(95 days)
Not Found
No
The device description and intended use are for standard blood collection and infusion sets with a mechanical safety feature. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No.
The device is used for the "short-term infusion of intravenous fluids" or "venous blood collection," which are procedures rather than therapeutic outcomes. Its primary function is to facilitate the delivery or collection of substances, not to treat a condition directly.
No
The devices are used for blood collection or fluid infusion, not for diagnosing conditions. They are tools for obtaining samples or delivering substances, not for analyzing or interpreting data to determine a diagnosis.
No
The device description clearly outlines physical components such as needles, tubing, Luer connectors, and safety mechanisms. The performance studies focus on physical and chemical properties, sterilization, and packaging, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are for the collection of venous blood and the short-term infusion of intravenous fluids. These are procedures performed directly on the patient for therapeutic or diagnostic purposes, but the device itself is not used to perform a diagnostic test in vitro (outside the body).
- Device Description: The device is a needle and tubing set designed for accessing the venous system. It facilitates the collection of a sample or the delivery of a substance, but it does not analyze or test the sample or substance itself.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not perform such analysis.
The device is a medical device used for patient access and fluid management, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by trained healthcare professionals in accordance with the instructions. The safety shield to aid in the protection agamst accidental needle stick injury.
Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.
Product codes (comma separated list FDA assigned to the subject device)
JKA, FMI, FPA
Device Description
The Blood Collection Set with Holder, Blood Collection Set, and Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector. The devices are individually wrapped and sterile with a luer port. The luer port can connect FDAcleared accessories like luer adapter, holder, etc.
The Safety Blood Collection Set with Holder, Safety Blood Collection Set, and Safety Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation and ensures the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without needle holder) is individually wrapped sterile with a luer port. The luer port can connect FDA-cleared accessories like luer adapter, holder, etc.
The safety feature is operated by releasing 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. There is no ability to clean and reuse these because the safety feature cannot be deactivated without bending the needle and rendering it unusable.
The devices are used for venous blood collection and/or the short-term infusion of intravenous fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions. It can be used with an intravascular administration set, syringe, or other device to administer fluids.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-Clinical Performance Testing was performed to evaluate the functional performance and safety of the subject device with the following standards: ISO 8536-4-2019, ISO 9626, ISO 7864, ISO 80369-7, ISO 80369-20, ISO 23908.
Biocompatibility testing followed ISO10993-5: 2009, ISO10993-10: 2021, ISO10993-23: 2021, ISO10993-11: 2017, ISO10993-4:2017, ISO10993-3.
Sterilization testing followed ISO11135-1, ISO11737-1, ISO11737-2, ISO10993-7, ANSI/AAMI ST72.
Packaging and Shelf Life testing followed ISO 11607-1:2006/(R) 2010, ASTM F1929-15, ASTM F1980-16, ASTM D3078-02 (2021), ASTM F88/F88M-15.
Specific tests conducted include: Accelerated Aging Test, Simulated shipping distribution testing, Visual inspection, Performance Inspection (Chemical performance and Physical performance), Sterile Test, Vacuum Leak Test, Dye penetration test, Tensile Seal Strength Test.
All the pre-determined acceptance criteria were met. No clinical study is included in this submission.
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 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.
December 22, 2023
Jiangsu Kangbao Medical Equipment Co., Ltd Wenbin Fan Deputy General Manager 78#, North Suzhong Road, Baoying Yangzhou, Jiangsu 225800 China
Re: K232881
Trade/Device Name: Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FMI, FPA Dated: November 21, 2023 Received: November 22, 2023
Dear Wenbin Fan:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director
2
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) K232881
Device Name
Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
Indications for Use (Describe)
Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by trained healthcare professionals in accordance with the instructions. The safety shield to aid in the protection agamst accidental needle stick injury.
Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.
