(255 days)
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Dr. J Spinal and Epidural Needles are supplied sterile, intended to be single use.
Dr. J Spinal Needles are composed of a stainless-steel cannula, a hub, a stainless-steel stylet and plunger.
A guide needle may be attached to this product. The spinal needle is supplied in either the Quincke Point (=K-3 Point) or the Pencil Point.
The Dr. J Epidural Needle is composed of a stainless-steel cannula with depth marker, a hub, a stainlesssteel stylet, a plunger and a wing. The Dr J Epidural Needle is supplied in Detachable wing type which has a curved needle tip design to protect the catheter from damage during catheterization.
This document is a 510(k) Premarket Notification from Dr. Japan Co., Ltd. for their Dr. J Spinal and Epidural Needles. It argues for substantial equivalence to a predicate device (Myco Medical Supplies, Inc.'s Dr. Japan's Phoenix Spinal & Epidural Needles, K990519). The core argument is that the "new" device is essentially the same as the predicate, with only a "modification to the outer box." As such, this is not a study proving a device meets acceptance criteria as would be done for a novel AI/ML medical device. Instead, it's a demonstration that the new version of an existing device continues to meet the safety and performance standards established for the old (predicate) device.
Therefore, the information regarding acceptance criteria and performance of an AI/ML device, as outlined in your prompt, is not directly applicable to this document. This document describes the "acceptance criteria" and "proof" in terms of adherence to established medical device standards and demonstrating that minor changes to a device do not negatively impact its existing, proven performance.
Here's a breakdown of how the provided text relates to your prompt, modified to reflect the nature of a 510(k) submission for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
This document doesn't provide a table of acceptance criteria in the sense of performance metrics for an AI/ML system (e.g., sensitivity, specificity). Instead, it lists various non-clinical tests performed to ensure the safety and effectiveness of the device (spinal and epidural needles) against established industry standards. The "reported device performance" is a statement that the device "passed all the testing and successfully demonstrate that subject device is as safe, as effective, and performs as well as legally marketed device predicate."
Table: Non-Clinical Testing and Acceptance Criteria (from the document)
| Category | Evaluation | Test Criteria (Acceptance Standard) | Reported Device Performance |
|---|---|---|---|
| Functional Performance | Stability test bonding to hub | ISO 7864 Sterile hypodermic needles for single use -- Requirements and test methods | Passed all testing |
| Stability test bending rigidity | ISO 9626 Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods | Passed all testing | |
| Penetration force and drag force for needles | ISO 7864 Sterile hypodermic needles for single use -- Requirements and test methods | Passed all testing | |
| Breakage test | ISO 9626 Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods | Passed all testing | |
| Fluid leakage test | ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications | Passed all testing | |
| Separation axial load test | ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications | Passed all testing | |
| Separation unscrewing test | ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications | Passed all testing | |
| Overriding test | ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications | Passed all testing | |
| Stability test bonding to hub | ISO 7864 Sterile hypodermic needles for single use -- Requirements and test methods | Passed all testing | |
| Stability test bending rigidity | ISO 9626 Stainless steel needle tubing for the manufacture of medical devices -- Requirements and test methods | Passed all testing | |
| Packaging | Dye Penetration Test | ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration Method A | Passed all testing |
| Seal Strength | EN 868-5:18 Packaging for terminally sterilized medical devices... + ASTM D4169-16 + ASTM F1886/ F1886M-09 | Passed all testing | |
| Transit Test | ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems DC13 | Passed all testing | |
| Sterility | GB/T14233 2-2005 Test methods for medical infusions, blood transfusions and injection device - Part 2: Biological test methods | Passed all testing (demonstrated compliance for sterility) | |
| Residuals | ISO10993-7 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization residuals + O: GB/T14233.1 + ECH: ISO10993-7 | Passed all testing (demonstrated compliance for residuals) | |
| Sterilization | Bioburden | ISO11737-1 Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products | Passed all testing |
| Biocompatibility | Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity | Passed all testing |
| Intracutaneous Reactivity | ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | Passed all testing | |
| Irritation | ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | Passed all testing | |
| Sensitization | ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | Passed all testing | |
| Acute Systemic Toxicity | ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | Passed all testing | |
| Hemolytic | ISO 10993-4 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood | Passed all testing | |
| Pyrogen | ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | Passed all testing |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document refers to "bench testing" and compliance with international standards (ISO, ASTM, EN, and Chinese/Japanese national standards). The sample sizes are not explicitly stated for each test, but it is implied that sufficient samples were tested to meet the requirements of the cited standards. Given the nature of medical device testing (e.g., destructive testing for mechanical properties, sterility, biocompatibility), these test sets are typically derived from production batches.
