(280 days)
Not Found
No
The summary describes a mechanical needle-free connector and its performance testing, with no mention of AI or ML.
No
The device is used to administer fluids and drugs, but it does not directly treat or prevent a disease; it is an accessory to an intravascular administration set.
No
Explanation: The device is described as 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." Its function is to facilitate the delivery or aspiration of fluids, drugs, or blood, not to provide diagnostic information.
No
The device description clearly indicates a physical, disposable medical device (Needle-Free Connector) intended for direct patient contact and fluid delivery. It undergoes bench testing, sterility testing, and biocompatibility testing, all indicative of a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to an intravascular administration set for delivering fluids to a patient's vascular system. This is a direct medical intervention on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description reinforces its use for direct injection, infusion, and aspiration of substances into the patient's bloodstream.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze a sample (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are designed to perform tests in vitro (outside the body).
The device described is a medical device used for administering substances to a patient, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
FPA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Sterility was assessed in accordance to ISO 11135:2007, Sterilization of Health 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)."
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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.
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
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/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
2
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
. | Device
Characteristic | Proposed Device | Predicate Device | Results |
|---------|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 1 | Product
Code | FPA | FPA | Same |
| 2 | Indications
for Use | 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 NAC PRN Needleless
Access 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 or artery. | Similar |
| 3 | Regulation
Number | 880.5440 | 880.5440 | Same |
| 4 | Design
Configuration | Image: Purple connector | Image: Blue connector | Similar |
| 5 | 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. And
it is also used as adapter
when connecting to a | 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. And it is also | Same |
| | | clockwise rotation is for
locking, and anticlockwise | Luer connector. All the
operations are usual, | |
| | rotation is for disconnecting. | | clockwise rotation is for | |
| | | | locking, and anticlockwise | |
| | | | rotation is for
disconnecting. | |
| 6 | Materials of main components | | | |
| | Top cover | polycarbonate | polycarbonate | Same |
| | Housing | polycarbonate | polycarbonate | Same |
| | Valve Plug | Silicone | Silicone | Same |
| | Protective
cap | Polypropylene | Polypropylene | Same |
| 7 | Single Use/
Reusable | Single patient use | Single patient use | Same |
| 8 | Primary
package | Poly pouch with Medical
dialysis paper | Poly pouch with Medical
dialysis paper | Same |
| 9 | Sterile
method | 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 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 | |
| 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) | |
| 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) | |
| 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) | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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) | |
| 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 | |
| Weld strength test | Conform with the internal criteria |
| Testing Items | Test Criteria |
| Cytotoxicity | ISO 10993-5: 2009 Biological Evaluation Of |
| Medical Devices - Part 5: Tests For In Vitro | |
| Cytotoxicity | |
| Sensitization | ISO 10993-10: 2010 Biological Evaluation |
| Of Medical Devices - Part 10: Tests For | |
| Irritation And Skin Sensitization | |
| Intracutaneous Reactivity Test | ISO 10993-10: 2010 Biological Evaluation |
| Of Medical Devices - Part 10: Tests For | |
| Irritation And Skin Sensitization | |
| Acute systemic toxicity | ISO 10993-11: 2006 Biological evaluation |
| of medical devices - Part 11: Tests for | |
| systemic toxicity | |
| Haemolysis | ASTM F 756-13: Standard Practice for |
| Assessment of Hemolytic Properties of | |
| Materials | |
| Pyrogenicity | ISO 10993-11: 2006 Biological evaluation |
| of medical devices - Part 11: Tests for | |
| systemic toxicity | |
| Subchronic Toxicity | ISO 10993-11: 2017 Biological evaluation |
| of medical devices - Part 11: Tests for | |
| systemic 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.