(232 days)
Not Found
No
The device description focuses on the physical components and mechanical function of a needle-free connector, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies listed are standard bench and biocompatibility tests for a physical medical device.
No
The device is described as an accessory for administering fluids, but it does not directly treat or diagnose a disease or condition.
No
The device is described as an accessory for administering fluids, and its testing involves biocompatibility and bench tests, not diagnostic performance metrics. There is no mention of it being used to identify or predict diseases.
No
The device description explicitly details physical components made of materials like polycarbonate, silicone, and ABS, and mentions sterilization and physical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of fluids to a patient through a cannula placed in a vein or artery. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description details a mechanical connector for fluid delivery, not a device used to examine specimens derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of disease.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, mechanical properties, and sterility, which are relevant to a device used for fluid administration, not diagnostic testing.
In summary, the device's function is to facilitate the delivery of fluids into the bloodstream, which is a medical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to patient through a cannula placed in the vein or artery.
Product codes
FLL, FPA
Device Description
The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory of an intravascular infusion device to connect a cannula placed in a vein or artery to infuse patients, including adults and pediatrics. The Needle Free Connector can be divided into two versions according to whether it has a protective cap or not. The Needle free connector with protective cap is composed of Body, Core, Polyester Shell or ABS Shell, and Protective Cap. The Needle free connector without protective cap is composed of Body, Core, Polyester Shell, or ABS Shell, or PC shell. The body is made from polycarbonate, the core made from silicone, the protective cap made from ABS. The PC shell of the device is clear with visible liquid pathway. The device is sterilized by EO gas and the sterilization process is validated. It is a luer activated device that eliminates the risk of needle-stick injuries and can be used for a maximum of 7 days following initial connection and 600 activations. It may be used with power injection procedure to a maximum pressure of 350psi.
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
Adults and pediatrics
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 subject device, Needle Free Connector, was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:
Biocompatibility Testing:
Per ISO 10993-1: 2018 and FDA guidance, the following tests were performed to ensure the biocompatibility of the subject device.
- In vitro cytotoxicity, per ISO 10993-5: 2009
- Skin sensitization, per ISO 10993-10: 2010
- Intracutaneous reactivity, per ISO 10993-10: 2010
- Pyrogenicity, per ISO 10993-11: 2017 and USP General Chapter
- Acute systemic toxicity, per ISO 10993-11: 2017
- Subacute toxicity, per ISO 10993-11: 2017
- Hemolysis, per ISO 10993-4: 2017 and ASTM F756-17.
Bench Testing:
Per ISO 8536-4: 2019, ISO 80369-7: 2021, FDA guidance "Intravascular Administration Sets Premarket Submission Notifications (FDA; July 11, 2008)", etc., the following tests were performed to ensure performance/functionality of the subject device.
- Appearance, per similar device and product characteristics.
- Dimensions, per FDA guidance, similar device and product characteristics.
- Particulate contamination, per ISO 8536-4: 2019.
- Tensile strength, per ISO 8536-4: 2019 and FDA guidance.
- Volume flow, per ISO 8536-4: 2019 and FDA guidance.
- Leakage, per ISO 8536-10: 2015 and FDA guidance.
- High pressure compatibility, per similar device and product characteristics.
- Interface test, per ISO 80369-7: 2021 and FDA guidance.
- Lumen volume, per FDA guidance, similar device and product characteristics.
- Functional activations, per FDA guidance, similar device and product characteristics.
- Protective cap, per ISO 8536-4: 2019 and FDA guidance.
- Conical fitting, per ISO 80369-7: 2021 and FDA guidance.
- Chemical performance, per ISO 8536-4: 2019.
- Sterility, per ISO 11135: 2014.
- Bacterial endotoxin, per ANSI/AAMI ST72: 2019.
- Microbial ingress testing, per FDA guidance.
- Package performance, per ISO 11607-1: 2019 and ISO 11607-2: 2019.
- Shelf Life Validation, per ASTM F1980-16.
Clinical Tests: Clinical tests were not required to demonstrate performance of Needle Free Connector. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests: Animal tests were not required to demonstrate performance of Needle Free Connector. Product functionality has been adequately assessed by non-animal tests.
