The Safety Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of 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 Needle with/without Holder is intended for single use only, which consists of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub. They are available in different configurations.

The Safety Blood Collection Needle with/without Holder is intended for single use only, which consists of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub, safety shield. They are available in different configurations. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

In addition, the proposed devices are available in different specifications of needle gauge(27G-18G) and length (1"-1.5").

The Luer Access Device- holder with Pre-attached Multiple Sample Adapter is intended for single use only, which consists of a holder, non-patient needle, rubber sleeve, and a male (or female) luer lock hub which mates the female (or male) connector of other medical devices. The luer hub is permanent assembled with holder. It can be used to establish a channel to connect with medical vacuum tubes and transfer fluids.

AI/ML Overview

This document is a 510(k) summary for a blood collection device, focusing on its substantial equivalence to predicate devices, rather than an AI/ML device study. Therefore, the requested information on acceptance criteria, AI/ML performance, and related study details is not present in the provided text.

The document discusses the substantial equivalence of the "Blood Collection Needle with/without Holder", "Safety Blood Collection Needle with/without Holder", and "Luer Access Device-holder with Preattached Multiple Sample Adapter" to existing predicate devices (K172763 and K991088).

Here's the relevant information that is available in the document:

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

The document lists various performance characteristics and standards, indicating that the proposed device complies with them. It doesn't necessarily present these as "acceptance criteria" in the formal sense that one might expect for a novel AI/ML device, but rather as compliance with established norms for similar medical devices.

Item	Acceptance Criteria (Standard/Requirement)	Reported Device Performance (Compliance Statement)
Performance (Needles)	ISO 9626, ISO 7864	Comply with ISO 9626, ISO 7864
Biocompatibility (Needles, leveraged from K172938)	ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization, Irritation), ISO 10993-11 (Acute Systemic Toxicity, Pyrogen), ASTM F756-17 (Hemocompatibility)	Testing leveraged from reference device K172938, results comply with ISO 10993 requirements
Biocompatibility (Luer Access Device-holder)	ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization, Irritation), ISO 10993-11 (Acute Systemic Toxicity, Pyrogen), ASTM F756-17 (Hemocompatibility)	Conform with ISO 10993 Standards
Sterilization Method	EO sterilized	EO sterilized
SAL (Sterility Assurance Level)	10-6	10-6
Endotoxin Limit	20 EU per device	20 EU per device
Extraction Force Test	Internal test	Able to successfully extract blood from a patient and fill blood tubes
Needle Gauge and Length	Varies by configuration (e.g., 20G~23G, 1"~~1.5") for proposed; (e.g., 18G~~23G, 1"~1.5") for predicate K172763	Proposed device has a broader range of gauges (27G-18G) and specified lengths. Difference does not affect safety/effectiveness.
Design Feature (Luer Access Device-holder)	Length: 60.8 ± 0.2 mm (proposed); 64.3 mm (predicate K991088)	Difference is just in dimension and does not affect intended use, safety, or effectiveness.
Performance (Luer Access Device-holder)	ISO 80369-7	Comply with ISO 80369-7
Label/Labeling	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801

2. Sample sized used for the test set and the data provenance: Not applicable. This document describes non-clinical performance and biocompatibility testing for a physical medical device (blood collection needles and holders), not an AI/ML system. There is no "test set" in the context of an AI/ML model for which sample size or data provenance would be relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as this is not an AI/ML device.

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, as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.

7. The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for this device's performance is established by compliance with international and national standards (e.g., ISO standards for sterility, biocompatibility, needle dimensions, performance).

8. The sample size for the training set: Not applicable, as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary of the Study:

The document describes non-clinical performance testing for a blood collection device to demonstrate its substantial equivalence to predicate devices. The studies involved:

Biocompatibility testing: This was either leveraged from a previous reference device (K172938) for the needles or conducted directly for the Luer Access Device-holder. The tests included in vitro cytotoxicity, skin sensitization, irritation sensitivity, acute systemic toxicity, pyrogen test, and hemocompatibility, all complying with ISO 10993 standards and ASTM F756-17.
Extraction Force Test: An internal test performed on the proposed device to demonstrate its ability to extract blood and fill tubes.
Compliance with various ISO standards: This includes standards for sterile hypodermic needles (ISO 7864), stainless steel needle tubing (ISO 9626), small-bore connectors (ISO 80369-7, ISO 80369-20), sterilization (ISO 11135), sharps injury protection (ISO 23908), and bacterial endotoxins (USP 41-NF 36:2018 <85>).
Sterilization validation: Demonstrated through compliance with EO sterilization, SAL of 10-6, and endotoxin limit of 20 EU per device.

The study concludes that, based on these comparisons and performance testing, the proposed devices are Substantially Equivalent (SE) to the predicate devices. No clinical studies were included in this submission.

