(171 days)
The intended use of the VanishPoint® I.V. Cathcter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). t The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.
The VanishPoint® I.V. Catheter is a safety device. The retracting introducer places the catheter portion in a vascular vessel in the same way as a conventional catheter, but upon removal of the placement needle, the caregiver activates a safety mechanism which retracts the needle completely into the handle/introducer assembly. In this way, if properly performed, it does not expose the caregiver to an accidental stick from a contaminated needle. The energy to retract the needle and chamber is provided by a spring interacting between the housing and the needle chamber assembly. Once the needle/chamber is retracted, the retracting introducer assembly is no longer required and taken away from the patient.
The provided text describes a 510(k) submission for a medical device (VanishPoint® I.V. Catheter), which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a new study to prove device performance against specific acceptance criteria. Therefore, several of the requested sections below cannot be fully populated as they pertain to such a study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the 510(k) summary. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (VanishPoint® I.V. Catheter, K051355) rather than presenting new performance data against specific acceptance criteria for a novel device. The text states:
- "The subject VanishPoint I.V. Catheter and the VanishPoint I.V. Catheter predicate device are very similar in design and technological characteristics."
- "The different materials are equivalent and the intended use is identical."
- "There is no substantive differences between the predicate device and subject device that would raise new issues of safety and effectiveness."
Therefore, the "acceptance criteria" here are implicitly tied to the safety and effectiveness profile of the predicate device, which the new device is claimed to match. No specific performance metrics or their corresponding acceptance thresholds are listed.
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or study with a defined sample size is described. The submission relies on the established safety and effectiveness of the existing predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No new clinical or performance study requiring expert adjudication for ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
Not applicable. No MRMC study is mentioned. The device is a physical medical device (catheter), not one that typically involves human readers interpreting data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. This is a 510(k) submission for a physical device demonstrating substantial equivalence, not a machine learning model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
{0}------------------------------------------------
Retractable Technologics, Inc. 510(k) Submission Date: 05/16/08
NOV - 7 2008
1081420 PREMARKET NOTIFICATION 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FOR VANISHPOINT® I.V. CATHETER (As Required By 21 CFR 807.93)
Contact Person:
Rhonda Wells Regulatory Affairs Manager
Date of Summary Preparation: May 16, 2008
Trade Name: VanishPoint® I.V. Catheter Common Name: Intravenous Catheter Classification Name: Intravascular Catheter
Device Classification: Class II
Legally Marketed Substantially Equivalent Device:
VanishPoint® I.V. Catheter (K051355)
Description of Device:
The VanishPoint® I.V. Catheter is a safety device. The retracting introducer places the catheter portion in a vascular vessel in the same way as a conventional catheter, but upon removal of the placement needle, the caregiver activates a safety mechanism which retracts the needle completely into the handle/introducer assembly. In this way, if properly performed, it does not expose the caregiver to an accidental stick from a contaminated needle. The energy to retract the needle and chamber is provided by a spring interacting between the housing and the needle chamber assembly. Once the needle/chamber is retracted, the retracting introducer assembly is no longer required and taken away from the patient.
Intended Use:
The intended use of the VanishPoint® I.V. Catheter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.
{1}------------------------------------------------
Page 2 of 2 Premarket Notification 510(k) Summary of Safety and Effectiveness for VanishPoint® I.V. Cathetcr
Comparison of Technical Characteristics:
The subject VanishPoint I.V. Catheter and the VanishPoint I.V. Catheter predicate device are very similar in design and technological characteristics. The different materials are equivalent and the intended use is identical.
Substantial Equivalence:
The VanishPoint I.V. Catheter is being expanded to offer additional customer preference options. There is no substantive differences between the predicate device and subject device that would raise new issues of safety and effectiveness. The devices are substantially equivalent.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2008
Ms. Rhonda Wells Regulatory Affairs Manager Retractable Technologies, Incorporated 511 Lobo Lane Little Elm, Texas 75068
Re: K081420
Trade/Device Name: VanishPoint® I.V. Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 10, 2008 Received: October 16, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suette Y. Michien-Davis
FOR DR. CHIU LIN
Chiu S. Lin, Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
510(k) Number (if known):
Device Name: VanishPoint® I.V. Catheter
Indications for Use:
The intended use of the VanishPoint® I.V. Cathcter is to provide safe and reliable access to the vascular system for short term use (less than 30 days). t The VanishPoint® I.V. Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. The VanishPoint I.V. Catheter aids in the prevention of needlestick injuries.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Antony D. rent
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K481420
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).