(379 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a standard arterial catheter, with no mention of AI or ML capabilities.
No
The device is described as an access device for monitoring pressure, which makes it a diagnostic tool rather than a therapeutic one.
Yes
The device description states it is "also intended to be used for pressure monitoring," which is a diagnostic function.
No
The device description clearly details physical components like catheters, needles, guide wires, and hubs, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "permit access to the peripheral arterial circulation" and "for pressure monitoring." This describes a device used in vivo (within the body) for accessing blood vessels and measuring pressure.
- Device Description: The description details a catheter assembly designed for insertion into the body using a specific technique. It focuses on the physical components and their function in accessing the circulatory system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis or testing of bodily fluids outside the body.
The device is clearly an invasive medical device used for accessing the arterial system, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The Arterial Catheter permits access to the peripheral arterial circulation.
Product codes
DQY
Device Description
The Arterial Catheter is a lumen peripherally inserted catheter assembly designed to perform short term access to the peripheral arterial circulatory system for less than 7 days, it is also intended to be used for pressure monitoring. It consists of an introducer needle or catheter-over-needle assembly, spring guide wire, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a flex tube end cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique, which divided into three types according to structure: Standard Seedinger; Modified Seedinger-Integrated; Modified Seedinger-Sleeve.
The Arterial Catheter is available in 18 ga, 20 ga, 21 ga, 22 ga and 24 ga, the corresponding diameter of guide wire is 0.025", 0.018", 0.015", 0.012". Configurations with usable lengths of 2.5 cm to 23 cm. The catheters are attached to an injection molded polyurethane hub with Luer lock fittings for access attachment.
The Arterial Catheter is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arterial circulation
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)
Clinical test: Clinical testing is not required.
Non-clinical data: Arterial Catheter comply with:
Performance: According to the requirements of FDA guidance ISO 10555-1:2013 we performed the following testing:
- Visual assessment
- Corrosion Resistance
- Liquid Leakage Testing
- Air Leakage Testing
- Flow Rate Testing Report
- Catheter Tensile Testing
- Guidewire Tensile Testing
- Dimensional verification
- Simulated use and Simulated Blood Withdrawal
- Kink Testing
- Torque Strength Testing
- Radiopacity Testing
- Needle testing: Visual assessment; Tensile strength testing of needle and hub; Penetration force
Shelf Life: Accelerated aging tests were conducted to confirm the validity of the 3 years shelf life.
Biocompatibility: The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1, "Biological Evaluation of Medical Devices".
Sterilization:
- ISO 11607-1:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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.
July 7, 2021
Haolang Medical USA Corporation Lisa Xu RA Manager 1100 Bellevue Way NE 8A-533 Bellevue, Washington 98004
Re: K201726
Trade/Device Name: Arterial Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 1, 2020 Received: September 18, 2020
Dear Lisa Xu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (https://www.fda.gov/medical-devices/ device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-andcontinuing-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-regulatory-assistance/contact-usdivision-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 Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201726
Device Name Arterial Catheter
Indications for Use (Describe)
The Arterial Catheter permits access to the peripheral arterial circulation.
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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3
510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: June 1, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Haolang Medical USA Corporation |
|---|---|
| Address: | 1100 Bellevue Way NE 8A-533, Bellevue, WA 98004 USA |
| Contact person: | Lisa Xu |
| Title: | RA Manager |
| E-mail: | lisa.xu@haolangmed.com |
| Tel: | 1-425-503-6325 |
2. Device Identification
| Trade/Device Name: | Arterial Catheter |
|---|---|
| Models: | 18Ga, 20Ga, 21Ga, 22Ga, 24Ga |
| Regulation Number: | 21 CFR 870.1250 |
| Common Name: | Percutaneous Arterial Catheter |
| Regulation Class: | Class II |
| Product Code: | DQY |
3. Predicate Device
| 510(K) number: | K171146 |
|---|---|
| Device Name: | Arrow Seldinger Arterial Catheterization Device |
| Manufacturer: | Arrow International, Inc. |
| Regulation Number: | 21 CFR 870.1250 |
| Regulation Name: | Percutaneous Catheter |
| Regulation Class: | Class II |
| Product Code: | DQY |
4. Device Description
The Arterial Catheter is a lumen peripherally inserted catheter assembly designed to perform short term access to the peripheral arterial circulatory system for less than 7 days, it is also intended to be used for pressure monitoring. It consists of an introducer needle or catheter-over-needle assembly, spring guide wire, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a flex tube end cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique, which divided into three types according to structure: Standard Seedinger; Modified Seedinger-Integrated; Modified Seedinger-Sleeve.
The Arterial Catheter is available in 18 ga, 20 ga, 21 ga, 22 ga and 24 ga, the corresponding diameter of guide wire is 0.025", 0.018", 0.015", 0.012". Configurations with usable lengths of
Haolang Medical USA Corporation
4
2.5 cm to 23 cm. The catheters are attached to an injection molded polyurethane hub with Luer lock fittings for access attachment.
The Arterial Catheter is provided sterile.
5. Indication for use
The Arterial Catheter permits access to the peripheral arterial circulation.
