The Safety Push Button Blood Collection Set is intended to be used for insertion into a patient's vascular system for blood specimens. When used without the male adapter, the device allows the clinician to obtain blood sampling from the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician. It aids in the prevention of accidental needle stick through the use of an active safety feature. The device is a sterile, multiple sample, single-use.

Device Description

The proposed device consists of these components: (1) Needle, (3) Spring, (4) Butterfly wings, (5) Hub, (6) Safety sheath, (7) Flexible tube, (8) Female luer, (9) Male luer hub, (10) Puncture needle, (11) Rubber sleeve, (12) Puncture needle protect cover or holder, (13) Safety push button protect cover. The proposed device have three configurations: With holder, With holder, Without male adapter. For without male adapter, there is a a protective cap to cover female luer. The proposed device is available various needle size and tube length. The range of needle size is from 25G(0.5mm). The range of tube length is from 10cm(4") to 30cm(12"). The proposed device have sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature. The proposed device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years. No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

AI/ML Overview

The provided document, a 510(k) Summary for the Safety Push Button Blood Collection Set, is a premarket notification to the FDA. It aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving that it meets specific, independently defined acceptance criteria through a clinical study.

Therefore, many of the requested details, such as a table of acceptance criteria with reported performance, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies, are not applicable or found in this type of submission. This document focuses on demonstrating equivalence through non-clinical testing and comparison of technical characteristics.

Here's an analysis of the provided information in relation to your request:

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

Not Applicable in this format. This document is a 510(k) submission for substantial equivalence, not a clinical trial report with defined acceptance criteria for a new performance claim. The "acceptance criteria" are implied by the performance standards the device was tested against and found to comply with, as detailed in Section 8 "Non-Clinical Test Conclusion."
Implied Performance: The document states that "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 applicable parts of the following standards." This implies the device performed within the specifications of these standards.
Specific Compliance Examples (from Section 8):
- Biological Safety: Complied with ISO 10993-7 (Ethylene Oxide Sterilization Residuals), ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and delayed-type hypersensitivity), ISO 10993-11 (systemic toxicity), USP <151> (Pyrogen Test), ASTM F756-17 (Hemolytic Properties), USP <85> (Bacterial Endotoxins Test).
- Packaging and Sterility: Complied with ASTM F1929-15 (detecting seal leaks), ASTM F88/F88M-21 (seal strength), ASTM F1886/F1886M-16 (integrity of seals by visual inspection), ISO 11607 and ISTA 3A (shelf-life validation for sterility maintenance over 3 years).
- Device Performance: Complied with ISO 80369-7 (small-bore connectors), ISO 8536-4 (infusion sets), ISO 9626 (stainless steel needle tubing), ISO 7864 (sterile hypodermic needles).
- Safety Feature: "Simulated Clinical Study for safety feature" and "Sharps injury protection testing in accordance with ISO 23908" were performed. The document states it aids in the prevention of accidental needle sticks.

A table summarizing this would look like:

Criterion Area	Applicable Standards/Tests	Device Performance (Implied by "complied")
Biological Safety	ISO 10993 (various parts), USP <151>, ASTM F756-17, USP <85>	Complies
Packaging/Sterility	ASTM F1929-15, ASTM F88/F88M-21, ASTM F1886/F1886M-16, ISO 11607, ISTA 3A	Complies, maintains sterility for 3 years
Device Functionality	ISO 80369-7, ISO 8536-4, ISO 9626, ISO 7864	Complies
Sharps Injury Protection	Simulated Clinical Study for safety feature, ISO 23908 sharpe injury protection testing, Extraction force testing	Complies, aids in prevention of accidental needle stick
Shelf Life	Accelerated aging tests against relevant performance standards (3 years)	Complies

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

Sample Size: Not explicitly stated for each test. The document refers to "non-clinical tests" and "verification or testing." For a 510(k) submission of a physical device like this, sample sizes would typically be determined by the specific ISO/ASTM standards being followed for each test (e.g., a certain number of units for sterility, strength, or material compatibility tests). These are typically in-house lab tests, not human subject studies.
Data Provenance: The tests were conducted by the manufacturer, Jiangsu Caina Medical Co., Ltd., based in China. The tests are non-clinical, likely in-house laboratory testing following international standards. No human data is involved. It's prospective testing of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. As a non-clinical device where substantial equivalence is demonstrated through engineering and material testing, there is no "ground truth" established by human experts in the way that would apply to an AI/imaging device (e.g., radiology reads). The "ground truth" is defined by the physical, chemical, and biological properties measured against established industry standards (ISO, ASTM, USP).

