(186 days)
The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.
The I.V. Extension Set may act as an extension of other infusion tubing intravenous fluids from a container to patient.
The propose device, I.V. Administration Set, is a single used device. It has seven models. The models and their features are listed in Table 1. There are seven different models, each configuration comprise of various components which may include: IV Chamber, Tubing, Roller Clamp, Y Site, Needle Free Valve, Slide Clamp, Back Check Valve, Male Luer Lock, 3 Way Stop Cock, Female Luer Lock, Flow Regulator, Rotating Luer Lock, T-Connector, Luer Lock Cap, Hanger, Drop, Female Luer Connector and Cap. The devices are provided sterile and single use. The proposed devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
Here's a breakdown of the acceptance criteria and study information based on the provided document, restructured to address your specific points.
First, it's important to note that this document is a 510(k) Premarket Notification for an I.V. Administration Set. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving independent effectiveness from scratch. Therefore, the "acceptance criteria" and "study" described herein are primarily focused on showing that the new device performs as safely and effectively as a legally marketed predicate, meeting relevant industry standards. It's not a study proving the clinical effectiveness of the device itself (like an AI algorithm's diagnostic performance), but rather its engineering performance and biocompatibility to ensure equivalent safety and function compared to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
For an I.V. Administration Set, the acceptance criteria are generally defined by compliance with recognized international standards (ISO, ASTM, USP) and demonstrating equivalent performance to the predicate device across critical parameters. The "reported device performance" is essentially that the proposed device demonstrated compliance with these standards and equivalency through non-clinical testing.
| Acceptance Criterion (Standard/Test) | Reported Device Performance |
|---|---|
| Functional/Performance Standards | |
| ISO 8536-4:2019 (Infusion sets for single use, gravity feed) | Complies (Performance Test Report) |
| ISO 8536-12:2007 AMD 1 2012 (Check valves) | Complies (Check valves Performance Test Report) |
| ISO 8536-14:2016 (Clamps and flow regulators) | Complies (Flow regulator Performance Test Report) |
| ISO 80369-7:2016 (Small-bore connectors for intravascular/hypodermic applications) | Complies (Luer Compliance Performance Test Report) |
| ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials) | Complies |
| ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Package by Dye Penetration) | Complies |
| Performance Testing - Bench (Particulate contamination, leakage, tensile strength, dimension, flow rate, filter efficiency, drip chamber, injection site) | Meets all design specifications. |
| Performance Testing - Microbial Ingress Test | Complies |
| Biocompatibility Standards | |
| ISO 10993-4:2017 (Interactions with blood) | Complies (Hemolysis Test Report) |
| ISO 10993-5:2009 (In vitro cytotoxicity) | Complies (Cytotoxicity Test Report) - No cytotoxicity. |
| ISO 10993-10:2010 (Irritation and skin sensitization) | Complies (Guinea Pig Maximization Test Report, Intracutaneous Reactivity Test Report) - No skin sensitization, no intracutaneous reactivity. |
| ISO 10993-11:2017 (Systemic Toxicity) | Complies (Systemic Toxicity Test Report) - No systemic toxicity. |
| ASTM F756-17 (Assessment of hemolytic properties) | (Covered by ISO 10993-4) |
| Sterilization & Endotoxin Standards | |
| ISO 11135:2014 (Ethylene oxide sterilization) | Complies (achieved SAL 10^-6) |
| USP 43-NF 38 <85> (Bacterial Endotoxins Test) | Complies (Endotoxin Limit: 20 EU per device) |
| USP 43-NF 38 <151> (Pyrogen Test) | Complies (Pyrogen Test Report) - No potential febrile reaction. |
| Shelf Life/Integrity | |
| ASTM F1980-16 (Accelerated Aging of Sterile Barrier Systems) | Complies (3 years shelf life maintained sterility) |
Note on "Remark" column from original table: The document highlights differences between the proposed device and the predicate in configuration, flow rate, pore size, and patient-contact material. For each difference, the applicant provides a justification that it does not affect the safety and effectiveness based on specific testing or the range of the parameter. For example, for "Flow Rate" and "Pore Size," the proposed device's values are stated to be within the predicate's range or to meet declared requirements. For "Patient-contact Material" and "Biocompatibility," comprehensive testing showed no adverse effects despite material differences.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of devices tested for leakage, tensile strength, or biocompatibility). It states "Non clinical tests were conducted to verify that the proposed device met all design specifications." For in-vitro tests and bench testing for device performance, samples are tested to statistical validity for the specific test method outlined in the standards (e.g., ISO, ASTM).
