The Disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients.

The Safelock disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to aid in the reduction of accidental needlesticks.

Device Description

The proposed devices are provided sterile, single use. The proposed devices are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients. It has two models, Safelock disposable blood collection set and Disposable blood collection set.

For disposable blood collection set, they consist nine pieces components: (1) needle protect cover (2) patient-end tube needle (3) double wing needle handle (4)flexing tube (5) connect A (6) non-patient needle hub (7) puncture needle (8) rubber sleeve (9) puncture needle protective cover.

For Safelock disposable blood collection sets, they consist twelve components: (1) needle protect cover (2) patient-end tube needle (3) safety needle handle (4) double wing (5) safety sheath (6) Locking joint (7) flexing tube (8) connect A (9) non-patient needle hub(10) puncture needle (11) rubber sleeve (12) puncture needle protect cover.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a new drug or high-risk device might.

Therefore, the information requested for a detailed study description such as sample sizes for test and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and how ground truth was established for the training set, is not present in this document.

The document primarily details non-clinical tests conducted to ensure the device meets design specifications and is safe and effective for its intended use, comparable to predicate devices.

Here's what information can be extracted or inferred:

1. Table of Acceptance Criteria (Inferred from non-clinical tests) and Reported Device Performance:

Acceptance Criteria (Standard / Test)	Reported Device Performance
Material Specifications:
ISO 9626:1991 AMENDMENT 1 2001 (Stainless steel needle tubing)	Complied with the standard.
Sterile Barrier Packaging:
Seal strength (ASTM F88/F88-09)	Test performed.
Internal pressure (ASTM F1140/F1140M-13)	Test performed.
Dye penetration (ASTM F 1929-12)	Test performed.
Sterilization & Shelf Life:
EO/ECH residue (ISO 10993-7:2008)	Test performed.
Bacteria Endotoxin Limit (USP 37-NF 32 `<85>`)	Test performed.
Shelf Life Evaluation (Physical, Mechanical, Chemical, Package, Sterility on accelerated aging samples)	Verified claimed shelf life.
Biocompatibility Testing:
Cytotoxicity (ISO 10993-5: 2009)	Test performed.
Intracutaneous Reactivity (ISO 10993-10: 2010)	Test performed.
Skin Sensitization (ISO 10993-10: 2010)	Test performed.
Acute Systemic Toxicity (ISO 10993-11:2006)	Test performed.
Biocompatibility (Overall)	Conformed with ISO 10993.
Sharps Injury Prevention (for Safelock model):
Simulated Clinical Study (FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, August 9, 2005)	Met pre-established criteria.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document for any of the non-clinical tests.
Data Provenance: The tests were conducted internally or by contracted labs. The document does not specify country of origin for the data, but the manufacturer is based in China. The tests are non-clinical (laboratory/bench tests), not human subject trials, so "retrospective or prospective" is not directly applicable in the typical sense.

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

Not applicable as no human-read test set requiring expert ground truth is described. The acceptance criteria are based on recognized international and national standards for device performance, materials, and safety.

4. Adjudication method for the test set:

Not applicable. No adjudication is described for the non-clinical tests.

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 MRMC study was conducted or mentioned, as this is not an AI-assisted device.

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

Not applicable, as this is not an algorithm-based device.

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

The "ground truth" for the non-clinical tests is adherence to the specified technical standards (e.g., ISO, ASTM, USP) and the FDA's guidance document for sharps injury prevention.

8. The sample size for the training set:

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable. No training set for an algorithm is mentioned.

Summary of what the document focuses on:

This 510(k) submission primarily relies on non-clinical bench testing and adherence to established standards to demonstrate the safety and effectiveness of the "Safelock Disposable Blood Collection Set" and "Disposable Blood Collection Set". The key finding is that these devices are "Substantially Equivalent (SE)" to existing predicate devices (EXEL Vaculet Blood Collection Set K020533 and SURSHIELD™ Safety Winged Blood Collection Set K031279), meaning they share similar intended use, technology, and performance characteristics, and do not raise new questions of safety or effectiveness. No clinical studies were included in this submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 11, 2015

Jiangyin Caina Technology Co., Ltd. c/o Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K151991

Trade/Device Name: Safelock Disposable Blood Collection Set, Disposable Blood Collection Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 10, 2015 Received: November 13, 2015

Dear Ms. 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K151991

Device Name Safelock Disposable Blood Collection Set Disposable Blood Collection Set

Indications for Use (Describe)

The Disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients.

