(318 days)
Not Found
No
The device description focuses on the physical characteristics and intended use of a catheter, with no mention of AI or ML capabilities.
No.
The device is used for diagnostic purposes (sampling of blood, measurement of intravascular arterial pressure) and for delivery of substances (infusion of medicinal products), but it does not treat a disease or condition itself.
No
Explanation: The device is primarily used for vascular access for infusion and sampling of blood, and measurement of intravascular arterial pressure. While blood sampling and pressure measurement can be part of diagnostic processes, the device itself is a catheter for access and measurement, not a device that directly performs diagnosis or analyzes results to provide a diagnosis.
No
The device description clearly details a physical catheter made of polyurethane with specific dimensions and features, 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 clearly describes a device for vascular access and infusion/sampling within the body (umbilical vessels). This is a direct medical intervention, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a catheter designed for insertion into blood vessels. This aligns with a medical device used for treatment or monitoring within the body, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of biological samples outside the body, or any other typical components or functions of an IVD.
Therefore, the UMBILICAL VESSELS CATHETER is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients:
Via the umbilical artery:
--- sampling of blood,
---measurement of intravascular arterial pressure.
Via the umbilical vein:
--- infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).
Product codes
FOS
Device Description
The UMBILICAL VESSELS CATHETER has catheters in single lumen and dual lumen. The catheters tube is made of radiopaque polyurethane which is insert molded to a polyurethane hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion.
Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 40 cm from the tip. Catheter placement must be confirmed by x-ray.
The UMBILICAL VESSELS CATHETER has 17 primary configurations: Catheters in 2 Fr., 2.5 Fr., 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr., 6.5 Fr. and 7 Fr. for Single lumen; 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr. and 6.5 Fr. for dual lumen. Each device will continue to be packaged in a Tyvek pouches are packaged in a carton. The UMBILICAL VESSELS CATHETER does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging are not made of natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
umbilical vessels
Indicated Patient Age Range
neonatal patients
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)
Nonclinical testing was performed for:
- Sterilization and shelf life: Tests include sterilization (ISO 11135:2014), seal strength (ASTM F88/F88M-09), integrity of seals (ASTM F1886-98), detecting seal leaks (ASTM F1929-98), internal pressurization failure resistance (ASTM F1140-00), performance testing of shipping containers (ASTMD4169-05), and determination of leaks by bubble emission (ASTM D3078-02). All tests passed.
- Biocompatibility: Tests include genotoxicity (ISO 10993-3:2014), hemocompatibility and hemolytic properties (ISO 10993-4:2006, ASTM F756), cytotoxicity (ISO 10993-5:2009), implantation (ISO 10993-6:2016), EO/ECH residual (ISO 10993-7:2008), sensitization (ISO10993-10:2010), irritation or intracutaneous reactivity (ISO 10993-10:2010), acute systemic toxicity (ISO 10993-11:2006), subacute/subchronic toxicity (ISO 10993-11:2006), material-mediated pyrogenicity (ISO 10993-11:2006), and Limulus Amebocyte Lysate (USP). All tests passed.
- Performance-bench: Tests include general requirements for intravascular catheters (ISO 10555-1:2013), conical fittings (ISO 594-1:1986, ISO 594-2:1998), and sterile hypodermic syringes (ISO7886-1:2017). All tests passed.
Key results: All nonclinical tests performed on the new devices passed, demonstrating compliance to applicable standards and substantial equivalence to the predicate 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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in a smaller font size.
May 6, 2021
Haolang Medical USA Corporation % Field Fu Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Bloack A, Zhongguan Times Square, Xili Town Shenzhen, Guangdong 518000 China
Re: K201697
Trade/Device Name: Umbilical Vessels Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOS Dated: March 29, 2021 Received: April 5, 2021
Dear Field Fu:
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201697
Device Name UMBILICAL VESSELS CATHETER
Indications for Use (Describe)
UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients:
Via the umbilical artery:
--- sampling of blood,
---measurement of intravascular arterial pressure.
Via the umbilical vein:
--- infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).
