(239 days)
AN-E epidural needle is intended for the transient delivery of anesthetics to provide neuraxial anesthesia or to facilitate placement of an epidural catheter.
AN-SI spinal needle and AN-SII spinal needle are intended for the transient delivery of anesthetics to provide neuraxial anesthesia.
The proposed device, Anesthesia conduction needles, including Epidural Needle for Single Use (AN-E), Spinal Needle for Single Use (AN-SI, AN-SII) was developed by LCCS Products Limited to meet urgent demands on prevention of cross- infection. Anesthesia conduction needles, is a kind of sterile and sharp hollow-device used for transferring anaesthetic to epidural cavities. The device can be used for introducing dedicated ducts into epidural cavities for convenience of injecting anaesthetic continuously. Anesthesia conduction needles fit into an introducer needle. This is a simple hypodermic needle to make the initial puncture through the skin to aid in the placement of the anesthesia conduction needle. The later can facilitate the placement of an epidural catheter for continuous infusion of local anesthetics into the epidural space. The needle tubing is stabilized during puncture with use of an inner stylet. This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for neuraxial anesthesia. Then the anesthetics can be applied transiently (i.e., within minutes) by the professional anesthetist. Alternatively or additionally, an epidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.The stylet hub is made of HDPE, the needle hub is made of resin, the raw material of the needle tubing and stylet is stainless steel, the jacket is PP, all the raw materials are biocompatible.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: AN-SI spinal needle, AN-SII spinal needle, AN-E epidural needle
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this medical device are primarily based on established international standards for medical needles and a comparison to a predicate device. The performance data is reported as meeting these standards and being similar to the predicate.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Conformance |
|---|---|---|
| Design Characteristics | - Diameters: Similar to predicate device cannulas (AN-SI, AN-II: 20g-27g; AN-E: 15g-20g) | - "The diameters of the AN-SI, AN-II and AN-E are 20g-27g, 22g-27g and 15g-20g successively, the diameters of the needles of this 510k submission are similar to the diameters of the cannulas covered by the predicate devices." (Page 2) |
| - Lengths: Tested for each size, appropriate for different patient groups and clinical applications | - "The lengths of the AN-SI, AN-II and AN-E are 25mm-200mm, 60mm-200mm and 50mm-150mm successively, different lengths used for different group of patient... Each size of the needles is tested following the ISO 9626, the test results show that each size of the needles meets the criteria of the standard." (Page 2) | |
| - Tip Specifications: Identical to predicate device tips | - "Tip specifications: the tips of the needles are identical to the tips of the predicate devices." (Page 2) | |
| Material Properties | - Stiffness: Meets ISO 9626 criteria | - "Plus the properties of stiffness and resistance to breakage are tested and the results are in the criteria of the ISO 9626." (Page 2) - "Each size of the needles is tested following the ISO 9626, the test results show that each size of the needles meets the criteria of the standard." (Page 3) |
| - Resistance to Breakage: Meets ISO 9626 criteria (and general standard requirements) | - "Plus the properties of stiffness and resistance to breakage are tested and the results are in the criteria of the ISO 9626." (Page 2) - "The results of the test of resistance to breakage show the needles of each size meet the standard requirements." (Page 3) | |
| - Biocompatibility: Raw materials comply with predicate device and standards (HDPE for stylet hub, resin for needle hub, stainless steel for tubing/stylet, PP for jacket) | - "all the raw materials are biocompatible." (Page 1) - "the AN-E, each size of AN-SI and AN-SII is composed of the same raw material...identical type and duration of patient contact." (Page 3) - Specific raw materials listed (K-Resin KR03, SUS 304) and certified as identical to predicate device's materials by the manufacturer of the predicate. (Page 5) | |
| Performance Standards | - Stainless Steel components: Conforms to ISO 9626 | - "Stainless Steel components: ISO 9626" (Page 2) - "ISO 9626:-1991/Amd. 1:2001(E) 'Stainless steel needle tubing for the manufacture of medical devices.'" (Page 3) - "Each size of the needles is tested following the ISO 9626, the test results show that each size of the needles meets the criteria of the standard." (Page 3) |
| - Hub: Conforms to ISO 594-1 and ISO 594-2 | - "Hub: ISO 594-1 and ISO 594-2" (Page 2) - "ISO 594-1:1986, 'Conical Fittings with a 6 % Luer taper for syringes, needles and certain other medical equipment - Part 1: General Requirements.'" (Page 3) - "ISO 594-2:1998 'Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Pant 2: Lock fittings.'" (Page 3) | |
| - Hub to Needle Bond Strength: Conforms to ISO 7864 | - "Hub to Needle Bond Strength: ISO 7864" (Page 2) - "ISO 7864:1993(E) 'Sterile hypodermic needles for single use.'" (Page 3) | |
| Sterilization | - Equivalent to predicate device (materials, packaging, and sterilization processes are the same) | - "Sterilization is equivalent to predicate device since the materials, packaging, and sterilization processed are the same." (Page 3) |
| Manufacturing Methods | - Identical to predicate device | - "Anesthesia conduction needles are processed using the identical manufacturing methods as the IMD's Tuohy needle; Quincke needle; Pencil Point needle" (Page 3) |
| Substantial Equivalence | - Demonstrates similarity and substantial equivalence to predicate devices (IMD's Tuohy needle; Quincke needle; Pencil Point needle K070354) in formation, technical characteristics, and function, including direct statement of substantial equivalence by the FDA. | - The entire submission aims to prove this. The conclusion states: "The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are similar, as well as substantially equivalent to the predicate devices." (Page 5) - "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (FDA 510(k) Clearance Letter, Page 6) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific numerical sample size used for the performance tests. It generally refers to "each size of the needles" being tested. For biocompatibility, it mentions "appendix B1 AN-E biocompatibility test and appendix B2 AN-SI biocompatibility test," implying samples of AN-E and AN-SI were tested.
