(268 days)
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 under the action of gravity.
The device is a Disposable infusion set with needle. Its configuration includes a Protective Cap of Closure-piercing Device, Closure-piercing Device, Clamp, Fluid channel (tubing), Drip chamber upper cover (including the dropper), Drip chamber, Drip chamber base (including Fluid Filter membrane), Flow regulator, Regulator wheel, Luer Lock Connector, Infusion needle hub, Needle tube, Plastic needle handle, Infusion needle protector, Integral air-inlet with air filter and closure, Tubing, Lubricant, and Adhesives. It has a Tubing Diameter of 4 mm and Filter Characteristics of 15µm. It is available in various Needle Gauges and Lengths.
The provided document is a 510(k) summary for a "Disposable infusion set with needle," which is a Class II medical device. This type of device is a physical medical device, not an AI/software device. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of AI/software performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, training/test set sample sizes for AI, etc.) is not applicable to this document.
The document discusses physical, mechanical, chemical, and biocompatibility testing according to various ISO and ASTM standards to demonstrate substantial equivalence to a predicate device.
However, to address the spirit of the request regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" for a physical medical device as described in this document, I can extract the relevant performance criteria and testing methods from the provided text.
Here's an interpretation based on the provided content for a physical medical device:
Acceptance Criteria and Device Performance for a Disposable Infusion Set with Needle
This document describes the regulatory submission for a Disposable Infusion Set with Needle (K232475) to demonstrate substantial equivalence to a predicate device (K163160). The "acceptance criteria" here refer to the performance requirements established by recognized standards, and the "study" refers to non-clinical performance testing conducted to prove the device meets these criteria.
1. Table of Acceptance Criteria and the Reported Device Performance
The document presents a comparison between the predicate device and the subject device, outlining various performance parameters. The "acceptance criteria" for the subject device are generally implied to be meeting the same performance standards as the predicate, or demonstrating that any differences do not adversely affect safety or performance, as evaluated against relevant ISO and ASRM standards.
"Reported Device Performance" is indicated by the statement that the subject device "met all design specifications as Substantially Equivalent (SE) to the predicate device" and that "The requirements of the standards are met." Specific quantitative results are generally not provided in this summary, but rather a confirmation of compliance.
| Parameter | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Infusion Set Performance | Compliance Confirmed | |
| Particulate contamination | Contamination index limit is less than 90 | Contamination index limit is less than 90 (Met) |
| Leakage | No leakage | No leakage (Met) |
| Tensile strength | Withstand a static tensile force of not less than 15N for 15s | Can withstand a static tensile force of 15 N for 15s (Met) |
| Closure piercing device | Comply the dimension of ISO 8536-4 | Comply the dimension of ISO 8536-4 (Met) |
| Air-inlet device | Flow of fluid reduced less than 20% of that from a freely ventilated container | Flow of fluid reduced less than 20% of that from a freely ventilated container (Met) |
| Fluid filter | Retention of latex particles is not less than 80% | Retention of latex particles is not less than 80% (Met) |
| Drip chamber and drip tube | 20 drops of distilled water equivalent to (1±0.1) ml/g | 20 drops of distilled water equivalent to (1±0.1) ml/g (Met) |
| Flow rate | Deliver not less than 1000ml | Deliver not less than 1000ml (Met) |
| Construction (Clamps) | Resist flow of fluid/air at 50 kPa when closed | Resist flow of fluid and air at an applied pressure of 50 kPa when closed (Met) |
| Needle Performance | Compliance Confirmed | |
| Cleanliness | Free from particles and extraneous matter | Free from particles and extraneous matter (Met) |
| Needle length | Meet ISO 7864:2016 Clause 4.10 | Met ISO 7864:2016 Clause 4.10 for respective gauges (e.g., 20.72mm for 23G) (Met) |
| Bond of hub and needle tube | Not broken by the minimum force | Not broken by the minimum force (Met) |
| Stiffness | Deflection is less than 0.50mm | Deflection is less than 0.50mm (Met) |
| Dimensions of needle tubing | Meet ISO 9626:2016 Clause 5.6 | Met ISO 9626:2016 Clause 5.6 for respective gauges (e.g., 0.627mm for 23G) (Met) |
