(217 days)
For spinal administration of anesthetic agents to provide regional anesthesia.
Not Found
I am sorry, but the provided text ({0}, {1}, {2}, {3}) does not contain information about acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification response from the FDA regarding a spinal needle, confirming its substantial equivalence to a legally marketed predicate device. It briefly mentions the "Indication For Use" of the device, but there are no details about specific performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
Therefore, I cannot provide the requested table or answer the specific questions about a device study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
200 Corporate Boulevard ockville MD 20850
OCT 2 5 2002
Mr. Sam Kumar President MYCO Medical, Incorporated 113 Centre West Court Cary, North Carolina 27513
Re: K020934
Trade/Device Name: Dr. Japan Facil Point Spinal Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: September 5, 2002 Received: September 20, 2002
Dear Mr. Kumar:
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.
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.
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Page 2 - Mr. Kumar
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy Al Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1__of_1 .
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、
510 (k) Number (if known): ___________________________________________________________________________________________________________________________________________________
:
Device Name:
Indication For Use: '
For spinal administration of anesthetic agents to provide regional anesthesia.
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
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:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANQTHER PAGE IF_NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use > Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off)
(Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number
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K021976 Page 1 Document Cover Sheet: Date of Submission: 13-JUN-2002 TANK HARTOREN AND THE BELLER FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON Description:
נו ווא היה מתחילה מתקנות מתחילת המועדות המונחים ומנור
עוד מערב מינער את קינג קינגע לאחר קינגע למענע מענט גענענט גענענט גענען ד
1 1180 000 0000 000 000 000 000 000 000 000 000 000 000 000 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Date of Scan:
29-OCT-2002
OBA 10/29/02
OBA 10/29/02
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| 510K Summary 25-OCT-2002 | 1 | 8 | 9 | |
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§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).