(144 days)
Not Found
No
The device description and performance studies focus on the physical components and safety features of a blood collection set, with no mention of AI or ML.
No
The device is described as a blood collection set for drawing blood specimens, which is a diagnostic procedure, not a therapeutic intervention.
No
This device is a blood collection set, used for drawing blood samples. It does not perform any analysis or interpretation of the collected blood, which are functions of a diagnostic device. Its purpose is solely for sample acquisition.
No
The device description explicitly lists multiple physical components (needles, tubing, handles, covers, etc.) and the performance studies focus on physical, mechanical, chemical, and sterilization testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect blood specimens from patients" for venipuncture. This is a sample collection device, not a device that performs a diagnostic test on the sample.
- Device Description: The description details the physical components of a blood collection set, including needles, tubing, and safety features. It does not describe any components or processes related to analyzing or testing the collected blood.
- Performance Studies: The performance studies focus on physical, mechanical, chemical, sterilization, shelf life, biocompatibility, and simulated clinical studies related to the collection process and safety features. There are no studies related to diagnostic performance (e.g., sensitivity, specificity, accuracy of a test).
- Lack of Diagnostic Function: The device's function is solely to obtain a blood sample. The diagnostic testing would be performed separately on the collected blood using other IVD devices or laboratory procedures.
In summary, this device is a tool for collecting a biological sample (blood), which is then used in subsequent diagnostic procedures. It does not perform the diagnostic test itself.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Shelf Life Evaluation: Physical, Mechanical, Chemical, Package and Sterility Tests were performed on accelerated aging samples to 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
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.
1
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
2
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) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
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and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
-
- Date of Preparation: 12/11/2015
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
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
4
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
5
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 |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package and Sterility |
| Tests were performed on accelerated aging samples to | |
| 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 |
6
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. -
- Substantially Equivalent (SE) Comparison
| Item | Proposed device | Predicate Device 1 | Predicate Device 2 |
|---|---|---|---|
| K020533 | K031279 | ||
| Product | Disposable blood collection set | ||
| 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. | ||
| 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
7
| | | | safety shield can be manually
activated to cover the needle
immediately after use to minimize
risk of accidental needlestick. |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The disposable blood collection
set and safelock disposable
blood collection set are intended
for collection of blood
specimens from patients. | EXEL Vaculet Blood Collection Set
is intended for collection of blood
specimens from patients. | SURSHIELD™ Safety Winged
Blood Collection Set is intended
for collection of blood specimens
from patients. |
| Feature | The needle is locked in safety
sheath by withdraw safety needle
handle backward | The device does not include safety
feature | The safety shield can be manually
activated to cover the needle after
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,
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.