The results of these tests confirm that the Needle Free Connector meets the design input requirements based on the intended use and support the conclusion that this device is as safe, as effective and performs as well as the legally marketed predicate device Clave® Connector (K970855, ICU Medical, Inc.).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
May 10, 2022
Medcaptain Life Science Co., Ltd. David Xia Official Correspondent 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen, 518118 Cn
Re: K213004
Trade/Device Name: Needle Free Connector Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 11, 2021 Received: April 2, 2021
Dear David Xia:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K213004
Device Name Needle Free Connector
Indications for Use (Describe)
The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to patient through a cannula placed in the vein or artery.
| 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 contains a logo with the text "MEDCAPTAIN" in a combination of gray and blue colors. To the right of the text, there is an orange bracket-like shape. Above the text, there are gray Chinese characters. The logo appears to be for a company or organization named "MEDCAPTAIN".
510(k) Summary
I. Submitter/510(k) Holder
| Submission: | Traditional 510(k) Premarket Notification | ||
|---|---|---|---|
| Submitter: | MEDCAPTAIN LIFE SCIENCE CO., LTD. | ||
| Address: | 601, Building C, Jinweiyuan Industrial Park, Pingshan | ||
| District, Shenzhen, Guangdong, CN 518118. | |||
| Contact Person: | David Xia | ||
| Telephone: | +86-755-28380626 | ||
| Telefax: | +86-755-84517910 | ||
| Email: | david.xia@medcaptain.com | ||
| Date prepared: | May 5, 2022 |
II. Device
| Device Trade Name: | Needle Free Connector |
|---|---|
| Device Common Name: | Intravascular Administration Set or Needleless Connector |
| Regulatory Name: | Intravascular Administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Product Code: | FPA |
| Product Code Name: | Set, Administration, Intravascular |
| Regulatory Class: | Class II |
| Review Panel: | General Hospital |
III. Predicate Device
The Needle Free Connector is substantially equivalent to the following legally marketed predicate device:
Predicate device: Clave® Connector (K970855, ICU Medical, Inc.) cleared on June 24, 1997.
IV. Device Description
The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory of an intravascular infusion device to connect a cannula placed in a vein or artery to infuse patients, including adults and pediatrics. The Needle Free Connector can be divided into two versions according to whether it has a protective cap or not. The Needle free connector with protective cap is composed of Body, Core, Polyester Shell or ABS Shell, and Protective Cap. The Needle free connector without protective cap is composed of Body, Core, Polyester Shell, or ABS Shell, or PC shell. The body is made from polycarbonate, the core made from silicone, Page 1 of 8
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Image /page/4/Picture/0 description: The image shows the logo for MEDCAPTAIN. The text "MED" is in gray, while "CAPTAIN" is in blue. To the right of the word "CAPTAIN" is an orange bracket. Above the word "MEDCAPTAIN" are three Chinese characters in gray.
the protective cap made from ABS. The PC shell of the device is clear with visible liquid pathway. The device is sterilized by EO gas and the sterilization process is validated. It is a luer activated device that eliminates the risk of needle-stick injuries and can be used for a maximum of 7 days following initial connection and 600 activations. It may be used with power injection procedure to a maximum pressure of 350psi.
The Needle Free Connector has 6 models and the differences for each model are listed in the following table 1:
| No. | Model | Description |
|---|---|---|
| 1 | NC11 | Green and opaque Polyester shell, with protective cap |
| 2 | NC12 | Green and opaque Polyester shell, without protective cap |
| 3 | NC13 | Green and opaque ABS shell, with protective cap |
| 4 | NC14 | Green and opaque ABS shell, without protective cap |
| 5 | NC15 | Green and clear PC shell, with protective cap |
| 6 | NC16 | Green and clear PC shell, without protective cap |
Table 1 Models of Needle Free Connector
V. Indications for Use
The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to patient through a cannula placed in the vein or artery.
VI. Comparison of Technological Characteristics with the Predicate Device
The subject device, Needle Free Connector, and the predicate device, Clave® Connector, are substantially equivalent in that these devices, have same intended use, indications for use, duration of use, etc., and same technological characteristics including functional use, technology and design, leakage, luer compatibility, chemical compatibility, material of internal conduit, biocompatibility, etc.
The differences between the subject and the predicate device include patient population, residual volume, gravity fluid flow, fluid displacement, activation times, pressure infusion, materials of housing and protective cap, sterilization, and shelf life.
Similarities and differences in technology characteristics are captured in the substantial equivalence comparison between the subject device, Needle Free Connector, and the predicate device, Clave® Connector, which are provided in Table 2.
