(199 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and standard medical device testing, with no mention of AI or ML.
No.
The device is used for blood collection, which is a diagnostic procedure, not a therapeutic one. Its primary function is to collect samples, not to treat a condition.
No
Explanation: The device is a blood collection set, used for the collection of venous blood, not for diagnosing a condition. It is designed to safely collect blood samples, which may then be used for diagnostic testing elsewhere, but the device itself does not perform the diagnosis.
No
The device description clearly outlines multiple physical components made of materials like stainless steel and plastic, and the performance studies focus on physical properties and standards related to hardware. There is no mention of software as a component or function of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "collection of venous blood." This is a pre-analytical step in the diagnostic process, but the device itself does not perform any diagnostic testing on the collected blood.
- Device Description: The description focuses on the physical components and function of the blood collection set, particularly the safety features for preventing needlestick injuries. It does not describe any components or processes related to analyzing the blood for diagnostic purposes.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze blood components, detect biomarkers, or provide any diagnostic information.
- Performance Studies: The performance studies focus on the physical and biological properties of the device (biocompatibility, sterility, strength, etc.) and its ability to safely collect blood. They do not involve evaluating the device's performance in a diagnostic context.
IVD devices are specifically designed to perform tests on specimens (like blood) to provide information for the diagnosis, treatment, or prevention of disease. This blood collection set is a tool used to obtain the specimen, but it does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needle stick injury.
Product codes (comma separated list FDA assigned to the subject device)
JKA, FMI
Device Description
The Safety Blood Collection Sets for Single Use are used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately the following venipuncture to aid in the protection against accidental needlestick injury. The Safety Blood Collect Sets is compatible for use with a tube and syringe. The product is to be used by appropriately trained healthcare professionals, only following the product instructions.
The Blood Collection needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub.
- The hub is threaded on one side to connect to the needle holder, which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber cap and a needle holder.
- The opposite end of the needle is 3/4" long for withdrawing blood and is fitted with a needle sheath.
The needle holder and needle sheath protect the needle.
The safety feature is operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is substantially equivalent to the predicate device.
The proposed devices are packaged as sterile, single-use, and single patient use only.
The proposed device consists of ten components:
-
- needle holder
-
- rubber sleeve
-
- puncture needle
-
- needle hub (male luer lock connector)
-
- connect base (female luer lock connector)
-
- flexing tube
-
- safety shield
-
- wings
-
- patient-end tube needle
-
- needle sheath
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous blood (from patient)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
appropriately trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the safety blood collection sets for single use met all requirements of related international standards, including biocompatibility, sterility, and product specifications. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing:
Performance Testing according to:
- ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use -Requirements and test methods
- ISO 80369-7 First edition 2016-10-15 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20 First edition 2015-05-15, small-bore connectors for liquids and gases in healthcare applications part 20: common test methods. (General I (QS/RM))
- ISO 23908 First edition 2011-06-11 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 6009 Fourth edition 2016-08-01 Hypodermic needles for single use Color coding for identification
Biocompatibility testing according to ISO10993-1, including:
- In Vitro Cytotoxicity (ISO10993-5: 2009)
- Skin Sensitization (ISO10993-10: 2010)
- Intracutaneous Reactivity Test (ISO10993-10: 2010)
- Acute Systemic toxicity (ISO10993-11:2006)
- Hemocompatibiltiy
- Pyrogenicity
All of the pre-determined acceptance criteria were met.
Sterility Information:
Sterilization conducted according to the following standards:
- ISO11135-1 Sterilization of health care products ethylene oxide part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices.
- ISO11737-1 Sterilization of medical devices-Microbiological Methods-Part 1: -Determination of the population of microorganisms on the product.
- ISO11737-2 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the validation of a sterilization process.
- ISO 10993-7 Biological evaluation of medical devices - Part 7: Test of Ethylene Oxide Residuals.
- ANSI/AAMI ST72 Bacterial endotoxins Test methods, routine monitoring, and alternatives to batch testing.
All of the pre-determined acceptance criteria were met.
Package and Shelf Life verification test conducted according to:
- AAMI/ANSI/ISO 11137-1:2006/(R) 2010 Sterilization of health care products -- Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
- AAMI/ANSI/ISO11737-2:2009 Sterilization of devices Microbiological methods - Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
- AAMI/ANSI/ISO 11607-1:2006/(R) 2010 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, 3ed.
- ASTM F1929-98 (2004) Standard Test Method for Detecting Seal Leaks in -Porous Medical Packaging by Dye Penetration
- ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM D3078-02 (2008), Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission. (Sterility)
- ASTM F88/F88M-09 Standard Test Method for Seal Strength of Flexible -Barrier Materials
Tests conducted:
- Product Performance Inspection (Chemical performance and Physical performance)
- Sterile Test
- Vacuum Leak Test
- Dye penetration test
- Agar Contact-Attack Test
- Tensile Seal Strength Test
- Accelerated Aging Test
The test result supports the shelf life claim for the subject device from the sterilization date. All of the pre-determined acceptance criteria were met.
No clinical study is included in this submission.
Key results: The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Safety Blood Collection Sets for Single Use is substantially equivalent to the Innovative Medical Technologies, Inc. Improsafe Blood Collection Set cleared under K123987 with respect to the indications for use, target populations, treatment method, and technological characteristics.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains 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.
