(276 days)
Not Found
No
The device description and performance studies focus on mechanical function and standard compliance, with no mention of AI/ML terms or capabilities.
No.
A therapeutic device is one that treats or alleviates a disease or condition. This device is used to inflate and deflate a balloon catheter during a PTCA or PTA procedure, which is an interventional procedure, but the device itself does not deliver therapy.
No
The device description indicates its purpose is to create and monitor pressure in a balloon, and to deflate a balloon dilatation catheter during PTCA or PTA procedures. This is a procedural/therapeutic function, not a diagnostic one.
No
The device description explicitly lists physical components such as a barrel, plunger, trigger, pressure gauge, and tubing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used in PTCA or PTA procedures to inflate and deflate balloon catheters. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a mechanical device for generating and monitoring pressure, consistent with its intended use in inflating balloons within the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information about a patient's health status based on such analysis. IVDs are designed for this purpose.
- Performance Studies: The performance studies focus on bench tests verifying mechanical specifications and equivalence to a predicate device used for the same procedural purpose. There are no studies related to diagnostic accuracy or performance.
In summary, the device's function is to physically manipulate a balloon catheter during a medical procedure, which is not the role of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MAV
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The profiles are white against a dark background, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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
-
- 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 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.
4
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.
5
510(k) Summary
| Item | Proposed Device | Predicate Device
K102648 | 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 or
PTA procedures to create and monitor pressure in the
balloon and to deflate the balloon dilatation catheter. | 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. | SE |
Table III-1 General information Comparison
| Table III--2 Performance Comparison | |
|---|---|
| Item | Proposed Device | Predicate Device
K102648 | Remark |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Principle
of
Operation | The plunger is free to move when the trigger is pushed
down. In this position you may pull the plunger to
aspirate or push it to inject for a quick fill. Release the
trigger to lock the plunger. To add and hold pressure in
increments, turn the handle clockwise with the trigger
in the up position. Press the trigger down and pull back
on the plunger to deflate. | The plunger is free to move when the trigger is
pushed down. In this position you may pull the
handle to aspirate or push it to inject for a quick fill.
Release the trigger to lock the plunger. To add and
hold pressure in increments, turn the handle
clockwise with the trigger in the up position. Press
the trigger down and pull back on the handle to
deflate. | SE |
| Components | A barrel, a plunger, a trigger, shell, a piston, a pressure
gauge, a tubing, a rotating adapter and stopcocks | A barrel, a plunger with handle, a trigger, shell, a
piston, a pressure gauge, a tubing, a rotating adapter
and stopcocks | Similar
Analysis 1 |
6
| 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 clarity | ||
| and added strength against high system pressure. |
- The threaded plunger assembly with a handle is made
of high impact resistant polyamides. - Controlled inflation and deflation is achieved by
manually pushing handle and press the trigger. - High-pressure polyurethane tubing with polyamides
provides links from the inflation barrel to the
angiographic catheter using a 6% conical locking
connector. | 1. The 20mL barrel is made of polycarbonate for
clarity and added strength against high system
pressure. - The pressurization system and the plunger are
made of high impact resistant polypropylene. - Controlled inflation and deflation is achieved by
manually pushing or pulling the plunger and press
the trigger. - High-pressure polyurethane tubing provides links
from the inflation barrel to the angiographic
catheter using a 6% conical locking connector. | SE |
| Where used | PTCA | PTCA | SE |
| Volume
and
pressure range | 20 mL, 030ATM | 20 mL, 030 ATM | SE |
Table III-3 Safety Comparison
| Item | Proposed Device | Predicate Device
K102648 | Remark | |
|-------------------------|----------------------------------------------------------------|---------------------------------------------------------------|-----------------------|----|
| Material | PC, PA+PU, ABS, PC alloy, Steel,
Silicon rubber, PA, rubber | PA, PC, PU etc. | Similar
Analysis 2 | |
| Biocompatibility | Conforms to the requirements of ISO
10993 series Standards | Conforms to the requirements of ISO 10993 series
Standards | 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 |
7
| Premarket Notification 510(k) Submission | 510(k) Summary | |||
|---|---|---|---|---|
| Package | ||||
| Integrity | Conforms to ISO 11607 | Conforms to ISO 11607 | SE | |
| EO | ||||
| Residual | 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.