(112 days)
This device is used when viscous liquid needs to be hand-force injected into a manifold or tubing set. The polycarbonate housing enables pressure to be exerted without fear of breakage. nowsing charice problams of so so catheterization procedure.
Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205
I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria. The documents are a regulatory approval letter (K972655) for "Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205" and an "Indications For Use" statement.
Specifically, the text is missing:
- A table of acceptance criteria and reported device performance: This information is not present. The letter only states that the device is "substantially equivalent" to predicate devices.
- Sample size used for the test set and data provenance: No details about a test set or its characteristics are provided.
- Number of experts and their qualifications for ground truth: No mention of experts or ground truth establishment for a test set.
- Adjudication method: Not discussed in the provided documents.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No information on such a study.
- Standalone performance study: No details about an algorithm-only performance study.
- Type of ground truth used: Not specified, as no study details are given.
- Sample size for the training set: Not mentioned.
- How ground truth for the training set was established: Not mentioned.
The documents focus solely on the regulatory approval process based on "substantial equivalence" to a predicate device, as opposed to a detailed performance study with specific acceptance criteria.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Larry G. Junker Vice President / General Manager Medical Specialties International, Inc. 615 Jasmine Avenue North Tarpon Springs, FL 34689
Re: K972655
NOV - 4 1997
Control Syringe Models 10200, 10201, 10202, 10203, 10204 and 10205 Dated: July 11, 1997 Received: July 15, 1997 Regulatory Class: II 21 CFR 892.1600/Procode: 90 IZI
Dear Mr. Junker:
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, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Pederal Register. Please note; this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regilation entitled, "Misbranding, by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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,
William Yiu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K972655 510(k) Number (if known): _
Device Name: Control Syringe
Indications For Use:
This device is used when viscous liquid needs to be hand-force injected into a manifold or tubing set. The polycarbonate housing enables pressure to be exerted without fear of breakage. nowsing charice problams of so so catheterization procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription UseX
(Per 21 CFR 801.109)
ੁੰਜ
Over The-Counter Use ... _____________________________________________________________________________________________________________________________________________________
(Optional Formal 1-2-96)
David h. Seymon
(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.