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
Product: Umbilical Vessels Catheter
510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Haolang Medical USA Corporation. |
|---|---|
| Address | 1100 Bellevue Way NE 8A-533 |
| Bellevue, WA 98004, USA | |
| Phone No. | 1-425-503-6325 |
| Fax No. | No. |
| Contact person | Lisa.Xu |
| Contact person's e-mail | lisa.xu@haolangmed.com |
| Date Prepared | May 30, 2020 |
1.2 Submission
- Correspondent
| Image: logo | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | |
| Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong | |
| Province, China | |
| Image: Chinese characters | |
| Phone No. | +86-755-86069197 |
| Contact person | Field Fu |
| Contact person's e-mail | field@cefda.com; info@cefda.com |
| Website | http://www.cefda.com |
2. Device information
| Trade name | Umbilical Vessels Catheter |
|---|---|
| Common name | Umbilical Vessels Catheter |
| Model | Single lumen catheter, dual lumen catheter |
| Classification | II |
| Classification name | Intravascular Catheter |
| Product code | FOS |
| Regulation No. | 880.5200 |
3. Legally Marketed Predicate Device
| Trade Name | Umbilical Vessels Catheter |
|---|---|
| 510(k) Number | K130725 |
| Product Code | FOS |
| Manufacturer | Covidien |
4
4. Device Description
The UMBILICAL VESSELS CATHETER has catheters in single lumen and dual lumen. The catheters tube is made of radiopaque polyurethane which is insert molded to a polyurethane hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion.
Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 40 cm from the tip. Catheter placement must be confirmed by x-ray.
The UMBILICAL VESSELS CATHETER has 17 primary configurations: Catheters in 2 Fr., 2.5 Fr., 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr., 6.5 Fr. and 7 Fr. for Single lumen; 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr. and 6.5 Fr. for dual lumen. Each device will continue to be packaged in a Tyvek pouches are packaged in a carton. The UMBILICAL VESSELS CATHETER does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging are not made of natural rubber latex.
5. Intended Use/Indication for Use
UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients:
Via the umbilical artery:
---sampling of blood,
---measurement of intravascular arterial pressure.
Via the umbilical vein:
---infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).
5
| Item | Proposed Device:
Umbilical Vessels Catheter | Predicate Device:
Umbilical Vessels Catheter
(K130725) | Comments |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Product Code | FOS | FOS | Same |
| Intended
Use/Indication for
use | UMBILICAL VESSELS
CATHETER is intended for
short-term vascular access
via umbilical vessels in
neonatal patients:
Via the umbilical artery:
---sampling of blood,
---measurement of
intravascular arterial
pressure.
Via the umbilical vein:
---infusion
(simultaneous infusion of
several medicinal products for
the dual lumen catheter). | The Argyle TM
Polyurethane
Umbilical Vessel
Catheter is
intended for
short-term vascular
access via
umbilical vessels in
neonatal patients. | SE, only
wording is
different (01). |
| Catheter Type | Single lumen and dual lumen | Single lumen | Different (02) |
| Catheter size | Single lumen:
(2 Fr, 2.5Fr, 2.8Fr, 3.0Fr,
3.5Fr, 4.0Fr, 5.0Fr, 6.0Fr,
6.5Fr, 7.0Fr) x (15cm, 20cm,
25cm, 28cm, 30cm, 32cm,
34cm, 35cm, 40cm);
Dual lumen:
(2.8Fr, 3.0Fr, 3.5Fr, 4.0Fr,
5.0Fr, 6.0Fr, 6.5Fr) x (15cm,
20cm, 25cm, 28cm, 30cm,
32cm, 34cm, 35cm, 40cm). | 2.5 Fr x 25 cm,
3.5 Fr x 25 cm,
and 5 Fr x 25 cm | Different (03) |
| Operation mode | Manual | Manual | Same |
| Radio-detectability | Yes | Yes | Same |
| Item | Proposed Device:
Umbilical Vessels Catheter | Predicate Device:
Umbilical Vessels
Catheter
(K130725) | Comments |
| water flow rate | The flowrate for each lumen is
not less than 80% of the
Nominal value for catheters of
nominal outside diameter less
than 1.0; and the flowrate for
each lumen is not less than
90% of the Nominal value for
catheters of nominal outside
diameter equal to 1.0 or
greater. | Not publicly
available | Comply with
ISO 10555-1 |
| Peak tensile force | More than 5N, 10N, or15N | Not publicly
available | SE (Comply
with ISO
10555-1) |
| Freedom from
leakage | No leakage for liquid and air | Not publicly
available | SE (Comply
with ISO
10555-1) |
| Material | Polyurethane
POM M370 44 | Not publicly
available | SE (Comply
with ISO
10993 series) |
6. Substantial Equivalence Comparison for Umbilical Vessels Catheter
6
Discussion on differences from the predicate device:
01:
The Umbilical Vessels catheter indications for use is more specific than the predicate. The indications for use for other currently marketed Umbilical catheters on the market are similar as they are indicated for blood sampling, pressure monitoring and administration of fluids and medications. Although the subject device and the predicate device wording is different, the intended use is the same.
02 & 03:
The subject device is available in single and double lumen catheter configuration, with sizes 2Fr to 7Fr and 15-40 cm lengths. The predicate device is only available in a single lumen configuration 2.5 Fr to 5 Fr 25 cm length. The Umbilical catheters currently on the market come in both single and double lumen configurations and are available in various sizes lengths between 2 Fr to 8 Fr.
