(19 days)
The VACLOK Syringe is intended to be used by a cardiologist or radiologist during angiographic or radiologic procedures.
The Merit Vaclok Syringe is a polycarbonate piston syringe modified for the use in applications requiring vacuum.
The provided text is related to a 510(k) premarket notification for the "VACLOK Syringe." This document focuses on the substantial equivalence of the VACLOK Syringe to a previously cleared device (Merit Coronary Control Syringe) for its intended use, rather than presenting a study with acceptance criteria and measured device performance in the way clinical studies for diagnostic accuracy or performance efficacy would.
Therefore, the provided document does not contain the information required to answer your request about acceptance criteria and a study proving a device meets those criteria.
Here's why and what's missing:
- No Acceptance Criteria: The document explicitly states: "Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act." This means there were no predefined quantitative criteria (e.g., sensitivity, specificity, accuracy, mechanical failure rates, etc.) that the device needed to meet.
- No Performance Study Results: The document summarizes a substantial equivalence argument, which typically involves comparing the new device's design, materials, and intended use to a predicate device. It does not present results from a clinical or laboratory performance study that would measure specific metrics against acceptance criteria.
- No Information on Sample Size, Ground Truth, Experts, etc.: Because no performance study is described, there's no mention of sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
In summary, the provided text describes a regulatory submission for a Class II medical device based on substantial equivalence, not a performance study designed to demonstrate meeting specific acceptance criteria.
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JAN - 5 2000
Attachment 4
SUMMARY OF SAFETY AND EFFECTIVENESS
| Submitted by Name/Address: | Chester McCoyRegulatory Affairs EngineerMerit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 253-1600 ext. 404 |
|---|---|
| Contact Person: | Same as above |
| Date Summary Prepared: | December 14, 1999 |
| Device/Trade Name: | VACLOKTM Syringe |
| Classification: | Class II |
Performance Standards:
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Device Description:
The Merit Vaclok Syringe is a polycarbonate piston syringe modified for the use in applications requiring vacuum.
Intended Use:
The Vaclok Syringe is intended to be used by a cardiologist or radiologist during angiographic or radiologic procedures.
Biocompatibility:
All materials used in the Vaclok Syringe are biocompatible.
Summary of Substantial Equivalence:
The Merit Vaclok Syringe is substantially equivalent to the previously cleared Merit Coronary Control Syringe.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2000
Mr. Chester McCoy Requlatory Affairs Engineer Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, Utah 84095
K994253 Re : Merit Coronary Control Syringe Trade Name: Class: II Product Code: FMF December 15, 1999 Dated: December 17, 1999 Received:
Dear Mr. McCoy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in
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Page 2 - Mr. McCoy
the Federal Register. Please note: this response to your premarket notification submission does not affect any prematice nocerright have under sections 531 through 542 of obligation you might under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sie\n privalence of your device to a legally rinding of bubbeanelar equits in a classification for your marketed predicate acits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in ritro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact che promotion and Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be information on your sion of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
Indications for Use Statement
K994253 510(k) Number (if Known)
Device Name VACLOKm Syringe
The VACLOK Syringe is intended to be used by a cardiologist or Indications for radiologist during angiographic or radiologic procedures. Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
✓
and the contract and the comments of the comments of
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Valerie Cuscente
vision Sign-6 Division of Dental, Info and General Hospita 510(k) Number
8
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).