(51 days)
Not Found
No
The description focuses on mechanical features for safety and blood collection, with no mention of AI/ML terms or functions.
No
The device is described as a blood collection set for obtaining specimens and preventing needlestick injuries, not for treating a disease or condition.
No
Explanation: The device is a blood collection set and its intended use is to obtain blood specimens, not to diagnose a condition.
No
The device description clearly describes a physical blood collection set with needles, tubing, and a retraction mechanism, indicating it is a hardware device, not software-only.
Based on the provided information, the VanishPoint® Blood Collection Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "obtain blood specimens from patients" and "provide safe and reliable access to the vascular system." This describes a device used for the collection of a biological sample from the body.
- Device Description: The description focuses on the physical components and the mechanism for preventing needlestick injuries. It describes a tool for blood collection, not a device that performs a diagnostic test on a sample in vitro (outside the body).
- Lack of Diagnostic Function: There is no mention of the device analyzing the blood sample, detecting specific substances, or providing any diagnostic information. Its function is solely to collect the sample safely.
- Predicate Device: The predicate device, the BD Vacutainer Push Button Blood Collection Set, is also a blood collection device, not an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The VanishPoint® Blood Collection Set's function is limited to the collection of the specimen itself.
N/A
Intended Use / Indications for Use
The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients. It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.
Product codes (comma separated list FDA assigned to the subject device)
FPA, JKA
Device Description
The VanishPoint® Blood Collection Set is designed to collect blood specimens from patients. The VanishPoint® Blood Collection Set aids in the prevention of needlestick injuries through its retraction mechanism. The device will initially be available with either 7" or 12" tubing, ¾" length needles and gauge sizes of 19, 21, 23 and 25.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
any patient population
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)
Engineering Testing: Various applicable performance tests were performed on the VanishPoint® Blood Collection Set. Some of the tests are needle pullout force, trigger force, tubing connection strength, tubing strength, air, liquid leakage and complete needle retraction. The subject device performed as expected in all areas of testing.
Simulated Use Study: A simulated use study utilizing healthcare professionals was performed using the VanishPoint® Blood Collection set in a variety of uses. The subject device was found suitable for the intended use.
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
KII2512
OCT 2 0 2011
Retractable Technologies, Inc. 510(k) Submission Date: 10/12/11
PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR VANISHPOINT® BLOOD COLLECTION SET (21 CFR 807.92)
| Applicant Name: | Retractable Technologies, Inc. |
|---|---|
| 511 Lobo Lane | |
| Little Elm, TX 75068 | |
| Phone: | 972-294-1010 |
| Contact Person: | Rhonda Wells |
| Regulatory Affairs Manager | |
| Date of Summary Preparation: | October 12, 2011 |
| Trade Name: | VanishPoint® Blood Collection Set |
| Common Name: | Blood Collection Set |
| Classification Name: | |
| Collection | Tubes, Vials, Systems, Serum Separators, Blood |
| Device Classification: | Class II |
| Legally Marketed Substantially Equivalent Device: | |
| K030573 - BD Vacutainer Push Button Blood Collection Set | |
| Description of Device: | The VanishPoint® Blood Collection Set is designed to collect |
| blood specimens from patients. The VanishPoint® Blood | |
| Collection Set aids in the prevention of needlestick injuries | |
| through its retraction mechanism. The device will initially be | |
| available with either 7" or 12" tubing, ¾" length needles and | |
| gauge sizes of 19, 21, 23 and 25. | |
| Intended Use: | The intended use of the VanishPoint® Blood Collection Set is |
| to provide safe and reliable access to the vascular system to | |
| obtain blood specimens from patients. It may be used for any | |
| patient population with consideration given to adequacy of | |
| vascular anatomy and appropriateness of procedure. | |
| The VanishPoint® Blood Collection Set aids in the prevention of | |
| needlestick injuries. | |
| The predicate device is indicated for both blood collection and | |
| intravenous administration of fluids | |
| Engineering Testing: | Various applicable performance tests were performed on the |
| VanishPoint® Blood Collection Set. Some of the tests are | |
| needle pullout force, trigger force, tubing connection strength, | |
| tubing strength, air, liquid leakage and complete needle | |
| retraction. The subject device performed as expected in all areas | |
| of testing. |
Page 5-1
1
Retractable Technologies, Inc. 510(k) Submission Date: 10/12/11
Simulated Use Study:
A simulated use study utilizing healthcare professionals was performed using the VanishPoint® Blood Collection set in a variety of uses. The subject device was found suitable for the intended use.
Comparison of Technical Characteristics:
The subject VanishPoint® Blood Collection Set and the predicate device are similar in design, technological characteristics and materials. Biocompatibility testing was performed on all materials in the subject device with acceptable results. Both devices labeled to obtain blood specimens from patients.
Substantial Equivalence:
The operation, similar design and materials between the predicate devices and the subject device do not raise new issues of safety and effectiveness. The difference in indications does not affect the safety and effectiveness of the subject device when used as labeled. It is our opinion that the devices are substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 0 2011
Ms. Rhonda Wells Regulatory Affairs Manager Retractable Technologies, Incorporated 511 Lobo Lane Little Elm, Texas 75068
Re: K112512
Trade/Device Name: VanishPoint® Blood Collection Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, JKA Dated: August 23, 2011 Received: August 31, 2011
Dear Ms. Wells:
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.
3
Page 2 - Ms. Wells
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Anthony D. Winter
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Retractable Technologies, Inc. 510(k) Submission Date: 08/19/11
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: VanishPoint® Blood Collection Set
Indications for Use:
The intended use of the VanishPoint® Blood Collection Set is to provide safe and reliable access to the vascular system to obtain blood specimens from patients. It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The VanishPoint Blood Collection Set aids in the prevention of needlestick injuries.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rili C. An 10/9/11
(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112512
(Optional Format 3-10-98)