(247 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of blood collection needles and adapters, with no mention of AI or ML capabilities.
No.
The device collects venous blood and connects medical devices; it is not designed to treat a disease or condition.
No
Explanation: The device is described as a blood collection device, specifically needles and holders used to collect venous blood. It does not perform analysis or interpretation of the collected blood to provide a diagnosis; its function is solely for sample acquisition.
No
The device description clearly outlines physical components such as needles, holders, hubs, and safety shields, indicating it is a hardware device for blood collection.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
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 devices themselves do not perform any diagnostic testing on the blood.
- Device Description: The description focuses on the physical components and function of creating a channel for blood collection. There is no mention of reagents, assays, or any process that analyzes the blood for diagnostic purposes.
- Lack of Diagnostic Information: The text does not describe any diagnostic claims, performance metrics related to diagnosis (like sensitivity, specificity), or any mention of analyzing the collected blood.
- Predicate Devices: The predicate devices listed are also blood collection devices, not IVD instruments or reagents.
These devices are classified as blood collection devices, which are used to obtain a sample that may then be used in an IVD test, but they are not IVDs themselves.
N/A
Intended Use / Indications for Use
The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood.
The Safety Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of blood.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood.
The Blood Collection Needle with/without Holder is intended for single use only, which consists of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub. They are available in different configurations.
The Safety Blood Collection Needle with/without Holder is intended for single use only, which consists of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub, safety shield. They are available in different configurations. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
In addition, the proposed devices are available in different specifications of needle gauge(27G-18G) and length (1"-1.5").
The Luer Access Device- holder with Pre-attached Multiple Sample Adapter is intended for single use only, which consists of a holder, non-patient needle, rubber sleeve, and a male (or female) luer lock hub which mates the female (or male) connector of other medical devices. The luer hub is permanent assembled with holder. It can be used to establish a channel to connect with medical vacuum tubes and transfer 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
Not Found
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 tests were conducted to verify that the proposed devices met all design specifications as was Substantially Equivalent (SE) to the predicate device. The tests performed on the relevant device configurations include:
Biocompatibility test:
Biocompatibility tests was leveraged from our own reference device Disposable Sterile Needle (K172938) for the Blood Collecting Needle with/without Holder and Safety Blood Collection Needle with/without Holder, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), irritation sensitivity (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), pyrogen test (ISO 10993-11) and Hemocompatibility Test (ASTM F756-17).
Biocompatibility tests was conducted on the Luer Access Device-holder with Preattached Multiple Sample Adapter, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), irritation sensitivity (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), pyrogen test (ISO 10993-11) and Hemocompatibility Test (ASTM F756-17).
Extraction Force Test:
The extraction force test was performed on proposed device. The test result demonstrated that the proposed device is able to successfully extract blood from a patient and fill blood tubes. This test is an internal test.
The test results demonstrated that the proposed devices comply with the following standards and guidance:
- ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008 Biological evaluation of medical devices - 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
- ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
- ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
- USP 41-NF 36:2018 Bacterial Endotoxins Test
- Simulated Use Study Sharps Injury Prevention Feature FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005
- USP Particular Matter in Injections
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.
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
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September 9, 2020
Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co. Ltd P.O Box 120-119 Shanghai, 200120 China
Re: K200027
Trade/Device Name: Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA Dated: July 24, 2020 Received: August 10, 2020
Dear Diana Hong:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-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,
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
2
Indications for Use
510(k) Number (if known) K200027
Device Name
Blood Collection Needle with/without Holder Safety Blood Collection Needle with/without Holder Luer Access Device-holder with Preattached Multiple Sample Adapter
Indications for Use (Describe)
The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood.
