(318 days)
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 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.
The provided text describes a 510(k) premarket notification for an Umbilical Vessels Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through extensive clinical studies involving AI. Therefore, most of the requested information regarding AI performance metrics, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.
However, I can extract information related to the device's functional performance and equivalence.
Here's a breakdown of what can be extracted based on your request:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense for the device's functional performance beyond complying with established standards. Instead, it demonstrates compliance with recognized industry standards. The "reported device performance" is a statement of "Pass" for each test, indicating that the device met the requirements of the specified standards.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Sterilization (ISO 11135:2014) | Pass |
| Seal Strength (ASTM F88/F88M-09) | Pass |
| Seal Integrity (ASTM F1886-98, Visual) | Pass |
| Seal Leaks (ASTM F1929-98, Dye P) | Pass |
| Internal Pressurization (ASTM F1140-00) | Pass |
| Performance Testing (ASTMD4169-05) | Pass |
| Leak Determination (ASTM D3078-02) | Pass |
| Repeat Seal Integrity (ASTM F1886-98) | Pass |
| Genotoxicity (ISO 10993-3:2014) | Pass |
| Hemocompatibility (ISO 10993-4:2006; ASTM F756) | Pass |
| Cytotoxicity (ISO 10993-5:2009) | Pass |
| Implantation (ISO 10993-6:2016) | Pass |
| EO, ECH Residual (ISO 10993-7:2008) | Pass |
| Sensitization (ISO 10993-10:2010) | Pass |
| Irritation/Intracutaneous Reactivity (ISO 10993-10:2010) | Pass |
| Acute Systemic Toxicity (ISO 10993-11:2006) | Pass |
| Subacute/Subchronic Toxicity (ISO 10993-11:2006) | Pass |
| Material-Mediated Pyrogenicity (ISO 10993-11:2006) | Pass |
| Limulus Amebocyte Lysate (USP<85>) | Pass |
| Intravascular Catheters (ISO 10555-1:2013) | Pass |
| Conical Fittings (ISO 594-1:1986) | Pass |
| Conical Fittings (ISO 594-2:1998) | Pass |
| Sterile Hypodermic Syringes (ISO7886-1:2017) | Pass |
| 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. (Comply with ISO 10555-1) | Reported as "Comply with ISO 10555-1" |
| Peak tensile force: More than 5N, 10N, or 15N (Comply with ISO 10555-1) | Reported as "SE (Comply with ISO 10555-1)" |
| Freedom from leakage: No leakage for liquid and air (Comply with ISO 10555-1) | Reported as "SE (Comply with ISO 10555-1)" |
| Material: Polyurethane POM M370 44 (Comply with ISO 10993 series) | Reported as "SE (Comply with ISO 10993 series)" |
2. Sample size used for the test set and the data provenance:
The document refers to "nonclinical testing" performed according to applicable standards. It does not specify the sample size for these tests. Data provenance is implied to be laboratory testing as part of the manufacturing and submission process, likely conducted in China where the correspondent is located. This is not retrospective clinical data from a specific country, but rather prospective bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. For this type of device and submission, "ground truth" related to expert consensus or clinical judgment on a test set (as would be relevant for an AI device) is not established. The ground truth here is adherence to engineering and biocompatibility standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective assessments, particularly in clinical image interpretations or similar AI-assisted diagnoses. Here, the tests are objective measurements against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical catheter, not an AI-powered diagnostic or assistive tool. There are no "human readers" interpreting data with or without AI assistance in the context of this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
For the non-clinical testing, the "ground truth" is defined by the requirements and specifications within the referenced international and national standards (e.g., ISO 11135, ASTM F88, ISO 10993 series for biocompatibility, ISO 10555-1 for intravascular catheters). The tests determine if the device meets these objective, pre-defined standards.
8. The sample size for the training set:
Not applicable. There is no AI model or "training set" for this device.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set.
