(199 days)
The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.
The RK 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 stainless steel stylet with a molded plastic hub is also provided with the device. The RK Epidural Needle will be provided as a sterile, single use, disposable device. The RK Epidural Needle will be available in a variety of lengths and gauges.
This 510(k) summary for the RK Epidural Needle (K072005) does not contain the information requested about acceptance criteria or a study proving the device meets said criteria.
The document is a traditional 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a dedicated study.
Here's why the requested information is absent:
- Substantial Equivalence: The primary method for clearance in this type of 510(k) is to show that the new device has "similar physical and technical characteristics" and the same "intended use" as legally marketed predicate devices. This approach argues that if the predicate devices are considered safe and effective, and the new device is substantially equivalent, then the new device is also safe and effective. It does not require a new clinical trial or performance study proving specific acceptance criteria are met in the same way a novel device or a device requiring a PMA would.
- Device Type: This is a Class II device (Anesthesia Conduction Needle). For such devices, often bench testing, material safety, and performance data comparing it to predicates (e.g., tip design, material strength, flow rates if applicable) are used to demonstrate equivalence, but not necessarily a formal clinical study with acceptance criteria in the sense of accuracy, sensitivity, or specificity.
- Content of the Summary: The provided text is a summary of the 510(k) application. It lists:
- Company information
- Date prepared
- Trade and common name
- Product class and classification
- Predicate device(s)
- Description of the device
- Intended Use
- Comparison to Predicate
- Conclusion affirming substantial equivalence.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or ground truth details from this document because it is not present. The document states that the comparison to predicate devices demonstrates that the RK Epidural Needle is safe and effective, implying that the safety and effectiveness are inferred from its similarity to already cleared devices, not from a new study designed to meet specific acceptance criteria.
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510(K) Summary
Company Information:
Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 (518) 725-0209 Contact: Katie Peters Manager of QA/RA
FEB - 7 cubs
Date Prepared:
September 7, 2006
Trade Name:
RK Epidural Needle
Common Name:
Epidural Needle
Product Class/Classification:
Class II 868.5150 Needle, Conduction, Anesthetic
Predicate Device(s):
Epimed International Epidural Needle (K030562) Epimed International RX Epidural Needle (K053318)
Description:
The RK 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 stainless steel stylet with a molded plastic hub is also provided with the device.
The RK Epidural Needle will be provided as a sterile, single use, disposable device. The RK Epidural Needle will be available in a variety of lengths and gauges.
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Intended Use:
The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.
Comparison to Predicate:
The RK Epidural Needle has similar physical and technical characteristics to the Epimed International Epidural Needles marketed under K030562 and K053318.
Conclusion:
The comparison to the predicate devices demonstrates that the RK Epidural Needle is safe and effective and is substantially equivalent to the predicate devices.
Epimed International, Inc.
Katie Peters
Katie Peters Manager of Quality Assurance/Regulatory Affairs
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.
Public Health Service
FEB - 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Epimed International, Incorporated C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K072005
Trade/Device Name: RK Epidural Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: January 22, 2008 Received: January 24, 2008
Dear Mr. Kogoma:
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. Kogoma
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.
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): |< 0 フ 2 0 0 S
Device Name: RK Epidural Needle
Indications For Use: The RK Epidural Needle is indicated for either single injection of drug or placement of an Epimed Spring Guided Catheter or traditional epidural catheter.
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)
Min Khin
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K072005
§ 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).