- Data Provenance: The testing was "non-clinical," meaning it was bench testing and in-vitro laboratory testing of the physical device components and assembled products. The manufacturer is BQ PLUS Medical Co., Ltd in Songjiang, Shanghai, China. The testing was presumably conducted by or on behalf of the manufacturer, likely in China. The data is prospective, generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. This is not a study involving human interpretation of medical images or data requiring expert consensus or ground truth establishment in a clinical sense. The "ground truth" for the performance criteria is defined by the technical specifications of the standards (e.g., a specific tensile strength value, a defined flow rate, a negative cytotoxicity result). These are objective measurements from laboratory and bench tests, not subjective interpretations by medical experts.
4. Adjudication Method for the Test Set
This is not applicable. Since the testing is objective and based on validated laboratory and bench test methods from international standards, there is no need for an adjudication method as would be required for subjective clinical assessments or image interpretations. The results are quantitative measurements against predefined pass/fail criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This submission is for a conventional medical device (I.V. Administration Set), not an AI/Software as a Medical Device (SaMD) that assists human readers. No MRMC study was performed, and human readers are not involved in the "reading" or "interpretation" of data generated by this device in a diagnostic sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI/Software as a Medical Device (SaMD). The "standalone performance" here would refer to the device's ability to meet its technical specifications independently, which is what the non-clinical bench testing demonstrated.
7. The Type of Ground Truth Used
The "ground truth" used for this device's acceptance is objective laboratory and bench test results against pre-defined specifications and compliance requirements of recognized international standards (e.g., ISO, ASTM, USP).
- Examples include measured flow rates, leakage rates, material properties (tensile strength, seal strength), biological responses (cytotoxicity, hemolysis), and sterility assurance levels.
- It is not based on expert consensus, pathology, or clinical outcomes data in the usual sense, as no clinical study was performed (or required for this type of 510(k)).
8. The Sample Size for the Training Set
This is not applicable. This is not an AI/machine learning device that requires a "training set" of data. The device's performance is based on its physical design, manufacturing processes, and materials, which are verified through the non-clinical testing described.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no training set for this type of medical device submission.
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August 14, 2021
BQ PLUS Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K210381
Trade/Device Name: I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: June 28, 2021 Received: July 15, 2021
Dear Diana Hong:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210381
Device Name I.V. Administration Set
Indications for Use (Describe)
The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.
The I.V. Extension Set may act as an extension of other infusion tubing intravenous fluids from a container to patient.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| ☑ Prescription Use (Ref 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart G) | ☑ Prescription Use (Ref 21 CFR 801 Subpart D) | ☑ Prescription Use (Ref 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart G) | ☐ Over-The-Counter Use (21 CFR 801 Subpart G) |
| ☑ Prescription Use (Ref 21 CFR 801 Subpart D) | ☑ Prescription Use (Ref 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart G) | ☐ Over-The-Counter Use (21 CFR 801 Subpart G) | |
| ☑ Prescription Use (Ref 21 CFR 801 Subpart D) | ||||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart G) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K210381
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K210381
-
- Date of Preparation: 06/28/2021
-
- Sponsor Identification
BQ PLUS Medical Co., Ltd No. 18, Cheye Road, Chedun Town, Songjiang Shanghai 201611, China
Establishment Registration Number: Not yet registered.
Contact Person: Jin Zhang Position: R&D Director Tel: +86-21-57609106 Email: eddie@bq-medical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net
- Identification of Proposed Device 4.
Trade Name: I.V. Administration Set Common Name: Intravascular Administration Set
Regulatory Information Classification Name: Set, Administration, Intravascular Classification: II Product Code: FPA Regulation Number: CFR 880. 5440
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Review Panel: General Hospital
Indications for Use:
The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features.