| Resistance to breakage | The tubing is not break | No breakage (Met) |
| Resistance to corrosion | No evidence of corrosion | No corrosion (Met) |
| Biocompatibility | Compliance Confirmed | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity (Met) |
| Intracutaneous Reactivity | No Intracutaneous Reactivity | No Intracutaneous Reactivity (Met) |
| Skin Sensitization | No Skin Sensitization | No Skin Sensitization (Met) |
| Acute Systemic Toxicity | No Acute Systemic Toxicity | No Acute Systemic Toxicity (Met) |
| Hemolysis | No Hemolysis | No Hemolysis (Met) |
| Pyrogen | No pyrogen | No pyrogen (Met) |
| Other tests | Compliance Confirmed | |
| Seal strength | (Standards apply, e.g., ASTM F88/F88M-15) | Met (Tests performed per ASTM F88/F88M-15) |
| Internal pressure | (Standards apply, e.g., ASTM F1140/F1140M-13) | Met (Tests performed per ASTM F1140/F1140M-13) |
| Dye Penetration | (Standards apply, e.g., ASTM F1929-15) | Met (Tests performed per ASTM F1929-15) |
| EO residue | (Standards apply, e.g., ISO 10993-7:2008) | Met (Tests performed per ISO 10993-7:2008) |
| ECH residue | (Standards apply, e.g., ISO 10993-7:2008) | Met (Tests performed per ISO 10993-7:2008) |
| Bacterial Endotoxin Limit | (Standards apply, e.g., USP NF <161>) | Met (Tests performed per USP NF <161>) |
| Shelf-Life Evaluation | Maintain performance after accelerated aging | Met (Physical, Mechanical, Chemical, Package & Sterility Tests on aged samples) |
| Transportation Testing | Maintain package integrity | Met (Tests performed to verify package integrity) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of infusion sets tested for leakage, tensile strength, etc.). It generally refers to compliance with recognized standards (e.g., ISO 8536-4, ISO 7864), which themselves specify required sample sizes for testing.
- Data Provenance: The tests are non-clinical (laboratory/bench testing) performed by the manufacturer, Shandong Zhushi Pharmaceutical Group Co., Ltd. in China. The data would be derived from these internal tests. The term "retrospective or prospective" is not applicable to this type of device performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable. For a physical medical device like an infusion set, "ground truth" is established by direct physical, chemical, and biological testing against engineering and safety standards, not by expert consensus or interpretation of images. The tests evaluate measurable properties (e.g., tensile strength, flow rate, particulate count, presence of toxins) directly.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in studies involving human interpretation (e.g., radiologists reviewing images) where there might be inter-reader variability. For physical device performance testing, results are typically objective measurements or observations against predefined pass/fail criteria from a standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This question is not applicable. MRMC studies are used to assess the performance of diagnostic devices or AI systems, particularly how human readers perform with and without AI assistance on cases. This device is an infusion set, not a diagnostic or AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This device is a physical medical device, not an algorithm or AI.
7. The type of ground truth used
For this physical medical device, the "ground truth" is defined by:
- Established Industry Standards: Such as ISO 8536-4, ISO 7864, ISO 9626, USP NF <788>, USP NF <161>, ISO 10993 series, ASTM F1929, ASTM F88, etc. These standards specify acceptable ranges, limits, or characteristics for device performance and material safety.
- Direct Measurement and Observation: Performance is determined by physical tests (e.g., measuring tensile strength, observing leakage), chemical analyses (e.g., residual EO, particulate count), and biological assays (e.g., cytotoxicity, pyrogen testing).
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a physical medical device. This term refers to data used to train an AI algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as #8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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.
May 10, 2024
Shandong Zhushi Pharmaceutical Group Co., Ltd % Bruce Cai Technical Manager Humiss Inc. RM62, No. 236, Renmin Road, Qingcun Town, Fengxian District Shanghai. 201414 China
Re: K232475
Trade/Device Name: Disposable infusion set with needle Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: February 2, 2024 Received: April 11, 2024
Dear Bruce Cai:
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"
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(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.
