AMSINO SUCTION CATHETER by AMSINO INTL., INC.

The provided text is a 510(k) clearance letter from the FDA for a device called "AMSINO® Suction Catheter." This letter indicates that the device has been found substantially equivalent to a predicate device, allowing it to be marketed.

However, the letter does not contain any information regarding acceptance criteria or a study proving the device meets those criteria. The content is purely administrative, focusing on the regulatory clearance process.

Therefore, I cannot provide the requested information from the given text.

To be clear:

Table of acceptance criteria and reported device performance: Not available.
Sample size and data provenance: Not available.
Number and qualifications of experts for ground truth: Not available.
Adjudication method for test set: Not available.
MRMC comparative effectiveness study: Not available.
Standalone performance study: Not available.
Type of ground truth used: Not available.
Sample size for training set: Not available.
How ground truth for training set was established: Not available.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

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Richard Y. Li, Ph.D. Amsino International, Inc. 833 Towne Center Drive 91767 Pomona, California

Re: K973199 AMSINO® Suction Catheter Requlatory Class: I (one) Product Code: 73 BSY Dated: August 21, 1997 Received: August 26, 1997

Dear Dr. Li:

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 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 requirements, 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 - Richard Y. Li, Ph.D.

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) 594-4648. 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 requlation 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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ENCLOSURE # 7

K973199 510(k) Number (if known):

vice Name: AMSINO: SUCTION CATHETER

Indications For Use:

Amsino Suction Catheter, tracheobronchial, is to be used to aspirate liquids or semisolids from a patient's upper airway.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUI: ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Congrular, Respiratory, Respiratory, Respiratory, 1997
Division of Cardiovascular, Respiratory, 1991 Division of Cardion of Cardion of Cardion of Carden Sign-Division of Cardiovascon
Division of Cardiovascological Devices
and Neurological Devices
and Neurological Divises and Neurological and Neurological and Neurological and Neu Prescription Use Over-The-Counter Use · 21 CFR 801.109) and 145
510(k) Number

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.6810 Tracheobronchial suction catheter.

(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.