(165 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or data processing.
No.
This device is designed for the transfer and mixing of drugs, not for therapeutic intervention or treatment of a disease or condition.
No
The device is described as a "Vented Vial Transfer Pin" intended for "transfer and mixing of drugs contained in a vial." Its components and functionality, such as a piercing spike, filter medium, and Luer connector, are all designed to facilitate the safe and sterile transfer of liquids and air, not to diagnose medical conditions.
No
The device description clearly outlines multiple physical components (protective cap, piercing spike, filter medium, filter shell, luer connector cap) and describes manufacturing processes (sterilization by EtO). This indicates a hardware-based medical device, not software-only.
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 transfer and mixing of drugs contained in a vial." This describes a device used in the preparation and administration of medications, not for testing biological samples to diagnose or monitor a medical condition.
- Device Description: The description details components for piercing vials, filtering air, and connecting to syringes. These are all functions related to drug handling.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (chemicals, proteins, DNA, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is clearly intended for the mechanical transfer and mixing of drugs, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Vented Vial Transfer Pin is intended for the transfer and mixing of drugs contained in a vial.
Product codes (comma separated list FDA assigned to the subject device)
LHI
Device Description
The proposed device consists of five components: (1) Protective cap, (2) Piercing spike, (3) Filter medium, (4) Filter shell, (5) Luer connector cap. The piercing spike contains the dual lumen channel for liquid and air. A 0.2um hydrophobic air filter medium is assembled to the end of air channel. This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/released air through filter medium. There is a female Luer lock connector in the end of liquid channel, it can be attached a device with a male Luer connector (e.g., standard syringe). The proposed device is available 2 specifications according to design, with security clip and without security clip. The Vented Vial Transfer Pin with Security Clip designed which can be fixed to a 13mm drug vial to prevent accidental separation.
The proposed device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
No DEHP, BPA and Natural Rubber Latex are added in the proposed device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facilities or in home environment by the patient or care-giver
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-7:2008 AMD.1:2019 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
- ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- USP Pyrogen Test
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
- ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible> Packaging by Visual Inspection
- USP Bacterial Endotoxins Test
- ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -Part 7:Connectors for intravascular or hypodermic applications
- ISO 8536-4:2019 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
Performance Testing conducted:
- Product Functionality Performance test (ISO8536-4,7.4 and ISO 80369-7)
- Filter Bursting Pressure (ISO8536-4,7.5)
- Flow Rate Testing (ISO8536-4,7.10)
- Cap/valve-housing detachment from body Test (ISO8536-4,7.3)
- Internal stress level for assembled product (ISO8536-4, 7.13)
Biocompatibility testing:
- Cytotoxicity: no cytotoxicity per ISO 10993-5
- Irritation: no irritation per ISO 10993-10
- Sensitization: no sensitization per ISO 10993-10
- Acute systemic toxicity: no acute systemic per ISO 10993-11
- Pyrogen: no pyrogen per USP
- Hemolysis: no hemolysis per ASTM F756
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 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 28, 2022
Jiangsu Caina Medical Co., Ltd. Jianwei Pan Regulatory Affairs No.23, Huanxi Road, Zhutang Town Jiangyin, Jiangsu 214415 China
Re: K221406
Trade/Device Name: Vented Vial Transfer Pin Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: September 27, 2022 Received: September 30, 2022
Dear Jianwei Pan:
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 and Part 809 ); medical device reporting (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)
Device Name Vented Vial Transfer Pin
Indications for Use (Describe)
The Vented Vial Transfer Pin is intended for the transfer and mixing of drugs contained in a vial.
× Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
3
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K221406 - 510(k) Summary
- Date of Preparation: Oct. 28, 2022 1.
-
- Sponsor Identification
Jiangsu Caina Medical Co., Ltd.
No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214415, China
Establishment Registration Number: 3005670221
Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu(@cainamed.com
Designated Submission Correspondent 3.
Mr. Jianwei pan (Primary Contact Person) Email: jianwei.pan@cainamed.com Ms. Tracy Gong (Alternative Contact Person) Email: tracy.gong@cainamed.com Tel: +86-510-86866666-8027 Fax: +86-510-86866666-8009
- Identification of Proposed Device 4.
Trade Name: Vented Vial Transfer Pin
Regulatory Information Classification Name: Intravascular administration set Common Name: I.V. Fluid Transfer Set Classification: II Product Code: LHI Regulation Number: 21 CFR 880.5440 Review Panel: General Hospital
4
Indications for Use Statement:
The Vented Vial Transfer Pin is intended for the transfer and mixing of drugs contained in a vial.
Device Description న్.
The proposed device consists of five components: (1) Protective cap, (2) Piercing spike, (3) Filter medium, (4) Filter shell, (5) Luer connector cap. The piercing spike contains the dual lumen channel for liquid and air. A 0.2um hydrophobic air filter medium is assembled to the end of air channel. This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/released air through filter medium. There is a female Luer lock connector in the end of liquid channel, it can be attached a device with a male Luer connector (e.g., standard syringe). The proposed device is available 2 specifications according to design, with security clip and without security clip. The Vented Vial Transfer Pin with Security Clip designed which can be fixed to a 13mm drug vial to prevent accidental separation.
The proposed device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
No DEHP, BPA and Natural Rubber Latex are added in the proposed device.
