(577 days)
Not Found
No
The description focuses on the physical components and sterilization of a fluid administration set, with no mention of AI or ML capabilities. The performance studies described are standard non-clinical tests for medical devices, not related to algorithmic performance.
No
The device is used for fluid administration into the vascular system, which is a treatment, but it is not described as directly diagnosing, curing, mitigating, treating, or preventing disease, which is the definition of a therapeutic device. It is an administration set, which is a delivery device.
No
Explanation: The device is described as being used for the "administration of fluids from a container into the patient's vascular system." This indicates a therapeutic or delivery function, not a diagnostic one. There is no mention of it collecting data, analyzing samples, or providing information for diagnosis.
No
The device description explicitly lists multiple hardware components such as luer locks, tubing, clamps, filters, and valves, and describes physical testing like sterilization and biocompatibility, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of fluids from a container into the patient's vascular system through a vascular access device." This describes a device used for delivering substances into the body, not for examining specimens from the body to provide diagnostic information.
- Device Description: The components listed (luer locks, tubing, flow regulators, clamps, filters, etc.) are all consistent with devices used for fluid administration, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens from the human body. This device operates in vivo (within the living body) for therapeutic purposes (fluid administration).
N/A
Intended Use / Indications for Use
The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. The intended populations include adults and pediatrics except neonates.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The proposed device is a single used device. It includes 30 models. For the 30 different models, each configuration comprises of various components which may include: Male luer lock and protector, Female luer lock and protector. Tube, Flow regulator, Clamp, multiple ways connector, Precision Liquid filter, Needle free connector, Check valve, Graduated flow regulator. Injection site and stopcock. The detail description of models is provided in Table 1.
The proposed devices are sterilized by EO to achieve a SAL 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's vascular system
Indicated Patient Age Range
Adults and pediatrics except neonates.
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 and was Substantially Equivalent (SE) to the predicate device.
Performance testing: The extension tube performance testing and connector testing were conducted on the proposed device; the test results demonstrated that the proposed device complies with the following standards:
- ISO 8536-4:2019 Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity A feed
- A ISO 8536-12:2007/AMD 1:2012 Infusion equipment for medical use — Part 12: Check valves
- A ISO 8536-13:2016 Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact
- ISO 8536-14:2016 Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
- ISO 80369-7:2021 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
Particular Matter: The particular matter testing was conducted on the subject device, the test results demonstrated that the proposed device complies with the following standard:
- USP Particular Matter in Injections.
Sterilization: EO/ECH residual testing was conducted on the proposed device per ISO 10993-7 Amendment - 1 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019).
Shelf life: A maximum shelf life of 5 years has been assigned to the proposed device. In order to demonstrate substantial equivalence between the subject and predicate device, the sponsor conducted accelerated aging on the proposed device and performed the following tests on the accelerated aged device to provide data for the device shelf life:
- Package integrity of aged device:
- Product performance testing
Packaging integrity: The package integrity performances of the proposed sterility maintenance package include visual inspection, seal strength and dye penetration resistance. The test results demonstrated that the proposed device complies with the following standards:
- ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials.
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration.
- ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
Shipping: A simulated transportation testing was conducted on the proposed device per ASTM D4169-22.
Biocompatibility: The exposure period of proposed device does not exceed 7 days, blood path, indirect contact, limited contact. Based on the above identified contact level and contact duration, it was tested for Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Pyrogen (ISO 10993-11), and Hemolysis (ISO 10993-4), subacute toxicity testing (ISO 10993-11).
Endotoxin limit: Endotoxin limit is established as 20 USP Endotoxin Unit (EU) for the proposed device. Test has been conducted by Limulus Amebocyte Lysate (LAL) method according to USP Bacterial Endotoxin Limit.
No clinical study is included in this submission.
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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2024
Shandong Ande Healthcare Apparatus Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co, Ltd. P.O. Box 120-119 Shanghai, 200120 China
Re: K222766
Trade/Device Name: Disposable Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: March 11, 2024 Received: March 11, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Pische Bennett
Porsche Bennett for David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,
2
General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K222766
Device Name Disposable Extension Set
Indications for Use (Describe)
The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. The intended populations include adults and pediatrics except neonates.
| 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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4
K22766- 510(k) Summary
Date of Preparation: 04/12/2024
1. Sponsor Identification
Shandong Ande Healthcare Apparatus Co., Ltd. No. 999, Zunxian Road, New & Hi-Tech Zone, Zibo, 255086 Shandong, P. R. China
Establishment Registration Number: 3012039263
Contact Person: Xiaolei Tian Position: R&D Director Tel: +86-533-3917821 Fax: +86-533-3143085 Email: tianxiaolei@andemed.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (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
5
3. Identification of Subject Device
Trade Name: Disposable Extension Set Common Name: Disposable Extension Set Regulation Name: Intravascular administration set Regulatory Class: II; Product Code: FPA; Regulation Number: 21 CFR 880.5440 Review Panel: General Hospital;
Indication for Use Statement:
The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. The intended populations include adults and pediatrics except neonates.