Summary

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September 9, 2020

Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co. Ltd P.O Box 120-119 Shanghai, 200120 China

Re: K200027

Trade/Device Name: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: July 24, 2020 Received: August 10, 2020

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 medical devices and radiation-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,

for Payal Patel Acting 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) K200027

Device Name

Blood Collection Needle with/without Holder Safety Blood Collection Needle with/without Holder Luer Access Device-holder with Preattached Multiple Sample Adapter

Indications for Use (Describe)

The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Exhibit # 2 510(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: K200027

1. Date of Preparation: 9/9/2020
1. Sponsor Identification

Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214415, China

Establishment Registration Number: 3005670221

Contact Person: Jianwei Pan Position: Quality Management Representative Tel: +86-18273696900 Email: jianwei.pan@cainamed.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

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

Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name:

Blood Collection Needle with/without Holder Safety Blood Collection Needle with/without Holder Luer Access Device-holder with Preattached Multiple Sample Adapter

Common Name: Blood specimen collection device

Regulatory Information

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

Indications for Use:

The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection 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 Safety Blood Collection Needle with/without Holder is intended for single use only, which consists

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of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub, safety shield. They are available in different configurations. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.

In addition, the proposed devices are available in different specifications of needle gauge(27G-18G) and length (1"-1.5").

న్. Identification of Predicate Devices

Predicate Device 1 510(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

Predicate Device 2 510(k) Number: K991088 Product Name: VACUTAINER® Brand Multiple Sample Luer Adapter Regulation Number: 862.1675 Product Code: JKA

1. Comparison of Technological Characteristics
  Table 1 Comparison of Technology Characteristics for Blood Collecting Needle with/without Holder and Safety Blood Collection Needle with/without Holder

ITEM	Proposed Device	Predicate Device K172763	Remark
Product Code	JKA	JKA	SE
Regulation Number	21CFR 862.1675	21CFR 862.1675

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Class	II	II	SE
Indications for Use	The Blood Collection Needlewith/without holder is intended to beused with vacuum blood collectiontube for the collection of venousblood.The Safety Blood Collection Needlewith/without Holder is intended to beused with vacuum blood collectiontube for the collection of venousblood. The safety shield is intendedto aid in the protection againstaccidental needle stick injury.	The Blood Collecting Needle isintended to be used with vacuumblood collection tube formultiple collection of venousblood.The Safety Blood CollectingNeedle is intended to be usedwith vacuum blood collectiontube for multiple collections ofvenous blood. The safety shieldis intended to aid in theprotection against accidentalneedle stick injury.	SE
Configurationand material	Non-patient Needle Cap(PP)Patient Needle Cap(PP)Holder(PP)Rubber Sleeve (Case Gather IsopreneRubber)Non- patient Needle Tube (StainlessSteel)Patient Needle Tube(Stainless Steel)Needle Tube (Stainless Steel)Luer Lock Male Hub(MABS)Luer Slip Male Hub(MABS)Needle Hub (PP or MABS)Safety Shield(PP) - only on theSafety Blood Collection NeedleconfigurationLubricant- Polydimethysiloxane	Protective Cover of Patient-endNeedle (PP)Protective Cover of Non-patientend Needle(PP)Needle Holder (PP)Rubber Sleeve (Natural Rubber)Non-patient end Needle(Stainless Steel)Patient-end Needle(Stainless Steel)Patient-end Needle Hub (PP)Non-patient end Needle Hub(ABS)Conical fittingLubricant: Epoxy Resin	SEAnalysis1
Operate mode	Manual	Manual	SE
Flashback Feature	Visible	Visible	SE
Safety Mechanism	The safety shield is intended toprevent needle sticks.Only on the Safety Blood CollectionNeedle configuration	The safety shield is intended toprevent needle sticks.	SE
Label/	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	SE
Labeling
Needle Gauge and Length	Gauge: 20G~23GLength: 1",1.25",1.5"	Gauge: 18G~23GLength: 1", 1 1/4", 1 1/2"	SEAnalysis1
	Gauge: 27G, 25G, 23G, 22G, 21G,20G, 18GLength: 1",1.25",1.5"	Gauge: 19G, 25GLength: 5/8", 3/4", 1", 1 1/4", 1 1/2", 1 3/4", 2"	2

Performance	Comply withISO 9626ISO 7864	Comply withISO 9626ISO 7864	SE


Biocompatibility
In Vitro Cytotoxicity
Skin Sensitization	Testing leveraged from referencedevice K172938	Conform with ISO 10993Standards	SEAnalysis3
Intracutaneous Reactivity
Acute Systemic Toxicity
Hemocompatibility
Sterilization
Method	EO sterilized	EO sterilized
SAL	10-6	10-6	SE
Endotoxin Limit	20 EU per device	20 EU per device

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SE Analysis 1 -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 safety or effectiveness. This was evaluated through the performance testing.