- Sample Size: Not specified quantitatively for each test, but implied to be sufficient as per the referenced standards (e.g., ISO, ASTM).
- Data Provenance: The document refers to the manufacturer as "Dr. Japan Co., Ltd." with an address in Tokyo, Japan, and "Tianjin Hanaco Medical Co., Ltd." potentially involved in manufacturing. The testing standards cited include those from China (e.g., GB/T14233) and Japan (e.g., ISO10993-7 reference for Japan). Therefore, the data provenance is likely from manufacturing and testing facilities in Japan and China.
- Retrospective or Prospective: These tests are generally prospective, as they are performed on newly manufactured devices specifically for the purpose of demonstrating compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device submission. Ground truth, in the context of an AI/ML device, refers to expert-annotated data for training and evaluating an algorithm's performance. For a physical medical device like a needle, "ground truth" is established by the performance characteristics defined in international standards and verified through laboratory testing. There are no "experts" establishing a "ground truth" for the test set in the way you've described for AI/ML. The experts here are the engineers and quality control personnel performing the tests according to the established protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve disagreements among human annotators or readers for ground truth establishment. For physical devices, "adjudication" is inherent in successfully meeting the specified limits/criteria of the referenced test 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
Not applicable. This is a physical medical device (needles), not an AI/ML system. There are no "human readers" or "AI assistance" involved in its primary function or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is defined by established international and national standards for medical device performance, safety, and biocompatibility. These standards represent a consensus within the medical device industry and regulatory bodies regarding the acceptable physicochemical, mechanical, sterile, and biological properties of such devices. For example, "ISO 7864 Sterile hypodermic needles for single use" defines the performance characteristics that a hypodermic needle must meet. The "proof" is the successful completion of tests demonstrating adherence to these standards.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth for training" for this physical device. The device is manufactured to precise specifications, and its performance is verified through testing against established standards.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 12, 2019
Dr. Japan Co., Ltd. % Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114
Re: K183316
Trade/Device Name: Dr J Spinal and Epidural Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: July 8, 2019 Received: July 9, 2019
Dear Yolanda Smith:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K183316
Device Name Dr J Spinal and Epidural Needle
Indications for Use (Describe)
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia
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."
Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
510(k) Summary
SPONSOR
| Company Name: | Dr. Japan Co., Ltd. |
|---|---|
| Company Address: | 1-1 Kagurazaka, Shinjuku-kuTokyo162-0825 Japan |
| Telephone: | 813-3513-8766 |
| Fax: | 813-3513-8226 |
| Contact Person: | Mitsuko Uchida |
| Summary Preparation Date: | August 2, 2019 |
DEVICE NAME
| Trade Name: | Dr. J Spinal and Epidural Needles |
|---|---|
| Common/Usual Name: | Spinal and Epidural Needles |
| Classification Name: | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Regulation Number: | 21 CFR 868.5150 |
| Product Code: | BSP |
| Device Class: | Class II |
PREDICATE DEVICE
Legally marketed Equivalent Device
| Company | Product | 510(k) # |
|---|---|---|
| Myco Medical Supplies, Inc. | Dr. Japan's Phoenix Spinal & Epidural Needles | K990519 |
DEVICE DESCRIPTION
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia. The Dr. J Spinal and Epidural Needles are supplied sterile, intended to be single use.
Dr. J Spinal Needles are composed of a stainless-steel cannula, a hub, a stainless-steel stylet and plunger.
A guide needle may be attached to this product. The spinal needle is supplied in either the Quincke Point (=K-3 Point) or the Pencil Point.
