The Safety Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Safety Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Safety Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Safety Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.

Device Description

The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood.

The Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Flexible tube, Connector Luer adapter and Holder.

The Safety Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield to aid in the protection against accidental needle stick injury. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Safety sheath, Flexible tube, Connector, Luer adapter and Holder.

The Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle hub, Luer adapter and Holder.

The Safety Blood Collection Needle with/without Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cannula, Safety sheath, Needle hub, Luer adapter and Holder.

The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. The Pre-attached Holder is designed to aid in protection against accidental non-patient needle injury and blood splatter. It is provided sterile and single use. The proposed devices are composed of Connect base (ABS), Non-patient end needle tube (Stainless Steel SUS304), Rubber sleeve (Gather Isoprene Rubber), Needle Holder (PP).

AI/ML Overview

The provided document is a 510(k) Summary for a Blood Collection Set. It does not contain information typically found in an AI/ML device submission regarding acceptance criteria, study details, human reader performance, or specific ground truth methodologies for algorithmic performance.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on regulatory requirements for a traditional medical device (not an AI/ML device). The "acceptance criteria" here refer to conformity with established industry standards and regulations for blood collection devices, rather than performance metrics for an AI algorithm.

Therefore, many of the requested fields cannot be directly answered from the provided text.

Here's an attempt to extract relevant information and explain why other fields are not applicable:

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

The document does not present specific quantitative acceptance criteria or numerical performance results in a table format as would be expected for an AI/ML device validating diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC). Instead, "acceptance criteria" are implied by adherence to recognized standards and successful completion of various tests.

Acceptance Criterion (Implied by Standards/Tests)	Reported Device Performance
Sterility	EO sterilized, SAL: 10-6
Endotoxin Limit	20 EU per device
Needle Performance (ISO 7864:2016, ISO 9626:2016)	Met the requirements of the standards for various gauges and lengths
Sharps Injury Protection (ISO 23908:2011, FDA Guidance)	Safety shield intended to prevent needle sticks; met requirements
Small-bore Connectors (ISO 80369-7:2016, ISO 80369-20:2015)	Met requirements
Seal Strength (ASTM F88/F88M-15)	Met requirements
Seal Leak Detection (ASTM F1929-15)	Met requirements
Bacterial Endotoxins (USP 41-NF 36:2018 <85>)	Met requirements
Biocompatibility (ISO 10993-5, 10, 11)	Complies with requirements (tests include cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, hemolytic properties, pyrogen, complement activation, PTT, platelet leukocyte count)
Ethylene Oxide Sterilization Residuals (ISO 10993-7:2008)	Met requirements
Sterilization Process Validation (ISO 11135:2014)	Met requirements
Particulate Matter in Injections (USP <788>)	Met requirements

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

This information is not applicable and not provided. The "test set" in this context refers to physical samples of the device undergoing mechanical, chemical, and biological testing, not a dataset for an algorithm. The document does not specify the number of physical units subjected to each test. Data provenance (country, retrospective/prospective) is typically for clinical data or imaging datasets, which are not relevant here.

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)

This is not applicable as the device is not an AI/ML diagnostic or image analysis tool requiring human expert annotation for ground truth. The "ground truth" for this device is established through validated laboratory testing protocols and adherence to international standards.

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

This is not applicable. Adjudication methods like 2+1 are used for resolving disagreements among human annotators in AI/ML performance studies. This is a traditional medical device demonstrating substantial equivalence through bench testing.

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

This is not applicable. No MRMC study was performed as this is not an AI-assisted diagnostic device. The document explicitly states: "No clinical study is included in this submission as the device does not require clinical studies to determine substantial equivalence with the predicate device."

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

This is not applicable. The device is a physical blood collection implement, not an algorithm.

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

The "ground truth" for this device's performance is established by objective measurements against recognized international standards and validated laboratory test methods. Examples include:

Physical dimensions and material properties.
Sterility validation (absence of microorganisms).
Chemical purity (endotoxin limits, residuals).
Biocompatibility (absence of toxic, irritating, or sensitizing effects on biological systems).
Mechanical integrity (seal strength, needle sharpness, flexibility).

8. The sample size for the training set

This is not applicable. There is no AI/ML component, so there is no "training set."

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

This is not applicable as there is no AI/ML component and therefore no training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 7, 2023

Yangzhou Medline Industry Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O. Box 120-119 Shanghai, 200120 China

Re: K230080

Trade/Device Name: Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood Collection Needle, Blood Collection Needle with Holder, Safety Blood Collection Needle, Safety Blood Collection Needle with Holder, Luer Adapter with Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA

Dated: June 7, 2023 Received: June 7, 2023

Dear Diana Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 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. 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

510(k) Number (if known)

K230080

Device Name

Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood Collection Needle, Blood Collection Needle with Holder, Safety Blood Collection Needle with Holder, Luer Adapter with Holder

Indications for Use (Describe)

The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary K230080

1. Sponsor Identification

Yangzhou Medline Industry Co., Ltd.