Table 2 Substantial Equivalence Comparison
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Image /page/5/Picture/0 description: The image shows the logo for MEDCAPTAIN. The text "MEDCAPTAIN" is written in a combination of gray and blue colors. To the right of the word "CAPTAIN" is an orange bracket. Above the word "MEDCAPTAIN" is the company name written in Chinese characters.
| Description | Clave® Connector
(Predicate device) | Needle Free Connector
(Subject device) | Comparison to
predicate device |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| 510(k) Number | K970855 | K213004 | N/A |
| Regulation Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical |
| Regulatory Name | Intravascular Administration Set | Intravascular Administration Set | Identical |
| Product Code | FPA | FPA | Identical |
| Regulatory Class | Class II | Class II | Identical |
| Intended Use | Needleless injection port to
access any vein, or artery. | Needleless injection port to access
any vein, or artery | Identical |
| Indications for use | The ICU Needleless Connector
is a single use, sterile, non-
pyrogenic device intended for
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. | The Needle Free Connector is a
disposable, sterile, non-pyrogenic
device intended for use as an
accessory to intravascular
administration set for the
administration of fluids to patient
through a cannula placed in the
vein or artery. | Identical |
| Functional use | Needleless connector | Needleless connector | Identical |
| Technology and design | Needleless connector and one
piece design activated by luer
connection to allow fluid flow. | Needleless connector and one piece
design activated by luer connection
to allow fluid flow. | Identical |
| Prescription/ Over-the-
Counter | Prescription | Prescription | Identical |
| Patient Population | Adults, pediatrics and
immunocompromised patients | Adults and pediatric population | Different
See Justification 1 |
| Duration of use | 7 days | 7 days | Identical |
| Performance | / | / | / |
| Residual volume: | 0.06mL | 0.05mL | Different
See Justification 2 |
| Gravity fluid flow: | 100mL/min | 150 mL/min | Different
See Justification 3 |
| Syringe disconnect:
fluid displacement | Negative displacement | Neutral displacement | Different
See Justification 4 |
| Activation times: | 96 intermittent, 3 extended time. | 600 activations | Different
See Justification 5 |
| Leakage: | Pass test | Pass test | Identical |
| Luer compatibility: | Yes | Yes | Identical |
| Pressure infusion: | Max. 400psi. | Max. 350psi | Different
See Justification 6 |
| Chemical | Lipids, alcohol | Lipids, alcohol | Identical |
| Description | Clave® Connector
(Predicate device) | Needle Free Connector
(Subject device) | Comparison to
predicate device |
| compatibility: | | | |
| Microbial ingress: | Pass test | Pass test | Identical |
| Other performance: | Pass test | Pass test | Identical |
| Materials | Internal conduit: Polycarbonate
Housing: Polyester
Silicone seal: Silicone rubber
Ring: PP
Lubricant: Flurosilicone
Breather cap: PP | Body: Polycarbonate
Housing: Polyester, or ABS or PC
Silicone seal: Silicone rubber
Lubricant: Silicone oil
Protective cap: ABS | Different
See Justification 7 |
| Packaging: | Packaging: Medical packaging
grade fiber-free peelable paper
lidding and pouching material | Packaging: Medical packaging
grade peelable paper and pouching
material | Identical |
| Biocompatibility | ISO 10993 | ISO 10993 | Identical |
| Sterilization | Gamma or E-beam | EO sterilization | Different
See Justification 8 |
| Sterile | Yes | Yes | Identical |
| Single Use | Yes | Yes | Identical |
| Shelf Life | 5 years | 3 years | Different
See Justification 9 |
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Image /page/6/Picture/0 description: The image shows the logo for MEDCAPTAIN. The text "MEDCAPTAIN" is written in a combination of gray and blue colors. To the right of the word "CAPTAIN" is an orange bracket. Above the word "MEDCAPTAIN" is the company name written in Chinese characters.
Justification 1: Patient population
The patient population of the subject device is adults and pediatrics, while the patient population of the predicate device is adults, pediatrics and immunocompromised patients. The immunocompromised patients can be adults or pediatrics, which is to say the adults or pediatrics contain the patient group of immunocompromised patients. The subject device specified "Adults and pediatrics" according to FDA specification on intended use population, and does not emphasize "immunocompromised patients". It can be considered the patient population of the subject device is substantially equivalent to that of the predicate device. The difference does not raise new or different questions regarding safety or effectiveness.