- Data Provenance: The tests were conducted by the submitter (LCCS Products Limited) or their manufacturing partner, likely in China (Guangzhou, Guangdong, China is the submitter's representative address). The nature of the tests (material properties, dimension conformance) indicates they are likely laboratory-based prospective testing of manufactured devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable in this context. The review is for a Class II medical device (needles) primarily based on engineering performance standards and substantial equivalence to a predicate device, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" is defined by industrial standards (ISO) and direct comparison to the predicate device specifications.
4. Adjudication Method
- N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert interpretation of images or clinical outcomes, to establish a "ground truth" when there's disagreement among experts. This type of study is not described for this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. These studies are relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to measure diagnostic accuracy and efficiency. This device is an anesthesia conduction needle, which is a physical tool, not a diagnostic algorithm.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
- Yes, in a sense, the primary performance evaluation for this device is "standalone." The device (the needle itself) is tested directly against physical and material standards (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2) and compared to the predicate device's specifications. There is no "human-in-the-loop" component in the device's intended function that would require such a study design. The performance relates to its physical integrity and dimensional accuracy.
7. Type of Ground Truth Used
The ground truth used for this device evaluation is primarily:
- Industry Standards: International Organization for Standardization (ISO) standards (ISO 9626, ISO 7864, ISO 594-1, ISO 594-2) define the acceptable physical and material properties.
- Predicate Device Specifications: The established characteristics (dimensions, materials, design) of the legally marketed predicate devices (IMD's Tuohy needle; Quincke needle; Pencil Point needle K070354).
8. Sample Size for the Training Set
- N/A. This is not an AI/ML device where a "training set" would be applicable. The development of the needle relies on engineering design and manufacturing processes, not machine learning.
9. How the Ground Truth for the Training Set Was Established
- N/A. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The design and manufacturing process would adhere to established engineering principles and standards.
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510(k) Summary
In accordance with the requirements of SMDA 1990 and 21 CFR 807.92 the following summary of information is provided:
| Date: | April 7, 2013 |
|---|---|
| Submitter: | LCCS Products Limited |
| Add: FLAT 1801A ,18/F., ON HONG COMMERCIAL BLDG, 145 | |
| HENNESSY ROAD, WANCHAI, HONGKONG | |
| Primary Contact Person: | Mike Gu |
| Regulatory Affairs Manager | |
| OSMUNDA Medical Device Consulting Co., Ltd. | |
| Tel: (+86) 20-6232 1333 | |
| Fax: (+86) 20-8633 0253 | |
| Email: mike.gu@osmundacn.com | |
| Secondary Contact Person: | Mrs. Elizabeth Ma |
| Vice President | |
| LCCS Products Limited | |
| Tel: +852-81368758 | |
| Fax: + 852-35430978 | |
| Email: Iccsmed@126.com | |
| Device: | |
| Trade Name: | AN-SI spinal needle, AN-SII spinal needle, AN-E epidural needle |
| Common/Usual Name: | Anesthesia conduction needles |
| Classification Names: | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Product Code: | BSP |
| Classification: | II |
| Predicate Device(s): | IMD's Tuohy needle; Quincke needle; Pencil Point needle (K 070354) |
| Device Description: | The proposed device, Anesthesia conduction needles, including |
| Epidural Needle for Single Use (AN-E), Spinal Needle for Single | |
| Use (AN-SI, AN-SII) was developed by LCCS Products Limited to | |
| meet urgent demands on prevention of cross- infection. | |
| Anesthesia conduction needles, is a kind of sterile and sharp | |
| hollow-device used for transferring anaesthetic to epidural | |
| cavities. The device can be used for introducing dedicated ducts | |
| into epidural cavities for convenience of injecting anaesthetic | |
| continuously. Anesthesia conduction needles fit into an | |
| introducer needle. This is a simple hypodermic needle to make | |
| the initial puncture through the skin to aid in the placement of | |
| the anesthesia conduction needle. The later can facilitate the |
placement of an epidural catheter for continuous infusion of
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local anesthetics into the epidural space.
