(51 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. 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 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.
The provided text describes a 510(k) submission for the VanishPoint® Blood Collection Set, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria based on studies involving AI or complex statistical analysis typical for diagnostic algorithms.
Therefore, many of the requested fields are not applicable to this document. The "acceptance criteria" here are that the device performs as expected and is substantially equivalent to a predicate device in terms of safety and effectiveness.
Here's the information based on the provided text, with explanations for non-applicable sections:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria/Requirement | Reported Device Performance/Result |
|---|---|---|
| Engineering Testing | Device must perform acceptably in various applicable performance tests. | "The subject device performed as expected in all areas of testing." (e.g., needle pullout force, trigger force, tubing connection strength, tubing strength, air/liquid leakage, complete needle retraction). |
| Biocompatibility | All materials in the subject device must be biocompatible. | "Biocompatibility testing was performed on all materials in the subject device with acceptable results." |
| Simulated Use Study | The device must be found suitable for its intended use by healthcare professionals in a simulated use environment. | "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." |
| Substantial Equivalence to Predicate Device (K030573) | The device must be similar in design, technological characteristics, and materials to the predicate device, and not raise new issues of safety and effectiveness despite differences in indications. The predicate device is the BD Vacutainer Push Button Blood Collection Set (K030573). The subject device's indication for use is "to provide safe and reliable access to the vascular system to obtain blood specimens from patients," and "aids in the prevention of needlestick injuries." The predicate device is indicated for both blood collection and intravenous administration of fluids. | "The subject VanishPoint® Blood Collection Set and the predicate device are similar in design, technological characteristics and materials." "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. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the engineering tests or biocompatibility. For the simulated use study, the sample size of healthcare professionals is not specified, nor is the number of "uses" performed.
- Data Provenance: Not specified. Given the nature of a 510(k) submission, the studies are typically conducted by or for the applicant (Retractable Technologies, Inc.), likely in the USA where the company is based. The studies would be considered prospective for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: For the simulated use study, it states "healthcare professionals" were utilized. The specific number is not provided, and no "ground truth" in the diagnostic sense was established by experts. Their role was to determine suitability for use.
- Qualifications of Experts: Not specified beyond "healthcare professionals."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This document describes performance and safety testing for a physical device, not a diagnostic algorithm requiring adjudicated ground truth.
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
- MRMC Study: No. This is not applicable. The device is a blood collection set, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is a physical medical device, not an algorithm. Its performance is inherent in its design and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For engineering tests, the "ground truth" is adherence to predefined engineering specifications and functional requirements (e.g., specific force values, absence of leakage). For biocompatibility, it's compliance with established biocompatibility standards. For the simulated use study, the "ground truth" was a subjective assessment by healthcare professionals that the device was "suitable for the intended use."
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. This is not a machine learning or AI device.
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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 collectblood specimens from patients. The VanishPoint® BloodCollection Set aids in the prevention of needlestick injuriesthrough its retraction mechanism. The device will initially beavailable with either 7" or 12" tubing, ¾" length needles andgauge sizes of 19, 21, 23 and 25. |
| Intended Use: | The intended use of the VanishPoint® Blood Collection Set isto provide safe and reliable access to the vascular system toobtain blood specimens from patients. It may be used for anypatient population with consideration given to adequacy ofvascular anatomy and appropriateness of procedure. |
| The VanishPoint® Blood Collection Set aids in the prevention ofneedlestick injuries. | |
| The predicate device is indicated for both blood collection andintravenous administration of fluids | |
| Engineering Testing: | Various applicable performance tests were performed on theVanishPoint® Blood Collection Set. Some of the tests areneedle pullout force, trigger force, tubing connection strength,tubing strength, air, liquid leakage and complete needleretraction. The subject device performed as expected in all areasof testing. |
Page 5-1
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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.
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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.
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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 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
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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)
§ 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.