-
- Identification of Predicate Device
510(k) Number: K101958 Product Name: AMSINO I.V. ADMINISTRATION AND EXTENSION SETS Manufacturer: AMSINO International, Inc
- Identification of Predicate Device
Indications for Use:
The AMSINO® I.V. ADMINISTRATION EXT'ENSION SET is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.
-
- Device Description
The proposed device is a single used device. It includes 30 models. For the 30 different models, each configuration comprises of various components which may include: Male luer lock and protector, Female luer lock and protector. Tube, Flow regulator, Clamp, multiple ways connector, Precision Liquid filter, Needle free connector, Check valve, Graduated flow regulator. Injection site and stopcock. The detail description of models is provided in Table 1.
- Device Description
The proposed devices are sterilized by EO to achieve a SAL 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
| No | Model (REF) | Configuration description |
|---|---|---|
| 1 | C2900000A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 2000mm) |
| 2 | C2900002B | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 2.3mm; ID: |
| 1.0mm; L: 2000mm) | ||
| 3 | C2900003A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 2000mm), Flow Regulator |
| 4 | C2900005B | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 2.3mm; ID: 1.0mm; L: 100mm), slide clamp |
| 5 | C2900007A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 100mm), Slide Clamp |
| 6 | C2900200B | Bi-fuse I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 2.3mm; ID: 1.0mm; L: 1000mm), Slide Clamp |
| 7 | C2900300B | Tri-fuse I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 2.3mm; ID: 1.0mm; L: 1400mm), Slide Clamp |
| 8 | C2900201A | Bi-fuse I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1000mm), Slide Clamp |
| 9 | C2900301A | Tri-fuse I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1400mm), Slide Clamp |
| 10 | C2960009B | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 2.3mm; ID: 1.0mm; L: 1500mm), Slide Clamp, 0.2µm Liquid filter |
| 11 | C2950010B | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 2.3mm; ID: 1.0mm; L: 1500mm), Slide Clamp, 1.2µm Liquid filter |
| 12 | C2960011A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1500mm), Slide Clamp, 0.2µm Liquid filter |
| 13 | C2950012A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1500mm), Slide Clamp, 1.2µm Liquid filter |
| 14 | C2962003A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1000mm), Slide Clamp, 0.2µm Liquid filter, Needle free connector |
| 15 | C2952004A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1000mm), Slide Clamp, 1.2µm Liquid filter, Needle free connector |
| 16 | C2902006A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 200mm), Slide Clamp, Needle free connector |
| 17 | C2902202A | Bi-fuse I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1000mm), Slide Clamp, Needle free connector |
| 18 | C2902301A | Tri-fuse I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1400mm), Slide Clamp, Needle free connector |
| 19 | C2902007B | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 2.3mm; ID: 1.0mm; L: 100mm), Slide Clamp, Needle free connector |
| 20 | C2902008A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1000mm), Slide Clamp. Needle free connector |
| 21 | C2902201B | Bi-fuse I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 2.3mm; ID: 1.0mm; L:230mm), Slide Clamp, Needle free connector |
| 22 | C2902300В | Tri-fuse I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 42.3; ID: 1.0mm; L: 320mm), Slide Clamp, Needle free connector |
| 23 | C2904000A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1500mm), Slide Clamp, Needle free connector, check valve |
| 24 | C2905000A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 150mm), Slide Clamp, Stopcock |
| 25 | C2903000A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1000mm), Slide Clamp, Graduated flow regulator |
| 26 | C2903001A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1500mm), Slide Clamp, Graduated flow regulator, injection site |
| 27 | C2903002A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1500mm), Slide Clamp, Graduated flow regulator, Needle free connector |
| 28 | C2901000A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: 3.0mm; L: 1000mm), Slide Clamp, injection site |
| 29 | C2961001A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: |
| 3.0mm; L: 1500mm), Slide Clamp, 0.2µm Liquid filter, injection site | ||
| 30 | C2951002A | I.V. Extension Set with Male Luer lock, Female Luer lock, Tubing (OD: 4.1mm; ID: |
