The inflation device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation catheter.

Device Description

The inflation device consists of barrel, threaded plunger assemble with a handle, a trigger, pressure gauge, an outer shell assembly that retains the internal components, and a pressure connecting tubing with rotating adapter. Also enclosed is a stopcock to aid in preparation and use of device. The inflation device is 20 mL disposable device capable of producing a maximum pressure of 30 atm.

The inflation device is sterilized by EO.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an "Inflation Device". This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing, rather than presenting a clinical study with detailed acceptance criteria for diagnostic performance. Therefore, many of the requested elements are not applicable to this type of submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or a specific clinical outcome. Instead, it refers to compliance with established international standards for medical devices and device specifications.

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance
Functional Performance	ISO 594-1:1986 (Conical Fittings, General Requirements)	Device complies with the standard.
	ISO 594-2:1998 (Conical Fittings, Lock Fittings)	Device complies with the standard.
	Device specifications (e.g., volume, pressure range, mechanism of operation)	Verified through bench tests; performance is equivalent to predicate device (20 mL, 0-30 ATM).
Biocompatibility	ISO 10993 series Standards	Conforms to requirements (No hemolysis, No Acute Systemic Toxicity, No cytotoxicity, No intracutaneous reactivity, No Sensitization).
Sterilization	Sterility Assurance Level (SAL)	10-6
	Sterilization Method	EO Sterilization
	Sterilization Validation	Conforms to ISO 11135
Packaging	Package Integrity	Conforms to ISO 11607
Material Residuals	EO Residual	Conforms to ISO 10993-7
Other Safety	Pyrogenicity	Non-pyrogenic
Labeling	FDA Requirements	Conforms to FDA Requirements

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

Sample Size: The document does not specify a "test set" in the context of clinical data. The tests performed are bench tests on the device itself (e.g., for mechanical properties, material testing). The number of units tested per bench test is not detailed.
Data Provenance: Not applicable as no human data is used. The tests are performed on the manufactured device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no ground truth established by experts in this context as it's a device performance study, not a diagnostic accuracy study relying on human interpretation.

4. Adjudication Method

Not applicable. No expert review or adjudication process is described as it's not a clinical study involving human assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a 510(k) submission for a physical medical device, not an AI software or diagnostic imaging tool. Therefore, a MRMC comparative effectiveness study is not performed or relevant.

6. Standalone Performance

Yes, in a way. The "standalone" performance here refers to the device's ability to meet its technical specifications and regulatory standards independently. The non-clinical bench tests assess the device's functional and safety characteristics in a standalone manner.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is compliance with established international standards (ISO) and the manufacturer's own validated specifications. For example, for conical fittings, the ground truth is adherence to ISO 594-1 and ISO 594-2 standards. For biocompatibility, it's the outcome of tests against ISO 10993 standards.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning model.

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

Not applicable.

Summary

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

October 6, 2017

Shanghai Kindly Medical Instruments Co., Ltd. Jeffery Hui Official Correspondent No. 925 Jinyuan Yi Rd Shanghai, 201803 CN

Re: K170027

Trade/Device Name: Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: MAV Dated: September 5, 2017 Received: September 7, 2017

Dear Jeffery Hui:

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 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 devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Kenneth J. Cavanaugh -S

for

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

Enclosure

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Indications for Use

510(k) Number (if known) K170027

Device Name Inflation Device

Indications for Use (Describe)

The inflation device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation 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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510(k) Summary - K170027

This 510(k) Summary is being submitted in accordance with the requirements of the guidance The 510(k) Program and 21 CFR 807.92.

510(k) Number: K170027

1. Date of Submission: Aug.03, 2017

2. Submitter

Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan vi Road, Shanghai, 201803, China Establishment Registration Number: 3009605245 Contact Person: Xu Jianhai Position: RA Supervisor Tel .: +086-021-59140056 Fax: +086-021-59140056 Email: xujianhai@kdlchina.net

3. Proposed Device

Proposed Device Name: Inflation Device Proposed Device Model: AI25 Classification: Class II Classification Name: Angiographic Injector And Syringe Regulation Number: 21 CFR 870.1650 Review Panel: Cardiovascular Product Code: MAV

4. Predicate device

510(k) Number: K102648 a. Product Name: ANT Inflation Device/ ANT Inflation Device Compact Pack Manufacturer: Shenzhen ANT Hi-Tech Industrial Co., Ltd.

5. Device description

The inflation device is sterilized by EO.

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6. Indications for Use Statement:

The inflation device is intended to be used in PTCA or PTA procedures to create and monitor pressure in the balloon and to deflate the balloon dilatation catheter.

7. Non-clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device. The test result demonstrates that the proposed devices comply with the following standards:

ISO 594-1:1986, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 1: General Requirements.

ISO 594-2 1998, Conical Fittings With A 6% (Luer) Taper For Syringes, Needles And Certain Other Medical Equipment - Part 2: Lock Fittings.

