SUMMED INFLATION DEVICE KIT by SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD

The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is intended for use in PTCA or PTA procedures to create and monitor pressure (by connecting the rotating male luer of inflation device with the balloon catheter's female luer) in the balloon and to deflate the balloon. The hemostatic valve is recommended for use during PTCA or PTA procedures in conjunction and/or diagnostic device (e.g. balloon dilatation catheters).Stopcock is used to release and purge any trapped air (if used).

Device Description

The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is 30ml disposable device capable of producing a maximum pressure of 40ATM. 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.

Hemostatic valve is a single Y connector, and may be composed of an insertion tool, and a torquer. The hemostasis valve is designed to provide a port for interventional system. The insertion tool 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 FDA 510(k) summary for the Sunmed™ Inflation Device (K133795) describes a device intended for use in PTCA or PTA procedures. However, it does not contain the detailed information required to fill out the user's requested template regarding acceptance criteria and a study proving those criteria are met.

Here's why and what information is available:

The document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove the device meets specific acceptance criteria through a clinical study in the way a PMA (Premarket Approval) might require.

Information NOT available in the provided text:

A table of specific numerical acceptance criteria (e.g., specific thresholds for pressure accuracy, deflation time, etc.) and the reported device performance against those criteria. The document mentions "non-clinical testing" but does not provide results or specific criteria.
Details about a specific study proving acceptance criteria:
- Sample size used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts, qualifications, or adjudication method for ground truth.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set (if applicable to an AI/algorithm-based device, which this is not).
- How ground truth for the training set was established.

What can be extracted and inferred from the document regarding testing:

Nature of Testing: The document states "Summary of Non-Clinical Testing" and explicitly says "Clinical Evaluation was not applicable." This indicates that the device's performance was evaluated through bench testing and biocompatibility studies, not human clinical trials against specific performance endpoints.
Types of Non-Clinical Tests Performed (as listed in section 7):
- Biocompatibility Testing:
  - Pyrogen Test
  - Endotoxin Test
  - Acute Systemic Toxicity Test (two kinds of solvent)
  - Intracutaneous Reactivity Test
  - In Vitro Cytotoxicity Test
  - Skin sensitization Test (two kinds of solvent)
  - In Vitro Hemolysis Study
  - Complement Activity Test (C3a, SC5b-9)
  - In Vivo Thrombogenicity
- Package Penetrate Testing
- Asepsis Testing
- Aging Testing
- EtO and ECH Residue Testing
- Bench Testing
Lack of Reported Performance Data: While these tests were performed, the document does not report the results of these tests or the specific acceptance criteria (e.g., "Pyrogen test result must be < X EU/mL"). It merely lists the tests as having been performed.
Basis for Substantial Equivalence: The conclusion (section 9) is based on the information presented, which includes technological comparison to predicate devices (K102648 and K032840) and the non-clinical testing performed. The device is considered substantially equivalent if its non-clinical performance and technological characteristics are similar enough to predicates that it raises no new questions of safety or effectiveness.

In summary, based only on the provided text, the requested table and detailed study information cannot be created because the document is a 510(k) summary focused on substantial equivalence rather than a detailed report of performance against specific, quantifiable acceptance criteria. The FDA's decision to clear the device implies that the submitted non-clinical data did meet the required standards for substantial equivalence, but those specific standards and results are not detailed in this summary.

Summary

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

December 12, 2014

Sunny Medical Device (Shenzhen) Co., Ltd. c/o James Qi Zhang 56 Lehigh Aisle Irvine, CA 92612

Re: K133795

Trade/Device Name: Sunmed™ Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: MAV Dated: September 17, 2014 Received: November 10, 2014

Dear Mr. Zhang:

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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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 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/Resourcesfor You/Industry/default.htm. 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 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 yours,

Melissa A. Torres -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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2. Indications for Use Statement

Indications for Use

510(k) Number (if known): K133795

Device Name: Sunmed™ Inflation Device

Indications for Use:

Prescription Use_ (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ (Part 21 CFR 801Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Sunny Medical Device (Shenzhen) Co., Ltd.

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3. 510(k) Summary

Sunny Medical Device (Shenzhen) Co., Ltd. 1. Submitted by: 4/F and 5/F, Dongpingxing Creative Science Park, Registered Address: Longgang District, Shenzhen, Guangdong, P.R. China 518172 Contact Address: 56 Lehigh Aisle Irvine, CA 92612 Telephone: (949)216-8838 Fax: (949)423-0168 Contact: JamesQi Zhang, General Manager jamesqizhang@gmail.com E-mail: Date: Sep17, 2014
1. Proposed Device:

Trade/Proprietary Name:	Sunmed™ Inflation Device
Common/Usual Name:	Disposable Inflation Device
Classification:	II
Classification Name:	Angiographic injector and syringe
Regulation Number:	870.1650
Product Code:	MAV

1. Predicate Device:

510(k)Number	Trade or Proprietary or ModelName	Manufacture
K102648	ANT Inflation Device/ ANTInflation Device Compact Pack	Shenzhen ANT Hi-TechIndustrial Co., Ltd.
K032840	Atrion Medical QL® InflationDevice	Atrion Medical Products, Inc.

4. Device description

Sunny Medical Device (Shenzhen) Co., Ltd.

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The Sunmed The Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is 30ml disposable device capable of producing a maximum pressure of 40ATM. 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.

1. Intended Use
  The Sunmed™ Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is intended for use in PTCA or PTA procedures to create and monitor pressure (by connecting the rotating male luer of inflation device with the balloon catheter's female luer) in the balloon and to deflate the balloon. The hemostatic valve kit is recommended for use during PTCA or PTA procedures in conjunction and/or diagnostic device (e.g. balloon dilatation catheters). Stopcock is used to release and purge any trapped air (if used).
1. Technological Comparison to Predicate Device
  The proposed device will use technology that is similar to the technology already in use by Shenzhen ANT Hi-Tech Industrial Co., Ltd. and Atrion Medical Products, Inc. The maximum pressure of the proposed device is the same as The Atrion Medical OL® Inflation Device. It has the same intended use, fundamental concepts and principles of operation as the ANT Inflation Device .The proposed device uses the same materials, packaging and sterilization method like each of the predicate devices.

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A detailed comparison of technological characteristics with the predicate devices is included insubstantial equivalence of the submission.

1. Summary of Non-Clinical Testing
  The following tests were performed on the Sunmed™ Inflation Device:
Biocompatibility Testing: Pyrogen Test Endotoxin Test Acute Systemic Toxicity Test(two kinds of solvent) Intracutaneous Reactivity Test In Vitro Cytotoxicity Test Skin sensitization Test (two kinds of solvent) In Vitro Hemolysis Study Complement Activity Test (C3a, SC5b-9) In Vivo Thrombogenicity
Package Penetrate Testing Asepsis Testing Aging Testing EtO and ECH Residue Testing Bench Testing
1. Clinical Evaluation was not applicable.
1. Conclusions

Based on the information presented in this 510(k) premarket notification, the Sunmed™ Inflation Device is considered substantially equivalent to the ANT Inflation Device and Atrion Medical QL® Inflation 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.