(60 days)
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adaper and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used for blood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
This document describes the premarket notification (510(k)) for the Promisemed Safety Winged Blood Collection Set. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (K170276). It does not involve AI or algorithms, but rather a physical medical device. Therefore, many of the requested elements regarding AI/algorithm performance are not applicable.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are demonstrated through adherence to various international and national standards, showing the device's conformance to established safety and performance benchmarks. The reported device performance is indicated by "passing results" for all tests.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| Physical Performance | |
| Needle appearance and cleanliness (ISO 7864:2016, clause 4.3) | Meets requirements |
| Needle Size color code (ISO 6009:2016) | Meets requirements |
| Needle Particulate contamination (USP <788>, METHOD 1, Test 1.B) | Meets requirements |
| Bonding strength: Needle and hub (ISO 7864:2016, clause 4.12) | Meets requirements |
| Bonding strength: Tubing and hub (ISO 8536-4:2019, clause 7.3) | Meets requirements |
| Bonding strength: Tubing and double wings luer adapter (ISO 8536-4:2019, clause 7.3) | Meets requirements |
| Infusion set leakage (ISO 8536-4:2019, clause 7.2) | Meets requirements |
| Needle patency of lumen (ISO 7864:2016, clause 4.13, a) | Meets requirements |
| Dimension: Blood collection needle (ISO 9626:2016, clause 5.6, table 1, (TW)) | Meets requirements |
| Dimension: Puncturing needle (ISO 9626:2016, clause 4.10.2, table1) | Meets requirements |
| Needle point (ISO 7864:2016, clause 4.11) | Meets requirements |
| Needle Lubrication: Appearance (ISO 7864:2016, clause 4.10.4) | Meets requirements |
| Needle Lubrication: Quantity (ISO 7886-1:2017, Annex F) | Meets requirements |
| Luer Connector (ISO 80369-7:2016, ISO 80369-20:2015) | Meets requirements |
| Tubing kink stability (ISO 20696:2018, clause 6.7) | Meets requirements |
| Puncture force of needle (ISO 7864:2016, clause 4.11) | Meets requirements |
| Safety protection mechanism (ISO 23908:2011) | Meets requirements |
| Stiffness of needle (ISO 9626:2016, clause 5.8, table 2 (TW)) | Meets requirements |
| Toughness of needle (ISO 9626:2016, clause 5.9) | Meets requirements |
| Resistance to corrosion of needle (ISO 9626:2016, clause 5.10) | Meets requirements |
| Chemical Performance | |
| Reducing matter (ISO 8536-4:2019, clause 8.1) | Meets requirements |
| Metal ions (ISO 8536-4:2019, clause 8.2) | Meets requirements |
| Limits for acidity or alkalinity (ISO 8536-4:2019, clause 8.3) | Meets requirements |
| Residue on evaporation (ISO 8536-4:2019, clause 8.4) | Meets requirements |
| Ethylene oxide residue (EO&ECH) (ISO 10993-7:2008, clause 4.3.4) | Meets requirements |
| Biological Performance (Biocompatibility) | |
| Bacterial endotoxin (USP <85>) | Passing results |
| Sterility (USP <71>) | Passing results |
| Pyrogen Test (Rabbit) (USP <151>) | Passing results |
| Hemolytic Properties (ASTM F756-17) | Passing results |
| Hematology (ISO 10993-4:2017) | Passing results |
| Platelet Count | Passing results |
| Partial Thromboplastin Time | Passing results |
| Cytotoxicity (ISO 10993-5:2009) | Passing results |
| Skin Sensitization (ISO 10993-10:2010) | Passing results |
| Intracutaneous Reactivity | Passing results |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Passing results |
| Safety Mechanism Activation (Sharps Injury Protection) | |
| Safety mechanism activation requirements (ISO 23908, internal protocol and test results) | Meets requirements |
| Safety overriding/unlocking force after activation requirements (ISO 23908, internal protocol and test results) | Meets requirements |
| Sterilization | |
| Sterility Assurance Level (SAL) of 10-6 (ISO 11135:2014 for Ethylene Oxide) | Validated |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test listed, but it indicates "Non-Clinical bench testing" was performed. The data provenance is implied to be from the manufacturer's internal testing in China (Promisemed Hangzhou Meditech Co., Ltd., Hangzhou City, Zhejiang, China). The tests are retrospective, as they are part of the device development and verification process before submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical medical device. Ground truth is established through adherence to international standards and validated laboratory testing procedures for physical, chemical, and biological properties, not through expert consensus on images or interpretations.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reading images) where disagreement might occur. For physical device testing, the results are typically quantitative or pass/fail based on established 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 product is a physical blood collection device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and human reader improvement are irrelevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This product is a physical blood collection device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by the specified international and national consensus standards (e.g., ISO, USP, ASTM) for medical devices, which define acceptable physical, chemical, and biological properties. This includes:
- Physical performance metrics: Bond strength, needle dimensions, patency, kink stability, puncture force, safety mechanism activation.