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices,
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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
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Indications for Use
Submission Number (if known)
Device Name
Disposable infusion set with needle
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 under the action of gravity.
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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510(k) SUMMARY
The assigned 510(k) number: K232475 Date prepared: May. 10, 2024
I. SUBMITTER
Manufacturer name: Shandong Zhushi Pharmaceutical Group Co., Ltd. Address; No. 6, Shande Road, Shan County, Heze City, Shandong Province, 274300, China Contact Person: Junhui Zhu Title: Manager Tel: +86-15764021131 Fax: +86-530-4265777 E-mail: 2307426957@qq.com
II. Correspondent Contact Information
Bruce Cai (Contact Person) Humiss Inc. Tel: +86-13585598660 E-mail: cc401vip@126.com
III. DEVICE
| Trade Name: | - Disposable infusion set with needle |
|---|---|
| Common Name | - Intravascular Administration Set |
| Classification Name | - Intravascular administration set |
| Regulation Number | - 21CFR 880.5440 |
| Regulation Number | - FPA |
IV.PREDICATE DEVICE
Predicate Device 510k number: K163160
Predicate device trade name: sterile single-use infusion set Predicate device common name: Intravascular Administration Set Predicate Device Manufacturer: JiangXi HongDa Medical Equipment Group Ltd. (No. 39 South Shengli Road, Jinxian County, Nanchang, CN 331700)
V. Device Description
Table 5.1. Device Description Summary for Disposable infusion set with needle
| Models | Subject Device |
|---|---|
| Product name | Disposable infusion set with needle |
| Indications for use | The device is intended to administer fluids from a container to apatient's vascular system through a needle or catheter inserted intothe vein under the action of gravity. |
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| Model name | SY03 |
|---|---|
| Configuration | Protective Cap of Closure-piercing DeviceClosure-piercing DeviceClampFluid channel (tubing)Drip chamber upper cover (including the dropper)Drip chamberDrip chamber base (including Fluid Filter membrane)Flow regulatorRegulator wheelLuer Lock ConnectorInfusion needle hubNeedle tubePlastic needle handleInfusion needle protectorIntegral air-inlet with air filter and closureTubingLubricantAdhesives |
| Tubing Diameter | 4 mm |
| Filter Characteristics | 15µm |
| Needle Gauge andLengths | 0.4mm(27G) x13.5mm, 0.45 mm (26 G) x13.5 mm, 0.45 mm(26 G) x15 mm, 0.5mm (25 G) x17.5mm, 0.55mm (24G) x17.5mm, 0.55mm (24 G) x20 mm, 0.6 mm (23 G) x22.5 mm, 0.6mm (23 G) x25 mm, 0.7 mm (22 G) x19 mm, 0.7 mm (22 G)x22.5 mm, 0.7 mm (22 G) x25 mm, 0.8 mm (21 G) x19 mm, 0.8mm (21 G) x28 mm, 0.9 mm (20 G) x26 mm, 0.9 mm (20 G)x28 mm, 1.1 mm (19G ) x 38 mm, 1.2mm (18 G) x19 mm,1.2mm (18 G) x26 mm, 1.2mm (18 G) x30 mm, 1.2mm (18 G)x38 mm |
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VI. Predicate Comparison
| Item | Predicate Device K163160 | Subject Device | Comparison | ||
|---|---|---|---|---|---|
| Product Code | FPA | FPA | Same | ||
| RegulationNumber | 21 CFR 880.5440 | 21 CFR 880.5440 | Same | ||
| Indication forUse | The device is intended toadminister fluids from acontainer to a patient'svascular system through aneedle or catheter insertedinto the vein. | The device is intended toadminister fluids from acontainer to a patient'svascular system througha needle or catheterinserted into the veinunder the action ofgravity. | Same | ||
| Component nameProtectorCap ofSpike | MaterialHDPE | Component nameProtectorCap ofSpike | MaterialPE | ||
| Spike | ABS | Spike | ABS | ||
| Air Vent | PVC | Air Vent | PVC | ||
| Configurationand material | DripChamber | PVC | Dripchamber | PVC | |