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)
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Exhibit # 2 Summary

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

The assigned 510(k) Number:_ K151991

1. Date of Preparation: 12/11/2015
1. Sponsor Identification

Jiangvin Caina Technology Co., Ltd. No.2, Taifu Road, Huashi Town, Jiangyin, Jiangsu, 214421, China

Establishment Registration Number: 3005670221

Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu@cainamedical.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

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

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Safelock disposable blood collection set Disposable blood collection set

Common Name: blood collection set

Regulatory Information

Classification Name: Set, Administration, Intravascular Classification: II Product Code: FPA Regulation Number: CFR 880.5440 Review Panel: General Hospital

Intended Use Statement:

The Disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients.

Device Description

5. Identification of Predicate Device

Predicate Device 1 510(k) Number: K020533 Product Name: EXEL Vaculet Blood Collection Set

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Regulation No.: CFR 880.5440 Product Code: FPA

Predicate Device 2 510(k) Number: K031279 Product Name: SURSHIELD™ Safety Winged Blood Collection Set Regulation No.: CFR 880.5440 Product Code: FPA

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 tests provided in this submission include:

Physical, Mechanical and Chemical Tests performed on the proposed device

ISO 9626:1991 AMENDMENT 1 2001 Stainless steel needle tubing for the manufacturing of medical devices

Sterile Barrier Packaging Testing performed on the proposed device:

Seal strength	ASTM F88/F88-09
Internal pressure	ASTM F1140/F1140M-13
Dye penetration	ASTM F 1929-12

Sterilization and Shelf Life Testing performed on the proposed device:

EO/ECH residue	ISO 10993-7:2008
Bacteria Endotoxin Limit	USP 37-NF 32 <85>
Shelf Life Evaluation	Physical, Mechanical, Chemical, Package and SterilityTests were performed on accelerated aging samples toverify the claimed shelf life of the device

Biocompatibility Testing:

The patient-contact materials of blood collection sets are identified and biocompatibility testing is performed, which include

Cytotoxicity	ISO 10993-5: 2009
Intracutaneous Reactivity	ISO 10993-10: 2010
Skin Sensitization	ISO 10993-10: 2010
Acute Systemic Toxicity	ISO 10993-11:2006

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Simulated Clinical Study performed on the proposed device:

A simulated clinical study was performed according to FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.

Clinical Test Conclusion 7.
No clinical study is included in this submission.
1. Substantially Equivalent (SE) Comparison

Item	Proposed device	Predicate Device 1	Predicate Device 2
		K020533	K031279
Product	Disposable blood collection setSafelock disposable blood collection set	EXEL Vaculet Blood Collection Set	SURSHIELDTM Safety Winged Blood Collection Set
Regulation No.	880.5440	880.5440	880.5440
Product Code	FPA	FPA	FPA
Indication for Use	The Disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients.The Safelock disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to prevent accidental needlesticks.	This device is an integral part of blood collection (intravenously) used in connection with luer adapter for collection of whole blood into tubes	The TERUMO® SURSHIELDTM Safety Winged Blood Collection Set is a winged blood collection needle intended for venipuncture to collec blood specimens from patients. The TERUMO ® SURSHIELDTM Safety Winged Blood Collection Set is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other conipatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle

Table 1 Comparison of between proposed device and predicate device

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			safety shield can be manuallyactivated to cover the needleimmediately after use to minimizerisk of accidental needlestick.
Intended Use	The disposable blood collectionset and safelock disposableblood collection set are intendedfor collection of bloodspecimens from patients.	EXEL Vaculet Blood Collection Setis intended for collection of bloodspecimens from patients.	SURSHIELD™ Safety WingedBlood Collection Set is intendedfor collection of blood specimensfrom patients.
Feature	The needle is locked in safetysheath by withdraw safety needlehandle backward	The device does not include safetyfeature	The safety shield can be manuallyactivated to cover the needle afteruse.
Sterile	Sterilized by EO	Sterilized by EO	Sterilized by EO
Single Use	Single Use	Single Use	Single Use
Performance	Complied with ISO 9626:1991,AMENDMENT 1 2001	unknown	unknown
Biocompatibility	Conform with ISO 10993	Conform with ISO 10993	Conform with ISO 10993

9. Substantially Equivalent (SE) Conclusion

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

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.