- Chemical properties: Absence of harmful residues or leaching.
- Biological properties: Biocompatibility tests (cytotoxicity, sensitization, irritation, systemic toxicity, hemolysis, pyrogenicity, bacterial endotoxin) and sterility.
- Outcomes: The device is designed to prevent needlestick injuries, and its safety mechanism is tested to meet this outcome requirement.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/machine learning model. There is no "training set" in the context of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
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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.
June 25, 2021
Promisemed Hangzhou Meditech Co., Ltd. % John Beasley Official Correspondent MedTech Review, LLC 257 Garnet Garden Street Henderson, Nevada 89015
Re: K211293
Trade/Device Name: Safety Winged Blood Collection Sets Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, FPA Dated: April 16, 2021 Received: April 26, 2021
Dear John Beasley:
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 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,
Payal Patel Acting 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)
K211293
Device Name
Safety Winged Blood Collection Set - Needle Diameter (21, 23, 25 Guage) - Tube Length (10, 19, 30 cm) - HOLDER, SBC-xxxxH, Safety Winged Blood Collection Set - Needle Diameter (21, 23, 25 Guage) - Tube Length (10, 19, 30 cm) - ADAPTER, SBC-xxxx A: Safety Winged Blood Collection Set - Needle Diameter (21, 23, 25 Guage) - Tube Length (10, 19, 30 cm) - W/O Puncture, SBC-
Indications for Use (Describe)
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adaper and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
| 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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Image /page/3/Picture/1 description: The image shows the logo for "Promisemed". The word "Promise" is in green and the word "med" is in blue. There is a blue molecule graphic above the word "Promise" and a registered trademark symbol to the right of the word "med". There is a black line underneath the logo.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, China.
510(k) Summary
Updated: 06/18/2021
| Contact Details | 21 CFR 807.92(a)(1) | |
|---|---|---|
| Applicant Name | Promisemed Hangzhou Meditech Co., Ltd. | |
| Applicant Address | No. 12, Longtan Road, Cangqian Street, Yuhang District, Hangzhou City,Zhejiang, 311121, CH | |
| Applicant Telephone Number | 865-718-8772985 | |
| Applicant Contact | Mr. Zearou Yang | |
| Applicant Contact Email | zearou.yang@promisemed.ca | |
| Correspondent Name | MedTech Review, LLC | |
| Correspondent Address | 257 Garnet Garden Street, Henderson, NV, 89015, US | |
| Correspondent TelephoneNumber | 1-612-889-5168 | |
| Correspondent Contact | Mr. John Beasley, RAC (US) | |
| Correspondent Contact Email | john@medtechreview.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Safety Winged Blood Collection Sets | |
| Common Name | Safety Blood Collection Device for Single Use | |
| Classification Name | NEEDLE, HYPODERMIC, SINGLE LUMEN | |
| Regulation Number | 880.5570 | |
| Product Code | FMI/FPA | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate [510(k)] # | Predicate Trade Name | Product Code |
| K170276 | Gemtier Medical (Shanghai) Inc. Safety Blood Collection Devicefor Single Use | FMI/FPA |
| Device Description Summary | 21 CFR 807.92(a)(4) | |
| The Promisemed Safety Blood Collection sets are single-use, sterile, venipuncture needles used forblood collection or short-term infusion of intravenous fluids (up to 2 hours under direct clinicalsupervision). The blood-collection needle is designed to be covered with a safety mechanism, which canbe activated to cover the needle immediately following venipuncture to aid in the protection againstaccidental needlestick injury. | ||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | |
| The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to aflexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collectionand/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). Theblood-collection needle is designed to be covered with a safety mechanism, which can be activated tocover the needle immediately following venipuncture to aid in the protection against accidentalneedlestick injury. |
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Image /page/4/Picture/0 description: The image shows the logo for "Promisemed". The word "Promise" is in green, and the word "med" is in blue. Above the word "Promise" is a green and blue atom-like structure. To the right of the word "Promisemed" is a circled R symbol.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.
