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Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles

Q: Who is the manufacturer of Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles?

Zhejiang Kindly Medical Devices Co., Ltd. filed the 510(k) submission for Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles (K171518).

Q: What is the FDA product code for Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles?

BSP. It is classified under 21 CFR 868.5150 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles?

Uniever Disposable Epidural Anesthesia Needle (K142553); UNIEVER Disposable Spinal Anesthesia Needle (K141126); CSEcure™ Combined Spinal/Epidural Anesthesia System with Lock (K993619).

K171518 · Zhejiang Kindly Medical Devices Co., Ltd. · BSP · Jan 5, 2018 · Anesthesiology

Device Facts

Record ID	K171518
Device Name	Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles
Applicant	Zhejiang Kindly Medical Devices Co., Ltd.
Product Code	BSP · Anesthesiology
Decision Date	Jan 5, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5150
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Epidural Anesthesia Needles are intended to be used for injection into the epidural space/or placing the epidural catheter into the epidural space. The Spinal Anesthesia Needles are intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management. The Combined Anesthesia Needles are intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space.

Device Story

Device consists of sterile, single-use anesthesia needles (Epidural, Spinal, and Combined sets) used by clinicians for neuraxial anesthesia. Epidural needles facilitate injection into the epidural space or catheter placement; spinal needles inject local anesthetic into the subarachnoid cavity; combined needles allow sequential spinal injection and epidural catheter placement. Needles feature stainless steel tubing, removable stylets to prevent lumen occlusion, and Luer-taper hubs. Combined sets include a conical locking fitting to secure the spinal needle within the epidural needle after dural puncture. Used in clinical settings for regional anesthesia and pain management. Output is the physical delivery of anesthetic agents; clinical decision-making relies on clinician assessment of patient anatomy and anesthesia requirements. Benefits include rapid onset of anesthesia and capability for continuous drug infusion.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), sterility (ISO 11135/11137), and mechanical performance (ISO 9626, ISO 7864, ISO 594).

Technological Characteristics

Stainless steel needle tubing (ISO 9626); Luer-taper fittings (ISO 594-1/2); EO sterilization (ISO 10993-7); single-use; manual operation; various gauges (14G-27G) and lengths. Biocompatibility per ISO 10993-4/5/10/11.

Indications for Use

Indicated for patients requiring regional anesthesia or pain management via injection of local anesthetics into the epidural space or subarachnoid cavity, or placement of an epidural catheter for continuous infusion.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

Uniever Disposable Epidural Anesthesia Needle (K142553)
UNIEVER Disposable Spinal Anesthesia Needle (K141126)
CSEcure™ Combined Spinal/Epidural Anesthesia System with Lock (K993619)

Related Devices

K183316 — Dr J Spinal and Epidural Needles · Dr. Japan Co., Ltd. · Aug 12, 2019
K131006 — ANESTHESIA CONDUCTION NEEDLES · Lccs Products Limited · Dec 6, 2013
K203668 — RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles · Myco Medical Supplies, Inc. · Sep 29, 2021
K120475 — ANESTHESIA CONDUCTION NEEDLES · Shanghai Samedical & Plastic Instruments Co., Ltd. · Dec 21, 2012
K983858 — SPINAL ANESTHESIA NEEDLES AND INTRODUCER NEEDLES · Sims Portex, Inc. · Jan 29, 1999

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 5, 2018 Zhejiang kindly Medical Devices Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China Re: K171518 Trade/Device Name: Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: December 11, 2017 Received: December 13, 2017 Dear Diana Hong: 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. 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 of medical device-related adverse events) (21 CFR 803); good {1}------------------------------------------------ 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Tara A. Ryan -S 2018.01.05 11:04:19 -05'00' for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171518 Device Name Spinal Anesthesia Needles, Epidural Anesthesia Needles, Combined Anesthesia Needles ### Indications for Use (Describe) The Epidural Anesthesia Needles are intended to be used for injection into the epidural space/or placing the enidural catheter into the epidural space. The Spinal Anesthesia Needles are intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management. The Combined Anesthesia Needles are intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Exhibit #2 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K171518 - 1. Date of Preparation: 01/02/2017 - 2. Sponsor Identification ## Zhejiang kindly medical devices Co., Ltd. No.758, 5th Binhai Road, Binhai Industrial Park, Longwan District, 325025 Wenzhou, Zhejiang Province, PRC. Establishment Registration Number: Not yet registered Contact Person: Zenghua Zhang Position: General Manager Tel: +86-577-86872005 Fax: +86-577-86374972 Email: zhangzh@kdlchina.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person) Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Spinal Anesthesia Needles Epidural Anesthesia Needles Combined Anesthesia Needles Common Name: Anesthesia conduction needle #### Regulatory Information Classification Name: Anesthesia conduction needle Classification: II; Product Code: BSP; Regulation Number: 21CFR 868.5150 Review Panel: Anesthesiology Intended Use Statement: The Epidural Anesthesia Needles are intended to be used for injection into the epidural space/or placing the epidural catheter into the epidural space. The Spinal Anesthesia Needles are intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management. The Combined Anesthesia Needles are intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space. Device Description The proposed device, Epidural Anesthesia Needles are available in a series combination of needle size and length. The needle tubing is stabilized during puncture with use of an inner stylet. The stylet is withdrawn after the epidural anesthesia needle its anatomical site for neuraxial anesthesia. Then an epidural catheter is introduced into epidural cavities for convenience of injecting anesthetic continuously. The proposed device, Spinal Anesthesia Needles are available in a series combination of needle size and length. The spinal anesthesia needle has a tightly fitting removable stylet that completely occludes the lumen to avoid block. The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic. The needles are available in Sprotte and Quincke two type. {5}------------------------------------------------ The proposed device, Combination Anesthesia Needle are instruments for a spinal (subarachnoid) injection of anesthetics, followed by the placement of an epidural catheter to allow modification of the spinal analgesia if necessary, or continuous infusion of local anesthetics into the epidural space for subsequent pain relief if required. The needles are a matched set. The epidural needle and the spinal needle are locked by conical fitting that enable the spinal needle to be locked into position once the dura has been pierced so that it is secured to the epidural needle to prevent accidental displacement. - ર. Identification of Predicate Devices Predicate Device 1 510(k) Number: K142553 Product Name: Uniever Disposable Epidural Anesthesia Needle Predicate Device 2 510(k) Number: K141126 Product Name: UNIEVER Disposable Spinal Anesthesia Needle Predicate Device 3 510(k) Number: K993619 Product Name: CSEcure™ Combined Spinal/Epidural Anesthesia System with Lock - 6. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - A ISO 9626:1991 AMD 1:2001 Stainless Steel Needle Tubing for the Manufacture of Medical Devices. - A ISO 7864:1993 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- Part 2: Lock fittings - > ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals; - > ASTM F88/88M-09 Standard test method for seal strength of flexible barrier materials; - > ASTM F1140/1140M-13 Standard test methods for internal pressurization failure resistance of {6}------------------------------------------------ unrestrained packages - > USP38-NF33 <85> Bacterial Endotoxins Test - > ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity. - > ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity - > ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity - > ISO 10993-4: 2002/Amd 1: 2006 Biological evaluation of medical devices- Part 4: Selection of tests for interactions with blood - 7. Clinical Test Conclusion No clinical study is included