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

Not Applicable. Adjudication methods are relevant for human interpretation of data, typically in clinical studies or expert review processes for AI. This is a non-clinical testing submission.

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

No. This is a physical medical device (blood collection set), not an AI-powered diagnostic or imaging device. MRMC studies are not relevant to its evaluation.

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)

Defined by International Standards/Lab Results. For this device, "ground truth" is implicitly established by the quantitative and qualitative results of highly standardized laboratory tests against predefined limits set by ISO, ASTM, and USP standards. For example:
- Sterility: Absence of microbial growth, reaching a SAL of 10^-6.
- Biocompatibility: No cytotoxicity, sensitization, irritation, pyrogenicity, or hemolysis as per standard tests.
- Physical Integrity: Meeting specified tensile strength, leak detection, and dimensional requirements.
- Sharps Injury Protection: Successful activation of the safety feature and prevention of needle sticks as per ISO 23908.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device. There is no "training set" in this context. The company manufactures these devices, and testing is done on production samples.

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

Not Applicable. See point 8.

Summary

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January 5, 2023

Jiangsu Caina Medical Co.,Ltd Jianwei Pan Regulatory Affairs No.23, Huanxi Rd, Zhutang Town Jiangyin, Jiangsu 214415 China

Re: K222834

Trade/Device Name: Safety Push Button Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FPA Dated: November 28, 2022 Received: December 5, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 Walloschek

David Wolloscheck, Ph.D. For Joyce M. Whang, Ph.D. Acting 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)

K222834

Device Name Safety Push Button Blood Collection Set

It aids in the prevention of accidental needle stick through the use of an active safety feature.

The device is a sterile, multiple sample, single-use.

× Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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K222834 - 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K222834

1. Date of Preparation: Jan. 03, 2023
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

1. Designated Submission Correspondent
  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: Safety Push Button Blood Collection Set

Common name: Blood Collection Set

Regulatory Information Classification Name: Blood specimen collection device Class: II

Regulation Number: 21 CFR 862.1675 Product Code: JKA and FPA Review Panel: General Hospital

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Indications for Use Statement:

న్. Device Description

The proposed device have three configurations: With holder, With holder, Without male adapter. For without male adapter, there is a a protective cap to cover female luer. The proposed device is available various needle size and tube length. The range of needle size is from 25G(0.5mm). The range of tube length is from 10cm(4") to 30cm(12").

The proposed device have sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature.

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 three years.

No DEHP, BPA and Natural Rubber Latex are added in the proposed device.

1. Identification of Predicate Device
  Predicate Device

510(k) Number: K153309

Product Name: BD Vacutainer UltraTouch Push Button Blood Collection Set

7. Substantially Equivalent (SE) Comparison

Table 1 Comparison of Technology Characteristics with K153309

ITEM	Proposed Device	Predicate Device	Comment
Product code	JKA and FPA	JKA and FPA	Same