6. Comparison to Predicate Device
Compared to the predicate devices, the subject device has same intended use, similar product design, performance effectiveness as the predicate device as summarized in the following table.
| Feature | Subject device | Predicate device | Comments |
|---|---|---|---|
| Manufacturer/ | |||
| K# | Haolang Medical USA | ||
| Corporation | Arrow International, Inc. | ||
| K171146 | -- | ||
| Trade name | |||
| and model | Arterial Catheter | Arrow Seldinger Arterial | |
| Catheterization Device | -- | ||
| Classifications | |||
| name and | |||
| Regulation | |||
| Name | 21 CFR 870.1250 | ||
| Percutaneous Catheter | |||
| Class II | |||
| DQY | 21 CFR 870.1250 | ||
| Percutaneous Catheter | |||
| Class II | |||
| DQY | Same | ||
| Indications for | |||
| use | The Arterial Catheter | ||
| permits access to the | |||
| peripheral arterial | |||
| circulation. | The Arrow Seldinger | ||
| Arterial Catheterization | |||
| Devices permit access to | |||
| the peripheral arterial | |||
| circulation or to other | |||
| small vessels | Same | ||
| Catheter | |||
| Gauge Sizes | 18 ga, 20 ga, 21 ga, 22 ga | ||
| and 24 ga | 18 ga, 20 ga, 22 ga and 24 | ||
| ga | We have one more | ||
| size than predicate | |||
| device, but we have | |||
| performed the | |||
| performance test, | |||
| the difference does | |||
| not raise the new | |||
| risk. | |||
| Catheter | |||
| Usable Length | 2.5 cm to 23 cm | 5cm - 23cm | According to |
| different usage | |||
| requirements, our | |||
| catheter length | |||
| range is larger, but | |||
| we have also | |||
| performed the | |||
| performance test on | |||
| which is smaller | |||
| than the range of | |||
| predicate device, the | |||
| difference does not | |||
| raise the new risk. | |||
| Introducer | |||
| needle size | 18Ga, 20Ga, 21Ga, | ||
| 22Ga,23Ga, 24Ga, 26Ga | 18 ga.: 18 ga X 5cm- | ||
| 7cm (2"-2 $\frac{3}{4}$ ") | |||
| 20 ga : 20 ga X 4cm- | Different, The | ||
| coverage of the | |||
| Introducer needle | |||
| 7cm (1 ½"- 2 ¾") | |||
| 22 ga.: 22 ga. X 4cm (1 | |||
| 1 ½") | size is more than | ||
| that of the predicate | |||
| device. We used a | |||
| thinner needle and | |||
| undergoing the | |||
| performance test | |||
| according to the ISO | |||
| 10555-1 and ISO |
- The
difference does not
affect the safety and
performance of the
device. | | |
| Spring Wire
Guide Size | 0.012", 0.015", 0.015",
0.018", 0.021", 0.025" | 18 ga.: 0.64mm diameter X
33.5cm-60cm (13"-23")
20 ga.: 0.533mm diameter X
35cm-50cm (13 ¾"-20")
22 ga.: 0.533mm
diameter X 35cm (13 ¾")
24 ga.: 0.46mm diameter
X 25cm (9 ¾") | Different, The size
coverage of spring
Wire Guide Size is
more than that of the
predicate device.
We are undergoing the
performance test
according to the ISO
10555-1 and ISO - The
difference does not
affect the safety and
performance of the
device. |
| Spring Wire
Guide Tip | Straight | Straight and J-tip | Same |
| Spring Wire
Guide Depth
Markings | Yes | Yes, etched on straight
spring wire guides. Not on J-
tip spring wire guides | Same |
| Introducer
Method | Introducer needle and
introducer catheter-over-
needle | Introducer needle and
introducer catheter-over-
needle | Same |
| Sterilization
Method | EO | EO | Same |
| Shelf life | 3 years | 2 years | Different, we have
conducted the shelf
life validation based
on the 3 years, the
performance is
acceptable, the
difference does not
affect the safety and
performance of the
device. |
| Packaging | PET/LDPE film mated
with Tyvek | PET/LDPE film mated
with Tyvek | Same |
| | | | |
| Material | 1. Introducer Needle: SUS 304 - Tubing, Catheter Hub
and Luer: PU - Needle Hub: ABS
- Spring guide wire: Niti&
Stainless Steel - Flex tube: PVC
- Guide wire slide: HDPE
- Catheter protector tube:
LDPE | 1. Introducer Needle: SUS 304 - Tubing, Catheter Hub and
Luer: Polyether urethane - Needle Hub: ABS
- Spring guide wire: SUS 304
- Flex tube: Not specified
- Guide wire slide: Not
specified - Catheter protector tube:
Not specified | Different, The
introducer needle
and the catheter
body are made of
the same material,
but the production
process and
chemical
characterization
information of the
material is unknown,
so it is impossible to
prove that its
biocompatibility is
equivalent. We
conducted the
biocompatibility
evaluation on
subject device and
determined the
endpoint according
to ISO 10993-1,
which prove that the
material of subject
device is
biocompatibility, the
difference of
material does not
affect the safety and
performance of the
device. |
5
Traditional 510(k) Submission of Arterial Catheter
6
7. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
Arterial Catheter comply with:
Performance:
According to the requirements of FDA guidance ISO 10555-1:2013 we performed the following testing:
- Visual assessment -
- -Corrosion Resistance
- Liquid Leakage Testing -
- Air Leakage Testing -
- Flow Rate Testing Report -
- Catheter Tensile Testing -
- Guidewire Tensile Testing -
Haolang Medical USA Corporation
7
- Dimensional verification -
- Simulated use and Simulated Blood Withdrawal -
- -Kink Testing
- -Torque Strength Testing
- Radiopacity Testing -
- Needle testing: Visual assessment; Tensile strength testing of needle and hub; Penetration force
Shelf Life:
Accelerated aging tests were conducted to confirm the validity of the 3 years shelf life.
Biocompatibility:
The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. The Biological Evaluation Tests are in compliance with the standards of ISO 10993-1, "Biological Evaluation of Medical Devices".
Sterilization:
- -ISO 11607-1:2016 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
- -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
9. Conclusion
Based on the results of above testing, the Arterial Catheter is substantially equivalent to the predicate device Arrow Seldinger Arterial Catheterization Device (K171146).