| FluidFilter | ABS | Drops ofbucket | ABS, FluidFiltermembranemade byPolyethersulfone filtrationmembrane(PES) | Difference 1 | |
| FlexibleTube | PVC | FlexibleTube | PVC | ||
| RollerClamp | HDPE | Regulating wheel | ABS | ||
| LatexTube | Polyisoprene | LatexTube | N/A | ||
| YInjectionSite | ABS | YInjectionSite | N/A | ||
| LuerLockConnector | ABS | LuerlockConnector | PVC | ||
| ProtectorCap ofLuerLockConnector | HDPE | ProtectorCap ofLuerLockConnector | |||
| NeedleHub | PP | Needlehub | PVC | ||
| NeedleTube | StainlessSteel | Needletube | Stainlesssteel | ||
| TubingDiameter | 3.9mm | 4 mm | Difference 2 | ||
| FilterCharacteristics | 15μm | 2µm, 3µm, 5µm | Difference 3 | ||
| Needle Gauge | 21G | 18G, 19G, 20G, 21G,22G, 23 G, 24G, 25G,26G, 27G | Difference 4 | ||
| Sterile | EO sterilized | EO sterilized | Same | ||
| 10-6 | 10-6 | Same | |||
| Single Use | Single Use | Single Use | Same | ||
| Infusion Set Performance | |||||
| Particulatecontamination | Contamination index limitis less than 90 | Contamination indexlimit is less than 90 | |||
| Leakage | No leakage | No leakage | |||
| Tensilestrength | Withstand a static tensileforce of not less than 15Nfor 15s | Can withstand a statictensile force of 15 N for15s | |||
| Closurepiercing device | Comply the dimension ofISO 8536-4 | Comply the dimension ofISO 8536-4 | |||
| Air-inlet device | Flow of fluid is reducedless than 20% of that froma freely ventilatedcontainer | Flow of fluid is reducedless than 20% of thatfrom a freely ventilatedcontainer | Same | ||
| Fluid filter | Retention of latex particlesis not less than 80% | Retention of latexparticles is not less than80% | |||
| Drip chamberand drip tube | 20 drops of distilled waterdelivered by the drip areequivalence to a volume of(1±0.1) ml (1±0.1) g | 20 drops of distilledwater delivered by thedrip are equivalence to avolume of (1±0.1) ml(1±0.1) g | |||
| Flow rate | Deliver not less than1000ml | Deliver not less than1000ml | |||
| Construction | The clamps can resist the | The clamps can resist the |
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| flow of fluid and air at anapplied pressure of 50 kPawhen closed. | flow of fluid and air at anapplied pressure of 50 kPa when closed. | ||
|---|---|---|---|
| Needle Performance | |||
| Cleanliness | Free from particles andextraneous matter | Free from particles andextraneous matter | Same |
| Needle length | 38mm (meet ISO7864:2016 Clause 4.10 of21G needle) | 20.72mm (meet ISO7864:2016 Clause 4.10of 23G needle) | Same |
| Bond of huband needle tube | Not broken by theminimum force | Not broken by theminimum force | Same |
| Stiffness | Deflection is less than0.50mm | Deflection is less than0.50mm | Same |
| Dimensions ofneedle tubing | 0.8mm (meet ISO9626:2016 Clause 5.6 of21G needle) | 0.627mm (meet ISO9626:2016 Clause 5.6 of23G needle) | Same |
| Resistance tobreakage | The tubing is not break | No breakage | Same |
| Resistance tocorrosion | No evidence of corrosion | No corrosion | Same |
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | |
| IntracutaneousReactivity | No IntracutaneousReactivity | No IntracutaneousReactivity | |
| SkinSensitization | No Skin Sensitization | No Skin Sensitization | Same |
| Acute SystemicToxicity | No Acute SystemicToxicity | No Acute SystemicToxicity | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| Pyrogen | No pyrogen | No pyrogen |
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VII Substantial Equivalence Discussion
The indications for use statement for the Disposable infusion set with needle subject device is equivalent to the predicate device. There are no technological differences between the predicate and subject devices except for the following: Components and materials, Tubing Diameter, Filter Characteristics, and Needle Gauge.
