Safelock Disposable Blood Collection Set, Disposable Blood Collection Set

K151991 · Jiangyin Caina Technology Co., Ltd. · FPA · Dec 11, 2015 · General Hospital

Device Facts

• Record ID: K151991
• Device Name: Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
• Applicant: Jiangyin Caina Technology Co., Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Dec 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended 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.

Device Story

Disposable blood collection sets; used for venipuncture to collect blood specimens into vacuum tubes. Safelock model includes safety sheath to reduce accidental needlesticks. Components include patient-end needle, double wing handle, flexing tube, and non-patient needle hub. Safelock model adds safety sheath and locking joint. Used in clinical settings by healthcare professionals. Safety mechanism activated by withdrawing needle handle backward to lock needle in sheath. Benefits include standardized blood collection and sharps injury prevention.

Clinical Evidence

No clinical study included. Simulated clinical study performed per FDA guidance 'Medical Device with Sharps Injury Prevention Feature' (2005) to evaluate safety mechanism; results met pre-established criteria. Bench testing included ISO 9626:1991 (needle tubing), ISO 10993 (biocompatibility), and ASTM standards for sterile barrier packaging (F88, F1140, F1929).

Technological Characteristics

Sterile, single-use blood collection sets. Materials conform to ISO 10993. Needle tubing meets ISO 9626:1991. Sterilization via Ethylene Oxide (EO). Features include safety sheath/locking joint for sharps protection. No electronic or software components.

Indications for Use

Indicated for venipuncture to collect blood specimens from patients using vacuum blood collection tubes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EXEL Vaculet Blood Collection Set (K020533)
• SURSHIELD™ Safety Winged Blood Collection Set (K031279)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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.

| 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
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. 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: [phone], Fax: [phone] Email: [e-mail]

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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.

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.

### 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.

#### 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 Sterility<br>Tests were performed on accelerated aging samples to<br>verify 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.

- 8. Substantially Equivalent (SE) Comparison

| Item | Proposed device | Predicate Device 1 | Predicate Device 2 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K020533 | K031279 |
| Product | Disposable blood collection set<br>Safelock 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.<br>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 manually<br>activated to cover the needle<br>immediately after use to minimize<br>risk of accidental needlestick. |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The disposable blood collection<br>set and safelock disposable<br>blood collection set are intended<br>for collection of blood<br>specimens from patients. | EXEL Vaculet Blood Collection Set<br>is intended for collection of blood<br>specimens from patients. | SURSHIELD™ Safety Winged<br>Blood Collection Set is intended<br>for collection of blood specimens<br>from patients. |
| Feature | The needle is locked in safety<br>sheath by withdraw safety needle<br>handle backward | The device does not include safety<br>feature | The safety shield can be manually<br>activated to cover the needle after<br>use. |
| Sterile | Sterilized by EO | Sterilized by EO | Sterilized by EO |
| Single Use | Single Use | Single Use | Single Use |
| Performance | Complied with ISO 9626:1991,<br>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.