8. Clinical Test

It is not applicable.

9. Summary Comparing the Technological Characteristics

The proposed device and predicate device have the same classification information, intended use, principle of operation, design and Volume and pressure range. The proposed device and the predicate's material have a little difference, and the whole device has been tested for material biocompatibility, the test result demonstrated that the device comply with the requirements of a series ISO 10993 standards.

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510(k) Summary

Item	Proposed Device	Predicate DeviceK102648	Remark
Product Code	MAV	MAV	SE
Regulation No.	21 CFR.870.1650	21 CFR.870.1650	SE
Class	Class II	Class II	SE
Intended Use	The inflation device is intended to be used in PTCA orPTA procedures to create and monitor pressure in theballoon and to deflate the balloon dilatation catheter.	The ANT inflation device is intended for use duringvascular procedures in conjunction withinterventional device such as balloon catheters tocreate and monitor pressure in the balloon catheter.	SE

Table III-1 General information Comparison

	Table III--2 Performance Comparison

Item	Proposed Device	Predicate DeviceK102648	Remark
PrincipleofOperation	The plunger is free to move when the trigger is pusheddown. In this position you may pull the plunger toaspirate or push it to inject for a quick fill. Release thetrigger to lock the plunger. To add and hold pressure inincrements, turn the handle clockwise with the triggerin the up position. Press the trigger down and pull backon the plunger to deflate.	The plunger is free to move when the trigger ispushed down. In this position you may pull thehandle to aspirate or push it to inject for a quick fill.Release the trigger to lock the plunger. To add andhold pressure in increments, turn the handleclockwise with the trigger in the up position. Pressthe trigger down and pull back on the handle todeflate.	SE
Components	A barrel, a plunger, a trigger, shell, a piston, a pressuregauge, a tubing, a rotating adapter and stopcocks	A barrel, a plunger with handle, a trigger, shell, apiston, a pressure gauge, a tubing, a rotating adapterand stopcocks	SimilarAnalysis 1

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Premarket Notification 510(k) Submission		Section Ⅲ-510(k) Summary	File No.2016000
Conical fitting	Conforms to ISO 594-1:1986 or ISO 594-2:1998	ANT Inflation Device compact Pack: a hemostasis,a torque device and a wire introducer.Conforms to ISO 594-1:1986 or ISO 594-2:1998	SE
Design	1. The 20mL barrel is made of polycarbonate for clarityand added strength against high system pressure.2. The threaded plunger assembly with a handle is madeof high impact resistant polyamides.3. Controlled inflation and deflation is achieved bymanually pushing handle and press the trigger.4. High-pressure polyurethane tubing with polyamidesprovides links from the inflation barrel to theangiographic catheter using a 6% conical lockingconnector.	1. The 20mL barrel is made of polycarbonate forclarity and added strength against high systempressure.2. The pressurization system and the plunger aremade of high impact resistant polypropylene.3. Controlled inflation and deflation is achieved bymanually pushing or pulling the plunger and pressthe trigger.4. High-pressure polyurethane tubing provides linksfrom the inflation barrel to the angiographiccatheter using a 6% conical locking connector.	SE
Where used	PTCA	PTCA	SE
Volumeandpressure range	20 mL, 0~30ATM	20 mL, 0~30 ATM	SE

Table III-3 Safety Comparison

Item	Proposed Device	Predicate DeviceK102648	Remark
Material	PC, PA+PU, ABS, PC alloy, Steel,Silicon rubber, PA, rubber	PA, PC, PU etc.	SimilarAnalysis 2
Biocompatibility	Conforms to the requirements of ISO10993 series Standards	Conforms to the requirements of ISO 10993 seriesStandards	SE
In Vitro Hemolytic	No hemolysis	No hemolysis	SE
Acute Systemic Toxicity	No Acute Systemic Toxicity	No Acute Systemic Toxicity	SE
In Vitro Cytotoxicity	No cytotoxicity	No cytotoxicity	SE
Skin Irritation	No intracutaneous reactivity	No intracutaneous reactivity	SE
Skin Sensitization	No Sensitization	No Sensitization	SE
Sterilization	SAL	10-6	10-6	SE
	Method	EO Sterilization	EO Sterilization	SE
	Validation	Conforms to ISO 11135	Conforms to ISO 11135	SE

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Premarket Notification 510(k) Submission		510(k) Summary
	PackageIntegrity	Conforms to ISO 11607	Conforms to ISO 11607	SE
	EOResidual	Conforms to ISO 10993-7	Conforms to ISO 10993-7	SE
	Pyrogen	Non-pyrogenic	Non-pyrogenic	SE
Label and labeling		Conforms to FDA Requirements	Conforms to FDA Requirements	SE

10.Conclusion

The proposed device, Inflation device, met all the predetermined acceptance criteria of design verfication and validation as specified by applicable standards and test protocols. The inflation device is substantially equivalent to the legally market predicate device.

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.