- Difference 1: The subject device has different components and materials compared to the predicate device, such as the predicate device's Injection Site, which the subject device doesn't have. These differences have no adverse effect on clinical safety and performance. The subject device was tested in accordance with ISO 8536-4 and ISO 10993. The requirements of the standards are met.
- Difference 2: The subject device has a different Tubing Diameter compared to the predicate device; predicate device's Tubing Diameter is 3.9 mm, subject device's Tubing Diameter is 4 mm. This slight difference has no adverse effect on clinical safety and performance. The subject device was tested in accordance with ISO 8536-4. The requirements of the standards are met.
- Difference 3: The subject device has different Filter Characteristics compared to the predicate device; predicate device's Filter size is 15um, subject device's Filter size is 2um, 3um, 5um. This difference has no adverse effect on clinical safety and performance. The subject device was tested in accordance with ISO 8536-4, and USP NF <788>. The requirements of the standards are met.
- Difference 4: The subject device has different Needle Gauges compared to the predicate device, predicate device's Needle Gauge is 21 G, subject device's Needle Gauges are 18G, 19G, 20G, 21G, 22G, 23 G, 24G, 25G, 26G, 27G. This difference has no adverse effect on clinical safety and performance. The subject device was tested in accordance with ISO 8536-4, ISO 7864, ISO 9626 which is same as predicate device. The requirements of the standards are met.
VIII. Performance Testing
The Disposable infusion set with needle described in this summary were tested and demonstrated to be in conformance with the following standards:
- ISO 8536-4:2019 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- . ISO 7864:2016 Fourth Edition: 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;
- . ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- . USP NF <788> Particulate Matter in Injections
- . USP NF <161> Bacterial endotoxin test
- . ISO 10993-4:2017 Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood
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- . ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
- . ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- . ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- . ISO 10993-11:2017 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity
- . ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- . ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- . ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- . ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- . ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- . ASTM F1980:2011 Standard Guide or Accelerated Aging of Sterile Barrier Systems for Medical Devices
- F1140/F1140M-13 (Reapproved 2020) e1 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
The Disposable infusion set with needle is considered in the category of "External Communicating Devices" and are in contact for a period less than 24 hours with "Indirect blood path" or "Circulating blood" (needles). Thus, hemocompatibility (ISO 10993-4:2017), cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2021), acute systemic toxicity (ISO 10993- 11:2017), irritation (ISO 10993-23:2021) were carried out for the device in question.
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the subject device met all design specifications as Substantially Equivalent (SE) to the predicate device. The tests conducted for this submission include:
Physical, Mechanical and Chemical Tests performed on the subject devices:
ISO 8536-4:2019 ISO 8536-14:2016 ISO 7864:2016 ISO 9626:2016 ISO 80369-7:2021
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Particulate matter: USP-NF<788> Sterile Barrier Packaging Testing performed on the subject device: Seal strength ASTM F88/F88-09 Internal pressure ASTM F1140/F1140M-13 Dye Penetration ASTM F 1929-15 Sterilization and Shelf-Life Testing performed on the subject device: EO residue ISO 10993-7:2008 ECH residue ISO 10993-7:2008 Bacteria Endotoxin Limit USP NF <161> Shelf-Life Evaluation Physical, Mechanical, Chemical, Package and Sterility Tests were performed on accelerated aged samples to verify the claimed shelf life of the device
Biocompatibility Testing:
The patient-contact materials of blood collection sets are identified and biocompatibility testing is performed according to ISO 10993 standards.
Transportation Testing
Transportation test is performed on the final product to verify its package integrity during transportation.
IX. Clinical Test Conclusion
No clinical trials were conducted in support of this 510(k).
X. Conclusion
Based on the comparison and analysis above, the subject devices are determined to be Substantially Equivalent (SE) to the predicate devices.
§ 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.