The Safety Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of blood.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Exhibit # 2 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K200027
-
- Date of Preparation: 9/9/2020
-
- Sponsor Identification
Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214415, China
Establishment Registration Number: 3005670221
Contact Person: Jianwei Pan Position: Quality Management Representative Tel: +86-18273696900 Email: jianwei.pan@cainamed.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Christina Wu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86(0)21 2281-5850 Fax: +1(0)360 925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name:
Blood Collection Needle with/without Holder Safety Blood Collection Needle with/without Holder Luer Access Device-holder with Preattached Multiple Sample Adapter
Common Name: Blood specimen collection device
Regulatory Information
Primary product code Regulation Name: Blood specimen collection device Classification: II Primary Product Code: JKA Regulation Number: 21 CFR 862.1675
Indications for Use:
The Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood.
The Safety Blood Collection Needle with/without holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
The Luer access device- holder with preattached multiple sample adapter is a sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of blood.
Device Description
The proposed devices are blood collection devices form a channel between patient's vein and the evacuated blood collection tube intended for collection of blood.
The Blood Collection Needle with/without Holder is intended for single use only, which consists of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub. They are available in different configurations.
The Safety Blood Collection Needle with/without Holder is intended for single use only, which consists
5
of a non-patient needle cap or holder, non-patient needle, rubber sleeve, patient needle cap, patient needle, hub, safety shield. They are available in different configurations. The safety shield will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
In addition, the proposed devices are available in different specifications of needle gauge(27G-18G) and length (1"-1.5").
The Luer Access Device- holder with Pre-attached Multiple Sample Adapter is intended for single use only, which consists of a holder, non-patient needle, rubber sleeve, and a male (or female) luer lock hub which mates the female (or male) connector of other medical devices. The luer hub is permanent assembled with holder. It can be used to establish a channel to connect with medical vacuum tubes and transfer fluids.
న్. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K172763 Product Name: Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder Regulation number: 862.1675 Product Code: JKA
Predicate Device 2 510(k) Number: K991088 Product Name: VACUTAINER® Brand Multiple Sample Luer Adapter Regulation Number: 862.1675 Product Code: JKA
-
- Comparison of Technological Characteristics
Table 1 Comparison of Technology Characteristics for Blood Collecting Needle with/without Holder and Safety Blood Collection Needle with/without Holder
- Comparison of Technological Characteristics
| ITEM | Proposed Device | Predicate Device K172763 | Remark |
|---|---|---|---|
| Product Code | JKA | JKA | SE |
| Regulation Number | 21CFR 862.1675 | 21CFR 862.1675 |
6
| Class | II | II | SE |
|---|---|---|---|
| Indications for Use | The Blood Collection Needle | ||
| with/without holder is intended to be | |||
| used with vacuum blood collection | |||
| tube for the collection of venous | |||
| blood. |
The Safety Blood Collection Needle
with/without Holder is intended to be
used with vacuum blood collection
tube for the collection of venous
blood. The safety shield is intended
to aid in the protection against
accidental needle stick injury. | The Blood Collecting Needle is
intended to be used with vacuum
blood collection tube for
multiple collection of venous
blood.
The Safety Blood Collecting
Needle is intended to be used
with vacuum blood collection
tube for multiple collections of
venous blood. The safety shield
is intended to aid in the
protection against accidental
needle stick injury. | SE |
| Configuration
and material | Non-patient Needle Cap(PP)
Patient Needle Cap(PP)
Holder(PP)
Rubber Sleeve (Case Gather Isoprene
Rubber)
Non- patient Needle Tube (Stainless
Steel)
Patient Needle Tube
(Stainless Steel)
Needle Tube (Stainless Steel)
Luer Lock Male Hub(MABS)
Luer Slip Male Hub(MABS)
Needle Hub (PP or MABS)
Safety Shield(PP) - only on the
Safety Blood Collection Needle
configuration
Lubricant- Polydimethysiloxane | Protective Cover of Patient-end
Needle (PP)
Protective Cover of Non-patient
end Needle(PP)
Needle Holder (PP)
Rubber Sleeve (Natural Rubber)
Non-patient end Needle
(Stainless Steel)
Patient-end Needle
(Stainless Steel)
Patient-end Needle Hub (PP)
Non-patient end Needle Hub
(ABS)
Conical fitting
Lubricant: Epoxy Resin | SE
Analysis
1 |
| Operate mode | Manual | Manual | SE |
| Flashback Feature | Visible | Visible | SE |
| Safety Mechanism | The safety shield is intended to
prevent needle sticks.
