(239 days)
K 070354
K 070354
No
The device description and intended use describe a simple mechanical needle for delivering anesthetics or placing catheters. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device facilitates the delivery of anesthetics, which are therapeutic agents, but the needles themselves are not therapeutic; they are instruments used in a medical procedure to administer treatment.
No
The device is intended for the delivery of anesthetics and the placement of catheters, which are therapeutic and interventional functions, not diagnostic ones.
No
The device description clearly describes physical needles made of stainless steel and other materials, intended for insertion into the body. It does not mention any software components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "transient delivery of anesthetics" and to "facilitate placement of an epidural catheter." This describes a device used for a medical procedure (administering medication and placing a catheter), not for testing samples from the human body to diagnose or monitor a condition.
- Device Description: The description details a sterile, sharp, hollow needle used for transferring anesthetic into the body. This aligns with a surgical or procedural device, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for a therapeutic and procedural purpose.
N/A
Intended Use / 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.
AN-SI spinal needle and AN-SII spinal needle are intended for the transient delivery of anesthetics to provide neuraxial anesthesia.
Product codes
BSP
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural cavities / epidural space / neuraxial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional anesthetist
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
Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalent to the predicate device. Results of performance testing indicate that the needles meet applicable sections of the standards referenced: 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.
Key Metrics
Not Found
Predicate Device(s)
IMD's Tuohy needle; Quincke needle; Pencil Point needle (K 070354)
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
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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 | Tuohy | ||
| needle | Quincke | |||||
| needle | Pencil | |||||
| Point | ||||||
| needle | ||||||
| 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 | 0.70 | |||||
| 0.80 | ||||||
| 0.90 | ||||||
| 1.10 | ||||||
| 1.20 | ||||||
| 1.50 | ||||||
| 1.60 | ||||||
| 1.80 | 0.40 | |||||
| 0.45 | ||||||
| 0.50 | ||||||
| 0.55 | ||||||
| 0.60 | ||||||
| 0.70 | ||||||
| 0.80 | ||||||
| 0.90 | 0.40 | |||||
| 0.45 | ||||||
| 0.50 | ||||||
| 0.55 | ||||||
| 0.63 | ||||||
| 0.7 | 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.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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.
7
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
8
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'