(226 days)
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.
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 The stylet is withdrawn after the epidural anesthesia needle its anatomical site for neuraxial anesthesia.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 The stylet is withdrawn after the spinal anesthesia needle has penetrated into the subarachnoid space for injecting anesthetic.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.
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.
Here's the information about the acceptance criteria and study as extracted from the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Epidural Anesthesia Needles | |
| Needle Gauge | 14G |
| Needle Length | 65mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm, 150mm (Proposed device), 30~160mm (Predicate) |
| Sterile | EO Sterilized, 10-6 |
| Single Use | Single Use |
| Needle Tip | Tuohy (Proposed device), Huber, Hustead and Crawford (Predicate) |
| Label/Labeling | Conform with 21 CFR 801 |
| Biocompatibility: Cytotoxicity | No Cytotoxicity |
| Biocompatibility: Intracutaneous Reactivity | No Intracutaneous Reactivity |
| Biocompatibility: Skin Sensitization | No Sensitization |
| Biocompatibility: Acute Systemic Toxicity | No Systemic Toxicity |
| Biocompatibility: Hemolysis | No Hemolysis |
| Biocompatibility: Pyrogen | No Pyrogen |
| Spinal Anesthesia Needles | |
| Needle Gauge | 18G |
| Needle Length | 40mm, 50mm, 65mm, 70mm, 80mm, 90mm, 120mm (Proposed device), 30~150mm (Predicate) |
| Sterile | EO Sterilized, 10-6 |
| Needle Tip | Quincke and Pencile (Proposed device), Sharp and blunt (Predicate) |
| Single Use | Single Use |
| Label/Labeling | Conform with 21 CFR 801 |
| Biocompatibility: Cytotoxicity | No Cytotoxicity |
| Biocompatibility: Intracutaneous Reactivity | No Intracutaneous Reactivity |
| Biocompatibility: Skin Sensitization | No Sensitization |
| Biocompatibility: Acute Systemic Toxicity | No Systemic Toxicity |
| Biocompatibility: Hemolysis | No Hemolysis |
| Biocompatibility: Pyrogen | No Pyrogen |
| Combined Anesthesia Needles | |
| Epidural Needle Gauge and Length | 14G |
| Spinal Needle Gauge and Length | 22G |
| Sterile | EO Sterilized, 10-6 |
| Single Use | Single Use |
| Label/Labeling | Conform with 21 CFR 801 |
| Biocompatibility: Cytotoxicity | No Cytotoxicity |
| Biocompatibility: Intracutaneous Reactivity | No Intracutaneous Reactivity |
| Biocompatibility: Skin Sensitization | No Sensitization |
| Biocompatibility: Acute Systemic Toxicity | No Systemic Toxicity |
| Biocompatibility: Hemolysis | No Hemolysis |
| Biocompatibility: Pyrogen | No Pyrogen |
| General acceptance criteria for all device types (implied by compliance to standards) | |
| Stainless Steel Needle Tubing | Complies with ISO 9626:1991 AMD 1:2001 |
| Sterile Hypodermic Needles for Single Use | Complies with ISO 7864:1993 |
| Conical fittings (Luer) Part 1: General requirements | Complies with ISO 594-1:1986 |
| Conical fittings (Luer) Part 2: Lock fittings | Complies with ISO 594-2:1998 |
| Ethylene oxide sterilization residuals | Complies with ISO 10993-7:2008 |
| Seal strength of flexible barrier materials | Complies with ASTM F88/88M-09 |
| Internal pressurization failure resistance of unrestrained packages | Complies with ASTM F1140/1140M-13 |
| Bacterial Endotoxins Test | Complies with USP38-NF33 <85> |
| Biological evaluation of medical devices (in vitro cytotoxicity) | Complies with ISO 10993-5:2009 |
| Biological evaluation of medical devices (irritation and delayed-type hypersensitivity) | Complies with ISO 10993-10:2010 |
| Biological evaluation of medical devices (systemic toxicity) | Complies with ISO 10993-11:2006 |
| Biological evaluation of medical devices (interactions with blood) | Complies with ISO 10993-4: 2002/Amd 1: 2006 |
2. Sample Size Used for the Test Set and the Data Provenance
The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." However, specific sample sizes for these non-clinical tests are not provided in the given text. The data provenance is also not explicitly stated beyond referring to international and US standards. It can be inferred that these non-clinical tests were conducted in a laboratory setting. The study is retrospective in the sense that it relies on existing predicate devices for comparison and established standards, rather than new prospective human trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The study relies on compliance with recognized standards and non-clinical testing rather than expert-derived ground truth based on patient data.
4. Adjudication Method for the Test Set
This information is not applicable as the study did not involve human interpretation of results requiring adjudication. It focused on objective performance against technical standards.
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
No MRMC comparative effectiveness study was done. This document pertains to the clearance of medical needles, which are physical devices, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the submission is for physical medical needles, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests appears to be defined by:
- Compliance with established international and US standards (e.g., ISO, ASTM, USP).
- Comparison to predicate devices in terms of technical characteristics and performance (e.g., biocompatibility test results like "No Cytotoxicity").
8. The sample size for the training set
This information is not applicable as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI/machine learning device.
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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
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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
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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)
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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
-
- Date of Preparation: 01/02/2017
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
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
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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.
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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
-
- 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:
- Non-Clinical Test Conclusion
-
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
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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
-
- Clinical Test Conclusion
No clinical study is included in this submission.
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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 areintended to be used for injection intothe epidural space/or placing theepidural catheter into the epiduralspace. | The Uniever Disposable EpiduralAnesthesia Needle is intended tobe used for injection into theepidural space/or placing theepidural catheter into the epiduralspace. |
| Configuration | Stylet HubStyletNeedle TubeNeedle HubNeedle Hub InsertProtective Cap of Needle | Stylet HubStyletNeedle TubeNeedle HubNeedle Hub InsertProtective Cap of Needle |
| Needle Gauge | 14G~22G | 14G~25G |
| Needle Length | 65mm, 70mm, 80mm, 90mm,100mm, 110mm, 120mm, 150mm | 30~160mm |
| Sterile | EO Sterilized10-6 | 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 areintended to be used for injection oflocal anesthetic agent into thesubarachnoid cavity for painmanagement. | UNIEVER Disposable SpinalAnesthesia Needle is intended tobe used for injection of localanesthetic agent into thesubarachnoid cavity for painmanagement. |
| Configuration | Stylet HubStyletNeedle TubeNeedle HubNeedle Hub InsertProtective Cap of NeedleCannula Needle Tube | Stylet HubStyletNeedle TubeNeedle HubNeedle Hub InsertProtective Cap of NeedleCannula Needle Tube |
| Needle Gauge | 18G~27G | 18G~29G |
| Needle Length | 40mm, 50mm, 65mm, 70mm, 80mm,90mm, 120mm | 30~150mm |
| Sterile | EO Sterilized10-6 | 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
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| Table 2 Comparison of Technology Characteristics for Spinal Anesthesia Needles | ||||
|---|---|---|---|---|
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| 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 HubStyletNeedle TubeNeedle HubNeedle Hub InsertProtective Cap of NeedleCannula Needle Tube | Stylet HubStyletNeedle TubeNeedle HubNeedle Hub InsertProtective Cap of NeedleCannula Needle Tube |
| Needle Gauge and Length | Epidural Needle14G | Spinal Needle22G |
| Epidural Needle17G, 18G | Spinal Needle26G, 27G132mm | |
| 90mm | ||
| Sterile | EO Sterilized10-6 | 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 | ||||||
|---|---|---|---|---|---|---|
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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.
§ 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).