(86 days)
The Titan Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The MTI HD Injector is intended for the infusion of physician-specified fluids with the MTI Titan™ Micro Catheter.
The MTI Titan™ Micro Catheter is an end-hole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity. The catheter is provided with a removable adapter for attachment to either standard luer fitting devices or the MTI HD Injector.
The HD Injector is a 1 mL syringe with threaded plunger and a vial septum-piercing needle. The connector at the distal end of the injector is threaded for connecting to the MTI Titan™ Micro Catheter.
The provided text describes a 510(k) submission for the MTI Titan™ Micro Catheter and MTI HD Injector, focusing on demonstrating substantial equivalence to predicate devices through in-vitro performance testing and biocompatibility verification.
Based on the provided information, here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The submission describes in-vitro performance testing for both the micro catheter and the injector. While specific numerical acceptance criteria (e.g., "burst pressure must exceed X psi") are not explicitly stated in the provided text, the text implies that the tests were conducted to demonstrate acceptable performance for intended use and substantial equivalence to predicate devices. The reported device performance is that the devices met these unstated criteria.
| Feature / Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| MTI Titan™ Micro Catheter | ||
| Dimensional Inspection | Conformance to design specifications | Met specifications |
| Tensile Strength Tests | Adequate strength for intended use (e.g., without breakage) | Adequately strong |
| Burst Pressure Tests | Ability to withstand internal pressure during infusion | Adequately resistant to burst |
| Flow Rate Tests | Acceptable flow characteristics for therapeutic agents/contrast media | Acceptable flow rates |
| Torque Tests | Adequate torque response for navigation and control | Acceptable torque performance |
| Performance under Simulated Conditions | Safe and effective operation in simulated anatomical environment | Performed safely and effectively |
| Biocompatibility | Conformance to ISO 10993-1 for external communicating, blood contact, limited exposure (<24 hrs) device | Confirmed biocompatible |
| MTI HD Injector | ||
| Dimensional Inspection | Conformance to design specifications | Met specifications |
| Injection Rate | Acceptable fluid delivery rate | Acceptable injection rate |
| Thread Engagement | Secure connection to catheter | Securely engaged |
| Clip Movement | Proper function of clip mechanism (if applicable) | Proper movement |
| Needle Detachment | Secure attachment of needle | Securely attached |
| Integrity of Attachment to Titan Micro Catheter | Secure connection between injector and catheter | Securely attached |
| Fit of Piston in Barrel | Smooth and proper piston movement | Proper fit and movement |
| Leakage | Prevention of fluid leakage | No leakage |
| Biocompatibility | Conformance to ISO 10993-1 for external communicating, blood contact, limited exposure (<24 hrs) device | Confirmed biocompatible |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of devices or units tested for each in-vitro performance test. It broadly states "performance testing of the MTI Titan™ Micro Catheter included..." and "The accessory MTI HD Injector underwent in-vitro performance testing including...". This implies that a sufficient sample size was used to demonstrate reliability and compliance with internal standards or good laboratory practices, but the specific numbers are not provided.
- Data Provenance: The data is retrospective in the sense that the studies were conducted as part of the 510(k) submission process for a device that was modified from previously cleared devices. The testing was conducted by Micro Therapeutics, Inc., likely at their facilities or through contracted labs. The country of origin for the data is implicitly the USA as the company is based in Irvine, CA, and the submission is to the US FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies described are in-vitro physical and functional performance tests and biocompatibility tests. There is no "ground truth" established by human experts in the context of clinical interpretation or diagnosis. The "ground truth" for these tests would be the established engineering specifications, published standards (like ISO 10993-1), and predicate device performance.
4. Adjudication Method for the Test Set
This is not applicable for in-vitro performance and biocompatibility testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. For in-vitro tests, results are typically objective measurements against predefined criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This document describes the 510(k) submission for a micro catheter and injector, which are medical devices, not an AI or diagnostic software. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This submission is for physical medical devices (catheter and syringe), not a diagnostic algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the in-vitro performance tests, the "ground truth" is based on:
- Engineering specifications and design requirements: Whether the dimensions, tensile strength, burst pressure, flow rates, and torque performance meet the predetermined acceptable ranges for the device's function.
- Established industry standards: For example, compliance with ISO 10993-1 for biocompatibility.
