AMSafe NeuFlo Needleless Connector

K220267 · Amsino International, Inc. · FPA · Oct 7, 2022 · General Hospital

Device Facts

• Record ID: K220267
• Device Name: AMSafe NeuFlo Needleless Connector
• Applicant: Amsino International, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Oct 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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.

Device Story

Single-use, sterile, non-pyrogenic needleless connector; accessory to intravascular administration sets. Operates via split-septum silicone seal covering internal hollow blunt spike; Luer activation compresses seal to open fluid pathway. Used in clinical settings for IV therapy access; physician/nurse-operated. Male Luer connector attachment enables fluid administration; clockwise rotation locks, anticlockwise disconnects. Provides needleless access to IV lines/catheters; reduces needlestick risk; maintains closed system integrity.

Clinical Evidence

Bench testing only. Performance verified via ISO 8536-4 (leakage, flow rate, particulate, chemical), ISO 80369-7 (Luer connection), and microbial ingress testing. Biocompatibility confirmed per ISO 10993 series (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemolysis). Sterility and pyrogenicity verified per ISO 8536-4 and USP <85>. Shelf life validated via ASTM F1980-16.

Technological Characteristics

Housing: Polycarbonate; Seal: Silicone; Spike: ABS; Cap: Polypropylene. Design: Split-septum silicone seal with internal hollow blunt spike. Connectivity: Standard Luer. Sterilization: ETO (SAL 10^-6). Standards: ISO 80369-7 (Luer), ISO 8536-4 (performance), ISO 10993 (biocompatibility), ASTM F1980-16 (shelf life).

Indications for Use

Indicated for patients requiring fluid administration via an intravascular administration set through a venous or arterial cannula. Prescription use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Clave Connector by ICU Medical Inc. (K970855)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] |
| Email Address: | [e-mail] |

# 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<br>AMSafe NeuFlo Needleless<br>Connector | Predicate<br>Clave Connector<br>(K970855) | Discussion<br>between Subject<br>device and<br>Predicate device |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>use | The AMSafe NeuFlo<br>Needleless Connector are<br>intended to use as an<br>accessory to intravascular<br>administration set for the<br>administration of fluids to a<br>patient through a cannula<br>placed in the vein or artery. | As an accessory to<br>intravascular<br>administration set for the<br>administration of fluids to<br>a patient through a<br>cannula placed in the vein<br>or artery. | Same |
| Prescription only<br>or over the<br>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<br>AMSafe NeuFlo Needleless<br>Connector | Predicate<br>Clave Connector<br>(K970855) | Discussion<br>between Subject<br>device and<br>Predicate device |
| Characteristics | split septum silicone seal<br>covers internal hollow blunt<br>spike, seal is compressed<br>upon a Luer activation, and<br>hollow blunt spike is formed<br>the fluid pathway | split septum silicone seal<br>covers internal hollow<br>blunt spike, seal is<br>compressed upon a Luer<br>activation, and hollow<br>blunt spike is formed the<br>fluid pathway | |
| Principle of<br>operation | The device is a sterile<br>single patient use<br>connector for needleless<br>access to the IV line and/or<br>IV catheter during IV<br>therapy.<br>It is used as injection site<br>when accessed by<br>attaching a male luer<br>connector to the device. All<br>the operations are usual,<br>clockwise rotation is for<br>locking, and anticlockwise<br>rotation is for<br>disconnecting. | The device is a sterile<br>single patient use<br>connector for needleless<br>access to the IV line<br>and/or IV catheter during<br>IV therapy.<br>It is used as injection site<br>when accessed by<br>attaching a male luer<br>connector to the device.<br>All the operations are<br>usual, clockwise rotation<br>is for locking, and<br>anticlockwise rotation is<br>for disconnecting. | Same |
| Materials of<br>main<br>components | Housing: Polycarbonate | Housing: Polyester | Different.<br>The housing and<br>spike material is<br>different between<br>predicate and<br>subject device. The<br>finished sample of<br>subject device has<br>been conducted<br>biocompatibility<br>test according to<br>ISO10993 standard |
| | Seal: Silicone | Seal: Silicone | |
| | Spike: ABS | Spike: Polycarbonate | |
| | Cap: Polypropylene | Cap: Polypropylene | |
| Performance<br>testing | The Luer adapter is<br>compliance with ISO80369-<br>7 | The Luer adapter is<br>compliance with<br>ISO80369-7 | Same |
| | Flow rate at 1m head<br>height is more than<br>1000mL in 10 mins per<br>ISO8536-4 | Flow rate at 1m head<br>height is more than<br>1000mL in 10 mins per<br>ISO8536-4 | Same |
| | No leakage per ISO8536-4<br>& ISO8536-8 | No leakage per ISO8536-<br>4 & ISO8536-8 | Same |
| | Microbial ingress testing:<br>infected bacterial<br>suspension deliberately,<br>simulated clinical use,<br>swabbed access port and<br>incubated filtered fluid, the<br>incubated results should<br>show that the swabbing | Microbial ingress testing:<br>infected bacterial<br>suspension deliberately,<br>simulated clinical use,<br>swabbed access port and<br>incubated filtered fluid, the<br>incubated results should<br>show that the swabbing | Same |
| Characteristic | Subject Device<br>AMSafe NeuFlo Needleless<br>Connector | Predicate<br>Clave Connector<br>(K970855) | Discussion<br>between Subject<br>device and<br>Predicate device |
| | was effective, or the device<br>has ability to resist bacterial<br>invasion. | was effective, or the<br>device has ability to resist<br>bacterial invasion. | |
| Biological<br>evaluation | Conform with ISO10993<br>series requirements | Conform with ISO10993<br>series requirements | Same |
| Single<br>use/reusable | Single use | Single use | Same |
| Sterile method | ETO sterilization<br>SAL10-6 | SAL10-6 | Different.<br>Not sure the<br>sterilization method<br>for predicate, but<br>SAL between<br>subject and<br>predicate is same.<br>The subject device<br>is used with<br>validated<br>sterilization<br>process. |
| Shelf life | 5 years | Not sure | Different.<br>The subject device<br>has passed the<br>accelerated 5years<br>aging 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 | Acceptance<br>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 | | | |

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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 chloride<br>injection extract | ISO10993-10 | ISO10993-10 | Pass |
| Skin sensitization test sesame oil extract | ISO10993-10 | ISO10993-10 | Pass |
| Intracutaneous reactivity test 0.9% sodium<br>chloride injection extract | ISO10993-10 | ISO10993-10 | Pass |
| Acute systemic toxicity test sesame oil<br>extract | ISO10993-11 | ISO10993-11 | Pass |
| Pyrogen test 0.9% sodium chloride injection<br>extract rabbit | ISO10993-11 | ISO10993-11 | Pass |
| Bacteria endotoxins test Gel-Clot technique | USP 43-NF<br><85> | USP 43-NF<br><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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