The Dr. J Epidural Needle is composed of a stainless-steel cannula with depth marker, a hub, a stainlesssteel stylet, a plunger and a wing. The Dr J Epidural Needle is supplied in Detachable wing type which has a curved needle tip design to protect the catheter from damage during catheterization.
{4}------------------------------------------------
DEVICE INDICATIONS FOR USE
Dr. J Spinal and Epidural Needles are intended to be used for injection of local anesthetics into a patient to provide regional anesthesia.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Dr. Japan Co., Ltd. is the manufacturer of the predicate device. This premarket notification represents a modification to the outer box only. The technological characteristics of the predicate device are not changed. The subject device is manufactured using the same inert, biocompatible material as the predicate device. In addition, bench testing was performed (see Section 18) to assure the performance and safety of subject device.
| Subject New Device | Predicate Device | Discussion | |
|---|---|---|---|
| Dr. J Spinal and Epidural Needles | Myco Medical Supplies, Inc. | ||
| K Number | K990519 | ||
| Manufacturer | Dr. Japan Co., Ltd.Tianjin Hanaco Medical Co., Ltd. | Dr. Japan Co., Ltd.Tianjin Hanaco Medical Co., | Same |
| Brand Name | Dr. J Spinal and Epidural Needles | Dr. Japan's Phoenix Spinal andEpidural Needles | |
| RegulationDescription | Anesthesia conduction needle | Anesthesia conduction needle | Same |
| Regulation No. | 21 CFR 868.5150 | 21 CFR 868.5150 | Same |
| Product Code | BSP | BSP | Same |
| Indications forUse | Intended to be used for injection oflocal anesthetics into a patient toprovide regional anesthesia | Intended to be used to inject localanesthetics into a patient toprovide regional anesthesia | Same |
| Principle ofOperation –Spinal Needle | Spinal anesthesia is a form ofregional anesthesia involving theinjection of a local anesthetic intothe subarachnoid space through aspinal needle.Regardless of the anesthetic agentused, the desired effect is to blockthe transmission of afferent nervesignals from peripheralnociceptors. Sensory signals fromthe site are blocked, therebyeliminating pain. | Spinal anesthesia is a form ofregional anesthesia involving theinjection of a local anesthetic intothe subarachnoid space througha spinal needle.Regardless of the anestheticagent used, the desired effect isto block the transmission ofafferent nerve signals fromperipheral nociceptors. Sensorysignals from the site are blocked,thereby eliminating pain. | Same |
| Principle ofOperation –EpiduralNeedle | Epidural anesthesia is a regionalanesthesia that blocks pain in aparticular region of the body. Anepidural needle is used to injectlocal anesthetic agent into theepidural space of the spinal cordto block the pain. To providecontinuous epidural anesthesia, asmall hollow catheter is threaded | Epidural anesthesia is a regionalanesthesia that blocks pain in aparticular region of the body. Anepidural needle is used to injectlocal anesthetic agent into theepidural space of the spinal cordto block the pain. To providecontinuous epidural anesthesia, asmall hollow catheter is threaded | Same |
| through the epidural needle intothe epidural space and left therewhile the needle is removed. | through the epidural needle intothe epidural space and left therewhile the needle is removed. | ||
| IntendedPatientPopulation | Adult and child | Adult and child | Same |
| Material Specifications | |||
| Needle/cannulamaterial | Cold-rolled stainless steel(JIS G4305-SUS304) | Cold-rolled stainless steel(JIS G4305-SUS304) | Same |
| Cannula depthmarkings | The system to cause a chemicalchange of the metal ion on thesurface to a black color byelectrolysis without changing thematerial of cannula. | The system to cause a chemicalchange of the metal ion on thesurface to a black color byelectrolysis without changing thematerial of cannula. | Same |
