(280 days)
The AMSafe® Sure-Lok™ Needle-Free Connector is an accessory to an Intra-vascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein.
The AMSafe® Sure-Lok™ Needle-Free Connector is a Needle-Free connector intended for single patient use, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids used as an accessory to an Intravascular administration set without the use of a needle, thus eliminating the risk of needlestick injuries. The AMSafe® Sure-Lok™ Needle-Free Connector is a closed, Luer activated device that allows for negative fluid displacement. The AMSafe® Sure-Lok™ Needle-Free Connector individually packaged is supplied as a sterile, non-pyrogenic, single use, disposable device.
The provided text is a 510(k) Summary for the AMSafe® Sure-Lok™ Needle-Free Connector, a medical device. This document describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness in comparison to a predicate device.
Here's an analysis of the acceptance criteria and study information, organized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Items | Test Criteria (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Visual inspection | Conform with the internal criteria | Met the acceptance criterion |
| Leakage test | Conform with ISO 8536-4 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013)]; Conform with ISO 8536-8: 2015 Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus | Met the acceptance criterion |
| Compatible with MLL fitting | Section 3: Dimensions and tolerances in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Met the acceptance criterion |
| Sealing performance | Section 4.2: leakage in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Met the acceptance criterion |
| Free Flow Rate | Conform with ISO 8536-4:2010 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013) | Met the acceptance criterion |
| Liquid leakage | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Air leakage | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Separation force | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Stress cracking | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Unscrewing torque | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Ease of assembly | Section 5.6: Ease of assembly in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings) | Met the acceptance criterion |
| Resistance to overriding | Conform with ISO80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications | Met the acceptance criterion |
| Weld strength test | Conform with the internal criteria | Met the acceptance criterion |
| Cytotoxicity | ISO 10993-5: 2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity | Met the acceptance criterion |
| Sensitization | ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | Met the acceptance criterion |
| Intracutaneous Reactivity Test | ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization | Met the acceptance criterion |
| Acute systemic toxicity | ISO 10993-11: 2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met the acceptance criterion |
| Haemolysis | ASTM F 756-13: Standard Practice for Assessment of Hemolytic Properties of Materials | Met the acceptance criterion |
| Pyrogenicity | ISO 10993-11: 2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met the acceptance criterion |
| Subchronic Toxicity | ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Met the acceptance criterion |
| Sterility | ISO 11135:2007, Sterilization of Health Care Products-Ethylene Oxide; ISO 10993-7: 1995 and 2008, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide sterilization residuals. | Assessed in accordance with standards and met acceptance criteria. Based on the conclusion, it implies that the device is sterile after processing. |
| Microbial ingress testing | Internal standard | Met the acceptance criterion |
| Biocompatibility (Overall Assessment) | ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (for "External communicating device, Blood path, indirect (>24 hours to 30 days)") | Assessed in accordance with the standard. Results from Cytotoxicity, Sensitization, Intracutaneous Reactivity Test, Acute systemic toxicity, Haemolysis, Pyrogenicity, and Subchronic Toxicity demonstrate no new issues of safety and efficacy. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that "Bench testing of the proposed devices is performed," and tests were conducted according to various ISO and ASTM standards. However, the specific sample sizes used for each individual test or for a comprehensive "test set" are not mentioned. The document does not specify data provenance (country of origin) or if the data was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the described studies are bench tests (physical and chemical testing of the device) rather than clinical studies requiring expert interpretation or ground truth establishment based on clinical observations or diagnoses.
4. Adjudication Method for the Test Set
This section is not applicable for the same reason as point 3. Bench testing adherence to standards usually relies on measurement and observation against pre-defined criteria, not expert adjudication of subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes bench testing and biocompatibility assessments, not comparative effectiveness studies with human readers or clinical outcomes. The goal was to demonstrate substantial equivalence to a predicate device through engineering and biological testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This question is not applicable as the device is a physical medical connector, not an AI algorithm.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" is defined by the specific requirements and limits set forth in the referenced international standards (ISO, ASTM) and the manufacturer's own internal criteria. For example, for a leakage test, the ground truth is "no leakage" or leakage within a specified limit according to the standard. For biocompatibility tests, the ground truth is a lack of cytotoxic, sensitizing, or toxic effects as defined by the respective ISO standards.
