(357 days)
The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.
The ASCPO Needle is a single lumen needle intended to inject fluids subcutaneously. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe.
The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer-slip and luer-lock syringes. Additionally, after withdrawal of the needle from the body, the needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.
The provided document describes the acceptance criteria and the study that proves the CCBIO ASCPO Needle meets these criteria, primarily focusing on its safety and performance aspects for its 510(k) submission (K214004) to the FDA.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on compliance with various international standards and internal specifications, rather than numerical performance metrics for a diagnostic algorithm. The device performance is reported as meeting these standards.
| Acceptance Criteria (Related to Performance) | Reported Device Performance |
|---|---|
| Sharps Injury Protection (SIP) Feature | The ASCPO Needle has a passive sharps protection feature that covers the cannula immediately and permanently after use. It was demonstrated to comply with FDA SIP Guidance and ISO 23908 standard. |
| Simulated Clinical Use Study (Failure Rate) | True failure rate (of the SIP feature) no higher than 0.7% with 97.5% confidence, and no higher than 1.1% with 99.5% confidence. |
| Compliance with ISO 23908:2016 (Sharps Injury Protection) | Tested and demonstrated compliance, including: Testing access to the sharp in safe mode, Security of safe mode protection, Challenging the device in safe mode, Testing simulated clinical use. |
| Compliance with ISO 7864:2016 (Sterile Hypodermic Needles) | Tested and demonstrated compliance, including: Cleanliness, Limits for acidity or alkalinity, Limits for extractable metals, Size designation, Color coding, Conical fitting, Effective needle length, Lubricant, Needle point, Bond between hub and needle tube, Patency of lumen, Sharps injury protection, Sterility, Biocompatibility. |
| Compliance with ISO 9626:2016 (Stainless Steel Needle Tubing) | Tested and demonstrated compliance, including: Surface finish and visual appearance, Cleanliness, Limits for acidity or alkalinity, Stiffness, Resistance to breakage, Resistance to corrosion. |
| Compliance with ISO 80369-7:2021 (Small-bore connectors) | Tested and demonstrated compliance, including: Leakage by pressure decay, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to unscrewing, Resistance to overriding. |
| Human Factor Study (Usability/Operation) | Meets all operation and usability requirements as recommended in TDICT SIP Evaluation plan. Labeling is effective and strongly likely to be read, user interface is well understood without prior education, provides sufficient information for safe and effective use. |
| Biocompatibility | Tested according to ISO 10993-1 and specific parts (Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Hemolysis, Ethylene oxide sterilization residuals). Met acceptance criteria. |
| Sterility | Assured by validated method (ISO 11135:2014) with SAL 10-6. EO and ECH residuals tested per ISO 10993-7:2008 and met criteria. |
| Shelf Life | Validated for 3 years. |
| Packaging | Tested according to ISO 11607-1 and ASTM D4169-22. |
| Particulate Matter | Tested according to USP 788. |
| Pyrogen Test | Tested according to USP<151>. |
| Measuring the penetration force | Meet internal CCBio specification. |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size:
- Simulated Clinical Use Study: 500 simulated injections.
- Human Factor Study: Not explicitly stated as a numerical 'sample size' for a test set, but it states "5 enrolled qualified evaluators." This implies the "sample" here refers to the number of users testing the device.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document mentions "510(k) summary... prepared at June 06, 2017" and the submitter's address is in Tainan, Taiwan. The studies are described as "non-clinical tests verification activities" and "Clinical Test Validation Activities." It's unclear if these were truly "clinical" studies in humans through a prospective trial, or simply simulated/human factor lab studies. Given the device type (a needle), it's highly likely these are laboratory-based validation tests and human factor assessments rather than large-scale patient-based clinical trials often associated with "clinical test validation" for other device types. The "Simulated Clinical Use Study" strongly suggests a laboratory simulation rather than real patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device validation does not involve establishing "ground truth" in the way an AI diagnostic algorithm would (e.g., through radiologists' consensus on images). Instead, the "ground truth" for a medical device like a needle is adherence to established engineering, material, and safety standards.
- For the Human Factor Study, "5 enrolled qualified evaluators" were used. Their specific qualifications (e.g., healthcare professionals, engineers, lay users) are not detailed beyond "qualified evaluators." They completed "TDICT SIP Evaluation Forms."
