(85 days)
The needle is used to access surgically implanted vascular ports.
Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.
In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.
Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle.
The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B and Type C), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.
The provided text describes a 510(k) premarket notification for the Promisemed Safety Huber Needle. This document focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device (Surecan Safety II, K170897) rather than providing a detailed study proving the device meets specific acceptance criteria for a novel technology.
The 510(k) clearance process does not typically involve a comparative effectiveness study (MRMC) with human readers or standalone AI performance studies, as it's for devices demonstrating substantial equivalence to pre-existing products, not necessarily for proving the clinical utility or superiority of a new diagnostic algorithm.
Therefore, the requested information about acceptance criteria and a study proving device performance in a clinical diagnostic context (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies) is not applicable to this type of device and submission. The "performance" discussed in this document refers to the adherence to engineering and safety standards.
However, I can extract the relevant "acceptance criteria" and "device performance" in the context of this 510(k) submission, which focuses on various engineering, material, and safety tests to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided document, noting where aspects are not applicable (N/A) due to the nature of a 510(k) submission for a physical medical device like a needle:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Compliance) |
|---|---|
| ISO 8536-4:2019 (Infusion sets for single use, gravity feed) | Complied |
| ISO 80369-7:2021 (Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications) | Complied |
| ISO 23908:2011 (Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling) | Complied (Specifically addresses sharps protection feature for Type B safety mechanism) |
| ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods) | Complied |
| ISO 7864:2016 (Sterile hypodermic needles for single use Requirements and test methods) | Complied |
| ANSI/AAMI CN27:2021 (General Requirements For Luer Activated Valves (LAVs) Incorporated Into Medical Devices For Intravascular Applications) | Complied |
| ASTM F3212-16 (Coring Testing of Huber Needles) | Complied |
| Power injection flow rate testing (non-standardized test) | Verified flow rate under 330 psi; 19, 20 gauge - 5mL/s; 22 gauge - 2 mL/s |
| USP <85> Bacterial Endotoxin Test | Complied (Pyrogen: Non pyrogenic) |
| Biocompatibility (ISO 10993 Series): | |
| ISO 10993-1: Classification | External communicating device, in contact with circulating blood with prolonged duration |
| ISO 10993-5:2009 (Tests for in Vitro Cytotoxicity) | No cytotoxicity |
| ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization) | No evidence of skin irritation, No evidence of sensitization |
| ISO 10993-11:2017 (Tests for systemic toxicity - Acute and Subchronic systemic toxicity) | No systemic toxicity |
| ISO 10993-3:2014 (Tests for genotoxicity, carcinogenicity and reproductive toxicity - Genotoxicity Test) | No evidence of mutagenicity |
| ISO 10993-4:2017 (Selection of tests for interactions with blood) | No evidence of hemolysis |
| ISO 10993-6:2016 (Tests for local effects after implantation) | No abnormal symptoms at the implantation site |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Complied |
| USP NF 2021 chapter <151> (Pyrogen Test) | Non pyrogenic |
| USP <788> (Particulate matter in injections) | Complied |
| Sterilization, Shipping, and Shelf-Life: | |
| ISO 11135:2014 (Sterilization of health-care products Ethylene oxide) | EO Sterilization, SAL = 10-6 (Complied) |
| Sterile Barrier Packaging Testing (Seal strength ASTM F88/F88-15) | Complied |
| Sterile Barrier Packaging Testing (Dye penetration ASTM F1929-15) | Complied |
| Sterility test USP39 <71> | Complied |
| Shelf life validation (ASTM F1980-16) | 3 years shelf life validated |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each test. For medical device testing against standards (like ISO or ASTM), sample sizes are generally specified by the standard or determined through a statistical rationale to ensure confidence in the results. This is common for bench testing.
- Data Provenance: The tests are "bench testing," meaning they were conducted in a laboratory setting. The manufacturer is Promisemed Hangzhou Meditech Co., Ltd. in Hangzhou City, Zhejiang, China. The data would be prospective, as these are tests performed on the manufactured device models to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information is not relevant to the type of device and submission. "Ground truth" established by experts (e.g., radiologists interpreting images) is specific to diagnostic AI/imaging devices. For a physical device like a needle, performance is assessed against engineering standards and material properties, not clinical expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable as there is no "adjudication" in the context of testing a physical device against engineering specifications. The results are physical measurements or observations of compliance.