8. The Sample Size for the Training Set
This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no training set for a physical medical device.
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September 5, 2018
Amsino International, Inc. Cathy Hong Senior RA Specialist 708 Corporate Center Drive Pomona, California 91768
Re: K173665
Trade/Device Name: AMSafe® Sure-LokTM Needle-Free Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: August 7, 2018 Received: August 9, 2018
Dear Cathy 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K173665
Device Name
AMSafe® Sure-Lok™ Needle-Free Connector
Indications for Use (Describe)
The AMSafe® Sure-Lok™ Needle-Free Connector is an accessory to an Intra-vascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein.
| 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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Image /page/3/Picture/0 description: The image is a logo for AMSINO, a healthcare company. The logo is in blue and white, with the company name in large, bold letters. Below the name is the tagline "Advancing Healthcare Worldwide" in a smaller font. The logo is simple and professional, and it conveys the company's mission to improve healthcare around the world.
Section 5: 510(k) Summary (K173665)
Submitter Information .
| Submitter: | Amsino International Inc. |
|---|---|
| 708 Corporate Center Drive, Pomona CA 91768, USA | |
| Contact Person: | Cathy Hong |
| Senior RA Specialist | |
| Phone: | +86(21)-69117118 |
| Fax: | +86(21)-59148142 |
| E-mail: | Cathy_Hong@amsino.com |
| Date Prepared: | 9/5/2018 |
. Device Information
Common or Usual Name: Needle-Free Connector Trade or Proprietary Name: AMSafe® Sure-Lok™Needle-Free Connector (AY0200S) Regulation Number: 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Panel: General Hospital Product Code: FPA
● Predicate Device Information
Device Name: NAC PRN Needleless Access Connector 510(k) Number: K992268
● Device Description:
The AMSafe® Sure-Lok™ Needle-Free Connector is a Needle-Free connector intended for single patient use, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids used as an accessory
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Image /page/4/Picture/0 description: The image is a logo for AMSINO, a healthcare company. The logo features the company name in large, bold, blue letters, with a blue line above and below the name. Below the company name, in smaller letters, is the tagline "Advancing Healthcare Worldwide".
AMSafe® Sure-Lok™ Needle-Free Connector Traditional 510(k) Premarket Notification
to an Intravascular administration set without the use of a needle, thus eliminating the risk of needlestick injuries. The AMSafe® Sure-Lok™ Needle-Free Connector is a closed, Luer activated device that allows for negative fluid displacement.
The AMSafe® Sure-Lok™ Needle-Free Connector individually packaged is supplied as a sterile, non-pyrogenic, single use, disposable device.
Indications for Use .
The AMSafe® Sure-Lok™ Needle-Free connector is an accessory to an intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein.
Product Comparison Summary ●
The proposed AMSafe® Sure-Lok™ Needle-Free Connector is equivalent to the Kipp Group's NAC PRN Needleless Access Connector. The proposed device has the same operation principle, the same materials and the same general characteristics with the predicate device. The indications for use of the proposed device is similar with the predicate device, "or artery" is removed as standard clinical practice does not include normal administration of fluids into artery.
