(385 days)
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 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.
The provided text describes a 510(k) premarket notification for the "VanishPoint® Blood Collection Set". The submission focuses on adding an additional indication for intermittent or short-term intravenous administration of fluid, as the device was previously cleared for blood collection only.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device for the new indication. The performance is described qualitatively.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Suitability for additional indication (intermittent/short-term IV fluid administration) | A simulated use study utilizing healthcare professionals was performed. 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. |
| No new issues of safety and effectiveness with the new indication | "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." |
| Functional testing (unchanged by new indication) | Previously presented functional testing (needle pullout force, trigger force, tubing connection strength, tubing strength, air, liquid leakage, and complete needle retraction) remained unaffected by the addition of the new indication. (Implies these met prior acceptance criteria). |
| Biocompatibility | Biocompatibility testing was performed and had acceptable results (under the previously cleared 510(k)). |
| Sterilization Validation | Sterilization Validation was completed (SAL 10^-6) according to applicable standards. |
| Extractables | An extractable study was performed with acceptable results to support the additional indication. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions a "simulated use study utilizing healthcare professionals" but does not specify the sample size for this study.
- Data Provenance: The study was a simulated use study, implying a controlled environment rather than real-world patient data. The country of origin is not explicitly stated, but the submission is to the FDA in the USA, suggesting the study was likely conducted in the USA or in a manner compliant with US regulatory guidelines. The study appears to be prospective in nature, designed specifically to evaluate the new indication.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "a simulated use study utilizing healthcare professionals".
- Number of experts: Not specified.
- Qualifications of experts: The general term "healthcare professionals" is used, but specific qualifications (e.g., nurses, phlebotomists, years of experience) are not detailed. Their role in establishing "ground truth" would likely be as evaluators of the device's performance in a simulated setting, providing feedback on usability, safety, and effectiveness.
4. Adjudication method for the test set:
- The document does not specify an adjudication method. For a simulated use study, "adjudication" in the sense of resolving discrepancies in expert interpretations of images or clinical findings is less applicable. The evaluation would likely involve collecting structured feedback or success/failure rates from the healthcare professionals.
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, an MRMC comparative effectiveness study was not done. This submission is for a medical device (blood collection set), not an AI-powered diagnostic or assistive tool involving human readers interpreting cases. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone (algorithm-only) performance study was not done. This device is a physical medical instrument, not an algorithm or software. Its performance inherently involves human interaction (healthcare professionals using it).
7. The type of ground truth used:
- For the simulated use study, the "ground truth" would be established by the observation and assessment of the device's performance by the healthcare professionals according to predefined criteria for safe and effective use during the simulated procedures. This would likely involve direct observation of usability, deployment of the safety mechanism, fluid administration rates if applicable, and absence of malfunctions. It is not based on pathology, expert consensus on a diagnostic finding, or long-term outcomes data in the usual sense.
8. The sample size for the training set:
- Not applicable. This device is a physical medical instrument, not an AI model or algorithm that requires a "training set" in the computational learning sense.
9. How the ground truth for the training set was established:
- Not applicable. As stated in point 8, there is no "training set" for this type of medical device.
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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 LaneLittle Elm, TX 75068 |
|---|---|
| Phone: | 972-294-1010 |
| Contact Person: | Rhonda WellsRegulatory 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 SetK112512 - 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. |
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| Engineering Testing: | The VanishPoint® Blood Collection Set was previously cleared assubstantially equivalent to the BD Vacutainer Push Button BloodCollection Set with 510(k) K112512. For the purpose of thissubmission only testing pertaining to the additional indication will beprovided. All other information can be referenced in the PredicateDevice Section. |
|---|---|
| Page 5-1 | |
| Simulated Use Study: | A simulated use study utilizing healthcare professionals wasperformed using the VanishPoint® Blood Collection set in a varietyof uses. The subject device was found suitable for the intended usesand is as safe and effective and performs at least as safely andeffectively 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.
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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.
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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
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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
§ 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.