Indications for Use Comparison
21 CFR 807.92(a)(5)
Other than the difference in the name of the device and the fact that they are all connected to flexible tubing (these are sets), there are no differences in the indications for use of the subject device when compared to the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
Compared with the predicate device, the subject device is identical in mechanism of action, materials, needle point, sterilization method, and biocompatibility. The subject device has the same performance specifications except for needle length. Through performance bench testing, the subject device and the predicate device demonstrated to be substantially equivalent.
| Specification | Predicate Device | Subject Device | Discussion ofDifferences |
|---|---|---|---|
| Device name | Safety Blood CollectionDevice for Single Use | Safety Winged BloodCollection Sets | The subject device bringsattention to the "wings" inthe device name, as wellas properly defines thedevice as a "set".The differences do notintroduce any newconcerns for safety orefficacy. |
| K number | K170276 | K211293 | - |
| Product code andclassification name | FMI, Needle,Hypodermic, SingleLumen | FMI, NeedleHypodermic, SingleLumen | No difference |
| Indications for use | The SAFETY BLOODCOLLECTION DEVICEFOR SINGLE USE is asingle-use, sterile,winged venipunctureneedle bonded to aflexible tubing with orwithout a luer adapterand/or tube holder.The SAFETY BLOODCOLLECTION DEVICEFOR SINGLE USE isused for bloodcollection and/or theshort-term infusion ofintravenous fluids (upto 2 hours under directclinical supervision).The venipunctureneedle is designed to | The safety wingedblood collection set issingle-use, sterile,winged venipunctureneedle bonded to aflexible tubing with orwithout a luer adapterand/or tube holder.The device is used forblood collection and/orthe short-term infusionof intravenous fluids(up to 2 hours underdirect clinicalsupervision). Theblood-collection needleis designed to becovered with a safetymechanism, which canbe activated to cover | Difference in the name ofthe device and the factthat they are allconnected to flexibletubing (these are sets).The differences do notintroduce any newconcerns for safety orefficacy. |
| Specification | Predicate Device | Subject Device | Discussion ofDifferences |
| be covered with asafety mechanism,which can be activatedto cover needleimmediately followingvenipuncture to aid inthe protection againstaccidental needlestickinjury. | the needle immediatelyfollowing venipunctureto aid in the protectionagainst accidentalneedlestick injury. | ||
| Indicated for infusion | Yes | Yes | No difference |
| Single use | Yes | Yes | No difference |
| Mechanism of safetyblood collection | Latch mechanism:press both sides of thesafety mechanism torelease the lock firstand then slide thesafety mechanism toactivate. | Latch mechanism:Place the index fingeron the curved design topress gently, hold thetwo wings by the thumbfinger and middle fingerand withdraw the wingsback to activate thesafety mechanism untilhearing sound ofCLICK. The click is asign that the Safetymechanism has beencorrectly activated | The subject devicerequires use of one fingerto press the release andincorporates the wings foractivating the safetymechanism.The differences do notintroduce any newconcerns for safety orefficacy. |
| Materials: | |||
| Venipuncture Needle | Stainless Steel | Stainless Steel | No difference |
| Tubing | PVC | PVC | No difference |
| Wing | PVC | PVC | No difference |
| Sleeve | PE | ABS | No difference |
| Retractable Cartridge | PE | PE | No difference |
| Luer adapter | PP | PVC | No difference |
| Tube Holder | PP | ABS | No difference |
| Blood collection needleprotector | PP | PE | No difference |
| Rubber cover | Synthetic Rubber | Nitrile Rubber | Predicate deviceunspecified.The use of nitrile rubberdoes not introduce anynew concerns for safetyor efficacy. |
| Specification | Predicate Device | Subject Device | Discussion ofDifferences |
| Components: | |||
| Tubing, Wing, Luerconnectors | Yes | Yes | No difference |
| Plastic sleeve,venipuncture needlestand | Yes | Yes | No difference |
| Luer adapter, tubeholder, blood collectionneedle, protectionmechanism | Yes | Yes | No difference |
| Performance: | |||
| Needle Gauge Sizes | 21G, 23G, 25G | 21G, 23G, 25G | No difference |
| Tubing Length | 10 cm to 35 cm | 10 cm, 19cm, 30 cm | No difference |
| Needle Length | 20mm | 19mm | The needle length of thesubject device is shorterin length (19mm) ascompared to thepredicate device (20mm).The short needle lengthallows the phlebotomist toinsert it at a shallow anglethat can increase theease of use andtherefore, does notintroduce any newconcerns for safety orefficacy. |
