(385 days)
No
The summary describes a mechanical blood collection set with a safety feature and does not mention any AI or ML components or functions.
No.
The device is primarily for blood sample collection, although it has a secondary use for short-term fluid administration, which is not the primary function of a therapeutic device designed for treating conditions.
No
The device description and intended use state that it is for blood collection and intermittent intravenous fluid administration. These are procedural functions, not diagnostic ones. Although blood collection is often a step in diagnostic processes, the device itself does not perform any diagnostic analysis or interpretation.
No
The device description clearly describes a physical medical device (blood collection set with needles and tubing) and does not mention any software components.
Based on the provided information, the VanishPoint® Blood Collection Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended use is to "obtain blood specimens from patients" and for "intermittent or short-term intravenous administration of fluid." While blood is collected, the device itself is for the collection and administration, not for performing a diagnostic test on the blood sample.
- Device Description: The description focuses on the physical components for blood collection and fluid administration (needles, tubing, safety mechanism).
- Lack of Diagnostic Function: There is no mention of the device analyzing the blood sample or providing any diagnostic information. IVD devices are designed to perform tests on biological samples to diagnose diseases or conditions.
- Performance Studies: The performance studies described are related to the safety and effectiveness of the blood collection and fluid administration process, not the accuracy of a diagnostic test.
In summary, the VanishPoint® Blood Collection Set is a medical device used for collecting blood samples and administering fluids, but it does not perform any diagnostic testing on those samples.
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.
The VanishPoint® Blood Collection Set is also indicated for intermittent or shortterm intravenous administration of fluid (up to 2 hours). 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
JKA, FPA
Device Description
The VanishPoint® Blood Collection Set is safety device that is sterile and non-pyrogenic and is designed for collection of blood specimens or intravenous administration of fluid. The device will initially be available with either 7" or 12" tubing, ¼" 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
healthcare professionals
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: The VanishPoint® Blood Collection Set was previously cleared as substantially equivalent to the BD Vacutainer Push Button Blood Collection Set with 510(k) K112512. For the purpose of this submission only testing pertaining to the additional indication will be provided. All other information can be referenced in the Predicate Device Section.
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 uses and is as safe and effective and performs at least as safely and effectively as the legally marketed predicate device.
Conclusion: The purpose of this submission is to add an additional indication to allow intermittent or short-term intravenous administration of fluid. The addition of this indication does not affect any of the previously presented functional testing such as needle pullout force, trigger force, ubing connection strength, tubing strength, air, liquid leakage and complete needle retraction. A Simulated Use Study was performed to ensure the subject device is suitable for the additional indication. In addition Biocompatibility testing was performed and the Sterilization Validation was completed (SAL 10") according to the applicable standards. The information included within this premarket notification demonstrates that the VanishPoint® Blood Collection Set is substantially equivalent to the predicate devices for the intended usage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030573 - BD Vacutainer Push Button Blood Collection Set
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
08/02/13
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: | January 23, 2013 |
AUG 2 3 2013
| Trade Name: | VanishPoint® Blood Collection Set |
|---|---|
| Common Name: | Blood Collection Set |
| Classification Name: | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device Classification: | Class II |
| Legally Marketed Substantially Equivalent Device: | K030573 - BD Vacutainer Push Button Blood Collection Set |
| K112512 - VanishPoint® Blood Collection Set | |
| Description of Device: | The VanishPoint® Blood Collection Set is safety device that is sterile and non-pyrogenic and is designed for collection of blood specimens or intravenous administration of fluid. The device will initially be available with either 7" or 12" tubing, ¼" 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. The VanishPoint® Blood Collection Set is also indicated for intermittent or short-term intravenous administration of fluid (up to 2 hours). 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 BD Vacutainer is indicated for both blood collection and intravenous administration of fluids. The VanishPoint® BCS was originally cleared for blood collection only. |
1
| Engineering Testing: | The VanishPoint® Blood Collection Set was previously cleared as
substantially equivalent to the BD Vacutainer Push Button Blood
Collection Set with 510(k) K112512. For the purpose of this
submission only testing pertaining to the additional indication will be
provided. All other information can be referenced in the Predicate
Device Section. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Page 5-1 |
| 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 uses
and is as safe and effective and performs at least as safely and
effectively as the legally marketed predicate device. |
Comparison of Technical Characteristics:
The subject VanishPoint® Blood Collection Set and the BD Vacutainer predicate device are similar in design, technological characteristics and materials. The subject device that is the purpose of this 510(k) submission is identical to the previously cleared VanishPoint® BCS device. To support the addition of the new indication, an extractable study was performed with acceptable results. Biocompatability testing was performed under the . previously cleared 510k submission. All three devices are labeled to obtain blood specimens from patients. The subject device and BD Vacutainer predicate device are also indicated for intravenous administration of fluid.
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 when used as labeled. The intended use of the predicate and subject devices is virtually identical. It is our opinion that the devices are substantially equivalent.
Conclusion: The purpose of this submission is to add an additional indication to allow intermittent or short-term intravenous administration of fluid. The addition of this indication does not affect any of the previously presented functional testing such as needle pullout force, trigger force, ubing connection strength, tubing strength, air, liquid leakage and complete needle retraction. A Simulated Use Study was performed to ensure the subject device is suitable for the additional indication. In addition Biocompatibility testing was performed and the Sterilization Validation was completed (SAL 10") according to the applicable standards. The information included within this premarket notification demonstrates that the VanishPoint® Blood Collection Set is substantially equivalent to the predicate devices for the intended usage.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person embracing another person, with a wavy line underneath.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 23, 2013
Retractable Technologies, Incorporated Ms. Rhonda Wells Regulatory Affairs Manager 511 Lobo Lane LITTLE ELM TX 75608
Re: K122355
Trade/Device Name: VanishPoint® Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: II Product Code: JKA, FPA Dated: August 20, 2013 Received: August 21, 2013
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 mav, 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 cither 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ | 22355
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.
The VanishPoint® Blood Collection Set is also indicated for intermittent or shortterm intravenous administration of fluid (up to 2 hours). 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)
Richard C. Chapman 2013.08.23 12:59:10 -04'00'
(Optional Format 3-10-98)
Olvision Slan-Off) livision of Anssthasiology, General Hospital
ifection Control, Dental Davices
510(k) Number_K122355
Page 4-1