4. Adjudication Method for the Test Set
Not applicable in the context of this device's validation. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in diagnostic imaging studies where expert readers independently review data, and conflicts are resolved by additional readers or consensus. This validation focuses on objective performance against engineering standards and user feedback, not diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No, an MRMC comparative effectiveness study was not performed. This type of study is specific to evaluating the impact of AI on human reader performance in diagnostic tasks and is not relevant for a medical device like a hypodermic needle. The human factor study assessed usability and safety features.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Not applicable. This is a physical medical device (a hypodermic needle), not a diagnostic algorithm or AI system. Its "performance" is inherent to its design, materials, and mechanical function, which were tested against defined standards independently (e.g., ISO standards).
7. The Type of Ground Truth Used
The "ground truth" for this medical device is the compliance with established international and FDA-recognized standards and internal specifications. For example:
- Engineering standards: ISO 23908 (sharp injury protection), ISO 7864 (hypodermic needles), ISO 9626 (needle tubing), ISO 80369-7 (small-bore connectors).
- Safety standards: ISO 10993 series (biocompatibility), ISO 11135 (sterilization), FDA guidance on SIP features.
- Objective measurements: Failure rates in simulated use, physical properties (e.g., bond strength, penetration force, leakage).
- User feedback: From qualified evaluators in the Human Factor Study.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a physical medical device, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.
December 13, 2022
CC Biotechnology Corporation Judy Cheng Regulatory Associate No. 68, Gongye 5th Rd., Annan Dist. Tainan. 709015 Taiwan
Re: K214004
Trade/Device Name: CCBIO ASCPO Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 18, 2022 Received: November 21, 2022
Dear Judy Cheng:
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 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
{1}------------------------------------------------
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 mediation-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,
Alan M.
Stevens -S3
CAPT Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K214004
Device Name CCBIO ASCPO Needle
Indications for Use (Describe)
The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.
| 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}------------------------------------------------
This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 at June 06, 2017.
The assigned 510(k) number is: K214004
-
- Submitter's Identifications:
| Applicant' Name: | CC Biotechnology Corporation |
|---|---|
| Address: | No. 68, Gongye 5th Rd., Annan Dist., Tainan City 709015,Taiwan (R.O.C). |
| Telephone: | 886-6-3845868 |
| Fax: | 886-6-3843968 |
| Official Correspondent: | Edgar Yeh |
| Date Prepared: | November 18, 2022 |
2. Name of the Device:
| Trade/Proprietary Name: | CCBIO ASCPO Needle, model BA-2001 |
|---|---|
| Common Name: | Single Lumen Hypodermic Needle |
| Classification Regulations: | Needle, Hypodermic, Single LumenClass II, 21 CFR 880.5570 |
| Product Code: | FMI |
| Classification Panel: | General hospital and personal use devices |
3 Device Description:
The ASCPO Needle is a single lumen needle intended to inject fluids subcutaneously. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe.
The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer-slip and luer-lock syringes. Additionally, after withdrawal of the needle from the body, the needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.
4. Intended Use:
The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose, and used for adults only. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.
-
- Information of the 510(k) Cleared Device (Predicate Device):
- BD Eclipse™ Needle (K100209). O
The reason for choosing BD Eclipse™ Needle (K100209) as the SE predicate model is because that the new ASCPO Needle and BD Eclipse™ Needle (K100209) have the same claim of indication for use for which both two models are claimed for prescription use of general purpose injection, and are compatible for use with standard luer-slip and luer-lock syringes.