The design and materials of the proposed devices are identical to the predicate device (K992268).
| No. | DeviceCharacteristic | Proposed Device | Predicate Device | Results |
|---|---|---|---|---|
| 1 | ProductCode | FPA | FPA | Same |
| 2 | Indicationsfor Use | The AMSafe® Sure-Lok™Needle-Free connector is anaccessory to an intra-vascularAdministration Set used as asecondary sterile injection sitefor delivery of fluids to apatient's vascular systemthrough a cannula inserted intoa vein. | The NAC PRN NeedlelessAccess Connector is anAccessory to an IntravascularAdministration Set used as asecondary sterile injectionsite for delivery of fluids to apatient's vascular systemthrough a cannula insertedinto a vein or artery. | Similar |
| 3 | RegulationNumber | 880.5440 | 880.5440 | Same |
| 4 | DesignConfiguration | Image: Purple connector | Image: Blue connector | Similar |
| 5 | Principle ofOperation | The device is a sterile singlepatient use connector forneedleless access to the IVline and/or IV catheter duringIV therapy. It is used asinjection site when accessedby attaching a male Luerconnector to the device. Andit is also used as adapterwhen connecting to a | The device is a sterilesingle patient useconnector for needlelessaccess to the IV line and/orIV catheter during IVtherapy. It is used asinjection site whenaccessed by attaching amale Luer connector tothe device. And it is also | Same |
| clockwise rotation is forlocking, and anticlockwise | Luer connector. All theoperations are usual, | |||
| rotation is for disconnecting. | clockwise rotation is for | |||
| locking, and anticlockwise | ||||
| rotation is fordisconnecting. | ||||
| 6 | Materials of main components | |||
| Top cover | polycarbonate | polycarbonate | Same | |
| Housing | polycarbonate | polycarbonate | Same | |
| Valve Plug | Silicone | Silicone | Same | |
| Protectivecap | Polypropylene | Polypropylene | Same | |
| 7 | Single Use/Reusable | Single patient use | Single patient use | Same |
| 8 | Primarypackage | Poly pouch with Medicaldialysis paper | Poly pouch with Medicaldialysis paper | Same |
| 9 | Sterilemethod | EO Sterile | EO Sterile | Same |
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Image /page/5/Picture/0 description: The image shows the AMSINO logo. The logo is in blue and white. Underneath the logo, the text "Advancing Healthcare Worldwide" is written.
Traditional 510(k) Premarket Notification
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Image /page/6/Picture/0 description: The image shows the logo for AMSINO, a healthcare company. The logo is in blue and white, with the company name in large, bold letters. Below the name is the tagline "Advancing Healthcare Worldwide". The logo is simple and professional, and it conveys the company's mission to improve healthcare around the world.
Traditional 510(k) Premarket Notification
Performance Data ●
The AMSafe® Sure-Lok™ Needle-Free Connector met the acceptance criterion for all functional, microbial ingress, sterility, biocompatibility and other performance criteria which verify it to be substantially equivalent to the predicate device.
Bench testing of the proposed devices is performed. Luer performance testing is conducted according to ISO 80369-7: 2016 Small-Bore Connectors For Liquids And Gases In Healthcare Applications - Part 7: Connectors For Intravascular or Hypodermic Applications which is replacement to ISO 594-2: 1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -Part 2: Lock. Testing was also provided according to ISO 594-2:1998.
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Image /page/7/Picture/0 description: The image shows the logo for AMSINO, a healthcare company. The logo is in blue and features the company name in large, bold letters. Below the name is the tagline "Advancing Healthcare Worldwide" in a smaller font. The logo is simple and professional, conveying a sense of trust and reliability.