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
510(k) SUMMARY K232881
| Preparation Date: | December 22, 2023 |
|---|---|
| Manufacturer's Name and Address: | Jiangsu Kangbao Medical Equipment Co., Ltd |
| 78#, North Suzhong Road | |
| Baoying, Yangzhou, Jiangsu, China 225800 | |
| Tel. +86-514-88223540 | |
| Fax +86-514-88232089 | |
| Corresponding Official: | Charles Mack |
| Telephone Number: | 931-625-4938 |
| Email Address: | charliemack@irc-us.com |
| Trade Name: | Winged Infusion Set. |
| Safety Winged Infusion Set, | |
| Blood Collection Set, | |
| Blood Collection Set with | |
| Holder. | |
| Safety Blood Collection Set, | |
| Safety Blood Collection set with Holder, | |
| Needle Holder | |
| Common Name(s): | Tubes, Vials, Systems, Serum |
| Separators, Blood Collection | |
| Regulation Name(s): | Blood specimen collection device |
| Regulation Number(s): | 21 CFR 862.1675 |
| Primary Product Code: | |
| Subsequent Product Codes: | JKA |
| FMI, FPA | |
| Device Class: | Class II |
5
| Primary Predicate Device: | K193074 |
|---|---|
| Trade Name: | Bevel Up Holder |
| Common Name: | tubes, vials, systems, serum separators, blood |
| collection | |
| Regulation Number: | 21 CFR 862.1675 |
| Product Code: | JKA |
| Predicate Device: | K214075 |
| Trade Name: | Safety Blood Collection / Infusion Set (with/without |
| needle holder), Blood Collection | |
| / Infusion Set (with/without needle holder) | |
| Common Name: | needle, hypodermic, single lumen |
| Regulation Number: | 21 CFR 880.5570 |
| Product Code: | FMI, FPA |
Device Description:
The Blood Collection Set with Holder, Blood Collection Set, and Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector. The devices are individually wrapped and sterile with a luer port. The luer port can connect FDAcleared accessories like luer adapter, holder, etc.
The Safety Blood Collection Set with Holder, Safety Blood Collection Set, and Safety Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation and ensures the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without needle holder) is individually wrapped sterile with a luer port. The luer port can connect FDA-cleared accessories like luer adapter, holder, etc.
The safety feature is operated by releasing 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. There is no ability to clean and reuse these because the safety feature cannot be deactivated without bending the needle and rendering it unusable.
The devices are used for venous blood collection and/or the short-term infusion of intravenous fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions. It can be used with an intravascular administration set, syringe, or other device to administer fluids.
Indications for Use
Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
6
Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions.
Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury.
Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection aqainst accidental needle stick injury.
Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles, and tubes. It is to be used by trained healthcare professional only.
7
Needle Holder
| Feature | Subject Device | Predicate Device | Discussion |
|---|---|---|---|
| 510(K) | K232881 | K193074 | - |
| Device Name | Needle Holder | BEVEL UP HOLDER | - |
| Indication for | |||
| Use | The Needle Holder is used for the collection of blood | ||
| specimen into the blood collection tubes in routine | |||
| venipuncture procedures. It is used with blood | |||
| collection sets, needles, and tubes. It is to be used by | |||
| trained healthcare professional only. | The Bevel Up Holder is used for the collection of blood | ||
| into blood collection tubes in routine venipuncture | |||
| procedures. It is used with blood collection sets, | |||
| needles, and tubes. The device is to be used by trained | |||
| healthcare professional only. | Identical | ||
| Product | |||
| Configuration | Clear plastic holder | Clear plastic holder | Identical |
| Material | Polypropylene | Polypropylene | Identical |
| Sterility | They are not sterilized when provided alone. | ||
| Sterilized when provided attached to the blood | |||
| collection set | Not sterilized | Note 1 | |
| Packaging | Bulk pack in poly bag or Blister packaging | Bulk pack in poly bag | Note 2 |
| Use | Single use | Single use | Identical |
| Biocompatibility | Complies with ISO 10993-1 | Complies with ISO 10993-1 | Identical |
| Shelf Life | Complies with ASTM F1980 5 years | 3 years | Note 3 |
| Feature | Subject Device | Predicate Device | Discussion |
| 510(K) | K232881 | K214075 | |
| Device Name | Winged Infusion Set, | ||
| Safety Winged Infusion Set, | |||
| Blood Collection Set, | |||
| Blood Collection Set with Holder, | |||
| Safety Blood Collection Set, | |||
| Safety Blood Collection Set with Holder, | |||
| Needle Holder | Safety Blood Collection / Infusion Set (with/without needle | ||
| holder). | |||
| Blood Collection / Infusion Set (with/without needle holder) | |||
| Indication for Use | Winged Infusion Set is indicated for the short-term | ||
| infusion of intravenous fluids for 2 hours or less. It is to | |||