{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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{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-533Bellevue, 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, LiuxianAvenue, Xili Town, Nanshan District, Shenzhen, GuangdongProvince, 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 |
| IntendedUse/Indication foruse | UMBILICAL VESSELSCATHETER is intended forshort-term vascular accessvia umbilical vessels inneonatal patients:Via the umbilical artery:---sampling of blood,---measurement ofintravascular arterialpressure.Via the umbilical vein:---infusion(simultaneous infusion ofseveral medicinal products forthe dual lumen catheter). | The Argyle TMPolyurethaneUmbilical VesselCatheter isintended forshort-term vascularaccess viaumbilical vessels inneonatal patients. | SE, onlywording isdifferent (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 VesselsCatheter(K130725) | Comments |
| water flow rate | The flowrate for each lumen isnot less than 80% of theNominal value for catheters ofnominal outside diameter lessthan 1.0; and the flowrate foreach lumen is not less than90% of the Nominal value forcatheters of nominal outsidediameter equal to 1.0 orgreater. | Not publiclyavailable | Comply withISO 10555-1 |
| Peak tensile force | More than 5N, 10N, or15N | Not publiclyavailable | SE (Complywith ISO10555-1) |
| Freedom fromleakage | No leakage for liquid and air | Not publiclyavailable | SE (Complywith ISO10555-1) |
| Material | PolyurethanePOM M370 44 | Not publiclyavailable | SE (Complywith ISO10993 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 androutine control of a sterilization process for medicaldevices | Pass |
| ASTM F88/F88M-09 | Standard Test Method for Seal Strength of FlexibleBarrier Materials | Pass |
| ASTM F1886-98 | Standard Test Method for Determining Integrity ofSeals for Flexible Packaging by Visual Inspection | Pass |
| ASTM F1929-98(Reapproved 2004) | Standard Test Method for Detecting Seal Leaks inPorous Medical Packaging by Dye Penetration | Pass |
| ASTM F1140-00 | Standard Test Methods for Internal PressurizationFailure Resistance of Unrestrained Packages forMedical Applications | Pass |
| ASTMD4169-05 | Standard Practice for Performance Testing ofShipping Containers and Systems | Pass |
| ASTM D3078-02 | Standard Test Method for Determination of Leaks inFlexible Packaging by Bubble Emission | Pass |
| ASTM F1886-98 | Standard Test Method for Determining Integrity ofSeals 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 | ISO10993-5:2009 | Standard Practice for Assessment ofHemolytic Properties of Materials. | Pass |
|---|---|---|---|
| Implantation | ISO10993-6:2016 | Biological evaluation of medical devices—Part 6: Tests for local effects afterimplantation | Pass |
| EO,ECH residual | ISO10993-7:2008 | Biological evaluation of medical devices-Part 7: Ethylene oxide sterilizationresiduals | Pass |
| Sensitization | ISO10993-10:2010 | Biological evaluation of medical devices—Part 10: Tests for irritation and skinsensitization | Pass |
| Irritation orIntracutaneousreactivity | ISO10993-10:2010 | Biological evaluation of medical devices-Part 10: Tests for irritation and skinsensitization | Pass |
| Acute Systemictoxicity | ISO10993-11:2006 | Biological evaluation of medical devices-Part 11: Tests for systemic toxicity | Pass |
| SubacuteSubchronic toxicity | ISO10993-11:2006 | Biological evaluation of medical devices-Part 11: Tests for systemic toxicity | Pass |
| Material-MediatedPyrogenicity | ISO10993-11:2006 | Biological evaluation of medical devices-Part 11: Tests for systemic toxicity | Pass |
| Limulus AmebocyteLysate | USP<85> | 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-usecatheters —Part 1: General requirements | Pass |
| ISO 594-1:1986 | Conical fittings with a 6% (Luer) taper for syringes,needles and certain other medical equipment - Part1: 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 - Part2: 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).
§ 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).