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:
- N/A. No MRMC comparative effectiveness study was done. This type of study is specifically for evaluating the impact of a diagnostic aid (often AI) on human reader performance, which doesn't apply to a Huber needle.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. No standalone algorithm performance was done. This device is a physical medical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" and "acceptance criteria" are defined by established international and national standards (e.g., ISO, ASTM, USP) for medical device design, manufacturing, safety, and performance. The performance tests yield objective measurements and observations (e.g., "No cytotoxicity," "Complied with ISO 23908") which serve as the "ground truth" of compliance with these standards.
8. The sample size for the training set:
- N/A. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for a physical medical 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 in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
June 8, 2023
Promisemed Hangzhou Meditech Co., Ltd. % Wei Shan Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building 300 Hennessy Road, Hong Kong, Hong Kong CHN
Re: K230715
Trade/Device Name: Promisemed Safety Huber Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: May 11, 2023 Received: May 12, 2023
Dear Wei Shan Hsu:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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 St
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
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Indications for Use
510(k) Number (if known) K230715
Device Name Promisemed Safety Huber Needle
Indications for Use (Describe)
The needle is used to access surgically implanted vascular ports.
Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.
In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1 Date Prepared
June 8th, 2023
Submitter's Information 2
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou
City, 311121 Zhejiang, China
Contact Name:
Zearou Yang
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
ന Trade Name, Common Name, Classification
Trade/Product Name: Promisemed Safety Huber Needle Regulation name: Hypodermic Single Lumen Needle Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: PTI
- ldentification of Predicate Device ব
K170897 Surecan Safety II
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Description of the Device റ
Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle.
The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B and Type C), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.
Image /page/4/Figure/5 description: The image shows the code rule for SHU-1919CHY. The last letter "Y" means that it has a Y injection site. The letter "H" means that the tubing is pressure resistant. The other letters represent the type of safety mechanism, needle length, and needle gauge.
Table 1. Model list
| Type | Model | Note | Gauge | Color |
|---|---|---|---|---|
| Type B | SHU-1919B, SHU-1925B, SHU-1938B | NA | ||
| SHU-1919BH, SHU-1925BH, SHU-1938BH | Pressure resistance up to 330 psi | |||
| SHU-1919BY, SHU-1925BY, SHU-1938BY | With Y-injection site | 19G | Cream | |
| SHU-1919BHY, SHU-1925BHY, SHU-1938BHY | Pressure resistance up to 330 psiwith Y-injection site | |||
| SHU-2019B, SHU-2025B, SHU-2038B | NA | |||
| SHU-2019BH, SHU-2025BH, SHU-2038BH | Pressure resistance up to 330 psi | |||
| SHU-2019BY, SHU-2025BY, SHU-2038BY | With Y-injection site | 20G | Yellow | |
| SHU-2019BHY, SHU-2025BHY, SHU-2038BHY | Pressure resistance up to 330 psiwith Y-injection site | |||
| SHU-2219B, SHU-2225B, SHU-2238B | NA | |||
| SHU-2219BH, SHU-2225BH, SHU-2238B | Pressure resistance up to 330 psi | |||
| SHU-2219BY, SHU-2225BY, SHU-2238BY | With Y-injection site | 22G | Black | |
| SHU-2219BHY, SHU-2225BHY, SHU-2238BHY | Pressure resistance up to 330 psiwith Y-injection site | |||
| Type C | SHU-1919C, SHU-1925C, SHU-1938C | NA | 19G | Cream |
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| SHU-1919CH, SHU-1925CH, SHU-1938CH | Pressure resistance up to 330 psi | ||
|---|---|---|---|
| SHU-1919CY, SHU-1925CY, SHU-1938CY | With Y-injection site | ||
| SHU-1919CHY, SHU-1925CHY, SHU-1938CHY | Pressure resistance up to 330 psiwith Y-injection site | ||
| SHU-2019C, SHU-2025C, SHU-2038C | NA | ||
| SHU-2019CH, SHU-2025CH, SHU-2038CH | Pressure resistance up to 330 psi | ||
| SHU-2019CY, SHU-2025CY, SHU-2038CY | With Y-injection site | 20G | Yellow |
| SHU-2019CHY, SHU-2025CHY, SHU-2038CHY | Pressure resistance up to 330 psiwith Y-injection site | ||
| SHU-2219C, SHU-2225C, SHU-2238C | NA | ||
| SHU-2219CH, SHU-2225CH, SHU-2238CH | Pressure resistance up to 330 psi | ||
| SHU-2219CY, SHU-2225CY, SHU-2238CY | With Y-injection site | 22G | Black |
| SHU-2219CHY, SHU-2225CHY, SHU-2238CHY | Pressure resistance up to 330 psiwith Y-injection site |
Image /page/5/Figure/3 description: The image shows two different types of Huber Needles, labeled as Type B and Type C. Type B has a wing hub and a protective shield, with the Huber Needle extending downwards. Type C also has a wing hub and a protective shield, but the design is more rounded compared to Type B, with the Huber Needle extending downwards as well.
