(147 days)
The OXTI Inflation Device is indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in a balloon dilation catheter.
The device consists of three major components; a) 30ml barrel, b) inflation mechanism and c) 6% standard conical fitting and stopcocks system for connecting to the PTCA catheter. The barrel has graduation markings at 0.5ml interval to the full 30ml capacity A dual scale pressure gauge mounted at distal end of the barrel is capable of indicating pressure up to 30atm at 1atm or 10psi intervals. Reinforced polyurethane tubing extending from the svringe exit port connects to a 6% male/female conical fitting for attaching to the 3-way stopcock and to the angiographic catheter.
Acceptance Criteria and Device Performance Study for OXTI Inflation Devices
This document summarizes the acceptance criteria and the study performed to demonstrate the OXTI Inflation Device meets these criteria, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Material Biocompatibility | Cytotoxicity | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) |
| Sensitization | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) | |
| Intracutaneous reactivity | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) | |
| Acute systematic toxicity | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) | |
| Hemocompatibility | (Implicit: Meet biocompatibility standards) | Tested and met (results not quantified but stated as satisfactory) | |
| Functional & Performance | 6% conical fitting efficacy | Per ISO 594.1 & 2 | Meets ISO 594.1 & 2 (results not quantified but stated as satisfactory) |
| Whole device resistance to water leakage | (Implicit: No leakage) | Meets (results not quantified but stated as satisfactory) | |
| Tubing joints resistance to tensile pull | (Implicit: Withstand specified tensile forces) | Meets (results not quantified but stated as satisfactory) | |
| Barrel and plunger resistance to water leakage | (Implicit: No leakage) | Meets (results not quantified but stated as satisfactory) | |
| Forces to initiate and continue pushing of plunger | (Implicit: Within acceptable ergonomic/functional range) | Meets (results not quantified but stated as satisfactory) | |
| Pressure Gauge Accuracy | Accuracy against a standard, calibrated gauge | Tested at 2atm pressure intervals up to 30atms (Implicit: Meets specified accuracy tolerances) | Meets (results not quantified but stated as satisfactory) |
Note: The provided 510(k) summary states that "Results of various tests support the claim that the OXTI Inflation Device meets requirements specified by various international voluntary standards and is substantially equivalent to legally marketed predicate devices." However, specific quantitative acceptance criteria or detailed numerical results for each test are not explicitly provided in this summary. The reported device performance is described as meeting the requirements.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes bench tests and material biocompatibility tests. These do not typically involve human subject data or a "test set" in the context of clinical studies.
- Sample Size for Test Set: Not applicable in the context of a clinical test set. For bench testing, the sample size would refer to the number of devices or components tested. This information is not specified in the provided summary.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for bench tests. The tests were performed as part of the device's pre-market evaluation by OXTI Corporation, located in New Taipei City, TAIWAN.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The tests performed are bench tests and biocompatibility tests, which rely on established scientific methods and standards (e.g., ISO for conical fittings, established toxicity protocols). Ground truth in this context is determined by adherence to these standards, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
Not applicable. As described above, the tests are technical/engineering and biocompatibility evaluations, not clinical assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The OXTI Inflation Device is a mechanical medical device for pressure creation and monitoring, not an imaging or diagnostic device that would utilize human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The OXTI Inflation Device is a mechanical device, not an algorithm. Its performance is inherent to its design and functional capabilities, not dependent on an algorithm operating alone.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation consists of established international voluntary standards (e.g., ISO 594.1 & 2 for conical fittings) and established scientific protocols for material biocompatibility testing. The "truth" is whether the device's physical and biological properties meet the requirements of these standards and protocols.
8. The Sample Size for the Training Set
Not applicable. The OXTI Inflation Device is a mechanical device, and its development and testing do not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set." The device's design and engineering are based on principles of mechanical design, material science, and established medical device requirements, rather than trained on data.
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K122152 e 16f2
DEC 1 4 2012
Pre-market Notification for OXTI Inflation Devices
510(k) Summary of Safety and Effectiveness
- Submitter
OXTI Corporation.
8th Floor, Unit 146, Jian 1st Road, Jhonghe District '
New Taipei City, TAIWAN 23585
Contact:
Mr. John Sung
Phone: +886 2 2225 4998 Ext. 20
2. Name and Classification of Device
| Trade Name: | OXTI Inflation Device |
|---|---|
| Common/Usual Name: | Balloon inflation syringe |
| Classification Name: | Angiographic injector and syringe |
| Regulation Medical Specialty: | Cardiovascular |
| Review Panel: | Cardiovascular |
| Classification Number: | 21CFR 870.1650 |
| Product Code: | MAV |
3. Predicate Device
| Trade Name | 510(k) Number | Decision Date |
|---|---|---|
| Dolphin Inflation Device | K042449 | 5/20/2005 |
| Indeflator Plus 30 Priority Pack | Kae2495 | 9/12/1996 |
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4. Device Description
The device consists of three major components; a) 30ml barrel, b) inflation mechanism and c) 6% standard conical fitting and stopcocks system for connecting to the PTCA catheter. The barrel has graduation markings at 0.5ml interval to the full 30ml capacity A dual scale pressure gauge mounted at distal end of the barrel is capable of indicating pressure up to 30atm at 1atm or 10psi intervals. Reinforced polyurethane tubing extending from the svringe exit port connects to a 6% male/female conical fitting for attaching to the 3-way stopcock and to the angiographic catheter.
5. Indications for Use
The OXTI Inflation Device is indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in a balloon dilation catheter.
6. Technological Characteristics
The 30 ml 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. A unique locking latch secures the plunger in place to maintain a constant pressure even if the user lets go of the device. High-pressure polyurethane tubing provides links from the inflation barrel to the angioplastic catheter using a 6% conical locking connector.
7. Performance Summary
- The whole device has been tested for material biocompatibility as listed below:
- Cytotoxicity:
- Sensitization;
- . Intracutaneous reactivity;
- Acute systematic toxicity; and
- 1 Hemocompatibility.
- Functional aspects and performance characteristics of the inflation device are verified through a series of bench tests which include:
- 6% conical fitting efficacy, per ISO 594.1 & 2, 0
- Whole device resistance to water leakage; D
- Tubing joints resistance to tensile pull; 1
- Barrel and plunger resistance to water leakage; and
- Forces to initiate and continue pushing of plunger; 1
- Pressure gauge accuracy was tested against a standard, calibrated gauge at 2atm ● pressure intervals for up to 30atms.
Results of various tests support the claim that the OXTI Inflation Device meets requirements specified by various international voluntary standards and is substantially equivalent to legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved, parallel lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 1 4 2012
Oxti Corporation c/o Joseph Chang Consultant 7128 Staffordshire Street Houston, Texas 77030
Re: K122152
Trade/Device Name: OXTI Inflation Device Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: MAV Dated: October 31, 2012 Received: November 5, 2012
Dear Mr. Chang:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Chang
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Matthew G. Hillebrenner
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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Indication for Use
510(k) Number (if known):
Device Name: OXTI Inflation Device
Indications for Use:
The OXTI Inflation Device is indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in the balloon dilation catheter.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hille
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K/27/52 42
Page 1 of
§ 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.