are intended for vascular access infusion and withdrawal of blood, blood products, and fluids, plasma pheresis, hyperalimentation, central venous blood sampling and continuous and intermittent drug infusion.

Device Description

Able® Central Venous Catheter is a polyurethane central venous catheter which is intended to insert into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously.

All the variants of applicant devices: single-lumen, and triple-lumen, and triple-lumen. There are outer diameter dimensions of 14 G, 16 G, 18 G, and 20 G in single-lumen catheters, 4 F, 5 F, 7 F and 8 F in double-lumen catheter, and 5.5 F and 7 F in triple-lumen catheter.

The applicant device mainly consists of 5 parts: distal end, catheter body of effective length, catheter junction, extension cannula, and catheter hub. Distal end is soft and flexible, which is intended to be located within the patient's vena cava. Catheter body of effective length is tubular and with no-communication single or multiple lumens. Catheter junction attaches catheter body of effective length and extension cannula. At the end of the extension cannula, there is female catheter hub for the connection.

AI/ML Overview

The provided text is a 510(k) summary for a Central Venous Catheter, which is a medical device. The information requested in your prompt (Acceptance Criteria, Sample Sizes, Ground Truth, MRMC studies, etc.) is typically associated with AI/software-as-a-medical-device (SaMD) submissions, especially for diagnostic or predictive algorithms.

The document you provided does not contain information related to AI/SaMD performance studies. It describes a physical medical device (catheter) and its testing against established physical and biological standards. Therefore, most of your specific questions cannot be answered from the given text.

However, I can extract the relevant information regarding the device's testing and acceptance criteria as described:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the physical device testing was done in compliance with various ISO standards and internal tests. The acceptance criteria for these tests are generally that the device "conforms" or "is in compliance" with these standards, meaning it met the specifications outlined within them. The document does not provide specific numerical ranges for acceptance or detailed performance data for each test beyond stating compliance.

Acceptance Criteria Category	Reported Device Performance
Biological Evaluation	In compliance with ISO 10993
Compatibility of Component Material	Provided (implies satisfactory)
Physical & Mechanical Standards	Conforms to ISO 10555-1 and ISO 10555-3
Specific Tests (e.g., Surface, Size, Flow Rate, Tensile Strength, Leakage, Radiodetectability etc.)	Testing to Support Substantial Equivalence included; Assumed to have met acceptance criteria for substantial equivalence, though specific numerical results or criteria are not detailed.

2. Sample Size used for the test set and the data provenance

The document does not specify sample sizes used for each of the physical and biological tests conducted (e.g., how many catheters were tested for flow rate or tensile strength). The data provenance is implied to be from Foshan Nanhai Bai He Medical Technology Co., Ltd. in China, as they are the manufacturer and submitter. The tests described are "testing to support substantial equivalence," which suggests prospective testing performed on manufactured devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The device is a physical medical device (catheter), not an AI/SaMD that requires expert ground truth for diagnostic or predictive accuracy. The "ground truth" for this device is based on established engineering and materials science standards (e.g., ISO 10993, ISO 10555-1, ISO 10555-3).

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert review of images or data in AI/SaMD studies. For a physical device, testing follows standardized methods, and results are typically objective measurements.

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

This question is not applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This document describes a physical medical device (catheter), not an AI application.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is based on predefined engineering specifications, material properties, and compliance with international standards (e.g., ISO 10993 for biocompatibility, ISO 10555-1 and ISO 10555-3 for intravascular catheters). These standards effectively serve as the "ground truth" against which the device's performance is measured.

8. The sample size for the training set

This question is not applicable. There is no AI algorithm described in this submission, so there is no "training set."

9. How the ground truth for the training set was established

This question is not applicable, as there is no AI algorithm or training set.

Summary

{0}------------------------------------------------

K070451
182

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.

The Assigned 510(k) Number is:

JUL 3 1 2007

1. Applicant Device Information

Trade/Proprietary Name: Able Central Venous Catheter Models:

14 G, 16 G, 18 G, and 20 G in single-lumen catheters;

4 F. 5 F, 7 F and 8 F in double-lumen catheter;

5.5 F and 7 F in triple-lumen catheter;

Common Name: Central Venous Catheter

Classification Name: Catheter, Intravascular, Therapeutic, Short-term less than 30 days

Device Class: II

Product Code: FOZ

Regulation Number: 880.5200

Intended Use:

The Central Venous Catheters are intended for vascular access infusion and withdrawal of blood, blood products, and fluids, central venous blood pressure monitoring (CVP), plasma pheresis, hyperalimentation, central venous blood sampling and intermittent drug infusion.

2. Submitter Information

Establishment Registration Name:

Foshan Nanhai Bai He Medical Technology Co., Ltd. No. 14 Haier Road, Guicheng, Nanhai District, Foshan City, Guangdong Province

China

Phone: +86-757-86280075

Fax: +86-757-86397179

Contact Person of the Submission:

Ms. Diana. Hong Shanghai Mid-link Consulting Co., Ltd. 1404, No 34, Lane 255 Wanping Road (S), Shanghai 200032

{1}------------------------------------------------

|607045/

273

China

Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong@mid-link.net

3. Predicate Device

a) Predicate device for single-lumen and double-lumen SPECATHB Central Venous Catheter Kits (K021130) Manufactured by: Special Medical Co. Ltd No. 3 Industrial Building, National Hi-Tech Development Zone GangKou Road Guangdong 528041, China

b) Predicate device for triple-lumen Sunder Central Venous Catheter Kit (K024007)

Manufactured by:

Sunder Biomedical Tech. Co., Ltd

1 OF- 1. 1-67, Wu-Chuan Rd., Taichuns. Taiwan 403

China .

4. Device Description

{2}------------------------------------------------

5. Test Data

K070451
3,f3

The all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the component material in the finished product was provided.

The applicant devices conform to ISO 10555-1 and ISO 10555-3.

Testing to Support Substantial Equivalence included:

Surface, Size, Distance Markings, Lumen Markings, Primary Volume Test, Break Force, Flow Rate Burst Pressure Test, Leakage, Tensile Strength Test, Radiodetectability, Hub Liquid Leakage, Hub Air Leakage, Hub Separation Force, Hub Stress Cracking, Label Information

6. Substantially Equivalence

Comparison Analysis:

The Applicant device has the same classification information, intended use, sterilization specifications, performance, biocompatibility, chemical specifications and similar physical and mechanical specifications with the predicate device. The only difference between applicant device and predicate device is some physical specifications variant which is too slight to influence the effectiveness and safety.

Conclusion:

The applicant device is Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, with three flowing lines representing the connection between them.

JUL 3 1 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Foshan Nanhai Bai He Medical Technology Company, Limited C/O Ms. Diana Hong Shanghai Mid-Link Business Consulting Company, Limited Suite 8D, No.19 Lane 999, Zhong Shan Nan Er Road Shanghai, China 528200

Re: K070451

Trade/Device Name: Able Central Venous Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: June 21, 2007 Received: July 19, 2007

Dear Ms 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{4}------------------------------------------------

Page 2 - Ms. Hong

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sugite y. Michiand.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K070451

1 of 1

Indications for Use

510(k) Number:

Device Name: __ Able Central Venous Catheter

Indications for Use:

The Central Venous Catheters including:

14 G, 16 G, 18 G, and 20 G in single-lumen catheters;

4 F. 5 F, 7 F and 8 F in double-lumen catheter;

5.5 F and 7 F in triple-lumen catheter;

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

rision Sign-Off) Chision of Anesthesiology, General Hospital, Infection Control, Dental Devices

Page

510(k) Number: 10999

Regulation Number and Section

§ 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).