The needle tubing is stabilized during puncture with use of an inner stylet. This stylet is withdrawn after the anesthesia conduction needle has reached its anatomical site for neuraxial anesthesia. Then the anesthetics can be applied transiently (i.e., within minutes) by the professional anesthetist. Alternatively or additionally, an epidural catheter may be placed through the anesthesia conduction needle. The needle is withdrawn and the epidural catheter tip may remain in the epidural space for pain treatment.The stylet hub is made of HDPE, the needle hub is made of resin, the raw material of the needle tubing and stylet is stainless steel, the jacket is PP, all the raw materials are biocompatible.
AN-E epidural needle is intended for the transient delivery of anesthetics to provide neuraxial anesthesia or to facilitate placement of an epidural catheter.
AN-SI spinal needle and AN-SII spinal needle are intended for the transient delivery of anesthetics to provide neuraxial anesthesia.
Intended Use:
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Technology characteristic : The diameters of the AN-SI, AN-II and AN-E are 20g-27g, 22g-27g and 15g-20g successively, the diameters of the needles of this 510k submission are similar to the diameters of the cannulas covered by the predicate devices. Plus the properties of stiffness and resistance to breakage are tested and the results are in the criteria of the ISO 9626. The lengths of the AN-SI, AN-II and AN-E are 25mm-200mm, 60mm-200mm and 50mm-150mm successively, different lengths used for different group of patient, for example an obese patient use a longer needle, and also the choose of length depends on the target site of the clinical application. The Anesthesia Conduction Needles' (AN-E, AN-SI, AN-SII) general design characteristics and functionality met performance standards requirements where applicable for: Stainless Steel components: ISO 9626 Hub: ISO 594-1 and ISO 594-2 Hub to Needle Bond Strength: ISO 7864 Tip specifications: the tips of the needles are identical to the tips of the predicate devices. Diameter: the diameters of the needles of this 510k submission are similar to the diameters of the cannulas covered by the predicate devices. Plus the properties of stiffness and resistance to breakage are tested and the results are in the criteria of the ISO 9626. Length: the lengths of the needles of this 510k submission are different as compared to the lengths of the needles in the predicate device needles. Different lengths used in different group of patient, it depends on the target site of the clinical application. Each size of the needles is tested following the ISO 9626, the test results show that each size of the needles meets the criteria of the standard. The results of the test of resistance to breakage show the needles of each size meet the standard requirements. Determination of Summary of Non-Clinical Tests Substantial Equivalence: Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalent to the predicate device:
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ISO 9626:-1991/Amd. 1:2001(E) "Stainless steel needle tubing for the manufacture of medical devices."
ISO 7864:1993(E) "Sterile hypodermic needles for single use."
ISO 594-1:1986, "Conical Fittings with a 6 % Luer taper for syringes, needles and certain other medical equipment - Part 1: General Requirements."
ISO 594-2:1998 "Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment- Pant 2:
Lock fittings. "
Each size of the needles is tested following the ISO 9626, the test results show that each size of the needles meets the criteria of the standard. The results of the test of resistance to breakage show the needles of each size meet the requirements.
Results of performance testing indicate that the needles meet applicable sections of the standards referenced.
Please refer to the appendix A performance test report, please refer to the appendix B1 AN-E biocompatibility test and appendix B2 AN-SI biocompatibility test
Sterilization is equivalent to predicate device since the materials, packaging, and sterilization processed are the same.