in this submission. {7}------------------------------------------------ #### 8. Substantially Equivalent (SE) Comparison | Item | Proposed Device | Predicate Device 1 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | BSP | K142553 | | Regulation Number | 21 CFR 868.5150 | Same | | Class | II | Same | | Intended Use | The Epidural Anesthesia Needles are intended to be used for injection into the epidural space/or placing the epidural catheter into the epidural space. | The Uniever Disposable Epidural Anesthesia Needle is intended to be used for injection into the epidural space/or placing the epidural catheter into the epidural space. | | Configuration | Stylet Hub Stylet Needle Tube Needle Hub Needle Hub Insert Protective Cap of Needle | Stylet Hub Stylet Needle Tube Needle Hub Needle Hub Insert Protective Cap of Needle | | Needle Gauge | 14G~22G | 14G~25G | | Needle Length | 65mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm, 150mm | 30~160mm | | Sterile | EO Sterilized 10-6 | Same | | Single Use | Single Use | Same | | Needle Tip | Tuohy | Huber, Hustead and Crawford | | Label/Labeling | Conform with 21 CFR 801 | Same | | Biocompatibility | | | | Cytotoxicity | No Cytotoxicity | Conform with ISO 10993 | | Intracutaneous Reactivity | No Intracutaneous Reactivity | | | Skin Sensitization | No Sensitization | | | Acute Systemic Toxicity | No Systemic Toxicity | | | Hemolysis | No Hemolysis | | | Pyrogen | No Pyrogen | | | Item | Proposed Device | Predicate Device 2 | | Product Code | BSP | Same | | Regulation Number | 21 CFR 868.5150 | Same | | Class | II | Same | | Intended Use | The Spinal Anesthesia Needles are intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management. | UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management. | | Configuration | Stylet Hub Stylet Needle Tube Needle Hub Needle Hub Insert Protective Cap of Needle Cannula Needle Tube | Stylet Hub Stylet Needle Tube Needle Hub Needle Hub Insert Protective Cap of Needle Cannula Needle Tube | | Needle Gauge | 18G~27G | 18G~29G | | Needle Length | 40mm, 50mm, 65mm, 70mm, 80mm, 90mm, 120mm | 30~150mm | | Sterile | EO Sterilized 10-6 | Same | | Needle Tip | Quincke and Pencile | Sharp and blunt | | Single Use | Single Use | Same | | Label/Labeling | Conform with 21 CFR 801 | Same | | Biocompatibility | Conform with ISO 10993 | | | Cytotoxicity | No Cytotoxicity | | | Intracutaneous Reactivity | No Intracutaneous Reactivity | | | Skin Sensitization | No Sensitization | | | Acute Systemic Toxicity | No Systemic Toxicity | | | Hemolysis | No Hemolysis | | | Pyrogen | No Pyrogen | | # Table 1 Comparison of Technology Characteristics for Epidural Anesthesia Needles {8}------------------------------------------------ | Table 2 Comparison of Technology Characteristics for Spinal Anesthesia Needles | | | | | |--------------------------------------------------------------------------------|--|--|--|--| | | | | | | {9}------------------------------------------------ | Item | Proposed Device | Predicate Device 3 | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | BSP | K993619 | | Regulation Number | 21 CFR 868.5150 | Same | | Class | II | Same | | Intended Use | The Combined Anesthesia Needles are intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space. | The combined spinal epidural needle kit is intended for injection of local anesthetics into the spinal and epidural spaces of a patient to provide regional anesthesia. The administration of the spinal anesthesia allows rapid anesthesia onset and the placement of an epidural catheter allows for bolus injections or continuous infusion of local anesthetics or other drugs into the epidural space. | | Configuration | Stylet Hub Stylet Needle Tube Needle Hub Needle Hub Insert Protective Cap of Needle Cannula Needle Tube | Stylet Hub Stylet Needle Tube Needle Hub Needle Hub Insert Protective Cap of Needle Cannula Needle Tube | | Needle Gauge and Length | Epidural Needle 14G~18G 60~120mm | Spinal Needle 22G~27G 110~150mm | | | Epidural Needle 17G, 18G | Spinal Needle 26G, 27G 132mm | | | 90mm | | | Sterile | EO Sterilized 10-6 | Same | | Single Use | Single Use | Same | | Label/Labeling | Conform with 21 CFR 801 | Same | | Biocompatibility | | | | Cytotoxicity | No Cytotoxicity | Conform with ISO 10993 | | Intracutaneous Reactivity | No Intracutaneous Reactivity | | | Skin Sensitization | No Sensitization | | | Acute Systemic Toxicity | No Systemic Toxicity | | | Hemolysis | No Hemolysis | | | Pyrogen | No Pyrogen | | | Table 3 Comparison of Technology Characteristics for Combined Anesthesia Needles | | | | | | | |----------------------------------------------------------------------------------|--|--|--|--|--|--| | | | | | | | | {10}------------------------------------------------ From above comparison table, the proposed devices have different combination of needle gauge and needle length compared with predicate devices. However, the different specification will be selected by physician per patient's condition. Therefore, this difference is not considered to affect substantially equivalence. - Substantially Equivalent (SE) Conclusion 9. Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.