6. Overall comparison table:
| ATTRIBUTE / | ASCPO Needle | BD Eclipse™ Hypodermic | Substantial Equivalence(SE) |
|---|---|---|---|
| CHARACTERISTIC | (Submitted Product) | Needle (Predicate Device) | Comparison |
| 'K" numbers | K214004 | K100209 | No Comment |
| Manufacturer | CC Biotechnology | Becton Dickison | No Comment |
| Intended Use | For use in the subcutaneousinjection of fluid for medicalpurpose, and used for adults. TheASCPO Needle is compatible foruse with standard luer slip and luerlock syringes. | Used for general purposeinjection and aspiration of fluidfrom vials, ampoules and parts ofthe body below the surface of theskin. The BD Eclipse Needle withSmartSlip™ Technology iscompatible for use with standardluer-slip and luer-lock syringes. | Similar, since they weredesigned for general injectionand are compatible for usewith luer-slip and luer-locksyringes. |
| OperatingPrinciple | This device is single lumen needleintended to inject fluidssubcutaneously and it has apassive sharps protection featurethat covers the cannulaimmediately and permanently afteruse | Composed of a typicalhypodermic needle with aone-piece hub/adapter andpivoting cover that is connectedto the adapter. When assemblethe plastic clip into the hub, theclip ensures that the needle isattached to a luer slip syringewith sufficient force by the user.The pivoting safety cover can bemanually rotated forward afteruse allowing for secureencapsulation of the needlepointmaking the product safe fordisposal | Different but not render non-substantial equivalence,since new device was testedand demonstrated to complywith FDA SIP Guidance andISO 23908 standard. |
| SIP Feature | passive sharps protection featurethat covers the cannulaimmediately and permanently afteruse | The pivoting safety cover can bemanually rotated forward afteruse allowing for secureencapsulation of the needlepointmaking the product safe fordisposal. | Different but not render non-substantial equivalence,since new device was testedand demonstrated to complywith FDA SIP Guidance andISO 23908 standard. |
| Connector type | Luer lock and luer slip | Luer lock and luer slip | Similar |
| Color coding | Per ISO 6009 | Per ISO 6009 | Similar |
| Tip configuration | triple sharpened,non-coring | triple sharpened,non-coring | Similar |
| Materials | Hub: Styrene ButadieneCopolymerCap: Polyoxymethylene | Hub: PolypropyleneCannula: Stainless SteelCannula Lubricant: Silicone | Different but no significantimpact on SE comparison. |
| Cannula: Stainless Steel | Needle/Safety Shield: | ||
| Cannula Lubricant: Silicone | Polypropylene | ||
| Needle/Safety Shield: | |||
| Polyoxymethylene | |||
| Adhesive: UV Acrylic | |||
| Specification | Needle Length: 1/2" | Needle Length: 1/2"- 1 ½ | Different but no significant |
| Needle Gauge: 27 Gauge | Needle Gauge: 18-30 Gauge | impact on SE comparison. | |
| Bevel: Regular, Short, | |||
| Intradermal | |||
| Packaging | Sterilization pouch | Sterilization pouch | Different but no significant |
| Shelf carton | Shelf carton | impact on SE comparison. | |
| Case carton | Case carton | ||
| Functional | ISO 23908:2011 | Hub/Needle Bond Strength: Met | Different but no significant |
| testing | ISO 7864:2016 | internal BD specification | impact on SE comparison, |
| ISO 9626:2016 | Needle Penetration Test: Met | since new device was tested | |
| ISO 80369-7:2021 | internal BD specification | and demonstrated to comply | |
| Measuring the penetration force: | Needle Shield Removal Forces: | with the related FDA | |
| Meet internal CCBio specification | Met internal BD specification | recognized ISO standards | |
| Leak Testing: Per ISO 594-2 | |||
| Sterilization | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Similar |
| SAL Level | SAL 10-6 | SAL 10-6 | Similar |
| Shelf Life | 3 Years | 5 Years | Different but no significant |
| impact on SE comparison. | |||
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Similar |
| Used as Rx or | Rx(Prescription Use) | Rx(Prescription Use) | Similar |
| OTC |
{4}------------------------------------------------
{5}------------------------------------------------
7. Comparison to the 510(k) Cleared Device (Predicate Device):
As per reasons for choosing BD Eclipse™ Needle (K100209), we conducted further comparison as follows :
● Comparison of Indication for use.
Based on this, the comparison for the indication for use between new and predicate model was provided hereafter.
| Model | ASCPO Needle(Submitted Product) | BD Eclipse™ Hypodermic Needle (Predicate Device) |
|---|---|---|
| 510(k) No. | K214004 | K100209 |
| Prescription or OTC | Prescription | Prescription |
{6}------------------------------------------------
| Indication for use | For use in the subcutaneousinjection of fluid for medicalpurpose. The ASCPO Needle iscompatible for use with standardluer slip and luer lock syringes. | Used for general purposeinjection and aspiration of fluidfrom vials, ampoules and parts ofthe body below the surface of theskin. The BD Eclipse Needle withSmartSlip™ Technology iscompatible for use with standardluer slip and luer lock syringes. |
|---|---|---|
| FDA product code | FMI | FMI |
Brief comparison result:
Based on comparison information as above mentioned, it is very clear that the "Indication for Use" for the new devices and 510(k) cleared devices are considered as "Substantially Equivalent", even though the Indication for use statement is not completely identical. The determination of substantial equivalence in indication for use is because of the following reasons:
- 1> Both these two models were designed for "general purpose injection"
- 2> Both these two models were claimed for "Prescription Use"
- 3> Both these two models were classified as FDA "FMI" product code.