6 Indication
The needle is used to access surgically implanted vascular ports.
Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only.
In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.
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7 Similarities and Differences of the Proposed Devices to the Predicate Devices
The Promisemed Safety Huber Needle is substantially equivalent to the predicate device, Surecan Safety II (K170897) in that these devices have similar intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. The differences between the subject device and predicate device do not raise new questions of safety and effectiveness.
| Subject Device | Predicate Device(K170897) | ||
|---|---|---|---|
| Trade Name | Promisemed SafetyHuber Needle | Surecan Safety II | Comments |
| Manufacturer | Promisemed HangzhouMeditech Co., Ltd | B. Braun Medical Inc | |
| Device Class | Class II | Class II | Same |
| Product Code | PTI | PTI | Same |
| Regulation number | 880.5570 | 880.5570 | Same |
| Regulation Name | Hypodermic SingleLumen Needle | Hypodermic SingleLumen Needle | Same |
| Intended Use | It is used to accesssurgically implantedvascular ports and isindicated for use in theadministration of fluidsand drugs. | Access surgicallyimplanted vascular portsfor the infusion of fluids,drugs, and bloodsampling | Similar¹The subjectdevice is notintended for bloodsampling. |
| Indications for Use | The needle is used toaccess surgicallyimplanted vascularports.Safety Huber Needles isa standard non coringintravascular infusion setwith a non-coring Hubertype right angle needleand a manually activatedneedle stick preventionsafety mechanism whichreduces the risk ofaccidental needlestickinjuries by sheathing theneedle. This device is foradult use only.In addition, when used | The Surecan Safety IIpower-injectable safetynon-coring needle is adevice intended forinsertion into theseptum of asubcutaneouslyimplanted port for theinfusion of fluids anddrugs, as well as bloodsampling through theport. The Surecan SafetyII safety feature ismanually activatedduring needle removal,and is designed to aid inthe prevention ofaccidental needle-sticks. | Similar²The subjectdevice is notintended for bloodsampling. |
| with ports that areindicated for powerinjection of contrastmedia into the centralvenous system, the highpressure resistant modelis indicated for high-pressure injection ofcontrast media for CTimaging. | When used with portsthat are indicated forpower injection ofcontrast media into thecentral venous system,the Surecan Safety IIneedle is also indicatedfor power injection ofcontrast media. | ||
| Safety MechanismDesign | Manually activatedsafety mechanism uponremoval of the needlefrom the implantedvascular port. | Manually activatedsafety mechanism uponremoval of the needlefrom the implantedvascular port. | Similar 3The subjectdevice hasadditional type ofsafety mechanism |
| Safety mechanism eitherhave a protective shieldcover the needle tip(Type B, figure1) or locksneedle into place when afirm stop is felt (Type C). | Safety mechanism locksneedle into place when afirm stop is felt.A green dot appears onthe clear bottom platewhen safety mechanismis fully engaged. | (Type B, refer toTable1 and Figure1) | |
| Do any setscontain anInjection Site /Luer AccessDevice? | Yes | Yes | Same |
| Needle beveldesign | Non-coring angledneedle | Non-coring angledneedle | Same |
| Needle Size | 19G,20G,22G | 19G,20G,22G | Same |
| Needle Length | 19mm (0.75 inch)25 mm (1.0 inch)38mm (1.5 inch) | 0.5 inch0.6 inch0.8 inch1.0 inch1.3 inch1.5 inch | Different4Predicate devicehas wider range. |
| Available for usewith contrastmedia? | Yes for "H" subtype(refer to Table 1) | Yes | Same |
| Does the devicehave wings? | Yes | Yes | Same |
| Reuse durability | Single use | Single use | Same |
| Ability towithstand powerinjection pressures | 330 psi ("H" subtype) | 325 psi | Similar5 |
| Flow rates(Pressureinjection) | 19, 20 gauge - 5mL/s | 19, 20 gauge - 5mL/s | Same |
| Biocompatibility | 22 gauge - 2 mL/sComplied with ISO10993 | 22 gauge - 2 mL/sComplied with ISO10993 | Similar6 |
| series standards, and the | series standards, and the | The subjectdevice conducted | |
| following tests areperformed | following tests areperformed | additional tests,i.e. implantation test andgenotoxicity test | |
| - Cytotoxicity: Nocytotoxicity | - Cytotoxicity: Nocytotoxicity | ||
| - Skin Irritation: Noevidence of skinirritation | - Skin Irritation: Noevidence of skinirritation | ||
| - Skin Sensitization: Noevidence of sensitization | - Skin Sensitization: Noevidence of sensitization | ||