The AN-E, each size of AN-SI and AN-SII is composed of the same raw material, each size of AN-E is composed of the same raw material, as well as the AN-SI, AN-SII and AN-E needles have the identical type and duration of patient contact. Additionally, Anesthesia conduction needles are processed using the identical manufacturing methods as the IMD's Tuohy needle; Quincke needle; Pencil Point needle
The following is the specification, Length and diameter comparison between the proposed device and predicate device:
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:
Traditional 510(k) Premarket Notification_Anesthesia conduction needles
| Proposed Device | Predicate Device | |||||
|---|---|---|---|---|---|---|
| Parameters | AN-E | AN-SI | AN-SII | Tuohyneedle | Quinckeneedle | PencilPointneedle |
| Specification | 20G(0.9)19G(1.1)18G(1.2)17G(1.4)16G(1.6)15G(1.8) | 27G(0.4)26G(0.45)25G(0.5)24G(0.55)23G(0.6)22G(0.7)21G(0.8)20G(0.9) | 27G(0.4)26G(0.45)25G(0.5)24G(0.55)23G(0.63)22G(0.7) | 20G(0.9),18G(1.2),17G(1.4),16G(1.6),15G(1.8) | 27G(0.4),26G(0.45),25G(0.5),24G(0.55),23G(0.6),22G(0.7),21G(0.8),20G(0.9),19G(1.1),18G(1.2),17G(1.4),16G(1.6) | 27G(0.4),26G(0.45),25G(0.5),24G(0.55),23G(0.6),22G(0.7),21G(0.8),20G(0.9) |
| Length | 50-150 | 25-200 | 60-200 | 35, 40,45, 55,57, 75,80, 85,90, 125 | 25~120 | |
| Diameter | 0.700.800.901.101.201.501.601.80 | 0.400.450.500.550.600.700.800.90 | 0.400.450.500.550.630.7 | 0.90,1.29,1.50,1.65,1.80 | 0.42,0.46,0.50,0.55,0.65,0.71,0.81,0.90,1.09,1.25 | 0.42,0.46,0.50,0.55,0.65,0.71,0.81,0.90 |
,
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Statement of the identical raw materials
LCCS PRODUCTS LIMITED applies 510k application of Anesthesia conduction needles, who formation, technical and function characters are the same with the anesthesia conducti needles manufactured by Shanghai SA Medical & Plastic Instruments Co., Ltd, who is t contract manufacturer of the specialty / anesthesia needles - Tuohy, Quincke and Pencil Po Needles produced by INTERNATIONAL MEDICAL DEVELOPMENT, INC.
LCCS's Anesthesia conduction needle is mainly used for epidural and/or spinal block (a called as epidural and/or spinal anesthesia) in human bodies. The needles have be categorized as following; Splnal Needle for Single Use (AN-SI Spinal Needles, AN-SII Spir Needle), and Epidural Needle for Single Use (AN-E Epidural Needles), They consist of five pa Stylet hub. Needle hub. Needle tubing, Stylot and Jacket; Needle hub, Needle tubing a Stylet contact directly or indirectly with patient, their raw materials are listed in the tal below:
| Parts | Material |
|---|---|
| Needle hub | K-Resin KR03 |
| Needle tubing | SUS 304 |
| Stylet | SUS 304 |
As demanded by IMD. Shanghai SA has manufactured the needle hub using K-Resin KRO3 sir 2009.
I certify that, in my capacity as Vice General Manager of Shanghai SA Medicai & Play Instruments Co., Ltd, The raw materials listed above of the Anesthesia conduction needles : identical to the raw materials of the IMD's specialty / anesthesia needles - Tuohy, Quincke a Pencil Point Needles as it was approved in K070354 in formulation, processing, and no oth chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mi release agents, etc.).
I certify that the information above is truthful and accurate and that no material fact has be omitted. Shanghai SA Medicai & Plastic Instruments Co., Ltd will bear all 1 legal responsibility if any Issue arises.
Signature (Shanghai SA):
Conclusion:
The comparison between the predicate devices and the proposed devices demonstrates that the proposed devices are similar, as well as substantially equivalent to the predicate devices. Anesthesia conduction needles can be claimed to be Substantially Equivalent (SE) to the predicate device, Predicate Device IMD's Tuohy needle; Quincke needle; Pencil Point needle K 070354.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2013
LCCS Products Limited C/O Mike Gu Regulatory Affairs Manager OSMUNDA Medical Device Consulting Co., Ltd. Junggui Business Building No. 982, 7th floor Congyun Rd., Baiyun District Guangzhou, Guangdong China 510420
Re: K131006
Trade/Device Name: AN-SI spinal needle, AN-SII spinal needle, AN-E epidural needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: November 5, 2013 Received: November 6, 2013
Dear Mr. Gu:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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Page 2 - Mr. Gu
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Image /page/7/Picture/8 description: The image contains a stylized signature or logo on the left, which appears to be handwritten with elaborate curves and loops. To the right of the signature, there is text that reads 'Tejashri P Clinical De DAGRID'. The text is vertically aligned and suggests a name and possibly a professional title or affiliation.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K131004
Device Name: AN-E epidural needle Common/Usual Name: Anesthesia conduction needles
Indications for Use:
AN-E epidural needle is intended for the transient delivery of anesthetics to provide neuraxial anesthesia or to facilitate placement of an epidural catheter.
Prescription UseX AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ (Part 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)
Nayan J. Patel -S 2013.12.06 14:08:02 -05'00'
§ 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).