Justification 2: Residual volume
The residual volume of the subject device is 0.05ml, and that of the predicate device is 0.06mL. There is minor difference between them. Minimal residual volume allows for lower the flushing volumes. Other commercially available needleless connectors have residual volumes from 0.018 ml to 0.8 ml.111 And this information of the subject device is labeled in the Instructions for use. The difference does not raise new or different questions regarding safety or effectiveness.
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Image /page/7/Picture/0 description: The image shows the logo for MEDCAPTAIN. The text "MEDCAPTAIN" is written in a sans-serif font, with "MED" in gray and "CAPTAIN" in blue. To the right of the text is an orange bracket. Above the text is the company name in Chinese characters.
Justification 3: Gravity fluid flow
The gravity of the subject device is not less than 150mL/min, and that of the predicate device Clave® Connector is 100mL/min. According to the 510 (k) Summary of Firefly Needleless Connector (K203796), the flow rate through a 20G catheter is 60 ml/min and, is used for most infusions, rapid fluid replacement, and routine blood transfusion. And other commercially available needleless connectors have flow rates from 24 ml/min to 533 ml/min.[1] So the flow rate of the subject device can meet the clinical use and is labelled in the Instructions for use. The difference does not raise new or different questions regarding safety or effectiveness.
Justification 4: Fluid displacement
The subject device is neutral displacement, whereas the predicate device is negative displacement. The fluid displacement of commercially available needleless connectors (neutral, negative, etc.), including negative Clave® Connector, were studied according to authoritative reference.121 The results demonstrated fluid movement/reflux volumes of 3.6 uL to 10.80 uL for neutral displacement, and 9.73 uL to 50.34 uL for negative displacement. The fluid displacement of the subject device is between 4.97 uL to 7.73 uL based on internal testing, while the fluid displacement of Clave® Connector is 8.02 (theoretical calculations) or 9.73 (actual in vitro venous values) according to the reference. There is a minor difference between them. The terms neutral and negative displacement are marketing terms, and there are no documents from any regulatory organizations providing guidance on the use of these terms.[3] We used neutral to define the subject device based on the common market practice. The difference does not raise new or different questions regarding safety or effectiveness.
Justification 5: Activation times
The subject device has 600 activation times whereas the predicate device has 99 times. The activation times of the subject device has been tested during design verification and shelf life validation. The test results showed that the subject device meets the specified performance. The difference does not raise new or different questions regarding safety or effectiveness.
[1] https://nursing.ceconnection.com/ovidfiles/00000446-201211000-00023.pdf (Needleless for IV catheters)
[2]https://www.researchgate.net/publication/321674078_Quantitative_assessment_of_reflux_in_commercially_a vailable needle-free IV_connectors (Quantitative assessment of reflux in commercially available needle-free IV
connectors)
[3] https://www.researchgate.net/publication/41028693 Needleless Connectors (Needleless Connectors: A Primer on Terminology)
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Image /page/8/Picture/0 description: The image shows the logo for MEDCAPTAIN. The text "MEDCAPTAIN" is displayed in a combination of gray and blue colors. To the right of the text, there is an orange bracket symbol. Above the text, there are three Chinese characters in gray.
Justification 6: Pressure infusion
The pressure infusion Max. 350psi of the subject device is less than 400psi of the predicate device, but it is higher than 325psi that labeled by other legally marketed needleless connector, such as MZ1000 (K132413), so the pressure infusion can meet clinical use. The subject device meets the specified pressure performance based on the performance test result, and the allowed maximum pressure will be labeled in the Instructions for use. So the difference does not raise new or different questions regarding safety or effectiveness.
Justification 7: Materials
The liquid pathway of the subject device is PC which is same to the material of the predicated device. The silicone seal is same as well. The housing material is different and no more information for the materials used by the predicate device. But the subject device was conducted biocompatibility evaluation and tests according to ISO 10993-1: 2018, including cytotoxicity, skin sensitization, intracutaneous reactivity, pyrogenicity, acute systemic toxicity, subacute toxicity and hemolysis, which can prove that the materials used for the device has no biological risk and the product is biocompatible. Based on bench testing of Needle Free Connector, the performance of the subject device meets the requirement of ISO 8536-4, ISO 80369-7, etc. The materials differences have no influence to the product performance. So the differences of materials do not raise new or different questions regarding safety or effectiveness.