| Stylet material | Spinal Needle: Stainless steel wirefor springEpidural Needle: Stainless steelwire for spring | Stainless steel wire for springEpidural Needle: Stainless steelwire for spring | Same |
| Stylet hubmaterial | Polycarbonate | Polycarbonate | Same |
| Retaining plate(Plunger) | Polycarbonate | Polycarbonate | Same |
| Final Needleassemblyprotection | Protector (polyethylene) | Protector (polyethylene orpolypropylene) | SimilarMinordifference(*1) |
| SterilizationMethod | Sterile EO (=ETO) | Sterile ETO | Same |
| Sterile package | Peel open type package usinglaminate film of polyester andpolyethylene / Tyvek high densitypolyethylene or medical gradecraft paper | Peel open type package usinglaminate film of polypropylene orpolyethylene / polyethylene ofhigh density or medical gradecraft paper | SimilarMinordifference(*2) |
COMPARISON OF TECHNICAL CHARACTERISTICS
{5}------------------------------------------------
Comparison Table of devices - Subject device
| Dr.J Brand | Item no | Length | Gauge | Point |
|---|---|---|---|---|
| Spinal Needle | 18Gx90mm (3.5") | 3.5" | 18G | K-3 |
| Spinal Needle | 19Gx90mm (3.5") | 3.5" | 19G | K-3 |
{6}------------------------------------------------
| Spinal Needle | 20Gx90mm (3.5") | 3.5" | 20G | K-3 |
|---|---|---|---|---|
| Spinal Needle | 22Gx90mm (3.5") | 3.5" | 22G | K-3 |
| Spinal Needle | 25Gx90mm (3.5") | 3.5" | 25G | K-3/ Pencil |
| Spinal Needle | 26Gx90mm (3.5") | 3.5" | 26G | K-3/ Pencil |
| Spinal Needle | 27Gx90mm (3.5") | 3.5" | 27G | K-3/ Pencil |
| Epidural Needle | 16Gx90mm (3.5") | 3.5" | 16G | Tuohy |
| Epidural Needle | 17Gx90mm (3.5") | 3.5" | 17G | Tuohy |
| Epidural Needle | 18Gx90mm (3.5") | 3.5" | 18G | Tuohy |
| Epidural Needle | 20Gx90mm (3.5") | 3.5" | 20G | Tuohy |
Comparison Table of devices – Predicate device
| Phoenix Brand | Item no | Length | Gauge | Point |
|---|---|---|---|---|
| Spinal Needle | 18Gx90mm (3.5") | 3.5" | 18G | K-3 |
| Spinal Needle | 19Gx90mm (3.5") | 3.5" | 19G | K-3 |
| Spinal Needle | 20Gx90mm (3.5") | 3.5" | 20G | K-3 |
| Spinal Needle | 22Gx90mm (3.5") | 3.5" | 22G | K-3 / Pencil |
| Spinal Needle | 25Gx90mm (3.5") | 3.5" | 25G | K-3/ Pencil |
| Spinal Needle | 26Gx90mm (3.5") | 3.5" | 26G | K-3/ Pencil |
| Spinal Needle | 27Gx90mm (3.5") | 3.5" | 27G | K-3/ Pencil |
| Epidural Needle | 16Gx90mm (3.5") | 3.5" | 16G | Tuohy |
| Epidural Needle | 17Gx90mm (3.5") | 3.5" | 17G | Tuohy |
| Epidural Needle | 18Gx90mm (3.5") | 3.5" | 18G | Tuohy |
| Epidural Needle | 20Gx90mm (3.5") | 3.5" | 20G | Tuohy |
Discussion of Similarities
The subject device and the predicate device have the same intended use, design, technological characteristics and similar materials.
Discussion of Differences
- *1: Predicate device used 2 types of protector, made in either polyethylene or polypropylene while subject device used only 1 type in polyethylene (in same material and specification as predicate device).
- *2: Tyvek high density polyethylene used in subject device showed similar safety and stability as polyethylene of high density used in predicate device. See Section 14 for test results.
- *3: Models of subject device (needle specification, gauge size and length etc.) are all included in the family of predicate device.
{7}------------------------------------------------
SAFETY AND EFFECTIVENESS CONCLUSIONS:
This submission represents only a modification to the outer box for the currently marketed predicate. Therefore, the similarities between the subject device and predicate device are numerous (as shown in the comparison table). These equivalencies combine to justify a substantially equivalent determination.
Shelf life – Packaging testing, Shelf life- Functionality testing and Sterilization (See Section 14 and Section 18) were conducted to show that the safety, integrity or functional characteristics of the subject device is assured.
