(134 days)
BKMI's Disposable Syringes, with or without attached BKMI disposable single lumen hypodermic needles, are intended to be sterile, single use, disposable, nonpyrogenic, nontoxic, calibrated, piston syringes intended for injecting fluids into, or withdrawing fluids out of, the body via a single lumen stainless steel hypodermic needle.
BKMI Disposable Piston Syringes With and Without Disposable Stainless Steel Single Lumen Hypodermic Needles
The provided text describes a 510(k) clearance for a medical device, the BKMI Disposable Syringe. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
The letter is a standard FDA clearance notification from 1997, confirming that the device is substantially equivalent to a predicate device and can be marketed. It focuses on regulatory compliance rather than performance study details.
Therefore, I cannot fulfill your request for information regarding:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
This type of detailed performance data is typically found in the 510(k) submission summary or device's design control documentation, which is not provided in this regulatory clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the words "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 4 1997
Suzanne Parisian, M.D. Consultant & President Medical Device Assistance, Incorporated ...... P.O. Box 296 """" "" Front Royal, Virginia 22630
K971487 Re : BKMI Disposable Syringe Trade Name: Regulatory Class: İI Product Code: FMI Dated: August 7, 1997 Received: August 8, 1997
Dear Dr. Parisian:
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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 Federal Register. Please note:
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Page 2 - Dr. Parisian
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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation 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,
Richard
Timo hv A. 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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SECTION VI. INDICATIONS STATEMENT
510K Number (if known): K97/487
Device Name: BKMI Disposable Piston Syringes With and Without Disposable Stainless Steel Single Lumen Hypodermic Needles
Indications for Use:
BKMI's Disposable Syringes, with or without attached BKMI disposable single lumen hypodermic needles, are intended to be sterile, single use, disposable, nonpyrogenic, nontoxic, calibrated, piston syringes intended for injecting fluids into, or withdrawing fluids out of, the body via a single lumen stainless steel hypodermic needle.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | Patricia Cucente |
| Division of Dental, Infection Control,and General Hospital Devices | |
| 510(k) Number | K971487 |
| Prescription Use | V |
| OR | Over-the-counter Use Insulin Syringe |
| (Per 21 CFR 801.109) | (Optional Format 1-2-95) |
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).