The ANT Inflation Device is intended for use during vascular procedures in conjunction with interventional device such as balloon catheters to create and monitor pressure in the balloon catheter.

The ANT Inflation Device Compact Pack:
-ANT Inflation Device: See description above.
-ANT Inflation Device Accessory Kit: The Accessory Kit is recommended for use during vascular procedures in conjunction and/or diagnostic device (e.g., balloon dilatation catheters, artherectorny devices, sent delivery systems, intravascular ultrasound devices.)

Device Description

ANT Inflation Device is a single-use, sterile device used in cardiovascular procedures to inflate and deflate balloon catheters. Pressure can be monitored via a pressure gauge. The manually operation of the device is achieved by the manipulation of a large handle to drive a piston housed within the body of the device. Careful and controlled inflation is achieved by rotating the handle clockwise. During inflation a unique cam locking mechanism maintains pressure up to 30 ATM.

ANT Inflation Device Accessory Compact Pack contains a hemostasis valve, a torque device, and a guide wire introducer. The hemostasis valve is designed to provide a port for interventional system. The guide wire introducer is used to facilitate placement of a guide wire tip through the hemostasis valve. The torque device is designed to hold the guide wire and provide a handle for manipulating.

AI/ML Overview

This document describes the ANT Inflation Device and ANT Inflation Device Compact Pack, which are intended for use during vascular procedures to create and monitor pressure in balloon catheters. The submission includes performance tests, biocompatibility tests and comparison to a predicate device to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Test Item	Acceptance Criteria (Implied)	Reported Device Performance
Accuracy of pressure gauge	Pressure readings comparable to a calibrated pressure gauge	Accurately pressurized to 4ATM, 16ATM, 27ATM, with readings comparable to the calibrated gauge. Results comparable to other commercially available devices.
Leak test	No leakage at tested pressures	No bubbles observed when immersed in water after being pressurized with water at 1ATM, 15ATM, 30ATM, and maintained for 2 minutes. Shows connection is comparable to other commercially available devices.
Competence test	Proper functioning with a legally marked catheter	Monitored pressure accurately during inflation and deflation with a legally marked catheter. Results comparable to other commercially available devices.
Biocompatibility	Meet ISO 10993-1:2003 requirements	Meets biocompatibility requirements of ISO 10993-1:2003 for both the Inflation Device and Accessory Pack components (as an external communicating device).

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the exact number of test samples used for each performance test (Accuracy of pressure gauge, Leak test, Competence test). It generally states "Completely packaged devices are chosen as the test samples" for the accuracy test and "Test samples were pressurized" for the leak test. The data provenance is not explicitly stated as retrospective or prospective, but these appear to be internal laboratory tests conducted by the manufacturer (Shenzhen ANT Hi-Tech Industrial Co., Ltd, China) for the purpose of this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The tests performed are objective performance measurements against established physical standards (calibrated pressure gauge) or pass/fail criteria (leakage, functional competence according to the device's design). No human expert interpretation of device output for medical diagnosis or treatment decisions was involved in establishing ground truth for these tests.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements and do not require adjudication.

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 device is a medical instrument (balloon inflation device), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a manually operated mechanical instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance tests consists of:

Calibrated Measurement: For the accuracy of the pressure gauge, the ground truth was established by a "calibrated pressure gauge."
Objective Criteria: For the leak test, the ground truth was the observable presence or absence of bubbles, indicating leakage. For the competence test, it was the observable proper functioning of the device during inflation and deflation when attached to a legally marked catheter.
Established Standards: For biocompatibility, the ground truth was compliance with the requirements of ISO 10993-1:2003, as assessed through specific tests outlined in the standard (e.g., ISO 10993-5, 10993-10, 10993-11, 10993-4).

8. The Sample Size for the Training Set

Not applicable. This device is a medical instrument, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this device does not involve AI/machine learning, there is no training set or associated ground truth for it.

Summary

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K102698 p 1/2.

510(k) summary

JUL - 1 2011

This 510(k) Summary is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR 807.92.

Sponsor:

Name: Shenzhen ANT Hi-Tech Industrial Co., Ltd Building 11, Lishan Industrial Park, Xinghai Ave, Nanshan Address: District, Shenzhen, Guangdong, 518052, China.

Telephone number: 86-755-86060992

86-755-86060991 Fax Number:

Date:	May 25, 2011
-------	--------------

Correspondent:

Contact person:	Lynn Fu
Address:	Building 11, Lishan Industrial Park, Xinghai Ave, Nanshan District, Shenzhen, Guangdong, 518052, China.

