SUCTION CATHETER by NI-MED, INC.

This document is a 510(k) clearance letter from the FDA for a medical device: a Suction Catheter Kit. This type of letter generally does not contain detailed information about acceptance criteria or specific study results that prove a device meets those criteria. The 510(k) process primarily demonstrates "substantial equivalence" to a predicate device, focusing on similar intended use and technological characteristics, rather than extensive clinical efficacy studies in many cases, especially for Class I devices like this one.

Therefore, most of the information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details) is typically not found in a 510(k) clearance letter for a Class I device.

Here's what can be inferred or explicitly stated from the provided text, and what cannot:

What can be inferred or explicitly stated:

Device Name: Suction Catheter Kit
Intended Use: "for the physician to aspirate liquids or semi-solids from a patient's upper airway."
Regulatory Class: I (one)
Product Code: 73 BSY
Device Manufacturer: Ni-Med, Inc.

Information NOT available in this document and therefore cannot be provided:

A table of acceptance criteria and the reported device performance: This document does not detail specific performance criteria (e.g., flow rate, suction pressure, material integrity over time) or the results of tests against such criteria. The FDA review focuses on substantial equivalence to a predicate, not necessarily detailed performance metrics for this specific device.
Sample size used for the test set and the data provenance: No information about a "test set" in the context of clinical studies is provided. The 510(k) submission would have included technical specifications and comparisons to a predicate device, but not detailed study design for a performance test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is described in this regulatory letter.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a physical medical device (suction catheter), not an AI-driven diagnostic or imaging device. Therefore, MRMC studies and AI-related metrics are entirely irrelevant and not performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As above, this is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable, as detailed performance studies with a "ground truth" are not described. The "ground truth" for a Class I device in a 510(k) context is often compliance with established standards, biocompatibility, and manufacturing quality, rather than clinical efficacy against a "ground truth" outcome.
The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device.
How the ground truth for the training set was established: Not applicable.

In summary, this document is a regulatory clearance for marketing, not a scientific publication detailing performance studies. For a Class I device like a suction catheter, the "study" proving it meets acceptance criteria typically refers to engineering tests, material compatibility tests, and comparison to a legally marketed predicate device, rather than extensive clinical trials or AI performance evaluations.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

Mr. Michael Giblin Director of Quality Assurance Ni-Med, Inc. P.O Box 871 1601 Air Park Drive Farmington, MO 63640-0871

Re: K981910 Suction Catheter Requlatory Class: I (one) Product Code: 73 BSY Dated: May 29, 1998 Received: June 1, 1998

Dear Mr. Giblin:

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 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 You may, therefore, market the device, subject to the Act (Act). general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Requlations, 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:

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Page 2 - Mr. Michael Giblin

General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (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.

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 the 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 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/dsma/dsmamain.html".

Sincerely yours,

DAspgh

for 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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August 20, 1998 K981910 Suction Catheter Kit

INDICATIONS FOR USE

The intended use of the NI-MED suction catheter kit is for the physician to aspirate liquids or semi-solids from a patient's upper airway.

\✓ Prescription Use

name

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number .

P.O. BOX 871 1601 AIR PARK DR FARMINGTON, MO 63640-0871 PHONE: 573-756-1255 FAX: 573-756-1256

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.