- 4> Both these two models were compatible for use with standard luer slip and luer lock syringes.
{7}------------------------------------------------
O Comparison of the Technology Aspect.
| The comparison for the technology aspect between new and predicate model was as the | ||
|---|---|---|
| following table. |
| Model | ASCPO Needle(Submitted Product) | BD EclipseTM HypodermicNeedle (Predicate Device) |
|---|---|---|
| 510(k) No. | K214004 | K100209 |
| Operationprinciple | This device is single lumen needleintended to inject fluidssubcutaneously and it has a passivesharps protection feature thatcovers the cannula immediately andpermanently after use | When assemble the plastic clip intothe hub, the clip ensures that theneedle is attached to a luer slipsyringe with sufficient force by theuser. The pivoting safety cover canbe manually rotated forward afteruse allowing for secureencapsulation of the needlepointmaking the product safe for disposal |
| SIP feature | passive sharps protection featurethat covers the cannula immediatelyand permanently after use | The pivoting safety cover can bemanually rotated forward after useallowing for secure encapsulation ofthe needlepoint making the productsafe for disposal. |
| Compliancestandard | ISO 23908 & FDA guidance for SIP | ISO 23908 & FDA guidance for SIP |
Brief comparison result:
In the actual device construction, there may be some in the SIP mechanism, namely K100209 is an activate type safety needle, but ASCPO Needle is a passive type safety needle. However, the SIP feature for both models was designed according to ISO 23908 standard and FDA Specific guidance for SIP feature. Therefore, we concluded that the ASCPO Needle is substantially equivalent with BD Eclipse™ Hypodermic needle(K100209) in the main technology aspect.
{8}------------------------------------------------
8. Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of the devices is as follows:
Biocompatibility has been tested according to the requirements of ISO10993-1. In consideration of the International Standard ISO 10993-1, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing, following biocompatibility tests were performed on the finished device to evaluate: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity and Hemolvsis
The sterility of the ASCPO Needle is assured by using a validated sterilization method which complies with the requirements of the FDA Recognized Consensus Standard: ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices. Ethylene oxide (EO) and Ethylene Chlorohydrin (ECH) residuals were tested according to ISO 10993-7: 2008 and met the acceptance criteria.
Meanwhile ASCPO Needle was tested to demonstrate to comply with the following standards: - ISO 23908:2016 "Sharp Injury protection- Requirements and test methods - SIP features for single use hypodermic needles,
-
ISO 7864:2016 "Requirements and test methods Sterile hypodermic needles for single use".
-
ISO 9626:2016 "Stainless steel needle tubing for the manufacture of medical devices.
-
ISO 80369-7:2021 "Small-bore connectors for liquids and gases in healthcare applications. Part 7: Connectors for intravascular or hypodermic applications."
-
ISO 10993-10: 2010 "Biological evaluation of medical devices Part 10: Tests for skin Sensitization."
-
ISO 10993-11: 2017 "Biological evaluation of medical devices Part 11: Tests for systemic toxicity."
-
ISO 10993-5: 2009 "Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity."
-
ISO 10993-7: 2008 "Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals."
-
USP<151>: 2020 "Pvrogen test."
-
ISO 11135: 2014 "Sterilization of health care products Ethylene oxide Requirements for development, validation and routine control of a sterilization process for medical devices."
-
ISO 11607-1: 2019 "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems,"
-
ASTM D4169-16 "Standard Practice for Performance Testing of Shipping Containers and Systems."
