(45 days)
The Flexible Introducer Cannula is intended for the epidural placement, directly The Flexible Introducer cannuid is Inventour of the opents to elicit regional anesthesia.
The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is also packaged with a stainless steel introducer needle which is removed after the device has been placed.
This document is a 510(k) summary for a medical device called the "Flexible Introducer Cannula." It details the device's characteristics, its intended use, and its comparison to a predicate device to establish substantial equivalence.
Based on the provided text, there is no information available about acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for a study involving the device's performance, nor a study proving such criteria are met.
The document is a regulatory submission focused on establishing substantial equivalence for a physical medical device (anesthesia conduction needle), not a software or AI/ML-driven device that would typically have performance metrics and acceptance criteria for classification or detection tasks.
Here's a breakdown of why this information is not present and what is discussed instead:
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Acceptance Criteria and Reported Device Performance: This device is a physical instrument. The "acceptance criteria" here are related to physical and technical characteristics and safety/effectiveness as compared to a predicate device, rather than statistical performance metrics for a diagnostic or AI system. The document states:
- "The Flexible Introducer Cannula has similar physical and technical characteristics to the predicate device and a similar intended use to the predicate device."
- "The testing performed and comparison to the predicate device demonstrates that the Flexible Introducer Cannula is safe and effective and is substantially equivalent to the predicate device."
- No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) are reported.
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Sample size for the test set and data provenance: Not applicable. There is no mention of a "test set" in the context of diagnostic performance data. The "testing performed" would likely refer to engineering validation and verification tests (e.g., materials testing, sterility, functionality) and comparison of physical attributes to the predicate.
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Number of experts and their qualifications for ground truth: Not applicable. Ground truth as typically defined for AI/ML performance studies is not relevant here. The "ground truth" for this device would be its physical conformance to specifications and its biological safety, established through standard engineering and biocompatibility testing.
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Adjudication method: Not applicable.
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MRMC comparative effectiveness study: Not applicable. There is no mention of human readers or AI assistance.
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Standalone performance study: Not applicable in the context of AI/ML. All the documentation describes the device's standalone characteristics and function.
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Type of ground truth used: For a physical medical device like this, "ground truth" means demonstrating the device meets design specifications, material properties, biocompatibility, and functional requirements. This is typically established through engineering tests, material science analysis, and preclinical studies where relevant. The summary provided does not detail these specific tests, but rather states that "testing was performed."
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Sample size for the training set: Not applicable. This is not an AI/ML device.
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How ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a traditional medical device (anesthesia conduction needle). It establishes substantial equivalence to a predicate device through comparison of physical and technical characteristics and intended use, rather than through performance metrics typically associated with AI/ML or diagnostic devices. Therefore, the specific questions regarding acceptance criteria, study details, and ground truth establishment in the context of AI/ML or diagnostic performance are not addressed by this document.
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Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The sequence starts with the letters 'KO', followed by the numbers '5', '1', '8', and '6'. The sequence concludes with the letter 'D'. The characters are written in a casual, slightly slanted style.
Section II
510(K) Summary
Company Information:
Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 (518) 725-0209 Contact: Christopher B. Lake Manager of QA/RA
Date Prepared:
July 6, 2005
Trade Name:
Flexible Introducer Cannula
Common Name:
Anesthesia Conduction Needle
Product Class/Classification:
Class II - MIA, 21 CFR 868.5150
Predicate Device(s):
Custom Medical Concepts Spinal Cord Access Epidural Introducer System (K904380)
Description:
The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is also packaged with a stainless steel introducer needle which is removed after the device has been placed.
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Intended Use:
For the administration of anesthetic agents to provide regional anesthesia.
Comparison to Predicate:
The Flexible Introducer Cannula has similar physical and technical characteristics to the predicate device and a similar intended use to the predicate device.
Conclusion:
The testing performed and comparison to the predicate device demonstrates that the Flexible Introducer Cannula is safe and effective and is substantially equivalent to the predicate device.
Epimed International, Inc.
Pell
Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The bird is positioned above a wavy line, possibly representing water or a horizon. Encircling the bird and wavy line is text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Mr. Christopher Lake Manager of QA/RA Epimed International, Incorporated 141 Sal Landrio Drive Johnstown, New York 12095
Re: K051860
Trade/Device Name: Flexible Introducer Cannula, Model 135-1837 Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: MIA Dated: July 6, 2005 Received: July 12, 2005
Dear Mr. Lake:
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 may or can been 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.
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Page 2 - Mr. Lake
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat 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. You must or any I vith 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 promaticated 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.gov/cdrh/industry/support/index.html.
Sincerely yours,
Siran Rumpe
Chiu Lin, Ph.D. 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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Indications for Use
510(k) Number (if known): K051860
Device Name: Flexible Introducer Cannula
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Flexible Introducer Cannula is intended for the epidural placement, directly The Flexible Introducer cannuid is Inventour of the opents to elicit regional anesthesia.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amy Slocum
(Division Sic ness boy Ceneral Hospital, not Control ್ತ
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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).