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.

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "Vented Vial Transfer Pin." It mostly focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against acceptance criteria for the new device as an AI or diagnostic tool.

However, it does list several non-clinical tests that were performed to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These tests, along with comments on the differences between the proposed and predicate devices, indirectly describe acceptance criteria and how the device met them.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria alongside reported performance in the general sense of a diagnostic or AI device. Instead, it lists standards with which non-clinical tests complied and states that the proposed device "met all design specifications" and "complies with the following standards." The comments section addresses differences between the proposed and predicate device and assures that these differences do not affect substantial equivalence on safety and effectiveness.

Here's an interpretation based on the provided text, focusing on the non-clinical tests:

Acceptance Criteria (Inferred from Standards & Test Objectives)	Reported Device Performance (Compliance)
Biocompatibility
No cytotoxicity (per ISO 10993-5:2009)	Achieved: "no cytotoxicity per ISO 10993-5"
No irritation (per ISO 10993-10:2010)	Achieved: "no irritation per ISO 10993-10"
No sensitization (per ISO 10993-10:2010)	Achieved: "no sensitization per ISO 10993-10"
No acute systemic toxicity (per ISO 10993-11:2017)	Achieved: "no acute systemic per ISO 10993-11"
No pyrogenicity (per USP <151>)	Achieved: "no pyrogen per USP"
No hemolysis (per ASTM F756-17)	Achieved: "no hemolysis per ASTM F756"
Sterility & Shelf Life
Sterility Assurance Level (SAL) of 10-6	Achieved: "Sterility Assurance Level (SAL) of 10-6"
Ethylene Oxide Sterilization Residuals within limits (per ISO 10993-7:2008 AMD.1:2019)	Achieved: "Examination of the Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals have met with ISO 10993-7AMD1:2019"
Maintenance of sterility for 5 years (packaging integrity per ISO 11607 and ISTA 3A)	Achieved: "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."
Packaging Integrity
No seal leaks (per ASTM F1929-15)	Not explicitly stated "achieved," but compliance with standard for packaging integrity is implied by being listed.
Seal strength (per ASTM F88/F88M-15)	Not explicitly stated "achieved," but compliance with standard for packaging integrity is implied.
Seal integrity (visual inspection per ASTM F1886/F1886M-16)	Not explicitly stated "achieved," but compliance with standard for packaging integrity is implied.
Bacterial Endotoxins
Within limits (per USP <85>)	Not explicitly stated "achieved," but compliance with standard is implied by being listed.
Performance Testing
Product Functionality Performance (ISO 8536-4, 7.4 and ISO 80369-7)	Achieved: "Non-clinical tests were conducted to verify that the proposed device met all design specifications" and "complies with the following standards".
Filter Bursting Pressure (ISO 8536-4, 7.5)	Achieved generally as part of "met all design specifications" and compliance.
Flow Rate Testing (ISO 8536-4, 7.10)	Achieved generally as part of "met all design specifications" and compliance.
Cap/valve-housing detachment from body Test (ISO 8536-4, 7.3)	Achieved generally as part of "met all design specifications" and compliance.
Internal stress level for assembled product (ISO 8536-4, 7.13)	Achieved generally as part of "met all design specifications" and compliance.
Small-bore connectors compliance (ISO 80369-7:2021)	Achieved: "demonstrated that the aged samples also complied with the requirements of ISO 8536-4 and ISO 80369-7"
Mechanical Strength (Cap Assembly)
Tensile strength of parts 15N for 15s	Achieved: "The tensile strength of parts have been tested at 15N for 15s. Both of them meet acceptable criteria."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to a physical medical device (Vented Vial Transfer Pin), not an AI/diagnostic software. Therefore, there is no "test set" in the context of data for an algorithm. The non-clinical tests would have involved physical samples of the device. The document does not specify the number of units tested for each non-clinical test.