| be used by appropriately trained healthcare | |||
| professionals in accordance with the instructions. | |||
| Safety Winged Infusion Set is indicated for the short- | |||
| term infusion of intravenous fluids for 2 hours or less. It | |||
| is to be used by appropriately trained healthcare | |||
| professionals in accordance with the instructions. The | |||
| safety shield is intended to aid in the protection against | |||
| accidental needle stick injury. | |||
| Blood Collection Set is indicated for venous blood | |||
| collection. It is to be used by appropriately trained | |||
| healthcare professionals in accordance with the | |||
| instructions. | |||
| Blood Collection Set with Holder is indicated for | |||
| venous blood collection. It is to be used by appropriately | |||
| trained healthcare professionals in accordance with the | |||
| instructions. | The Safety Blood Collection / Infusion Set (with/without | ||
| needle holder) is indicated for venous blood collection | |||
| and/or the short-term infusion of intravenous fluids for 2 | |||
| hours or less. It is to be used by appropriately trained | |||
| healthcare professionals in accordance with the | |||
| instructions. The safety shield is intended to aid in the | |||
| protection against accidental needle stick injury. | |||
| The Blood Collection / Infusion Set (with/without | |||
| needle holder) is indicated for venous blood collection | |||
| and/or the short-term infusion of intravenous fluids for 2 | |||
| hours or less. It is to be used by appropriately trained | |||
| healthcare professionals in accordance with the | |||
| instructions. | Similar | ||
| Note 1 | |||
| Feature | Subject Device | Predicate Device | Discussion |
| 510(K) | K232881 | K214075 | - |
| Safety Blood Collection Set is indicated for venous | |||
| blood collection. It is to be used by appropriately trained | |||
| healthcare professionals in accordance with the | |||
| instructions. The safety shield is intended to aid in the | |||
| protection against accidental needle stick injury. | |||
| Safety Blood Collection set with Holder is indicated | |||
| for venous blood collection. It is to be used by | |||
| appropriately trained healthcare professionals in | |||
| accordance with the instructions. The safety shield is | |||
| intended to aid in the protection against accidental | |||
| needle stick injury. | |||
| Needle Holder is used for the collection of blood | |||
| specimen into the blood collection tubes in routine | |||
| venipuncture procedures. It is used with blood collection | |||
| sets, needles and tubes. It is to be used by trained | |||
| healthcare professional only. | |||
| Safety Feature | The needle is locked in safety sheath after use for the | ||
| Safety Blood Collection / Winged Infusion Set | |||
| (with/without needle holder). Slide the safety shield | |||
| forward and pull the tubing backward until an audible | |||
| click is heard. | |||
| There is no safety mechanism for the Blood Collection | |||
| Set / Winged Infusion Set (with/without needle holder). | For the Safety Blood Collection / Infusion Set (with/without | ||
| needle holder), the needle is locked in safety sheath after | |||
| use by sliding the safety shield forward with pulling the | |||
| tubing backward until an audible click is heard. | |||
| For the Blood Collection / Infusion Set (with/without needle | |||
| holder), no safety mechanism. | Identical | ||
| Material | |||
| Needle tube | SUS304 | SUS304 | Identical |
| Flexing tube | PVC | PVC | Identical |
| Luer adapter | ABS | ABS | Identical |
| Needle sheath | HDPE | HDPE | Identical |
| Safety shield | Polypropylene | Polypropylene | Identical |
| Rub sleeve | Gather Isoprene Rubber | Gather Isoprene Rubber | Identical |
| Feature | Subject Device | Predicate Device | Discussion |
| 510(K) | K232881 | K214075 | - |
| Lubricate | Silicone oil | Silicone oil | |
| Adhesive | Epoxy Resin | Epoxy Resin | |
| Needle Gauge | 18G, 19G, 20G, 21G, 22G, 23G, | ||
| 24G, 25G, 26G, 27G | 18G, 19G, 20G, 21G, 22G, | ||
| 23G, 24G, 25G, 26G, 27G; | Identical | ||
| Needle Length | 1/2" - 1 1/8" | 1/2" - 1 1/8" | Identical |
| Flexing tubing Length | 4"; 7½"; 12" | 7½"; 12" | Note 2 |
| Hub/Needle bond strength | Complies with ISO7864 | Complies with ISO7864 | Identical |
| Biocompatibility | Complies with ISO10993-1 | Complies with ISO10993-1 | Identical |
| Performance | Complies with ISO 9626 | ||
| ISO 7864 | |||
| ISO 80369-7 | |||
| ISO 80369-20 | |||
| ISO 23908 | |||
| ISO 6009 | |||
| ISO 8536-4 | Complies with ISO 9626 | ||
| ISO 7864 | |||
| ISO 80369-7 | |||
| ISO 80369-20 | |||
| ISO 23908 | |||
| ISO 6009 | |||
| ISO 8536-4 | Identical | ||
| Sterilization | EO | EO | Identical |
| Sterile | Yes | Yes | Identical |
| SAL | 10-6 | 10-6 | Identical |
| Disposable | Yes | Yes | Identical |
| Single Patient Use | Yes | Yes | Identical |
| Shelf life | ASTM F 1980 5 years | ASTM F 1980 5 years | Identical |
Note 1
When the needle holder of the subject device is provided alone for sale, it is not sterilized the same as the predicate device.
