(249 days)
The AMSafe® NeuFloTM Needleless Connector are intended to use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
AMSafe® NeuFlo™ Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set.
The provided text is a 510(k) summary for the AMSafe® NeuFlo™ Needleless Connector. This document outlines the device's characteristics, its comparison to a predicate device, and the non-clinical testing performed to demonstrate substantial equivalence.
However, the provided text does not describe a study involving an AI/Machine Learning device, nor does it detail a study that proves a device meets acceptance criteria in the context of AI/ML performance metrics like sensitivity, specificity, or reader studies.
Instead, it details the acceptance criteria and results for a physical medical device. The criteria are based on compliance with established ISO standards and other tests to confirm physical, chemical, and biological performance. The "performance" described refers to the functionality and safety of the needleless connector itself, not AI model performance.
Therefore, I cannot fulfill the request as it pertains to AI/Machine Learning evaluation criteria, sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set sample size, or training set ground truth establishment in the context of an AI/ML device.
The document speaks to the following for the physical medical device:
1. A table of acceptance criteria and the reported device performance:
The document provides a table under "g) Summary of Non-clinical testing (Bench)" listing tests, methods, acceptance criteria, and conclusions (Pass/Fail).
| Test | Method | Acceptance Criteria | Conclusion |
|---|---|---|---|
| Physical Performance test | |||
| Leakage Test | ISO8536-4 | ISO8536-4 | Pass |
| Luer adapter connection | ISO80369-7 | ISO80369-7 | Pass |
| Free Flow rate | ISO8536-4 | ISO8536-4 | Pass |
| Particulate contamination | ISO8536-4 | ISO8536-4 | Pass |
| Chemical performance test | |||
| Reducing matter | ISO8536-4 | ISO8536-4 | Pass |
| Metal ions | ISO8536-4 | ISO8536-4 | Pass |
| Titration acidity or alkalinity | ISO8536-4 | ISO8536-4 | Pass |
| Residue on evaporation | ISO8536-4 | ISO8536-4 | Pass |
| UV absorption of extract solution | ISO8536-4 | ISO8536-4 | Pass |
| EO residual test | ISO10993-7 | ≤10µg/g | Pass |
| Biological performance test | |||
| Sterility test | ISO8536-4 | ISO8536-4 | Pass |
| Pyrogenicity | ISO8536-4 | ISO8536-4 | Pass |
| Biocompatibility test | |||
| In vitro cytotoxicity test | ISO10993-5 | ISO10993-5 | Pass |
| Skin sensitization test 0.9% sodium chloride injection extract | ISO10993-10 | ISO10993-10 | Pass |
| Skin sensitization test sesame oil extract | ISO10993-10 | ISO10993-10 | Pass |
| Intracutaneous reactivity test 0.9% sodium chloride injection extract | ISO10993-10 | ISO10993-10 | Pass |
| Acute systemic toxicity test sesame oil extract | ISO10993-11 | ISO10993-11 | Pass |
| Pyrogen test 0.9% sodium chloride injection extract rabbit | ISO10993-11 | ISO10993-11 | Pass |
| Bacteria endotoxins test Gel-Clot technique | USP 43-NF <85> | USP 43-NF <85> | Pass |
| Subchronic systemic toxicity test | ISO10993-11 | ISO10993-11 | Pass |
| In Vitro hemolytic properties test | ISO10993-4 | ISO10993-4 | Pass |
For the other points (2-9), as explained, the document pertains to a physical medical device and its compliance with standards, not an AI/ML device performance study. Thus, no information is available regarding:
- Sample size used for the test set and data provenance (in an AI/ML context).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc. for an AI/ML model).
- Sample size for the training set.
- How the ground truth for the training set was established.
