device. The test conducted on the proposed device are listed in following
Physical, Mechanical and Chemical Tests performed on the proposed devices include The
following items were tested on Infusion Sets with Precision Filter for Single Use:
ISO 8536-4:2010 and AMD 1 2013 ISO 8536-5: 2004 ISO 8536-14:2016 ISO 594-2:1998 ISO 7864:2016 ISO 9626:2016
The following items were tested for Precision Infusion Filter for Single Use: ISO
8536-4: 2010 and AMD 1 2013 ISO 594-2:1998
The following items were tested for Extended Infusion Sets for Single Use: ISO 8536-4:2010 and AMD 1 2013 ISO 594-2:1998
Sterile Barrier Packaging Testing performed on the all proposed devices, the test items are listed in following:
| Seal strength | ASTM F88/F88-15 |
|---|---|
| Dye Penetration | ASTM F 1929-15 |
Sterilization and Shelf Life Testing performed on the all proposed devices, the test items ar e listed in following:
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package and Sterility Tests were performed on aging samples to verify the claimed shelf life of the device. |
Biocompatibility Test
Biocompatibility test was conducted on the largest size of proposed device, the test items include Cytotoxicity (ISO 10993-5), Intracutaneous reactivity (ISO 10993-10), Skin
10
Sensitization (ISO 10993-10), Acute Systematic Toxicity (ISO 10993-11), Hemolysis (ASTM F756), Pyrogen (USP ), Complement activation (ISO 10993-4) and Thrombosis (ISO 10993-4).
Conclusion:
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.