Performance testing was performed per recognized standards ISO 10555-1 and ISO 594-1/ISO 594-2, demonstrating that differences in physical characteristics (e.g. single lumen or dual lumen, length, size, etc.) do not raise new or different questions of safety and effectiveness.
7
7. Non-clinical Testing
All nonclinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the tests demonstrate the compliance to the standards.
| Standard | Standard Title | Test Results |
|---|---|---|
| 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 | Pass | |
| ASTM F88/F88M-09 | Standard Test Method for Seal Strength of Flexible | |
| Barrier Materials | Pass | |
| ASTM F1886-98 | Standard Test Method for Determining Integrity of | |
| Seals for Flexible Packaging by Visual Inspection | Pass | |
| ASTM F1929-98 | ||
| (Reapproved 2004) | Standard Test Method for Detecting Seal Leaks in | |
| Porous Medical Packaging by Dye Penetration | Pass | |
| ASTM F1140-00 | Standard Test Methods for Internal Pressurization | |
| Failure Resistance of Unrestrained Packages for | ||
| Medical Applications | Pass | |
| ASTMD4169-05 | Standard Practice for Performance Testing of | |
| Shipping Containers and Systems | Pass | |
| ASTM D3078-02 | Standard Test Method for Determination of Leaks in | |
| Flexible Packaging by Bubble Emission | Pass | |
| ASTM F1886-98 | Standard Test Method for Determining Integrity of | |
| Seals for Flexible Packaging by Visual Inspection | Pass |
a) The tests concerned sterilization and shelf life as follow:
b) The tests concerned biocompatibility as follow:
| Test Item | Reference | Standard Title | Test Results |
|---|---|---|---|
| Genotoxicity | ISO 10993-3:2014 | Biological evaluation of medical devices | |
| —Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity | Pass | ||
| Hemocompatibility, | |||
| Hemolytic | ISO 10993-4:2006; | ||
| ASTM F756, | Biological evaluation of medical devices | ||
| —Part 4: Selection of tests for interactions with blood; | Pass |
8
| Cytotoxicity | ISO
10993-5:2009 | Standard Practice for Assessment of
Hemolytic Properties of Materials. | Pass |
|-----------------------------------------------|----------------------|------------------------------------------------------------------------------------------------------|------|
| Implantation | ISO
10993-6:2016 | Biological evaluation of medical devices
—Part 6: Tests for local effects after
implantation | Pass |
| EO,ECH residual | ISO
10993-7:2008 | Biological evaluation of medical devices
-Part 7: Ethylene oxide sterilization
residuals | Pass |
| Sensitization | ISO10993-10:2
010 | Biological evaluation of medical devices
—Part 10: Tests for irritation and skin
sensitization | Pass |
| Irritation or
Intracutaneous
reactivity | ISO
10993-10:2010 | Biological evaluation of medical devices
-Part 10: Tests for irritation and skin
sensitization | Pass |
| Acute Systemic
toxicity | ISO
10993-11:2006 | Biological evaluation of medical devices
-Part 11: Tests for systemic toxicity | Pass |
| Subacute
Subchronic toxicity | ISO
10993-11:2006 | Biological evaluation of medical devices
-Part 11: Tests for systemic toxicity | Pass |
| Material-Mediated
Pyrogenicity | ISO
10993-11:2006 | Biological evaluation of medical devices
-Part 11: Tests for systemic toxicity | Pass |
| Limulus Amebocyte
Lysate | USP | United States Pharmacopoeia | Pass |
c) Software validation
Not applicable, the subject devices are non-active products.
d) Electric safety
Not applicable, the subject devices are non-active products.
e) The tests concerned performance-bench as follow:
| Standard | Standard Title | Test Result |
|---|---|---|
| ISO 10555-1:2013 | Intravascular catheters — Sterile and single-use | |
| catheters —Part 1: General requirements | Pass | |
| ISO 594-1:1986 | Conical fittings with a 6% (Luer) taper for syringes, | |
| needles and certain other medical equipment - Part | ||
| 1: General requirements | Pass |
9
| Standard | Standard Title | Test Result |
|---|---|---|
| ISO 594-2:1998 | Conical fittings with a 6% (Luer) taper for syringes, | |
| needles and certain other medical equipment - Part | ||
| 2: Lock fittings | Pass | |
| ISO7886-1:2017 | Sterile hypodermic syringes for single use - Part 1: | |
| Syringes for manual use | Pass |
8. Animal study data
Substantial equivalence does not depend on animal study data.
9. Clinical Testing
Substantial equivalence does not depend on the clinical test data.
10. Conclusions
Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate devices (K130725).