| 3.0mm; L: 1500mm), Slide Clamp, 0.2µm Liquid filter, injection site |
Table 1 Description of Models
6
7
6. Substantially Equivalent (SE) Comparison
Table 2 Comparison with K101958
| Table 2 Comparison with K101958 | ||||
|---|---|---|---|---|
| Item | Proposed Device | Predicate Device | Remark | |
| K222766 | K101958 | |||
| 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 used for the | |||
| administration of fluids from a | ||||
| container into the patient's | ||||
| vascular system through a | ||||
| vascular access device. The | ||||
| intended populations include | ||||
| adults and pediatrics except | ||||
| neonates. | The AMSINO® I.V. | |||
| ADMINISTRATION | ||||
| EXTENSION SET is a | ||||
| device intended to | ||||
| administer fluids from a | ||||
| container to a patient's | ||||
| vascular system through a | ||||
| catheter inserted into a | ||||
| vein. | Same | |||
| Models | C2900000A, | |||
| C2900003A, | ||||
| C2900007A, | ||||
| C2900300B, | ||||
| C2900301A, | ||||
| C2950010B, | ||||
| C2950012A, | ||||
| C2952004A, | ||||
| C2902202A, | ||||
| C2902007B, | ||||
| C2902201B, | ||||
| C2904000A, | ||||
| C2903000A, | ||||
| C2903002A, | ||||
| C2901000A, | ||||
| C2951002A | C2900002B, | |||
| C2900005B, | ||||
| C2900200B, | ||||
| C2900201A, | ||||
| C2960009B, | ||||
| C2960011A, | ||||
| C2962003A, | ||||
| C2902006A, | ||||
| C2902301A, | ||||
| C2902008A, | ||||
| C2902300B, | ||||
| C2905000A, | ||||
| C2903001A, | ||||
| C2961001A | No product models were | |||
| exposed in K101958 | ||||
| 510(k) summary | ||||
| Different, | ||||
| Comment 1 | ||||
| Main Configuration/Components | Male luer lock | |||
| Female luer lock | Luer adapter/connectors | Different, | ||
| Comment 2 | ||||
| Slide clamp | Clamp | |||
| Injection set | latex-free injection port | |||
| Tubing | Tubing | |||
| Flow regulator | Flow controller | |||
| Graduated flow regulator | ||||
| 0.2µm/1.2µm Liquid filter | Filter | |||
| Needle free connector | Needleless injection port | |||
| Stopcock | Stopcock | |||
| 3-way connector, 4-way connector | Manifold | |||
| / | Flash bulb | |||
| / | Y-site | |||
| / | Drip chamber | |||
| Single Use | Single Use | Single Use | Same | |
| Prescription Use | Yes | Yes | Same | |
| Total Length | 100mm~2000mm | Unknown | Different, | |
| Comment 3 | ||||
| Tubing diameters | ID:1.0mm,OD:2.3mm | |||
| ID:3.0mm,OD:4.1mm | Smallbore | |||
| Standard Bore | Different, | |||
| Comment 4 | ||||
| Priming Volume | 0.23ml ~13.25ml | Unknown | Different, | |
| Comment 3 | ||||
| Patient Contact | ||||
| Materials | Male luer lock | Acrylonitrile Butadiene Styrene | ||
| (ABS) | ||||
| Female luer lock | Acrylonitrile Butadiene Styrene | |||
| (ABS) | ||||
| Injection set | Acrylonitrile Butadiene Styrene | |||
| (ABS) | ||||
| Polyisoprene Rubber | ||||
| Tubing | Poly Vinyl Chloride (PVC) | |||
| Flow regulator | Acrylonitrile Butadiene Styrene | |||
| (ABS) | Unknown | Different, | ||
| Comment 5 | ||||
| Graduated | ||||
| flow regulator | Acrylonitrile Butadiene Styrene | |||
| (ABS) | ||||
| Silicon Rubber | ||||
| Liquid filter | Acrylonitrile Butadiene Styrene | |||
| (ABS) | ||||
| Polyether sulfone (PES) | ||||
| Poly Tetra Fluoro Ethylene | ||||
| (PTFE) | ||||
| Needle | ||||
| free | ||||
| connector | Polycarbonate (PC) | |||
| Silicon Rubber | ||||
| Stopcock | Acrylonitrile Butadiene Styrene | |||
| (ABS) | ||||
| 3-way | ||||
| connector, | ||||
| 4-way | ||||
| connector | Poly Vinyl Chloride (PVC) | |||
| Biocompatibility | Cytotoxicity | Cytotoxicity | Different, | |
| Comment 6 | ||||
| Skin Sensitization | Skin Sensitization | |||
| Intracutaneous Reactivity | Irritation, | |||
| Acute Systemic Toxicity | Acute Systemic Toxicity | |||
| Pyrogen Test | / | |||
| Hemolysis Test | Hemocompatibility Test | |||
| Performance | ||||
| Standard | ISO 8536-4 | |||
| ISO 8536-11 | ||||
| ISO 8536-12 | ||||
| ISO 8536-13 | ||||
| ISO 8536-14 | ||||
| ISO 80369-7 | ||||
| ISO 80369-20 | ISO 8536-4 | |||
| ISO 8536-11 | ||||
| ISO 8536-12 | ||||
| ISO 8536-13 | ||||
| ISO 8536-14 | ||||
| ISO 594-1 | ||||
| ISO 594-2 | Different, | |||
| Comment 7 | ||||
| Sterilization | ||||
| method | EO sterilization | EO sterilization | Same | |
| Shelf life | 5 years | Unknown | Different, | |
| Comment 8 |
8
9
Comment 1 -Models
The proposed device has 30 models, the predicate device didn't include product model information in K101958, 510(k) summary. This difference does not raise different questions of safety and effectiveness.