In addition, the materials of rubber sleeve and hub from proposed device are different with predicate device. However, the biocompatibility test for proposed device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantial equivalence on safety and effectiveness.

SE Analysis 2- 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. This difference does not affect raise new or different questions of safety or effectiveness

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SE Analysis 3- Biocompatibility

The patient-contact materials of proposed device are different with the patient-contact materials of predicate device.

The patient contact material and manufacturing process for the proposed device is same as the reference device K172938. Therefore, new biocompatibility tests were not performed on the proposed device. And were leveraged from the reference device (K172938). Therefore, the proposed device will not raise any safety issues and is substantially equivalent to the predicate device.

The differences in technological characteristics were evaluated through performance testing.

Table 2 Comparison of Technology Characteristics for Luer Access Device-holder with Preattached Multiple Sample Adapter

ITEM	Proposed Device	Predicate Device K991088	Remark
Product Code	JKA	JKA	SE
Regulation Number	21CFR 862.1675	21CFR 862.1675	SE
Class	II	II	SE
Number of Uses	Single-use	Single-use	SE
Indications for Use	The Luer access device- holder withpreattached multiple sample adapteris a sterile, non-invasive deviceused to connect devices with maleor female luer connectors to bloodcollection tubes for the collection ofblood.	The VACUTAINER® Brand LuerAdapter is a sterile, non-invasivedevice used to connect venousaccess devices such as needles,blood collection sets, and infusionsets to blood collection tubes.They are also used in connectionwith non-needle devices forcollection of blood from catheters.The VACUTAINER® Brand LuerAdapter is sold by itself and as acomponent of otherVACUTAINER Brand devices.	SEAnalysis 4
Material	Luer Lock Male Hub( MABS)Non-patient NeedleTube( Stainless Steel)Rubber Sleeve (Isoprene Rubber)Holder(PP)	Hub(Polystyrene)Cannula( Stainless Steel)Sheath(Isoprene Rubber)Holder(Polypropylene (PP))	SEAnalysis 5
Label/Labeling	Conform with 21 CFR Part 801	Conform with 21 CFR Part 801	SE

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Design Feature	Length:60.8±0.2mm	Length: 64.3 mm	SEAnalysis 6
Performance	Comply with ISO 80369-7	Comply with ISO 80369-7	SE
Biocompatibility
In Vitro Cytotoxicity
Skin Sensitization	Conform with ISO 10993Standards	Conform with ISO 10993Standards	SE
Intracutaneous Reactivity
Acute Systemic Toxicity
Hemocompatibility
Sterilization
Method	EO sterilized	EO sterilized
SAL	10-6	10-6	SE
Endotoxin Limit	20 EU per device	20 EU per device

SE Analysis 4 - Indications for Use

The proposed device and the predicate device is used to connect devices to blood collection tubes used for sampling. The differences in indications for use does not change the intended use of the device, which is to collect blood and connect to blood collection tubes for sampling.

SE Analysis 5- Material

The materials of hub from proposed device are different with predicate device. However, the biocompatibility test for proposed device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantially equivalence on safety and effectiveness.

SE Analysis 6- Design Feature

The length of between the proposed device and predicate device is different. However, this difference is just in dimension. Different length device will be selected by physician per patient's condition. This difference does not affect intended use. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.

The differences between proposed device and predicated device include Material of product and Length. These differences do not raise any question regarding its safety and effectiveness. The differences in technological characteristics may be evaluated through performance testing.

1. Non-Clinical Test Summary for the Subject Devices
  Non clinical tests were conducted to verify that the proposed devices met all design specifications as

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was Substantially Equivalent (SE) to the predicate device. For full titles of the standards and guidances used, see below. The tests performed on the relevant device configurations include:

Biocompatibility test

Biocompatibility tests was leveraged from our own reference device Disposable Sterile Needle (K172938) for the Blood Collecting Needle with/without Holder and Safety Blood Collection Needle with/without Holder, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), irritation sensitivity (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), pyrogen test (ISO 10993-11) and Hemocompatibility Test (ASTM F756-17).

Biocompatibility tests was conducted on the Luer Access Device-holder with Preattached Multiple Sample Adapter, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), irritation sensitivity (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), pyrogen test (ISO 10993-11) and Hemocompatibility Test (ASTM F756-17).

Extraction Force Test

The extraction force test was performed on proposed device. The test result demonstrated that the proposed device is able to successfully extract blood from a patient and fill blood tubes. This test is an internal test.

The test results demonstrated that the proposed devices comply with the following standards and guidance. The following tests were conducted as applicable to the subject devices:

ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-7:2008 Biological evaluation of medical devices - 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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)]
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
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

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ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
USP 41-NF 36:2018 <85> Bacterial Endotoxins Test
Simulated Use Study Sharps Injury Prevention Feature FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005
USP <788> Particular Matter in Injections
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above and the performance testing conducted, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.

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.