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RegulationNo.	21 CFR 862.1675	21 CFR 862.1675	Same
RegulationName	Blood specimen collection device	Blood specimen collection device	Same
Class	II	II	Same
Indicationsfor use	The Safety Push Button BloodCollection Set is intended to be usedfor insertion into a patient's vascularsystem for blood specimens. Whenused without the male adapter, thedevice allows the clinician to obtainblood sampling from the female hubwith a syringe, if necessary, or canbe used for short-term (up to 2hours), single infusions withconsideration given to patient sizeand appropriateness for the solutionbeing infused. The device is not tobe left in place and remain under thedirect supervision of a clinician. Itaids in the prevention of accidentalneedle stick through the use of anactive safety feature. The device is asterile, multiple sample, single-use.	The BD Vacutainer® UltraTouch™Push Button Blood Collection Set isa sterile, multiple sample, single-usefixed winged blood collection setintended for venipuncture to obtainblood specimens from patients.When used without the maleadapter, the device allows theclinician to obtain blood sampling tothe female hub with a syringe, ifnecessary, or can be used forshort-term, single infusions withconsideration given to patient sizeand appropriateness for the solutionbeing infused. The device is not tobe left in place and remain under thedirect supervision of a clinician.The recommended use of the deviceis to activate the needle safetyfeature prior to removal from thevenipuncture site. The retraction ofthe intravenous (IV) end of theneedle aids in the prevention ofaccidental needlestick injury.	DifferentSeeComment 1
Configuration	Three configuration:Without holder,With holder,Without male adapter	Two configuration:with an integrated male luer adapterwhich connects to a holder,without the male luer adapter	DifferentSeeComment 2
Consisted of	(1) Needle cap, (2) Needle, (3)Spring, (4) Butterfly wings, (5)Hub, (6) Safety sheath, (7) Flexibletube, (8) Female luer, (9) Male luerhub, (10) Puncture needle, (11)Rubber sleeve, (12) Puncture needleprotect cover or holder, (13) Safety	Needle protector,Stainless steel cannula (Intravenousend and Non-patient end ofcannula),Stainless steel spring,Hub, front and rear barrel,Wings,Tubing,Female luer connector and an	Same
	push button protect cover.	optional male luer adapter,
		Luer Cap
patientcontactmaterial	Stainless steel SUS304,Methyl methacrylate acrylonitrilebutadiene styrene plastics(MABS),Acrylonitrile Butadiene StyreneCopolymer(ABS),Polyvinyl chloride(PVC),Isoprene Rubber,Polydimethysiloxane,Color additive	Polypropylene,Stainless Steel 304,PVC,Silicone,ABS,Isoprene Rubber	SeeComment 3
ExpirationDate	3 years	2 years	SeeComment 4
Sterile	Sterile	Sterile	Same
Sterilemethod	EtO Sterilized	Gamma	SeeComment 5
SAL	10-6	10-6	Same
Single use	Yes	Yes	Same
Environmentof use	Healthcare facilities by trainedmedical professional	Healthcare facilities by trainedmedical professional	Same
Needle size	Needle gauge 25G,23G,22G,21G,20G,Needle length 1/2", 5/8", 3/4"	Needle gauge 25G,23G,21GNeedle length 3/4"	SeeComment 6
Tube length	10cm(4"), 180cm(7"), 30cm(12")	7" and 12"	SeeComment 6
principles ofoperation	When vacuum blood collection tubeis use, blood flow into bloodcollection tube via the device underthe action of differential pressure.	When vacuum blood collection tubeis use, blood flow into bloodcollection tube via the device underthe action of differential pressure.	Same
Activationmode	Manual, active safety feature,retraction by spring	Manual, active safety feature,retraction by spring	Same

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Comment 1

The proposed indications for use, are similar to the predicate indications for use. The difference is commented as follows:

-the short term is clearly defined for up to 2 hours in indications for use of proposed device. It does not raise new questions of safety/effectiveness, however users are more aware of the safe use time.

-in predicate indications for use, the recommended use is to activate the needle safety feature prior to removal from the venipuncture site. The needle safety feature can be activated before or after the needle leaves the body, which will not cause new safety/effectiveness. It aids in the prevention of accidental needle stick through the use of an active safety feature.

So the differences are not a significant change.

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Comment 2

The predicate device is two configuration: with an integrated male luer adapter which connects to a holder(without holder) and without the male luer adapter is intended to installed the holder and held during operation. The proposed device is expanded into two configurations, pre installed holder and without holder. This gives users more choices. The pre installed holder do not change any function of proposed device. So the differences are not a significant change.

Comment 3

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, Irritation 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 4

The expiration date for the proposed device is different from predicate device. The proposed devices have been performed 3 years accelerated aging and demonstrated that the aged samples also complied with the requirements of relevant performance standards. The ability of immediate package of the proposed device to maintain the device in a sterile state for a period of 3 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 5

The sterile method of proposed device is Eto, the sterile method of predicate device is Gamma. Both of them achieve a Sterility Assurance Level (SAL) of 10-5. Examination of the Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals have met with ISO 10993-7,AMD1:2019, this sterilization difference does not affect substantially equivalence on safety and effectiveness.

Comment 6

The needle size and tube length is different between proposed device and predicate device. The proposed device have expanded of needle and tube range. These extended devices have been verified according to ISO 9626, ISO 7864, ISO 8536-4. The difference does not affect substantially equivalence on safety and effectiveness.

8. 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 applicable parts of the following standards:

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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 <151> 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-21 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 <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
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods

In addition, the following verification or testing is performed to meet the stated performance requirements:

Extraction force testing in simulation using
Simulated Clinical Study for safety feature
Sharps injury protection testing in accordance with ISO 23908
1. Clinical Test Conclusion

No clinical study was included in this submission.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device in intended use, principles of operation, technology, design, materials and performance.

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.