-
USP 788" Particulate Matter in Injections "
| Standard | Test Performed |
|---|---|
| ISO 7864: 2016 | Cleanliness |
| Limits for acidity or alkalinity | |
| Limits for extractable metals | |
| Size designation | |
| Color coding | |
| Conical fitting (per ISO 80369-7: 2021) | |
| Effective needle length | |
| Lubricant | |
| Needle point | |
| Bond between hub and needle tube | |
| Patency of lumen | |
| Sharps injury protection (per ISO 23908: 2011) | |
| Sterility | |
| Biocompatibility | |
| ISO 9626: 2016 | Surface finish and visual appearance |
| Cleanliness | |
| Limits for acidity or alkalinity | |
| Stiffness | |
| Resistance to breakage | |
| Resistance to corrosion | |
| ISO 80369-7: 2021 | Leakage by pressure decay |
| Sub-atmospheric pressure air leakage | |
| Stress cracking | |
| Resistance to separation from axial load | |
| Resistance to separation from unscrewing | |
| Resistance to overriding | |
| ISO 23908: 2011 | Testing access to the sharp in safe mode |
| Security of safe mode protection | |
| Challenging the device in safe mode | |
| Testing simulated clinical use | |
| ISO 10993-10: 2010 | Tests for skin sensitization |
| ASTM F756-17 | Standard Practice for Assessment of Hemolytic Properties of |
| Materials | |
| ISO 10993-11: 2017 | Tests for systemic toxicity |
| ISO 10993-5: 2009 | Tests for in vitro cytotoxicity |
| USP<151>: 2020 | Pyrogen test |
| ISO 11135: 2014 | Validation and routine control of a sterilization process for medical |
| devices | |
| ISO 10993-7: 2008 | Ethylene oxide sterilization residuals |
| ISO 11607-1 | Tests for materials, sterile barrier systems and packaging |
| systems. | |
| ASTM D4169-22 | Performance Testing of Shipping Containers and Systems. |
| USP 788 | Particulate Test |
The tests completed under each standard as shown in the table below:
{9}------------------------------------------------
Additionally, the shelf-life validation reports were also included in the submission to demonstrate that the ASCPO Needle is adequate for use as claimed 3 years life time.
Discussion: The Compliance to applicable voluntary standards as above mentioned indicates that the new device in this submission used the same standards as that of predicate device.
{10}------------------------------------------------
Therefore; we consider that the compliance of standards included in our submission is adequate for the determination of substantial equivalence.
9. Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of Device is as follows:
The Simulated Clinical Use Study and Human Factor Study were conducted and performed according to the method as recommended in the FDA specific guidance, entitle "Medical Devices with Sharps Injury Preventive Features".
For the Simulated Clinical Use Testing, 500 simulated injections were completed. The testing data indicated that no any failure was observed in a test run of 500 devices, so it would be 97.5% confident that the true failure rate was no higher than 0.7% and 99.5% confident that it was no higher than 1.1% based on the statistical data as presented in the Simulated Clinical Use Test Report. This testing result complies with the acceptance requirement as specified in the FDA guidance for SIP features as above mentioned.
For the Hunan Factor Study, TDICT SIP Evaluation Forms were completed by 5 enrolled qualified evaluators according to the validation study protocol. The investigation results demonstrated that the ASCPO Needle meets all the operation and usability requirements as recommended in TDICT SIP Evaluation plan, the labeling is effective and strongly likely to be read, that the user interface is well understood by potential user without prior education, and that it provides sufficient information and/or is designed as expected by end-users for a safe and effective use of the device.
10. Summary for the technology comparison.
Based on the evidence conducted and completed for the non-clinical and clinical test validation activities as above mentioned, we draw up the summary that the ASCPO Needle was designed, manufactured, verified and validated to comply with the main technology requirements as specific FDA guidance, entitle "Medical Devices with Sharps Injury Preventive Features" as well as the product related FDA recognized standards namely ISO 10993-1 & related biocompatibility test standards, ISO 11135, ISO 23908, ISO 7864, ISO 9626, ISO 80369-7, ISO 10993-10, ISO 10993-11, ISO 10993-5, ISO 10993-7, USP<151>, ISO 11135, ISO 11607-1, ASTM D4169-22 and USP 788.
Therefore, we concluded that the ASCPO Needle new device is substantially equivalent to the predicate device in the technology aspect.
11. Conclusions
The details of assessments and testing as above mentioned were included in the whole package of this 510(k) submission. Through the detailed assessments and testing as mentioned above, we believe we have provided sufficient information to prove "SE" (Substantial Equivalence) for the ASCPO Needle new device and the chosen predicate devices as mentioned in this 510(k) summary.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).