No. 108, Jinshan Road, Economic Development Zone Yangzhou, China 225000

Establishment Registration Number: 3017180772

Contact Person: Hu Tingting Position: General Office Director Tel: 0514-87525616 Fax: 0514-87525631 Email: office@cnmedical.net

Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Xingqi Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net

Date of Preparation: 07/07/2023

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4. Subject Device

Trade Name: Blood Collection Set,

Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood Collection Needle, Blood Collection Needle with Holder, Safety Blood Collection Needle, Safety Blood Collection Needle with Holder, Luer Adapter with Holder
Common Name: Blood Collection Systems

Regulatory Information

Classification Name: Blood specimen collection device Classification: Class II Product Code: JKA Regulation Number: 21CFR 862.1675

5. Identification of Predicate Devices

Predicate Device 510(k) Number: K172763 Product Name: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder Regulation number: 862.1675 Product Code: JKA

6. Device Description

The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood.

The Blood Collection Set with/without Holder is intended to be used with vacuum blood collection tube for 2 / 10

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multiple collections of venous blood. It is provided sterile and single use. The proposed devices are composed of Needle cap, Needle cannula, Needle handle, Flexible tube, Connector Luer adapter and Holder.

The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood. The Pre-attached Holder is designed to aid in protection against accidental non-patient needle injury and blood splatter. It is provided sterile and single use. The proposed devices are composed of Needle cannula, Safety sheath, Needle hub, Luer adapter and Holder.

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7. Indication for Use:

The Blood Collection Set is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Set with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Needle is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Blood Collection Needle with Holder is intended to be used with vacuum blood collection tube for multiple collections of venous blood.

The Luer adapter with Holder is intended to be used with vein puncture needle and vacuum blood collection tube for multiple collections of venous blood.

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Comparison of Technological Characteristics 8.

ITEM	Proposed Device	Predicate DeviceK172763	Remark
Product Code	JKA	JKA	Same
RegulationNumber	21CFR 862.1675	21CFR 862.1675	Same
Classification	II	II	Same
Indicationsfor Use	The Blood Collection Needle isintended to be used with vacuumblood collection tube for multiplecollections of venous blood.	The Blood Collecting Needle isintended to be used with vacuumblood collection tube for multiplecollections of venous blood.	Analysis 1
	The Safety Blood Collection Needleis intended to be used with vacuumblood collection tube for multiplecollections of venous blood. Thesafety shield is intended to aid inthe protection against accidentalneedle stick injury.	The Safety Blood CollectingNeedle is intended to be used withvacuum blood collection tube formultiple collections of venous blood.The safety shield is intended to aid inthe protection against accidentalneedle stick injury.
	The Blood Collection Needle withHolder is intended to be used withvacuum blood collection tube formultiple collections of venousblood.	The Blood Collecting Needle withHolder is intended to be used withvacuum blood collection tube formultiple collections of venousblood.
	The Safety Blood Collection Needlewith Holder is intended to be usedwith vacuum blood collection tubefor multiple collections of venousblood. The safety shield is intendedto aid in the protection againstaccidentalneedle stick injury.	The Safety Blood CollectingNeedle with Holder is intended to beused with vacuum blood collectiontube for multiple collections ofvenous blood. The safety shield isintended to aid in the protectionagainst accidental needle stickinjury.
	The Blood Collection Set isintended to be used with vacuum	The Blood Collecting Set isintended to be used with vacuumblood collection tube for multipla

	Table 1 Comparison of Technology Characteristics

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blood collection tube for multiplecollections of venous blood.	collections of venous blood.
The Safety Blood Collection Set isintended to be used with vacuumblood collection tube for multiplecollections of venous blood. Thesafety shield is intended to aid in theprotection against accidental needlestick injury.	The Safety Blood Collecting Set isintended to be used with vacuumblood collection tube for multiplecollections of venous blood. Thesafety shield is intended to aid in theprotection against accidental needlestick injury.
The Blood Collection Set withHolder is intended to be used withvacuum blood collection tube formultiple collections of venousblood.	The Blood Collecting Set withHolder is intended to be used withvacuum blood collection tube formultiple collections of venousblood.
The Safety Blood Collection Setwith Holder is intended to be usedwith vacuum blood collection tubefor multiple collections of venousblood. The safety shield is intendedto aid in the protection againstaccidental needle stick injury.	The Safety Blood Collecting Setwith Holder is intended to be usedwith vacuum blood collection tubefor multiple collections of venousblood. The safety shield is intendedto aid in the protection againstaccidental needle stick injury.
The Luer adapter with Holder isintended to be used with veinpuncture needle and vacuum bloodcollection tube for multiplecollections of venous blood.