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October 7, 2022
Amsino International, Inc. Jane Gao VP of R&D and RA 708 Corporate Center Drive Pomona, California 91768
Re: K220267
Trade/Device Name: AMSafe® NeuFlo™ Needleless Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: September 9, 2022 Received: September 9, 2022
Dear Jane Gao:
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/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 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,
David Wolloscheck, Ph.D. For 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) K220267
Device Name AMSafe® NeuFloTM Needleless Connector
Indications for Use (Describe)
The AMSafe® NeuFloTM Needleless Connector are intended to use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
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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K220267 510(k) Summary
| a)Submitter information: | |
|---|---|
| Preparation Date: | 09/09/2022 |
| Manufacturer's Name: | Amsino International Inc. |
| 708 Corporate Center Drive, Pomona, CA91768 | |
| Correspondions official : | Jane Gao |
| VP of R&D and RA | |
| Mobile: +86 139 1614 7664 | |
| Email Address: | Jane_gao@amsino.com |
b) Device information:
| Trade Name: | AMSafe® NeuFlo™ Needleless Connector |
|---|---|
| Common or Usual Name: | Needless connector |
| Regulation Name: | Intravascular administration set |
| Regulation Number: | 21 CFR 880.5440 |
| Product Code: | FPA |
| Device Class: | Class II |
c)Identification of legally marketed devices:
- Predicate device: Clave Connector by ICU Medical Inc. [K970855]
d) Device Description:
AMSafe® NeuFlo™ Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set.
e)Indication for Use:
The AMSafe® NeuFlo™ Needleless Connector are intended to use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
f)Substantial Equivalence Discussion
The table below includes a comparison of the intended use and technological characteristics between the new device and those of the predicate device:
| Characteristic | Subject DeviceAMSafe NeuFlo NeedlelessConnector | PredicateClave Connector(K970855) | Discussionbetween Subjectdevice andPredicate device |
|---|---|---|---|
| Indications foruse | The AMSafe NeuFloNeedleless Connector areintended to use as anaccessory to intravascularadministration set for theadministration of fluids to apatient through a cannulaplaced in the vein or artery. | As an accessory tointravascularadministration set for theadministration of fluids toa patient through acannula placed in the veinor artery. | Same |
| Prescription onlyor over thecounter | Prescription only | Prescription only | Same |
| Product Code | FPA | FPA | Same |
| Technological | The design principle is the | The design principle is the | Same |
| Characteristic | Subject DeviceAMSafe NeuFlo NeedlelessConnector | PredicateClave Connector(K970855) | Discussionbetween Subjectdevice andPredicate device |
| Characteristics | split septum silicone sealcovers internal hollow bluntspike, seal is compressedupon a Luer activation, andhollow blunt spike is formedthe fluid pathway | split septum silicone sealcovers internal hollowblunt spike, seal iscompressed upon a Lueractivation, and hollowblunt spike is formed thefluid pathway | |
| Principle ofoperation | The device is a sterilesingle patient useconnector for needlelessaccess to the IV line and/orIV catheter during IVtherapy.It is used as injection sitewhen accessed byattaching a male luerconnector to the device. Allthe operations are usual,clockwise rotation is forlocking, and anticlockwiserotation is fordisconnecting. | The device is a sterilesingle patient useconnector for needlelessaccess to the IV lineand/or IV catheter duringIV therapy.It is used as injection sitewhen accessed byattaching a male luerconnector to the device.All the operations areusual, clockwise rotationis for locking, andanticlockwise rotation isfor disconnecting. | Same |
| Materials ofmaincomponents | Housing: Polycarbonate | Housing: Polyester | Different.The housing andspike material isdifferent betweenpredicate andsubject device. Thefinished sample ofsubject device hasbeen conductedbiocompatibilitytest according toISO10993 standard |
| Seal: Silicone | Seal: Silicone | ||
| Spike: ABS | Spike: Polycarbonate | ||
| Cap: Polypropylene | Cap: Polypropylene | ||
| Performancetesting | The Luer adapter iscompliance with ISO80369-7 | The Luer adapter iscompliance withISO80369-7 | Same |