-
- Identification of Predicate Device
Predicate Device 510(k) Number: K160503 Product Name: Vented Vial Adapter Transfer Device - 13mm
- Identification of Predicate Device
6. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-7:2008 AMD.1:2019 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
- A ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
-
ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- A USP Pyrogen Test
- A ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
-
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
-
ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
5
- ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible > Packaging by Visual Inspection
-
USP Bacterial Endotoxins Test
-
ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications -Part 7:Connectors for intravascular or hypodermic applications
- ISO 8536-4:2019 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity > feed
-
- Clinical Test Conclusion
Not applicable
- Substantially Equivalent (SE) Comparison 8.
| Table 1 Comparison of Technology Characteristics with K160503 |
|---|
| ITEM | Proposed Device | Predicate Device
K160503 | Comment |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Product code | LHI | LHI | Same |
| Regulation
No. | 21 CFR 880.5440 | 21 CFR 880.5440 | Same |
| Regulation
Name | Intravascular administration set | Intravascular administration set | Same |
| Class | II | II | Same |
| Indications
for use | The Vented Vial Transfer Pin is
intended for the transfer and mixing
of drugs contained in a vial. | The Vented Vial Adapter
Transfer Device is intended for
the transfer and mixing of
drugs contained in a vial. | Same |
| Configuration | Dual lumen piercing spike. A 0.2µm
hydrophobic air filter medium is
assembled to the end of air channel. | Vial adapter body contains the
dual lumen piercing spike,
Assembled 0.2µm hydrophobic
air path filter. | Same |
| material | Acrylonitrile Butadiene Styrene
Copolymer(ABS),
Polyvinyl chloride(PVC) or ABS,
Polytetrafluoroethylene(PTFE),
Polypropylene (PP),
White color additive,
Blue color additive | Polycarbonate,
PTFE membrane,
Non-woven polyester | Different;
See
Comment 1 |
| Expiration
Date | 5 years | 3years | Different; See
Comment 2 |
| Sterile | Sterile | Sterile | Same |
| Sterile
method | EtO Sterilized | Gamma | Different; See
Comment 3 |
| SAL | 10-6 | 10-6 | Same |
| Single use | Yes | Yes | Same |
| Environment
of use | Healthcare facilities or in home
environment by the patient or
care-giver | Healthcare facilities or in home
environment by the patient or
care-giver | Same |
| Body
Diameter | Vented Vial Transfer Pin to fit
13mm vials or other equivalent drug
vials,
Vented Vial Transfer Pin with
Security Clip only to fit 13mm
vials. | 18.5mm to fit 13mm Vials | Different;
See
Comment 4 |
| | | | |
| | | | |
| | | | |
| Air Filtration | 0.2 micron hydrophobic Filter | 0.2 micron hydrophobic Filter | Same |
| Cap Assembly | Assembly Attached Ultrasonically
or bonding | Assembly Attached
Ultrasonically | Different; See
Comment 5 |
| Vial Adapter
Fit (Vial Side) | Snap Fit to Vial and "Tight Grip"
Feature | Snap Fit to Vial and "Tight
Grip" Feature | Same |
| Piercing
Spike | Plastic - Dual Lumen | Plastic - Dual Lumen | Same |
| Performance
Testing | Product Functionality Performance
test(ISO8536-4,7.4 and ISO
80369-7),
Filter Bursting
Pressure(ISO8536-4,7.5),
Flow Rate
Testing(ISO8536-4,7.10),
Cap/valve-housing detachment from
body Test(ISO8536-4,7.3),
Internal stress level for assembled
product (ISO8536-4, 7.13) | Product Functionality
Performance test according to
IFU,
Filter Bursting Pressure,
Flow Rate Testing,
Cap/valve-housing detachment
from body Test,
Internal stress level for
assembled product. | Same |
| | | | |
| | | | |
| | | | |
| | | | |
| Biocompatibil
ity | Cytotoxicity: no cytotoxicity per
ISO 10993-5 | with ISO 10993 | Same |
| | Irritation: no irritation per ISO
10993-10 | | |
| | Sensitization: no sensitization per
ISO 10993-10 | | |
| | Acute systemic toxicity: no acute
systemic per ISO 10993-11 | | |
| | Pyrogen: no pyrogen per USP | | |
| | Hemolysis: no hemolysis per ASTM
F756 | | |
| | | | |
| | | | |
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7
Comment 1
The patient contact materials for the proposed device are different from predicate device. According to guidance, Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the proposed device is external communicating device of Blood path, indirect and limited contact. The Cytotoxicity test, Sensitization test, Acute systemic toxicity test, Pyrogen test, Hemolysis test have been performed for proposed device. Therefore, this material difference does not affect substantially equivalence on safety and effectiveness.
Comment 2
The expiration date for the proposed device is different from predicate device. The proposed devices have been performed 5 years accelerated aging and demonstrated that the aged samples also complied with the requirements of ISO 8536-4 and ISO 80369-7. The ability of immediate package of the proposed device to maintain the device in a sterile state for a period of 5 years has been validated in accordance with ISO 11607 and ISTA 3A. Therefore, this expiration date difference does not affect substantially equivalence on safety and effectiveness.
Comment 3
The sterile method of proposed device is Eto. the sterile method of predicate device is Irradiation. Both of them achieve a Sterility Assurance Level (SAL) of 104. Examination of the Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals have met with ISO 10993-7AMD1:2019, this sterilization difference does not affect substantially equivalence on safety and effectiveness.
Comment 4
The body diameter is different between proposed device and predicate device. The proposed device have two specifications, with security clip and without security clip. The body diameter of device with security clip is same with predicate device to fit 13mm vials. The body diameter of device without security clip is added to fit 13mm vials or other equivalent drug vials. The difference does not affect substantially equivalence on safety and effectiveness.
Comment 5
The cap assembly is different between proposed device and predicate device. The proposed device have two method, ultrasonic welding and bonding. The tensile strength of parts have been tested at 15N for 15s. Both of them meet acceptable criteria. The difference does not affect substantially equivalence on safety and effectiveness.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device with respect to the indications for use, target populations, treatment method, and technological characteristics.