| -Acute and SubchronicSystemic Toxicity: Nosystemic toxicity | -Acute and SubchronicSystemic Toxicity: Nosystemic toxicity | ||
| -Hemolysis: No evidenceof hemolysis | - Hemocompatibility: Noevidence of hemolysis | ||
| -Implantation: Noabnormal symptoms atthe implantation site | -Pyrogen: Non pyrogenic | ||
| - Genotoxicity: Noevidence ofmutagenticity | |||
| -Pyrogen: Non pyrogenic | |||
| Configuration andMaterials | 1. Huber needle:X5CrNi18-102. Tubing: TPU3. Luer lock connector:Copolyester4. Y-injection site:Copolyester andsilicon5. Protective base: Foamand Copolyester6. Wing hub/Protectiveshield: PP7.Clamp: POM8.Cap/Needle Sheath: PE | Unknown | Unknown7The material'sbiosafety isaddressed throughbiocompatibilitytesting per ISO10993. |
| Performance | Complied with ISO80369-7:2021, ISO8536-4:2019, ISO 23908, ISO9626:2016, ISO7864:2016, ANSI/AAMICN27:2021, ASTM F3212-16 | Complied with ISO 594-2:1998, ISO 8536-4:2010,ISO 23908:2011, ISO9626:1991, JIST3221:2011 | Similar8The ISO 594-2:1998 has beenreplaced by ISO80369-7:2021.The subjectdevice meets the |
| FDA recognizedstandards. | |||
| Sterilizationmethod and SAL | EO SterilizationSAL = 10-6 | EO SterilizationSAL = 10-6 | Same |
A detailed comparison to the predicate is provided in Table 1.
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Discussions of differences in technological characteristics
The subject device has the similar intended use, indications for use, technological characteristics, safety mechanism design when compared to the predicate device. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices.
Note 1 and 2: The subject device is not intended for blood sampling, this difference does not affect the substantial equivalence of the device.
Note 3: The subject device has additional type of safety mechanism (Type B, Figure 1) to protect against sharps injury. The sharps protection feature is addressed through testing per ISO23908.
Note 4: The needle length of subject device is within the range of predicate device. The difference needle length does not affect the substantial equivalence of the device.
Note 5: The "H" subtype (refer to Table 1) of subject device withstands power injection pressures of 330 psi, which is higher than predicate device. The flow rate under 330 psi has been verified.
Note 6 and 7: The biocompatibility tests conducted demonstrated the safety of subject device.
Note 8: The subject device meets the requirements of FDA recognized standards.
The differences above do not impact the substantial equivalence of the device.
Performance Testing Summary 8
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
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- ISO 8536-4 :2019 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
- ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications
- · ISO 23908:2011, Sharps injury protection Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- · ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
- ANSI/AAMI CN27:2021 General Requirements For Luer Activated Valves (LAVs) Incorporated Into Medical Devices For Intravascular Applications
- ASTM F3212-16 Standard Test Method for Coring Testing of Huber Needles
- · Power injection flow rate testing (non-standardized test)
- USP<85> Bacterial Endotoxin Test
Biocompatibility
In accordance with ISO 10993-1 the device is classified as External communicating device, in contact with circulating blood with prongled duration. The biosafety tests that required consideration were validated:
- 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: Tests for Irritation and Skin Sensitization
- · ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute and Subchroic systemic toxicity
- ISO 10993-3:2014 Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity-Genotoxicity Test
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- ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation
- · ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
- USP NF 2021 chapter <151> Pyrogen Test
- · USP<788> Particulate matter in injections
- Sterility, Shipping, and Shelf-Life
- · ISO 11135:2014, Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
- · Sterile Barrier Packaging Testing performed on the proposed device:
- Seal strength ASTM F88/F88-15
- Dye penetration ASTM F1929-15
- Sterility test USP39 <71>
- Shelf life of 3 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- の Conclusion
Based on the information provided within this 510(k) submission, the differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed predicate device.
§ 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).