Only on the Safety Blood Collection
Needle configuration | The safety shield is intended to
prevent needle sticks. | SE |
| Label/ | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | SE |
| Labeling | | | |
| Needle Gauge and Length | Gauge: 20G23G23G
Length: 1",1.25",1.5" | Gauge: 18G
Length: 1", 1 1/4", 1 1/2" | SE
Analysis
1 |
| | Gauge: 27G, 25G, 23G, 22G, 21G,
20G, 18G
Length: 1",1.25",1.5" | Gauge: 19G, 25G
Length: 5/8", 3/4", 1", 1 1/4", 1 1/2", 1 3/4", 2" | 2 |
| | | | |
| Performance | Comply with
ISO 9626
ISO 7864 | Comply with
ISO 9626
ISO 7864 | SE |
| | | | |
| | | | |
| Biocompatibility | | | |
| In Vitro Cytotoxicity | | | |
| Skin Sensitization | Testing leveraged from reference
device K172938 | Conform with ISO 10993
Standards | SE
Analysis
3 |
| Intracutaneous Reactivity | | | |
| Acute Systemic Toxicity | | | |
| Hemocompatibility | | | |
| Sterilization | | | |
| Method | EO sterilized | EO sterilized | |
| SAL | 10-6 | 10-6 | SE |
| Endotoxin Limit | 20 EU per device | 20 EU per device | |
7
SE Analysis 1 -Configuration and material
The configuration difference between proposed device and predicate device is only the description of component. They have same configuration. The difference in the description of component does not affect the safety or effectiveness. This was evaluated through the performance testing.
In addition, the materials of rubber sleeve and hub from proposed device are different with predicate device. However, the biocompatibility test for proposed device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantial equivalence on safety and effectiveness.
SE Analysis 2- Needle Gauge and Length
The needle gauge and length of between the proposed device is different. However, this difference is just in dimension. Different gauge and length device will be selected by the end user. This difference does not affect raise new or different questions of safety or effectiveness
8
SE Analysis 3- Biocompatibility
The patient-contact materials of proposed device are different with the patient-contact materials of predicate device.
The patient contact material and manufacturing process for the proposed device is same as the reference device K172938. Therefore, new biocompatibility tests were not performed on the proposed device. And were leveraged from the reference device (K172938). Therefore, the proposed device will not raise any safety issues and is substantially equivalent to the predicate device.
The differences in technological characteristics were evaluated through performance testing.
Table 2 Comparison of Technology Characteristics for Luer Access Device-holder with Preattached Multiple Sample Adapter
| ITEM | Proposed Device | Predicate Device K991088 | Remark |
|---|---|---|---|
| Product Code | JKA | JKA | SE |
| Regulation Number | 21CFR 862.1675 | 21CFR 862.1675 | SE |
| Class | II | II | SE |
| Number of Uses | Single-use | Single-use | SE |
| Indications for Use | The Luer access device- holder with | ||
| preattached multiple sample adapter | |||
| is a sterile, non-invasive device | |||
| used to connect devices with male | |||
| or female luer connectors to blood | |||
| collection tubes for the collection of | |||
| blood. | The VACUTAINER® Brand Luer | ||
| Adapter is a sterile, non-invasive | |||
| device used to connect venous | |||
| access devices such as needles, | |||
| blood collection sets, and infusion | |||
| sets to blood collection tubes. | |||
| They are also used in connection | |||
| with non-needle devices for | |||
| collection of blood from catheters. | |||
| The VACUTAINER® Brand Luer | |||
| Adapter is sold by itself and as a | |||
| component of other | |||
| VACUTAINER Brand devices. | SE | ||
| Analysis 4 | |||
| Material | Luer Lock Male Hub( MABS) | ||
| Non-patient Needle | |||
| Tube( Stainless Steel) | |||
| Rubber Sleeve (Isoprene Rubber) | |||
| Holder(PP) | Hub(Polystyrene) | ||
| Cannula( Stainless Steel) | |||
| Sheath(Isoprene Rubber) | |||
| Holder(Polypropylene (PP)) | SE | ||
| Analysis 5 | |||
| Label/Labeling | Conform with 21 CFR Part 801 | Conform with 21 CFR Part 801 | SE |
9
| Design Feature | Length:60.8±0.2mm | Length: 64.3 mm | SE
Analysis 6 |
|---------------------------|-------------------------------------|-------------------------------------|------------------|