- Performance of predicate devices: The "ground truth" indirectly involves demonstrating similar performance characteristics to the legally marketed predicate devices to establish substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The studies involve physical testing of manufactured devices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
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Micro Therapeutics, Inc.
Traditional 510(k) (modifications to K993672 and K011535) Titan™ Micro Catheter and MTI HD Injector Syringe June 18, 2002
4. 510(k) Summary
| Prepared June 18, 2002 | |||
|---|---|---|---|
| TRADE NAMEGENERIC NAMECLASSIFICATION | Titan™ Micro Catheter and accessory HD InjectorCatheter, Continuous Flush and SyringeClass II (21 CFR 870.1210) and Class II 21 CFR870.4450 | ||
| SUBMITTED BY | Micro Therapeutics, Inc.2 GoodyearIrvine, CA 92618 | CONTACT | Bill HyattRegulatory Affairs(949) 837-3700 |
| PREDICATEDEVICE(S) | MTI Rebar™ Micro Catheter (K993672)MTI Cadence Precision Injector (K011535) | ||
| DEVICEDESCRIPTION | The MTI Titan™ Micro Catheter is an end-hole, single-lumen catheter designed tobe introduced over a steerable guidewire into the vasculature. The catheter has asemi-rigid proximal shaft which transitions into the flexible distal shaft to facilitatethe advancement of the catheter in the anatomy. Dual radiopaque markers at thedistal end facilitate fluoroscopic visualization. The outer surface of the catheter iscoated to increase lubricity. The catheter is provided with a removable adapter forattachment to either standard luer fitting devices or the MTI HD Injector.The HD Injector is a 1 mL syringe with threaded plunger and a vial septum-piercingneedle. The connector at the distal end of the injector is threaded for connecting tothe MTI Titan™ Micro Catheter. | ||
| INDICATIONS FORUSE | The Titan Micro Catheter is intended for the controlled selective infusion ofphysician-specified therapeutic agents or contrast media into the vasculature of theperipheral and neuro anatomy.The MTI HD Injector is intended for the infusion of physician-specified fluids withthe MTI Titan™ Micro Catheter | ||
| TESTING | In-vitro performance testing of the MTI Titan™ Micro Catheter includeddimensional inspection, tensile strength tests, burst pressure tests, flow rate tests,torque tests and performance under simulated conditions. The accessoryMTI HD Injector underwent in-vitro performance testing including dimensionalinspection, injection rate, thread engagement, clip movement, needle detachment,integrity of attachment to Titan Micro Catheter, fit of piston in barrel and leakage.The biocompatibility of the MTI Titan™ Micro Catheter and accessoryMTI HD Injector was verified in accordance with ISO 10993-1, BiologicalEvaluation of Medical Devices. Test results confirmed biocompatibility of thecatheter and injector when tested as an external communicating, blood contact,limited exposure (<24 hrs) device. | ||
| SUMMARY OFSUBSTANTIALEQUIVALENCE | The MTI Titan™ Micro Catheter and the accessory HD Injector are substantiallyequivalent to the predicate devices in intended use and principles of operation. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2002
Micro Therapeutics, Inc. c/o Mr. Bill Hyatt 2 Goodyear Irvine, CA 92618
Re: K022003
MTI Titan™ Micro Catheter MTI HD Injector Regulation Number: 870.1340, 870.1650 Regulation Name: Catheter Introducer. Angiographic Injector and Syringe Regulatory Class: Class II (two) Product Code: DYB, DQF Dated: June 18, 2002 Received: June 19, 2002
Dear Mr. Hyatt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Mr. Bill Hyatt
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kela Tule
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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Micro Therapeutics, Inc.
Traditional 510(k) (modifications to K993672 and K011535) Titan™ Micro Catheter and MTI HD Injector Syringe June 18, 2002
Indications for Use Statement 6.
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
MTI Titan™ Micro Catheter MTI HD Injector
Indications for Use:
The Titan Micro Catheter is intended for the controlled selective infusion of physician-specified therapeutic agents or contrast media into the vasculature of the peripheral and neuro anatomy.
The MTI HD Injector is intended for the infusion of physicianspecified fluids with the MTI Titan™ Micro Catheter.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over the Counter Use__________ OR Prescription Use_ (Per 21 CFR 801.109) Division of Cardiova
510(k) Number
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).