Justification 8: Sterilization
The subject device is sterilized by EO gas compared to the predicate device which is sterilized by Gamma or E-beam. Both methods of sterilization are widely used in the medical device industry and utilize FDA recognized standards for sterilization validation. The EO sterilization process of the subject has been evaluated according to 14-529 ISO 11135: 2014, and after sterilization, the performance, such as biocompatibility and bench testing, are conducted and all meet the specified requirements. The EO and ECH residuals were tested and met the acceptance criteria. The device can keep a sterility assurance level 10th after sterilization, which is same to the predicate device that sterilized by Gamma or E-beam. So the difference does not raise new or different questions regarding safety or effectiveness.
Justification 9: Shelf life
The shelf life of the subject device was validated according to 14-484 ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. After validation and test, it is proved that the product will be valid within 3 year's shelf life. The shelf life of the predicate device is 5 years which is different from that of the subject device, but there is no influence if the subject device is intended for use within the period of validity. So the difference does not raise new or different
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Image /page/9/Picture/0 description: The image shows the logo for MEDCAPTAIN, a company that appears to be related to medicine. The text "MEDCAPTAIN" is written in a combination of gray and blue letters, with the "CAPTAIN" portion in blue. To the right of the company name is a graphic in orange that resembles a speech bubble. Above the company name are some Asian characters in gray.
questions regarding safety or effectiveness.
Based on the above analysis, the subject device is substantially equivalent to the predicate device and the differences do not raise new or different questions regarding safety or effectiveness.
VII. Performance Data
The subject device, Needle Free Connector, was subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:
Biocompatibility Testing:
Per ISO 10993-1: 2018 and FDA guidance, the following tests were performed to ensure the biocompatibility of the subject device.
- In vitro cytotoxicity, per ISO 10993-5: 2009 ●
- Skin sensitization, per ISO 10993-10: 2010
- Intracutaneous reactivity, per ISO 10993-10: 2010 ●
- Pyrogenicity, per ISO 10993-11: 2017 and USP General Chapter
- Acute systemic toxicity, per ISO 10993-11: 2017 ●
- Subacute toxicity, per ISO 10993-11: 2017 ●
- Hemolysis, per ISO 10993-4: 2017 and ASTM F756-17 .
Bench Testing:
Per ISO 8536-4: 2019, ISO 80369-7: 2021, FDA guidance "Intravascular Administration Sets Premarket Submission Notifications (FDA; July 11, 2008)", etc., the following tests were performed to ensure performance/functionality of the subject device.
- Appearance, per similar device and product characteristics. ●
- Dimensions, per FDA guidance, similar device and product characteristics. ●
- Particulate contamination, per ISO 8536-4: 2019. ●
- Tensile strength, per ISO 8536-4: 2019 and FDA guidance.
- Volume flow, per ISO 8536-4: 2019 and FDA guidance.
- Leakage, per ISO 8536-10: 2015 and FDA guidance. ●
- High pressure compatibility, per similar device and product characteristics.
- . Interface test, per ISO 80369-7: 2021 and FDA guidance.
- Lumen volume, per FDA guidance, similar device and product characteristics. ●
- Functional activations, per FDA guidance, similar device and product ● characteristics.
- Protective cap, per ISO 8536-4: 2019 and FDA guidance.
- Conical fitting, per ISO 80369-7: 2021 and FDA guidance. ●
- Chemical performance, per ISO 8536-4: 2019. ●
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Image /page/10/Picture/0 description: The image contains the logo for MEDCAPTAIN. The text "MEDCAPTAIN" is written in a combination of gray and blue letters. To the right of the text is an orange bracket. Above the text "MEDCAPTAIN" are three gray Chinese characters.
- Sterility, per ISO 11135: 2014. ●
- . Bacterial endotoxin, per ANSI/AAMI ST72: 2019.
- Microbial ingress testing, per FDA guidance.
- Package performance, per ISO 11607-1: 2019 and ISO 11607-2: 2019. ●
- Shelf Life Validation, per ASTM F1980-16. ●
Clinical Tests:
Clinical tests were not required to demonstrate performance of Needle Free Connector. Product functionality has been adequately assessed by non-clinical tests.
Animal Tests:
Animal tests were not required to demonstrate performance of Needle Free Connector. Product functionality has been adequately assessed by non-animal tests.
VIII. Conclusions
The results of these tests confirm that the Needle Free Connector meets the design input requirements based on the intended use and support the conclusion that this device is as safe, as effective and performs as well as the legally marketed predicate device Clave® Connector (K970855, ICU Medical, Inc.).