| Needle Point | 3-bevel | 3-bevel | No difference |
| Sterile | Ethylene Oxide | Ethylene Oxide | No difference |
| Non-pyrogen | Yes | Yes | No difference |
| Shelf life | 3 years | 3 years | No difference |
| Biocompatibility | Cytotoxicity, SkinSensitization, Irritation,Acute SystemicToxicity, Hemolysis,Pyrogenicity, BacterialEndotoxins testinghave passing results | Cytotoxicity, SkinSensitization, Irritation,Acute SystemicToxicity, Hemolysis,Pyrogenicity, BacterialEndotoxins testinghave passing results | No difference |
| Physicalperformance | Needle appearance and cleanliness | ISO 7864:2016, clause 4.3 | |
| Needle Size color code | ISO 6009:2016 | ||
| Needle Particulate contamination | USP<788>, METHOD 1, Test 1.B | ||
| Bondingstrength: | Needle and hub | ISO 7864:2016, clause 4.12 | |
| Tubing and hub | ISO 8536-4:2019, clause 7.3 | ||
| Tubing and double wingsluer adapter | ISO 8536-4:2019, clause 7.3 | ||
| Infusion set leakage | ISO 8536-4:2019, clause 7.2 | ||
| Needle patency of lumen | ISO 7864 :2016, clause 4.13, a) | ||
| Dimension | Blood collection needle | ISO 9626 :20 16, clause 5.6, table 1, (TW) | |
| Puncturing needle | ISO 9626 :2016, clause 4.10.2, table1 | ||
| Needle point | ISO 7864:2016, clause 4.11 | ||
| NeedleLubrication | Appearance | ISO 7864:2016, clause 4.10.4, | |
| Quantity | ISO 7886-1:2017, Annex F | ||
| Luer Connector | ISO 80369-7:2016ISO 80369-20:2015 | ||
| Tubing kink stability | ISO 20696:2018, clause 6.7 | ||
| Puncture force of needle | ISO 7864:2016, clause 4.11 | ||
| Safety protection mechanism | ISO 23908:2011 | ||
| Stiffness of needle | ISO 9626 :2016, clause 5.8, table 2 (TW) | ||
| Toughness of needle | ISO 9626:2016, clause 5.9 | ||
| Resistance to corrosion of needle | ISO 9626 :2016, clause 5.10 | ||
| Chemicalperformance | Reducing matter | ISO 8536-4:2019, clause 8.1 | |
| Metal ions | ISO 8536-4:2019, clause 8.2 | ||
| Limits for acidity or alkalinity | ISO 8536-4:2019, clause 8.3 | ||
| Residue on evaporation | ISO 8536-4:2019, clause 8.4 | ||
| Ethylene oxide residue (EO&ECH) | ISO 10993-7:2008, clause 4.3.4 | ||
| Biologicalperformance | Bacterial endotoxin | USP <85> | |
| Sterility | USP <71> | ||
| Pyrogen Test (Rabbit) | USP <151> | ||
| Hemolytic Properties | ASTM F756-17 | ||
| Hematology | ISO 10993-4:2017 | ||
| Platelet Count | |||
| Partial Thromboplastin Time | |||
| Cytotoxicity | ISO 10993-5:2009 | ||
| Skin Sensitization | ISO 10993-10:2010 | ||
| Intracutaneous Reactivity | |||
| Acute Systemic Toxicity | ISO 10993-11:2017 |
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Image /page/5/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a stylized font, with the "Pro" in green and the rest of the word in blue. Above the "m" is a graphic of two circles connected by a line, with a green circle at the top. To the right of the word is the registered trademark symbol.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, China.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a combination of green and blue colors. There is a green and blue graphic above the word, and a registered trademark symbol to the right of the word.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District,
Hangzhou City, 311121 Zhejiang, China.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a combination of green and blue colors. The "P" is green, while the rest of the letters are blue. Above the word is a blue molecular structure with a green circle at the top right. There is a registered trademark symbol to the right of the word.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Non-Clinical Summary:
The needle, tubing, hub, and luer connectors meet the following physical, chemical, biological requirements:
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the logo for "Promisemed". The word "Promisemed" is written in a combination of green and blue colors. The "P" is green, while the rest of the word is blue. There is a blue atom-like structure above the word, with a green circle at the top.
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China.
Sharps injury protection: Device meets safety mechanism activation requirements as per ISO 23908, internal protocol and test results
Sharps injury protection: Device meets safety overriding/unlocking force after activation requirements as per ISO 23908, internal protocol and test results
Sterilization: A Sterility Assurance Level (SAL) of 10-6 has been validated in accordance with the requirements of ISO 11135:2014 for Ethylene Oxide.
Clinical Summary: Not applicable. Substantial equivalence does not depend on clinical test data.
Conclusion:
Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to the legally marketed predicate device (K170276).
§ 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).