(106 days)
The Flexible Spinal Needle is intended for the administration of anesthetic agents to provide regional anesthesia.
The Flexible Spinal Needle consists of a coated flexible stainless steel cannula with a molded plastic hub. A stylet is also provided with the device which consists of a stainless steel cannula and a molded plastic hub. The Flexible Spinal Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.
This document is a 510(k) summary and FDA clearance letter for a Flexible Spinal Needle. It describes the device and its intended use, and compares it to predicate devices. However, the document does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing:
- Type of device: This is a medical device (a spinal needle), not a software or AI-driven diagnostic device. The questions about "algorithm only without human-in-the loop performance," "effect size of how much human readers improve with AI," and "sample size for the training set" are specific to AI/ML or diagnostic software and are not applicable to a physical medical instrument like this.
- Study Design: The document states "Bench Testing performed on the Flexible Spinal Needle to compare performance characteristics to the predicate device(s) confirmed that the performance of the Flexible Spinal Needle is similar to the predicate device(s)." This is a very high-level summary and doesn't provide the specifics requested in your prompt.
Therefore, most of the requested information cannot be extracted from the provided text.
Information that can be inferred or stated as not available:
- Table of acceptance criteria and reported device performance: Not provided. The document generally states "performance... is similar to the predicate device(s)," but no specific criteria or performance metrics are listed.
- Sample size used for the test set and data provenance:
- Sample size: Not specified. "Bench Testing" is mentioned.
- Data provenance: Not specified. Assumed to be lab/bench test data, not patient data in the typical sense requested by "country of origin" or "retrospective/prospective."
- Number of experts and qualifications: Not applicable/Provided. Bench testing doesn't typically involve human experts in this context.
- Adjudication method: Not applicable/Provided.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not conducted/applicable as this is not an AI/ML diagnostic system.
- Standalone (algorithm only) performance: Not applicable. This is a physical device.
- Type of ground truth used: Not explicitly stated for bench testing, but likely derived from engineering specifications and predicate device performance standards.
- Sample size for the training set: Not applicable. There is no "training set" for a physical device undergoing bench testing for 510(k) clearance in this manner.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes a 510(k) clearance for a physical medical device (spinal needle) based on substantial equivalence to predicate devices through bench testing. It does not provide the detailed study design, acceptance criteria, or performance metrics typically found in documentation for AI/ML or diagnostic software evaluations, as implied by most of your detailed questions.
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MAR 3 1 2005
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 RA/QA
Trade Name:
Flexible Spinal Needle
Common Name:
Flexible Spinal Needle
Product Class/Classification:
Class II
Predicate Device(s):
Epimed Quincke Spinal Needle (K022029) Custom Medical Concepts Spinal Cord Access Epidural Introducer System (K904380)
Description:
The Flexible Spinal Needle consists of a coated flexible stainless steel cannula with a molded plastic hub. A stylet is also provided with the device which consists of a stainless steel cannula and a molded plastic hub.
The Flexible Spinal Needle will be provided as a sterile, single use, disposable device and will be available in a variety of lengths and gauges.
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Intended Use:
For the administration of anesthetic agents to provide regional anesthesia.
Comparison to Predicate:
The Flexible Spinal Needle has similar characteristics attributes to both the Epimed Quincke Spinal Needle marketed under K022029 and the Custom Medical Concepts Spinal Cord Access Epidural Introducer System marketed under K904380.
Non-Clinical Data:
Bench Testing performed on the Flexible Spinal Needle to compare performance characteristics to the predicate device(s) confirmed that the performance of the Flexible Spinal Needle is similar to the predicate device(s).
Conclusion:
The comparison to the predicate device(s) demonstrates that the Flexible Spinal Needle is safe and effective and is substantially equivalent to the predicate device(s).
Very truly yours,
Epimed International, Inc.
Chad
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. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 1 2005
Mr. Christopher B. Lake Manager of Regulatory Affairs/Quality Assurance Epimed International, Incorporated 141 Sal Landrio Drive Crossroads Business Park Johnstown, New Jersey 12095
Re: K043467
:
Trade/Device Name: Flexible Spinal Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: February 21, 2005 Received: February 24, 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 mensiale comments, 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 approvisions of the Act. The general controls provisions of the Act include econorols 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 (1 mr 1), it e 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.
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Page 2 - Mr. Lake
Please be advised that FDA's issuance of a substantial equivalence determination does not r least be advised mat I Da determination that your device complies with other requirements mean that I DA mas made a aves and regulations administered by other Federal agencies. Of the Act of ally I oderal batales and sequirements, including, but not limited to: registration 1 ou must comply with an the Pisoeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF rev or), quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quality ijo 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) I mis letter will and w yourse organ.
Premarket notification. The FDA finding of substantial equivalence of your device to a premiarket notification. - The PDF results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not to to your and (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 may obtain 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,
Chiu Lin, Ph.D.
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): unk
Device Name: Flexible Spinal Needle
Indications for Use:
The Flexible Spinal Needle is intended for the administration of anesthetic agents to provide regional anesthesia.
x Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cucu Salum
(3) Number:_
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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).