{8}------------------------------------------------
SUMMARY OF NON-CLINICAL TESTING
Nonclinical testing as shown in the summary below was conducted to ensure the safety and effectiveness of subject device. Subject device passed all the testing and successfully demonstrate that subject device is as safe, as effective, and performs as well as legally marketed device predicate.
| Category | Evaluation | Test Criteria |
|---|---|---|
| FunctionalPerformance | Stability test bonding tohub | ISO 7864 Sterile hypodermic needles for single use --Requirements and test methods |
| Stability test bendingrigidity | ISO 9626 Stainless steel needle tubing for themanufacture of medical devices -- Requirements and testmethods | |
| Penetration force and dragforce for needles | ISO 7864 Sterile hypodermic needles for single use --Requirements and test methods | |
| Breakage test | ISO 9626 Stainless steel needle tubing for themanufacture of medical devices -- Requirements and testmethods | |
| Fluid leakage test | ISO 80369-7 Small-bore connectors for liquids andgases in healthcare applications -- Part 7: Connectors forintravascular or hypodermic applications | |
| Separation axial load test | ISO 80369-7 Small-bore connectors for liquids andgases in healthcare applications -- Part 7: Connectors forintravascular or hypodermic applications | |
| Separation unscrewingtest | ISO 80369-7 Small-bore connectors for liquids andgases in healthcare applications -- Part 7: Connectors forintravascular or hypodermic applications | |
| Overriding test | ISO 80369-7 Small-bore connectors for liquids andgases in healthcare applications -- Part 7: Connectors forintravascular or hypodermic applications | |
| Stability test bonding tohub | ISO 7864 Sterile hypodermic needles for single use --Requirements and test methods | |
| Stability test bendingrigidity | ISO 9626 Stainless steel needle tubing for themanufacture of medical devices -- Requirements and testmethods | |
| Dye Penetration Test | ASTM F 1929-15 Standard Test Method for DetectingSeal Leaks in Porous Medical Packaging by DyePenetration Method A | |
| Seal Strength: | EN 868-5:18 Packaging for terminally sterilized medicaldevices. Sealable pouches and reels of porous andplastic film construction. Requirements and test methodsAnnex DASTM D4169-16 Standard Practice for PerformanceTesting of Shipping Containers and Systems DC13ASTM F1886/ F1886M-09 Standard Test Method forDetermining Integrity of Seals for Flexible Packaging byVisual Inspection. | |
| Packaging | Transit Test | |
| Sterility | GB/T14233 2-2005 Test methods for medicalinfusions, blood transfusions and injection device - Part 2:Biological test methods | |
| Residuals | ISO10993-7 Biological evaluation of medicaldevices -- Part 7: Ethylene oxide sterilization residuals EO: GB/T14233.1 Test methods for medicalinfusions, blood transfusions and injection device - Part 1:Chemical analysis methodECH: ISO10993-7 Biological evaluation of medicaldevices -- Part 7: Ethylene oxide sterilization residuals | |
| Sterilization | ||
| Bioburden | ISO11737-1 Sterilization of health care products --Microbiological methods -- Part 1: Determination of apopulation of microorganisms on products | |
| Biocompatibility | Cytotoxicity | ISO 10993-5 Biological evaluation of medical devices --Part 5: Tests for in vitro cytotoxicity |
| Intracutaneous Reactivity | ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | |
| Irritation | ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | |
| Sensitization | ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization | |
| Acute Systemic Toxicity | ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity | |
| Hemolytic | ISO 10993-4 Biological evaluation of medical devices --Part 4: Selection of tests for interactions with blood | |
| Pyrogen | ISO 10993-11 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity |
Summary of Non-Clinical Testing
{9}------------------------------------------------
SUBSTANTIAL EQUIVALENCE CONCLUSION
The evaluation of subject device classification, indications for use, and technological characteristics demonstrate substantial equivalence to the predicate device. The only difference between marketed predicate device and subject device is a modification to the outer box.
No new issues of safety and effectiveness questions are raised by the subject device when compared to the predicate device.
§ 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).