(79 days)
The RX Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
The RX Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a custom trimmed shaft and a molded plastic hub. The RX Epidural Needle will be provided as a sterile, single use, disposable device. The RX Epidural Needle will be available in a variety of lengths and gauges.
The provided text is a 510(k) summary for a medical device called the "RX Epidural Needle" and the FDA's response letter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data on a pre-defined test set.
Therefore, many of the requested categories for describing acceptance criteria and study details cannot be filled from the given text. This type of submission relies on the established safety and effectiveness of a predicate device, not on a new clinical or performance study with defined acceptance criteria for a novel device.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided from the text. The document does not describe specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy, or other performance metrics) because it's a 510(k) submission for substantial equivalence. It compares the device to a predicate based on "similar physical and technical characteristics" rather than new performance data against numerical targets.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Cannot be provided from the text. No specific test set or associated data provenance is mentioned as this is a substantial equivalence submission, not a de novo study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Cannot be provided from the text. Ground truth establishment is not described as there is no specific "test set" and corresponding study in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided from the text. No adjudication method is described.
5. 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
- Not applicable / Cannot be provided from the text. This device is an epidermal needle, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Cannot be provided from the text. This device is an epidermal needle, not an algorithm, so standalone performance in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Cannot be provided from the text. No ground truth is described.
8. The sample size for the training set
- Not applicable / Cannot be provided from the text. No training set is mentioned.
9. How the ground truth for the training set was established
- Not applicable / Cannot be provided from the text. No training set or ground truth establishment is mentioned.
Summary based on the document:
The provided document describes a 510(k) summary for a medical device. The core of a 510(k) submission is to demonstrate substantial equivalence to a predicate, legally marketed device. This means the device is as safe and effective as a legally marketed device and does not require a new Premarket Approval (PMA) application.
In this specific case, the RX Epidural Needle is deemed substantially equivalent to the Epimed International Epidural Needle (K030562). The "study" (or rather, the basis for approval) is this comparison.
- Acceptance Criteria: Implicitly, the acceptance criterion for a 510(k) is demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate device.
- Reported Device Performance: The document states, "The RX Epidural Needle has similar physical and technical characteristics to the Epimed International Epidural Needle marketed under K030562." This is the reported "performance" in the context of this type of submission. Specific numerical performance metrics were not required or provided in the summary.
- Study Design: This was a comparison study based on device characteristics, not a clinical trial or performance study with a test set of data.
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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:
October 31, 2005
Trade Name:
RX Epidural Needle
Common Name:
Epidural Needle
Product Class/Classification:
Class II 868.5150 Needle, Conduction, Anesthetic
Predicate Device(s):
Epimed International Epidural Needle (K030562)
Description:
The RX Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a custom trimmed shaft and a molded plastic hub.
The RX Epidural Needle will be provided as a sterile, single use, disposable device. The RX Epidural Needle will be available in a variety of lengths and gauges.
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Intended Use:
The RX Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
Comparison to Predicate:
The RX Epidural Needle has similar physical and technical characteristics to the Epimed International Epidural Needle marketed under K030562.
Conclusion:
The comparison to the predicate device demonstrates that the RX Epidural Needle is safe and effective and is substantially equivalent to the predicate device.
Epimed International, Inc.
Signature
Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs
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Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Mr. Christopher Lake Manager of Quality Assurance and Regulatory Affairs Epimed International, Inc. 141 Sal Landrio Dr. Crossroads Business Park Johnstown, NY 12095
Re: K053318
Trade/Device Name: RX Epidural Needle Regulation Number: 868.5150 Regulation Name: Anethesia conduction needle Regulatory Class: II Product Code: BSP Dated: November 28, 2005 Received: December 6, 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 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 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. 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), please contact the Office of Compliance at (240) 276-0115. 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,
Susan Tunne
for 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. KOS 3318
Device Name: Rx Epidural Needle
Indications For Use:
The RX Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
Prescription Use __ × (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)
Cee Sulion
ology General Hospital,
Control. Dental Devices
K093318
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).