February 23, 2021
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K202188
Trade/Device Name: Safety Blood Collection Sets for Single Use Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA, FMI
Dear Charles Mack:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 19, 2021. Specifically, FDA is updating this SE Letter to include the secondary product code (FMI) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6029, Payal.Patel@fda.hhs.gov.
Sincerely,
James M. Simpson Jr -
S7
For 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
1
Image /page/1/Picture/0 description: The image contains 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.
February 19, 2021
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Charles Mack Principal Engineer Irc 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K202188
Trade/Device Name: Safety Blood Collection Sets for Single Use Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: January 8, 2021 Received: January 19, 2021
Dear Charles Mack:
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 mav, 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
2
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,
James M. Simpson Jr -
S7
For 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
3
Indications for Use
510(k) Number (if known) K202188
Device Name Safety Blood Collection Sets for Single Use
Indications for Use (Describe)
The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield to cover the needle immediately following blood collection 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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4
K202188 510(k) SUMMARY
| Preparation Date: | February 23, 2021 |
|---|---|
| Manufacturer's Name and Address: | Anhui Hongyu Wuzhou Medical |
| Manufacturer Co., Ltd. | |
| No. 2 Guanyin Road, Economic | |
| Development Zone, Taihu, Anqing City, | |
| Anhui Province China246400 | |
| Mr. Bingyi Xiang | |
| General Manager | |
| Tel: +86-556 5129666 | |
| Fax: +86-556 4249999 | |
| Email: birrell@hongyu-wuzhou.com, | |
| FDA Establishment Registration No.: | |
| 3012116434 | |
| Corresponding Official: | IRC USA |
| 2950 E Lindrick Dr., Chandler, Arizona | |
| 85249, USA | |
| Mr. Charles Mack | |
| PRINCIPAL ENGINEER | |
| Tel: 931-6254938 | |
| Email: charliemack@irc-us.com | |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Safety Blood Collection Sets for Single- |
| Use | |
| Common Name(s): | Blood collection |
| Regulation Name(s): | Blood specimen collection device |
| Regulation Number(s): | 21CFR862.1675 |
| Product Code: | JKA (Primary) |
| FMI (Secondary) | |
| Device Class: | Class II |
| Predicate Device: | Innovative Medical Technologies, Inc. |
| Improsafe Blood Collection Set | |
| K133097 |
5
Device Description:
The Safety Blood Collection Sets for Single Use are used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately the following venipuncture to aid in the protection against accidental needlestick injury. The Safety Blood Collect Sets is compatible for use with a tube and syringe. The product is to be used by appropriately trained healthcare professionals, only following the product instructions.
The Blood Collection needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub.
- The hub is threaded on one side to connect to the needle holder, which is used to । guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber cap and a needle holder.
- The opposite end of the needle is 3/4" long for withdrawing blood and is fitted with a needle sheath.
The needle holder and needle sheath protect the needle.
The safety feature is operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is substantially equivalent to the predicate device.
The proposed devices are packaged as sterile, single-use, and single patient use only.
The proposed device consists of ten components:
-
- needle holder
-
- rubber sleeve
-
- puncture needle
-
- needle hub (male luer lock connector)
-
- connect base (female luer lock connector)
-
- flexing tube
-
- safety shield
-
- wings
-
- patient-end tube needle
-
- needle sheath
6
The subject device is classified as externally communicating devices, contact circulating blood for limited contact (44N | Complies with ISO7864:
21G>44N
23G>34N
25G>22N | Both comply with ISO7864. |
| Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | There is no difference, as both
comply with ISO10993-1 |
| Performance | Complies with
ISO 9626
ISO 7864
ISO 80369-7
ISO 80369-20
ISO 23908
ISO 6009 | Complies with
ISO 9626
ISO 7864
ISO 594-1
ISO 594-2
ISO 23908:2011
ISO 10555-1
ASTM F2132- Needle penetration | Both devices demonstrate
compliance with ISO standards
showing safe and effective use per
the Indications for use. |
| Sterilization | EO | EO | Same sterilization method, no
differences. |
| Sterile | Yes | Yes | Subject and predicate are delivered
sterile. |
| SAL | 10-6 | 10-6 | Subject and predicate have the same
SAL. |
| Disposable | Yes | Yes | Subject and predicate are
disposable. |
| Single Patient Use | Yes | Yes | Subject and predicate are for single
patient use. |
Comparison of Technological Characteristics with the Predicate Device
8
Note 1:
Although the material of proposed and the predicate device is not available, the patient-contact material of the proposed device material conforms to the ISO 10993 series of standards the same as predicate device. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
Note 2:
Both devices conform to the same performance standards.
9
Performance Testing
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the safety blood collection sets for single use met all requirements of related international standards, including biocompatibility, sterility, and product specifications. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
Non-clinical Testing
Performance Testing
- ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
- ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use -Requirements and test methods
- ISO 80369-7 First edition 2016-10-15 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20 First edition 2015-05-15, small-bore connectors for liquids and gases in healthcare applications part 20: common test methods. (General I (QS/RM))
- ISO 23908 First edition 2011-06-11 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 6009 Fourth edition 2016-08-01 Hypodermic needles for single use Color coding for identification
Biocompatibility
The new device complies with the biocompatibility requirement defined in ISO10993-1. Patient contact classification: externally communicating devices, contact circulating blood for limited contact (