The I.V. Extension Set may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
Device Description
The propose device, I.V. Administration Set, is a single used device. It has seven models. The models and their features are listed in Table 1.
| Model | Feature |
|---|---|
| BQ-SYQ-001 | I.V. Administration Set with T connector, Y site, flow regulator, NeedleFree Valve |
| BQ-SYQ-002 | I.V. Administration Set with Hanger |
| BQ-SYQ-003 | I.V. Administration Set with Y site, Needle free Valve |
| BQ-SYQ-004 | I.V. Administration Set with Flow Regulator |
| BQ-YCG-017 | I.V. Extension Set with T connector, Needle Free Valve |
| BQ-YCG-018 | I.V. Extension Set with Needle Free Valve |
| BQ-YCG-019 | I.V. Extension Set with male/female luer lock |
Table 1 Description of Models
There are seven different models, each configuration comprise of various components which may include: IV Chamber, Tubing, Roller Clamp, Y Site, Needle Free Valve, Slide Clamp, Back Check Valve, Male Luer Lock, 3 Way Stop Cock, Female Luer Lock, Flow Regulator, Rotating Luer Lock, T-Connector, Luer Lock Cap, Hanger, Drop, Female Luer Connector and Cap. The devices are provided sterile and single use.
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 3 years.
-
ડ. Identification of Predicate Devices
510(k) Number: K121803 Product Name: Acta Medical Intravascular Administration Set -
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
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-
ISO 8536-4:2019 Infusion equipment for medical use, Part 4: Infusion sets for single use, gravity feed
-
ISO 8536-12:2007 AMD 1 2012 Infusion equipment for medical use- Part 12: Check valves
- A ISO 8536-14:2016 Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
- A ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications -Part 7: Connectors for intravascular or hypodermic applications
- A ISO 10993-4:2017 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
-
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cvtotoxicity:
- A ISO 10993-10: 2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization;
- A ISO10993-11: 2017, Biological evaluation of medical devices-Part 11: Tests for Systemic Toxicity
- A 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 [Including: Amendment 1 (2018)]
-
ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F756-17 Standard practice for assessment of hemolytic properties of materials A
- A ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- A ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- USP 43-NF 38 <85> Bacterial Endotoxins Test A
-
USP 43-NF 38 <151> Pyrogen Test
Biocompatibility Testing
The contact level of the proposed device is blood path, indirect and the contact duration is prolonged duration. The proposed device was evaluated for the following tests. The results of the biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.
- Hemolysis Test Report A
- A Cytotoxicity Test Report
- A Guinea Pig Maximization Test Report
- A Intracutaneous Reactivity Test Report
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-
Systemic Toxicity Test Report
-
Pyrogen Test Report
Performance Testing-Bench
Particulate contamination, leakage, tensile strength, dimension of the closure-piercing device, determination of flow rate when using an air-inlet device, tubing, efficiency of the fluid filter, drip chamber and drip tube, Flow rate of infusion fluid and injection site Performance Test Report of ISO 8536-4
- A Check valves Performance Test Report of ISO 8536-12
- A Flow regulator Performance Test Report of ISO 8536-14
- A Luer Compliance Performance Test Report of ISO 80369-7
Performance Testing-Microbial Ingress Test
-
Microbial Ingress Testing
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Summary of Technological Characteristics 8.
| ITEM | Proposed DeviceI.V. Administration Set | Predicate DeviceK121803 | Remark |
|---|---|---|---|
| Regulation Number | CFR 880.5440 | CFR 880.5440 | Same |
| Product Code | FPA | FPA | Same |
| Class | II | II | Same |
| Indications for Use | The I.V. Administration Setintended use is to deliver sterile,infusion fluid from a containerto the patient with or withoutflow control features.The I.V. Extension Set may actas an extension of otherinfusion tubing in deliveringintravenous fluids from acontainer to patient. | Acta Medical Intravascularadministration set intended use isto deliver sterile, infusion fluidfrom a container to the patient withor without flow control features.Acta Medical infusion tubing mayact as an extension of otherinfusion tubing in deliveringintravenous fluids from a containerto patient. | Same |
| Configuration ofI.V. AdministrationSet | IV Chamber,Tubing,Roller Clamp,Y Site, | Protector Cap of SpikeSpikeAir VentAir Filter | Different1 |
