(87 days)
An Epidural Needle is indicated for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter.
Epidural needles are instruments used for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter into the epidural space for continuous infusion of anesthetic agents into the epidural space for subsequent pain relief if required.
The needle consists of a plastic Luer hub, a stainless steel cannula, a plastic stylet and removable wings. The needle cannula has 10cm depth markings on it to assist in the needle placement.
The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The needles are provided with a Tuohy point in both 17g and 18g sizes.
This document describes the FDA 510(k) submission for Epidural Anesthesia Needles, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics. Therefore, many of the requested elements for an AI/device performance study are not applicable or explicitly stated in this type of submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from standards) | Reported Device Performance (as stated in submission) |
|---|---|---|
| Stainless Steel Components | ISO 9626 (likely for dimensions, mechanical properties, surface finish, etc.) | "meets performance standards where applicable" |
| Luer Hub | ISO 594-1 and ISO 594-2 (likely for dimensions, gauge size, freedom from leakage, etc.) | "meets performance standards where applicable" |
| Hub to Needle Bond Strength | ISO 7864 (likely for testing the integrity of the bond) | "meets performance standards where applicable" |
| Visual Characteristics | Not explicitly stated (likely absence of defects, proper assembly) | "performs equivalently to the predicate device" |
| Dimensional Characteristics | Not explicitly stated (likely within manufacturing tolerances) | "performs equivalently to the predicate device" |
| Overall Performance | Not explicitly stated (likely functional use parameters) | "performs equivalently to the predicate device" |
Important Note: The document states that the new device has "the same technological characteristics as the predicate devices" and "meets performance standards where applicable for: ISO 9626, ISO 594-1 and ISO 594-2, ISO 7864." The performance is reported as performing "equivalently to the predicate device" and that "data submitted demonstrates that the epidural needle performs equivalently to the predicate device" across visual, performance, and dimensional characteristics. Specific numerical performance results against these ISO standards are not provided in this summary.
Regarding the Absence of an AI/Device Performance Study:
The provided text is a 510(k) summary for a medical device (Epidural Anesthesia Needles) seeking substantial equivalence to a predicate device. It is not an AI/ML medical device submission, nor does it describe a study establishing clinical performance of a diagnostic or therapeutic AI product. Therefore, the following points are not applicable to this document as it does not describe such a study:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device; no test set of data is described.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for data is established.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for adjudication.
- 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. This is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth for data is established.
- 8. The sample size for the training set: Not applicable. No training set for an algorithm.
- 9. How the ground truth for the training set was established: Not applicable. No ground truth for an algorithm.
Summary of the Study (as described in the 510(k) summary):
The "study" described is a non-clinical data submission aimed at demonstrating substantial equivalence to a predicate device (K000495, Ballard Medical Products Epidural and Spinal Needles).
- Study Type: Non-clinical (bench testing, materials verification).
- Objective: To show that the Epidural Anesthesia Needles have the same technological characteristics and perform equivalently to the predicate device.
- Data Provenance: Not specified, but generally refers to internal company testing and adherence to international standards (ISO 9626, 594-1, 594-2, 7864).
- Ground Truth: The "ground truth" in this context is the established performance and safety of the predicate device and compliance with relevant ISO standards. Equivalence is the metric.
- Clinical Data: Explicitly stated as "Not required," indicating that the non-clinical data was sufficient for the substantial equivalence determination for this device type.
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SECTION 5, 510(k) Summary
Company Information:
Smiths Medical ASD, Inc. 10 Bowman Dr Keene, NH 03431 (603) 352-3812, prompt 4, ext 2923 Contact: Cynthia Engelhardt Regulatory Affairs Specialist
Summary Prepared: January 30, 2009
Product Name:
Trade Name: Epidural Anesthesia Needles
Common Name: Epidural Anesthesia Needles
Classification Name: Needle, Conduction, Anesthetic (W/Wo Introducer) (21 CFR 868.5150, Product Code BSP)
Predicate Device(s):
K000495, Ballard Medical Products Epidural and Spinal Needles (Now Kimberly Clark)
Device Description:
Epidural needles are instruments used for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter into the epidural space for continuous infusion of anesthetic agents into the epidural space for subsequent pain relief if required.
The needle consists of a plastic Luer hub, a stainless steel cannula, a plastic stylet and removable wings. The needle cannula has 10cm depth markings on it to assist in the needle placement.
The needles are provided as sterile, single use, disposable devices. They may be packaged individually or included in our regional anesthesia trays. The needles are provided with a Tuohy point in both 17g and 18g sizes.
Indications for Use:
An Epidural Needle is indicated for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter.
smiths medical
bringing technology to life
Smiths Medical North America 10 Bowman Drive Keene, NH 03431 T: 603 352 3812 F: 603 357 1614 www.smiths-medical.com
MAY
- 1 2009
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Technological Characteristics:
The Smiths Medical Epidural Anesthesia Needles have the same technological characteristics as the predicate devices identified above. The Smiths Medical Epidural Anesthesia Needles are equivalent in design, physical dimensions, Luer hub, metal and plastic materials to the predicate devices.
The Smiths Medical Epidural Anesthesia Needles general design characteristics and functionality are similar in that they meet performance standards where applicable for:
Stainless Steel components: ISO 9626 Hub: ISO 594-1 and ISO 594-2 Hub to Needle Bond Strength: ISO 7864
All statements and representations set forth herein regarding or related to "substantially equivalent" or "substantial equivalence" are in the limited context of the definition and purpose of substantial equivalence in the Federal Food, Drug, and Cosmetic Act, as amended, and applicable regulations of the Food and Drug Administration, and are not made in the context of, for any purpose related to, or as an admission against interest under, any other laws or regulations, including patent laws (whether in the context of patent infringement or otherwise).
Non-Clinical Data:
Data submitted demonstrates that the epidural needle performs equivalently to the predicate device. Data submitted covers visual, performance and dimensional characteristics
Clinical Data:
Not required.
Conclusion:
The proposed device is safe and effective and is substantially equivalent to the predicate device.
Very truly yours.
SMITHS MEDICAL ASD, INC.
Cmttu
Cynthia Engelhardt Regulatory Affairs Specialist
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
MAY - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cindy Engelhardt Regulatory Affairs Specialists Smiths Medical ASD, Incorporated 10 Bowman Drive Kecne, New Hampshire 03431
Re: K090261
Trade/Device Name: Epidural Anesthesia Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: January 30, 2009 Received: February 3, 2009
Dear Ms. Engelhardt:
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 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.
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.
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Page 2- Ms. Engelhardt
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Quoen
Susan Runner, D.D.S., MA Acting 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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SECTION 4, Indications for Use Statement
Indications for Use
510(k) Number (if known):
Device Name: Epidural Anesthesia Needles
Indications for Use:
An Epidural Needle is indicated for the injection of anesthetic agents into the epidural space or to facilitate the placement of an epidural catheter.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
9
L. Schutthe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 090261
§ 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).