(87 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and equivalence to a predicate device, with no mention of AI or ML.
Yes
The device is used to inject anesthetic agents for pain relief, which is a therapeutic purpose.
No.
The device is used to inject anesthetic agents or facilitate catheter placement for pain relief, not for diagnosing a medical condition.
No
The device description clearly outlines physical components (plastic Luer hub, stainless steel cannula, plastic stylet, removable wings) and is described as a sterile, single-use, disposable device, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is an "Epidural Needle" used for the "injection of anesthetic agents into the epidural space" or to "facilitate the placement of an epidural catheter." This is a direct intervention on the patient's body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes based on laboratory results.
Therefore, this device falls under the category of a surgical or procedural device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
BSP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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.
3
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
4
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)
Page 1 of 1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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