| Configuration ofI.V. Extension Set | Needle Free Valve,Slide Clamp,Back Check Valve,Male Luer Lock,3 Way Stop Cock,Female Luer Lock,Flow Regulator,Rotating Luer Lock,T-Connector,Luer Lock Cap,Hanger,Drop | Drip ChamberFluid FilterFlexible TubeFlow RegulatorCheck ValveNeedle Free Y Injection SiteRoller ClampY Injection SitePrecision FilterPinch ClampLuer Lock ConnectorProtector Cap of Luer LockConnector | Same |
| Tubing,Needle Free Valve,Slide Clamp,Male Luer Lock,Female Luer Lock,Rotating Luer Lock,T-Connector,Luer Lock Cap,Female Luer Connector,Cap | Tubing,Needle Free Valve,Slide Clamp,Male Luer Lock,Female Luer Lock,Rotating Luer Lock,T-Connector,Luer Lock Cap,Female Luer Connector,Cap | ||
| Operation Mode | Manual | Manual | Same |
| Label/Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | Same |
| Infusion SetPerformance | Conform with ISO 8536-4:2010and ISO 8536-12: 2004 | Conform with ISO 8536-4:2010and ISO 8536-12: 2004 | Same |
| Flow Rate of FlowRegulator (ml/h) | 20 to 250 | 5 to 250 | Different2 |
| Pore Size ofMembrane | 15μm | 0.2μm, 1.2μm, 15μm | Different3 |
| Patient- contact Material | Different4 | ||
| IV Chamber | ABS,PVC | Acrylonitrile Butadiene Styrene | |
| Tubing | PVC | ||
| Y Site | PC | Non-DEHP Poly Vinyl Chloride | |
| Needle Free Valve | ABS, PP, Silicone | ||
| Back Check Valve | ABS,TPE | Polypropylene (non fluid pathwaymaterial, utilized in protective capsonly) | |
| Male Luer Lock | ABS | ||
| 3 Way Stop Cock | PC, PP, POM | ||
| Female Luer Lock | PC | Silicone | |
| Flow Regulator | ABS, | ||
| Rotating Luer Lock | PC | ||
| T-Connector | PC | ||
| Luer Lock Cap | PP | ||
| Drop | ABS | ||
| Female LuerConnector | PC | ||
| Cap | ABS | ||
| Biocompatibility | |||
| Cytotoxicity | No cytotoxicity. | ||
| Max Sensitization | No skin sensitization. | ||
| IntracutaneousReactivity Test | No intracutaneous reactivity. | The specific test items areunknown. However, the productshould meet the requirements ofISO10993 series standards. | Different5 |
| Acute SystemicToxicity Test | No systemic toxicity. | ||
| Pyrogen Test | No potential febrile reaction. | ||
| Hemolysis Test | No Hemolysis | ||
| Sterilization | |||
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | $1.0×10-6$ | $1.0×10-6$ | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Single Use | Yes | Yes | Same |
Table 1 Comparison of Technology Characteristics
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Different 1 - Configuration
The configuration for proposed device is different from predicate device. The components of proposed device are same with the components of predicate device. Only the component name is different. Thus, this difference does not affect the safety and effectiveness of the proposed device.
Different 2- Flow Rate
The flow rate for proposed device is different from predicate device. However, the flow rate range of the proposed device is within the flow rate rang of the predicate device. And the test result for proposed device show that flow regulator can meet its declared flow rate requirements. Thus, this difference does not affect the safety and effectiveness of the proposed device.
Different 3- Pore Size of Membrane
The pore size of membrane for proposed device is different from predicate device. However, the pore size of membrane for proposed device is within the pore size of membrane for predicate device. And the test result for proposed device shows that the retention of latex particles on the filter can meet its declared pore size of membrane. Thus, this difference does not affectiveness of the proposed device.
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Different 4- Patient- contact Material
The patient contact materials for proposed device are different from predicate device. However, the biocompatibility test for proposed device was performed and the result show there is no adverse effect. Thus, this difference does not affect the safety and effectiveness of the proposed device.
Different 5- Biocompatibility
The biocompatibility of Proposed Device and Predicate Device are should meet the requirements of ISO10993 series standards; although we do not know the specific test items of Predicate Device, but the biocompatibility tests of Proposed Device have been performed in Cytotoxicity, Max Sensitization, Intracutaneous Reactivity Test, Acute Systemic Toxicity Test, Pyrogen Test and Hemolysis Test. These studies can demonstrate the biocompatibility of Proposed Device. Thus, this difference does not affect the safety and effectiveness of the proposed device.
-
- Conclusion
Through performance testing the subject device has demonstrated substantial equivalence to the predicate device.
- Conclusion
§ 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.