(249 days)
Not Found
No
The document describes a standard medical device (needleless connector) and its performance testing, with no mention of AI or ML capabilities.
No
A therapeutic device is used to treat, cure, mitigate, or prevent a disease or condition. This device is described as an accessory to an administration set for delivering fluids, not for therapeutic intervention itself.
No
The device is described as an accessory to an intravascular administration set for fluid administration, and its performance studies focus on physical, chemical, and biological properties rather than diagnostic capabilities.
No
The device description explicitly states it is a "single use, sterile, non-pyrogenic device" and describes extensive physical, chemical, and biological performance testing, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the administration of fluids to a patient through a cannula placed in a vein or artery. This is a direct interaction with the patient's circulatory system for therapeutic or diagnostic fluid delivery, not for examining specimens in vitro (outside the body).
- Device Description: It's described as an accessory to an intravascular administration set, further reinforcing its role in direct patient care.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely for facilitating the delivery of substances into the body.
N/A
Intended Use / Indications 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.
Product codes
FPA
Device Description
AMSafe® NeuFlo™ Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Physical Performance test: Leakage Test (Pass), Luer adapter connection (Pass), Free Flow rate (Pass), Particulate contamination (Pass).
- Chemical performance test: Reducing matter (Pass), Metal ions (Pass), Titration acidity or alkalinity (Pass), Residue on evaporation (Pass), UV absorption of extract solution (Pass), EO residual test (Pass).
- Biological performance test: Sterility test (Pass), Pyrogenicity (Pass).
- Biocompatibility test: In vitro cytotoxicity test (Pass), Skin sensitization test 0.9% sodium chloride injection extract (Pass), Skin sensitization test sesame oil extract (Pass), Intracutaneous reactivity test 0.9% sodium chloride injection extract (Pass), Acute systemic toxicity test sesame oil extract (Pass), Pyrogen test 0.9% sodium chloride injection extract rabbit (Pass), Bacteria endotoxins test Gel-Clot technique (Pass), Subchronic systemic toxicity test (Pass), In Vitro hemolytic properties test (Pass).
- Shelf life: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Clave Connector by ICU Medical Inc. [K970855]
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
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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3
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 Device
AMSafe NeuFlo Needleless
Connector | Predicate
Clave Connector
(K970855) | Discussion
between Subject
device and
Predicate device |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications 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. | As an accessory to
intravascular
administration set for the
administration of fluids to
a patient through a
cannula placed in the vein
or artery. | Same |
| Prescription only
or over the
counter | Prescription only | Prescription only | Same |
| Product Code | FPA | FPA | Same |
| Technological | The design principle is the | The design principle is the | Same |
| Characteristic | Subject Device
AMSafe NeuFlo Needleless
Connector | Predicate
Clave Connector
(K970855) | Discussion
between Subject
device and
Predicate device |
| Characteristics | split septum silicone seal
covers internal hollow blunt
spike, seal is compressed
upon a Luer activation, and
hollow blunt spike is formed
the fluid pathway | split septum silicone seal
covers internal hollow
blunt spike, seal is
compressed upon a Luer
activation, and hollow
blunt spike is formed the
fluid pathway | |
| Principle of
operation | The device is a sterile
single patient use
connector for needleless
access to the IV line and/or
IV catheter during IV
therapy.
It is used as injection site
when accessed by
attaching a male luer
connector to the device. All
the operations are usual,
clockwise rotation is for
locking, and anticlockwise
rotation is for
disconnecting. | The device is a sterile
single patient use
connector for needleless
access to the IV line
and/or IV catheter during
IV therapy.
It is used as injection site
when accessed by
attaching a male luer
connector to the device.
All the operations are
usual, clockwise rotation
is for locking, and
anticlockwise rotation is
for disconnecting. | Same |
| Materials of
main
components | Housing: Polycarbonate | Housing: Polyester | Different.
The housing and
spike material is
different between
predicate and
subject device. The
finished sample of
subject device has
been conducted
biocompatibility
test according to
ISO10993 standard |
| | Seal: Silicone | Seal: Silicone | |
| | Spike: ABS | Spike: Polycarbonate | |
| | Cap: Polypropylene | Cap: Polypropylene | |
| Performance
testing | The Luer adapter is
compliance with ISO80369-
7 | The Luer adapter is
compliance with
ISO80369-7 | Same |
| | Flow rate at 1m head
height is more than
1000mL in 10 mins per
ISO8536-4 | Flow rate at 1m head
height is more than
1000mL in 10 mins per
ISO8536-4 | Same |
| | No leakage per ISO8536-4
& ISO8536-8 | No leakage per ISO8536-
4 & ISO8536-8 | Same |
| | Microbial ingress testing:
infected bacterial
suspension deliberately,
simulated clinical use,
swabbed access port and
incubated filtered fluid, the
incubated results should
show that the swabbing | Microbial ingress testing:
infected bacterial
suspension deliberately,
simulated clinical use,
swabbed access port and
incubated filtered fluid, the
incubated results should
show that the swabbing | Same |
| Characteristic | Subject Device
AMSafe NeuFlo Needleless
Connector | Predicate
Clave Connector
(K970855) | Discussion
between Subject
device and
Predicate device |
| | was effective, or the device
has ability to resist bacterial
invasion. | was effective, or the
device has ability to resist
bacterial invasion. | |
| Biological
evaluation | Conform with ISO10993
series requirements | Conform with ISO10993
series requirements | Same |
| Single
use/reusable | Single use | Single use | Same |
| Sterile method | ETO sterilization
SAL10-6 | SAL10-6 | Different.
Not sure the
sterilization method
for predicate, but
SAL between
subject and
predicate is same.
The subject device
is used with
validated
sterilization
process. |
| Shelf life | 5 years | Not sure | Different.
The subject device
has passed the
accelerated 5years
aging test |
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4
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5
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 | 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 | | | |
Page 3 | 4
6
| 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 | ||
| USP 43-NF | |||
| 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.