(81 days)
The Bioplate Shunt Connector is indicated for use in the joining and fixation of silicone rubber catheters with a nominal I.D. of 1.25 mm (.050%) when combined with nonabsorbable sutures in a surgical application.
Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
The Bioplate Shunt Connector
The provided text is a 510(k) premarket notification letter from the FDA for a device called "The Bioplate Shunt Connector." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory information. However, it does not contain any information about acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement for proving the device meets acceptance criteria.
The information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth) is typically found in a clinical study report or a more detailed technical submission than an FDA 510(k) clearance letter.
Therefore, I cannot provide a response to your request based on the given input text.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Mr. Eric Hohenstein Biomedics, Inc. 536 South Rimpau Boulevard Los Angeles, California 90020
Re: K984583 Trade Name: Bioplate Shunt Connector Regulatory Class: II Product Code: JXG Dated: December 21, 1998 Received: December 24, 1998
Dear Mr. Hohenstein:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have 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 Contine 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 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 (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: 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 regulations.
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Page 2 – Mr. Eric Hohenstein
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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િવેલું કું 8 રુપર થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા 510(k) Number (if known):_
Device Name:
The Bioplate Shunt Connector
Indications for Use:
The Bioplate Shunt Connector is indicated for use in the joining and fixation of silicone rubber catheters with a nominal I.D. of 1.25 mm (.050%) when combined with nonabsorbable sutures in a surgical application.
Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | x |
|---|---|
| (Per 21 CFR 801.109) | 24 |
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(Division Sign-Off)
Division of General Res 510(k) Number
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).