Traditional 510(k) Premarket Notification
| Testing Items | Test Criteria |
|---|---|
| Visual inspection | Conform with the internal criteria |
| Leakage test | Conform with ISO 8536-4 Infusion equipment formedical use - Part 4: Infusion sets for single use,gravity feed [Including: Amendment 1 (2013)Conform with ISO 8536-8: 2015 Infusion Equipmentfor Medical Use - Part 8: Infusion Sets for Single Usewith Pressure Infusion Apparatus |
| Compatible with MLLfitting | Section 3: Dimensions and tolerances in ISO 594-2:1998 Conical fittings with 6 % (Luer) taper forsyringes, needles and certain other medicalequipment -Part 2: Lock fittings) |
| Sealing performance | Section 4.2: leakage in ISO 594-2:1998 Conicalfittings with 6 % (Luer) taper for syringes, needles andcertain other medical equipment -Part 2: Lock fittings) |
| Free Flow Rate | Conform with ISO 8536-4:2010 Infusion equipmentfor medical use - Part 4: Infusion sets for single use,gravity feed [Including: Amendment 1 (2013) |
| Liquid leakage | Conform with ISO80369-7: 2016 Small-BoreConnectors For Liquids And Gases In HealthcareApplications - Part 7: Connectors For Intravascular orHypodermic Applications |
| Air leakage | Conform with ISO80369-7: 2016 Small-BoreConnectors For Liquids And Gases In HealthcareApplications - Part 7: Connectors For Intravascular orHypodermic Applications |
| Separation force | Conform with ISO80369-7: 2016 Small-BoreConnectors For Liquids And Gases In HealthcareApplications - Part 7: Connectors For Intravascular orHypodermic Applications |
| Stress cracking | Conform with ISO80369-7: 2016 Small-BoreConnectors For Liquids And Gases In HealthcareApplications - Part 7: Connectors For Intravascular orHypodermic Applications |
| Unscrewing torque | Conform with ISO80369-7: 2016 Small-BoreConnectors For Liquids And Gases In HealthcareApplications - Part 7: Connectors For Intravascular orHypodermic Applications |
| Ease of assembly | Section 5.6: Ease of assembly in ISO 594-2:1998Conical fittings with 6 % (Luer) taper for syringes,needles and certain other medical equipment -Part 2:Lock fittings) |
| Resistance to overriding | Conform with ISO80369-7: 2016 Small-BoreConnectors For Liquids And Gases In HealthcareApplications - Part 7: Connectors For Intravascular orHypodermic Applications |
| Weld strength test | Conform with the internal criteria |
| Testing Items | Test Criteria |
| Cytotoxicity | ISO 10993-5: 2009 Biological Evaluation OfMedical Devices - Part 5: Tests For In VitroCytotoxicity |
| Sensitization | ISO 10993-10: 2010 Biological EvaluationOf Medical Devices - Part 10: Tests ForIrritation And Skin Sensitization |
| Intracutaneous Reactivity Test | ISO 10993-10: 2010 Biological EvaluationOf Medical Devices - Part 10: Tests ForIrritation And Skin Sensitization |
| Acute systemic toxicity | ISO 10993-11: 2006 Biological evaluationof medical devices - Part 11: Tests forsystemic toxicity |
| Haemolysis | ASTM F 756-13: Standard Practice forAssessment of Hemolytic Properties ofMaterials |
| Pyrogenicity | ISO 10993-11: 2006 Biological evaluationof medical devices - Part 11: Tests forsystemic toxicity |
| Subchronic Toxicity | ISO 10993-11: 2017 Biological evaluationof medical devices - Part 11: Tests forsystemic toxicity |
Sterility was assessed in accordance to ISO 11135:2007, Sterilization of Health
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Image /page/8/Picture/0 description: The image shows the AMSINO logo. The logo is in blue and white. The text "AMSINO" is in large, bold letters, and below it is the text "Advancing Healthcare Worldwide" in a smaller font. There are two blue lines above and below the text.
Traditional 510(k) Premarket Notification Care Products-Ethylene Oxide and ISO 10993-7: 1995 and 2008, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide sterilization residuals.
Microbial ingress testing was conducted to an internal standard.
Biocompatibility for the AMSafe® Sure-Lok™ Needle-Free Connector was assessed in accordance with ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. According to Section 5 of ISO 10993-1: 2009, the proposed device is classified as a "External communicating device, Blood path, indirect (>24 hours to 30 days)." Based on the assessment of the device, the following tests were performed:
Results of the testing demonstrate that there are no new issues of safety and efficacy that are raised with the AMSafe® Sure-Lok™ Needle-Free connector.
Conclusions ●
The information provided within this pre-market notification demonstrates that the AMSafe® Sure-Lok™ Needle-Free Connector is substantially equivalent to the predicate device.
§ 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.