Comment 2 - Main Configuration/Components
The proposed device only includes extension sets, while the predicate device includes administration sets and extension sets. The main configurations of the proposed device are similar as those of the extension sets of predicate device. However, the components of the proposed device are included in predicate device. Moreover, all configurations are broadly used throughout the medical industry, and their functions are the same or similar. Performance tests have been completed on the proposed device and the test results demonstrate that the device does not raise different questions of safety and effectiveness.
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Comment 3 -Total Length and Priming Volume
The total length and priming volume of the proposed device may be different from those of the predicate device. Performance tests have been completed on the proposed device and the test results demonstrate that the device does not raise different questions of safety and effectiveness.
Comment 4 - Tubing diameters
The tubing diameters of the proposed device may be different from those of the predicate device. Performance tests have been completed on the proposed device and the test results demonstrate that the device does not raise different questions of safety and effectiveness.
Comment 5 & Comment 6- Patient Contact Materials & Biocompatibility
The patient contact materials for predicate device are different from those of the predicate devices. However, biocompatibility testing was performed on the proposed device. The data demonstrates there is no adverse effect from the material. Therefore, this difference in the patient contact material does not raise different questions of safety and effectiveness.
Comment 7 - Performance Standard
Both ISO 80369-7 and ISO 80369-20 of the proposed device and ISO 594-2 of predicate device are used to specify the requirements on conical fitting with a 6% (Luer) taper for intravascular or hypodermic applications. ISO 594-1 and ISO 594-2 is superseded by ISO 80369-7. The subject device was adequately tested to currently recognized performance standards for the device type.
Comment 8 - Shelf life
The predicate device's shelf life is unknown. The subject device performance has been adequately tested over the proposed shelf life. In addition, the expiration date of the product is included in the product labels to inform the end user of the shelf life. Therefore, this difference does not raise different questions of safety and effectiveness.
7. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device.
Performance testing:
The extension tube performance testing and connector testing were conducted on the proposed device; the test results demonstrated that the proposed device complies with the following standards:
- ISO 8536-4:2019 Infusion equipment for medical use -- Part 4: Infusion sets for single use, gravity A feed
- A ISO 8536-12:2007/AMD 1:2012 Infusion equipment for medical use — Part 12: Check valves
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- A ISO 8536-13:2016 Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact
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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 80369-7:2021 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
Particular Matter:
The particular matter testing was conducted on the subject device, the test results demonstrated that the proposed device complies with the following standard:
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USP Particular Matter in Injections.
Sterilization:
EO/ECH residual testing was conducted on the proposed device per ISO 10993-7 Amendment - 1 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019).
Shelf life:
A maximum shelf life of 5 years has been assigned to the proposed device. In order to demonstrate substantial equivalence between the subject and predicate device, the sponsor conducted accelerated aging on the proposed device and performed the following tests on the accelerated aged device to provide data for the device shelf life:
- ♪ Package integrity of aged device:
- A Product performance testing
Packaging integrity:
The package integrity performances of the proposed sterility maintenance package include visual inspection, seal strength and dye penetration resistance. The test results demonstrated that the proposed device complies with the following standards:
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ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials.
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ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration.
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ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
Shipping:
A simulated transportation testing was conducted on the proposed device per ASTM D4169-22.
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Biocompatibility:
The exposure period of proposed device does not exceed 7 days, blood path, indirect contact, limited contact. Based on the above identified contact level and contact duration, it was tested for Cytotoxicity (ISO 10993-5), Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Pyrogen (ISO 10993-11), and Hemolysis (ISO 10993-4), subacute toxicity testing (ISO 10993-11).
Endotoxin limit:
Endotoxin limit is established as 20 USP Endotoxin Unit (EU) for the proposed device. Test has been conducted by Limulus Amebocyte Lysate (LAL) method according to USP Bacterial Endotoxin Limit.
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- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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Substantially Equivalent (SE) Conclusion 9.
The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The Disposable Extension Set is substantially equivalent to the AMSINO IV Administration and Extension Sets, K101958, with respect to indications for use, treatment method, and technological characteristics.