When the needle holder of the subject device is provided and attached to the blood collection as part of the system conforming to the applicable standards. The needle holded attached to the blood collection set is EO sterlized in accordance with ISO11135-1:
Second edition 2014. Therefore, the difference does not raise new questions about the safety and effectiveness of the subject device.
Note 2
More packaging types of the subject device are available than the predicate device, but they conform to the same andards. Therefore, this difference does not raise new or different questions of safety and effectiveness.
Note 2
The subject device has a shelf life longer than the prodical device was tested to applicable performance standards and
8
the design outputs met the design inputs over the proposed 5 year shelf life. Therefore, the different questions of safety and effectiveness.
Blood Collection/Infusion Set
9
10
Note 1
The indication for use of subject devices. The wording is slightly different; each subject device's IFU is listed individually for explicit identification (blood collection or infect for sales individually). It does not raise new questions of safety or effectiveness.
Note 2
The flexing tubing length of the subject devices is available in more sizes than the predicates, but the same applicable performance standards. Therefore, this difference does not raise new questions of safety or effectiveness.
11
Non-Clinical Performance Testing
Testing was performed to evaluate the functional performance and safety of the subject device with the following standards:
Performance
- ISO 8536-4-2019 Infusion equipment for medical use --Part 4: Infusion sets for single use, gravity feed
- -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
Biocompatibility
The subject device is classified as external communication device and contact circulating blood for limited contact (duration ≤ 24 h).
- -ISO10993-5: 2009 In Vitro Cytotoxicity
- ISO10993-10: 2021 Skin Sensitization -
- -ISO10993-23: 2021 Intracutaneous Reactivity Test
- ISO10993-11: 2017 Acute Systemic Toxicity -
- ISO10993-4:2017 Coagulation test -
- -ISO10993-4: 2017 Complement activity (SC5b-9) Test
- -ISO10993-4: 2017 Hemolytic Properties Test
- ISO10993-3 Ames Test -
- -ISO10993-3 Mammalian Chromosome Aberration Test
12
Sterilization:
The devices are EO sterilized. The sterilization was conducted according to the following standards:
- ISO11135-1 Sterilization of health care products ethylene oxide part 1: i 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.
- ISO10993-7 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.
Packaging and Shelf Life:
- 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 F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM D3078-02 (2021), Standard Test Method for Determination of Leaks in - Flexible Packaging by Bubble Emission. (Sterility)
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
The tests were conducted as noted below:
- Accelerated Aging Test -
- Simulated shipping distribution testing
- -Visual inspection
- Performance Inspection (Chemical performance and Physical performance) -
- -Sterile Test
- Vacuum Leak Test -
- Dye penetration test -
- -Tensile Seal Strength Test
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All the pre-determined acceptance criteria were met.
Clinical Data: No clinical study is included in this submission.
Conclusions:
Based on the verification test results, the subject device, Jiangsu Kangbao Medical Equipment Co., Ltd, Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set Safety Blood Collection set with Holder and Needle Holder conforms to the requirements of the exact standard, such as performance and biocompatibility, as the predicate devices. The subject device uses the same fundamental scientific technology and indications for use and functionality. The differences do not raise new questions about the safety and effectiveness of the proposed device.