| Performance | Comply with ISO 80369-7 | Comply with ISO 80369-7 | SE |
| Biocompatibility | | | |
| In Vitro Cytotoxicity | | | |
| Skin Sensitization | Conform with ISO 10993
Standards | Conform with ISO 10993
Standards | SE |
| Intracutaneous Reactivity | | | |
| Acute Systemic Toxicity | | | |
| Hemocompatibility | | | |
| Sterilization | | | |
| Method | EO sterilized | EO sterilized | |
| SAL | 10-6 | 10-6 | SE |
| Endotoxin Limit | 20 EU per device | 20 EU per device | |
SE Analysis 4 - Indications for Use
The proposed device and the predicate device is used to connect devices to blood collection tubes used for sampling. The differences in indications for use does not change the intended use of the device, which is to collect blood and connect to blood collection tubes for sampling.
SE Analysis 5- Material
The materials of hub from proposed device are different with predicate device. However, the biocompatibility test for proposed device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantially equivalence on safety and effectiveness.
SE Analysis 6- Design Feature
The length of between the proposed device and predicate device is different. However, this difference is just in dimension. Different length device will be selected by physician per patient's condition. This difference does not affect intended use. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
The differences between proposed device and predicated device include Material of product and Length. These differences do not raise any question regarding its safety and effectiveness. The differences in technological characteristics may be evaluated through performance testing.
-
- Non-Clinical Test Summary for the Subject Devices
Non clinical tests were conducted to verify that the proposed devices met all design specifications as
- Non-Clinical Test Summary for the Subject Devices
10
was Substantially Equivalent (SE) to the predicate device. For full titles of the standards and guidances used, see below. The tests performed on the relevant device configurations include:
Biocompatibility test
Biocompatibility tests was leveraged from our own reference device Disposable Sterile Needle (K172938) for the Blood Collecting Needle with/without Holder and Safety Blood Collection Needle with/without Holder, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), irritation sensitivity (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), pyrogen test (ISO 10993-11) and Hemocompatibility Test (ASTM F756-17).
Biocompatibility tests was conducted on the Luer Access Device-holder with Preattached Multiple Sample Adapter, include in vitro cytotoxicity test (ISO 10993-5), skin sensitization test (ISO 10993-10), irritation sensitivity (ISO 10993-10), Acute Toxicity Test (ISO 10993-11), pyrogen test (ISO 10993-11) and Hemocompatibility Test (ASTM F756-17).
Extraction Force Test
The extraction force test was performed on proposed device. The test result demonstrated that the proposed device is able to successfully extract blood from a patient and fill blood tubes. This test is an internal test.
The test results demonstrated that the proposed devices comply with the following standards and guidance. The following tests were conducted as applicable to the subject devices:
-
ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
-
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-7:2008 Biological evaluation of medical devices - 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009)]
-
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
-
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the > development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
-
ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
-
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
11
-
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
-
ASTM F756-17: Standard Practice for Assessment of Hemolytic Properties of Materials
-
USP 41-NF 36:2018 Bacterial Endotoxins Test
-
Simulated Use Study Sharps Injury Prevention Feature FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005
-
USP Particular Matter in Injections
-
- Clinical Test Conclusion
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above and the performance testing conducted, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion