(201 days)
It is intended for use in the aspiration of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick.
The Verisafe Safety sterile needles are sterile, single use, standard hypodermic needle with a shield to enclose the needle after use. The Verisafe Safety sterile needles are for use with syringes. The device mainly consists of hub, needle cap and safety shield. It is packaged in a sealed sterility barrier. This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control. Sterilized by ETO, shelf life 5 years.
The provided text describes a 510(k) premarket notification for the "Verisafe Safety sterile needles." This submission aims to demonstrate substantial equivalence to a predicate device, the "Sol-Care Safety Needle (K123684)." The document primarily focuses on explaining how the new device meets performance and biocompatibility standards rather than setting specific acceptance criteria with numerical targets against which device performance is reported.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly define acceptance criteria as numerical targets, but rather lists a series of tests and reference standards that the device "Complied with." For example, for "Cytotoxicity," the reported performance is "No cytotoxicity."
| Acceptance Criteria (Implied from Standard Requirement) | Reported Device Performance (as per document) |
|---|---|
| Appearance (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Cleanliness (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Color code (EN ISO 6009:2016) | Each color is in accordance with ISO 6009 |
| Dimensions (EN ISO 7864:2016, EN ISO 9626:2016) | Complied with EN ISO 7864:2016, EN ISO 9626:2016 |
| Length of the needle (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Lubricant (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Needle point (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Penetration force (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Bond between needle and hub (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Patency of lumen (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Needle cap | (No specific compliance statement given, but implied by overall compliance with relevant standards) |
| Stiffness (EN ISO 9626:2016) | Complied with EN ISO 9626:2016 |
| Resistance to breakage (EN ISO 9626:2016) | Complied with EN ISO 9626:2016 |
| Resistance to corrosion (EN ISO 9626:2016) | Complied with EN ISO 9626:2016 |
| Safety feature (Activate force) (EN ISO 23908:2013) | Complied with EN ISO 23908:2013 |
| Safety feature (Reuse Prevention) (EN ISO 23908:2013) | Complied with EN ISO 23908:2013 |
| Safety feature (Safety Performance) (EN ISO 23908:2013) | Complied with EN ISO 23908:2013 |
| Small-bore connector dimensions (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Positive pressure liquid leakage (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Sub-atmospheric pressure air leakage (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Stress cracking (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Resistance to separation from axial load (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Resistance to separation from unscrewing (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Resistance to overriding (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Particulate contamination (USP 39 <788>) | Complied with USP 39 <788> |
| Acidity and alkalinity (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Extractable metals (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Package appearance (ASTM F1886/F1886M – 16) | Complied with ASTM F1886/F1886M – 16 |
| Seal strength (EN 868-5:2018) | Complied with EN 868-5:2018 |
| Dye penetration (ASTM F1929-15) | Complied with ASTM F1929-15 |
| Sterility (USP 39 <71>) | Complied with USP 39 <71> |
| Bacterial endotoxin (USP 40 <85>) | Complied with USP 40 <85> |
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxicity |
| Skin Sensitization (ISO 10993-10:2021) | No evidence of sensitization |
| Intradermal reaction test (ISO 10993-23:2021) | No evidence of irritation |
| Acute systemic toxicity (ISO 10993-11:2017) | No systemic toxicity |
| Pyrogen study (ISO 10993-11:2017, USP43-NF37<151>) | Non pyrogenic |
| In Vitro Hemolytic Properties Test (ASTM F756-17) | No effect |
| Ethylene Oxide residues (ISO 10993-7:2008) | Complied with ISO 10993-7:2008 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists various performance and biocompatibility tests. For these types of tests (e.g., physical properties, chemical analysis, biological reactivity), sample sizes are not explicitly stated. These are typically bench tests conducted in a laboratory setting. The country of origin for the device manufacturer is China (Promisemed Hangzhou Meditech Co., Ltd.), so it's highly probable the testing was conducted there. The nature of these tests is prospective for the device being evaluated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to the tests described. The tests are largely objective and based on established international and national standards (ISO, ASTM, USP). Ground truth is established by the methods outlined in these standards, not by expert consensus in a clinical diagnostic sense. For example, "No cytotoxicity" is a result of a lab test, not an expert's opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretation (e.g., image reading) requires consensus among experts. This is not relevant for the bench and lab tests described in the document for a hypodermic needle. The compliance to standards is determined by measuring objective parameters.
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
An MRMC study is performed in the context of diagnostic devices, often involving interpretation of medical images by human readers with or without AI assistance. This is not applicable to the "Verisafe Safety sterile needles," which is a medical device for fluid aspiration/injection and needle stick prevention, not a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question applies to AI/software as a medical device. The "Verisafe Safety sterile needles" is a mechanical medical device, not an AI or software product. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance and biocompatibility tests is based on the objective measurement and assessment against predetermined specifications and thresholds outlined in the referenced international standards (e.g., ISO, ASTM, USP). For example, a "No cytotoxicity" ground truth is established by a quantitative cell viability assay, and "Sterility" is determined by microbiological cultures. It's not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather adherence to a scientifically established benchmark defined by the standards.
8. The sample size for the training set
This question is relevant for machine learning or AI models. Since the "Verisafe Safety sterile needles" is a physical medical device and not an AI or software product, there is no "training set."
9. How the ground truth for the training set was established
As there is no training set for this device, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 15, 2023
Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street. Cangqian Community Yuhang District Hangzhou City, Zhejiang 311121 China
Re: K222271
Trade/Device Name: Verisafe Safety sterile needles Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, hypodermic, single lumen Regulatory Class: Class II Product Code: FMI Dated: December 14, 2022 Received: December 14, 2022
Dear Zearou Yang:
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
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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 (OS) 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
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Indications for Use
510(k) Number (if known) K22271
Device Name
Verisafe Safety Sterile Needles
Indications for Use (Describe)
It is intended for use in the aspiration of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K22271 510k Summary
1. Date Prepared
February 14th, 2023
2. Submitter's Information
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:
3. Trade Name, Common Name, Classification
Trade/Product Name: Verisafe Safety sterile needles
Common Name: Safety sterile needles
Classification name: Needle, hypodermic, single lumen
Regulation Number: 880.5570
Device Class: Class II
Product Code: FMI
4. Identification of Predicate Device
K123684: Sol-Care Safety Needle
5. Description of the Device
The Verisafe Safety sterile needles are sterile, single use, standard hypodermic needle with a shield to enclose the needle after use.
The Verisafe Safety sterile needles are for use with syringes.
The device mainly consists of hub, needle cap and safety shield. It is packaged in a
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sealed sterility barrier. This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control.
Sterilized by ETO, shelf life 5 years.
6. Indication
It is intended for use in the aspiration and injection of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick.
7. Similarities and Differences of the Proposed Devices to the Predicate Devices
Promisemed Safety sterile needles are substantially equivalent to the predicate device, Sol-Care Safety Needle, K123684 in that these devices have same 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 affect the basic design principle, usage of the subject device. A detailed comparison to the predicate is provided in Table 1.
| Items | Subject Device | Predicate Device(K123684) | Comments |
|---|---|---|---|
| Trade Name | Verisafe Safety sterileneedles | Sol-Care Safety Needle; | |
| Manufacturer | Promisemed HangzhouMeditech Co., Ltd | Sol-Millennium. Medical.Inc. | |
| Device Class | Class II | Class II | Similar |
| Product Code | FMI | FMI | Similar |
| Regulation number | 880.5570 | 880.5570 | Similar |
| Regulation Name | Needle, hypodermic,single lumen | Needle, hypodermic,single lumen | Similar |
| Intended Use/Indications for Use | It is intended for use in theaspiration and injection offluids for medical purposes.When the safety shield ismanually activated, it willcover the needleimmediately after use tominimize risk of accidentalneedle stick. | It is intended for use in theaspiration and injection offluids for medical purposes.When the safety shield ismanually activated, it willcover the needleimmediately after use tominimize risk of accidentalneedle stick. | Similar |
| OperatingPrinciple | When the safety shield ismanually activated, it willcover the needle immediatelyafter use to minimize risk ofaccidental needle stick. | The Sol-Care Safety Needle hasa shield that covers the needlepoint after use. In theactivated position, the needleshield guards againstaccidental needle stick duringnormal handling and disposalof the used needle/syringecombination. | Similar |
| Needle Gauge | 18G, 19G, 20G, 21G, 22G, 23G,24G, 25G, 26G, 27G, 28G, 29G,30G | 18G, 19G, 20G, 21G, 22G, 23G,24G, 25G, 26G, 27G, 28G, 29G,30G | Similar |
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| Needle Length | 1/2in, 3/4in, 5/8in, 1in, 1 1/4in,1 1/2in, 2 in | 3/8 in to 1 1/2 in | Different, Subjectdevices have moreneedle lengths thanpredicate device. |
|---|---|---|---|
| Needle hubcolor | Per ISO 6009:Pink/18G, Cream/19G,Yellow/20G, Light green/21G,Black/22G, Light blue/23G,Medium purple /24G,Orange /25G, Brown /26G,Medium grey /27G,Blue - green /28G, Red /29G,Yellow /30G. | Per ISO 6009:Pink/18G, Cream/19G,Yellow/20G, Light green/21G,Black/22G, Light blue/23G,Medium purple /24G,Orange /25G, Brown /26G,Medium grey /27G,Blue - green /28G, Red /29G,Yellow /30G. | Each color is inaccordance with ISO6009. |
| Reuse durability | Single Use | Single Use | Similar |
| Biocompatibility | Complied with ISO10993 seriesstandards, and the followingtests are performed- Cytotoxicity: No cytotoxicity- Intracutaneous ReactivityNo evidence of irritation- Skin Sensitization: Noevidence of sensitization- Acute Systemic Toxicity: Nosystemic toxicity- Pyrogen: Non pyrogenic- Platelet Count: No effect- Hemolysis: No effect | Per ISO 10993-1 | Similar |
| Materials | - Needle: Stainless Steel(06Cr19Ni10)- Hub: Polypropylene (PP)- Need Cap: Polypropylene(PP) | - Needle: Stainless Steel(06Cr19Ni10)- Hub: Polypropylene (PP)- Need Cap: Polypropylene(PP) | Similar |
| Performance | Complied with ISO 7864, ISO9626, ISO 80369-7 | Complied with ISO 7864, ISO9626, ISO 80369-7 | Similar |
| Sterilizationmethod | EO Sterilization | EO Sterilization | Similar |
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 and standard are provided in Table 2 and Table 3.
• Table 2 Performances
| No. | Test item | Reference recognized standards |
|---|---|---|
| 1. | 1.1 Appearance | EN ISO 7864:2016, Sterile hypodermic syringes for single use -Requirements and test methods |
| 1.2 Cleanliness | ||
| 2. | Color code | EN ISO 6009:2016, Hypodermic needles for single use - Colourcoding for identification |
| 3. | 3.1 Dimensions | EN ISO 7864:2016, Sterile hypodermic syringes for single use -Requirements and test methods |
| EN ISO 9626:2016, Stainless steel needle tubing for themanufacture of medical devices — Requirements and test methods | ||
| 3.2 Length of theneedle | EN ISO 7864:2016, Sterile hypodermic syringes for single use –Requirements and test methods | |
| 4. | Lubricant | EN ISO 7864:2016, Sterile hypodermic syringes for single use -Requirements and test methods |
| 5. | Needle point | EN ISO 7864:2016, Sterile hypodermic syringes for single use -Requirements and test methods |
| 6. | Penetration force | EN ISO 7864:2016, Sterile hypodermic syringes for single use -Requirements and test methods |
| 7. | Bond betweenneedle and hub | EN ISO 7864:2016, Sterile hypodermic syringes for single use -Requirements and test methods |
| 8. | Patency of lumen | EN ISO 7864:2016, Sterile hypodermic syringes for single use –Requirements and test methods |
| 9. | Needle cap | / |
| 10. | 10.1 Stiffness | EN ISO 9626:2016, Stainless steel needle tubing for themanufacture of medical devices - Requirements and test methods |
| 10.2 Resistance tobreakage | EN ISO 9626:2016, Stainless steel needle tubing for themanufacture of medical devices - Requirements and test methods | |
| 10.3 Resistance tocorrosion | EN ISO 9626:2016, Stainless steel needle tubing for themanufacture of medical devices — Requirements and test methods | |
| 11. | 11.1Safety feature(Activate force) | EN ISO 23908:2013, Sharps injury protection- Requirements andtest methods — Sharps protection features for single-usehypodermic needles, introducers for catheters and needles used forblood sampling |
| 11.2Safety feature(ReusePrevention) | EN ISO 23908:2013, Sharps injury protection- Requirements andtest methods — Sharps protection features for single-usehypodermic needles, introducers for catheters and needles used forblood sampling | |
| 11.3Safety feature(SafetyPerformance) | EN ISO 23908:2013, Sharps injury protection- Requirements andtest methods — Sharps protection features for single-usehypodermic needles, introducers for catheters and needles used forblood sampling | |
| 12. | 12.1 Dimension | ISO 80369-7:2021, Small-bore connectors for liquids and gases inhealthcare applications - Part 7: Connectors for intravascular orhypodermic applications |
| 12.2 Positivepressure liquidleakage | ISO 80369-7:2021, Small-bore connectors for liquids and gases inhealthcare applications - Part 7: Connectors for intravascular orhypodermic applications | |
| 12.3 Subatmosphericpressure air leakage | ISO 80369-7:2021, Small-bore connectors for liquids and gases inhealthcare applications - Part 7: Connectors for intravascular orhypodermic applications | |
| 12.4 Stress cracking | ISO 80369-7:2021, Small-bore connectors for liquids and gases inhealthcare applications - Part 7: Connectors for intravascular orhypodermic applications | |
| 12.5 Resistance toseparation fromaxial load | ISO 80369-7:2021, Small-bore connectors for liquids and gases inhealthcare applications - Part 7: Connectors for intravascular orhypodermic applications | |
| 12.6 Resistance toseparation fromunscrewing | ISO 80369-7:2021, Small-bore connectors for liquids and gases inhealthcare applications - Part 7: Connectors for intravascular orhypodermic applications | |
| 12.7 Resistance tooverriding | ISO 80369-7:2021, Small-bore connectors for liquids and gases inhealthcare applications - Part 7: Connectors for intravascular orhypodermic applications | |
| 13. | Particulatecontamination | USP 39 $<788>$ Particulate matter in injections |
| 14. | Acidity andalkalinity | EN ISO 7864:2016, Sterile hypodermic syringes for single use –Requirements and test methods |
| 15. | Extractable metals | EN ISO 7864:2016, Sterile hypodermic syringes for single use –Requirements and test methods |
| 16. | Packageappearance | ASTM F1886/F1886M – 16 Standard Test Method for DeterminingIntegrity of Seals for Flexible Packaging by Visual Inspection |
| 17. | Seal strength | EN 868-5:2018 Packaging for terminally sterilized medical devicesPart 5: Sealable pouches and reels of porous materials and plasticfilm construction - Requirements and test methods |
| 18. | Dye penetration | ASTM F1929-15 Standard Test Method for Detecting Seal Leaks inPorous Medical Packaging by Dye Penetration |
| 19. | Sterility | USP 39 $<71>$ Sterility tests |
| 20. | Bacterial endotoxin | USP 40 $<85>$ Bacterial endotoxins test |
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・ Table 3 Biocompatibility
| No. | Test item | Reference recognized standards |
|---|---|---|
| 1. | In Vitro Cytotoxicity - MTT Method,MEM with 10% FBS extract | ISO 10993-5:2009 – Biological Evaluation ofMedical Devices -- Part 5: Tests for in VitroCytotoxicity |
| 2. | Skin Sensitization – Guinea PigMaximization, 0.9% sodium chlorideextract and sesame oil extract | ISO 10993-10:2021, Biological Evaluation ofMedical Devices -- Part 10: Tests for Irritation andSkin Sensitization |
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| 3. | Intradermal reaction test,0.9% sodium chloride extract andsesame oil extract | ISO 10993-23:2021, Biological evaluation ofmedical devices - Part 23: Tests for irritation |
|---|---|---|
| 4. | Acute systemic toxicity0.9% sodium chloride extract andsesame oil extract | ISO 10993-11:2017, Biological evaluation ofmedical devices - Part 11: Tests for systemictoxicity- Acute systemic toxicity and pyrogen test |
| 5. | Pyrogen study in rabbits0.9% sodium chloride injection | ISO 10993-11:2017, Biological evaluation ofmedical devices - Part 11: Tests for systemictoxicity- Acute systemic toxicity and pyrogen testUSP43-NF37<151> Pyrogen Test |
| 6. | In Vitro Hemolytic Properties Test | ASTM F756-17 Standard Practice for Assessmentof Materials |
| 7. | Ethylene Oxide residues EO ECH Test | ISO 10993-7:2008, Biological evaluation ofmedical devices — Part 7: Ethylene oxidesterilization residuals |
Conclusion 9.
The comparison of intended use, technological characteristics, and performance data of the subject device has demonstrated substantial equivalence to the 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).