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Configurationand material	Blood Collection Needlewith/without Holder, Safety Blood Collection Needle with/withoutHolder:Needle cap (PP)Needle tube (Stainless SteelSUS304)Needle Hub (PP)Needle Holder (PP)Non-patient end needle tube(Stainless Steel SUS304)Connector base (ABS)Rubber sleeve (Gather IsopreneRubber)Safety Sheath(PP)Non-patient end needle cap (PP)Blood Collection Set with/withoutHolder, Safety Blood CollectionSet with/without Holder:Needle cap (PVC)Needle tube (Stainless SteelSUS304)Needle Wing (PVC)Flexible Tube (PVC)Needle Hub (ABS)Connect base (ABS)Non-patient end needle tube(Stainless Steel SUS304)Rubber sleeve (Gather IsopreneRubber)Non-patient end needle cap (PP)Safety Sheath(PP)Needle Holder (PP)	Patient-end Needle (Stainless Steel)Protective Cover of Patient-endNeedle (PP)Patient-end Needle Hub (PP)Non-patient end Needle Hub (ABS)Non-patient end Needle (StainlessSteel)Rubber Sleeve (Natural Rubber)Protective Cover of Non-patientend Needle (PP)Double Wing (PVC)Flexible Tube (PVC)Conical Fitting Connector (ABS)Conical Fitting (ABS)Safety Shield (PP)Needle Holder (PP)	Analysis 2
-------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------

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510(k) Summary

K230080

	Luer adapter with Holder
	Connect base (ABS)Non-patient end needle tube(Stainless Steel SUS304)Rubber sleeve (Gather Isoprene Rubber)Needle Holder (PP)
Operate mode	Manual	Manual	Same
Needle Gaugeand Length	21G, 22G, 23G, 25G5/8", 3/4", 1/2", 1", 1 1/4", 1 1/2"	18G, 19G, 20G, 21G, 22G, 23G, 25G5/8", 3/4", 1", 1 1/4", 1 1/2", 1 3/4",2"	Analysis 3
SafetyMechanism	The safety shield is intended toprevent needle sticks	The safety shield is intended toprevent needle sticks	Same
Label/Labeling	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	Same
Sterilization	EO sterilized	EO sterilized	Same
	SAL: 10-6	SAL: 10-6
	Endotoxin Limit: 20 EU per device	Endotoxin Limit: 20 EU per device
Single Use	Single Use	Single Use	Same
Biocompatibility	In Vitro Cytotoxicity	In Vitro Cytotoxicity	Same
	Skin Sensitization	Skin Sensitization
	Intracutaneous Reactivity	Intracutaneous Reactivity
	Acute Systemic Toxicity	Acute Systemic Toxicity
	Hemolytic PropertiesPyrogen	Hemolytic PropertiesPyrogen

Analysis 1- Indications for Use

The Indications for Use between proposed device and predicate device is similar. Because the needle holder is used as part of the predicate device, the proposed device is an independent needle holder, the Luer adapter with Holder, but the Indications for Use are the same. Therefore, this difference is not determined to affect substantially equivalence on safety and effectiveness.

Analysis 2 -Configuration and material

The configuration difference between proposed device and predicate device is only the description of component. They have same configuration. The difference in the description of component does not affect the indications for use. In addition, the material of rubber sleeve from proposed device is different with predicate device. However, the biocompatibility test for proposed device has been tested and the results

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comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantially equivalence on safety and effectiveness.

Analysis 3 -Needle Gauge and Length

The needle gauge and length of between the proposed device is different. However, this difference is just in dimension. Different gauge and length device will be selected by the end user. In addition, needles were tested according to ISO 7864:2016 and ISO 9626:2016 standards, and the results met the requirements of the standards. Therefore, this difference does not affect raise new or different questions of safety or effectiveness

1. Non-Clinical Test Conclusion
  The test results demonstrated that the proposed device complies with the following standards and guidance. The following tests were conducted as applicable to the subject devices:

Bench Test

▶ ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
V ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
► ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
► ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
レ ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
レ ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
レ ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
▶ ASTM F88/F88M-15: Standard Test Method for Seal Strength of Flexible Barrier Materials
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
USP 41-NF 36:2018 <85> Bacterial Endotoxins Test レ
▶ Simulated Use Study Sharps Injury Prevention Feature FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005
▶ USP <788> Particular Matter in Injections

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Biocompatibility

The subject device is classified as externally communicating medical device with circulating blood contact for limited exposure.

Biocompatibility tests was conducted on the subject device, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), and irritation sensitivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Pyrogen (USP <151>), Hemolysis Test (ASTM F756-2017), Complement Activation Test (ISO 10993-4), Partial Thromboplastin Time Study (ISO 10993-4) and Platelet Leukocyte Count Study (ISO 10993-4).

1. Clinical Test Conclusion
  No clinical study is included in this submission as the device does not require clinical studies to determine substantial equivalence with the predicate device
1. Conclusion
  It can be concluded that the differences between the subject devices, Blood collection Set with/without holder, Safety Blood Collection set with/without holder, Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without holder and Luer Adapter with Holder, and the predicate devices, Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder and Safety Blood Collecting Set, do not raise any new or different questions of safety or effectiveness. The subject devices are substantially equivalent to the predicate devices cleared under K172763 with respect to the indications for use, target population, treatment method, and technological characteristics.

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.