Proposed Device:

Trade Name:	ANT Inflation Device/ ANT Inflation Device Compact Pack
Common Name:	Angiographic injection/system
Classification Name:	Balloon Inflation Device
Device Class:	II
Regulation Number:	870.1650
Device Code:	MAV

Predicate Device:

INDEFLATIOR PLUS 30 Inflation Device and PLUS 30 PRIORITY PACK as cleared in K962495.

Intended Use:

The ANT Inflation Device is intended for use during vascular procedures in conjunction with interventional device such as balloon catheters to create and monitor pressure in the balloon catheter.

The ANT Inflation Device Compact Pack is a combination of the ANT Inflation Device and ANT Inflation Device Accessory Pack.

-ANT Inflation Device: See description above.
-ANT Inflation Device Accessory Pack: The Accessory Pack is recommended for use during vascular procedures in conjunction and/or

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1107648

diagnostic device (e.g., balloon dilatation catheters, artherector devices, sent delivery systems, intravascular ultrasound devices.}

Device Description:

Summary of the Studies

Performance test:

Accuracy of pressure gauge: Completely packaged devices are chose as the test samples. Filled them with water and connected to a calibrated pressure gauge, then pressurized to 3 settings, 4ATM, 16ATM, 27ATM, read the pressure and compared it to the calibrated gauge reading. This test showed the results comparable to other commercially device.

Leak test: Test samples were pressurized with water at 1ATM, 15ATM, 30ATM, and maintained 2 minutes. When immerse the samples into water, bubble occur indicate a leakage of the device. This test shows the connection of the device is comparable to other commercially device.

Competence test: attach the finished device to a legally marked catheter, and monitor the pressure during inflation and deflation. This test showed the results comparable to other commercially device.

Biocompatibility test:

ANT Inflation Device, when connected to a competent device such as a balloon catheter, is a closed system and does not delivery contrast or fluids to the circulation system. ANT Inflation Device Accessory Pack may contact the blood path indirectly as an external communicating device. Both of them meet the

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K102648 P73

biocompatibility requirements of ISO 10993-1:2003.

Test Item	Standard
Vitro Cytotoxicity	ISO 10993-5
Delayed-type hypersensitivity	ISO 10993-10
irritation	ISO 10993-10
System toxicity	ISO 10993-11
Interactions with blood (Haemolysis test)	ISO 10993-4
Interactions with blood (Platelet adhesion)	ISO 10993-4
Interactions with blood (prothrombin time)	ISO 10993-4
Complement Activation Test	ISO 10993-4
In vitro Thrombogenicity	ISO 10993-4

Clinical Tests: Not Applicable

Substantial Equivalence:

Based on the intended use, summary of the studies, the subject device, ANT Inflation Device/ ANT Inflation Device Compact Pack, meet the requirements that are considered adequate for its intended use and is substantially equivalent to the INDEFLATIOR PLUS 30 Inflation Device and PLUS 30 PRIORITY PACK.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Shenzhen ANT Hi-Tech Industrial Co., Ltd. c/o Ms. Lynn Fu Building 11, Lishan Industrial Park Xinghai Ave., Nanshan District Shenzhen, Guangdong China 518052

JUL - 1 2011

K102648 Re:

Trade/Device Name: ANT Inflation Device and ANT Inflation Device Compact Pack Regulation Number: 21 CFR 870.1650 Regulation Name: Syringe, Balloon Inflation Regulatory Class: Class II Product Code: MAV Dated: Not Dated Received: June 23, 2011

Dear Ms. 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. 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

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Page 2 – Ms. Lynn Fu

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 (reporting of medical

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Bram D. Zuckerplan, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number: K002VHB

Device Name: ATN Inflation Device ANT Inflation Device Compact Pack

Indications for Use:

The ANT Inflation Device is intended for use during vascular procedures in conjunction with interventional device such as balloon catheters to create and monitor pressure in the balloon catheter.

The ANT Inflation Device Compact Pack:

-ANT Inflation Device: See description above.

-ANT Inflation Device Accessory Kit: The Accessory Kit is recommended for use during vascular procedures in conjunction and/or diagnostic device (e.g., balloon dilatation catheters, artherectorny devices, sent delivery systems, intravascular ultrasound devices.)

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)

F.l. Q. hor BDZ

510(k) Number: K102648

Page 1 of 1

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.