(364 days)
Not Found
No
The device description and intended use focus on manual operation and mechanical components for inflation and pressure monitoring. There is no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes.
The device is intended for use in PTCA or PTA procedures to create and monitor pressure in a balloon and to deflate the balloon, which are therapeutic actions.
No
The device description clearly states its purpose is to create and monitor pressure in a balloon, and to deflate the balloon, in PTCA or PTA procedures. While it connects to a diagnostic device (e.g., balloon dilatation catheters), the inflation device itself is a tool for therapy delivery, not for diagnosing conditions.
No
The device description explicitly details physical components like an inflation device, stopcock, hemostatic valve, piston, handle, and pressure gauge, indicating it is a hardware device.
Based on the provided information, the Sunmed The Inflation Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in PTCA or PTA procedures to create and monitor pressure in a balloon catheter and to deflate it. This is a therapeutic or interventional procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a mechanical device for generating and monitoring pressure, along with accessories for accessing blood vessels. This aligns with a device used in a clinical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
- Predicate Devices: The predicate devices listed (ANT Inflation Device, Atrion Medical QL® Inflation Device) are also devices used in interventional cardiology procedures, not IVDs.
In summary, the Sunmed The Inflation Device is a medical device used in interventional procedures on patients, not a device used for testing biological samples in a laboratory setting.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
MAV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- 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
Clinical Evaluation was not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three faces overlapping to represent the department's focus on people and health. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
1
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:
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).
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)
Page 1of 1
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
-
- 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 |
-
- Predicate Device:
| 510(k)
Number | Trade or Proprietary or Model
Name | Manufacture |
|------------------|------------------------------------------------------------|----------------------------------------------|
| K102648 | ANT Inflation Device/ ANT
Inflation Device Compact Pack | Shenzhen ANT Hi-Tech
Industrial Co., Ltd. |
| K032840 | Atrion Medical QL® Inflation
Device | Atrion Medical Products, Inc. |
4. Device description
Sunny Medical Device (Shenzhen) Co., Ltd.
4
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.
-
- 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).
- Intended Use
-
- 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.
- Technological Comparison to Predicate Device
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A detailed comparison of technological characteristics with the predicate devices is included insubstantial equivalence of the submission.
-
- Summary of Non-Clinical Testing
The following tests were performed on the Sunmed™ Inflation Device:
- Summary of Non-Clinical Testing
-
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 -
- Clinical Evaluation was not applicable.
-
- 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.