Data provenance is not applicable here as it refers to typical AI/diagnostic data (e.g., patient images, medical records).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical medical device, not an AI or diagnostic tool that requires ground truth established by medical experts for performance evaluation. The "ground truth" for this device's performance would be derived from the physical and chemical properties and test outcomes according to the cited standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI/diagnostic software study involving human readers or adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this physical device, the "ground truth" is established by:

Compliance with international and national standards (e.g., ISO, ASTM, USP) for materials, sterility, packaging, and functional performance.
Material properties and test results from laboratory analyses (e.g., cytotoxicity, hemolytic properties, tensile strength).
Physical measurements and functional tests directly assessing the device's ability to perform its intended function (e.g., flow rate, filter bursting pressure).

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. This is a physical device, not an AI/ML algorithm.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K221406

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)

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K221406 - 510(k) Summary

Date of Preparation: Oct. 28, 2022 1.
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

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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 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.

1. Identification of Predicate Device
  Predicate Device 510(k) Number: K160503 Product Name: Vented Vial Adapter Transfer Device - 13mm

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 < 151> 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

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ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible > Packaging by Visual Inspection
USP <85> 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
1. Clinical Test Conclusion

Not applicable

Substantially Equivalent (SE) Comparison 8.

		Table 1 Comparison of Technology Characteristics with K160503

ITEM	Proposed Device	Predicate DeviceK160503	Comment
Product code	LHI	LHI	Same
RegulationNo.	21 CFR 880.5440	21 CFR 880.5440	Same
RegulationName	Intravascular administration set	Intravascular administration set	Same
Class	II	II	Same
Indicationsfor use	The Vented Vial Transfer Pin isintended for the transfer and mixingof drugs contained in a vial.	The Vented Vial AdapterTransfer Device is intended forthe transfer and mixing ofdrugs contained in a vial.	Same
Configuration	Dual lumen piercing spike. A 0.2µmhydrophobic air filter medium isassembled to the end of air channel.	Vial adapter body contains thedual lumen piercing spike,Assembled 0.2µm hydrophobicair path filter.	Same
material	Acrylonitrile Butadiene StyreneCopolymer(ABS),Polyvinyl chloride(PVC) or ABS,Polytetrafluoroethylene(PTFE),Polypropylene (PP),White color additive,Blue color additive	Polycarbonate,PTFE membrane,Non-woven polyester	Different;SeeComment 1
ExpirationDate	5 years	3years	Different; SeeComment 2
Sterile	Sterile	Sterile	Same
Sterilemethod	EtO Sterilized	Gamma	Different; SeeComment 3
SAL	10-6	10-6	Same
Single use	Yes	Yes	Same
Environmentof use	Healthcare facilities or in homeenvironment by the patient orcare-giver	Healthcare facilities or in homeenvironment by the patient orcare-giver	Same
BodyDiameter	Vented Vial Transfer Pin to fit13mm vials or other equivalent drugvials,Vented Vial Transfer Pin withSecurity Clip only to fit 13mmvials.	18.5mm to fit 13mm Vials	Different;SeeComment 4



Air Filtration	0.2 micron hydrophobic Filter	0.2 micron hydrophobic Filter	Same
Cap Assembly	Assembly Attached Ultrasonicallyor bonding	Assembly AttachedUltrasonically	Different; SeeComment 5
Vial AdapterFit (Vial Side)	Snap Fit to Vial and "Tight Grip"Feature	Snap Fit to Vial and "TightGrip" Feature	Same
PiercingSpike	Plastic - Dual Lumen	Plastic - Dual Lumen	Same
PerformanceTesting	Product Functionality Performancetest(ISO8536-4,7.4 and ISO80369-7),Filter BurstingPressure(ISO8536-4,7.5),Flow RateTesting(ISO8536-4,7.10),Cap/valve-housing detachment frombody Test(ISO8536-4,7.3),Internal stress level for assembledproduct (ISO8536-4, 7.13)	Product FunctionalityPerformance test according toIFU,Filter Bursting Pressure,Flow Rate Testing,Cap/valve-housing detachmentfrom body Test,Internal stress level forassembled product.	Same




Biocompatibility	Cytotoxicity: no cytotoxicity perISO 10993-5	with ISO 10993	Same
	Irritation: no irritation per ISO10993-10
	Sensitization: no sensitization perISO 10993-10
	Acute systemic toxicity: no acutesystemic per ISO 10993-11
	Pyrogen: no pyrogen per USP
	Hemolysis: no hemolysis per ASTMF756

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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.

Regulation Number and Section

§ 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.