| Flow rate at 1m headheight is more than1000mL in 10 mins perISO8536-4 | Flow rate at 1m headheight is more than1000mL in 10 mins perISO8536-4 | Same | |
| No leakage per ISO8536-4& ISO8536-8 | No leakage per ISO8536-4 & ISO8536-8 | Same | |
| Microbial ingress testing:infected bacterialsuspension deliberately,simulated clinical use,swabbed access port andincubated filtered fluid, theincubated results shouldshow that the swabbing | Microbial ingress testing:infected bacterialsuspension deliberately,simulated clinical use,swabbed access port andincubated filtered fluid, theincubated results shouldshow that the swabbing | Same | |
| Characteristic | Subject DeviceAMSafe NeuFlo NeedlelessConnector | PredicateClave Connector(K970855) | Discussionbetween Subjectdevice andPredicate device |
| was effective, or the devicehas ability to resist bacterialinvasion. | was effective, or thedevice has ability to resistbacterial invasion. | ||
| Biologicalevaluation | Conform with ISO10993series requirements | Conform with ISO10993series requirements | Same |
| Singleuse/reusable | Single use | Single use | Same |
| Sterile method | ETO sterilizationSAL10-6 | SAL10-6 | Different.Not sure thesterilization methodfor predicate, butSAL betweensubject andpredicate is same.The subject deviceis used withvalidatedsterilizationprocess. |
| Shelf life | 5 years | Not sure | Different.The subject devicehas passed theaccelerated 5yearsaging test |
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The subject device is same in both indications for use and technological characteristics when compared to the predicate device, the difference is the material, sterilization method and shelf life. However, this difference does not affect the performance and safety of the device as evidenced by the performance, stability and biocompatibility verification testing conducted on the subject device.
g) Summary of Non-clinical testing (Bench)
The non-clinical testing for The AMSafe NeuFlo Needleless Connector was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
The following performance testing was conducted on the finished device.
| Test | Method | Acceptancecriteria | Conclusion |
|---|---|---|---|
| Physical Performance test | |||
| Leakage Test | ISO8536-4 | ISO8536-4 | Pass |
| Luer adapter connection | ISO80369-7 | ISO80369-7 | Pass |
| Free Flow rate | ISO8536-4 | ISO8536-4 | Pass |
| Particulate contamination | ISO8536-4 | ISO8536-4 | Pass |
| Chemical performance test |
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| Reducing matter | ISO8536-4 | ISO8536-4 | Pass |
|---|---|---|---|
| Metal ions | ISO8536-4 | ISO8536-4 | Pass |
| Titration acidity or alkalinity | ISO8536-4 | ISO8536-4 | Pass |
| Residue on evaporation | ISO8536-4 | ISO8536-4 | Pass |
| UV absorption of extract solution | ISO8536-4 | ISO8536-4 | Pass |
| EO residual test | ISO10993-7 | ≤10µg/g | Pass |
| Biological performance test | |||
| Sterility test | ISO8536-4 | ISO8536-4 | Pass |
| Pyrogenicity | ISO8536-4 | ISO8536-4 | Pass |
| Biocompatibility test | |||
| In vitro cytotoxicity test | ISO10993-5 | ISO10993-5 | Pass |
| Skin sensitization test 0.9% sodium chlorideinjection extract | ISO10993-10 | ISO10993-10 | Pass |
| Skin sensitization test sesame oil extract | ISO10993-10 | ISO10993-10 | Pass |
| Intracutaneous reactivity test 0.9% sodiumchloride injection extract | ISO10993-10 | ISO10993-10 | Pass |
| Acute systemic toxicity test sesame oilextract | ISO10993-11 | ISO10993-11 | Pass |
| Pyrogen test 0.9% sodium chloride injectionextract rabbit | ISO10993-11 | ISO10993-11 | Pass |
| Bacteria endotoxins test Gel-Clot technique | USP 43-NF<85> | USP 43-NF<85> | Pass |
| Subchronic systemic toxicity test | ISO10993-11 | ISO10993-11 | Pass |
| In Vitro hemolytic properties test | ISO10993-4 | ISO10993-4 | Pass |
The shelf life of the final finished sterilized device was evaluated according to the recognized consensus standard ASTM F1980-16 to verify that the subject device will remain within specification during the prescribed 5 years shelf life when stored under the labeled storage conditions.
h) Conclusions:
Based on a comparison of technological characteristics, intended use between subject device and predicate, and performance test results, we conclude that AMSafe NeuFlo Needleless Connector is as safe and effective and is substantially equivalent to the predicate device.
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§ 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.